GOG Reports on Evaluation of Pemetrexed in Treatment of Recurrent Platinum-Resistant Ovarian Cancer

A phase II Gynecologic Oncology Group (GOG) clinical study found that pemetrexed (Altima®)-an antifolate antineoplastic agent that disrupts folate-dependent cell replication metabolic processes-is sufficiently active in the treatment of recurrent platinum-resistant ovarian cancer to warrant further investigation.  “Thus [pemetrexed] should be considered for combination with other agents, especially carboplatin, in first-line therapy,” said David Miller, M.D., F.A.C.S. (University of Texas Southwestern Medical Center, Dallas, USA) and colleagues.

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David Miller, M.D. F.A.C.S., Professor, Gynecologic Oncology, University of Texas Southwestern Medical Center

A phase II Gynecologic Oncology Group (GOG) clinical study found that pemetrexed (Altima®)-an antifolate antineoplastic agent that disrupts folate-dependent cell replication metabolic processes-is sufficiently active in the treatment of recurrent platinum-resistant ovarian cancer to warrant further investigation.  “Thus [pemetrexed] should be considered for combination with other agents, especially carboplatin, in first-line therapy,” said David Miller, M.D., F.A.C.S. (University of Texas Southwestern Medical Center, Dallas, USA) and colleagues.

The purpose of the GOG study was to estimate the antitumor activity of pemetrexed in patients with persistent or recurrent, platinum-resistant epithelial ovarian or primary peritoneal cancer and to determine the nature and degree of toxicities.  The patients that participated in the study experienced disease progression on platinum-based primary chemotherapy or recurred within 6 months. Pemetrexed at a dose of 900 mg/m2 was administered as an intravenous infusion over 10 minutes every 21 days. Dose delay and adjustments were permitted for toxicity. Treatment was continued until disease progression or unacceptable adverse effects.  From July 6, 2004, to August 23, 2006, 51 patients enrolled in the study.  A total of 259 cycles (median, four; range one to 19 cycles) of pemetrexed were administered, with 40% of the patients receiving six or more cycles.

According to the investigators, the study produced the following results:

  • No treatment -related deaths were reported;
  • Eighteen patients (38%) had progressive disease. Three patients (6%) were not assessable;
  • One patient (2%) had a complete response (CR) and nine patients (19%) had partial responses (PRs), with a median duration response of 8.4 months. Seventeen patients (35%) had stable disease (SD) for a median of 4.1 months. Clinical benefit rate (CR + PR + SD) was 56%; and

Based upon the foregoing results, the investigators noted that pemetrexed “exhibited activity more favorable than that seen in other agents that have been test in first-line combinations by the GOG.” Pemetrexed, according to the investigators, has sufficient activity in the treatment of recurrent platinum-resistant ovarian cancer at the dose and schedule tested to warrant further investigation.

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