ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ......

27
Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Martin M, Holmes FA, Ejlertsen B, et al, for the ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2017; published online Nov 13. http://dx.doi.org/10.1016/S1470- 2045(17)30717-9.

Transcript of ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ......

Page 1: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

Supplementary appendixThis appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors.

Supplement to: Martin M, Holmes FA, Ejlertsen B, et al, for the ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2017; published online Nov 13. http://dx.doi.org/10.1016/S1470-2045(17)30717-9.

Page 2: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

1

SUPPLEMENTARY APPENDIX

List of investigators and countries ................................................................................................................. ........ 2

Academic Steering Committee and Independent Data Monitoring Committee ............................................. ........ 4

Figure S1. Kaplan-Meier curves for distant disease-free survival in the intention-to-treat population ................... 5

Figure S2. Kaplan-Meier curves for invasive-free disease survival in the amended intention-to-treat population . 6

Figure S3. Kaplan-Meier curves for invasive-free disease survival at 2 years post-randomisation among

re-consented patients ............................................................................................................................................... 7

Figure S4. Kaplan-Meier curves for invasive-free disease survival according to time from completion of prior

adjuvant trastuzumab to randomisation ............................................................................................................... ... 8

Figure S5. Subgroup analysis of invasive disease-free survival in patients who had received prior trastuzumab

within 1 year of randomisation ................................................................................................................................ 9

Figure S6. Mean daily grade of diarrhoea over time in the safety population ....................................................... 10

Table S1. Baseline biomarker status (local laboratory) in the intention-to-treat population ............................... . 11

Table S2. Analysis of invasive disease-free survival at 2 years post-randomisation ........................................... . 12

Table S3. Incidence of unsolicited serious non-treatment-emergent adverse events in the safety population ...... 13

Table S4. Reasons for deaths (neratinib and placebo groups combined) ............................................................... 16

Table S5. Summary of study sites, principle investigators responsible for each site, and the number of patients

enrolled from each site .......................................................................................................................................... 17

Page 3: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

2

LIST OF INVESTIGATORS AND COUNTRIES

We would like to acknowledge the following investigators who also participated in this trial: Australia: D.

Campbell; A. Chan; J. Coward; R. De Boer; T. Healey; R. Hui; D. Kotasek; P. Mainwaring; W. Patterson; Bahamas:

T. Turnquest; Belgium: C. Andre; A. Bols; M. Borms; I. Deleu; R. D'Hondt; K. Geldhof; G. Jerusalem; S. Luce;

W. Lybaert; J. Mebis; C. Nouwynck; G. Pelgrims; V. Philippe; V. Richard; J-P. Salmon; J. Verschuere; P. Vroman;

Brazil: C. Barrios; Bulgaria: T. Koynova; V. Marinova-Venkova; P. Petrov; V. Popov; V. Taskova; C. Timcheva;

A. Tomova; Canada: J-P. Ayoub; J. Chang; S. Chia; F. Couture; C. Desbiens; B. Dingle; P. Dube; D. Grenier; D.

R. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; C. Luk; Y. Rahim; S. Sridhar; J. Wilson; R. Yasmin;

China: Z. Jiang; D-G. Liu; R. Luo; Z-Z. Shen; Q. Sun; Z-S. Tong; S. Wang; X. Wang; B. Xu; J. Yang; Colombia:

S. Franco; M. E. G. Fernandez; G. Rojas; Croatia: D. Gugic; D. Labudovic; R. Separovic; T. Silovski; R. Tomek;

Z. Vojnovic; D. Vrbanec; Czech Republic: O. Bednarik; V. Benesova; P. Garnolova; K. Petrakova; J. Prausova;

M. Smakal; J. Vanasek; Denmark: L. Adrian; A. Andreeva; B. J. Antonovic; B. Bjerregaard Jensen; S. Cold; B.

Ejlertsen; V. Glavicic; V. Haahr; E. Harder-Brix; E. H. Jakobsen; A. S. Knoop; D. Kristensen; S. Langkjer; A.

Luczak; P. Sørensen; S. Vallentin; P. Vestlev; S. Wahlstrom; France: J-P. Bergerat; E. Bourbouloux; P. Bougnoux;

L. Cany; D. Chocteau-Bouju; B. Coudert; V. Delacroix; S. Delaloge; T. Delozier; V. Dieras; M. Espie; L-M.

Dourthe; J-P. Jacquin; D. Khayat; C. Levy; D. Machover; A. Mailliez; D. Mayeur; M-A Mouret-Reynier; M.

Mousseau; J-M. Nabholtz; D. Pouessel; A. Samreen; C. Segura-Ojezzar; N. Trufflandier; L. Vanlemmens; C.

Veyret; Germany: R. Adrion; K. Apel; J. Barinoff; J. Bischoff; P. Bojko; R. E. Felberbaum; D. Fischer; S. Fries;

S. Fuxius; P. Garnolova; G. Graffunder; F. Griesinger; B. Grischke; J. Hackmann; E-M. L. Hanker; B. Heinrich; C.

Jackisch; W. Janni; J. Janssen; P. Klare; C-H. Koehne; M. Kusche; C. Liedtke; H-J. Lück; D. Mahmoud; N.

Marschner; V. Moebus; M. Neumann; R. Neumeister; T. Neunhoeffer; T. Noesselt; D. Ossenbühl; F. Overkamp;

A. Prechtl; B. Rack; R. Repp; M. Rezai; J. Schilling; M. Schmidt; B. Schnappauf; A. Schneeweiss; V. Schulz; I.

Schwaner; K. Schwedler; D. Seeger; H. Tesch; A. von der Assen; G. von Minckwitz; A-S. Vesper; A. Wolfgang;

Greece: G. Fountzilas; V. Georgoulias; S. Kakolyris; H. Kalofonos; D. Mavroudis; C. Papandreou; D. Pectasidis;

D. Pectasidis; I. Varthalitis; Hong Kong: L. Chow; J. W. Y. Chui; R. H-S. Liang; T-Y. Ng; W-H Tsang; T. C. C.

Yau; Hungary: M. Dank; Z. Faluhelyi; L. Hornyak; I. Láng; Z. Nagy; G. Pajkos; B. Pikó; Z. Pólya; E. Simo; É.

Somogyiné; Á. Wéber; Israel: K. Drumea; N. Efrat; D. Geffen; B. Kaufman; Italy: F. Angelini; S. Barni; P. Bidoli;

C. Buscarino; G. Cartenì; S. Cinieri; F. Cognetti; A. De Matteis; L. Dogliotti; M. Di Palma; C. Falci; A. Falcone;

T. Gamucci; D. Giuffrida; G. Gorzegno; C. Gridelli; A. Jirillo; R. Maisano; M. Nardi; F. Nuzzo; F. Roila; E.

Ruggeri; H. J. Soto Parra; P. Tassone; G. Tonini; Japan: K. Aogi; K. Higaki; M. Hirofumi; Y. Hozumi; H. Inaji;

K. Inoue; Y. Ito; M. Ishida; M. Ishitobi; H. Iwata; K. Katsumasa; S. J. Kim; K. Kuroi; N. Masuda; T. Miyaki; H.

Mukai; R. Nishimura; S. Ohno; S. Ohtani; Y. Rai; F. Sato; N. Sato; S. Shimizu; O. Shinji; T. Sugie; K. Taguchi; T.

Taguchi; M. Takahashi; S. Takao; M. Tanaka; Y. Tokuda; E. Tokunaga; T. Ueno; J. Watanabe; N. Yamamoto; H.

Yamashiro; Lithuania: A. Ciceniene; E. Juozaityte; Macedonia: S. Smichkoska; Malaysia: A. Z. Bustam; Malta:

S. Brincat; Mexico: B. Sanchez-Llamas; Netherlands: J. Braun; M. Dercksen; F. Erdkamp; J. B. Heijns; G. S.

Madretsma; J. E. A. Portielje; S. Radema; J. Ruit; A. Ten Tije; C. Van Groeningen; New Zealand: A. Bashford; V.

Harvey; Peru: V. Bermudez; Poland: R. Banas; E. Chmielowska; M. Czerniawska-Meler; L. Grzeda; J. Jassem; K.

Krzemieniecki; K. Lesniewski-Kmak; A. Piktel; M. Suszko-Kazarnowicz; W. Rogowski; T. Sarosiek; M.

Wojtukiewicz; K. Wozniak; Romania: A. Eniu; P. Iorga; D. Lungulescu; Serbia: S. Filipovic; Z. Neskovic-

Konstantinovic; Z. Tomasevic; Singapore: Y-S. Yap; Slovakia: M. Kakalejcik; M. Mikulova; S. Spanik; M.

Wagnerova; South Korea: Y. J. Choi; S-A. Im; Y-H. Im; S-B. Kim; K.S. Lee; I. H. Park; K. H. Park; J. S. Ro;

Spain: M.G. Alonso; M. Angel de la Cruz Mora; A. Arance; A. Arcusa; A. Avelia Mestre; J. Baena Canadá; N.

Batista Lopez; B. Bermejo de las Heras; J. C. Camara Toral; I. Calvo Plaza; J. Cassinello Espinosa; J. I. Chacon

Lopez-Muniz; B. Cirauqui; C. Crespo Massieu; R. Cubedo Cervera; J. R. De La Haba Rodriguez; S. del Barco

Berron; M. del Pilar Lopez Alvarez; J. R. Ferrer; J. Florian Gerico; J. García-Sáenz; S. González Jimenez; S.

Gonzalez Santiago; C. Jara Sanchez; M. Lomas-Garrido; M. Margeli Vila; M. Martin Jimenez; N.J. Martinez; E.

