Adverse events as a potential clinical marker of antitumor efficacy in ovarian cancer patients treated with poly ADP-ribose polymerase (PARP) inhibitor

Objectives: PARP inhibitor (PARPi) is an important progress in ovarian cancer treatment. The available evidence suggests that BRCAm and HRD-positive are effective biological markers for PARPi. We investigated the relationship between adverse events (AEs) and efficacy of PARPi in ovarian cancer patients. Methods: A total of 78 ovarian cancer patients underwent Olaparib and Niraparib were retrospectively analyzed, including from July 2018 to July 2020. AEs were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) v5.0. Chi-square test or fisher exact tests was performed to see the association between categorical variables. Logistic regression analysis was conducted to investigate the association between independent variables and the disease control. The progression-free survival(PFS) was compared between AEs variables by the log-rank test. Results: Patients with AEs in the first one week had a higher disease control rate (DCR) compared with after one week (86.11% versus 60.98%, p=0.013). Serious AEs (SAEs) had a significantly higher DCR (81.40% versus 60.60%, p=0.045). There were associations between anemia and DCR in both occurrence(79.63% versus 56.52%, p=0.037) and grade(100% versus 73.17%, p=0.048). The PFS among patients with hematological toxicity was longer (median: 30 weeks [95% CI: 20.78, 39.22]) than with no-hematological toxicity patients (median: 20 weeks [95% CI: 13.61, 26.39], hazard ratio[HR]: 0.56, p=0.047). Patients with hematological toxicity within four weeks had prolonged median PFS than who with hematological toxicity after four weeks (40 versus 22 weeks, HR:0.36, p=0.003). Conclusions: The early presence of AEs, and SAEs of PARPi were related to the antitumor efficacy, which may be a valid and easily measurable clinical marker in ovarian cancer patients PARP inhibitor (PARPi) is an important progress in ovarian cancer treatment. The available evidence suggests that BRCAm and HRD-positive are effective biological markers for PARPi. We investigated the relationship between adverse events (AEs) and efficacy of PARPi in ovarian cancer patients. A total of 78 ovarian cancer patients underwent Olaparib and Niraparib were retrospectively analyzed, including from July 2018 to July 2020. AEs were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE) v5.0. Chi-square test or fisher exact tests was performed to see the association between categorical variables. Logistic regression analysis was conducted to investigate the association between independent variables and the disease control. The progression-free survival(PFS) was compared between AEs variables by the log-rank test. Patients with AEs in the first one week had a higher disease control rate (DCR) compared with after one week (86.11% versus 60.98%, p=0.013). Serious AEs (SAEs) had a significantly higher DCR (81.40% versus 60.60%, p=0.045). There were associations between anemia and DCR in both occurrence(79.63% versus 56.52%, p=0.037) and grade(100% versus 73.17%, p=0.048). The PFS among patients with hematological toxicity was longer (median: 30 weeks [95% CI: 20.78, 39.22]) than with no-hematological toxicity patients (median: 20 weeks [95% CI: 13.61, 26.39], hazard ratio[HR]: 0.56, p=0.047). Patients with hematological toxicity within four weeks had prolonged median PFS than who with hematological toxicity after four weeks (40 versus 22 weeks, HR:0.36, p=0.003). The early presence of AEs, and SAEs of PARPi were related to the antitumor efficacy, which may be a valid and easily measurable clinical marker in ovarian cancer patients