High-Dose Pemetrexed Offers Only Modest Efficacy Compared With Low Dose for Ovarian Cancer: Presented at SGO
By Michael Casasnovas
TAMPA, Fla -- March 14, 2008 -- High-dose pemetrexed appears to be more active than low-dose pemetrexed in platinum-resistant epithelial ovarian cancer, but the increase in dose from 500 to 900 mg/m2 failed to improve response rates, progression-free survival, or overall survival.
"In the absence of any apparent dose response, the 500 mg/m2 dose has the preferable toxicity profile," said Ignace Vergote, MD, PhD, Chief, Department of Gynaecological Oncology, University Hospital, Leuven, Belgium.
Dr. Vergote presented the findings in a poster session here on March 11 at the Society of Gynecologic Oncologists (SGO) 2008 Annual Meeting on Women's Cancer.
Researchers randomised 51 women to pemetrexed 500 mg/m2 and 51 to pemetrexed 900 mg/m2. All the women had a good performance status and adequate kidney function, and had cancer recurrence less than 6 months after they received definitive treatment.
Pemetrexed was administered on day 1 of each 21-day cycle for up to 6 cycles of treatment. The patients were also given folate and vitamin B12 supplementation to prevent haematological adverse effects, and dexamethasone as prophylaxis against rash.
A total of 47 patients (92.2%) in the low-dose arm and all patients in the high-dose arm completed treatment.
Overall response rate was 9.3% in the low-dose group and 10.4% in the high-dose group. Median progression-free survival was 2.8 months in each arm. Median overall survival was 11.9 months in the low-dose arm and 10.3 months in the high-dose arm. The differences did not reach statistical significance for any of the results, Dr. Vergote said.
One death occurred in the low-dose patient population and 6 deaths occurred in the high-dose group. The deaths occurred during the trial or within 30 days after the trial concluded. Dr. Vergote said 2 of the deaths in the high-dose group were judged to be possibly drug-related.
Grade 3/4 toxicities occurred in 26 patients (55.3%) among the low-dose patients and in 28 patients (54.9%) among the high-dose patients. Eight patients (17.0%) on low-dose pemetrexed had serious adverse events compared with 14 patients (27.5%) on the high dose of the drug. Two of the serious adverse events were considered to be possibly drug related.
[Presentation title: A Randomized Phase II Study of Standard-Versus High-Dose Pemetrexed in Platinum-Resistant Epithelial Ovarian Cancer. Abstract 256]
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