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Annals of Oncology Advance Access published online on June 21, 2006
Annals of Oncology, doi:10.1093/annonc/mdl146
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© 2006 European Society for Medical Oncology
Received February 15, 2006
Revised May 11, 2006
Accepted May 18, 2006

original article

Phase II trial of temozolomide and cisplatin followed by whole brain radiotherapy in non-small-cell lung cancer patients with brain metastases: a GLOT-GFPC study

A. B. Cortot 1, L. Gerinière 1, G. Robinet 2, J.-L. Breton 3, R. Corre 4, L. Falchero 5, H. Berard 6, C. Gimenez 7, J.-M. Chavaillon 8, M. Perol 9, P. Bombaron 10, C. Mercier 11, and P.-J. Souquet 1 *

1 Service de Pneumologie, Centre Hospitalier Lyon Sud, Pierre-Bénite
2 Service d'Oncologie Thoracique, Centre Hospitalier Universitaire Morvan, Brest
3 Service de Pneumologie, Centre Hospitalier, Belfort
4 Service de Pneumologie, Hôpital Pontchaillou, Rennes
5 Service de Pneumologie, Centre Hospitalier, Villefranche-Sur-Saône
6 Service de Pathologie Respiratoire, Hôpital d'Instruction des Armées Sainte-Anne, Toulon
7 Service d'Oncologie Respiratoire, Hôpital Sainte-Marguerite, Marseille
8 Service de Médecine, Centre Hospitalier de la Fontonne, Antibes
9 Service de Pneumologie, Hôpital de la Croix-Rousse, Lyon
10 Service de Pneumologie, Centre Hospitalier, Mulhouse
11 Service de Biostatistique, Centre Hospitalier Lyon Sud, Pierre-Bénite, France

* To whom correspondence should be addressed.
P.-J. Souquet, E-mail: pierre-jean.souquet{at}chu-lyon.fr


  Abstract

Background: Brain metastases (BM) considerably worsen the prognosis of non-small-cell lung cancer (NSCLC) patients. The usefulness and choice of chemotherapy remain uncertain in this indication since these patients are excluded from most clinical trials. We conducted a phase II study to determine the efficacy and tolerability of up-front chemotherapy with association of temozolomide and cisplatin in NSCLC patients with BM.

Patients and methods: Fifty NSCLC patients with BM received temozolomide (200 mg/m2/day for 5 days every 28 days) and cisplatin (75 mg/m2 at day 1 of each cycle), up to six cycles, followed by whole brain radiotherapy (WBRT). An evaluation was carried out every two cycles and after WBRT. WBRT was performed earlier in case of progressive disease at any time or stable disease after cycle 4.

Results: Eight objective responses were achieved (16%). Overall median survival was 5 months. Median time to progression was 2.3 months. Ten patients (20%) presented a grade 3/4 neutropenia and 11 patients (22%) presented a grade 3/4 thrombopenia.

Conclusion: This study demonstrates a lack of efficacy of up-front chemotherapy with association of temozolomide and cisplatin in these patients. Nevertheless, it supports the feasibility of chemotherapy before brain radiotherapy in NSCLC patients with BM.

Keywords: brain metastases; cisplatin; NSCLC; temozolomide.
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