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Urological Oncology: Bladder, Penis and Urethral Cancer, and Basic Principles of Oncology Re: SUCCINCT: An Open-Label, Single-Arm, Non-Randomised, Phase 2 Trial of Gemcitabine and Cisplatin Chemotherapy in Combination with Sunitinib as First-Line Treatment for Patients with Advanced Urothelial Carcinoma T. Geldart, J. Chester, A. Casbard, S. Crabb, T. Elliott, A. Protheroe, R. A. Huddart, G. Mead, J. Barber, R. J. Jones, J. Smith, R. Cowles, J. Evans and G. Griffiths Royal Bournemouth Hospital, Bournemouth, Institute of Cancer and Genetics, and Wales Cancer Trials Unit, School of Medicine, Cardiff University and Velindre Cancer Centre, Velindre Hospital, Cardiff, St. James’ University Hospital, Leeds, University of Southampton Faculty of Medicine, Southampton General Hospital, Southampton, Christie Hospital, Manchester, Churchill Hospital, Oxford, Institute of Cancer Research and Royal Marsden Hospital, Surrey and Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom Eur Urol 2015; 67: 599e602.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.09.005 available at http://jurology.com/ Editorial Comment: In this multi-institutional trial of advanced urothelial carcinoma 63 treatment naive patients received gemcitabine-cisplatin chemotherapy combined with sunitinib. Overall response rate was 64%. At 6 months 52% of patients were progression-free, and median overall survival was 12 months. Several key findings were noted by the authors. There was significant hematological toxicity that resulted in delay of treatment or reduction and/or discontinuation of the sunitinib. In addition, the greater than 60% progression-free rate at 6 months that was prespecified was not met. Finally, the authors do not recommend proceeding with a phase III evaluation of this combination regimen. Although these investigators should be applauded for attempting to improve outcomes in these patients who need better alternatives, their findings reinforce the difficulty in recruiting and appropriately stratifying these individuals. Sam S. Chang, MD
Suggested Reading Gandhi N, Baras A, Munari E et al: Gemcitabine and cisplatin neoadjuvant chemotherapy for muscle-invasive urothelial carcinoma: predicting response and assessing outcomes. J Urol, suppl., 2015; 193: e923, abstract MP72e08. Yuh BE, Ruel N, Wilson TG et al: Pooled analysis of clinical outcomes with neoadjuvant cisplatin and gemcitabine chemotherapy for muscle invasive bladder cancer. J Urol 2013; 189: 1682.
Re: Comparing Open Radical Cystectomy and Robot-Assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial B. H. Bochner, G. Dalbagni, D. D. Sjoberg, J. Silberstein, G. E. Keren Paz, S. M. Donat, J. A. Coleman, S. Mathew, A. Vickers, G. C. Schnorr, M. A. Feuerstein, B. Rapkin, R. O. Parra, H. W. Herr and V. P. Laudone Urology Service, Department of Surgery, and Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, and Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, and Department of Urology, Tulane University School of Medicine, New Orleans, Louisiana Eur Urol 2015; 67: 1042e1050.
0022-5347/15/1946-0001/0 THE JOURNAL OF UROLOGY® Ó 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2015.09.005 Vol. 194, 1-2, December 2015 Printed in U.S.A.
