Chemoradiotherapy combined with intracavitary hyperthermia for anal cancer: feasibility and long-term results from a phase II randomized trial
Autor: | C. Dardoufas, Lambros Vlahos, Nikolaos K. Uzunoglu, C. Papavasiliou, John Kouvaris, Vassilis Kouloulias, Costas Gennatas, G. Plataniotis |
---|---|
Rok vydání: | 2005 |
Předmět: |
Hyperthermia
Male Cancer Research medicine.medical_specialty Mitomycin law.invention Randomized controlled trial law Diathermy Antineoplastic Combined Chemotherapy Protocols Medicine Anal cancer Humans In patient Aged business.industry Long term results Middle Aged medicine.disease Anus Neoplasms Combined Modality Therapy Survival Analysis Surgery Oncology Female Dose Fractionation Radiation Fluorouracil business Chemoradiotherapy |
Zdroj: | American journal of clinical oncology. 28(1) |
ISSN: | 1537-453X |
Popis: | The purpose of this study was to investigate in a randomized way the clinical benefit of addition of intracavitary hyperthermia (ICHT) to a conventional chemoradiotherapy schedule in patients with T2-T3N0M0 anal cancer.Patients were randomly assigned to undergo chemotherapy with 5-fluorouracil (5-FU) and mitomycin-C combined with radiotherapy with (arm A: 24 patients) or without ICHT (arm B: 25 patients). A microwave applicator operating at 433 MHz inserted into the anal-rectal cavity was used for ICHT. Patients in both arms received 1000 mg/m2 per day of 5-FU on days 1-4 and days 28-31 plus 15 mg/m mitomycin-C on day 1. Radiotherapy was administered with a dose of 41.4 Gy (1.8 Gy per fraction) plus a booster dose of 14 Gy (2 Gy per fraction).One patient from group A developed severe mucositis, whereas no severe morbidity was noted in the rest of the patients in both groups. The incidence of lower-intestine acute reactions was higher in the ICHT arm. After a 5-year follow up in the hyperthermia arm, 23 of 24 patients (95.8%) preserved their anorectal function and avoided permanent colostomy, whereas in the second arm, 17 of 25 (68.0%) had sphincter preservation. Local recurrence-free survival time was significantly higher in the ICHT arm (P = 0.0107, log rank test), whereas no significant difference in overall survival was noted.The addition of ICHT to the chemoradiotherapy schedule of anal cancer seems to offer a new effective and safe therapeutic modality. The preservation of anorectal function seems to be the significant clinical benefit of adjuvant ICHT. |
Databáze: | OpenAIRE |
Externí odkaz: |