Cisplatin in combination with metronomic vinorelbine as front-line treatment in advanced non-small cell lung cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG)

• Published in: Cancer chemotherapy and pharmacology 2015-04, Vol.75 (4), p.821-827
• Main Authors: Katsaounis, P., Kotsakis, A., Agelaki, S., Kontopodis, E., Agelidou, A., Kentepozidis, N., Vamvakas, L., Christopoulou, A., Karachaliou, N., Hatzidaki, D., Georgoulias, V.
• Format: Article
• Language: English
• Subjects: Administration, Metronomic; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Cisplatin - administration & dosage; Cisplatin - adverse effects; Cisplatin - therapeutic use; Disease-Free Survival; Female; Humans; Kaplan-Meier Estimate; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Invasiveness; Neoplasm Staging; Oncology; Original Article; Pharmacology/Toxicology; Vinblastine - administration & dosage; Vinblastine - adverse effects; Vinblastine - analogs & derivatives; Vinblastine - therapeutic use
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-015-2707-x

Purpose To evaluate the safety and efficacy of metronomic vinorelbine in combination with cisplatin as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC). Patients and methods A total of 41 patients with inoperable stage IIIb or stage IV NSCLC (14 with adenocarcinomas, 19 with squamous cell carcinoma and eight with other types), PS = 0–2, were treated with cisplatin (80 mg/m 2 ) in combination with oral metronomic vinorelbine (60 mg total dose, every other day) in cycles of 21 days. Results A total of 35 patients who received at least one cycle of chemotherapy were evaluable for toxicity and response. Partial response was achieved in 13 patients (ORR 37.1 %; CI 21.1–53.1 %) and stable disease in 10 (28.6 %). After a median follow-up period of 26.2 months (range 0.5–33.4 months), the median progression-free survival was 4.2 months and the median overall survival 12.0 months. The 1-year survival rate was 52.6 %. Myelosuppression was the main adverse event with grade 3 and 4 neutropenia occurring in five (14.3 %) and six (17.1 %) patients, respectively. Three of these patients presented with febrile neutropenia and there was one death due to sepsis. Non-hematologic toxicities were mild. Conclusion Cisplatin in combination with metronomic vinorelbine is an active, although myelotoxic, therapeutic option in the first-line setting for the treatment of patients with locally advanced and metastatic non-small cell lung cancer, which merits further evaluation in randomized trials.