Identifying the Optimal Number of Neoadjuvant Chemotherapy Cycles in Patients with Muscle-Invasive Bladder Cancer

David D'Andrea, Peter C. Black, Homayoun Zargar, C. P. Dinney, Francesco Soria, M. S. Cookson, Jeffrey S Montgomery, Wassim Kassouf, Marc A Dall'Era, Srikala S. Sridhar, John S McGrath, Jonathan Wright, Andrew C. Thorpe, J. M. Holzbeierlein, Diego Carrión, Ettore Di Trapani, Trinity J Bivalacqua, Scott North, Daniel A Barocas, Yair LotanPetros Grivas, Andrew J Stephenson, Bas W van Rhijn, Siamak Daneshmand, Philippe E Spiess, Shahrokh F Shariat, Kamran Zargar-Shoshtari, Laura S Mertens, Adrian S Fairey, Maria C Mir, Laura-Maria Krabbe, Niels-Erik Jacobsen, Nikhil Vasdev, Evan Y Yu, Evanguelos Xylinas, Benjamin Pradere, Renate Pichler, Nicholas J Campain, J. A. Seah, C. E. Ercole, Simon Horenblas, J. Aning, Todd M Morgan, Jay B Shah, Marco Moschini

Research output: Contribution to journalArticlepeer-review


Purpose:We investigated the pathological response rates and survival associated with 3 vs 4 cycles of cisplatin-based neoadjuvant chemotherapy (NAC) in patients with cT2-4N0M0 muscle invasive bladder cancer.Materials and Methods:In this cohort study we analyzed clinical data of 828 patients treated with NAC and radical cystectomy between 2000 and 2020. A total of 384 and 444 patients were treated with 3 and 4 cycles of NAC, respectively. Pathological objective response (pOR; ypT0-Ta-Tis-T1 N0), pathological complete response (pCR; ypT0 N0), cancer-specific survival and overall survival were investigated.Results:pOR and pCR were achieved in 378 (45%; 95% CI 42, 49) and 207 (25%; 95% CI 22, 28) patients, respectively. Patients treated with 4 cycles of NAC had higher pOR (49% vs 42%, p=0.03) and pCR (28% vs 21%, p=0.02) rates compared to those treated with 3 cycles. This effect was confirmed on multivariable logistic regression analysis (pOR OR 1.46 p=0.008, pCR OR 1.57, p=0.007). On multivariable Cox regression analysis, 4 cycles of NAC were significantly associated with overall survival (HR 0.68; 95% CI 0.49, 0.94; p=0.02) but not with cancer-specific survival (HR 0.72; 95% CI 0.50, 1.04; p=0.08).Conclusions:Four cycles of NAC achieved better pathological response and survival compared to 3 cycles. These findings may aid clinicians in counseling patients and serve as a benchmark for prospective trials. Prospective validation of these findings and assessment of cumulative toxicity derived from an increased number of cycles are needed.

Original languageEnglish
Pages (from-to)70-76
Number of pages7
JournalAUA Journal of Urology
Issue number1
Early online date27 Aug 2021
Publication statusPublished - 1 Jan 2022


  • drug administration schedule
  • neoadjuvant therapy
  • survival
  • urinary bladder neoplasms


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