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Poster display session

4031 - FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases (RCSM): final results of the FFCD 1102 phase II trial.

Date

09 Sep 2017

Session

Poster display session

Presenters

Jean-Baptiste BACHET

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

J. BACHET1, O. Lucidarme2, C.B. Levache3, E. Maillard4, J.L. Raoul5, T. Lecomte6, C. Desauw7, F. Brocard8, S. Pernot9, G. Breysacher10, J. Lagasse11, F. Di Fiore12, P.L. Etienne13, O. Dupuis14, A. Aleba15, C. Lepage16, J. Taieb17

Author affiliations

  • 1 Gastroenterology And Digestive Oncology, Groupe Hospitalier Pitié Salpetriere, 75651 - Paris/FR
  • 2 Radiology, Groupe Hospitalier Pitié Salpetriere, 75651 - Paris/FR
  • 3 Digestive Oncology, Clinique Francheville, 24000 - Périgueux/FR
  • 4 Biostatistics, FFCD-, 21079 - Dijon/FR
  • 5 Medical Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 6 Department Of Gastroenterology, CHU de Tours, Hôpital Trousseau, 37170 - Chambray-lès-Tours/FR
  • 7 Medical Oncology, C.H.U. Claude Huriez, 59037 - Lille/FR
  • 8 Medical Oncology, Polyclinique de Gentilly, 54000 - Nancy/FR
  • 9 Digestive Oncology, Hôpital européen Georges-Pompidou, 75015 - Paris/FR
  • 10 Gastroenterolgy, CH Pasteur, 68024 - Colmar/FR
  • 11 Gastroenterology And Digestive Oncology, CH Orleans, 45100 - Orleans/FR
  • 12 Department Of Oncology, CHU Charles Nicolle, 76031 - Rouen/FR
  • 13 Digestive Oncology, Clinique Armoricaine de Radiologie, 22000 - St. Brieuc/FR
  • 14 Medical Oncology, Clinique Victor Hugo, 72000 - Le Mans/FR
  • 15 Digestive Oncology, CH General (Niort), 79021 - Niort/FR
  • 16 Gastroenterology, CHU Le Bocage, FFCD, Burgundy University, INSERM U866, 21079 - Dijon/FR
  • 17 Department Of Gastroenterology And Digestive Oncology, Hôpital Européen Georges Pompidou, Paris/FR
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Resources

Abstract 4031

Background

Optimal therapeutic strategy in patients (pts) with RCSM remains discussed and many front-line options can be discussed to best treat primary tumor and metastatic disease: surgery (S), radiotherapy (RT), chemoradiotherapy (CRT) or chemotherapy (CT). The FFCD 1102 trial evaluated the efficacy of upfront FOLFIRINOX in this setting.

Methods

Chemotherapy-naïve pts with RCSM received FOLFIRINOX: oxaliplatin 85 mg/m2 d1 + irinotecan 180 mg/m2 D1 + leucovorin 400 mg/m2 d1 followed by 5FU 400 mg/m2 bolus d1 and 2,400 mg/m2 46h continuous infusion biweekly; 8 cycles were mandatory. CT-scan and MRI at baseline, 2 and 4 months (m) were centrally reviewed. The objective responses were assessed on CT-scan for metastases (RECIST criteria) and MRI for rectal tumor (volume decrease ≥ 70%). The primary endpoint was disease control rate at 4 m (4m DC). With a Simon 2-stage design, a targeted (H1) 4m DC > 75% was defined (unilateral alpha of 5% and statistical power of 90%).

Results

65 pts were enrolled (07/2012 to 02/2015): male 78%; median age 61 years; PS 0-1 99%; liver metastases 92%; ³2 metastatic sites 63%. All pts received at least 1 cycle of CT, and 85% the 8 planned cycles. The 4m DC was 94% (95% CI, 86.3-97.8). Percentages of patients with local symptoms (rectal bleeding, rectal syndrome, sub-occlusion) were 72%, 16% and 10% at baseline, 2 and 4 m, respectively. For evaluable pts at 4 m, response rates of metastases and primary tumor were 86% (55/64) and 62.5% (30/48). Median follow-up was 35.0 m (95% CI, 31.3-43.7). After 8 cycles of FOLFIRINOX, therapeutic strategy was investigators’ choice: 60 pts (92%) received CT, 38 (58%) had a RT or CRT, 32 (49%) a rectal tumor resection (RS), and 22 (34%) a surgery and/or ablation of their metastases (MS). On ITT, median PFS and OS were 10.9 m (95% CI, 8.8-12.9) and 33.4 m (95% CI, 22.6-38.2), respectively. OS were 17.6 m (95% CI, 11.8-26.4) in 28 pts (43%) who had no surgery, 38.8 m (95% CI, 13.6-44.6) in 15 pts (23%) who had RS only, and 42.1 m [33.45-NA] in 22 pts who had MS.

Conclusions

Front-line FOLFIRINOX allows a good local and distant control of RCSM, and leaves the opportunity to decide best therapeutic strategy according to the response obtained after the induction step.

Clinical trial identification

Clinicaltrials.gov:

Legal entity responsible for the study

FFCD (Fédération Francophone de Cancérologie Digestive)

Funding

FFCD (Fédération Francophone de Cancérologie Digestive)

Disclosure

J-B. Bachet: Honoraria: Bayer, Celgene, Sanofi; consulting or advisory role: Amgen, Bayer, Merck Serono, Servier; travel, accommodations: Celgene, Merck Serono. O. Lucidarme: Consulting or advisory role: Boehringer-Ingelheim; travel, accomodations: Bracco Diagnostics. C.B. Levache: Honoraria: Amgen, Roche/Genentech; consulting or advisory role: Amgen, Roche/Genentech; travel, accommodations: Amgen, Roche/Genentech. J.L. Raoul: Honoraria: Celgene, Merck Serono; consulting or advisory role: Bayer, BTG, Taiho Pharmaceutical; research funding: Celgene. S. Pernot: Honoraria: Amgen. J-P. Lagasse: Expert testimony: Sanofi; travel, accommodations: Ipsen, Merck Serono, Novartis. F. Di Fiore: Honoraria: Amgen, Merck Serono, Roche/Genentech, Sanofi. C. Lepage: Travel, accommodations: Ipsen. J. Taieb: Honoraria: Amgen, Celgene, Lilly, Merck Serono, Roche/Genentech; travel, accommodations: Amgen, Celgene, Merck Serono, Roche/Genentech. All other authors have declared no conflicts of interest.

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