A phase 2 study of gemcitabine and epirubicin for the treatment of pleural mesothelioma: a North Central Cancer Treatment Study, N0021
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, North Central Cancer Treatment Group, Edward Wos, Harold E Windschitl, Loren K Tschetter, Albert Bernath, Philip J Stella, Shaker R Dakhil, John W Kugler, Donald B Wender, Paul L Schaefer, Paul Schwarzenberger, Martin Wiesenfeld, Roscoe F Morton, James D Bearden 3rd, Anthony J Jaslowski, 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, North Central Cancer Treatment Group, Edward Wos, Harold E Windschitl, Loren K Tschetter, Albert Bernath, Philip J Stella, Shaker R Dakhil, John W Kugler, Donald B Wender, Paul L Schaefer, Paul Schwarzenberger, Martin Wiesenfeld, Roscoe F Morton, James D Bearden 3rd, Anthony J Jaslowski
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-dose and 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.
Source: PubMed