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...

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Veröffentlicht in:	Journal of clinical oncology Jg. 28; H. 29; S. 4450
Hauptverfasser:	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
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 10.10.2010
Schlagworte:	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
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Abstract	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.
AbstractList	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.PURPOSEThe 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).PATIENTS AND METHODSWithin 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%).RESULTSBetween 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.CONCLUSIONAdjuvant 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. 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.
Author	Van Cutsem, Eric Haustermans, Karin Peeters, Marc Polus, Marc Van Laethem, Jean-Luc Azria, David Lutz, Manfred Van Tienhoven, Geertjan Hammel, Pascal Praet, Michel Vergauwe, Philippe Mornex, Françoise Budach, Volker Collette, Laurence Mauer, Murielle
Author_xml	– sequence: 1 givenname: Jean-Luc surname: Van Laethem fullname: Van Laethem, Jean-Luc email: JL.Vanlaethem@erasme.ulb.ac.be organization: Department of Gastroenterology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium. JL.Vanlaethem@erasme.ulb.ac.be – sequence: 2 givenname: Pascal surname: Hammel fullname: Hammel, Pascal – sequence: 3 givenname: Françoise surname: Mornex fullname: Mornex, Françoise – sequence: 4 givenname: David surname: Azria fullname: Azria, David – sequence: 5 givenname: Geertjan surname: Van Tienhoven fullname: Van Tienhoven, Geertjan – sequence: 6 givenname: Philippe surname: Vergauwe fullname: Vergauwe, Philippe – sequence: 7 givenname: Marc surname: Peeters fullname: Peeters, Marc – sequence: 8 givenname: Marc surname: Polus fullname: Polus, Marc – sequence: 9 givenname: Michel surname: Praet fullname: Praet, Michel – sequence: 10 givenname: Murielle surname: Mauer fullname: Mauer, Murielle – sequence: 11 givenname: Laurence surname: Collette fullname: Collette, Laurence – sequence: 12 givenname: Volker surname: Budach fullname: Budach, Volker – sequence: 13 givenname: Manfred surname: Lutz fullname: Lutz, Manfred – sequence: 14 givenname: Eric surname: Van Cutsem fullname: Van Cutsem, Eric – sequence: 15 givenname: Karin surname: Haustermans fullname: Haustermans, Karin
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/20837948$$D View this record in MEDLINE/PubMed
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Snippet	The role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the...
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SubjectTerms	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
Title	Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study
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