ABSTRACT
INTRODUCTION: Our systematic review and meta-analysis aimed to evaluate the clinical efficacy and safety of Rucaparib, a PARP inhibitor (PARPi), in patients with ovarian cancer and BRCA mutation. METHODS: Online databases were comprehensively searched for all phase III Randomized trials that used Rucaparib therapy for ovarian cancer patients and patients having BRCA mutation. Efficacy results are progression-free survival and overall response rate in addition to addressing its safety concerns. RESULTS: After pooling data from 4 clinical trials, the analysis showed a significant improvement in PFS among ovarian cancer patients and for the maintenance therapy with a hazard ratio (HR) of 0.49 (95% CI 0.34-0.73, p = 0.0003) and 0.42 (95% CI 0.29-0.62, p < 0.0001), respectively. For patients with BRCA mutations, the PFS showed significant improvement with a (HR) of 0.42 (95% CI 0.25-0.71, p < 0.001). A difference was observed in the risk of grade ≥ 3 TEAEs between the two groups (RR = 2.48; 95% CI 1.40-4.37). CONCLUSION: Rucaparib demonstrated significant efficacy in improving PFS and ORR in ovarian cancer patients, particularly those having BRCA mutations. However, they should be closely monitored due to the greater risk of various adverse effects.
Subject(s)
Ovarian Neoplasms , Humans , Female , Randomized Controlled Trials as Topic , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/genetics , Indoles/adverse effects , Mutation , Clinical Trials, Phase III as TopicABSTRACT
INTRODUCTION: We aimed to describe the clinical efficacy and safety of tislelizumab, a new (PD-1) inhibitor, in patients with malignant solid tumors. METHODS: We searched relevant databases for phase III randomized controlled trials, including patients with solid tumors. The following outcomes are of interest: overall response rate (OS), overall survival (ORR), progression-free survival (PFS), disease control rate (DCR), and treatment-related adverse events (TRAE). We conducted subgroup analyses based on the line of therapy, type of solid tumor, and tislelizumab alone or combined with chemotherapy. RESULTS: Seven phase III RCTs with 3478 were included in the meta-analysis. Pooled analysis demonstrated that tislelizumab significantly improved ORR and DCR with (OR) of 2.59 (95% (CI) = 2.15-3.12, p < 0.00001) and 1.78 (95% CI = 1.43-2.21, p > 0.00001), respectively. Pooled HRs for OS and PFS were 0.71 (95% CI = 0.65-0.78, p > 0.00001) and 0.68 (95% CI = 0.54-0.84, p = 0.0005), respectively. CONCLUSION: Overall, based on this meta-analysis, the available data strongly supports the utilization of tislelizumab in the treatment of malignant solid tumors. PROSPERO REGISTRATION NUMBER: CRD42023408815.
Subject(s)
Neoplasms , Humans , Antibodies, Monoclonal, Humanized/adverse effects , Neoplasms/drug therapy , Neoplasms/pathology , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the clinical efficacy and safety of Capivasertib on patients with solid tumors. METHODS: Data from four RCTs were pooled to create a systematic review and meta-analysis focusing on Capivasertib-treated patients with solid tumor. Progression-free survival (PFS) and adverse events (AE) were the primary outcomes. RESULTS: A total of 540 individuals from four RCTs were included. The analysis showed that Capivasertib improved PFS for the ITT population with an HR of 0.75 (95% CI = 0.62-0.90, p = 0.002), whereas it did not show improvement in PFS of the PI3K/AKT/PTEN-altered group with an HR = 0.61 (95% CI = 0.32-1.16, p = 0.13). The analysis also showed that Capivasertib improved OS for the ITT population with an HR = 0.61 (95% CI = 0.47-0.78, p = 0.0001). For safety, four studies were included; statistical differences between Capivasertib and placebo were found in discontinuation of Capivasertib due to toxicity or AE (RR = 2.37, 95% CI = 1.37-4.10, p = 0.002). CONCLUSION: Capivasertib plus chemotherapy or hormonal therapy combination has shown promising antitumor efficacy and promising safety profile in the treatment of individuals with solid tumor.
