Phase II Trial Shows Activity of Pemetrexed Plus Cisplatin in Treatment of Advanced, Persistent, or Recurrent Cervical Carcinoma
In a phase II Gynecologic Oncology Group (GOG) trial reported in the Journal of Clinical Oncology, Miller et al found that the combination of pemetrexed (Alimta) and cisplatin produced responses in the treatment of advanced, persistent, or recurrent cervical cancer.
In the study, 54 patients from five GOG member institutions with disease not amenable to curative treatment who had received no cytotoxic therapy for advanced or recurrent disease were treated between September 2008 and November 2011 with pemetrexed 500 mg/m2 and cisplatin 50 mg/m2 intravenously every 21 days until disease progression or intolerability.
Toxicity
Overall, 26% of patients received more than nine cycles of treatment. The most common adverse events of any grade were anemia (96%), gastrointestinal events (93%), constitutional events (89%), and nausea (83%). The most common grade 3 or 4 adverse events were neutropenia (35%), leukopenia (28%), and metabolic toxicity (28%). Dose reductions due to adverse events were required for both cisplatin and pemetrexed in 9% of patients and for cisplatin alone in 6%. There were no treatment-related deaths.
Responses
The overall response rate was 31% (95% confidence interval = 19.5%-45.6%), including 1 complete response and 16 partial responses. Median duration of response was 7.6 months. All 17 responders (38%) were among the 45 patients with measurable tumor in nonradiated disease sites. Responses were observed in 14 (33%) of 43 patients with squamous histology and 3 (27%) of 11 with adenocarcinoma and in 7 (26%) of 27 who had received cisplatin with radiation therapy and 10 (37%) of 27 who had not received cisplatin. Stable disease was observed in 44% of patients, with a median duration of 5.1 months. Median progression-free survival was 5.7 months (range, 0.3–38.6 months) and median overall survival was 12.3 months (range, 0.3–38.6 months).
The investigators concluded: “Pemetrexed combined with cisplatin is an active and tolerable treatment for advanced, persistent, or recurrent carcinoma of the cervix. This combination should be further developed in the treatment of cervical cancer.”
David Scott Miller, MD, of the University of Texas Southwestern Medical Center at Dallas, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by grants from the National Cancer Institute. The study authors reported no potential conflicts of interest.
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