Phase III study of radiation therapy with or without Cis-platinum in patients with unresectable squamous or undifferentiated carcinoma of the head and neck: An intergroup trial of the Eastern Cooperative Oncology Group (E2382)

Harry Quon, Traci Leong, Robert Haselow, Bruce Leipzig, Jay Cooper, Arlene A. Forastiere

Research output: Contribution to journalArticle

Abstract

Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m 2. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m 2 to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.

Original languageEnglish (US)
Pages (from-to)719-725
Number of pages7
JournalInternational Journal of Radiation Oncology, Biology, Physics
Volume81
Issue number3
DOIs
StatePublished - Nov 1 2011

Fingerprint

Cisplatin
Squamous Cell Carcinoma
radiation therapy
platinum
Neck
Radiotherapy
cancer
Head
Carcinoma
toxicity
Survival
rank tests
Deglutition
tumors
Radiation
dosage
curves
radiation
Neoplasms

Keywords

  • Cisplatin
  • Late complications
  • Randomized
  • Unresectable
  • Weekly cisplatin

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

Cite this

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title = "Phase III study of radiation therapy with or without Cis-platinum in patients with unresectable squamous or undifferentiated carcinoma of the head and neck: An intergroup trial of the Eastern Cooperative Oncology Group (E2382)",
abstract = "Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m 2. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9{\%} vs. 3{\%}, p = 0.03) and laryngeal (11{\%} vs. 4{\%}, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m 2 to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.",
keywords = "Cisplatin, Late complications, Randomized, Unresectable, Weekly cisplatin",
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T1 - Phase III study of radiation therapy with or without Cis-platinum in patients with unresectable squamous or undifferentiated carcinoma of the head and neck

T2 - An intergroup trial of the Eastern Cooperative Oncology Group (E2382)

AU - Quon, Harry

AU - Leong, Traci

AU - Haselow, Robert

AU - Leipzig, Bruce

AU - Cooper, Jay

AU - Forastiere, Arlene A.

PY - 2011/11/1

Y1 - 2011/11/1

N2 - Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m 2. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m 2 to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.

AB - Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. Methods and Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m 2. Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test. Results: Between 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group. Conclusion: The addition of concurrent weekly cisplatin at 20 mg/m 2 to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.

KW - Cisplatin

KW - Late complications

KW - Randomized

KW - Unresectable

KW - Weekly cisplatin

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