Annals of Oncology Advance Access originally published online on May 25, 2008
Annals of Oncology 2008 19(10):1691-1697; doi:10.1093/annonc/mdn354
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lung cancer |
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.
Key words: 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.