Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of...

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Landscape of systemic therapy for recurrent ovarian cancer Sandro Pignata Istituto Nazionale Tumori di Napoli

Transcript of Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of...

Page 1: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Landscape of systemic therapy

for recurrent ovarian cancerSandro Pignata

Istituto Nazionale Tumori di Napoli

Page 2: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Disclosures

• Honoraria from AZ Roche Clovis Tesaro Pharmamar MSD Incyte

Pfizer Merck Genmab

• Funding from AZ Roche MSD

2

Page 3: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Treatment for recurrent disease:

standard treatmentSandro Pignata

National Cancer Institute, Naples, Italy

Page 4: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

• Marisa 69 Y

• Serous High grade, stage IIIc

• First line chemo includin bevacizumab

• Recurring with carcinomatosis

How we decide next therapy?

What is changed in clinical practice since 2017?

Page 5: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Is Platinum free Interval still the main driver of our

decision?

What is changed in clinical practice since 2017?

Page 6: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

The concept of PFI is not the only driver of our decisions today

Biology, histology, treatment free interval,…. more important?

The resistance to platinum-based treatment is not a categorical variable

Page 7: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological
Page 8: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

ESMO-ESGO Consensus Conference on Ovarian Cancer

Pathology and molecular biology, early and advanced stages, borderline ovarian tumours and recurrent disease

© 2018 European Society of Gynaecological Oncology, European Society for Medical Oncology. All rights reserved.

Coming soon…..

Page 9: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients with recurrent OC

ESGO ESMO guidelines: Treatment of recurrent OC

9

Surgery an option?

(AGO score, etc.)

Tumour biology/histology

Number of prior lines of treatment

Prior response

TFI for platinum

Persistent toxicity

Symptoms

Patient preference

Unfit or not willing to receive

anticancer therapyBest supportive care

Platinum might not be the best option

• Early symptomatic release

• Progression on prior platinum

• Platinum intolerability

Platinum might be the best option/

re-challenge seems to be justified

• Response to prior platinum

ESGO ESMO Consensus Guidelines – Oral Presentation at ESGO 2018

Page 10: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients candidate to receive platinum again

Page 11: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients candidate to receive platinum again: Histology/Biology

• Are histolgy driven therapies feasible in

our practice?

• Do we have good biomarkers?

Page 12: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

12

OVARIAN CANCER IS NOT A SINGLE DISEASE

Page 13: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological
Page 14: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients candidate to receive platinum: What is changed for 2017?

Biomarkers?

Page 15: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Olaparib, Niraparib and Rucaparib

highly effective in BRCA mut

Niraparib

gBRCA mut

21 vs 5.5 months (HR 0.27)

Olaparib

gBRCA mut

19.3 vs 5.5 months (HR 0.27)

Rucaparib

gBRCA mut

16.6vs 5.4 months (HR 0.27)

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1. Matulonis UA, et al. Int J Gynecol Cancer 2008;18:1183-1193; 2. Mirabeau-Beale KL, et al. Gynecol

Oncol 2009;114:353-359; 3. Kyriacou J, et al. Can Oncol Nurs J 2017;27:236-242.

Should we still do “Watch & Wait”?

0

10

20

30

40

50

60

70

Psychologicaldistress

Fear of CA-125testing

Fear ofrecurrence

Scoressuggestive of

PTSD

Psychological assessments of early-stage ovarian cancer survivors (N=58)1

Su

rviv

ors

(%

)

Fear of disease recurrence is a psychological burden

Page 17: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

PARP inhibitor in maintenance for All responders to platinum-based chemotherapy in late relapse

NIRAPARIB MAINTENANCE THERAPY IMPROVED PFS

BRCAwt, breast cancer susceptibility; CI, confidence interval; gBRCAmut, germline breast cancer susceptibility gene mutation; HR, hazard ratio; HRD, homologous recombination deficiency; neg, negative; PARP, poly adenosine diphosphate ribose polymerase; PFS, progression-free survival; pos, positive.

Mirza MR et al. N Engl J Med. 2016;375:2154–64.