Martínez de Dueñas; P. Martinez del Prado; S. Morales; A. Murias-Rosales; A. Perello Martorell; S. Pernas Simón;

M. Ramos-Vázquez; A. Rodriguez Lescure; X. Rubio; M. Ruiz-Borrego; A. Ruiz Simon; A. Sanchez-Muñoz; C.

Saura Manich; B. G. Suarez; J. C. Toral-Pena; A. A. Torres; A. Urruticoechea Ribate; J. Valero Alvarez Gallego;

A. G. Zotano; Sweden: N. Loman; Switzerland: C. Clemens; W. Mingrone; R. Popescu; D. Rauch; Taiwan: K-J.

Chang; S-C. Chen; M-F. Hou; Y-S. Lu; Turkey: N. Alkis; S. Askoy; K. Altundag; G. Basaran; M. Benekli; S.

Buyukberber; A. Ciltas; T. Evrensel; E. Gokmen; M. Ozguroglu; P. Saip; A. Sevinc; I. Somali; S. Turhal; U. Yilmaz;

P. F. Yumuk; United Kingdom: H. Algurafi; A. Anand; D. Anderson; A. Armstrong; J. Barret; J. Bishop; I.

Boiangiu; A. D. Chetiyawarda; R. Coleman; J. Conibear; W. Ella; A. Harnett; S. Khan; J. Mansi; T. Perren; A.

Page 4: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

3

Robinson; M. J. Rolles; R. R. Roylance; A. Samreen; J. Stebbing; United States of America: R. Abbasi; J.

Abraham; C. A. Alemany; N. Alkhouri; R. Alexander; M. Ali; D. Anderson; I. Anderson; T. Anderson; S. Ban; S.

Baidas; R. Bajaj; P. Beatty; N. Belman; J. A. Berman; W. Berry; M. Bhandari; R. Birhiray; P. M. Blanchet; D.

Brandt; R. Bose; A. Bova; F. A. Brescia; D. Brooks; J. K. Burris; P. Byeff; H. Caldera; J. Call; G. Capo; R. R.

Carroll; M. Castine III; J. R. Caton Jr; M. Charif; J. Chien; J. J. Choate; Y. Choi; S. Chui; D. Citrin; M. Citron; B.

W. Clowney; M. Conde; W. Conkright; A. Conlin; T. Cosgriff; C. Croot; M. A. Danso; A. Dekker; A. Delmas; A.

DeMichele; N. Denduri; A. Desai; L. Dickerson; S. Di Sean Kendall; L. P. Dreibach; R. Droder; K. Edmiston; A.

Eiseman; D. Ellison; C. Encarnacion; J. Eneman; N. Erickson; D. Faig; L. Flaherty; M. R. Flores; P. Flynn; M.

Francisco; Y.A.R. Gaffar; E. Gartner; M. A. Ghraowi; G. F. Geils; R. Gordon; I. Gore; N. Green; R. Greenberg; A.

Greenspan; A. Gonzalez; M. Gonzalez; M. Gupta; P. J. Harris; B. B. Haley; S. Hallmeyer; V. Hansen; W. Harker;

B. Hellerstedt; C. Henderson; P. Hergenroeder; J. Hill; K. Hoelzer; V. Holden; F. A. Holmes; O. Howard; D.

Hufnagle; N. Iannotti; E. Ibrahim; R. Inhorn; K. Jabboury; K. Jain; S. Jain; C. Jani; R. Jaslow; M. C. Jones; K. S.

Lanier; B. Lozada; E. Kaplan; R. H. Kawanchi; M. Keaton; P. D. Kenyon; K. Kemmer; A. Khojasteh; H. Khurshid;

G. Kimmick; L. Klein; A. Kohn; L. R. Kong; P. Kovach; R. M. Kramer; A. Krie; K. Kubiak; M. Kubiak; J. W.

Leach; T. Lee; D. Lindquist; J. Link; J. Lucas; S-W. Luoh; C. Lynch; S. McCachren; R. McDonough; K. McIntyre;

M. McLaughlin; J. Mace; A. Mahmood; A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R.

Michaelson; B. Mirtsching; R. Mocharnuk; M. Monga; M. Morginstin; B. Moy; K. Nahum; S. Narula; B. Nguyen;

J. Nichols; T. Niederman; D. Nixon; Y. Novik; E. O’Brien; I. Okazaki; I. Oliff; I. Oliff; T. O'Rourke; G. Ortega; C.

Osborne; Y. Ottaviano; A. Padmanabhan; S. Papish; D. Patel; D. Patt; L. Pawl; A. S. Pierson; T. J. Pluard; M.

Porubcin; S. Prakash; F. Qazi; G. K. Rainey; T. Rakowski; R. Rao; V. Rao; M. Rarick; C. Reynolds; J. M. Rhee;

R. L. Rice; D. Richards; D. Riseberg; E. Rivera; R. Rivera; N. Robert; M. S. Roberts; E. L. Robin; G. Rodriguez;

E. J. Rupard; R. Ruxer; M. Salkeni; M. Saltzman; I. J. Sanchez-Rivera; S. Sawhney; L. Schlabach; W. G. Schmidt;

G. Schwartz; F. Senecal; S. Shah; L. Shinn; M. Shirinian; A. Sidrys; P. Silverman; D. H. Sikes; J. Smith II; J. Smith;

R. Somer; E. Spremulli; H. A. Steele; A. Stopeck; S. Swain; R. Swart; E. Tan; E. Tan-Chiu; C. K. Tin-U; D. Testori;

G. Thomas; A. Traynor; J. Trey; M. Tsai; A. Vasileios; M. Vaysburd; I. Vaziri; M. Venigalla; F. Volterra; N.

Vrindavanam; J. Wade; W. Wang; R. Weigand; P. Weinstein; P. Whitworth; M. Wilkinson; S. Wilks; S. Witherby;

I. Wiznitzer; K. R. Yanagihara; O. Yvonne; A. Zahalsky.

Page 5: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

4

ACADEMIC STEERING COMMITTEE

Carlos Barrios, MD (Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre, Brazil);

Arlene Chan, MD (Breast Cancer Research Centre-WA & Curtin University, Perth, Australia); Stephen Chia, MD

(BC Cancer Agency, Vancouver, BC, Canada); Suzette Delaloge, MD (Institut Gustave Roussy, Villejuif, France);

Bent Ejlertsen, MD (Rigshospitalet, Copenhagen, Denmark); Michael Gnant, MD (Department of Surgery and

Comprehensive Cancer Centre, Medical University of Vienna, Vienna, Austria); Frankie Ann Holmes, MD (Texas

Oncology, P.A., Houston, TX, USA); James Ingle*; Hiroji Iwata, MD (Aichi Cancer Center, Chikusa-ku, Nagoya,

Japan); Janine Mansi, MD (Guy's Hospital, London, BRC, King's College, London, United Kingdom); Miguel

Martin, MD (Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense de Madrid, Madrid,

Spain); Beverly Moy, MD (Massachusetts General Hospital Cancer Center, Boston, MA, USA); Gunter von

Minckwitz, MD (Luisenkrankenhaus, German Breast Group Forschungs GmbH, Düsseldorf, Neu-lsenburg,

Germany); Marc Buyse, ScD (International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium).

*Original ASC only.

INDEPENDENT DATA MONITORING COMMITTEE

Joanne Mortimer, MD (City of Hope, CA, USA); Mohammad Jahanzeb, MD (University of Miami, FL, USA); Jack

di Palma, MD (USA Gastroenterology, Mobile, AL, USA); Kendra Schmid, PhD (University of Nebraska Medical

Center, NE, USA).

Page 6: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

5

Figure S1. Kaplan-Meier curves for distant disease-free survival in the intention-to-treat population

Page 7: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

6

Figure S2. Kaplan-Meier curves for invasive-free disease survival in the amended intention-to-treat

population

Amended intention-to-treat population defined as all patients with node-positive disease and randomised within 1

year of completion of prior trastuzumab therapy.

Page 8: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

7

Figure S3. Kaplan-Meier curves for invasive-free disease survival at 2 years post-randomisation among

re-consented patients

Page 9: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

8

Figure S4. Kaplan-Meier curves for invasive disease-free survival according to time from completion of prior

adjuvant trastuzumab to randomisation, showing patients who had received prior trastuzumab within 1 year

of randomisation (A) and patients who had received prior trastuzumab more than 1 year before

randomisation (B)

Page 10: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

9

Figure S5. Subgroup analysis of invasive disease-free survival in patients who had received prior trastuzumab

within 1 year of randomisation

*Stratification factor. The dashed line indicates a hazard ratio of 1.0, the null hypothesis value.

Page 11: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

10

Figure S6. Mean daily grade of diarrhoea over time in the safety population

NCI CTC, National Cancer Institute Common Terminology Criteria, version 3·0.

Page 12: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

11

Table S1. Baseline biomarker status (local laboratory) in the intention-to-treat population

Neratinib

(N=1420)

Placebo

(N=1420)

Total

(N=2840)

ER/PR receptor status, n (%)

ER+/PR+ 574 (40·4) 560 (39·4) 1134 (39·9)

ER+/ER– 173 (12·2) 195 (13·7) 368 (13·0)

ER–/PR+ 54 (3·8) 49 (3·5) 103 (3·6)

ER+/PR unknown 17 (1·2) 16 (1·1) 33 (1·2)

ER unknown/PR+ 0 1 (0·1) 1 (0·0)

ER–/PR unknown 1 (0·1) 0 1 (0·0)

ER–/PR– 601 (42·3) 599 (42·2) 1200 (42·3)

ER = oestrogen receptor; PR = progesterone receptor.

