Citations 2
Multicenter Phase II Clinical Trial of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy for Patients With High-Grade Upper Tract Urothelial Carcinoma
Coleman, Jonathan , Yip, Wesley , Wong, Nathan C. , Sjoberg, Daniel D. , Bochner, Bernard H. , Dalbagni, Guido , Herr, Harry W., Eugene, K. , Donahue, Timothy F. , Kim, Kwanghee , Vargas, H. Alberto, Alvim, Ricardo , Ghafoor, Soleen , Benfante, Nicole , Meraney, Anoop, Shichman, Steven J., Kamradt, Jeffrey M., Nair, Suresh , Baccala, Angelo A., Palyca, Paul, Lash, Bradley W. , Rizvi, Muhammad A. , Swanson, Scott K., Muina, Antonio F, Teo, Min Yuen , Bajorin, Dean F. , Coleman, Jonathan A , Cha, Eugene K , Donahue, Timothy F , Pietzak, Eugene J , Hakimi, A Ari , Al-Ahmadie, Hikmat A , Alvim, Ricardo G , Nair, Suresh , Apolo, Andrea B , Iyer, Gopa , Rosenberg, Jonathan E , Teo, Min Y , Bajorin, Dean , Donat, S. Machele
Journal of Clinical Oncology | January 5, 2023 | Volume: 41 | Issue: 8 | Pages: 1618-1625
PURPOSE Neoadjuvant chemotherapy (NAC) has proven survival benefits for patients with invasive urothelial carcinoma of the bladder, yet its role for upper tract urothelial carcinoma (UTUC) remains undefined. We conducted a multicenter, single-arm, phase II trial of NAC with gemcitabine and split-dose cisplatin (GC) for patients with high-risk UTUC before extirpative surgery to evaluate response, survival, and tolerability. METHODS Eligible patients with defined criteria for high-risk localized UTUC received four cycles of split-dose GC before surgical resection and lymph node dissection. The primary study end point was rate of pathologic response (defined as < ypT2N0). Secondary end points included progression-free survival (PFS), overall survival (OS), and safety and tolerability. RESULTS Among 57 patients evaluated, 36 (63%) demonstrated pathologic response (95% CI, 49 to 76). A complete pathologic response (ypT0N0) was noted in 11 patients (19%). Fifty-one patients (89%) tolerated at least three complete cycles of split-dose GC, 27 patients (47%) tolerated four complete cycles, and all patients proceeded to surgery. With a median follow up of 3.1 years, 2- and 5-year PFS rates were 89% (95% CI, 81 to 98) and 72% (95% CI, 59 to 87), while 2- and 5-year OS rates were 93% (95% CI, 86 to 100) and 79% (95% CI, 67 to 94), respectively. Pathologic complete and partial responses were associated with improved PFS and OS compared with nonresponders (≥ ypT2N any; 2-year PFS 100% and 95% v 76%, P < .001; 2-year OS 100% and 100% v 80%, P < .001). CONCLUSION NAC with split-dose GC for high-risk UTUC is a well-tolerated, effective therapy demonstrating evidence of pathologic response that is associated with favorable survival outcomes. Given that these survival outcomes are superior to historical series, these data support the use of NAC as a standard of care for high-risk UTUC, and split-dose GC is a viable option for NAC.
Open Versus Robotic Cystectomy: A Propensity Score Matched Analysis Comparing Survival Outcomes
Moschini, Marco , Zamboni, Stefania , Mathiéu, Romain , Xylinas, Évanguelos , Tan, Wei Shen , Kelly, John D. , Simone, Giuseppe , Meraney, Anoop, Krishna, Suprita, Konety, Badrinath R. , Mattei, Agostino , Baumeister, Philipp , Mordasini, Livio , Montorsi, Francesco , Briganti, Alberto , Sanchez‐Salas, Rafael , Cathelineau, Xavier , Rink, Michael , Karakiewicz, Pierre I. , Koupparis, Anthony , Kassouf, Wassim , Scherr, Douglas S. , Ploussard, Guillaume , Boorjian, Stephen A. , Sooriakumaran, Prasanna , Larcher, Alessandro , Simone, Giuseppe , Gallina, Andrea , Lotan, Yair , Moschini, Marco , Soria, Francesco , Baumeister, Philipp, Gallina, Andrea , Stabile, Armando , Necchi, Andrea , Rouprêt, Morgan , Lotan, Yair , Shariat, Shahrokh F.
Journal of Clinical Medicine | August 9, 2019 | Volume: 8 | Issue: 8 | Pages: 1192
Background: To assess the differential effect of robotic assisted radical cystectomy (RARC) versus open radical cystectomy (ORC) on survival outcomes in matched analyses performed on a large multicentric cohort. Methods: The study included 9757 patients with urothelial bladder cancer (BCa) treated in a consecutive manner at each of 25 institutions. All patients underwent radical cystectomy with bilateral pelvic lymphadenectomy. To adjust for potential selection bias, propensity score matching 2:1 was performed with two ORC patients matched to one RARC patient. The propensity-matched cohort included 1374 patients. Multivariable competing risk analyses accounting for death of other causes, tested association of surgical technique with recurrence and cancer specific mortality (CSM), before and after propensity score matching. Results: Overall, 767 (7.8%) patients underwent RARC and 8990 (92.2%) ORC. The median follow-up before and after propensity matching was 81 and 102 months, respectively. In the overall population, the 3-year recurrence rates and CSM were 37% vs. 26% and 34% vs. 24% for ORC vs. RARC (all p values > 0.1), respectively. On multivariable Cox regression analyses, RARC and ORC had similar recurrence and CSM rates before and after matching (all p values > 0.1). Conclusions: Patients treated with RARC and ORC have similar survival outcomes. This data is helpful in consulting patients until long term survival outcomes of level one evidence is available.