NiraparibPlacebo

gBRCAmut100

75

50

25

0

0 4 8 12 16 20 24

Months since randomisation

PF

S (

%)

gBRCAmut (n=203)

Niraparib (n=138) Placebo (n=65)

21.0 5.5

HR=0.27

95% CI 0.17–0.41,

P<0.001

Non-gBRCAmut HRD-pos100

75

50

25

0

0 4 8 12 16 20 24

Months since randomisation

PF

S (

%)

Non-gBRCAmut HRD-pos (n=162)

Niraparib (n=106) Placebo (n=56)

12.9 3.8

HR=0.38

95% CI 0.24–0.59,

P<0.001

HRD-neg (n=134)

Niraparib (n=92) Placebo (n=42)

6.9 3.8

HR=0.58

95% CI 0.36–0.92,

P<0.023

100

75

50

25

0

0 4 8 12 16 20 24

Months since randomisation

PF

S (

%)

Non-gBRCAmut overall (n=350)

Niraparib (n=234) Placebo (n=116)

9.3 3.9

HR=0.45

95% CI 0.34–0.61,

P<0.001

Niraparib study NOVAPFS months

NiraparibPlacebo

NiraparibPlacebo

HRD-neg100

75

50

25

0

0 4 8 12 16 20 24

Months since randomisation

PF

S (

%)

NiraparibPlacebo

Non-gBRCAmut overall

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Rucaparib maintenance

BID, twice daily; BRCA, breast cancer gene; CR, complete response; HRR, homologous recombination repair; ITT, intention to treat; PFS, progression free survival;

PR, partial response; R, randomisarion; gBRCA, germline breast cancer gene; sBRCA, somatic breast cancer gene; OC, ovarian cancer

1. Ledermann J, et al. Lancet Oncol 2014;15:852-861.

2. Pujade-Lauraine E, et al. Lancet Oncol 2017;18:1274-1284.

3. Coleman RL, et al. Lancet 2017;390:1949-1961.

Placebo

N=189

Rucaparib

600 mg BID

N=375

Primary endpoint

Investigator-assessed PFS in molecularly

defined HRR gene status subgroups

• BRCAmut

• HRD

• ITT

Patients

• High-grade serous or endometrioid epithelial OC, primary peritoneal, or fallopian tube cancers

• ≥2 prior lines of platinum-based treatments

• Sensitive to penultimate platinum

• Responding to most recent platinum (CR or PR)

• CA-125 within normal range

• No restriction on size of residual tumour

R2:1

ARIEL33 (Phase III)

N=564

Page 19: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

LONG-TERM EXPOSURE TO OLAPARIB IN STUDY 19

• Median follow-up of 5.9 years: 15 patients (11%) still receiving olaparib(8 BRCAm, 7 BRCAwt); one patient (<1%) still receiving placebo (BRCAm)

0

5

10

15

20

25

30

35

40

45

50

≥1 ≥2 ≥3 ≥4 ≥5 ≥6

Pati

en

ts o

n o

lap

ari

b (

%)

Time on olaparib (years)

Overall study population

BRCAm subgroup

BRCAwt subgroup

Courtesy of J Ledermann ASCO 2016

33%

19%

14% 14%12%

5%

Page 20: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

When Platinum is an option: Chemotherapy followed by PARPi

• PARPi prolong PFS in patients that respond to platinum

based therapy

• No significant difference in efficacy appears among the

different PARPi

• Effect larger in BRCA mut

• Long responders not strictly related to BRCA status

Page 21: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

When Platinum is an option: Chemotherapy followed by PARPi

Open questions?

• What happens after PARPi?

• Mechanism of resistance?

• How to identify long responders?

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Mechanism of resistance to PARPi?

Page 23: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Targeting angiogenesis has a role in patients candidatesfor Platinum rechallange?

Page 24: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

AGO Ovar 2.21 (Pfisterer ESMO 2018)

0

0,5

1

0 6 12 18 24 30 36 42 48 54

HR = 0.807 (95% P = 0.0128

Carbo PLD bev better than Carbo Gem bev

• 655 patients randomized

• First recurrence

• Previous bev allowed

• Previous surgery allowed

Page 25: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Chemotherapy plus or minus bevacizumab for platinum-sensitive ovarian cancer patients recurring after a bevacizumab containing first line. The randomized phase 3 trial MITO16B - MaNGO OV2B -

ENGOT OV17

Sandro Pignata, Domenica Lorusso, Florence Joly, Ciro Gallo, Nicoletta Colombo, Cristiana Sessa, Aristotelis

Bamias, Carmela Pisano, Frédéric Selle, Eleonora Zaccarelli, Giovanni Scambia, Patricia Pautier,

Maria Ornella Nicoletto, Ugo De Giorgi, Coraline Dubot, Alessandra Bologna, Michele Orditura,

Isabelle Ray-Coquard, Francesco Perrone, Gennaro Daniele

on the behalf of MITO, GINECO, MaNGO, SAKK and HeCOG groups

Sandro Pignata

Page 26: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

PFS Investigator assessed

Standard Experimental Log Rank

P

# events 161 143

Median PFS 8.8 mos 11.8 mos <0.001

HR* (95%CI) 0.51 (0.41-0.65)

