C Theodore1, I Skoneczna2, I Bodrogi3, M Leahy4, J M Kerst5, L Collette6, K Ven6, S Marréaud6, R D T Oliver7. 1. Department of Medicine, Institut Gustave Roussy, Villejuif, France. Electronic address: c.theodore@hopital-foch.org. 2. Department of Urology, Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland. 3. Department of Medicine, National Institute of Oncology, Budapest, Hungary. 4. Department of Oncology, St James's University Hospital, Leeds, UK. 5. Department of Oncology, Netherlands Cancer Institute/Antoni Van Leeuwenhoek Hospital, Amsterdam, The Netherlands. 6. Statistic Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium. 7. Department of Oncology, St Bartholomews, London, UK.
Abstract
BACKGROUND: The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer. PATIENTS AND METHODS: Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m(2)) on days 1, 8 and 15 and cisplatin (80 mg/m(2)) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1-N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (alpha = 10%, power = 95%). RESULTS: Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy. CONCLUSION: The study fails to demonstrate a response rate significantly >30%. The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.
BACKGROUND: The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer. PATIENTS AND METHODS: Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m(2)) on days 1, 8 and 15 and cisplatin (80 mg/m(2)) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1-N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (alpha = 10%, power = 95%). RESULTS: Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy. CONCLUSION: The study fails to demonstrate a response rate significantly >30%. The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.
Authors: Lance C Pagliaro; Dallas L Williams; Danai Daliani; Michael B Williams; William Osai; Michael Kincaid; Sijin Wen; Peter F Thall; Curtis A Pettaway Journal: J Clin Oncol Date: 2010-07-12 Impact factor: 44.544
Authors: Suzanne Richter; J Dean Ruether; Lori Wood; Christina Canil; Patricia Moretto; Peter Venner; Joel Gingerich; Urban Emmenegger; Andrea Eisen; Pawel Zalewski; Anthony Joshua; Som Dave Mukherjee; Daniel Heng; Piotr Czaykowski; Denis Soulieres; Norman Blais; Ricardo Rendon; Neil Fleshner; Juanita M Crook; Srikala S Sridhar Journal: Can Urol Assoc J Date: 2013 Nov-Dec Impact factor: 1.862