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Randomized Controlled Trial Multicenter Study Comparative Study
Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01.
- Pierre Fournel, Alain Vergnenégre, Gilles Robinet, Hervé Léna, Radj Gervais, Hervé Le Caer, Souquet Pierre-Jean PJ University Hospital Lyon, France., Jean-Michel Chavaillon, Marie-Cécile Bozonnat, Jean-Pierre Daurès, Christos Chouaid, Isabelle Martel-Lafay, and GFPC and IFCT Team.
- University Hospital Saint-Etienne, France. Electronic address: pierre.fournel@icloire.fr.
- Eur. J. Cancer. 2016 Jan 1; 52: 181-7.
PurposeThe objective of this randomised phase II study was to evaluate the impact in terms of response and toxicities of induction or consolidation chemotherapy respectively before or after concurrent chemoradiotherapy in unresectable stage III non-small-cell lung cancer.Patients And MethodsIn the induction arm, patients received induction chemotherapy with cisplatin (80 mg/m(2)) and paclitaxel (200 mg/m(2)) on days 1 and 29 followed by a concurrent chemoradiotherapy (66 Gy in 33 fractions, cisplatin 80 mg/m(2) days 1, 29 and 57, vinorelbine 15 mg/m(2) days 1, 8, 29, 36, 57 and 64). In consolidation arm, the same concurrent chemoradiotherapy began on day 1 followed by two cycles of cisplatin and paclitaxel.ResultsOne hundred twenty seven patients were randomised. The intent to treat response rates in induction and consolidation arms were 58% and 56% respectively. Median survival was 19.6 months in induction arm and 16.3 months in consolidation arm and 4-year survival rates were 21% and 30% respectively. Haematologic and non-haematologic toxicities were similar in both arms, except grade 3/4 oesophagitis, more frequent in consolidation arm than in induction arm (17% versus 10%).ConclusionCisplatin-based chemotherapy as induction or consolidation with concurrent chemoradiotherapy can be administrated safely. Response rates were similar in both arms with a trend in favour for consolidation arm for long-term survival.Copyright © 2015 Elsevier Ltd. All rights reserved.
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