*adjusted by:

age, PS, centre size, bevacizumab at relapse, chemo backbone,

residual disease at initial surgery

0.0

00

.25

0.5

00

.75

1.0

0

Pro

ba

bili

ty o

f P

FS

202 179 83 30 9 3 0 0 0Experimental203 137 35 10 5 1 0 0 0Control

Number at risk

0 6 12 18 24 30 36 42 48months

Control Experimental

Kaplan-Meier survival estimates

Sandro Pignata

Page 27: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

When Platinum is an option: Chemotherapy combined with bevacizumab

• Bevacizumab combined to chemotherapy prolong PFS

and has higer response rates compared to chemo alone

• Carbo PLD the best chemo option

• Bev after bev prolong PFS

When??

Page 28: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients with recurrent OC

ESGO ESMO guidelines: Treatment of recurrent OC

Surgery an option?

(AGO score, etc.)

Tumour biology/histology

Number of prior lines of treatment

Prior response

TFI for platinum

Persistent toxicity

Symptoms

Patient preference

Unfit or not willing to receive

anticancer therapyBest supportive care

Platinum might not be the best option

• Early symptomatic release

• Progression on prior platinum

• Platinum intolerability

Platinum might be the best option/

re-challenge seems to be justified

• Response to prior platinum

Eligible for platinum/

potentially platinum-responsive

No priority for symptomatic

response or contraindications to

bevacizumab

Platinum-based re-challenge

Offer PARPi after response to

platinum if not contraindicated

(observed platinum response)

Priority for symptomatic response

and no contraindications to

bevacizumab

Offer platinum-based

re-challenge plus bevacizumab

ESGO ESMO Consensus Guidelines – Oral Presentation at ESGO 2018

Page 29: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients not candidate to receive platinum again

Page 30: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Summary of recommendations LoE GoR Consensus

There are currently no molecular biomarkers to predict platinum-response.

Resistance to platinum in recurrent ovarian cancer is a therapeutic-oriented definition :

1. Proven platinum resistance: progression during platinum therapy

2. Assumed /expected platinum resistance: early symptomatic relapse with low probability of

response to platinum.

These patients should be treated with sequential non-platinum therapy adding bevacizumab if

indicated.

Sensitivity to platinum in recurrent ovarian cancer is a therapeutic-oriented definition :

1. Proven platinum sensitivity: response to platinum; these patients can receive maintenance

PARP inhibitors

2. Assumed /expected platinum sensitivity: previous response to platinum without early symptomatic

relapse; these patients should be treated with platinum-based therapy adding bevacizumab or

followed by maintenance PARP Inhibitor therapy, if indicated. This group includes those who did

not receive prior platinum or those who received adjuvant platinum post-surgery without any

evaluable residual disease to assess chemotherapy response .

I-IV A

Yes: 75% (30 voters)

No: 10% (4 voters)

Abstain: 2.5% (1 voter)

Missing: 12.5% (5 voters)

RECURRENT DISEASE

What defines platinum resistance and how does that influence subsequent treatment?

© 2018 European Society of Gynaecological Oncology, European Society for Medical Oncology. All rights reserved.

Page 31: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients with proven platinum resistance

Page 32: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

No news from 2017!!

• Single agent non platinum therapy is the standard

• Bevacizumab combined to chemotherapy in patients

bevacizumab naive

Page 33: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Patients with assumed/expected platinum resistance

Page 34: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Trabectedin/PLD vs. PLD monotherapy: Results of the OVA-301 trial in platinum-sensitive ROC

• Response Rate (CR+PR):1

– Trabectedin/PLD: 35.3%

– PLD: 22.6% p=0.0042

Median PFS1

Time (months)

1. Monk BJ et al. J Clin Oncol. 2010; 28(19):3107-3114; 2. Krasner CN et al. Gynecol Oncol. 2012; 127: 161-167; 3. Colombo N. Expert Rev Anticancer

Ther. 2018;18(sup1):13-17.

Global Health Status Scale Over

Time2

Page 35: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Trabectedin/PLD in real-life clinical practice:

• Prospective, European phase IV NIMES-ROC: trabectedin/PLD in platinum-sensitive ROC

Pignata S, et al. Ann Oncol. 2018; vol 29 (Supl 8) pages 352 Abs Nº987P

• Preliminary results of an Interim Analysis; N=158

• Trabectedin/PLD was administered:

• As 2nd line in ≈ 25% of patients

• As 3rd line in ≈ 34% of patients

• As 4th or further line in ≈ 40% of patients

• Patients received a median of 6 cycles of trabectedin/PLD (range: 1-34)

• An overall response rate of 38% and a disease control rate of 66.5% were reported.

