INTRODUCTION: Concurrent chemotherapy and radiotherapy is recommended for the treatment of locally advanced unresectable head and neck (H&N) cancer. OBJECTIVE: The primary purpose of the Phase I part of the study was to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of docetaxel with hyperfractionation radiotherapy. The primary objective of the Phase II part was to determine the response rate to the RD of treatment and, secondarily, to assess the toxicity of the schedule, time to progression, duration of response and overall survival (OS). MATERIALS AND METHODS: Patients (n=9 in Phase I; n=19 in Phase II) had unresectable H&N cancer. The starting docetaxel dose was 20 mg/m(2) plus hyperfractionated radiotherapy. Ramping of docetaxel was 5 mg/m(2) if MTD was not reached. RESULTS: MTD of docetaxel was 20 mg/m(2). Limiting toxicities were grade 4 pneumonia and grade 4 mucositis. The RD was 15 mg/m(2). Phase II initial response was 76% (CR=18%; PR=9%); updated response was 89% (CR=59%; PR=29%). The median progression-free survival was 7.8 months (95%CI: 0-22.3) and the median OS was 15.1 months (95%CI: 0-35.9). Grade 3-4 toxicities included mucositis (91%), pneumonia (27%) and fatigue (27%). There were 5 toxic deaths (2 from intestinal perforation, 3 from pneumonia). CONCLUSIONS: Weekly docetaxel+hyperfractionation radiotherapy is active but with high toxicity rates and, hence, this treatment regimen would be difficult to justify.
INTRODUCTION: Concurrent chemotherapy and radiotherapy is recommended for the treatment of locally advanced unresectable head and neck (H&N) cancer. OBJECTIVE: The primary purpose of the Phase I part of the study was to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of docetaxel with hyperfractionation radiotherapy. The primary objective of the Phase II part was to determine the response rate to the RD of treatment and, secondarily, to assess the toxicity of the schedule, time to progression, duration of response and overall survival (OS). MATERIALS AND METHODS:Patients (n=9 in Phase I; n=19 in Phase II) had unresectable H&N cancer. The starting docetaxel dose was 20 mg/m(2) plus hyperfractionated radiotherapy. Ramping of docetaxel was 5 mg/m(2) if MTD was not reached. RESULTS: MTD of docetaxel was 20 mg/m(2). Limiting toxicities were grade 4 pneumonia and grade 4 mucositis. The RD was 15 mg/m(2). Phase II initial response was 76% (CR=18%; PR=9%); updated response was 89% (CR=59%; PR=29%). The median progression-free survival was 7.8 months (95%CI: 0-22.3) and the median OS was 15.1 months (95%CI: 0-35.9). Grade 3-4 toxicities included mucositis (91%), pneumonia (27%) and fatigue (27%). There were 5 toxic deaths (2 from intestinal perforation, 3 from pneumonia). CONCLUSIONS: Weekly docetaxel+hyperfractionation radiotherapy is active but with high toxicity rates and, hence, this treatment regimen would be difficult to justify.
Authors: Anthony J Cmelak; Sigui Li; Meredith A Goldwasser; Barbara Murphy; Michael Cannon; Harlan Pinto; David I Rosenthal; Maura Gillison; Arlene A Forastiere Journal: J Clin Oncol Date: 2007-09-01 Impact factor: 44.544
Authors: Roy B Tishler; Charles M Norris; A Dimitrios Colevas; Carolyn C Lamb; Daniel Karp; Paul M Busse; Asa Nixon; Robert Frankenthaler; Bernadette Lake-Willcutt; Rosemary Costello; Maryann Case; Marshall R Posner Journal: Cancer Date: 2002-10-01 Impact factor: 6.860
Authors: Jean-Pierre Pignon; Nathalie Syz; Marshall Posner; Robert Olivares; Laurence Le Lann; Antoine Yver; Ariane Dunant; Freddi Lewin; David N Dalley; Adriano Paccagnella; Samuel G Taylor; Christian Domenge; Jean Bourhis; Madhu Mazumdar Journal: Anticancer Drugs Date: 2004-04 Impact factor: 2.248
Authors: D Schrijvers; C Van Herpen; J Kerger; E Joosens; C Van Laer; A Awada; D Van den Weyngaert; H Nguyen; C Le Bouder; J A Castelijns; J Kaanders; P De Mulder; J B Vermorken Journal: Ann Oncol Date: 2004-04 Impact factor: 32.976