www.jurology.com Dochead: Urological Survey
LIT 5.4.0 DTD JURO12898_proof 5 September 2015 1:45 pm EO:
j
58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 1 113 114
2
115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160
BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.09.006 available at http://jurology.com/ Editorial Comment: The authors of this prospective randomized trial evaluated 118 patients undergoing radical cystectomy at Memorial Sloan Kettering Cancer Center between 2010 and 2013. Importantly the primary end point was perioperative complication rates (modified Clavien system), and the urinary diversion was performed by skilled “open” surgeons. The study was designed to detect a 20% improvement in the robotic cystectomy arm. Interestingly during the study 617 patients were evaluated for inclusion and only 118 underwent randomization. Secondary end points included estimated blood loss, operative time, margin status, 3 and 6-month quality of life outcomes, operating room costs and total hospitalization costs. At the planned interim analysis no significant difference in complication rates was identified between the groups. The 90-day complication rate was 62% in the robotic arm and 66% in the open cystectomy arm. Robotic cystectomy resulted in less blood loss but longer operative times. From an oncologic standpoint positive surgical margin rates and lymph node counts were similar between the groups. Mean hospital stay was the same, at 8 days for both groups, and quality of life outcomes were similar between the groups at 3 and 6 months. The debate rages on between the pros and cons of robotic radical cystectomy.1 With prospective randomized trial NCT01157676 Parekh et al will help to elucidate the oncologic efficacy of this procedure (https://clinicaltrials.gov/ct2/show/NCT01157676). Although theoretical concerns may exist, none have been proved for other cancer types. This important study evaluates complications at a single center and uses different surgeons for the extirpative portion of the procedure but the same surgeon for the reconstruction portion of the proceduredmany times conjectured to be the “cause” of the majority of complications. As with every procedure we perform, competing factors influence the decisions we make with our patients, including oncologic outcomes, perioperative variables such as time and estimated blood loss and transfusion requirements, our individual skill and experience with the technology, costs, and patient history and desires. Currently I represent an amalgam of this study as more than 75% of the cystectomies I perform are robotic and I perform open urinary diversion. Sam S. Chang, MD 1. Johar RS, Hayn MH, Stegemann AP et al: Complications after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol 2013; 64: 52.
Suggested Reading Zhumkhawala A, Kozinn S, Chan K et al: A decade of robotic cystectomy: surgical characteristics and oncologic outcomes. J Urol, suppl., 2015; 193: e856, abstract MP67e18.
Dochead: Urological Survey
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161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206
Urological Oncology: Bladder, Penis and Urethral Cancer, and Basic Principles of Oncology Re: SUCCINCT: An Open-Label, Single-Arm, Non-Randomised, Phase 2 Trial of Gemcitabine and Cisplatin Chemotherapy in Combination with Sunitinib as First-Line Treatment for Patients with Advanced Urothelial Carcinoma T. Geldart, J. Chester, A. Casbard, S. Crabb, T. Elliott, A. Protheroe, R. A. Huddart, G. Mead, J. Barber, R. J. Jones, J. Smith, R. Cowles, J. Evans and G. Griffiths Royal Bournemouth Hospital, Bournemouth, Institute of Cancer and Genetics, and Wales Cancer Trials Unit, School of Medicine, Cardiff University and Velindre Cancer Centre, Velindre Hospital, Cardiff, St. James’ University Hospital, Leeds, University of Southampton Faculty of Medicine, Southampton General Hospital, Southampton, Christie Hospital, Manchester, Churchill Hospital, Oxford, Institute of Cancer Research and Royal Marsden Hospital, Surrey and Institute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom Eur Urol 2015; 67: 599e602.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.09.005 available at http://jurology.com/ Editorial Comment: In this multi-institutional trial of advanced urothelial carcinoma 63 treatment naive patients received gemcitabine-cisplatin chemotherapy combined with sunitinib. Overall response rate was 64%. At 6 months 52% of patients were progression-free, and median overall survival was 12 months. Several key findings were noted by the authors. There was significant hematological toxicity that resulted in delay of treatment or reduction and/or discontinuation of the sunitinib. In addition, the greater than 60% progression-free rate at 6 months that was prespecified was not met. Finally, the authors do not recommend proceeding with a phase III evaluation of this combination regimen. Although these investigators should be applauded for attempting to improve outcomes in these patients who need better alternatives, their findings reinforce the difficulty in recruiting and appropriately stratifying these individuals. Sam S. Chang, MD
Suggested Reading Gandhi N, Baras A, Munari E et al: Gemcitabine and cisplatin neoadjuvant chemotherapy for muscle-invasive urothelial carcinoma: predicting response and assessing outcomes. J Urol, suppl., 2015; 193: e923, abstract MP72e08. Yuh BE, Ruel N, Wilson TG et al: Pooled analysis of clinical outcomes with neoadjuvant cisplatin and gemcitabine chemotherapy for muscle invasive bladder cancer. J Urol 2013; 189: 1682.
