PEPCOL: a GERCOR randomized phase II study of nanoliposomal irinotecan PEP02 (MM-398) or irinotecan with leucovorin/5-fluorouracil as second-line therapy in metastatic colorectal cancer.

Autor: Chibaudel B; Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France.; Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France.; Preclinical and Translational Cancer Research Unit, AAREC Filia Research (AFR), Paris, France., Maindrault-Gœbel F; Department of Medical Oncology, Saint-Antoine Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Paris, France., Bachet JB; Department of Gastroenterology, La Pitié-Salpetrière Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Paris, France., Louvet C; Department of Medical Oncology, Montsouris Mutualiste Institute, Paris, France., Khalil A; Department of Medical Oncology, Tenon Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Paris, France., Dupuis O; Department of Medical Oncology, Victor Hugo Clinic, Le Mans, France., Hammel P; Department of Gastroenterology, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Clichy, France., Garcia ML; Department of Medical Oncology, Saint-Antoine Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Paris, France., Bennamoun M; Department of Medical Oncology, Montsouris Mutualiste Institute, Paris, France., Brusquant D; Groupe Coopérateur Multidisciplinaire en Oncologie (GERCOR), Paris, France., Tournigand C; Department of Medical Oncology, Henri Mondor Hospital, Créteil, France., André T; Department of Medical Oncology, Saint-Antoine Hospital, Assistance Publique des Hôpitaux de Paris (APHP), Paris, France., Arbaud C; Methodological and quality of life unit in oncology (EA3181) & Quality of life and cancer clinical research platform, CHU Besançon, Besançon, France., Larsen AK; Cancer Biology and Therapeutics, INSERM U938 and Pierre and Marie Curie University, Paris, France., Wang YW; PharmaEngine, Inc., Taipei, Taiwan., Yeh CG; PharmaEngine, Inc., Taipei, Taiwan., Bonnetain F; Methodological and quality of life unit in oncology (EA3181) & Quality of life and cancer clinical research platform, CHU Besançon, Besançon, France., de Gramont A; Department of Medical Oncology, Franco-British Institute, Levallois-Perret, France.
Jazyk: angličtina
Zdroj: Cancer medicine [Cancer Med] 2016 Apr; Vol. 5 (4), pp. 676-83. Date of Electronic Publication: 2016 Jan 24.
DOI: 10.1002/cam4.635
Abstrakt: A multicenter, open-label, noncomparative, randomized phase II study (PEPCOL) was conducted to evaluate the efficacy and safety of the irinotecan or PEP02 (MM-398, nanoliposomal irinotecan) with leucovorin (LV)/5-fluorouracil (5-FU) combination as second-line treatment in patients with metastatic colorectal cancer (mCRC). Patients with unresectable mCRC who had failed one prior oxaliplatin-based first-line therapy were randomized toirinotecan with LV/5-FU (FOLFIRI) or PEP02 with LV/5-FU (FUPEP; PEP02 80 mg/m(2) with LV 400 mg/m(2) on day 1 and 5-FU 2400 mg/m(2) on days 1-2). Bevacizumab (5 mg/kg, biweekly) was allowed in both arms. The primary endpoint was 2-month response rate (RR). Fifty-five patients were randomized (FOLFIRI, n = 27; FUPEP, n = 28). In the intent-to-treat population (n = 55), 2-month RR response rate was observed in two (7.4%) and three (10.7%) patients in the FOLFIRI and FUPEP arms, respectively. The most common grade 3-4 adverse events reported in the respective FOLFIRI and FUPEP arms were diarrhea (33% vs. 21%), neutropenia (30% vs. 11%), mucositis (11% vs. 11%), and grade 2 alopecia (26% vs. 25%). FUPEP has activity and acceptable safety profile in oxaliplatin-pretreated mCRC patients.
(© 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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