Page 13: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

12

Table S2. Analyses of invasive disease-free survival at 2 years post-randomisation

Population Estimated invasive disease-free survival rate

at 2 years (95% CI), %

Hazard ratio

(95% CI)

P value†

Neratinib

(n=1420)

Placebo

(n=1420)

Intention-to-treat 94·3

(92·9‒95·4)

91·7

(90·1‒93·1)

0·68

(0·51‒0·91)*

0·009*

Amended intention-to-treat‡ 93·1

(91·2‒94·6)

89·9

(87·8‒91·7)

0·67

(0·48‒0·93)

0·016

CI = confidence interval.

* Stratified by randomisation factors.

† Two-sided log-rank test.

‡ Defined as all patients with node-positive disease and randomised within 1 year of completion of prior

trastuzumab therapy.

Page 14: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

13

Table S3. Incidence of unsolicited serious non–treatment-emergent adverse events in the safety population*

Neratinib

(n=1408)

Placebo

(n=1408)

Any adverse event 62 (4·4) 72 (5·1)

Cellulitis 3 (0·2) 4 (0·3)

Acute myocardial infarction 2 (0·1) 1 (0·1)

Adenocarcinoma of colon 2 (0·1) 2 (0·1)

Diarrhoea 2 (0·1) 0 (0·0)

Lumbar vertebral fracture 2 (0·1) 0 (0·0)

Lung neoplasm malignant 2 (0·1) 0 (0·0)

Pyelonephritis 2 (0·1) 0 (0·0)

Rectal cancer 2 (0·1) 0 (0·0)

Syncope 2 (0·1) 0 (0·0)

Abdominal hernia 1 (0·1) 0 (0·0)

Abdominal pain 1 (0·1) 1 (0·1)

Acute kidney injury 1 (0·1) 0 (0·0)

Adenocarcinoma 1 (0·1) 0 (0·0)

Arthritis 1 (0·1) 1 (0·1)

Arthritis bacterial 1 (0·1) 0 (0·0)

Back pain 1 (0·1) 0 (0·0)

Bladder cancer 1 (0·1) 0 (0·0)

Cardiac arrest 1 (0·1) 0 (0·0)

Cardio-respiratory arrest 1 (0·1) 1 (0·1)

Cerebral infarction 1 (0·1) 0 (0·0)

Cerebrovascular accident 1 (0·1) 2 (0·1)

Cholecystitis 1 (0·1) 1 (0·1)

Cholelithiasis 1 (0·1) 0 (0·0)

Chronic obstructive pulmonary disease 1 (0·1) 1 (0·1)

Colitis 1 (0·1) 1 (0·1)

Colon cancer 1 (0·1) 1 (0·1)

Colon cancer metastatic 1 (0·1) 1 (0·1)

Completed suicide 1 (0·1) 0 (0·0)

Condition aggravated 1 (0·1) 1 (0·1)

Dehydration 1 (0·1) 0 (0·0)

Device related infection 1 (0·1) 1 (0·1)

Dyspnoea 1 (0·1) 0 (0·0)

Encephalitis autoimmune 1 (0·1) 0 (0·0)

End stage renal disease 1 (0·1) 0 (0·0)

Endometrial adenocarcinoma 1 (0·1) 0 (0·0)

Endometrial cancer 1 (0·1) 1 (0·1)

Endometriosis 1 (0·1) 0 (0·0)

Erysipelas 1 (0·1) 1 (0·1)

Febrile neutropenia 1 (0·1) 0 (0·0)

Femur fracture 1 (0·1) 1 (0·1)

Gastrointestinal haemorrhage 1 (0·1) 1 (0·1)

Hiatus hernia 1 (0·1) 0 (0·0)

Humerus fracture 1 (0·1) 0 (0·0)

Continued next page

Page 15: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

14

Neratinib

(N=1408)

Placebo

(N=1408)

Hypokalaemia 1 (0·1) 0 (0·0)

Hysterectomy 1 (0·1) 0 (0·0)

Infection 1 (0·1) 1 (0·1)

Intervertebral disc degeneration 1 (0·1) 0 (0·0)

Jugular vein thrombosis 1 (0·1) 0 (0·0)

Lipoma of breast 1 (0·1) 0 (0·0)

Lower limb fracture 1 (0·1) 0 (0·0)

Lung adenocarcinoma stage IV 1 (0·1) 0 (0·0)

Lung infection 1 (0·1) 0 (0·0)

Mastectomy 1 (0·1) 0 (0·0)

Non-cardiac chest pain 1 (0·1) 1 (0·1)

Osteomyelitis 1 (0·1) 0 (0·0)

Pleural effusion 1 (0·1) 1 (0·1)

Pneumonia 1 (0·1) 2 (0·1)

Pneumonia legionella 1 (0·1) 0 (0·0)

Postoperative fever 1 (0·1) 0 (0·0)

Respiratory arrest 1 (0·1) 0 (0·0)

Respiratory failure 1 (0·1) 0 (0·0)

Salivary gland adenoma 1 (0·1) 0 (0·0)

Sepsis 1 (0·1) 1 (0·1)

Seroma 1 (0·1) 0 (0·0)

Small cell lung cancer metastatic 1 (0·1) 0 (0·0)

Spindle cell sarcoma 1 (0·1) 0 (0·0)

Subdural haematoma 1 (0·1) 0 (0·0)

Thyroid cancer 1 (0·1) 0 (0·0)

Upper respiratory tract infection 1 (0·1) 0 (0·0)

Abscess limb 0 (0·0) 1 (0·1)

Ankle fracture 0 (0·0) 1 (0·1)

Appendicitis 0 (0·0) 2 (0·1)

Asthma 0 (0·0) 1 (0·1)

Cachexia 0 (0·0) 1 (0·1)

Cardiac disorder 0 (0·0) 1 (0·1)

Cardiac failure 0 (0·0) 1 (0·1)

Cardiogenic shock 0 (0·0) 1 (0·1)

Cerebral ischaemia 0 (0·0) 1 (0·1)

Chest pain 0 (0·0) 1 (0·1)

Cholecystitis acute 0 (0·0) 1 (0·1)

Clostridium difficile colitis 0 (0·0) 1 (0·1)

Compression fracture 0 (0·0) 1 (0·1)

Deep vein thrombosis 0 (0·0) 1 (0·1)

Diffuse large B-cell lymphoma 0 (0·0) 1 (0·1)

Fallopian tube cancer 0 (0·0) 1 (0·1)

Gastric operation 0 (0·0) 1 (0·1)

Headache 0 (0·0) 1 (0·1)

Hepatic failure 0 (0·0) 1 (0·1)

Hepatorenal syndrome 0 (0·0) 1 (0·1)

Hypercalcaemia 0 (0·0) 1 (0·1)

Continued next page

Page 16: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

15

Neratinib

(N=1408)

Placebo

(N=1408)

Hypersensitivity 0 (0·0) 1 (0·1)

Hypertriglyceridaemia 0 (0·0) 1 (0·1)

Infectious colitis 0 (0·0) 1 (0·1)

Knee arthroplasty 0 (0·0) 2 (0·1)

Knee operation 0 (0·0) 1 (0·1)

Lumbar radiculopathy 0 (0·0) 1 (0·1)

Malignant melanoma 0 (0·0) 1 (0·1)

Medication error 0 (0·0) 1 (0·1)

Myocardial infarction 0 (0·0) 1 (0·1)

Neoplasm 0 (0·0) 1 (0·1)

Neoplasm malignant 0 (0·0) 2 (0·1)

Osteoarthritis 0 (0·0) 1 (0·1)

Osteochondrosis 0 (0·0) 1 (0·1)

Ovarian cancer 0 (0·0) 1 (0·1)

Ovarian cyst 0 (0·0) 2 (0·1)

Papillary thyroid cancer 0 (0·0) 1 (0·1)

Paraplegia 0 (0·0) 1 (0·1)

Pneumonitis 0 (0·0) 1 (0·1)

Pneumothorax 0 (0·0) 1 (0·1)

Pulmonary embolism 0 (0·0) 1 (0·1)

Radiculopathy 0 (0·0) 1 (0·1)

Radius fracture 0 (0·0) 1 (0·1)

Renal cell carcinoma 0 (0·0) 1 (0·1)

Retinal artery occlusion 0 (0·0) 1 (0·1)

Sarcoma uterus 0 (0·0) 1 (0·1)

Septic shock 0 (0·0) 1 (0·1)

Spinal laminectomy 0 (0·0) 1 (0·1)

Spinal osteoarthritis 0 (0·0) 1 (0·1)

Tachycardia 0 (0·0) 1 (0·1)

Tibia fracture 0 (0·0) 2 (0·1)

Transient global amnesia 0 (0·0) 1 (0·1)

Transient ischaemic attack 0 (0·0) 1 (0·1)

Uterine leiomyoma 0 (0·0) 1 (0·1)

Vestibular disorder 0 (0·0) 1 (0·1)

Wound dehiscence 0 (0·0) 1 (0·1)

* Events reported after the last dose of study treatment plus 28 days until June 23, 2017. Safety population

defined as all patients who received at least one dose of study treatment.