Page 36: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Trabectedin/PLD in real-life clinical practice:

• Prospective, European phase IV NIMES-ROC trial evaluating the use of trabectedin/PLD in

platinum-sensitive ROC:

Pignata S, et al. Ann Oncol. 2018; vol 29 (Supl 8) pages 352 Abs Nº987P

Page 37: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Trabectedin/PLD in BRCAmut platinum-sensitive ROC:

• The population of BRCA mutated patients is enriched in advanced lines of ovarian cancer.2

Trabectedin/PLD in BRCAmut patients showed:

1. Nicoletto TJ, et al. Tumori. 2015 Sep-Oct;101(5):506-510; 2. Alsop K, et al. J Clin Oncol. 2012;30:2654-63; 3. Monk BJ, et al. Ann Oncol. 2015;

26(5):914-20; 4. Lorusso D, et al. Ann Oncol. 2014;25(suppl 4): iv309.

• Longer PFS and OS compared to PLD in BRCA mut3

• Higher rates of response and survival4

Trabectedin/PLD: 23.8 months

PLD: 12.5 months

p=0.0086

Trabectedin/PLD: 13.5 months

PLD: 5.5 months

p=0.0002

Median OSMedian PFS

BRCA-mutated: 52.2 %

Wild type: 39.5 %

Overall response rate

Page 38: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

DESIGN

MITO-23Randomized phase III trial on Trabectedin (ET 743) vs clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients

Recurrent ovarian, primary peritoneal or

fallopian tube cancers of BRCA mutated or

BRCAness phenotype

R (1:1)

Arm A: III line chemotherapy (physician choice)

- PLD 40 mg/mq d1 q28;- Topotecan 4 mg/mq d1,8,15 q 28- Weekly Paclitaxel 80 mg/mq d1,8,15 q28- Gemcitabine 1000 mg/mq gg1,8,15 q28- Carboplatin AUC 5 g 1 q 21

Arm B: Trabectedin 1.3 mg/m2 -3h D1, q21

OBJECTIVES1. PRIMARY:

▪ Overall Survival (OS)

2. STRATIFICATION CRITERIA:

– Measurable Disease

– Platinum Sensitivity

– Number of Previous CHT Lines (<3 vs >3)

– BRCA status

Accrual completed

Page 39: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

New concepts under investigation: The near horizon

Second line – PARPi/IO-based regimens

Niraparib – TSR 042

Carboplatin–paclitaxel–

Atezo–PARPi

Carboplatin–paclitaxel +/-

checkpoint inhibitor

Carboplatin–paclitaxel +/-

checkpoint inhibitor–bev

Checkpoint inhibitor-based regimens

Checkpoint inhibitor monotherapy or in combination with liposomal doxorubicin

Until progression

Atezo PARPi maintenance

Checkpoint inhibitor maintenance

Checkpoint inhibitor +

bev maintenance

MITO32 ENGOT OV51

Anita

JAVELIN OVARIAN 200

Atalante

KEYNOTE-100, JAVELIN OVARIAN 200

Immunotherapy in combination with PARPi TOPACIO/KEYNOTE-162

ADC, antibody-drug conjugate; Bev, bevacizumab; OC, ovarian cancer; PARPi, poly-ADP ribose polymerase inhibitor

Mirvetuximab soravtansine FORWARD I

Second-line – Checkpoint inhibitor/Bev-based regimens

(FRα)-targeting ADC

Page 40: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

DNA damage and cell cycle checkpoint pathways

p21p53

CDK

Cyclin

Cell

cycle

WEE-1

CDC25A/B/C

CHK2

CHK1

Double

Strand

Breaks

ATM

DNA

replication

stressATR

DNA

damage

G1

G2

Page 41: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Prexasertib: inhibitor of both CHK1 and CHK2in heavily pretreated recurrent OC

months

HGSOC

BRCAwt

gBRCAm

OvCa

ORR= 7/20 (35%)

ORR= 0/6Partial response

White: platinum-sensitive disease

Grey: platinum-resistant or refractory

disease

Page 42: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Conclusions

• Decisions not only based on PFI

• Other factors to be considered (histology, biology…)…but

not always treatments available

• PARPi as maintenance have strong activity in the

recurrence

• Bevacizumab chemo regimens effective in recurrent

patients

• Effect of maintenance on the following therapies still

poorly investigated

Page 43: Landscape of systemic therapy for recurrent ovarian cancer · Psychological assessments of early-stage ovarian cancer survivors (N=58)1 Fear of disease recurrence is a psychological

Having more options is always better for our

patients

But the right sequence may be important…