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See Latest ArticlesA phase 2 study of platinum and gemcitabine in patients with advanced salivary gland cancer
Cancer, 11/25/09
Laurie SA et al. – This regimen did not meet the predefined criteria to be declared active in advanced salivary gland cancers. Enrollment of patients with these rare cancers into well-designed clinical trials remains an urgent priority.
Methods- Fit, consenting adult patients had advanced, metastatic, or locoregionally recurrent salivary gland cancer (any histologic subtype) that was not suitable for radiation or surgery.
- Therapy comprised of gemcitabine at dose of 1000 mg/m2 administered intravenously on Days 1 and 8, and cisplatin at dose of 70 mg/m2 on Day 2, of a 21-day cycle
- If carboplatin substituted, administered on Day 1, targeted to area under concentration-time curve of 5 mg/mL/s
- Response assessed every 2 cycles according to Response Evaluation Criteria In Solid Tumors
- Patients received up to 6 cycles
- Primary endpoint objective response ;2-stage design used, with a response rate of 45% required to declare regimen active
- 33 eligible patients enrolled, of whom 30 response evaluable
- 8 objective responses observed (1 complete and 7 partial) for response rate of 24% (95% confidence interval, 11-42%), with responses observed in histologic subtypes
- Toxicity within that expected for this combination
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