Page 17: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

16

Table S4. Reasons for deaths (neratinib and placebo groups combined)

Reason N

Disease progression 102

Unknown 8

Acute or chronic respiratory failure and multiple organ failure secondary to congestive

heart failure decompensation, gastrointestinal bleeding, and anaemia

1

Metastatic small cell lung cancer 1

Acute myeloid leukaemia 1

Gastric cancer 1

Brain cancer (second unrelated primary) 1

Heart defect 1

Respiratory failure 1

Suicide 1

Brain haemorrhage 1

Myocardial infarction 1

Autoimmune encephalitis, pneumonia, and cerebrovascular disease 1

Total 121

Deaths reported as of March 1, 2017.

Page 18: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

17

Table S5. Summary of study sites, principle investigators responsible for each site, and the number of

patients enrolled from each site

Principle investigator(s) Investigational site Country Patients

randomised, n

Arlene Chan Mount Hospital, Perth Australia 46

Vernon Harvey; Anna Bashford Auckland Hospital, Auckland New Zealand 31

Robert Separovic; Rudolf Tomek Klinika Za Tumore, Zagreb Croatia 29

Erhan Gokmen Ege University, Izmir Turkey 29

Nicholas J. Robert; Neelima Denduri Virginia Cancer Specialists, Fairfax USA 29

Ira Gore Jr. Alabama Oncology, Birmingham USA 26

Suzette Delaloge Institut Gustave Roussy, Villejuif France 25

John W. Smith II Northwest Cancer Specialists, PC, Vancouver USA 25

Norikazu Masuda National Hospital Organization Osaka National

Hospital, Osaka Japan 23

S. Di Sean Kendall; William Graydon

Harker Utah Cancer Specialists, Utah USA 23

Katarina Petrakova Masarykuv Onkologicky ustav, Brno Czech Republic 22

Amparo Ruiz Simon; Angel Guerrero

Zotano Instituto Valenciano de Oncologia, Valencia Spain 22

Zorica Tomasevic; Zora Neskovic Konstantinovic

Institute of Oncology and Radiology of Serbia, Belgrade

Serbia 22

Nicholas O. Iannotti Hematology Oncology Associates of Treasure Coast, Port Saint Lucie

USA 21

Erik Hugger Jakobsen Vejle Sygehus, Velje Denmark 20

Pierfrancesco Tassone Tommaso Campanella Cancer Center, Catanzaro Italy 20

Gladys I. Rodriguez South Texas Oncology and Hematology, San Antonio USA 20

Anil Abrahma Joy Cross Cancer Institute, Edmonton Canada 19

Noelia Jáñez Martinez; Carmen Crespo

Massieu Hospital Universitario Ramon y Cajal, Madrid Spain 19

Sung-Bae Kim Asan Medical Center, Seoul Korea 19

Snezana Smickoska University Clinic for Radiotherapy and Oncology,

Skopje Macedonia 19

Isil Somali; Ugur Yilmaz Dokuz Eylul Universitesi Tip Fakultesi, Izmir Turkey 19

Friedrich Overkamp Oncologianova GmbH, Recklinghausen Germany 18

Mirta Garcia Alonso; Adolfo Murias Rosales

Compejo Hospitalario Materno Insular de Las Palmas Spain 18

Audrone Ciceniene Oncology Institute of Vilnius University, Vilnius Lithuania 18

Soeren Cold; Ann Soegaard Knoop Odense University Hospital, Odense Denmark 17

Beth A. Hellerstedt; Debra Patt Texas Oncology, PA, Austin USA 17

Serafin Morales Murillo Hospital Universitari Arnau de Vilanova de Lleida, Lleida

Spain 16

John S. Link Breastlink Medical Group Inc, Long Beach USA 16

Ingrid A. Mayer; Julie Ann Means-Powell

Vanderbilt-Ingram Cancer Center, Nashville USA 16

Rina Hui Sydney West Cancer Trials Centre, Westmead Australia 15

Manuel Ruiz Borrego Hospital Universitario Virgen del Rocio, Sevilla Spain 15

Miguel Martin Jimenez Hospital General Universitario Gregorio Maranon,

Madrid Spain 15

Kenichi Inoue Saitama Cancer Center, Saitama Japan 15

Francis M. Senecal Northwest Medical Specialties PLLC, Tacoma USA 15

Richard Hendry De Boer Royal Melbourne Hospital, Melbourne Australia 14

Zhenzhou Shen Fudan University Cancer Hospital, Shanghai China 14

Adam Andrzej Luczak Aalborg Sygehus, Aalborg Denmark 14

Anne Armstrong Christie Hospital, Manchester UK 14

Janice Wing-hang Tsang; Joanna W.Y.

Chui Queen Mary Hospital, Hong Kong Hong Kong 14

Istvan Lang Orszagos Onkologiai Intezet "B" Belgyogyaszati

osztaly, Budapest Hungary 14

Yoshiaki Rai Hakuaikai Medical Corporation Sagara Hospital, Kagoshima

Japan 14

Yasuo Hozumi Jichi Medical University Hospital, Tochigi Japan 14

Albert J. Ten Tije Amphia Ziekenhuis, Breda Netherlands 14

Manish Bhandari Christ Hospital of Cincinnati, Cincinnati USA 14

Cynthia R.C. Osborne Texas Oncology, PA, Dallas USA 14

Shoichiro Ohtani; Kenji Higaki Hiroshima City Hospital, Hiroshima Japan 13

Page 19: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

18

Principle investigator(s) Investigational site Country Patients

randomised, n

Kenichi Watanabe; Kazunori Taguchi;

Masato Takahashi

National Hospital Organization Hokkaido Cancer

Center, Hokkaido Japan 13

Sladjana Filipovic Clinical Centre Nis, Nis Serbia 13

Vincent L. Hansen North Utah Associates, Ogden USA 13

Beverly Moy Dana Farber Cancer Institute, Boston USA 13

Vijayarama Phooshkooru Rao Mid Dakota Clinic PC, Bismarck USA 13

Manish Gupta Texas Oncology, PA, Garland USA 13

Petar Petrov District Dispensary for Oncology Diseases Internal Unit, Plovdiv

Bulgaria 12

Bruno Coudert Centre Georges Francois Leclerc, Dijon France 12

Zeljko Vojnovic General Hospital Varazdin, Varazdin Croatia 12

Zsofia Polya Jósa András Oktatókórház Egészségügyi Szolgáltató,

Nyiregyhaza Hungary 12

Naohito Yamamoto; Toshiko Miyaki Chiba Cancer Center, Chiba Japan 12

Stephen Brincat Sir Paul Boffa Hospital, Floriana Malta 12

Krzysztof Lesniewski-Kmak Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow

Poland 12

Ewa Chmielowska Centrum Onkologii im. Prof. Franciszka, Bydgoszcz Poland 12

Ruemu E. Birhiray Hematology Oncology of Indiana, Indianapolis USA 12

Marc L. Citron ProHealth Care Associates, Lake Success USA 12

Steven William Papish Hematology and Oncology Associates of Northern New Jersey, Morristown

USA 12

William R. Berry Raleigh Hematology Oncology Associates, PC,

Raleigh USA 12

Sven Tyge Langkjer Aarhus University Hospital, Aarhus Denmark 11

Jose Angel Garcia Saenz Hospital Clinico San Carlos, Madrid Spain 11

Ana Maria Arance Hospital Clinic i Provincial de Barcelona, Barcelona Spain 11

Noa Efrat Kaplan Medical Center, Rehovot Israel 11

Tomasz Sarosiek; Lukasz Grzeda Centrum Medyczne Ostrobramska Niepubliczny,

Warsaw Poland 11

Yvonne Manalo Coastal Bend Cancer Center, Corpus Christi USA 11

Julie C. Smith Wenatchee Valley Medical Center, Wenatchee USA 11

Irfan Vaziri Great Plains Regional Medical Center, North Platte USA 11

Beverly Moy Massachusetts General Hospital, Boston USA 11

Tabitha Healey North Adelaide Oncology, North Adelaide Australia 10

Yasmin Rahim; Cynthia Luk Southlake Regional Health Centre, Newmarket Canada 10

Brian Dingle London Regional Cancer Program, London Canada 10

Sandra Franco Administradora Country SA, Bogota Colombia 10

Peter Grundtvig Sorensen Herlev Hospital, Herlev Denmark 10

Anjana Anand; Sarah Khan Nottingham City Hospital, Nottingham UK 10

George Fountzilas Papageorgiou General Peripheral Hospital of

Thessaloniki, Thessaloniki Greece 10

Kenjiro Aogi National Hospital Organization Shikoku Cancer

Center, Ehime Japan 10

Satoru Shimizu Kanagawa Cancer Center, Kanagawa Japan 10

Stanislav Spanik; Milada Mikulova Interna onkologicka klinika, Bratislava Slovakia 10

Robert A. Somer Cooper University Hospital, Voorhees USA 10

Patrick J. Flynn Minnesota Oncology Hematology, PA, Minneapolis USA 10

Paul Mainwaring; Jermaine Coward Mater Adult Hospital, South Brisbane Australia 9

Guy Jerusalem Centre Hospitalier Universitaire de Liege, Liege Belgium 9

Bent Ejlertsen Rigshospitalet, Copenhagen Denmark 9

Carine Segura-Ojezzar; Christelle Levy; Thierry Delozier

Centre Francois Baclesse, Caen France 9

David Khayat Hopital Pitie-Salpetriere, Paris France 9

Robert E. Coleman Weston Park Hospital, Sheffield UK 9

Martin J. Rolles Singleton Hospital, Swansea UK 9

Janine Mansi Guy's Hospital, London UK 9

Robert Maisano; Mario Nardi Azienda Opsedaliera Bianchi Melacrino Morelli,

Reggio Calabria Italy 9

Yoshinori Ito Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo

Japan 9

Perran Fulden Yumuk; Gul Basaran;

