Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: A phase II study of the Southwest Oncology Group (SWOG 9810) Journal Article
| Authors: | Kalmadi, S. R.; Rankin, C.; Kraut, M. J.; Jacobs, A. D.; Petrylak, D. P.; Adelstein, D. J.; Keohan, M. L.; Taub, R. N.; Borden, E. C. |
| Article Title: | Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: A phase II study of the Southwest Oncology Group (SWOG 9810) |
| Abstract: | 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. © 2007 Elsevier Ireland Ltd. All rights reserved. |
| Keywords: | adult; clinical article; controlled study; treatment response; aged; aged, 80 and over; disease-free survival; middle aged; overall survival; clinical trial; constipation; disease course; drug activity; fatigue; neutropenia; cisplatin; diarrhea; drug dose reduction; side effect; gemcitabine; disease free survival; chemotherapy; controlled clinical trial; infection; multiple cycle treatment; neutrophil count; phase 2 clinical trial; sensory neuropathy; anemia; blood toxicity; leukopenia; mucosa inflammation; nausea; thrombocytopenia; antineoplastic combined chemotherapy protocols; dehydration; peripheral neuropathy; creatinine blood level; histology; coughing; dyspnea; febrile neutropenia; confidence interval; malaise; disease severity; malignant mesothelioma; mesothelioma; muscle weakness; thrombocyte count; somnolence; recombinant granulocyte colony stimulating factor; erythrocyte transfusion; deoxycytidine; phase ii; granulocyte colony stimulating factor; cytopenia; pleura; pleural neoplasms; hypersensitivity reaction; performance; adult respiratory distress syndrome; motor neuropathy; perception deafness; pleural disease |
| Journal Title: | Lung Cancer |
| Volume: | 60 |
| Issue: | 2 |
| ISSN: | 0169-5002 |
| Publisher: | Elsevier Ireland Ltd. |
| Date Published: | 2008-05-01 |
| Start Page: | 259 |
| End Page: | 263 |
| Language: | English |
| DOI: | 10.1016/j.lungcan.2007.09.018 |
| PUBMED: | 18006112 |
| PROVIDER: | scopus |
| PMCID: | PMC2702658 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 19" - "Export Date: 17 November 2011" - "CODEN: LUCAE" - "Source: Scopus" |
