PURPOSE A phase II study (ClinicalTrials.gov identifier: NCT00628251 ) showed activity of olaparib capsules versus pegylated liposomal doxorubicin in patients with germline BRCA-mutated platinum-resistant or partially platinum-sensitive relapsed ovarian cancer. We conducted a phase III trial (SOLO3) of olaparib tablets versus nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy. PATIENTS AND METHODS In this randomized, open-label trial, patients were randomly assigned 2:1 to olaparib 300 mg twice a day or physician’s choice single-agent nonplatinum chemotherapy (pegylated liposomal doxorubicin, paclitaxel, gemcitabine, or topotecan). The primary end point was objective response rate (ORR) in the measurable disease analysis set assessed by blinded independent central review (BICR). The key secondary end point was progression-free survival (PFS) assessed by BICR in the intent-to-treat population. RESULTS Of 266 randomly assigned patients, 178 were assigned to olaparib and 88 to chemotherapy. In patients with measurable disease (olaparib, n = 151; chemotherapy, n = 72), the BICR-assessed ORR was significantly higher with olaparib than with chemotherapy (72.2% v 51.4%; odds ratio [OR], 2.53 [95% CI, 1.40 to 4.58]; P = .002). In the subgroup who had received 2 prior lines of treatment, the ORR was 84.6% with olaparib and 61.5% with chemotherapy (OR, 3.44 [95% CI, 1.42 to 8.54]). BICR-assessed PFS also significantly favored olaparib versus chemotherapy (hazard ratio, 0.62 [95% CI, 0.43 to 0.91]; P = .013; median, 13.4 v 9.2 months). Adverse events were consistent with the established safety profiles of olaparib and chemotherapy. CONCLUSION Olaparib resulted in statistically significant and clinically relevant improvements in ORR and PFS compared with nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy.

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We have developed a robust model to predict the risk of distant recurrence in patients with locally advanced cervical cancer. Further, we discussed how the selective enrichment of the patient population could facilitate clinical trials of systemic chemotherapy in locally advanced cervical cancer.

The aim of this review is to examine the current status of gynecological cancer in China focusing on epidemiological data. Epidemiological data on gynecological cancer in China is sparse. Therefore, most of the data were estimated via extrapolation based on a few available datasets. Cervical cancer is relatively rare and the incidence and mortality rate are largely decreasing. However, in young women, the incidence and mortality rates are increasing. The overall and age-specific incidence rates of cervical cancer appear to be varied according to geographical areas. The overall prevalence rate of human papillomavirus (HPV) in China is similar with other eastern Asian countries, but the age-specific HPV prevalence showed sustained high HPV prevalence rates in elderly women. There is not yet an established national program for cervical cancer prevention. The incidence rate of corpus and ovarian cancers in China slightly increased between 2000 and 2005, but is still lower than Japan or Korea. There is no reliable, national-level data on mortality rates of corpus and ovarian cancer in China. Breast cancer is one of the most rapidly increasing cancers in China. The increase was sharper in young women than in elderly women. Both increased risk and change of population size/structure contributed to the increase of breast cancer.