Nazim Serdar Turhal Marmara University, Istanbul Turkey 9

Mary J. Wilkinson Medical Oncology & Hematology Associates of

Northern Virginia, Fairfax USA 9

Page 20: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

19

Principle investigator(s) Investigational site Country Patients

randomised, n

Nathan B. Green Southeast Nebraska Hematology & Oncology

Consultants, PC, Lincoln USA 9

Algis P. Sidrys Cookeville Regional Cancer Center, Cookeville USA 9

Sigrun Hallmeyer Oncology Specialists, SC, Park Ridge USA 9

Douglas J. Testori Hanover Medical Specialists, PA, Wilmington USA 9

Srikala Sridhar Princess Margaret Hospital, Toronto Canada 8

Jose Chang Lakeridge Health Oshawa, Oshawa Canada 8

Qiang Sun Peking Union Medical College Hospital, Beijing China 8

Carlos Jara Sanchez; Xabier Rubio Hospital Universitario Fundacion de Alcorcon,

Madrid Spain 8

Maria Lomas Garrido Complejo Hospitalario de Jaen, Jaan Spain 8

Juan Rafael De La Haba Rodriguez Hospital Universitario Reina Sofia, Cordoba Spain 8

Antoni Avelia Mestre; Julio Rifa Ferrer; Antonia Perello Martorell

Hospital Universitario Son Espases, Palma de Mallorca

Spain 8

Sonia del Barco Berron ICO de Girona - Hospital Universitario de Girona Dr.

Josep Trueta, Girona Spain 8

Zsuzsanna Nagy Fovarosi Onkormanyzat Szent Imre Korhaz,

Budapest Hungary 8

Maki Tanaka Kurume Daiichi Social Insurance Hospital, Fukuoka Japan 8

Young-Hyuck Im Samsung Medical Center, Seoul Korea 8

Robert R. Carroll; Laura C. Dickerson Florida Cancer Specialists & Research Institute,

Gainesville USA 8

Joseph R. Mace Gulfcoast Oncology Associates, St Petersburg USA 8

Ragene Rivera El Paso Cancer Treatment Center - West, El Paso USA 8

Leonard M. Klein Cancer Care & Hematology Specialists of

Chicagoland, Niles USA 8

Robert Ruxer Texas Oncology PA, Fort Worth USA 8

Sharon T. Wilks Cancer Care Centers of South Texas, San Antonio USA 8

Dusan Kotasek Adelaide Cancer Centre Research, Adelaide Australia 7

Violina Taskova; Vasil Popov Interdistrict Dispensary for Oncology Diseases,

Varna Bulgaria 7

Constanta Timcheva; Violetka Marinova-Venkova

Specialised Hospital of Active Treatment in Oncology, Sofia

Bulgaria 7

Christine Desbiens Centre Hospitalier Affilie Universitaire de Quebec,

Qubec Canada 7

Jean-Pierre Ayoub CHUM Hôpital Notre-Dame, Montreal Canada 7

Debjani Grenier CancerCare Manitoba, Winnipeg Canada 7

Norbert Marschner Praxis für interdisziplinaere Onkologie & Haematologie GbR, Freiburg

Germany 7

Hans Tesch Onkologische Gemeinschaftspraxis Frankfurt,

Frankfurt am Main Germany 7

Hans-Joachim Lueck Fachpraxis fuer Frauenheilkunde, Hannover Germany 7

Jan Janssen Gemeinschaftspraxis fuer Haematologie und

Onkologie, Westerstede Germany 7

Ingo Schwaner Onkologische Schwerpunktpraxis, Berlin Germany 7

Eva Harder Brix; Stine Wahlstrom Hillerod Hospital, Hillerod Denmark 7

Susanne Vallentin; Dan Kristensen;

Anna Andreeva; Vesna Glavicic Næstved Sygehus, Onkologisk Afdeling, Næstved Denmark 7

Isabel Calvo Plaza Hospital de Madrid Norte-Sanchinarro, Madrid Spain 7

Antonio Anton Torres Hospital Universitario Miguel Servet, Zaragoza Spain 7

Corinne Veyret Centre Henri Becquerel, Rouen France 7

Jean-Pierre Bergerat Centre Hospitalier Universitaire Strasbourg,

Strasbourg France 7

Emmanuelle Bourbouloux Centre Rene Gauducheau, Saint-Herblain France 7

Wendy Ann Ella; Hafiz Algurafi; Anne

Robinson Southend University Hospital, Westcliffe-on-Sea UK 7

Hiroji Iwata Aichi Cancer Center, Nagoya Japan 7

Seung Jin Kim; Tetsuya Taguchi Osaka University Hospital, Osaka Japan 7

Elona Juozaityte Kaunas University of Medicine Hospital, Kaunas Lithuania 7

Stanley Madretsma; Sandra Radema Gelre ZH, Apeldoorn Netherlands 7

Wojciech Rogowski; Malgorzata

Czerniawska-Meler

Zaklad Opieki Zdrowotnej MSWiA z Warminsko,

Olsztyn Poland 7

Maria Wagnerova Oddelenie radioterapie a onkologie, Kosice Slovakia 7

Donald A. Richards Texas Oncology, PA, Tyler USA 7

Elizabeth Tan-Chiu Florida Cancer Research Institute, Plantation USA 7

Page 21: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

20

Principle investigator(s) Investigational site Country Patients

randomised, n

Charles Arthur Henderson; Asskikis

Vasileios

Peachtree Hematology Oncology Consultants, PC,

Atlanta USA 7

Viran Roger Holden St. John's Medical Research Institute Inc, Springfield USA 7

Xiaojia Wang Zhejiang Cancer Hospital, Hangzhou China 6

Zhongsheng Tong Tianjin Cancer Hospital, Tianjin China 6

Junlan Yang Chinese People's Liberation Army General Hospital, Beijing

China 6

Manuel Enrique Gonzalez Oncomedica SA IMAT, Cordoba Colombia 6

Gunter von Minckwitz; Mahdi Rezai Luisenkrankenhaus, Duesseldorf Germany 6

John Hackmann Marienhospital Witten, Witten Germany 6

Eduardo Martinez de Dueñas Consorcio Hospitalario Provincial de Castellon, Castellon

Spain 6

Begoña Bermejo de las Heras Hospital Clinico Universitario de Valencia, Valencia Spain 6

Louis Marie Dourthe Clinique Sainte Anne, Strasbourg France 6

Philippe Bougnoux; Dorothee Chocteau-

Bouju Centre Hospitalier Universitaire Bretonneau, Tours France 6

Stylianos Kakolyris University Hospital of Alexandroupoli,

Alexandroupoli Greece 6

Haralabos Kalofonos University General Hospital of Patras, Patras Greece 6

Dimitrios Pectasidis University General Hospital "ATTIKON", Athens Greece 6

Ting Ying Ng Tuen Mun Hospital, Hong Kong Hong Kong 6

Gabor Pajkos Bacs-Kiskun Megyei Korhaz, Onkoradiologiai kozpont, Kecskemet

Hungary 6

Eva Ezer Somogyine Kaposi Mor Oktato Korhaz, Kaposvar Hungary 6

Giuseppe Tonini Universita Campus Bio-Medico, Rome Italy 6

Dario Giuffrida Istituto Oncologico del Mediterraneo, Viagrande Italy 6

Shintaro Takao Hyogo Cancer Center, Hyogo Japan 6

Makoto Ishitobi; Hideo Inaji Osaka Medical Center for Cancer and Cardiovascular

Diseases, Osaka Japan 6

Yutaka Tokuda Tokai University Hospital, Kanagawa Japan 6

Katarzyna Wozniak Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Szpital Wojewodzki Oddzial, Jelenia Gora Poland 6

Dan Lungulescu SC Oncolab SRL, Dolj Romania 6

Yen-Shen Lu; King-Jen Chang National Taiwan University Hospital, Taipei Taiwan 6

Christopher Charles Croot; Julian Hill North Mississippi Hematology and Oncology Associates, Ltd, Tupelo

USA 6

Albert Dekker Facey Medical Foundation, Mission Hills USA 6

Neil D. Belman Oncology-Hematology of Lehigh Valley, PC,

Bethlehem USA 6

Richard A. Michaelson; Miguel Conde Saint Barnabas Medical Center, Livingston USA 6

Kathleen Kemmer; Stephen Chui;

Shiuh-Wen Luoh

Oregon Health and Science University, Cancer

Institute, Portland USA 6

Kenneth Nahum Jersey Shore University Medical Center, Neptune USA 6

Frankie Ann Holmes Texas Oncology, PA, Houston USA 6

Andrew R. Greenspan Central Indiana Cancer Centers, Indianapolis USA 6

Joni C. Nichols Cancer Care Northwest-North, Spokane USA 6

Carlos A. Encarnacion Texas Oncology, PA, Waco USA 6

Thomas M.J. Niederman University Cancer Institute, LLC USA 6

Roland Alexander; Robert Gordon;

Theresa Lee

PinnacleHealth Hematology Oncology Associates,

Harrisburg USA 6

Antoanet Tomova District Dispensary for Oncology Diseases Internal Unit, Plovdiv

Bulgaria 5

Daniel Rauch Spital STS AG, Thun Switzerland 5

Razvan Andrei Popescu Hirslanden Medical Center, Aarau Switzerland 5

Gustavo Adolfo Rojas Oncologos del Occidente, Pereira Colombia 5

Jaroslav Vanasek Pardubicka Krajska Nemocnice, Pardubice Czech Republic 5

Tanja Neunhoeffer; Jana Barinoff Dr. Horst Schmidt Klinik GmbH, Wiesbaden Germany 5

