Strategies to improve the outcome of locally advanced pancreatic cancer patients. Christophe Louvet Institut Mutualiste Montsouris, Paris
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1 Strategies to improve the outcome of locally advanced pancreatic cancer patients Christophe Louvet Institut Mutualiste Montsouris, Paris ESMO 16th WCGIC, Barcelona. June 25th, 2014
2 Disclosures C. Louvet Celgene Roche Nucana
3 Background Role of radiation therapy in locally advanced pancreatic cancer highly debated Local control remains an important issue chemoradiation (CRT) High rate of distant metastasis chemotherapy
4 Frontline CRT versus chemotherapy in LAPC Gem CRT Chauffert B et al. Ann Oncol 2008 Loehrer P et al. J Clin Oncol 2011 Contradictory results
5 Induction CT followed by CRT in LAPC CRT after 3 months of induction chemotherapy Huguet F et al, J Clin Oncol 2007 Promising strategy
6 Authors Treatment N pts PFS (months) OS (months) 1-year survival (%) Huguet CT (retrosp) CT then CRT Krishnan CRT (retrosp) CT then CRT Brunner (retrosp) CRT CRT then CT Ko CT then CRT (phase 2) (32% PD after CT) (12.7) (17) Schneider (phase 2) CT - CRT - CT
7 SCALOP (phase 2) Concurrent chemotherapy? 74 pts Gem-Cap x 3 R CRT 50.4 Gy with capecitabine CRT 50.4 Gy with gemcitabine 15.2 months 13.4 months p= 0.01 Mukherjee S et al. Lancet Oncol 2013
8 EVALUATION : non progressive EVALUATION : non progressive LAP07 study EVALUATION EVALUATION EVALUATION R1 R2 Cape XRT R2 Cape XRT Until progression 1 month = Gemcitabine (1000 mg/m 2 )/wkx3 Erlotinib : 100 mg/d with gem 150 mg/d as single agent Cape XRT Capecitabine plus radiation Quality assurance Secondary surgery allowed at any time
9 Objectives of LAP07 study Primary objective: to assess whether administering CRT increases overall survival in patients whose tumor is controlled after 4 months of induction chemotherapy Secondary objectives: - Role of erlotinib - Progression free survival (PFS) - Tolerance - Impact of Radiation Therapy Quality Assessment (RTQA) 1 - Predictive molecular markers, circulating tumor cells 2 1 Huguet F et al. ASTRO 2013; 2 Bidard FC et al. Ann Oncol 2013
10 Flow Chart Assessed for eligibility (n= 449) 1 st Randomization Intent-to-treat principle (n= 442) Excluded (n= 7) Gemcitabine (n= 223) Gemcitabine + erlotinib (n= 219) Chemotherapy (n= 136) 2 nd Randomization Intent-to-treat principle (n= 269) Chemoradiotherapy (n= 133) Excluded (39.1%) (n= 173) 111 progressive disease 15 toxicity 11 delay 11 patients' will 16 investigator decision 6 intercurrent disease 3 surgery
11 Overall Survival
12 Site of progression R2 patients: 236/269 patients (88%) with tumor progression 93 with local progression only (39.4%) 122 with metastatic (± local) progression (51.7%) 21 unknown (8.9%) Chemotherapy (n= 125) Chemoradiation (n= 111) LA 58 (46%) 35 (32%) M+ 55 (44%) 67 (60%) p=0.035 unknown 12 (10%) 9 (8%)
13 Progression Free Survival
14 Treatment Free Survival
15 LAP07 Conclusions LAP07 prospectively confirmed the value of frontline chemotherapy in LAPC patients Overall survival in CRT arm is not superior to chemotherapy arm in LAPC patients with tumor controlled after 4 months of chemotherapy However, trend for PFS in favor of CRT In the CRT arm, patients had a significantly less local tumor progression and a longer period without chemotherapy
16 Strategies to improve the outcome of LAPC patients 1 Improvement of systemic chemotherapy
17 FOLFIRINOX Overall Survival 1.00 HR=0.57 : 95%CI [ ] Stratified Log-rank test, p< Number at risk Gemcitabine Folfirinox Months Gemcitabine Folfirinox
18 Proportion of Survival Nab-P + Gem Overall Survival OS, months Events/N (%) Median (95% CI) 75 th Percentile 0.8 nab-p + Gem 333/431 (77) 8.5 ( ) Gem 359/430 (83) 6.7 ( ) HR = % CI ( ) P = Pts at Risk Months nab-p + Gem: Gem: Von Hoff et al., ASCO GI 2013 LBA148
19 Nab-Paclitacel + FOLFOX Phase I study (Saffran, ASCO 2014) Very promising results
20 Strategies to improve the outcome of LAPC patients 1 Improvement of systemic chemotherapy 2- Personalized medicine
21 Strategies to improve the outcome of LAPC patients 1 Improvement of systemic chemotherapy 2- Personalized medicine Prognostic factor analysis from LAP07 Biomarkers and targeted drugs
22 SPARC
23 Gemcitabine: mechanisms of action Intracellular uptake hent1 hcnt 3 Activation dck Nucleoside Phosphate Kinase Inactivation CDA DCTD 5 -NT Action Inhibition DNA synthesis
24 hent1 «Positive» trials Negative trials RTOG (adjuvant, retrospective) Clovis C (metastatic, prospective) French-Belgium series (adjuvant, retrospective) ECOG (metastatic, retrospective) ESPAC 1&3 (adjuvant, retrospective) CONKO-01 (adjuvant, retrospective)
25 =?
