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Study drug is first to help patients with recurrent low-grade ovarian cancer
Date:2/8/2013

isease.

High-grade serous ovarian cancer is susceptible to chemotherapy upon relapse or recurrence.

Median overall survival not reached

Cancer-causing genetic mutations in BRAF and KRAS genes occur more frequently in low-grade ovarian cancer, so the researchers chose a drug that targets the molecular network that includes those genes.

Selumetinib inhibits MEK1/2, a critical molecule in what's known as the MAPK pathway, which includes BRAF and KRAS.

All 52 patients had received at least one previous therapy, with 30 having had three or more. Clinical trial results with selumetinib include:

  • Median progression-free survival of 11 months and 34 patients (65 percent) went at least six months without their disease worsening.
  • Two-year overall survival of 55 percent.
  • Median overall survival had not been reached, because more than half of patients (61 percent) remained alive at the time of data cutoff for the study.
  • No treatment-related deaths.

Side effects ranged from cardio and gastrointestinal toxicity to pain, fatigue, anemia and dermatological effects. Of the 52 patients, 22 had their doses reduced and 13 ultimately left the study due to side effects.

Researchers obtained tumor samples sufficient for DNA analysis from 34 patients. While 14 patients had KRAS mutations and two had BRAF mutations, there was no connection between having those mutations and whether the patients responded to selumetinib.

Gershenson said researchers will further explore the question of matching drug to mutation during a larger phase 2/3 clinical trial that he will lead with investigators from the NCI Gynecological Oncology Group and the United Kingdom. The study will enroll 250 patients and is likely to begin later this summer.

Phase 2 trials generally do not include a control or comparison group, but the team noted treatment results for 58 women not in the trial who wer
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Contact: Scott Merville
smerville@mdanderson.org
713-792-0661
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert  

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