Biweekly schedule of cisplatin with prolonged infusion of gemcitabine in advanced non small cell lung cancer (NSCLC)

Abstract

17093 Background: Firstly, we conducted a phase I of a biweekly schedule of cisplatin with prolonged infusion of gemcitabine (10 mg/m2/min) and stablished the dose to perform a phase II. We present final results of a phase II with this combination. Methods: Patients with cytologically or histologically confirmed NSCLC stage IIIB and IV were included. Treatment consisted of Cisplatin 50 mg/m2 days 1 and 15 with Gemcitabine 1600 mg/m2 in 160 minutes (10 mg/m2/min), days 1 and 15 every 28 days. Chemotherapy was administered to a maximum of 6 cycles; if radiotherapy was planned, patients received 4 cycles. Results: From March-04 to January-05, 55 patients were included. Patient characteristics: Median age 59 years (35–75). Gender: 51 male 4 female. ECOG performance status 0/1/2: 8/43/4. Histology: Squamous cell carcinoma 26 (47.3%), adenocarcinoma 22 (40%), large cell carcinoma 2 (3.6%), undifferentiated 5 (9%). Stage: IIIA 2 (3.6%), IIIB 27 (49.1%) and IV 26 (47.3%). Treatment compliance: Administrations: Mean 6.7 and median 8 (1–12). Dose intensity: Cisplatin 20.35 mg/m2/week (81%) Gemcitabine 632.61 mg/m2/week (79%). Toxicity: Extrahematological toxicity grade 3/4 per patient: nausea 10/0, emesis 6/0, asthenia 31/1, anorexia 14/0, mucositis 1/0, diarrhoea 1/1, infection 4/0, hepatic 2/0, vascular 0/1 (pulmonary thromboembolism). Neurotoxicity grade 1, 13 pt and grade 2, 1 pt. Hematological toxicity grade 3/4: anemia 1/0, thrombocytopenia 5/1, neutropenia 21/9 and neutropenic fever 4/0. Nine patients were hospitalised due to toxicity. There was one toxic death. Response rate: Response was evaluated in 52 pt (3 pt died after first cycle). Overall response rate was 38.1% (95% CI 50.93–25.26%). Complete response 2 (3.6%), Partial response 19 (34.5%), Stable disease 23 (41.8%), Progressive disease 8 (14.5%). Survival: Overall median survival was 9.6 months (95% CI 7.76–11.43): stage III 10.46 and stage IV 8.8. Overall progression-free survival was 8.06 months (95% CI 5.95–10.18): stage III 8.9 and stage IV 6.3. Conclusions: Biweekly cisplatin with prolonged infusion of gemcitabine is an active regimen for advanced NSCLC with a good toxicity profile. This better rational way of gemcitabine infusion should be more profoundly explored. No significant financial relationships to disclose.