Re: Comparing Open Radical Cystectomy and Robot-Assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial B. H. Bochner, G. Dalbagni, D. D. Sjoberg, J. Silberstein, G. E. Keren Paz, S. M. Donat, J. A. Coleman, S. Mathew, A. Vickers, G. C. Schnorr, M. A. Feuerstein, B. Rapkin, R. O. Parra, H. W. Herr and V. P. Laudone Urology Service, Department of Surgery, and Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, and Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, and Department of Urology, Tulane University School of Medicine, New Orleans, Louisiana Eur Urol 2015; 67: 1042e1050.
0022-5347/15/1946-0001/0 THE JOURNAL OF UROLOGY® Ó 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2015.09.005 Vol. 194, 1-2, December 2015 Printed in U.S.A.
www.jurology.com Dochead: Urological Survey
LIT 5.4.0 DTD JURO12898_proof 5 September 2015 1:45 pm EO:
j
58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 1 113 114
2
115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160
BLADDER, PENIS AND URETHRAL CANCER, AND BASIC PRINCIPLES OF ONCOLOGY
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.09.006 available at http://jurology.com/ Editorial Comment: The authors of this prospective randomized trial evaluated 118 patients undergoing radical cystectomy at Memorial Sloan Kettering Cancer Center between 2010 and 2013. Importantly the primary end point was perioperative complication rates (modified Clavien system), and the urinary diversion was performed by skilled “open” surgeons. The study was designed to detect a 20% improvement in the robotic cystectomy arm. Interestingly during the study 617 patients were evaluated for inclusion and only 118 underwent randomization. Secondary end points included estimated blood loss, operative time, margin status, 3 and 6-month quality of life outcomes, operating room costs and total hospitalization costs. At the planned interim analysis no significant difference in complication rates was identified between the groups. The 90-day complication rate was 62% in the robotic arm and 66% in the open cystectomy arm. Robotic cystectomy resulted in less blood loss but longer operative times. From an oncologic standpoint positive surgical margin rates and lymph node counts were similar between the groups. Mean hospital stay was the same, at 8 days for both groups, and quality of life outcomes were similar between the groups at 3 and 6 months. The debate rages on between the pros and cons of robotic radical cystectomy.1 With prospective randomized trial NCT01157676 Parekh et al will help to elucidate the oncologic efficacy of this procedure (https://clinicaltrials.gov/ct2/show/NCT01157676). Although theoretical concerns may exist, none have been proved for other cancer types. This important study evaluates complications at a single center and uses different surgeons for the extirpative portion of the procedure but the same surgeon for the reconstruction portion of the proceduredmany times conjectured to be the “cause” of the majority of complications. As with every procedure we perform, competing factors influence the decisions we make with our patients, including oncologic outcomes, perioperative variables such as time and estimated blood loss and transfusion requirements, our individual skill and experience with the technology, costs, and patient history and desires. Currently I represent an amalgam of this study as more than 75% of the cystectomies I perform are robotic and I perform open urinary diversion. Sam S. Chang, MD 1. Johar RS, Hayn MH, Stegemann AP et al: Complications after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol 2013; 64: 52.
Suggested Reading Zhumkhawala A, Kozinn S, Chan K et al: A decade of robotic cystectomy: surgical characteristics and oncologic outcomes. J Urol, suppl., 2015; 193: e856, abstract MP67e18.
Dochead: Urological Survey
LIT 5.4.0 DTD JURO12898_proof 5 September 2015 1:45 pm EO:
161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206