Gerd Graffunder Frauenarzt-Zentrum-Zehlendorf, Berlin Germany 5

Peter Bojko; Abenhardt Wolfgang Fachpraxis fuer Innere Medizin

Elisenhof, Muenchen Germany 5

Bernhard Heinrich Onkologische Praxis, Augsburg Germany 5

Albert von der Assen Niels-Stensen-Kliniken, Georgsmarienhuette Germany 5

Lene Adrian; Bogovic Jurij Antonovic Onkologisk Ambulatorium, Sonerborg Denmark 5

Manuel Ramos Vazquez Centro Oncologico de Galicia, A Coruna Spain 5

Santiago Gonzalez Santiago Hospital San Pedro de Alcantara, Caceres Spain 5

Page 22: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

21

Principle investigator(s) Investigational site Country Patients

randomised, n

Veronique Dieras Institut Curie, Paris France 5

Jill Mercia Bishop North West Cancer Treatment Centre, Bodelwydan UK 5

Timothy John Perren St James's University Hospital, Leeds UK 5

Ioannis Varthalitis General Hospital of Chania Ag. Georgios, Chania Greece 5

Vassilis Georgoulias; Dimitris

Mavroudis University Hospital of Heraklion, Heraklion Greece 5

Louis W. C. Chow UNIMED Medical Institute, Hong Kong Hong Kong 5

Chung Cheung Thomas Yau; Raymond Hin-Suen Liang

Queen Mary Hospital, Hong Kong Hong Kong 5

Bela Piko Bekes Megyei Pandy Kalman Korhaz, Gyula Hungary 5

Agnes Weber Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi, Miskolc

Hungary 5

Bella Kaufman Sheba Medical Center, Tel Hashomer Israel 5

Karen Drumea Rambam Health Care Campus, Haifa Israel 5

Andrea De Matteis; Francesco Nuzzo Fondazione Giovanni Pascale Istituto Nazionale per

lo Studio e la Cura dei Tumori, Napoli Italy 5

Giacomo Carteni Azienda Ospedaliera Cardarelli, Napoli Italy 5

Shinji Ohno; Mayumi Ishida; Eriko

Tokunaga

National Hospital Organization Kyushu Cancer

Center, Kukouka Japan 5

Nobuaki Sato Niigata Cancer Center Hospital, Niigata Japan 5

Katsumasa Kuroi Tokyo Metropolitan Cancer & Infectious Disease

Center, Tokyo Japan 5

Reiki Nishimura Kumamoto Municipal Hospital, Kumamoto Japan 5

Junichiro Watanabe Shizuoka Cancer Center, Shizuoka Japan 5

Yoon Ji Choi; Kyong Hwa Park Korea University Medical Center, Seoul Korea 5

Marek Wojtukiewicz Bialostockie Centrum Onkologii im. M.

Sklodowskiej-Curie w Bialymstoku, Bialystok Poland 5

Jacek Jassem Uniwersyteckie Centrum Kliniczne, Gdansk Poland 5

Niklas Loman Skånes Universitetssjukhus Malmö, Lund Sweden 5

Mustafa Kadri Altundag; Sercan Aksoy Hacettepe University, Sihhiye/Ankara Turkey 5

Pinar Saip Istanbul University, Instanbul Turkey 5

Muhammad Amjad Ali Quincy Medical Group, Quincy USA 5

James Lloyd Wade III Decatur Memorial Hospital, Decatur USA 5

(Amy) Jo Chien University of California San Francisco, San Francisco USA 5

Debra Brandt Northwestern Connecticut Oncology and Hematology

Associates, Torrington USA 5

Yelena Novik NYU Clinical Cancer Center, New York USA 5

Chirag Jani Phoebe Cancer Center, Albany USA 5

Robert L. Rice; Yousuf A. Gaffar Alliance Hematology Oncology PA, Westminster USA 5

