BACKGROUND: This phase I study was designed to determine the maximum tolerated dose (MTD) and preliminary efficacy of docetaxel with concurrent radiotherapy (RT), in high-risk squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: Eligible patients had resected squamous cell carcinoma of the head and neck, histologically involved lymph nodes, and/or extranodal disease, and/or involved surgical margins and performance status 0 to 1. Treatment included weekly docetaxel with concurrent RT in a dose-finding study; a subsequent small cohort of patients was treated using the MTD of docetaxel. RESULTS: Twenty patients were enrolled. Planned accrual was 25, but the study was closed prematurely because of slow accrual. The MTD was 15 mg/m2. Dose-limiting toxicity was oral stomatitis. Therapy was well tolerated. Five patients experienced locoregional relapse at a median follow-up of 32 months. CONCLUSION: Docetaxel with concurrent RT has acceptable toxicity. This approach warrants further investigation in a phase II trial.
BACKGROUND: This phase I study was designed to determine the maximum tolerated dose (MTD) and preliminary efficacy of docetaxel with concurrent radiotherapy (RT), in high-risk squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: Eligible patients had resected squamous cell carcinoma of the head and neck, histologically involved lymph nodes, and/or extranodal disease, and/or involved surgical margins and performance status 0 to 1. Treatment included weekly docetaxel with concurrent RT in a dose-finding study; a subsequent small cohort of patients was treated using the MTD of docetaxel. RESULTS: Twenty patients were enrolled. Planned accrual was 25, but the study was closed prematurely because of slow accrual. The MTD was 15 mg/m2. Dose-limiting toxicity was oral stomatitis. Therapy was well tolerated. Five patients experienced locoregional relapse at a median follow-up of 32 months. CONCLUSION:Docetaxel with concurrent RT has acceptable toxicity. This approach warrants further investigation in a phase II trial.
Authors: Jay S Cooper; Thomas F Pajak; Arlene A Forastiere; John Jacobs; Bruce H Campbell; Scott B Saxman; Julie A Kish; Harold E Kim; Anthony J Cmelak; Marvin Rotman; Mitchell Machtay; John F Ensley; K S Clifford Chao; Christopher J Schultz; Nancy Lee; Karen K Fu Journal: N Engl J Med Date: 2004-05-06 Impact factor: 91.245
Authors: Jacques Bernier; Christian Domenge; Mahmut Ozsahin; Katarzyna Matuszewska; Jean-Louis Lefèbvre; Richard H Greiner; Jordi Giralt; Philippe Maingon; Frédéric Rolland; Michel Bolla; Francesco Cognetti; Jean Bourhis; Anne Kirkpatrick; Martine van Glabbeke Journal: N Engl J Med Date: 2004-05-06 Impact factor: 91.245
Authors: A D Colevas; P M Busse; C M Norris; M Fried; R B Tishler; M Poulin; R L Fabian; T J Fitzgerald; A Dreyfuss; E S Peters; S Adak; R Costello; J J Barton; M R Posner Journal: J Clin Oncol Date: 1998-04 Impact factor: 44.544
Authors: A I Dreyfuss; J R Clark; C M Norris; R M Rossi; J W Lucarini; P M Busse; M D Poulin; L Thornhill; R Costello; M R Posner Journal: J Clin Oncol Date: 1996-05 Impact factor: 44.544
Authors: Jacques Bernier; Jay S Cooper; T F Pajak; M van Glabbeke; J Bourhis; Arlene Forastiere; Esat Mahmut Ozsahin; John R Jacobs; J Jassem; Kie-Kian Ang; J L Lefèbvre Journal: Head Neck Date: 2005-10 Impact factor: 3.147
Authors: Marshall R Posner; Diane M Hershock; Cesar R Blajman; Elizabeth Mickiewicz; Eric Winquist; Vera Gorbounova; Sergei Tjulandin; Dong M Shin; Kevin Cullen; Thomas J Ervin; Barbara A Murphy; Luis E Raez; Roger B Cohen; Monica Spaulding; Roy B Tishler; Berta Roth; Rosana del Carmen Viroglio; Varagur Venkatesan; Ilya Romanov; Sanjiv Agarwala; K William Harter; Matthew Dugan; Anthony Cmelak; Arnold M Markoe; Paul W Read; Lynn Steinbrenner; A Dimitrios Colevas; Charles M Norris; Robert I Haddad Journal: N Engl J Med Date: 2007-10-25 Impact factor: 91.245
Authors: E Tomiak; M J Piccart; J Kerger; S Lips; A Awada; D de Valeriola; C Ravoet; D Lossignol; J P Sculier; V Auzannet Journal: J Clin Oncol Date: 1994-07 Impact factor: 44.544
Authors: G Catimel; J Verweij; V Mattijssen; A Hanauske; M Piccart; J Wanders; H Franklin; N Le Bail; M Clavel; S B Kaye Journal: Ann Oncol Date: 1994-07 Impact factor: 32.976