Annals of Oncology Advance Access published online on May 25, 2008
Annals of Oncology, doi:10.1093/annonc/mdn354
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A phase III randomised study of concomitant induction radiochemotherapy testing two modalities of radiosensitisation by cisplatin (standard versus daily) for limited small-cell lung cancer
1 Institut Jules Bordet, Brussels, Belgium
2 CHRU Calmette, Lille, France
3 Hellenic Cancer Institut, St-Savas Hospital, Athens, Greece
4 CH de Douai, France
5 CHU de Charleroi, Belgium
6 Hôpital de Hayange France
7 CHR St-Joseph-Warquignies, Boussu, Belgium
Correspondence to: Prof. J. P. Sculier, Department of Critical Care & Thoracic Oncology, Institut Jules Bordet, Université Libre Bruxelles (ULB), 1, rue Héger-Bordet, B-1000 Bruxelles, Belgium. Tel: +32 2 541 31 85; Fax: +32 2 534 37 56; E-mail: sculier{at}bordet.be
Background: The purpose of this study was to determine in limited small-cell lung cancer if locoregional irradiation concurrently with induction chemotherapy with cisplatin and etoposide prolongs survival when cisplatin is given daily as a radiosensitiser.
Patients and methods: Two-hundred and four eligible patients were randomised between standard radiosensitised induction chemoradiotherapy (arm A) with cisplatin (90 mg/m2 day 1) plus etoposide and daily radiosensitised induction chemoradiotherapy (arm B) with cisplatin (6 mg/m2/day) plus etoposide. Chemotherapy and chest irradiation (39.90 Gy in 15 fractions >3 weeks) both started on day 1.
Results: There was no difference in survival between both arms with respective median, 2 and 5 years of 15.5 months, 35% and 18% in arm A and 17.0 months, 38% and 21% in arm B (P = 0.50). Performance status and T status were identified as independent prognostic factors for survival. In terms of local control rate, there was a statistical trend in favour of arm A with 2% only local relapse versus 10% in arm B. Daily cisplatin radiosensitisation was associated with more oesophagitis and thrombopenia but less nephrotoxicity.
Conclusion: Induction chemoradiotherapy resulted in both arms in good long-term survival, comparable to the best reported results and without improvement by daily cisplatin administration.
small cell lung cancer, radiochemotherapy, limited disease, cisplatin
Received for publication March 13, 2008. Revision received April 21, 2008. Accepted for publication April 22, 2008.