Mark R. Keaton Augusta Oncology Associates PC, Augusta USA 5

Rajesh Bajaj McLeod Oncology and Hematology Associates,

Florence USA 5

Gretchen Kimmick Duke University Medical Center, Durham USA 5

David Campbell; Richard Hendry De

Boer Western Hospital, Melbourne Australia 4

Theodore Turnquest Affinity Research Limited, Nassau Bahamas 4

Pierre Dube; Sideras Lucas Hopital Maisonneuve – Rosemont, Montreal Canada 4

Stephen Chia British Columbia Cancer Agency, Vancouver Canada 4

Binghe Xu Cancer Hospital, Beijing China 4

Joerg Schilling Onkologische Schwerpunktpraxis, Berlin Germany 4

Klaus Apel Facharzt fuer Frauenheilkunde und Geburtshilfe,

Erfurt Germany 4

Peter Grundtvig Sorensen; Peter Michael Vestlev

Roskilde Sygehus, Roskilde Denmark 4

Erik Hugger Jakobsen; Brita

Bjerregaard Jensen Sydvestjysk Sygehus Esbjerg, Esbjerg Denmark 4

Vera Haahr Regionshospital Viborg, Viborg Denmark 4

Alvaro Rodriguez Lescure Hospital General Universitario de Elche, Elche Spain 4

Begona Grana Suarez; Cristina Saura

Manich Hospital Universitario Vall d´Hebron, Barcelona Spain 4

Jean-Philippe Jacquin Institut de Cancerologie de la Loire (ICL) France 4

Ion Boiangiu; Ahmed Samreen University Hospitals of Leicester, Leicester UK 4

Magdolna Dank Semmelweis Egyetem Radiologiai es Onkoterapias Klinika, Budapest

Hungary 4

Cristina Falci; Antonio Jirillo Universita degli Studi di Padova, Padova Italy 4

Page 23: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

22

Principle investigator(s) Investigational site Country Patients

randomised, n

Saverio Cinieri Presidio Ospedaliero di Summa Antonio Perrino,

Brindisi Italy 4

Takayuki Ueno; Fumiaki Sato; Hiroyasu Yamashiro; Tomoharu Sugie

Kyoto University Hospital, Kyoto Japan 4

Keun Seok Lee; Jung Sil Ro; In Hae

Park National Cancer Center, Gyeonggi-do Korea 4

Anita Zarina Bustam University Malaya Medical Centre, Kuala Lumpur Malaysia 4

MalgorzataSuszko-Kazarnowicz; Artur

Piktel Olsztynski Osrodek Onkologiczny, Olsztyn Poland 4

Krzysztof Krzemieniecki Samodzielny Publiczny Zaklad Opieki Zdrowotnej

Szpital Uniwersytecki w Krakowie, Krakow Poland 4

Polizenia Georgeta Iorga Spitalul Universitar de Urgenta, Bururesti Romania 4

Yoon Sim Yap National Cancer Centre Singapore, Singapore Singapore 4

Marian Kakalejcik Poliklinika ADUS, Poprad Slovakia 4

Alper Sevinc Gaziantep University, Sehitkamil/Gaziantep Turkey 4

Mustafa Ozguroglu Istanbul University, Cerrahpasa Turkey 4

Shin-Cheh Chen Chang Gung Medical Foundation, Taipei Branch Taiwan 4

Richard H. Greenberg The Center for Cancer and Hematologic Disease,

Cherry Hill USA 4

Allan D. Eisemann Rutland Regional Medical Center, Rutland USA 4

Robert Droder East Texas Medical Center Cancer Institute, Tyler USA 4

M. Rashid Abbasi Oncology and Hematology Specialist, Danville USA 4

Marina Vaysburd Cedar-Sinai Medical Group, Beverly Hills USA 4

Humberto Jose Caldera Hematology Oncology Associates, Loxahatchee USA 4

Barbara Bacsik Haley University of Texas Southwestern Medical Center,

Dallas USA 4

Erwin Robin Munster Community Hospital, Munster USA 4

Roger C. Inhorn Mercy Hospital, Portland USA 4

David Hufnagel; Peter D. Kenyon Samaritan Hematology & Oncology Consultants,

Corvallis USA 4

Ellen Spremulli Anniston Oncology, Anniston USA 4

Paula Silverman University Hospitals Case Medical Center (UHCMC), Cleveland

USA 4

Sharad Jain Texas Oncology, PA, Denton USA 4

Robert Weigand St. Joseph Oncology Inc, St Joseph USA 4

Jeroen Mebis VZW Jesseziekenhuis - campus Virga Jesse, Hasselt Belgium 3

Tatyana Koynova District Dispensary for Oncology Diseases Internal

Unit – Sofia EOOD, Sofia Bulgaria 3

Bernard Lesperance Hopital du Sacre-Coeur de Montreal, Montreal Canada 3

Jana Prausova Fakultni Nemocnice v Motole, Praha Czech Republic 3

Claus-Henning Kohne Klinikum Oldenburg gGmbH, Oldenburg Germany 3

Andreas Schneeweiss Universitaetsfrauenklinik, Heidelberg Germany 3

Christian Jackisch Klinik für Gynaekologie und Geburtshilfe, Offenbach Germany 3

Stefan Fuxius Onkologische Schwerpunktpraxis, Heidelberg Germany 3

Ricardo Cubedo Cervera Hospital Puerta de Hierro-Majadahonda,

Majadahonda Spain 3

Ander Urruticoechea Ribate; Sonia

Pernas Simon

ICO de Barcelona - Hospital Duran i Reynals,

Barcelona Spain 3

Jose Valero Gallego Hospital Provincial de Zamora, Zamora Spain 3

Angels Arcusa Lanza Consorci Sanitari de Terrassa, Terrassa Spain 3

Maria del Pilar Alvarez Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife

Spain 3

Jesus Florian Gerico Hospital de Barbastro, Barbastro Spain 3

Laurent Cany Polyclinique Francheville, Perigueux France 3

Justin Stebbing Charing Cross Hospital, London UK 3

Damir Gugic; Dejan Labudovic University Hospital Centre Osijek, Osijek Croatia 3

Damir Vrbanec University Hospital Zagreb, Zagreb Croatia 3

Fausto Roila Azienda Ospedaliera S. Maria, Terni Italy 3

Sandro Barni Ospedali Treviglio Caravaggio, Treviglio Italy 3

Paolo Bidoli Azienda Ospedaliera San Gerardo, Monza Italy 3

Hirofumi Mukai National Cancer Center Hospital East, Chiba Japan 3

Vanessa Bermudez Clínica Vista Alegre / Unidad de Investigacion, Surco Peru 3

Alexandru Eniu Institutul Oncologic "Prof. Dr. Ion Chiricuta", Cluj-Napoca

Romania 3

Barry C. Mirtsching Center for Research and Treatment PA, Dallas USA 3

Page 24: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

23

Principle investigator(s) Investigational site Country Patients

randomised, n

Emad Ibrahim Beaver Medical Group, LP, Highland USA 3

Joan Trey; Paul Francis Hergenroeder MetroHealth Medical Center, Cleveland USA 3

Aftab Mahmood; Anneliese Gonzalez Cancer Specialists of South Texas PA, Corpus Christi USA 3

Edward H. Kaplan; Stacy Ban North Shore Cancer Research Association, Skokie USA 3

Dhimant Patel Aurora Health Care Medical Center, Green Bay USA 3

Billy Clowney Santee Hematology Oncology, Sumter USA 3

Karen Hoelzer Springfield Clinic LLP, Springfield USA 3

Garry H. Schwartz Carolinas Medical Center NorthEast, Concord USA 3

Jame Abraham; Mohamed Salkeni West Virginia University - Mary Babb Randolph

Cancer Center, Morgantown USA 3

Sunil Narula Midwest Center for Hematology Oncology, Joliet USA 3

Khaled Jabboury Jabboury Foundation for Cancer Research Inc,

Houston USA 3

Robert Scott Mocharnuk Simmons Cancer Institute at Southern Illinois

University School of Medicine, Springfield USA 3

Richard H. McDonough; David H. Sikes; Ronald H. Kawanchi

Florida Medical Clinic, PA, Zephyrhillis USA 3

Larry Schlabach Erlanger Health System, Chattanooga USA 3

Samuel Spence McCachren, Jr. Thompson Cancer Survival Center, Knoxville USA 3

Thomas M. Cosgriff Hematology Oncology Specialties LLC, New Orleans USA 3

Luke Dreisbach Desert Hematology Oncology Medical Group, Inc, Rancho Mirage

USA 3

Angela DeMichele University of Pennsylvania, Philadelphia USA 3

Lawrence Pawl Medical Specialty Associates, Grand Rapids USA 3

Jennifer Lucas California Cancer Care Inc, Greenbrae USA 3

Lowell C. Shinn; Nabiel Alkhouri;

Manish Monga Wheeling Hospital, Wheeling USA 3

Deborah L. Lindquist Arizona Oncology Associates, Sedona USA 3

Thomas C. Anderson Texas Oncology, PA, Bedford USA 3

Humera Khurshid; Sabrina Witherby Memorial Hospital of Rhode Island, Pawtucket USA 3

Nicholette Erickson; Ann Traynor Central Maine Medical Center, Lewiston USA 3

Ron Bose; Timothy J. Pluard Washington University School of Medicine, St Louis USA 3

Michael C. Jones The Jones Clinic, PC, Germantown USA 3

Sucharu Prakash Texas Oncology, PA, Paris USA 3

Fabio Volterra Eastchester Center for Cancer Care, Bronx USA 3

Gerardo Capo Trinitas Comprehensive Cancer Center, Elizabeth USA 3

Lawrence E. Flaherty; Elaina Gartner Barbara Ann Karmanos Cancer Institute, Detroit USA 3

Said Baidas MD Anderson Cancer Center, Orlando USA 3

Ian Okazaki Straub Clinic and Hospital, Honolulu USA 3

Bichlien Nguyen Long Beach Memorial Medical Center, Long Beach USA 3

Thomas Rakowski The Valley Hospital, Paramus USA 3

Ira Oliff Orchard Healthcare Research Inc, Skokie USA 3

Joseph W. Leach; Kendra Kubiak;

Michaela Tsai; Daniel Anderson Park Nicollet Institute, St Louis Park USA 3

Philippe Vroman OL Vrouw Ziekenhuis, Aalst Belgium 2

Ines Deleu; Willem Lybaert AZ Nikolaas, St Nikolaas Belgium 2

Marleen Borms AZ Groeninge, Kortrijk Belgium 2

Felix Couture Hotel Dieu de Levis Hospital, Quebec Canada 2

Jonathan J. Wilson Humber River Regional Hospital, Weston Canada 2

Gordon Hunt; David R. Holland Jack Ady Cancer Centre, Lethbridge Canada 2

Walter Mingrone Kantonsspital Olten, Olten Switzerland 2

Donggeng Liu; Shusen Wang Sun Yat-Sen University Cancer Center, Guangzhou China 2

Zefei Jiang The Hospital Affiliated Academy Military Medical

Science, Beijing China 2

Vera Benesova Nemocnice Jihlava, Jihlava Czech Republic 2

Martin Smakal; Petra Garnolova Institut Onkologie a reahabilitace na Plesi, Nova Ves pod Plesi

Czech Republic 2

Monika Neumann; Wolfgang Janni;

Anne-Sophie Vesper Universitaetsklinikum Duesseldorf, Duesseldorf Germany 2

Dorothea Fischer; Cornelia Liedtke Universitaetsklinikum Schleswig-Holstein

Brustzentrum, Leubeck Germany 2

Eva-Maria Grischke Universitaetsfrauenklinik Tuebingen, Tuebingen Germany 2

Dietmar Seeger St. Marienhospital Vechta, Vechta Germany 2

Page 25: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

24

Principle investigator(s) Investigational site Country Patients

randomised, n

Volker Moebus Staedtische Kliniken Frankfurt am Main-Hoechst

Frauenklinik, Frankfurt am Main Germany 2

Anita Prechtl Praxis Gynaekologie Arabella Muenchen, Muenchen Germany 2

Juan Carlos Camara Toral Hospital de Torrevieja, Alicante Spain 2

Alfonso Sanchez Munoz Hospital Clinico Universitario Virgen de la Victoria,

Malaga Spain 2

Sonia Gonzalez Jimenez Hospital Mutua de Terrassa, Terrassa Spain 2

Javier Cassinello Espinosa Hospital Universitario de Guadalajara, Guadalajara Spain 2

Beatriz Cirauqui; Mireia Margeli Vila Hospital Universitari Germans Trias i Pujol,

Barcelona Spain 2

Norberto Batista Lopez Hospital Universitario de Canarias, Tenerife Spain 2

Jose Ignacio Chacon Lopez-Muniz;

Miguel Angel de la Cruz Mora Hospital Virgen de la Salud, Toledo Spain 2

Audrey Mailliez; Laurence Vanlemmens Centre Oscar Lambret, Lille France 2

Damien Pouessel; Marc Espie Hopital Henri Mondor, Paris France 2

Marc Espie Hopital Saint-Louis, Paris France 2

Rebecca Roylance; John Conibear St. Bartholomew's Hospital, London UK 2

Adrian Harnett Norfolk & Norwich University Hospitals, Norwich UK 2

David Geffen Soroka University MC, Beer-Sheva Israel 2

Enzo Maria Ruggeri Ospedale Belcolle Viterbo, Viterbo Italy 2

Teresa Gamucci Ospedale SS Trinita, Sora Italy 2

Cees J. Van Groeningen Ziekenhuis Amstelland, Amstelveen Netherlands 2

Renata Banas Szpital Wojewodzki im. Sw. Lukasza Samodzielny,

Tarnow Poland 2

Niklas Loman Skånes Universitetssjukhus, Malmo Sweden 2

Necati Alkis Dr. Abdurrahman Yurtarslan Ankara Oncology

Hospital, Demetevler/Ankara Turkey 2

Ming-Feng Hou Kaohsiung Medical University Chung-Ho Memorial

Hospital, Kaohsiung Taiwan 2

Amy K. Krie Avera Cancer Institute, Sioux Falls USA 2

Nandagopal S. Vrindavanam Signal Point Clinical Research Center, LLC,

Middletown USA 2

Orion M. Howard Southwestern Vermont Health Care, Bennington USA 2

Dennis Citrin Midwestern Regional Medical Center, Zion USA 2

Mark S. Morginstin; Ajit Desai Albert Einstein Cancer Center, Philadelphia USA 2

Ines J. Sanchez Center for Integrative Cancer Medicine, PA, El Paso USA 2

David Allen Nixon, Jr. Northeast Arkansas Clinic, Jonesboro USA 2

Patrick G. Beatty Montana Cancer Specialists, Missoula USA 2

Kathryn Edmiston University of Massachusetts Memorial Medical

Center, Worcester USA 2

Jonathan D. Eneman; Marilyn

McLaughlin York Hospital Oncology Treatment Center, York USA 2

Cynthia A. Lynch; Edward O'Brien Guthrie Clinic Ltd, Sayre USA 2

Justin A. Call Northern Michigan Regional Hospital, Petoskey USA 2

Keith S. Lanier; Alison Conlin Providence Cancer Center, Portland USA 2

Donald J. Brooks Arizona Oncology Associates, Tuscon USA 2

Kristi McIntyre Texas Oncology, PA, Dallas USA 2

Marc A. Saltzman Innovative Medical Research of South Florida Inc,

Aventura USA 2

Michael J. Castine III Hematology-Oncology Clinic, Baton Rouge USA 2

Gregory L. Ortega Mid Florida Hematology & Oncology Centers, PA,

Orange City USA 2

Young M. Choi Wheaton Franciscan Cancer Care-All Saints, Racine USA 2

Craig H. Reynolds Ocala Oncology Center, Ocala USA 2

Frankie Ann Brescia; Rita Kramer Medical University of South Carolina, Charleston USA 2

