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A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck.

Publication ,  Journal Article
Brizel, DM; Leopold, KA; Fisher, SR; Panella, TJ; Fine, RL; Bedrosian, CL; Kenan, PD; Huang, A; Womack, T; Bjurstrom, T
Published in: Int J Radiat Oncol Biol Phys
January 1, 1994

PURPOSE: This study was designed to test the toxicity and efficacy of a regimen of twice daily irradiation and concurrent multiagent chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck. METHODS AND MATERIALS: This was a prospective Phase I/II trial. Patients received 125 cGy b.i.d. to 7000 cGy with a 6 hr interfraction interval. Chemotherapy was given during weeks 1 and 6 of irradiation and consisted of a 5 day infusion of 5-fluorouracil at 600 mg/M2/day and 5 daily injections of cisplatin at 12 mg/M2/day. Two additional cycles of chemotherapy were given after the completion of radiotherapy. RESULTS: Forty-six patients were evaluable: 28 had technically unresectable disease and 18 had resectable tumors. All had Stage III or IV disease: 84% had T3 or T4 primaries while 53% had > or = N2 neck disease. The primary acute toxicity, confluent mucositis, was seen in 74% of patients. Late side effects occurred in four patients. Median follow-up is 36 months (range 25-44 months). Kaplan-Meier estimates of 2-year disease-free survival and overall survival are 65% and 73%, respectively, while 2-year local regional control and distant disease-free survival are 72% and 88%, respectively. Multivariate analysis revealed that resectability and receiving > 2 cycles of chemotherapy significantly influenced local regional control while age < 60 significantly influenced disease-free survival. CONCLUSION: This form of treatment can be delivered safely. The encouraging results have led to the initiation of a Phase III trial comparing this regimen with b.i.d. radiation alone.

Duke Scholars

Published In

Int J Radiat Oncol Biol Phys

DOI

ISSN

0360-3016

Publication Date

January 1, 1994

Volume

28

Issue

1

Start / End Page

213 / 220

Location

United States

Related Subject Headings

  • Survival Analysis
  • Radiotherapy Dosage
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Mucous Membrane
  • Head and Neck Neoplasms
  • Follow-Up Studies
  • Fluorouracil
  • Combined Modality Therapy
  • Cisplatin
 

Citation

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Brizel, D. M., Leopold, K. A., Fisher, S. R., Panella, T. J., Fine, R. L., Bedrosian, C. L., … Bjurstrom, T. (1994). A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys, 28(1), 213–220. https://doi.org/10.1016/0360-3016(94)90160-0
Brizel, D. M., K. A. Leopold, S. R. Fisher, T. J. Panella, R. L. Fine, C. L. Bedrosian, P. D. Kenan, A. Huang, T. Womack, and T. Bjurstrom. “A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck.Int J Radiat Oncol Biol Phys 28, no. 1 (January 1, 1994): 213–20. https://doi.org/10.1016/0360-3016(94)90160-0.
Brizel DM, Leopold KA, Fisher SR, Panella TJ, Fine RL, Bedrosian CL, et al. A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 1994 Jan 1;28(1):213–20.
Brizel, D. M., et al. “A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck.Int J Radiat Oncol Biol Phys, vol. 28, no. 1, Jan. 1994, pp. 213–20. Pubmed, doi:10.1016/0360-3016(94)90160-0.
Brizel DM, Leopold KA, Fisher SR, Panella TJ, Fine RL, Bedrosian CL, Kenan PD, Huang A, Womack T, Bjurstrom T. A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 1994 Jan 1;28(1):213–220.
Journal cover image

Published In

Int J Radiat Oncol Biol Phys

DOI

ISSN

0360-3016

Publication Date

January 1, 1994

Volume

28

Issue

1

Start / End Page

213 / 220

Location

United States

Related Subject Headings

  • Survival Analysis
  • Radiotherapy Dosage
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Mucous Membrane
  • Head and Neck Neoplasms
  • Follow-Up Studies
  • Fluorouracil
  • Combined Modality Therapy
  • Cisplatin