How Many Cycles of Cisplatin-Based Chemotherapy Before Cystectomy Is Enough?
Posted: Monday, November 8, 2021
The phase III VESPER study, performed by Christian Pfister, MD, PhD, of Charles Nicolle University Hospital, Rouen, France, and colleagues, shed light on the optimal number of neoadjuvant cisplatin-based chemotherapy cycles for patients with muscle-invasive bladder cancer. These data, published in Clinical Genitourinary Cancer, concluded that patients should receive a minimum of four chemotherapy cycles to optimize their chances of pathologic complete response at cystectomy. However, further studies on patient survival benefits are warranted.
A total of 493 patients with muscle-invasive bladder cancer were randomly assigned to receive six cycles of methotrexate, vinblastine, doxorubicin, and cisplatin (n = 248) or four cycles of gemcitabine and cisplatin (n = 245). The criteria for local tumor control included pathologic downstaging, organ-confined disease, and pathologic complete response at cystectomy. In addition, creatinine clearance was calculated before each cycle to determine renal impairment (< 60 mL/min).
The median patient age was 63 years, and the median creatinine clearance was 87 mL/min; 10% of participants had a creatinine clearance of less than 60 mL/min. The total cycles of chemotherapy administered were 2,128, including 2,120 with cisplatin, and full doses of cisplatin were delivered in 1,866 cycles. Renal failure led to the discontinuation of treatment for 23 patients across both arms. There was no observed difference in median creatinine clearance values for the first four cycles, although there was a mild decrease in patients who received two additional cycles of methotrexate, vinblastine, doxorubicin, and cisplatin.
Organ-confined disease, pathologic downstaging, and pathologic complete response were observed in 70%, 56%, and 39% of participants, respectively. Individuals who received four cycles of cisplatin in the gemcitabine-and-cisplatin arm achieved better outcomes than those receiving up to three cycles. In addition, increasing the number of cycles beyond four in the group given methotrexate, vinblastine, doxorubicin, and cisplatin did not appear to achieve higher local tumor control rates.
Disclosure: The study authors reported no conflicts of interest.