Comparative effectiveness and integrated safety of goserelin sustained-release microspheres versus implants in prostate cancer: a patient-based real-world study and systematic review with meta-analysis.

内容摘要

To evaluate the effectiveness of goserelin sustained-release microspheres versus sustained-release implants for androgen deprivation therapy (ADT) in patients with prostate cancer in a real-world setting, and to compare their safety profiles by integrating evidence from published studies. This retrospective study included 87 patients with prostate cancer who received goserelin-based ADT at Peking University Cancer Hospital Inner Mongolia Hospital between August 2024 and September 2025. Forty-four patients received goserelin sustained-release microspheres, and 43 received sustained-release implants. During the 12-week observation period, patients received median administrations of three and one, respectively, corresponding to comparable ADT exposure. Analyses were patient-based. The primary endpoint was the proportion achieving total prostate-specific antigen (TPSA) <0.2 ng/mL at day 85 (D85), with day 29 (D29) assessed as an early response point. A prespecified exploratory non-inferiority framework with a -10% margin was applied, with sensitivity analyses using TPSA <0.1 ng/mL. A PRISMA-compliant systematic review searched PubMed, Embase, Cochrane Library, and Web of Science through February 1, 2026. Eligible studies reporting goserelin safety outcomes were included. Safety outcomes were harmonized as any-grade adverse events (AEs), serious AEs, and grade &#x2265;3 AEs. Pooled incidences were calculated using single-arm meta-analysis. Median age was 72 years, and median follow-up was 85 days. Baseline disease stage differed between groups, with more metastatic disease in the implant group. At D29, TPSA response rates were 81.8% and 95.2% in the microsphere and implant groups, respectively. At D85, rates were 86.4% and 93.0%, meeting the prespecified non-inferiority criterion. Sensitivity analyses using TPSA <0.1 ng/mL were consistent. The systematic review included three studies comprising 665 patients. The pooled incidence of any-grade AEs was 59.2%, with substantial heterogeneity, whereas pooled incidences of serious AEs and grade &#x2265;3 AEs were 6.1% and 8.9%, respectively, with no new safety signals. Goserelin sustained-release microspheres demonstrated comparable real-world biochemical activity to sustained-release implants over matched 12-week ADT exposure. Although early PSA differences and baseline disease-stage imbalance warrant consideration, integrated evidence supports goserelin microspheres as an alternative ADT formulation with a manageable safety profile. https://www.crd.york.ac.uk/PROSPERO/view/, identifier CRD420261327915.