Phase I trial of tirapazamine, cisplatin, and concurrent accelerated boost reirradiation in patients with recurrent head and neck cancer.
Details
Serval ID
serval:BIB_9158A41C9974
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Phase I trial of tirapazamine, cisplatin, and concurrent accelerated boost reirradiation in patients with recurrent head and neck cancer.
Journal
International Journal of Radiation Oncology, Biology, Physics
ISSN
0360-3016 (Print)
ISSN-L
0360-3016
Publication state
Published
Issued date
2007
Peer-reviewed
Oui
Volume
67
Number
3
Pages
678-684
Language
english
Notes
Publication types: Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
Abstract
PURPOSE: Reirradiation (re-RT) with concurrent chemotherapy offers a therapeutic option in patients who have locoregional recurrence of head and neck cancer (HNC). The hypoxic cell sensitizer, tirapazamine (TPZ), has demonstrated promising results in first-line therapy for HNC. This phase I trial was designed to test the feasibility of giving TPZ in the re-RT setting.
METHODS AND MATERIALS: Patients with recurrent HNC who received prior radiotherapy (RT) were enrolled and received TPZ (260 mg/m2) and cisplatin (50 mg/m2) Weeks 1, 3, and 5 concurrently with RT (72 Gy, 42 fractions over 6 weeks). TPZ (160 mg/m2) alone was added on Days 1, 3, and 5 of Week 2 (cohort 1) or Weeks 2 and 4 (cohort 2).
RESULTS: Twenty-five subjects were enrolled, 7 and 18 on cohorts 1 and 2, respectively. Significant toxicities included Grade 3 dermatitis (20%) and Grade 3 mucositis (40%). Dose-limiting toxicity was observed on cohort 2 (1 patient with aspiration pneumonia). Four deaths occurred during treatment. Two fatalities occurred after completing therapy as a result of carotid artery rupture. With a minimum and median follow-up of 14 and 24 months, respectively, median overall survival was 14 months with actuarial 1-year and 2-year survival of 56% and 27%, respectively.
CONCLUSION: Reirradiation with concomitant chemotherapy including TPZ in patients with unresectable recurrent HNC is feasible and results in long-term survival in a significant proportion of patients.
METHODS AND MATERIALS: Patients with recurrent HNC who received prior radiotherapy (RT) were enrolled and received TPZ (260 mg/m2) and cisplatin (50 mg/m2) Weeks 1, 3, and 5 concurrently with RT (72 Gy, 42 fractions over 6 weeks). TPZ (160 mg/m2) alone was added on Days 1, 3, and 5 of Week 2 (cohort 1) or Weeks 2 and 4 (cohort 2).
RESULTS: Twenty-five subjects were enrolled, 7 and 18 on cohorts 1 and 2, respectively. Significant toxicities included Grade 3 dermatitis (20%) and Grade 3 mucositis (40%). Dose-limiting toxicity was observed on cohort 2 (1 patient with aspiration pneumonia). Four deaths occurred during treatment. Two fatalities occurred after completing therapy as a result of carotid artery rupture. With a minimum and median follow-up of 14 and 24 months, respectively, median overall survival was 14 months with actuarial 1-year and 2-year survival of 56% and 27%, respectively.
CONCLUSION: Reirradiation with concomitant chemotherapy including TPZ in patients with unresectable recurrent HNC is feasible and results in long-term survival in a significant proportion of patients.
Keywords
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Squamous Cell/drug therapy, Carcinoma, Squamous Cell/radiotherapy, Cisplatin/administration & dosage, Cisplatin/adverse effects, Combined Modality Therapy/adverse effects, Combined Modality Therapy/methods, Confidence Intervals, Feasibility Studies, Female, Head and Neck Neoplasms/drug therapy, Head and Neck Neoplasms/radiotherapy, Humans, Male, Middle Aged, Neoplasm Recurrence, Local/drug therapy, Neoplasm Recurrence, Local/radiotherapy, Radiation-Sensitizing Agents/administration & dosage, Radiation-Sensitizing Agents/adverse effects, Radiotherapy Dosage, Retreatment, Triazines/administration & dosage, Triazines/adverse effects
Pubmed
Web of science
Create date
01/12/2014 18:30
Last modification date
20/08/2019 15:54