Irinotecan and vinorelbine in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. A phase II study of the Hellenic Cooperative Oncology Group

• Published in: Anticancer research Vol. 22; no. 6B; p. 3501
• Main Authors: Pectasides, D, Fountzilas, G, Rigopoulos, A, Bountouroglou, N G, Koutras, A, Glotsos, J, Onyenadum, A, Makatsoris, Th, Kalofonos, H P
• Format: Journal Article
• Language: English
• Published: Greece 01.11.2002
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Carboplatin - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Cisplatin - therapeutic use; Drug Resistance, Neoplasm; Female; Humans; Lung Neoplasms - drug therapy; Male; Middle Aged; Vinblastine - administration & dosage; Vinblastine - adverse effects; Vinblastine - analogs & derivatives
• ISSN: 0250-7005

To evaluate the efficacy and tolerability of irinotecan plus vinorelbine every 2 weeks in patients with advanced non-small cell lung cancer (NSCLC), previously treated with platinum-based chemotherapy. Forty-one patients with advanced NSCLC, refractory or resistant to platinum derivatives, were treated on an out-patient basis with irinotecan 150 mg/m2 intravenous (i.v.) and vinorelbine 25 mg/m2 on days 1 and 15. Chemotherapy was repeated every 4 weeks. The response was evaluated every two cycles. On an intent-to-treat analysis, 6 patients (14.6%) [95% confidence interval (CI) 5.57% to 29.17%] achieved partial response (PR), 15 (36.6%) stable disease (SD) and 20 (48.8%) progressive disease (PD). The median time to tumor progression (TTP) was 4.9 months (range 0.17-15.5 months), the median survival time was 7.8 months (range 0.9 to 19.6 months) and the 1-year survival rate was 37%. Symptomatic benefit response including improvement of performance status (PS), dyspnea, anorexia and fatigue, cessation of hemoptysis, fever and reduction of cough and pain was seen in 10 to 42% of patients. No patient experienced grade 3/4 anemia. Grade 3/4 thrombocytopenia occurred in 2 (5%) patients. Five patients (12%) developed grade 3/4 neutropenia and 5 (12%) had neutropenic fever that required hospitalization, but was successfully treated with antibiotics and G-CSF support. One patient (2%) developed grade 4 fatigue and was withdrawn. Other grade 3/4 adverse events included diarrhea (n = 3; 2 required hospitalization), alopecia (n = 5) and neurotoxicity (n = 1). Six patients required a dose reduction. The combination of irinotecan plus vinorelbine administered every 2 weeks demonstrated rather low activity in advanced NSCLC patients who had previously failed platinum-based chemotherapy, but it was well-tolerated and was associated with increased 1-year survival rate and improvement in cancer related symptoms.