(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to a podium session of invasive bladder cancer studies. Dr. Luigi Nocera discussed the results of his group’s study evaluating neoadjuvant chemotherapy versus immunotherapy in cisplatin-eligible patients undergoing a radical cystectomy for muscle invasive bladder cancer.
Neoadjuvant cisplatin-based chemotherapy has long been established as standard of care treatment of cisplatin-eligible patients with muscle invasive bladder cancer (MIBC) undergoing a radical cystectomy, following results of the SWOG-8710 trial by Grossman et al. that demonstrated a 5-year OS benefit of 14% (57% versus 43%, p=0.06).1 More recently, the open-label, single-arm, phase II PURE-01 study of neoadjuvant pembrolizumab demonstrated pT0 rates of 42% in patients with ≤cT3bN0 disease undergoing a RC.2 To date, there are no studies prospectively comparing neoadjuvant chemotherapy and immunotherapy approaches in this setting. As such, the aim of this study was to compare neoadjuvant cisplatin-based chemotherapy and immunotherapy (i.e., pembrolizumab) treatment approaches in MIBC patients undergoing an RC.
This was a retrospective analysis of two prospectively maintained institutional datasets, based at the Moffit Cancer Center and Vita-Salute San Raffaele University in Milan. This study included cisplatin eligible MIBC patients, with patients with cN+ disease or having received adjuvant chemotherapy excluded from the analysis. The study endpoints were recurrence-free survival and the proportion of patients with pT0N0 at final pathology. Survival analysis using Kaplan Meier curves with inverse-probability treatment weighting adjustments and univariable/multivariable logistic regression analyses were employed.
This analysis included 346 patients, of whom 255 (74%) and 91 (26%) received chemotherapy and immunotherapy, respectively. pT0N0 disease was observed in 47% of patients in the immunotherapy group compared to 24% in the chemotherapy group (p<0.001). Unadjusted survival analysis using Kaplan Meier curves demonstrated superior recurrence-free survival outcomes in the immunotherapy group (24-month RFS: 87% versus 77%, p<0.01). This difference was even more pronounced after IPTW adjustment for age, gender, pathologic stage, CIS, variant histology, with 24-months RFS of 93% and 77%, respectively (p=0.01).
On multivariable analysis, as demonstrated below, odds of pT0N0 disease were significantly higher in the immunotherapy patients (OR: 3.8, 95% CI: 2.2 – 6.7).
Based on these results, Dr. Nocera concluded that these findings suggest a potentially higher benefit of pembrolizumab with respect to the oncologic outcomes (both RFS and pathologic response), even after adjustment for potential confounders.
Presented by: Luigi Nocera, MD, Urology Resident Physician, Vita-Salute San Raffaele University, Milan, Italy
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023
References:- Grossman HB, Natale RB, Tangen CM, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med 2003;349(9):859-66.
- Necchi A, Anichini A, Raggi D, et al. Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Arm, Phase II Study. J Clin Oncol 2018 Dec 1;36(34):3353-3360.