Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study

The role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer. Within 8 weeks after surgery, patients w...

Celý popis

Uložené v:

Podrobná bibliografia
Vydané v:	Journal of clinical oncology Ročník 28; číslo 29; s. 4450
Hlavní autori:	Van Laethem, Jean-Luc, Hammel, Pascal, Mornex, Françoise, Azria, David, Van Tienhoven, Geertjan, Vergauwe, Philippe, Peeters, Marc, Polus, Marc, Praet, Michel, Mauer, Murielle, Collette, Laurence, Budach, Volker, Lutz, Manfred, Van Cutsem, Eric, Haustermans, Karin
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 10.10.2010
Predmet:	Adult Aged Antimetabolites, Antineoplastic - adverse effects Antimetabolites, Antineoplastic - therapeutic use Chemotherapy, Adjuvant Combined Modality Therapy Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Diarrhea - chemically induced Drug Administration Schedule Fatigue - chemically induced Feasibility Studies Female Humans Kaplan-Meier Estimate Male Middle Aged Nausea - chemically induced Pancreatic Neoplasms - drug therapy Pancreatic Neoplasms - radiotherapy Pancreatic Neoplasms - surgery Radiotherapy, Adjuvant Treatment Outcome
ISSN:	1527-7755, 1527-7755
On-line prístup:	Zistit podrobnosti o prístupe
Tagy:	Pridať tag Žiadne tagy, Buďte prvý, kto otaguje tento záznam!

Popis
Shrnutí:	The role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer. Within 8 weeks after surgery, patients were randomly assigned to receive either four cycles of gemcitabine (control arm) or gemcitabine for two cycles followed by weekly gemcitabine with concurrent radiation (50.4 Gy; CRT arm). The primary objective was to exclude a < 60% treatment completion and a > 40% rate of grade 4 hematologic or GI toxicity in the CRT arm with type I and II errors of 10%. Secondary end points were late toxicity, disease-free survival (DFS), and overall survival (OS). Between September 2004 and January 2007, 90 patients were randomly assigned (45:45). Patient characteristics were similar in both arms. Treatment was completed per protocol by 86.7% and 73.3% (80% CI, 63.1% to 81.9%; 95% CI, 58.1% to 85.4%) in the control and CRT arms, respectively, and grade 4 toxicity was 0% and 4.7% (two of 43; 80% CI, 1.2% to 11.9%), respectively. In the CRT arm, three patients experienced grade 3-related late toxicity. Median DFS was 12 months in the CRT arm and 11 months in the control arm. Median OS was 24 months in both arms. First local recurrence was less frequent in the CRT arm (11% v 24%). Adjuvant gemcitabine-based CRT is feasible, well-tolerated, and not deleterious; adding this treatment to full-dose adjuvant gemcitabine after resection of pancreatic cancer should be evaluated in a phase III trial.
Bibliografia:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3
ISSN:	1527-7755 1527-7755
DOI:	10.1200/JCO.2010.30.3446