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Olaparib tablet shows promise in pretreated ovarian cancer

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Oral olaparib tablets combined with a weekly regimen of carboplatin and paclitaxel was safe for use in patients with advanced ovarian cancer who have failed to respond to first-line therapy, according to early preliminary data.

“This study is one of the first studies to use olaparib tablets instead of olaparib capsules,” researcher Saul Rivkin, MD, founder and chairman of the Marsha Rivkin Center for Ovarian Cancer Research, said in a press release. “The goal was to find the maximum tolerated dose of olaparib tablets plus weekly metronomic carboplatin and paclitaxel in patients with relapsed ovarian cancer. This treatment regimen provided a response rate of 66% in heavily pretreated ovarian cancer patients.”

Saul Rivkin

In the current phase 1b/2 study, Rivkin and colleagues evaluated 14 patients with stage III or IV relapsed ovarian cancer who had failed first-line platinum-containing chemotherapy. The median age of the study cohort was 58 years with a median of four previous treatment regimen.

The patients underwent testing for BRCA1/2 mutations and were started on a regimen of metronomic therapy of paclitaxel 60 mg/m² IV and carboplatin area under the curve (AUC) 2 IV treatment weekly for 3 of 4 weeks.

The olaparib dose was increased until the maximum tolerated dose was reached. The patients were monitored for toxicity and response, and the combination regimen was continued until dose-limiting toxicity or disease progression was observed.

Rivkin and colleagues found that the maximum tolerated dose of oral olaparib was 150 mg twice a day for three consecutive days of each week. The regimen was continued for a median of 9.3 cycles and a mean of 7.3 cycles.

No grade 4 toxicities were noted. Among grade 3 toxicities, the most prevalent were neutropenia, leukopenia, lymphopenia, anemia, fatigue and myelodysplastic syndrome. The researchers observed no signs of gastrointestinal, cardiac, hepatic, pulmonary or dermatologic toxicities.

Pre-study allergic reactions occurred in two patients, and these patients were desensitized to carboplatin after they were enrolled. A mild allergic reaction to the chemotherapy occurred in one patient, but did not require desensitization.

A complete response was achieved in four patients, a partial response was achieved in three patients, three patients maintained stable disease, two experienced disease progression and two could not be assessed. Three of the four complete responses occurred in patients with BRCA mutations, and of the progressive disease patients, one exhibited a BRCA mutation.

“The outlook for ovarian cancer patients with advanced disease is not equivalent to that of breast cancer, and a lot of work needs to be done to improve the cure rate,” Rivkin said in the release. “Medical researchers are discovering and investigating new and innovative therapies for the treatment of ovarian cancer. We are constantly working toward improving the quality of life and survival for all ovarian cancer patients.”

For more information:

Rivkin S. Presented at: Marsha Rivkin Center for Ovarian Cancer Research-AACR 10th Biennial Ovarian Cancer Research Symposium; Sept. 8-9, Seattle.

Disclosure: The study was funded by the Dulien Fund and AstraZeneca. The researchers report no relevant financial disclosures.