John Stamos - Public Service Announcement
Pretreated Ovarian Cancer Patients Respond To Gemcitabine, Cisplatin
LONG BEACH, CA – A chemotherapy doublet of gemcitabine (Gemzar, Lilly) and cisplatin (Platinol, Bristol-Myers Squibb) may improve outcomes for patients with relapsed ovarian cancer.
In a phase-2 study, 19 of 27 patients responded to the doublet. Responses observed in heavily pretreated and platin-resistant patients indicate the doublet has activity in drug-refractory patients, said Robert A.Nagourney, MD, the director and founder of Rational Therapeutics™, a research laboratory here.
New Strategies
Most patients with ovarian cancer present with advanced-stage disease and, after initial treatment with carboplatin (Paraplatin, Bristol-Myers Squibb) or cisplatin plus paclitaxel, relapse within five years. "As a result, there is a crucial need to develop new strategies for the management of relapsed disease," Nagourney said.
This phase-2 study repeated the chemotherapy doublet on days one and eight to help overcome cisplatin resistance. Of the 27 patients in the study, 21 had progressed after one or more chemotherapy regimes for systemic recurrence. The other six had recurrent disease after initial postoperative therapy.
Patients received 30 mg/m² of cisplatin plus 740 mg/m² of gemcitabine on days one and eight of each 21-day cycle. The trial design incorporated a close modification schedule based on the known toxicity profiles of each drug. Hematologic toxicities led to gemcitabine reductions; nausea and vomiting, neuropathy or renal toxicity led to cisplatin reductions.
Platinum-sensitive response
The overall response was 70%, with a complete response rate of 26%. The median time to progression for objective responders was 7.9 months, according to the study.
According to criteria from the Gynecologic Oncology Group, 14 patients had platinum-resistance disease and 13 had platinum-sensitive disease. The overall response rate was higher for platinum-sensitive patients: 84%, which included four complete responses and seven partial responses. Toxicities with the doublet were primarily hematologic, with episodes of grade-4 neutropenia, thrombocytopenia and leukopenia. The only non-hematologic grade-4 toxicity was two patients with alopecia.
For more information:
Nagourney RA. Brewer CA. Radecki S. et al, Phase II trial fo gemcitabine plus cisplatin repeating doublet therapy in previously treated, relapsed ovarian cancer patients. Gynecol Oncol. 2003:88:35-39.
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