Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck

Toxicities and responses

Adam S. Garden, Bonnie S. Glisson, K. Kian Ang, William H. Morrison, Scott M. Lippman, Robert M. Byers, Fady Geara, Gary L. Clayman, Dong M. Shin, David Callender, Fadlo R. Khuri, Helmuth Goepfert, Waun K. Hong, Lester J. Peters

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Purpose: Extrapolating from our experience delivering a 'boost' field of radiation concurrently with fields treating both gross and subclinical disease at the end of a course of radiation therapy, we developed a regimen to deliver concurrent chemotherapy during the last 2 weeks of a conventionally fractionated course of radiation. Patients and Methods: Patients had stage III or IV biopsy-proven squamous cell carcinoma originating from a head and neck mucosal site. The regimen was 70 Gy delivered over 7 weeks with concurrent fluorouracil (5-FU) and cisplatin given daily with each radiation dose during the last 2 weeks. A phase I study was performed to determine the maximum-tolerated dose (MTD) before a phase II study was conducted. Results: The MTD was 400 mg/m2 per day for 5-FU and 10 mg/m2 per day for cisplatin. Mucositis persisting more than 6 weeks after therapy was the dose-limiting toxicity. A total of 60 patients were treated on the two phases of the study. Eighteen patients (35%) treated at the MTD developed prolonged mucositis. There were two cases of neutropenic sepsis, including one fatality. The actuarial 2-year rates for overall survival, freedom from relapse, and local control were 62%, 59%, and 80%, respectively. Conclusion: Preliminary locoregional control rates seem to be higher than those reported for treatment with radiation alone. Toxicity was also greater than that seen with radiation alone, but the regimen was designed to deliver an intense treatment schedule, which could be completed without significant interruptions, and to obtain high control rates above the clavicles. These end points were achieved.

Original languageEnglish (US)
Pages (from-to)2390-2395
Number of pages6
JournalJournal of Clinical Oncology
Volume17
Issue number8
StatePublished - Aug 1999
Externally publishedYes

Fingerprint

Maximum Tolerated Dose
Radiation
Drug Therapy
Fluorouracil
Mucositis
Cisplatin
Clavicle
Squamous Cell Carcinoma
Sepsis
Appointments and Schedules
Neck
Radiotherapy
Therapeutics
Survival Rate
Head
Carcinoma, squamous cell of head and neck
Biopsy
Recurrence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Garden, A. S., Glisson, B. S., Kian Ang, K., Morrison, W. H., Lippman, S. M., Byers, R. M., ... Peters, L. J. (1999). Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck: Toxicities and responses. Journal of Clinical Oncology, 17(8), 2390-2395.

Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck : Toxicities and responses. / Garden, Adam S.; Glisson, Bonnie S.; Kian Ang, K.; Morrison, William H.; Lippman, Scott M.; Byers, Robert M.; Geara, Fady; Clayman, Gary L.; Shin, Dong M.; Callender, David; Khuri, Fadlo R.; Goepfert, Helmuth; Hong, Waun K.; Peters, Lester J.

In: Journal of Clinical Oncology, Vol. 17, No. 8, 08.1999, p. 2390-2395.

Research output: Contribution to journalArticle

Garden, AS, Glisson, BS, Kian Ang, K, Morrison, WH, Lippman, SM, Byers, RM, Geara, F, Clayman, GL, Shin, DM, Callender, D, Khuri, FR, Goepfert, H, Hong, WK & Peters, LJ 1999, 'Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck: Toxicities and responses', Journal of Clinical Oncology, vol. 17, no. 8, pp. 2390-2395.
Garden, Adam S. ; Glisson, Bonnie S. ; Kian Ang, K. ; Morrison, William H. ; Lippman, Scott M. ; Byers, Robert M. ; Geara, Fady ; Clayman, Gary L. ; Shin, Dong M. ; Callender, David ; Khuri, Fadlo R. ; Goepfert, Helmuth ; Hong, Waun K. ; Peters, Lester J. / Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck : Toxicities and responses. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 8. pp. 2390-2395.
@article{9e0b908fef314c6c95b1efd8045e0463,
title = "Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck: Toxicities and responses",
abstract = "Purpose: Extrapolating from our experience delivering a 'boost' field of radiation concurrently with fields treating both gross and subclinical disease at the end of a course of radiation therapy, we developed a regimen to deliver concurrent chemotherapy during the last 2 weeks of a conventionally fractionated course of radiation. Patients and Methods: Patients had stage III or IV biopsy-proven squamous cell carcinoma originating from a head and neck mucosal site. The regimen was 70 Gy delivered over 7 weeks with concurrent fluorouracil (5-FU) and cisplatin given daily with each radiation dose during the last 2 weeks. A phase I study was performed to determine the maximum-tolerated dose (MTD) before a phase II study was conducted. Results: The MTD was 400 mg/m2 per day for 5-FU and 10 mg/m2 per day for cisplatin. Mucositis persisting more than 6 weeks after therapy was the dose-limiting toxicity. A total of 60 patients were treated on the two phases of the study. Eighteen patients (35{\%}) treated at the MTD developed prolonged mucositis. There were two cases of neutropenic sepsis, including one fatality. The actuarial 2-year rates for overall survival, freedom from relapse, and local control were 62{\%}, 59{\%}, and 80{\%}, respectively. Conclusion: Preliminary locoregional control rates seem to be higher than those reported for treatment with radiation alone. Toxicity was also greater than that seen with radiation alone, but the regimen was designed to deliver an intense treatment schedule, which could be completed without significant interruptions, and to obtain high control rates above the clavicles. These end points were achieved.",
author = "Garden, {Adam S.} and Glisson, {Bonnie S.} and {Kian Ang}, K. and Morrison, {William H.} and Lippman, {Scott M.} and Byers, {Robert M.} and Fady Geara and Clayman, {Gary L.} and Shin, {Dong M.} and David Callender and Khuri, {Fadlo R.} and Helmuth Goepfert and Hong, {Waun K.} and Peters, {Lester J.}",
year = "1999",
month = "8",
language = "English (US)",
volume = "17",
pages = "2390--2395",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "8",

