Annals of Oncology 12:59-67, 2001
© 2001 European Society for Medical Oncology
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Results of a phase III study of early versus delayed whole brain radiotherapy with concurrent cisplatin and vinorelbine combination in inoperable brain metastasis of non-small-cell lung cancer: Groupe Françcais de Pneumo-Cancéerologie (GFPC) Protocol 95–1*
1Centre Hospitalier Universitaire Morvan Brest
2Hopital Samte Marguerite Marseille
3Centre Hospitalier Belfort
4Hopital Ponlchaillou Rennes
5Centre Hospitalier Universitaire et Centre René Gauducheau Nantes
6Centre Hospitalier Universitaire Nunes
7Centre Hospitalier Universitaire Rouen
8Centre Hospitalier Universitaire Saint-Euenne
9Centre Hospitalier Universitaire Strasbourg
10Centre Hospitalier Valence
11Centre Léon Bérard
12GFPC Centre Hospitalier Universitaire Lyon, France
PURPOSE: To determine if the timing of whole brain radiotherapy (WBRT) with respect to chemotherapy with cisplatin and vinorelbine would influence survival in patients with non-small-cell lung cancer (NSCLC) and concurrent brain metastasis.
PATIENTS AND METHODS: One hundred seventy-six patients with brain metastasis from NSCLC were included in the study between July1995 and October 1997 All patients received chemotherapy with cisplatin 100 mg/m2on day 1 and vinorelbine 30 mg/m2on days 1, 8, 15, 22 Cycles were repeated every four weeks. Evaluation of response was performed after two, four or six cycles After two cycles, chemotherapy was administered to the responders to a maximum of six cycles. Patients were randomised to receive WBRT 30 Gy/10 fx/12 days and delayed corticosteroids,(arm A) for the intracranial nonresponders, or early on day 1 to 12 during the first cycle of chemotherapy (arm B)
RESULTS: One hundred seventy-one patients were eligible, eighty-six in arm A and eighty-five in arm B, none had received prior chemotherapy; seventy-six and seventy-three, respectively,, were assessable for response There was a 21% overall objective response rate (OR) (with1 complete response and 17 partial responses) after two cycles of chemotherapy alone (arm A) and a 20% OR (with 17 partial responses) to chemotherapy and early WBRT (arm B). The intracranial OR was 27% and 33%, respectively (P=0 12) The six months survival rate (46% and 40%) and the median survival duration (24 and 21 weeks, respectively) were not significantly different between the two arms (P= 0 83, log-rank test) The major toxicity was severe or life-threatening neutropenia (grade 4), which occurred in 35% of arm A patients and 36% of arm B patients. There were thirteen treatment-related deaths(six in arm A and seven in arm B). There was no difference between the arms for haematological and neuro-toxicities.
CONCLUSIONS: These results confirm the efficacy of chemotherapy in brain metastases of NSCLC and suggest that the timing (early or delayed) of WBRT did not influence survival of NSCLC with brain metastasis treated with concurrent chemotherapy.
brain metastases, chemotherapy, lung cancer, radiotherapy
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