• Simon Pernot, Olivier Pellerin, Pascal Artru, Carole Montérymard, Denis Smith, Jean-Luc Raoul, Christelle De La Fouchardière, Laetitia Dahan, Rosine Guimbaud, David Sefrioui, Jean-Louis Jouve, Côme Lepage, David Tougeron, Julien Taieb, and for FFCD1201-DEBIRI investigators/Collaborators.
• Département de Gastroentérologie et d'Oncologie Digestive, Hôpital Européen George Pompidou, Paris, France. simon.pernot@gmail.com.
• Br. J. Cancer. 2020 Aug 1; 123 (4): 518-524.

BackgroundChemo-embolisation with drug-eluting beads loaded with irinotecan (DEBIRI) increased survival as compared with intravenous irinotecan in chemorefractory patients with liver-dominant metastases from colorectal cancer (LMCRC). First-line DEBIRI with systemic chemotherapy may increase survival and secondary resection.MethodsIn the FFCD-1201 single-arm Phase 2 study, patients with untreated, non-resectable LMCRC received DEBIRI plus mFOLFOX6. Four courses of DEBIRI were performed alternating right and left lobe or two sessions with both lobes treated during the same session.ResultsFifty-seven patients were enrolled. Grade 3-5 toxicities were more frequent when both lobes were treated during the same session (90.5% versus 52.8%). Nine-month PFS rate was 53.6% (95% CI, 41.8-65.1%). The objective response rate (RECIST 1.1) was 73.2%, and the secondary R0 surgery was 33%. With a median follow-up of 38.3 months, median OS was 37.4 months (95% CI, 25.7-45.8), and median PFS 10.8 months (95% CI, 8.2-12.3).ConclusionsFront-line DEBIRI + mFOLFOX6 should not be recommended as the hypothesised 9-month PFS was not met. However, high response rate, deep responses, and prolonged OS encourage further evaluation in strategies integrating biologic agent, in particular in patients with secondary surgery as the main goal.Clinical Trial RegistrationNCT01839877.

32 keywords...

hide…