C-Reactive Protein Is a Potential Prognostic Marker in Patient with Advanced or Metastatic Urothelial Carcinoma Treated with Enfortumab Vedotin: A Multi-Center Retrospective Study.

BACKGROUND: In the EV-301 trial, enfortumab vedotin prolonged survival in patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based therapy and programmed cell death 1/programmed death-ligand 1 inhibitor. However, real-world Asian data are limited, and potential prognostic markers are non-existent. We aimed to investigate potential prognostic markers for enfortumab vedotin therapy in Asian patients. METHODS: We retrospectively enrolled 61 Japanese patients treated with enfortumab vedotin therapy at our hospital and affiliated hospitals between January 2019 and September 2023. RESULTS: Enrolled patients (38 men, 23 women; median age 74 [IQR: 68-79] years) had bladder cancer (26 patients) or upper-tract urothelial carcinoma (35 patients). Fifty-four patients reported adverse events (grade >3 in 12). Skin disorders, pruritus, and neuropathy were common adverse effects. The median overall survival was 17.1 months (95% confidence interval: 10.0-not applicable). In multivariate analysis, the C-reactive protein level was an independent marker predicting favorable overall survival with enfortumab vedotin. Patient characteristics did not differ between C-reactive protein-high and -low groups. CONCLUSIONS: Our study provides real-world data showing that enfortumab vedotin prolonged survival in Asian patients similar to the EV-301 trial. Additionally, the C-reactive protein level might be considered a prognostic marker of enfortumab vedotin therapy in such patients.

[INSURANCE COVERAGE FOR INFERTILITY TREATMENT SINCE APRIL 2022: HOW MALE INFERTILITY TREATMENT HAS CHANGED IN INSURANCE MEDICAL INSTITUTION -FROM THE QUESTIONNAIRE FOR JAPAN SOCIETY FOR REPRODUCTIVE MEDICINE MALE INFERTILITY SPECIAL INTEREST GROUP (SIG)].

(Introduction) Beginning in April of 2022, infertility services-including assisted reproductive technologies and examinations and treatments for male infertility-were covered by health insurance in Japan. Although these changes are expected to bolster birth rates in Japan, increased numbers of patients and surgeries are anticipated, particularly following reductions in patient visits caused by COVID-19. (Materials and methods) We surveyed 13 members of the Male Infertility Special Interest Group of the Japanese Society for Reproductive Medicine using Microsoft Forms. Respondents were asked about the number of new male infertility patients and surgeries at their respective facilities before the COVID-19 pandemic, after the first wave, after the sixth wave, and after the insurance changes to cover treatments for male infertility. Respondents were also asked to describe challenges in meeting the demand created by these insurance coverage changes. (Results) Patients and surgeries (varicocelectomy and testicular sperm extraction) declined markedly after the first wave of COVID-19 but gradually recovered after the sixth wave. However, once male infertility-related services were covered by insurance in Japan, respondents observed a marked increase in new patients and surgeries compared to pre-COVID-19. The most frequently reported problem was that sperm cryopreservation was not covered by insurance. (Conclusions) This survey should be readministered after additional time has passed to capture longer-term changes following changes to insurance coverage in Japan. We anticipate the responses to the survey will reflect ongoing challenges associated with changes in insurance coverage for male infertility-related services.