Olaparib plus paclitaxel and carboplatin chemotherapy followed by olaparib maintenance therapy improved progression-free survival compared to chemotherapy alone in platinum-sensitive ovarian cancer, according to the results of a study presented at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois.
Ovarian cancer has the highest mortality rate of all gynecologic cancers. It is the fifth leading cause of cancer death among U.S. women, with roughly 22,000 new cases and 15,000 deaths predicted for 2012.
Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Some targeted therapies block growth signals from reaching cancer cells, others reduce the blood supply to cancer cells, and still others stimulate the immune system to recognize and attack the cancer cell. Depending on the specific “target,” targeted therapies may slow cancer cell growth or increase cancer cell death.
Olaparib is a targeted drug called a PARP inhibitor. The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Drugs that inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy. Cancers that have a DNA repair deficiency are thought to be particularly likely to respond to PARP inhibitors, and up to half of high-grade serous ovarian cancers may fall into this category.
This study involved 152 women with recurrent platinum-sensitive serous ovarian cancer, all of whom had received up to 3 previous platinum-containing regimens. The patients were randomized to receive one of two regimens: six cycles of olaparib, paclitaxel, and carboplatin followed by maintenance therapy with olaparib or six cycles of paclitaxel and carboplatin with no further therapy. The primary endpoint of the study was progression-free survival (PFS) and secondary endpoints were overall survival (OS), objective response rate (ORR), and safety.
The results indicated that olaparib plus chemotherapy followed by maintenance with olaparib showed a significant improvement in PFS—12.2 months compared to 9.6 months in the chemotherapy group. The study is still being followed for overall survival data. Olaparib appeared to be well tolerated—the most common adverse events were hair loss, nausea, and fatigue.
The researchers concluded that olaparib maintenance therapy after four to six cycles of olaparib plus concurrent paclitaxel and carboplatin significantly increased PFS compared to no further therapy in patients with recurrent platinum-sensitive ovarian cancer. Future studies will focus on determining the optimal patient population for olaparib maintenance therapy and defining an acceptable dose and schedule.
Oza AM, Cibula D, Oaknin A, et al. Olaparib plus paclitaxel plus carboplatin (P/C) followed by olaparib maintenance treatment in patients (pts) with platinum-sensitive recurrent serous ovarian cancer (PSR SOC): A randomized, open-label phase II study. Presented at the 2012 annual meeting of the American Society of Clinical Oncology, June 1-5, 2012, Chicago, IL. Abstract 5001.
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