Frontline gemcitabine and cisplatin based chemotherapy in patients with NSCLC inoperable brain metastases

Abstract

7117 Background: Inoperable brain metastases in NSCLC treated with whole brain radiotherapy (WBR) reach a median survival shorter than 6 months. We have proposed in this situation, a frontline chemotherapy association. The purpose of this study is to evaluate the efficacy of gemcitabine and cisplatin in the treatment of NSCLC patients with unresectable brain metastases. Patients and methods: Patients with NSCLC and unresectable CNS metastasis, after signed informed consent, received gemcitabine 1000 mg/m2 and cisplatin 50 mg/m2, both delivered on days 1 and 8, every 3 to 4 weeks. Results: 40 consecutive patients were enrolled in our institution. 35 chemotherapy-naïve had synchronous brain metastases. 5 patients were enrolled after brain relapse following previous chemotherapy (disease free interval: mean: 13.2 months, range: 9–26). 3 patients are not evaluable because of early death, after 0, 6 and 8 weeks, respectively. After 2 cycles, the response rate (RR) in brain metastases was 62% in 36 evaluable patients. After 4 cycles the RR was 86% in 21 evaluable patients . With 9 complete responses and 14 partial responses, the overall RR was 64%. 2 patients had stable disease. All but 3 of the responding patients had a response on their primary lung tumor lesion. The mean duration of response was 6.8 months and the overall mean survival is 6.0 months overall and 7,2 months in responding patients. Toxicity: no infection, no bleeding, no non-hemato toxicity > gr2 was seen; no particular CNS toxicity post RT was noticed (46% of the patients received WBR) . Conclusions: This chemotherapy regimen shows encouraging activity in NSCLC patients with inoperable CNS metastases. We will present the general characteristics and prognostic factors of these patients in june 2004. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly