Abstract
BACKGROUND
Malignant pleural mesothelioma (MPM) is increasing rapidly worldwide. Currently, pemetrexed plus cisplatin chemotherapy showed a survival advantage versus cisplatin alone. No impact on patient survival of surgery, radiotherapy, or their combination has been demonstrated.
METHODS
Eight centers in northeastern Italy participated in a Phase II multicenter study. Chemotherapy was comprised of carboplatin area under the concentrationโtime curve 5 on Day 1 and gemcitabine 1000 mg/m^2^ on Days 1, 8, and 15. This cycle was repeated every 4 weeks.
RESULTS
Between July 1996 and September 2000, 50 patients were treated. Of the sample, 68% were males, 88% had a Eastern Cooperative Oncology Group performance status score of 0โ1, 56% had Stage IโII disease, 68% had epithelioid histology, and 62% had no previous treatments. The delivered dose intensity of gemcitabine was 617 mg/m^2^ per week, which was 82% of the planned dose (750 mg/m^2^ per week). For carboplatin, the delivered dose intensity was 80 mg/m^2^ per week. Overall, 44% of 15th day doses were omitted or reduced. Twentyโsix percent of the patients had partial responses (95% confidence interval: 15โ40%) and 24% had disease progression. None of the patients had complete responses. The median response duration was 55 weeks (range, 13โ113 weeks). Patients had good clinical benefit. For example, 46% had improved dyspnea, 40% improved in weight, and 26% experienced pain reduction. Patients developed Grade 3โ4 leukopenia during 18 cycles (11%) of chemotherapy. Grade 3โ4 thrombocytopenia occurred more frequently, i.e., there were 24 episodes (15%) among 17 patients. Grade 3 anemia developed among patients during eight cycles (5%). None of the patients developed Grade 3โ4 nonhematologic toxicity. The median survival of this sample of patients was 66 weeks with 53%, 30%, and 20% of patients alive at 1, 2, and 3 years, respectively. The median progressionโfree survival period was 40 weeks.
CONCLUSIONS
The gemcitabine/carboplatin combination is a valid option in the treatment of MPM due to its acceptable toxicity profile, the good response rate, and the clinical benefit to patients. Minor adjustments in schedule (3โweek cycles instead of 4โweek cycles) would permit a more optimal treatment administration. Cancer 2003;97:2791โ7. ยฉ 2003 American Cancer Society.
DOI 10.1002/cncr.11405