Neoadjuvant gemcitabine plus cisplatin produced a favorable pathologic response rate and was well tolerated in patients with high-grade upper tract urothelial carcinoma (UTUC), according to researchers.
“We conclude that this is a standard of care option for high-grade upper tract urothelial carcinoma,” said Wesley Yip, MD, of Memorial Sloan Kettering Cancer Center in New York, New York.
Dr Yip presented these findings at the ASCO Genitourinary Cancers Symposium 2022.
The multicenter, phase 2 study (ClinicalTrials.gov Identifier: NCT01261728) included 57 evaluable patients with high-grade UTUC. At baseline, the patients’ median age was 66 years (range, 58-71 years), 63% were men, and 95% were White.
Patients were scheduled to receive 4 cycles of gemcitabine plus cisplatin, followed by radical nephroureterectomy or uterectomy with templated lymph node dissection.
In all, 89% of patients received at least 3 cycles of neoadjuvant chemotherapy. All patients underwent surgery at a median of 7 weeks.
The primary endpoint was pathologic response rate, with a rate exceeding 60% deemed “promising.” The primary endpoint was met, as the pathologic response rate was 63%. This included a complete response in 19% of patients.
The median follow-up was 3.1 years. The progression-free survival rate was 78% at 2 years and 65% at 5 years. The overall survival rate was 93% at 2 years and 79% at 5 years.
Pathologic response was associated with improved progression-free and overall survival at 2 years (P <.001 for both), Dr Yip noted.
The most common grade 3 or higher toxicities were lymphopenia (33%), neutropenia (32%), and hyperglycemia (14%). Dose reductions were required in 21% of patients, and 14% of patients stopped neoadjuvant treatment early.
At 30 days, the rate of grade 3 or higher surgical complications was 11%.
“Neoadjuvant chemotherapy was well tolerated, with minimal delay to surgery or impact on perioperative outcomes,” Dr Yip concluded.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Yip W, Coleman J, Wong NC, et al. Final results of a multicenter prospective phase II clinical trial of gemcitabine and cisplatin as neoadjuvant chemotherapy in patients with high-grade upper tract urothelial carcinoma. Presented at ASCO GU 2022; February 17-19, 2022. Abstract 440.
This article originally appeared on Cancer Therapy Advisor