Phase II study of niraparib in recurrent or persistent rare fraction of gynecologic malignancies with homologous recombination deficiency (JGOG2052) / 부인종양

Background@#Poly (adenosine diphosphate)-ribose polymerase (PARP) inhibitors for tumors with homologous recombination deficiency (HRD), including pathogenic mutations in BRCA1/2, have been developed. Genomic analysis revealed that about 20% of uterine leiomyosarcoma (uLMS) have HRD, including 7.5%–10% of BRCA1/2 alterations and 4%–6% of carcinomas of the uterine corpus, and 2.5%–4% of the uterine cervix have alterations of BRCA1/2. Preclinical and clinical case reports suggest that PARP inhibitors may be effective against those targets. The Japanese Gynecologic Oncology Group (JGOG) is now planning to conduct a new investigator-initiated clinical trial, JGOG2052. @*Methods@#JGOG2052 is a single-arm, open-label, multi-center, phase 2 clinical trial to evaluate the efficacy and safety of niraparib monotherapy for a recurrent or persistent rare fraction of gynecologic malignancies with BRCA1/2 mutations except for ovarian cancers. We will independently consider the effect of niraparib for uLMS or other gynecologic malignancies with BRCA1/2 mutations (cohort A, C) and HRD positive uLMS without BRCA1/2 mutations (cohort B). Participants must have 1–3 lines of previous chemotherapy and at least one measurable lesion according to RECIST (v.1.1). Niraparib will be orally administered once a day until lesion exacerbation or unacceptable adverse events occur. Efficacy will be evaluated by imaging through an additional computed tomography scan every 8 weeks. Safety will be measured weekly in cycle 1 and every 4 weeks after cycle 2 by blood tests and physical examinations. The sample size is 16–20 in each of cohort A and B, and 31 in cohort C. Primary endpoint is the objective response rate.

A Survey Using a Terminal Care Attitude Scale Intended for Oncologists and Palliative Care Staff

Purpose: This study aimed to analyze the terminal care attitudes of healthcare members engaged in palliative care and the factors associated with these attitudes. Methods: We conducted a survey for healthcare members engaging in palliative care including oncologists and palliative care doctors using the Japanese version of the Frommelt Attitudes Toward Care of the Dying (FATCOD B-J), a scale that measures the attitude of medical stuff toward the care of dying patients. Results: A total of 223 (response rate=42.2%) responses were obtained and analyzed. Multiple regression analysis using the FATCOD B-J total score as the objective variable showed that 30s had lower partial regression coefficients than 40s (−3.8). Higher “satisfaction from work” and “interest in palliative care” were associated with greater partial regression coefficients (+5.7, +6.2). Conclusion: A sense of satisfaction and interest in palliative care may be important to cultivate terminal care attitudes among health care providers involved in palliative care.