“These results show that treatment with pembrolizumab offers a clinically meaningful therapeutic option for a subset of patients with previously treated advanced cervical cancer,” Chung and colleagues wrote. No treatment-related adverse events led to death. Grade 3 to grade 4 events, experienced by 12.2% of patients, included increased alanine aminotransferase (3.1%) and increased aspartate aminotransferase (2%). Nearly two-thirds of patients (65.3%) experienced treatment-related adverse events, including hypothyroidism (10.2%), decreased appetite (9.2%), fatigue (9.2%) and diarrhea (8.2%). Median OS was 11 months (95% CI, 9.1-14.1) in the PD-L1-positive population and 9.4 months (95% CI, 7.7-13.1) in the total population. Median PFS was 2.1 months (95% CI, 2-2.2), with an estimated 6-month PFS rate of 25%. Median time to response was 2.1 months (range, 1.6-4.1) and median duration of response was not reached.Įighty-four patients (85.7%) experienced disease progression or died (n = 68) by the time of data cutoff. Nine of the 12 patients who achieved a response continued to respond after 9 months or more. The ORR among patients previously treated with chemotherapy for recurrent or metastatic disease was 14.3% (95% CI, 7.4-24.1). The ORR among patients with PD-L1-positive tumors was 14.6% (95% CI, 7.8-24.2). The 12 responders all had PD-L1-positive tumors. Results showed an ORR of 12.2% (95% CI, 6.5-20.4), with three patients achieving a complete response and nine achieving a partial response. Median number of doses was five (range, 1-33). Median duration of pembrolizumab treatment was 2.9 months (range, 1 day-22.1 months). Median follow-up was 10.2 months (range, 0.6-22.7).īy the date of data cutoff, 88 patients had discontinued pembrolizumab, most (n = 64) because of disease progression. Objective response rate served as the primary endpoint, with safety, duration of response, PFS and OS as secondary endpoints. Imaging of the tumor occurred every 9 weeks for the first year and every 12 weeks afterward. Patients received 200 mg pembrolizumab every 3 weeks for 2 years or until disease progression, intolerable toxicity, or physician or patient decision to withdraw. The cohort included 82 patients (83.7%) with PD-L1-positive tumors, 77 of whom had been treated for recurrent or metastatic cancer with one or more lines of chemotherapy. “In recent years, there has been a reduced incidence of cervical cancer in developed countries related to systematic screening, and we may expect the incidence and mortality rates to decline further if widespread vaccination against human papillomavirus is adopted.”Ĭhung and colleagues analyzed the safety and efficacy of pembrolizumab in a cohort of 98 patients (median age, 46 years range, 24-75) with previously treated advanced cervical cancer. “Cervical cancer is the fourth leading cause of cancer-related mortality in women worldwide,” Hyun Cheol Chung, MD, PhD, professor at Yonsei University College of Medicine in Seoul, South Korea, and colleagues wrote. Pembrolizumab monotherapy appeared safe and induced durable antitumor responses in patients with advanced cervical cancer, according to interim results of the phase 2 KEYNOTE-158 study published in Journal of Clinical Oncology.īased on these results, the FDA granted accelerated approval of pembrolizumab (Keytruda, Merck) for patients with advanced PD-L1-positive cervical cancer whose disease progressed during or after chemotherapy. If you continue to have this issue please contact to Healio
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