Abstract | BACKGROUND: 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.
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Authors | C Theodore, I Skoneczna, I Bodrogi, M Leahy, J M Kerst, L Collette, K Ven, S Marréaud, R D T Oliver, EORTC Genito-Urinary Tract Cancer Group |
Journal | Annals of oncology : official journal of the European Society for Medical Oncology
(Ann Oncol)
Vol. 19
Issue 7
Pg. 1304-1307
(Jul 2008)
ISSN: 1569-8041 [Electronic] England |
PMID | 18417462
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)
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Chemical References |
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Irinotecan
- Cisplatin
- Camptothecin
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Topics |
- Adult
- Aged
- Antineoplastic Agents
(administration & dosage)
- Antineoplastic Agents, Phytogenic
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, analogs & derivatives)
- Carcinoma, Squamous Cell
(drug therapy, pathology)
- Cisplatin
(administration & dosage, adverse effects)
- Drug Administration Schedule
- Feasibility Studies
- Follow-Up Studies
- Humans
- Irinotecan
- Male
- Middle Aged
- Penile Neoplasms
(drug therapy, pathology)
- Time Factors
- Treatment Outcome
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