26 Biomarker Prognostic Predictive Current clinical impact CA 19.9 Yes No No CTC / cdna Yes No No mirnas Yes No? (Anti-sens) Proteomic / LAMC Yes No No Genomic profiles Yes No No hent1 No Yes (Gem) Likely (Gem) dck No Yes (Gem) Likely (Gem) CDA No Yes (Gem toxicity) Likely (Gem) SPARC Yes?? (Abraxane) Histone modifications Yes?? (5FU) Hedgehog Yes?? (HH inhibitors) CXCR4 Yes?? (CXCR4 inhibitors) HGF / c-met Yes?? (c-met inhibitors) SMAD4??? HER2??? (HER2 inhibitors) EGFR? (No) No No VEGFR? (No) No No IGFR? (No) No No
27 Strategies to improve the outcome of LAPC patients 1 Improvement of systemic chemotherapy 2- Personalized medicine 3- Improvement of chemoradiation
28 Strategies to improve the outcome of LAPC patients 1 Improvement of systemic chemotherapy 2- Personalized medicine 3- Improvement of chemoradiation Dose radiation Target volume IMRT, gating concurrent radiosenziter
29 Strategies to improve the outcome of LAPC patients 1- Improvement of systemic chemotherapy 2- Personalized medicine 3- Improvement of chemoradiation 4- Improvement in strategy and techniques
30 Strategies to improve the outcome of LAPC patients 1- Improvement of systemic chemotherapy 2- Personalized medicine 3- Improvement of chemoradiation 4- Improvement in strategy and techniques Increased time of systemic CT before CTRT? Place of secondary surgery after systemic CT and CTRT? Place of HIFU?
31 RTOG 1201 will help address the question of whether more effective chemotherapy impacts the role of radiation in locally advanced disease Locally advanced PDAC Stratify: SMAD4 status (? predicts patterns of local vs distant disease progression) Gemcitabine/nab-paclitaxel x 3 months 3D-CRT + cape 50.4 Gy IMRT + cape 63 Gy Continue chemotherapy (P.I.: Christopher Crane, MD Anderson)
32 Phase III SCALOP 2 design LAPC patients, PS pts GEM/Nab-Paclitaxel ou GEMCAP x 3 cycles Randomise if eligible for CRT (65%) 1:1:1:1:1 between arms A-E Then GEM/Nab-Paclitaxel x 1 cycle whilst RT is planned Arm A n=33 Gemcap 50.4 Gy n=66 - Nelfinavir n=66 Arm B n=33 CAPE 50.4Gy/28F + Nelfinavir n=66 Arm C n=33 CAPE 50.4Gy/28F +Nelfinavir 60 Gy n=66 Arm D n=33 CAPE 60Gy/30F Arm E n=33 CAPE 60Gy/30F + Nelfinavir
33 Methodological and medico-economic issues Systematic QoL studies? Composite endpoints? Amount of requested material for genomic issues? Place of «liquid biopsies»? Cost of new drugs and of CTRT?
34 Strategies to improve the outcome of LAPC patients 1- Improvement of systemic chemotherapy 2- Personalized medicine 3- Improvement of chemoradiation 4- Improvement in strategy and techniques 5- Methodological and medico-economic issues
35 Never give up!
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