Neoadjuvant chemotherapy plus immunotherapy appears to be more efficacious than chemotherapy alone as a bladder-sparing therapy in patients with localized muscle-invasive bladder cancer (MIBC), according to findings presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
The real-world study compared the efficacy of neoadjuvant chemotherapy plus immunotherapy vs chemotherapy alone in patients with cT2-4bN0-3M0-1a pathological and imaging diagnosed MIBC. “Either chemotherapy (gemcitabine and cisplatin/carboplatin) plus immunotherapy (PD-1 checkpoint inhibitor, including pembrolizumab tislelizumab and toripalimab) or chemotherapy alone were given as patients’ wish,” the investigators explained.
Complete response rate (CR) was the primary endpoint of the study and disease control rate (DCR), progression free survival (PFS), bladder-intact disease free survival (BI-DFS), and toxicity were the secondary endpoints.
Of the total 41 patients included in the analysis, 25 received combination therapy and 16 received chemotherapy. Baseline characteristics of the 2 treatment groups were well balanced. The study authors reported the median follow-up time to be 15.3±4.4 months. A total of 34 patients were in the efficacy evaluable population, 22 of which were in the combination group and 12 of which were in the chemotherapy only group.
Findings of the analysis revealed a CR rate of 50.0% for the combination group compared with 0% for the chemotherapy alone group. Disease progression was observed in 1 combination therapy patient and 3 chemotherapy patients. The DCRs were reported to be 95.5% for the combination group and 66.7% for the chemotherapy group (P =.003).
Of the patients in the combination group, 12 had radiotherapy and 6 had radical cystectomy followed by neoadjuvant therapies. Of the patients in the chemotherapy group, 2 had radiotherapy and 3 had radical cystectomy. “The one-year PFS rates were 95.5% and 62.5% for combination group and chemotherapy group (P =.010), and the one-year BI-DFS were 66.1% vs 27.5% respectively (P =.159),” the study authors added.
The bladder-preserving combined-modality therapies were found to be well tolerated with manageable side effects; 15.9% of patients in the combination group experienced grade 3/4 hematological system adverse events compared with 6.4% of patients in the chemotherapy alone group (P =.021).
Shen Y, Wen F, Zhang P, Lin T. Real-world study of chemotherapy plus immunotherapy versus chemotherapy alone as neoadjuvant treatment guided bladder-sparing therapy for localized muscle-invasive bladder cancer. Presented at: ASCO-GU 2022; February 17-19, 2022; Abstract 499.
This article originally appeared on MPR