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

Abstract Purpose The objective of this randomised phase II study was to evaluate the impact in terms of response and toxicities of inductionor consolidation chemotherapy respectively before or after concurrent chemoradiotherapyin unresectable stage III non-small-cell lung cancer. Patients and methods In the inductionarm, patients received induction chemotherapywith 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, vinorelbine15 mg/m 2 days 1, 8, 29, 36, 57 and 64). In consolidation arm, the same concurrent chemoradiotherapybegan on day 1 followed by two cycles of cisplatin and paclitaxel. Results One hundred twenty seven patients were randomised. The intent to treat response rates in inductionand consolidation arms were 58% and 56% respectively. Median survival was 19.6 months in inductionarm 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 inductionarm (17% versus 10%). Conclusion Cisplatin-based chemotherapy as inductionor consolidation with concurrent chemoradiotherapycan be administrated safely. Response rates were similar in both arms with a trend in favour for consolidation arm for long-term survival.