Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: A Phase II Study of the Gynecologic Oncology Group

Roswell Park Cancer Institute, Buffalo, New York, United States
Gynecologic Oncology (Impact Factor: 3.69). 12/2006; 103(2):446-50. DOI: 10.1016/j.ygyno.2006.03.018
Source: PubMed

ABSTRACT To evaluate the safety and efficacy of cisplatin plus gemcitabine in persistent or recurrent platinum-resistant ovarian and primary peritoneal cancer.
Eligible, consenting subjects with measurable disease and one prior platinum-based regimen, but no prior gemcitabine, were to receive intravenous cisplatin followed by gemcitabine on days 1 and 8 every 28 days.
Between December 2000 and March 2003, 59 patients were enrolled from 24 institutions; two were ineligible. During the first stage of accrual, 27 subjects received cisplatin 30 mg/m2 and gemcitabine 750 mg/m2. In the second stage, gemcitabine was reduced to 600 mg/m2 because of hematologic toxicity at the higher dose. There were 4 complete and 5 partial responses for an overall response rate of 16% (9/57). Thirty-one women (54%) had stable disease. Median time to progression was 5.4 months. Overall survival was 14.9+ months. Grade 4 toxicities were hematologic, except one cutaneous reaction.
Cisplatin plus gemcitabine, in the doses and schedule employed, has modest activity in this patient population.

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    • "The ORR was 39.4%, the median PFS was 7.1 months and the median survival 18.6 months. These results compared favorably with those obtained with the combination of GEM and PLD [29] [30] and were comparable with those achieved with CDDP and GEM [11] [12] [13] [14] and similar to those obtained in our previous study using the alternating regimen of GEM/PLD and CDDP/CTX [19]. The combination of PLD, CTX and oxaliplatin was administered in recurrent EOC as second-line treatment [31]. "
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    • "The patients were heterogeneous and included platinum sensitive and platinumresistant patients. Because of the pre-clinical and clinical data suggesting synergism between gemcitabine and platinum, and the high response rates in platinum-resistant patients, we decided to include platinum-resistant patients [4] [5] [7] [8]. "
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