Gemcitabine and vinorelbine in pemetrexed-pretreated patients with malignant pleural mesothelioma

✍ Scribed by Paolo A. Zucali; Giovanni L. Ceresoli; Isabella Garassino; Fabio De Vincenzo; Raffaele Cavina; Elisabetta Campagnoli; Federico Cappuzzo; Silvia Salamina; Hector J. Soto Parra; Armando Santoro

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 112 KB
• Volume: 112
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.23337

✦ Synopsis

Abstract

BACKGROUND

Pemetrexed‐cisplatin chemotherapy is the standard of care in the first‐line treatment of unresectable malignant pleural mesothelioma (MPM). Second‐line cytotoxic therapy is considered for a growing group of patients, but the optimal treatment has not been defined to date. Gemcitabine and vinorelbine have shown activity in the first‐line setting. The objective of this study was to evaluate the activity and toxicity of the gemcitabine‐vinorelbine combination in pemetrexed‐pretreated patients with MPM.

METHODS

From January 2004 to September 2006, 30 consecutive patients who were pretreated with pemetrexed with or without a platinum‐derivative were enrolled. Gemcitabine 1000 mg/m^2^ and vinorelbine 25 mg/m^2^ were administered intravenously on Days 1 and 8 every 3 weeks. Treatment was repeated for a maximum of 6 cycles or until progression or unacceptable toxicity.

RESULTS

A partial response was observed in 3 patients (10%; 95% confidence interval [CI], 2.1–26.5%), and 10 patients (33.3%; 95% CI, 17.3–52.8%) had stable disease after treatment. Overall, 13 patients (43.3%; 95% CI, 25.5–62.6%) achieved disease control. The median time to progression was 2.8 months (range, 0.6–12.1 months), and the median survival was 10.9 months (range, 0.8–25.3 months). Hematologic toxicity was acceptable, with grade 3 or 4 neutropenia occurring in 11% of patients and thrombocytopenia occurring in 4% of patients; no case of febrile neutropenia was observed. Nonhematologic toxicity generally was mild.

CONCLUSIONS

The gemcitabine and vinorelbine combination was moderately active and had an acceptable toxicity profile in pemetrexed‐pretreated patients with MPM. The role of second‐line treatment in MPM needs to be evaluated in prospective trials in large series of patients who are stratified according to previous treatment and prognostic factors. Cancer 2008. © 2008 American Cancer Society.