G R Pond1, J Bellmunt2, J E Rosenberg3, D F Bajorin3, A M Regazzi3, T K Choueiri4, A Q Qu4, G Niegisch5, P Albers5, A Necchi6, G Di Lorenzo7, R Fougeray8, Y-N Wong9, S S Sridhar10, Y-J Ko11, M I Milowsky12, M D Galsky13, G Sonpavde14. 1. McMaster University, Hamilton, ON. 2. University Hospital del Mar, Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain. 3. Memorial Sloan Kettering Cancer Center, New York, NY. 4. Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA. 5. Heinrich Heine University, Dusseldorf, Germany. 6. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 7. University Federico II, Naples, Italy. 8. Institut de Recherche Pierre Fabre, Boulogne, France. 9. Fox Chase Cancer Center, Philadelphia, PA. 10. Princess Margaret Hospital, Toronto, ON. 11. Sunnybrook Odette Cancer Centre, Toronto, ON. 12. University of North Carolina, Chapel Hill, NC. 13. Tisch Cancer Center Institute, Mount Sinai School of Medicine, New York, NY. 14. University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL. Electronic address: gsonpavde@uabmc.edu.
Abstract
BACKGROUND: The differential impact of the number of prior lines of therapy and the setting of prior therapy (perioperative or metastatic) is unclear in advanced urothelial carcinoma. PATIENTS AND METHODS: Ten phase II trials of salvage chemotherapy, biologic agent therapy, or both, enrolling 731 patients, were available. Data on the number of prior lines of therapy and the setting of prior therapy were required in addition to known previously recognized prognostic factors: time from prior chemotherapy, hemoglobin level, performance status, and liver metastasis status. Cox proportional hazards regression was used to evaluate the association of the number of prior lines and prior perioperative therapy with overall survival (OS) as the primary clinical endpoint. Trial was a stratification factor. RESULTS: A total of 711 patients were evaluable. The overall median progression-free survival and OS were 2.7 and 6.8 months, respectively. The number of prior lines was 1 in 559 patients (78.6%), 2 in 111 (15.6%), 3 in 29 (4.1%), 4 in 10 (1.4%), and 5 in 2 (0.3%). Prior perioperative chemotherapy was given to 277 (39.1%) and chemotherapy for metastatic disease to 454 (64.1%). The number of prior lines was not independently associated with OS (hazard ratio, 0.99; 95% CI, 0.86-1.14). Prior perioperative chemotherapy was a favorable factor for OS on univariate but not multivariate analysis. CONCLUSION: The number of prior lines of therapy and prior perioperative chemotherapy were not independently prognostic in patients with urothelial carcinoma receiving salvage therapy. Adoption of these data in salvage therapy trials should enhance accrual, the interpretability of results, and drug development.
BACKGROUND: The differential impact of the number of prior lines of therapy and the setting of prior therapy (perioperative or metastatic) is unclear in advanced urothelial carcinoma. PATIENTS AND METHODS: Ten phase II trials of salvage chemotherapy, biologic agent therapy, or both, enrolling 731 patients, were available. Data on the number of prior lines of therapy and the setting of prior therapy were required in addition to known previously recognized prognostic factors: time from prior chemotherapy, hemoglobin level, performance status, and liver metastasis status. Cox proportional hazards regression was used to evaluate the association of the number of prior lines and prior perioperative therapy with overall survival (OS) as the primary clinical endpoint. Trial was a stratification factor. RESULTS: A total of 711 patients were evaluable. The overall median progression-free survival and OS were 2.7 and 6.8 months, respectively. The number of prior lines was 1 in 559 patients (78.6%), 2 in 111 (15.6%), 3 in 29 (4.1%), 4 in 10 (1.4%), and 5 in 2 (0.3%). Prior perioperative chemotherapy was given to 277 (39.1%) and chemotherapy for metastatic disease to 454 (64.1%). The number of prior lines was not independently associated with OS (hazard ratio, 0.99; 95% CI, 0.86-1.14). Prior perioperative chemotherapy was a favorable factor for OS on univariate but not multivariate analysis. CONCLUSION: The number of prior lines of therapy and prior perioperative chemotherapy were not independently prognostic in patients with urothelial carcinoma receiving salvage therapy. Adoption of these data in salvage therapy trials should enhance accrual, the interpretability of results, and drug development.
Authors: Guru Sonpavde; Gregory R Pond; Jonathan E Rosenberg; Dean F Bajorin; Toni K Choueiri; Andrea Necchi; Giuseppe Di Lorenzo; Joaquim Bellmunt Journal: J Urol Date: 2015-08-17 Impact factor: 7.450
Authors: Jennifer A Locke; Gregory Russell Pond; Guru Sonpavde; Andrea Necchi; Patrizia Giannatempo; Ravi Kumar Paluri; Guenter Niegisch; Peter Albers; Carlo Buonerba; Giuseppe Di Lorenzo; Ulka N Vaishampayan; Scott A North; Neeraj Agarwal; Syed A Hussain; Sumanta Pal; Bernhard J Eigl Journal: Clin Genitourin Cancer Date: 2015-10-24 Impact factor: 2.872
Authors: Jose Luis Perez-Gracia; Yohann Loriot; Jonathan E Rosenberg; Thomas Powles; Andrea Necchi; Syed A Hussain; Rafael Morales-Barrera; Margitta M Retz; Günter Niegisch; Ignacio Durán; Christine Théodore; Enrique Grande; Xiaodong Shen; Jingjing Wang; Betty Nelson; Christina L Derleth; Michiel S van der Heijden Journal: Eur Urol Date: 2017-12-20 Impact factor: 20.096
Authors: Giuseppe Di Lorenzo; Carlo Buonerba; Teresa Bellelli; Concetta Romano; Vittorino Montanaro; Matteo Ferro; Alfonso Benincasa; Dario Ribera; Giuseppe Lucarelli; Ottavio De Cobelli; Guru Sonpavde; Sabino De Placido Journal: Medicine (Baltimore) Date: 2015-12 Impact factor: 1.817