The optimal number of induction chemotherapy cycles in clinically lymph node-positive bladder cancer.

To investigate the optimal number of induction chemotherapy cycles needed to achieve a pathological response in patients with clinically lymph node-positive (cN+) bladder cancer (BCa) who received three or four cycles of induction chemotherapy followed by consolidative radical cystectomy (RC) with pelvic lymph node dissection.

We included 388 patients who received three or four cycles of cisplatin/gemcitabine or (dose-dense) methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), followed by consolidative RC for cTanyN1-3M0 BCa. We compared pathological complete (pCR = ypT0N0) and objective response (pOR = yp ≤T1N0) between treatment groups. Predictors of pCR and/or pOR were assessed using uni- and multivariable logistic regression analysis. The secondary endpoints were overall (OS) and cancer-specific survival (CSS). We evaluated the association between the number of induction chemotherapy cycles administered and survival outcomes on multivariable Cox regression.

Overall, 101 and 287 patients received three or four cycles of induction chemotherapy, respectively. Of these, 72 (19%) and 128 (33%) achieved pCR and pOR response, respectively. The pCR (20%, 18%) and pOR (40%, 31%) rates did not differ significantly between patients receiving three or four cycles (P > 0.05). The number of cycles was not associated with pCR or pOR on multivariable logistic regression analyses. The 2-year OS estimates were 63% (95% confidence interval [CI] 0.53-0.74) and 63% (95% CI 0.58-0.7) for patients receiving three or four cycles, respectively. Receiving three vs four cycles was not associated with OS and CSS on uni- or multivariable Cox regression analyses.

Pathological response and survival outcomes did not differ between administering three or four induction chemotherapy cycles in patients with cN+ BCa. A fewer cycles (minimum three) may be oncologically sufficient in patients with cN+ BCa, while decreasing the wait for definitive local therapy in those patients who end up without a response to chemotherapy. This warrants further validation.

BJU international. 2024 Mar 12 [Epub ahead of print]

Markus von Deimling, Laura S Mertens, Marc Furrer, Roger Li, Guus A H Tendijck, Jacob Taylor, Felice Crocetto, Moritz Maas, Andrea Mari, Renate Pichler, Marco Moschini, Karl H Tully, David D'Andrea, Ekaterina Laukhtina, Francesco Del Giudice, Gautier Marcq, Maud Velev, Andrea Gallioli, Simone Albisinni, Keiichiro Mori, Abhinav Khanna, Michael Rink, Margit Fisch, Andrea Minervini, Peter C Black, Yair Lotan, Philippe E Spiess, Bernhard Kiss, Shahrokh F Shariat, Benjamin Pradere, CLIPOLY Study Group Collaborators

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Department of Urology, The Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Urology, University Hospital of Bern, University of Bern, Bern, Switzerland., Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA., Department of Urology, University of Texas Southwestern, Dallas, TX, USA., Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples "Federico II", Naples, Italy., Department of Urology, Eberhard Karls University Tübingen, Tübingen, Germany., Unit of Oncologic Minimally-Invasive Urology and Andrology, Department of Experimental and Clinical Medicine, Careggi Hospital, University of Florence, Florence, Italy., Department of Urology, Comprehensive Cancer Center Innsbruck, Medical University of Innsbruck, Innsbruck, Austria., Department of Urology, Urological Research Institute, Vita-Salute San Raffaele, Milan, Italy., Department of Urology and Neurourology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany., Department of Maternal Infant and Urologic Sciences, Policlinico Umberto I Hospital, "Sapienza" University of Rome, Rome, Italy., Department of Urology, CHU Lille, Claude Huriez Hospital, Lille, France., Department of Cancer Medicine, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain., Urology Unit, Department of Surgical Sciences, Tor Vergata University Hospital, University of Rome Tor Vergata, Rome, Italy., Department of Urology, The Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Mayo Clinic, Rochester, MN, USA., Department of Urology, Marienkrankenhaus, Hamburg, Germany., Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.