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A phase II trial of Vinorelbine and Cisplatin (VP) in stage IIIB non-small cell lung cancer (NSCLC)

Domenii publicaţii > Ştiinţe medicale + Tipuri publicaţii > Articol în revistã ştiinţificã

Autori: Mihailov A, Ciuleanu TE, Todor N, Curca R, Iancu D, Taju N, Cebotaru C, Radulescu I, Neacsu C, Eniu A, Cainap C, Banu E, Homokos H, Ghilezan N.

Editorial: Radioterapie & Oncologie Medicala, VII(2), p.158-162, 2001.

Rezumat:

Vinorelbine is considered the most active Vinka alkaloid in NSCLC, and its association with Cisplatin is still considered the most cost/effective protocol in many institutions. Purpose: To assess, in a phase II trial, the results obtained in locoregionally advanced (stage III B) NSCLC patients with VP combination, delivered in an outpatient setting. Methods: From VIU1999 to V /2000,23 previously untreated patients received VP (Vinorelbine 25 mg/m2, days 1, 8, 15 and Cisplatin 100 mg/m2 day 1 with saline hyperhidration) q3wks. The patients had 3 cycles followed by radiotherapy (RT) at 60 Gy; if indicated. Patients with pleural effusions or necrotic tumor had no RT and continued VP up to 6 cycles (less if progressive disease). Results: Males 83%, age 60 (47-72), WHO PS 1 in 17,2 in 4,3 in 2 patients; histology: large cells 12, squamous 7, adenocarcinoma 4. Toxicity: 58 cycles were given, with no toxic death but 1 withdrawal due to persistent grade 2 nephrotoxicity. Toxicity was mild overall. Grade 3-4 neutropenia occurred in 6 cycles. Grade 3 nausea/vomiting occurred in 1 patient. Activity: at the time of the analysis, 21 were evaluable for response, and 9 patients had an objective response (OR) to CT (=43%, CI [9%-65%]), 2 complet responses (CRs), 7 partial responses (PRs). Survival (S): median S is 8.3 months, with a projected 47% one-year survival. As of June 2000, 18 patients were alive and 5 have died by disease progression (2 locoregional failure, 3 locoregional failure and distant metastases). Conclusion: The combination of Vinorelbine and Cisplatin proved active in advanced NSCLC patients and was safely delivered in an outpatient setting, with manageable toxicity.

Cuvinte cheie: cancer pulmonar, chimioterapie // lung cancer, chemotherapy