}

TY - JOUR

T1 - Phase I/II trial of radiation with chemotherapy 'boost' for advanced squamous cell carcinomas of the head and neck

T2 - Toxicities and responses

AU - Garden, Adam S.

AU - Glisson, Bonnie S.

AU - Kian Ang, K.

AU - Morrison, William H.

AU - Lippman, Scott M.

AU - Byers, Robert M.

AU - Geara, Fady

AU - Clayman, Gary L.

AU - Shin, Dong M.

AU - Callender, David

AU - Khuri, Fadlo R.

AU - Goepfert, Helmuth

AU - Hong, Waun K.

AU - Peters, Lester J.

PY - 1999/8

Y1 - 1999/8

N2 - Purpose: Extrapolating from our experience delivering a 'boost' field of radiation concurrently with fields treating both gross and subclinical disease at the end of a course of radiation therapy, we developed a regimen to deliver concurrent chemotherapy during the last 2 weeks of a conventionally fractionated course of radiation. Patients and Methods: Patients had stage III or IV biopsy-proven squamous cell carcinoma originating from a head and neck mucosal site. The regimen was 70 Gy delivered over 7 weeks with concurrent fluorouracil (5-FU) and cisplatin given daily with each radiation dose during the last 2 weeks. A phase I study was performed to determine the maximum-tolerated dose (MTD) before a phase II study was conducted. Results: The MTD was 400 mg/m2 per day for 5-FU and 10 mg/m2 per day for cisplatin. Mucositis persisting more than 6 weeks after therapy was the dose-limiting toxicity. A total of 60 patients were treated on the two phases of the study. Eighteen patients (35%) treated at the MTD developed prolonged mucositis. There were two cases of neutropenic sepsis, including one fatality. The actuarial 2-year rates for overall survival, freedom from relapse, and local control were 62%, 59%, and 80%, respectively. Conclusion: Preliminary locoregional control rates seem to be higher than those reported for treatment with radiation alone. Toxicity was also greater than that seen with radiation alone, but the regimen was designed to deliver an intense treatment schedule, which could be completed without significant interruptions, and to obtain high control rates above the clavicles. These end points were achieved.

AB - Purpose: Extrapolating from our experience delivering a 'boost' field of radiation concurrently with fields treating both gross and subclinical disease at the end of a course of radiation therapy, we developed a regimen to deliver concurrent chemotherapy during the last 2 weeks of a conventionally fractionated course of radiation. Patients and Methods: Patients had stage III or IV biopsy-proven squamous cell carcinoma originating from a head and neck mucosal site. The regimen was 70 Gy delivered over 7 weeks with concurrent fluorouracil (5-FU) and cisplatin given daily with each radiation dose during the last 2 weeks. A phase I study was performed to determine the maximum-tolerated dose (MTD) before a phase II study was conducted. Results: The MTD was 400 mg/m2 per day for 5-FU and 10 mg/m2 per day for cisplatin. Mucositis persisting more than 6 weeks after therapy was the dose-limiting toxicity. A total of 60 patients were treated on the two phases of the study. Eighteen patients (35%) treated at the MTD developed prolonged mucositis. There were two cases of neutropenic sepsis, including one fatality. The actuarial 2-year rates for overall survival, freedom from relapse, and local control were 62%, 59%, and 80%, respectively. Conclusion: Preliminary locoregional control rates seem to be higher than those reported for treatment with radiation alone. Toxicity was also greater than that seen with radiation alone, but the regimen was designed to deliver an intense treatment schedule, which could be completed without significant interruptions, and to obtain high control rates above the clavicles. These end points were achieved.

UR - http://www.scopus.com/inward/record.url?scp=0032784696&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0032784696&partnerID=8YFLogxK

M3 - Article

VL - 17

SP - 2390

EP - 2395

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 8

ER -