Adjuvant therapies for RCC Dr. Camillo Porta S.C. di Oncologia Medica I.R.C.C.S. Policlinico San...

Adjuvant therapies for RCC

Dr. Camillo PortaS.C. di Oncologia MedicaI.R.C.C.S. Policlinico San Matteo, Pavia

Back to the basics:terminology

• Adjuvant therapy:– additional cancer treatment given after the

primary treatment to lower the risk that the cancer will come back

NCI Dictionary of Cancer Terms

The natural history of RCC

• Presentation at diagnosis1:– 45% with localized disease– 25% with locally advanced disease– 20–30% metastatic disease

• 33% of patients treated for localized disease will develop metastatic disease2

1. National Cancer Institute. SEER cancer statistics fact sheet: cancer of the kidney and renal pelvis. Accessed 2009;2. Flanigan RC et al. Curr Treat Options Oncol 2003;4:385–90.

Completed RCTs of adjuvant TxClosed adjuvant trials N Author (year) Outcome of the study

RT vs. observation 72 Kjaer (1987) negative

MPA vs. observation 136 Pizzocaro (1987) negative

Aut. tumor vaccine + BCG vs. observation 43 Adler (1987) negative

Aut. tumor vaccine ± BCG vs. observation 120 Galligioni (1996) negative

UFT vs. observation 71 Naito (1997) negative

IFN- vs. observation 247 Pizzocaro (2001) negative

IFN- NL vs. observation 283 Messing (2003) negative

HD IL-2 vs. observation 69 Clark (2003) negative

Autologous tumor vaccine vs. observation 553 Jocham (2004) positive in terms of PFS (p=0.02)

s.c. IL-2 + IFN- + 5-FU vs. observation 203 Atzpodien (2005) negative

s.c. IL-2 + IFN- vs. observation 310 Passalacqua (2007) negative

Aut. tumour-derived HSP-96-peptide complexvs. observation

918 Wood C (2008) negative

Thalidomide vs. observation 46* Margulis (2009) negative*trial stopped due to inefficacy

s.c. IL-2 + IFN- + 5-FU vs. observation 550 Aitchinson (2012) negative

Girentuximab (anti-CAIX MoAb) vs. observation

856 Belldegrun (2013) negative

Meta-analysis of RCTsof adjuvant Tx

Massari F, et al. Clin Genitourin Cancer 2013 (E-pub ahead of print)

Ongoing RCTs oftargeted agents as adjuvant Tx

Ongoing adjuvant trials

SORCE (MRC/EORTC)Sorafenib 1 year (+ 2 years placebo) vs. Sorafenib 3 years vs. placebo 3 years

1656 Leibovich score of 3 to 8.Primary end-point: DFS

Closed at enrolment;no data available yet

ASSURE (ECOG)Sunitinib 1 year vs. Sorafenib 1 year vs. placebo 1 year

1923 T3b-4 N0, T1-4 N+, or T1-4 with positive margins or

vascular invasion)Primary end-point: DFS


S-TRAC (Pfizer)Sunitinib 1 year vs. placebo 1 year

856 High risk according to UISS.Primary end-point: DFS


EVEREST (SWOG)Everolimus vs. placebo (days 1-42; treatment repeats every 6 weeks for 9 courses)

1218 Pathologically intermediate high-risk or very high-risk.

Primary end-point: DFS

Not yet enrolling(US only)

VEG113387 PROTECT study (GSK)Pazopanib 1 year vs. placebo 1 year

1500 Intermediate and high risk.Primary end-point: DFS


NCT01599754 (SFJ Pharmaceuticals)Axitinib 3 yeas vs. placebo 3 years

592 pT2 or higher, pNx pN0 or pN1, M0, Fuhrman G3-4 and

ECOG PS 0-1Primary end-point: DFS

Enrolling(Japan only)

What theoretically hampersthe adjuvant use of antiangiogenics?

Adjuvant Tx for RCC:conclusions

• To date, no treatment emerged as a standard of care in this setting

• Presently, patients should be thus offered just obser-vation

• Enrollment into well-desigend and adequately con-ducted RCTs is mandatory

Thank You for Your kind attention!!!

[email protected]

Adjuvant therapies for RCC Dr. Camillo Porta S.C. di Oncologia Medica I.R.C.C.S. Policlinico San...

Documents

Transcript of Adjuvant therapies for RCC Dr. Camillo Porta S.C. di Oncologia Medica I.R.C.C.S. Policlinico San...