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A randomized phase II study of 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy compared with bevacizumab plus 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy for intermediate-stage and T4N0-1 head and neck cancers.

Publication ,  Journal Article
Salama, JK; Haraf, DJ; Stenson, KM; Blair, EA; Witt, ME; Williams, R; Kunnavakkam, R; Cohen, EEW; Seiwert, T; Vokes, EE
Published in: Ann Oncol
October 2011

INTRODUCTION: We conducted a randomized phase II study to evaluate the impact of adding bevacizumab (B) to 5-fluorouracil (5-FU), hydroxyurea (HU), and radiotherapy (FHX) for intermediate-stage and select T4 head and neck squamous cell cancers (HNSCC). PATIENTS AND METHODS: Eligible patients had newly diagnosed HNSCC. Randomization was 2:1 in favor of BFHX. All patients received 500 mg HU p.o. b.i.d., 600 mg/m(2)/day continuous infusion 5-FU, and b.i.d. radiotherapy with or without bevacizumab 10 mg/kg administered on day 1 of each 14-day cycle. Patients received five cycles consisting of chemoradiotherapy for 5 days followed by 9 days without therapy. RESULTS: Twenty-six patients were enrolled (19 BFHX and 7 FHX). The study was halted following unexpected locoregional progression. Two-year survival was 68%; 89% treated with FHX and 58% (95% confidence interval 33% to 78%) treated with BFHX. Two-year locoregional control was 80% after chemoradiotherapy and 85% after surgical salvage. All locoregional progression occurred in T4 tumors randomized to BFHX. Two patients receiving BFHX died during therapy, and one died shortly after therapy. No catastrophic bleeding events were seen. CONCLUSIONS: Locoregional progression seen in T4N0-1 tumors treated with BFHX was unexpected and led to study termination. The addition of bevacuzimab to chemoradiotherapy for HNSCC should be limited clinical trials.

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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

October 2011

Volume

22

Issue

10

Start / End Page

2304 / 2309

Location

England

Related Subject Headings

  • Squamous Cell Carcinoma of Head and Neck
  • Radiotherapy Dosage
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Hydroxyurea
  • Humans
  • Head and Neck Neoplasms
  • Fluorouracil
 

Citation

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Salama, J. K., Haraf, D. J., Stenson, K. M., Blair, E. A., Witt, M. E., Williams, R., … Vokes, E. E. (2011). A randomized phase II study of 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy compared with bevacizumab plus 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy for intermediate-stage and T4N0-1 head and neck cancers. Ann Oncol, 22(10), 2304–2309. https://doi.org/10.1093/annonc/mdq736
Salama, J. K., D. J. Haraf, K. M. Stenson, E. A. Blair, M. E. Witt, R. Williams, R. Kunnavakkam, E. E. W. Cohen, T. Seiwert, and E. E. Vokes. “A randomized phase II study of 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy compared with bevacizumab plus 5-fluorouracil, hydroxyurea, and twice-daily radiotherapy for intermediate-stage and T4N0-1 head and neck cancers.Ann Oncol 22, no. 10 (October 2011): 2304–9. https://doi.org/10.1093/annonc/mdq736.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

October 2011

Volume

22

Issue

10

Start / End Page

2304 / 2309

Location

England

Related Subject Headings

  • Squamous Cell Carcinoma of Head and Neck
  • Radiotherapy Dosage
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Hydroxyurea
  • Humans
  • Head and Neck Neoplasms
  • Fluorouracil