Aimee D. Kohn Cascade Cancer Center, Kirkland USA 2

John P. Micha; Jessica M. Rhee Gynecologic Oncology Associates, Newport Beach USA 2

Satish Shah Gettysburg Cancer Center, Gettysburg USA 2

David A. Riseberg Mercy Medical Center, Baltimore USA 2

William Kevin Patterson The Queen Elizabeth Hospital, Adelaide Australia 1

Jean-Paul Salmon; Chantal Andre Centre Hospitalier Regional de la Citadelle, Liege Belgium 1

Alain Bols AZ St Jan Ruddershove, Brugge Belgium 1

Randal D'hondt AZ Damiaan - Site Sint-Jozef, Oostende Belgium 1

Sylvie Luce; Claire Nouwynck Cliniques Universitaires de Bruxelles, Bruxelles Belgium 1

Page 26: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

25

Principle investigator(s) Investigational site Country Patients

randomised, n

Gino Pelgrims Sint-Elisabeth Ziekenhuis, Turnhout Belgium 1

Vincent Richard Centre Hospitalier Universitaire Ambroise Paré,

Mons Belgium 1

Johan Verschuere AZ Zusters van Barmhartigheid, Ronse Belgium 1

Kurt Geldhof Jan Yperman Ziekenhuis, Leper Belgium 1

Clemens Caspar Kantonsspital Baden, Baden Switzerland 1

Rongcheng Luo Southern Medical University Nanfang Hospital,

Guangzhou China 1

Otakar Bednarik Fakultni Nemocnice Brno, Brno Czech Republic 1

Kathrin Schwedler Frauenklinik der J.W. Goethe-Universitat, Frankfurt

am Main Germany 1

Marcus Schmidt Klinikum der Johannes Gutenberg-Universitaet,

Mainz Germany 1

Joachim Bischoff; Romy Neumeister Universitaetsklinikum Magdeburg, Magdeburg Germany 1

Brigitte Rack Klinikum Innenstadt der Universitaet Muenchen,

Muenchen Germany 1

Roland Repp; Stefan Fries; Ralf Adrion Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie, Bamberg

Germany 1

Volker Schulz MVZ Abtrs & Partner Kiel, Kiel Germany 1

Peter Klare Praxisklinik Krebsheilkunde fuer

Frauen/Brustzentrum, Berlin Germany 1

Dirk Ossenbuhl; Jakob Manfred Kusche; Mahmoud Danei

Marienhospital Aachen, Aachen Germany 1

Frank Griesinger Pius-Hospital Oldenburg, Oldenburg Germany 1

Jose Manuel Baena Canada Hospital Universitario Puerta del Mar, Cadiz Spain 1

Purificacion Martinez del Prado Hospital de Basurto, Vizcaya Spain 1

David Machover Hopital Paul Brousse, Villejuif France 1

Didier Mayeur Hopital de Versailles, Le Chesnay France 1

Nathalie Trufflandier Centre Hospitalier Universitaire De Bordeaux Saint

Andre, Bordeaux France 1

Valerie Delecroix Pôle Hospitalier Mutualiste, Saint-Nazaire France 1

Mireille Mousseau Hopital Albert Michalon, Grenoble France 1

Marie-Ange Mouret-Reynier; Jean-Marc Nabholtz

Centre Jean Perrin, Clermont-Ferran France 1

Anula D. Chetiyawardana Queens Hospital, Burton-on-Trent UK 1

Christos Papandreou University General Hospital of Larissa, Larissa Greece 1

Lajos Hornyak; Zsolt Faluhelyi;

Erzsebet Simo

Veszprem Megyei Csolnoky Ferenc Korhaz,

Veszprem Hungary 1

Mario Di Palma Ospedale San Pietro Fatebenefratelli, Roma Italy 1

Francesco Cognetti Medica Istituti Fisioterapici Ospitalieri - Istituto

Regina Elena, Roma Italy 1

Gabriella Gorzegno; Luigi Dogliotti Azienda Ospedaliera San Luigi Gonzaga, Orbassano Italy 1

Cesare Gridelli Ospedale San Giuseppe Moscati, Avellino Italy 1

Alfredo Falcone Riuniti Azienda Ospedaliero-Universitaria Pisana,

Pisa Italy 1

Hector Soto Parra; Calogero Buscarino AOU Policlinico - Vittorio Emanuele, Catania Italy 1

Seock-Ah Im Seoul National University Hospital, Seoul Korea 1

Benito Sanchez Llamas Nucleo De Especialidades Oncologicas, Guadalajara Mexico 1

Wouter Dercksen Maxima Medisch Centrum, Noord Brabant Netherlands 1

Franciscus Erdkamp Orbis Medisch Centrum, Sittard-Geleen Netherlands 1

J.B. Ruit; Hans Braun Vlietland Ziekenhuis, Schiedam Netherlands 1

Joanneke E.A. Portielje Haga Ziekenhuis, Den Haag Netherlands 1

Suleyman Buyukberber; Mustafa Benekli; Aydin Ciltas

Gazi Universitesi Tip Fakultesi, Besevler/Ankara Turkey 1

Andrew J. Zahalsky Andrew J. Zahalsky, MD, PC, Monongahela USA 1

Rebecca Jaslow Thomas Jefferson University, Philadelphia USA 1

Gary W. Thomas South Carolina Cancer Specialists, Hilton Head

Island USA 1

Archana Maini; Israel Wiznitzer Broward General Medical Center, Fort Lauderdale USA 1

Ali Khojasteh Columbia-Capitol Comprehensive Cancer Care

Clinic, Jefferson City USA 1

Manuel Francisco Gonzalez Francisco Gonzalez MD PA, Columbia USA 1

Lynn R. Kong Ventura County Hematology-Oncology Specialists,

Oxnard USA 1

Aruna Padmanabhan Temple University Hospital, Philadelphia USA 1

William A. Conkright Purchase Cancer Group, Paducah USA 1

Page 27: ExteNET 5-year analysis - thelancet.com. Holland; G. Hunt; A. A. Joy; B. Lesperance; S. Lucas; ... A. Maini; Y. Manalo; I. A. Mayer; J. Means-Powell; J. Micha; R. ... Beverly Moy,

26

Principle investigator(s) Investigational site Country Patients

randomised, n

Sandra M. Swain Washington Hospital Center, Washington USA 1

Douglas E. Faig North Broward Medical Center, Deerfield Beach USA 1

Kirti Jain Ashland-Bellefonte Cancer Center, Ashland USA 1

Ronald H. Yanagihara Ronald H. Yanagihara, Gilroy USA 1

Yvonne Ottaviano Harry and Jeanette Weinberg Cancer Center, Baltimore

USA 1

Beverly Moy Beth Israel Deaconess Medical Center, Boston USA 1

Heather A. Steele; Gordon K. Rainey; Penelope J. Harris; Jason K. Burris; Erik

J. Rupard; Esther Tan; Andrew Delmas

Dwight David Eisenhower Army Medical Center,

Fort Gordon USA 1

Pat W. Whitworth Nashville Breast Cancer, Nashville USA 1

Abby R. Bova Mercy Clinic Oncology and Hematology – McAuley,

Oklahoma City USA 1

Ian C. Anderson Redwood Regional Medical Group, Santa Rosa USA 1

Mihran Shirinian Glendale Adventist Medical Center Cancer Services,

Glendale USA 1

Caesar Tin-u Texas Oncology, PA, Sugar Land USA 1

Timothy J. O'Rourke Cancer & Hematology Centers of Western Michigan,

Grand Rapids USA 1

Michael S. Roberts Arizona Oncology Associates, PC, Phoenix USA 1

Michael Francisco; A. Scott Pierson Portneuf Medical Center, Pocatello USA 1

Peter D. Byeff Cancer Center of Central Connecticut, Southington USA 1

Peter A. Kovach; John R. Caton, Jr. Willamette Valley Cancer Institute and Research

Center, Springfield USA 1

Mark Urban Rarick Kaiser Permanente Northwest Region Oncology

Hematology, Portland USA 1

William G. Schimidt, Jr. Bend Memorial Clinic, Bend USA 1

Alison T. Stopeck; Rachel Swart Arizona Cancer Center, Tuscon USA 1

Maria Regina Carrillo Flores; Carlos A.

Alemany; Brennely Lozada Cancer Centers of Florida, Orlando USA 1

Paul L. Weinstein Hematology Oncology, PC, Stanford USA 1

Wei Wang San Francisco Oncology Associates, San Francisco USA 1

Michael Porubcin Medical Arts Association, Ltd, Moline USA 1

David M. Ellison; George F. Geils Charleston Hematology Oncology Associates, PA,

Charleston USA 1

Edgardo Rivera The Methodist Hospital, Houston USA 1

Mahmoud Charif University of Cincinnati Cancer Center, Cincinnati USA 1