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Gastrointestinal tumours, colorectal 1

893 - Bevacizumab (Bev) or cetuximab (Cet) plus chemotherapy after progression with bevacizumab plus chemotherapy in patients with wild-type (WT) KRAS metastatic colorectal cancer (mCRC): final analysis of a French randomized, multicenter, phase II study (PRODIGE 18).

Date

09 Sep 2017

Session

Gastrointestinal tumours, colorectal 1

Topics

Cytotoxic Therapy;  Colon and Rectal Cancer

Presenters

Jaafar Bennouna

Citation

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

Authors

J. Bennouna1, S. Hiret2, C. Borg3, A. Bertaut4, O. Bouche5, G. Deplanque6, E. Francois7, T. Conroy8, F. Ghiringhelli9, G. des Guetz10, J. Seitz11, P. Artru12, T. Stanbury13, S. Charpentier14, M. Denis14, A. Adenis15

Author affiliations

  • 1 Imad - Digestive Oncology, CHU Nantes, 44093 - Nantes/FR
  • 2 Medical Oncology, Institut de Cancérologie de l'Ouest, 44805 - Saint-Herblain/FR
  • 3 Medical Oncology, CHU de Besançon, 2500 - Besançon/FR
  • 4 Biostatistics, Georges-Francois Leclerc Cancer Center, 21000 - Dijon/FR
  • 5 Gastroenterology, CHU reims, Reims/FR
  • 6 Medical Oncology, Hopital Riviera Chablais, 1800 - Vevey/CH
  • 7 Medical Oncology, Centre Antoine Lacassagne, Nice/FR
  • 8 Medical Oncology, Institut de Cancérologie de Lorraine, 54519 - Vandoeuvre-Lès-Nancy/FR
  • 9 Medical Oncology, Georges-Francois Leclerc Cancer Center, 21000 - Dijon/FR
  • 10 Medical Oncology, CHU Saint-Denis, 87 - Limoges/FR
  • 11 Gastroenterology, APHM, 13385 - Marseille/FR
  • 12 Gastroenterology, Hôpital Privé Jean Mermoz, 69373 - Lyon/FR
  • 13 Investigation Center, Unicancer, 75013 - Paris/FR
  • 14 Molecular Biology, CHU Nantes, 44093 - Nantes/FR
  • 15 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
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Abstract 893

Background

Second-line treatment with chemotherapy plus Bev or Cet is now established as a valid option in mCRC. The main objective of this French multicenter, randomized open phase II trial, was to evaluate the Progression Free Survival (PFS) rate at 4 months with chemotherapy plus Bev or Cet in patients with disease progression after Bev plus chemotherapy.

Methods

The main eligibility criterion was disease progression after bevacizumab + 5-FU with irinotecan or oxaliplatin in patients with WT KRAS exon 2 mCRC. Patients were randomized in Arm A (FOLFIRI or mFOLFOX6 plus Bev) or in Arm B (FOLFIRI or mFOLFOX6 plus Cet); the chemotherapy doublet was chosen according to the first line (cross over). Analyses were performed in ITT population. They were repeated on the KRAS + NRAS WT population and in the triple negative population (KRAS, NRAS, and BRAF negative).

Results

From October 2010 to May 2015, 133 patients were included in 25 sites (1 patient ineligible): 85 males (64%), PS 0 (74, 56%), 1 (54, 41%), unknown (4, 3%). The 4-month PFS rate was 80.3% [95%CI (68.0% - 88.3%)] in Arm A and 66.7% [95%CI (53.6% - 76.8%)] in Arm B. Median PFS was 7.1 months in Arm A vs 5.6 months in Arm B (p = 0.060). Median OS reached 15.8 months in Arm A vs 10.4 months in Arm B (p = 0.073). Tumors samples were collected by a central laboratory and 95 were analysed using the KRAS/BRAF mutation analysis panel kit (KRAS exon 2,3,4 and BRAF V600E) and NRAS mutation detection kit (exons 2,3,4; Entrogen). On the whole, 81 patients were KRAS and NRAS WT (41 in Arm A and 40 in Arm B). Median PFS was respectively 7.8 months and 5.6 months in Arm A and Arm B (p = 0.076); median OS was 21.0 months in Arm A vs 10.7 months in arm B (p = 0.324). 73 were negative for the 3 genes (n = 36 and 37). Their median PFS were 8.2 months in Arm A) vs 5.7 months in arm B (p = 0.100). Median OS was 21.1 months vs 12.6 months (p = 0.365).

Conclusions

PRODIGE18 study is in favour of bevacizumab continuation beyond progression with chemotherapy cross over in WT RAS mCRC initially treated with first-line Bev plus chemotherapy.

Clinical trial identification

Clinical trial information:

Legal entity responsible for the study

UNICANCER

Funding

Roche

Disclosure

J. Bennouna: Advisory Board for Roche, Boehringer Ingelheim, AstraZeneca, Servier, BMS. S. Hiret: Roche, Boehringer Ingelheim, AstraZeneca. C. Borg: Roche, Sanofi, Servier. O. Bouche: Roche, Merck, Amgen, Lilly, Pierre Fabre, Boehringer Ingelheim, Novartis. E. Francois: Advisory Board: Roche, Merck. F. Ghiringhelli: Roche, Sanofi, Amgen, BMS. J-F. Seitz: Roche, Merck, Sanofi. P. Artru: Roche, Merck, Amgen. A. Adenis: Roche. All other authors have declared no conflicts of interest.

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