Post-gemcitabine therapy for patients with advanced pancreatic cancer - A comparative review of randomized trials evaluating oxaliplatin- and/or irinotecan-containing regimens.
A systematic review and critical evaluation of randomized trial evidence for oxaliplatin- or irinotecan-containing regimens in patients with advanced pancreatic cancer previously treated with gemcitabine has not yet been published. We conducted a comparative systematic review of randomized trials evaluating oxaliplatin- or irinotecan-based therapies in patients with advanced pancreatic cancer previously treated with gemcitabine to assess trial similarity and the feasibility of performing an indirect treatment comparison (ITC). Studies were identified through PubMed and key oncology conference abstracts. The following trials met our criteria: NAPOLI-1 (nanoliposomal irinotecan [nal-IRI] or nal-IRI+5-fluorouracil [5-FU]/leucovorin [LV] vs 5-FU/LV), CONKO-003 (oxaliplatin+5-FU/LV [OFF] vs 5-FU/LV), PANCREOX (oxaliplatin+5-FU/LV [mFOLFOX6] vs 5-FU/LV), and Yoo et al. (2009) (irinotecan+5-FU/LV [mFOLFIRI3] vs mFOLFOX). Fundamental differences were identified in study design (i.e., number of study sites, number of countries), patient (i.e., locally advanced vs metastatic disease, stratification variables, prior and subsequent treatments) and treatment (i.e., regimens, dose intensity) characteristics, and primary and secondary outcomes (i.e., primary vs secondary outcomes, overall survival [OS], progression-free survival [PFS]) among the 4 included trials. Our comparative review demonstrated significant dissimilarity across trials, which precluded conducting an ITC. In the absence of head-to-head nal-IRI- and/or oxaliplatin-based therapy trials, clinicians are advised to interpret these studies separately within the context of their individual patient population.
Medical School Hannover, Department of Gastroenterology, Hematology and Endocrinology, Carl-Neubergstr. 1, 30659 Hannover, Germany. Electronic address: vogel.arndt@mh-hannover.de.
Arndt
A
Vogel
Dipartimento di Medicina Clinica e Sperimentale "F. Magrassi", Seconda Università degli Studi di Napoli, Via S. Pansini 5, 80131 Napoli, Italy. Electronic address: Fortunato.CIARDIELLO@unina2.it.
Fortunato
F
Ciardiello
Department of Medical Oncology, The Christie NHS Foundation Trust, Wilmslow Road, Manchester M20 4BX, United Kingdom. Electronic address: Richard.Hubner@christie.nhs.uk.
Richard A
RA
Hubner
Department of Hepato-Gastroenterology and Digestive Oncology, CHU Bordeaux, Hôpital Haut-Lévêque, avenue de Magellan, 33600 Pessac, France. Electronic address: jean-frederic.blanc@chu-bordeaux.fr.
Jean-Frédéric
JF
Blanc
Medical Oncology Department, Ramon y Cajal University Hospital, IRYCIS, Alcala University, Carretera Colmenar Viejo km 9.1, 28034 Madrid, Spain. Electronic address: acarrato@telefonica.net.
Alfredo
A
Carrato
Shire, 650 East Kendall Street, Cambridge, MA 02145, United States. Electronic address: Yoojung.yang@baxalta.com.
Yoojung
Y
Yang
Pharmerit International, 4350 East West Highway, Suite 430, Bethesda, MD 20814, United States. Electronic address: dpatel@pharmerit.com.
Dipen A
DA
Patel
Pharmerit International, 4350 East West Highway, Suite 430, Bethesda, MD 20814, United States. Electronic address: vektare@pharmerit.com.
Varun
V
Ektare
Shire, Thurgauerstrasse 130, 8152 Glattpark (Opfikon), Zürich, Switzerland. Electronic address: Floris.de.Jong@shire.com.
Floris A
FA
de Jong
University of British Columbia, BC Cancer Agency, 600 W. 10th Avenue, Vancouver, BC V5Z 4E6, Canada. Electronic address: sgill@bccancer.bc.ca.
Sharlene
S
Gill
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008081:Liposomes; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016032:Randomized Controlled Trials as Topic; D000093542:Gemcitabine
D008081:Liposomes; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin; D000093542:Gemcitabine
Indirect treatment comparison (ITC); Irinotecan; Nanoliposomal irinotecan/nal-IRI; Oxaliplatin; Pancreatic cancer; Randomized trial