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: 3.77). 12/2006; 103(2):446-50. DOI: 10.1016/j.ygyno.2006.03.018
Source: PubMed


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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    • "When toxicity is used as a measure of radiochemotherapeutic activity and/or efficacy, responses in phase I radiochemotherapy studies may occur at a fraction of an investigational anticancer agent’s own active phase II dose and schedule. To illustrate this point in uterine cervix cancer treatment, gemcitabine given for radiosensitization [125 mg/m2 (Chavez-Blanco et al., 2005)] is a fraction (16%) of when gemcitabine is administered as a single agent [800 mg/m2 (Schilder et al., 2005)] or combined in a gemcitabine (800 mg/m2)-cisplatin (30 mg/m2) regimen (Brewer et al., 2006). As another example in uterine cervix cancer radiochemotherapy, much less (−75%) triapine (25 mg/m2) is administered for cisplatin radiochemosensitization (Kunos et al., 2010) than when used as a single agent [96 mg/m2 (Nutting et al., 2009)]. "
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