Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer.

BACKGROUND: Recurrent cervical cancer is a life-threatening disease, with limited treatment options available when disease progression occurs after first-line combination therapy. METHODS: We conducted a phase 3, multinational, open-label trial of tisotumab vedotin as second- or third-line therapy in patients with recurrent or metastatic cervical cancer. Patients were randomly assigned, in a 1:1 ratio, to receive tisotumab vedotin monotherapy (2.0 mg per kilogram of body weight every 3 weeks) or the investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival. RESULTS: A total of 502 patients underwent randomization (253 were assigned to the tisotumab vedotin group and 249 to the chemotherapy group); the groups were similar with respect to demographic and disease characteristics. The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group (11.5 months [95% confidence interval {CI}, 9.8 to 14.9] vs. 9.5 months [95% CI, 7.9 to 10.7]), results that represented a 30% lower risk of death with tisotumab vedotin than with chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 to 0.89; two-sided P = 0.004). The median progression-free survival was 4.2 months (95% CI, 4.0 to 4.4) with tisotumab vedotin and 2.9 months (95% CI, 2.6 to 3.1) with chemotherapy (hazard ratio, 0.67; 95% CI, 0.54 to 0.82; two-sided P<0.001). The confirmed objective response rate was 17.8% in the tisotumab vedotin group and 5.2% in the chemotherapy group (odds ratio, 4.0; 95% CI, 2.1 to 7.6; two-sided P<0.001). A total of 98.4% of patients in the tisotumab vedotin group and 99.2% in the chemotherapy group had at least one adverse event that occurred during the treatment period (defined as the period from day 1 of dose 1 until 30 days after the last dose); grade 3 or greater events occurred in 52.0% and 62.3%, respectively. A total of 14.8% of patients stopped tisotumab vedotin treatment because of toxic effects. CONCLUSIONS: In patients with recurrent cervical cancer, second- or third-line treatment with tisotumab vedotin resulted in significantly greater efficacy than chemotherapy. (Funded by Genmab and Seagen [acquired by Pfizer]; innovaTV 301 ClinicalTrials.gov number, NCT04697628.).

A multisite study of the prevalence of serious mental illness, PTSD, and substance use disorders of women in jail.

OBJECTIVES: This multisite study aimed to answer the following research questions about women in urban and rural jails. First, what is the current and lifetime prevalence of serious mental illness (major depressive disorder, bipolar disorder, and psychotic spectrum disorders) of women in jail? Second, what level of impairment is associated with their serious mental illness? Third, what is the proportion of incarcerated women with serious mental illness who also have posttraumatic stress disorder (PTSD), a substance use disorder, or both? METHODS: Participants were 491 women randomly sampled in jails in Colorado, Idaho, South Carolina, and the metropolitan area of Washington, D.C. Structured interviews assessed lifetime and 12-month prevalence of disorders and level of impairment. RESULTS: Forty-three percent of participants met lifetime criteria for a serious mental illness, and 32% met 12-month criteria; among the latter, 45% endorsed severe functional impairment. Fifty-three percent met criteria for ever having PTSD. Almost one in three (29%) met criteria for a serious mental illness and PTSD, 38% for a serious mental illness and a co-occurring substance use disorder, and about one in four (26%) for all three in their lifetime. CONCLUSIONS: The prevalence of serious mental illness and its co-occurrence with substance use disorders and PTSD in this multisite sample suggest the critical need for comprehensive assessment of mental health at the point of women's entry into the criminal justice system and the necessity for more programs that offer alternatives to incarceration and that can address the complexity of female offenders' treatment needs.