Wednesday, December 28, 2011 (Last Updated: 12/29/2011)WEDNESDAY, Dec. 28 (HealthDay News) -- A new orally active poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib, has been found to have similar efficacy to pegylated liposomal doxorubicin (PLD) for the treatment of patients with ovarian cancer that has recurred or progressed following treatment with platinum-based chemotherapy, according to a study published online Dec. 27 in the Journal of Clinical Oncology.
Stan B. Kaye, M.D., of the Institute of Cancer Research in Surrey, U.K., and colleagues compared the efficacy and safety of olaparib with that of PLD in a multicenter, open-label, randomized, phase II study involving 97 patients with recurrent ovarian cancer with a confirmed germline BRCA1 or BRCA2 mutation. Patients received olaparib 200 mg twice daily (32 patients), olaparib 400 mg twice daily (32 patients), or PLD 50 mg/m² intravenously every 28 days (33 patients). The primary end point was Response Evaluation Criteria in Solid Tumors (RECIST)-assessed progression-free survival (PFS), and the secondary end points included objective response rate (ORR), duration of response, changes in tumor size, and overall survival.
The researchers found RECIST-assessed median PFS and ORR to be similar for patients receiving olaparib 200 mg (6.5 months and 25 percent), olaparib 400 mg (8.8 months and 31 percent), or PLD (7.1 months and 18 percent). The most common adverse events in olaparib-treated patients were mild to moderate fatigue, gastrointestinal symptoms, anemia, and rash. In PLD-treated patients, the most common treatment-related adverse events included stomatitis and palmar-plantar erythrodysesthesia. Given these data, along with data from previous studies, the 400-mg dose of olaparib administered twice daily is the dosage suggested for future studies.
"Both PARP inhibitors and PLD are likely to play important roles in the management of patients with recurrent advanced ovarian cancer and BRCA1/2 mutations, and differences in the tolerability and route of administration will be of importance in individualizing their treatment," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca, which provided funding for this study.
Hematology & Oncology
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