A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma : A North Central Cancer Treatment Study, N0021

✍ Scribed by Scott H. Okuno; Robert Delaune; Jeff A. Sloan; Nathan R. Foster; Matthew J. Maurer; Marie-Christine Aubry; Kendrith M. Rowland Jr; Gamini S. Soori; Daniel A. Nikcevich; Carl G. Kardinal; Donald W. Northfelt; Alex A. Adjei

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 110 KB
• Volume: 112
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/cncr.23313

✦ Synopsis

Abstract

BACKGROUND.

The North Central Cancer Treatment Group (NCCTG) conducted a phase 2 study to evaluate the antitumor activity of the combination of gemcitabine and epirubicin in patients with pleural mesothelioma who received no more than 1 prior chemotherapy regimen.

METHODS.

A total of 23 patients were accrued between August 2001 and April 2002 and received gemcitabine at a dose of 1000 mg/m^2^ intravenously over 30 minutes weekly every 2 weeks and epirubicin at a dose of 90 mg/m^2^ intravenously on Day 1 on an every‐21‐days cycle (high‐dose patient group). Between August 2002 and April 2004, an additional 45 patients were treated at a reduced dose of gemcitabine of 750 mg/m^2^ and epirubicin at a dose of 70 mg/m^2^ with the same schedule (low‐dose patient group).

RESULTS.

In the high‐dose patient group, the confirmed response rate was 13% (95% confidence interval [95% CI], 3–34%). The median survival was 9.3 months (95% CI, 7.4–10.7 months) and the median time to disease progression was 6.3 months (95% CI, 3.0–7.6 months). In the low‐dose patient group, the confirmed response rate was 7% (95% CI, 0–28%). The median survival was 5.7 months (95% CI, 4.7–8.7 months) and the median time to disease progression was 4.2 months (95% CI, 2.7–5.6 months). Toxicity was moderate to severe. In the high‐doseand low‐dose groups, 87% and 60% of patients, respectively, experienced at least 1 adverse event of grade 4 or higher (according to National Cancer Institute Common Toxicity Criteria [version 2.0]). The quality of life remained similar from baseline to the end of the 2 cycles of treatment in the high‐dose group but worsened in the low‐dose group.

CONCLUSIONS.

In the current study, the combination regimen of gemcitabine and epirubicin was found to demonstrate minimal antitumor activity against pleural mesothelioma. Cancer 2008. © 2008 American Cancer Society.