Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: A phase II study of the Southwest Oncology Group (SWOG 9810)

Lung Cancer. 2007 Nov 13 [Epub ahead of print] [Link]

Kalmadi SR, Rankin C, Kraut MJ, Jacobs AD, Petrylak DP, Adelstein DJ, Keohan ML, Taub RN, Borden EC.

Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, OH, United States.


Purpose: The purpose of this open-label phase II SWOG study was to evaluate the activity of gemcitabine (Gemzar®; Eli Lilly, Indiana, USA) and cisplatin combination therapy, in patients with unresectable malignant mesothelioma of the pleura.

Patients and methods: Fifty eligible chemotherapy naïve patients with histologically proven malignant mesothelioma of the pleura, and a SWOG performance status 0–2 were enrolled between February 1999 and August 2000. Treatment consisted of gemcitabine 1000 mg/m2 and cisplatin 30 mg/m2 on days 1, 8 and 15 of a 28-day cycle, until progression of disease or two cycles beyond complete response.

Results: Using SWOG response criteria, one patient had a confirmed complete response and five patients had a confirmed partial response, for a total response rate of 12% (95% CI 5–24%). All the responses were seen in patients with epithelioid or unspecified histology. Stable disease was seen in 25 patients (50%). The median overall survival was 10 months (95% CI 7–15 months), with a median progression-free survival of 6 months. Sixteen patients experienced Grade 4 toxicity. Twelve of these Grade 4 toxicities were hematologic. There were no treatment-related deaths.

Conclusions: Cisplatin–gemcitabine combination chemotherapy has modest activity with an acceptable toxicity profile, as first line treatment for patients with malignant mesothelioma.

Keywords: Malignant mesothelioma; Cisplatin; Gemcitabine; Chemotherapy; Phase II; Pleural disease