Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer

Phase III randomized Intergroup study 0099

Muhyi Al-Sarraf, Michael LeBlanc, P. G Shanker Giri, Karen K. Fu, Jayo Cooper, Te Vuong, Arlene A. Forastiere, George Adams, Wael A. Sakr, David E. Schuller, John F. Ensley

Research output: Contribution to journalArticle

Abstract

Purpose: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. Materials and Methods: Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during radiotherapy; postradiotheraphy, chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for throe courses. Patients wore stratified by tumor stage, nodal stage, performance status, and histology. Results: Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for flu chemoradiotheraphy group. The 3-year PFS rate was 24% versus 69%, respectively (P <.001). The median survival time was 34 months for the radiotherapy group and not reached for the chemoradiotherapy group, and the 3-year survival rate was 47% versus 78%, respectively (P= .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomized to radiotherapy was 46%, and for the chomoradiotherapy group was 76% (P <.001). Conclusion: We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.

Original languageEnglish (US)
Pages (from-to)1310-1317
Number of pages8
JournalJournal of Clinical Oncology
Volume16
Issue number4
StatePublished - Apr 1998
Externally publishedYes

Fingerprint

Nasopharyngeal Neoplasms
Chemoradiotherapy
Radiotherapy
Disease-Free Survival
Survival Rate
Survival Analysis
Cisplatin
Drug Therapy
Radiation Oncology
Survival
Fluorouracil
Histology

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Al-Sarraf, M., LeBlanc, M., Giri, P. G. S., Fu, K. K., Cooper, J., Vuong, T., ... Ensley, J. F. (1998). Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized Intergroup study 0099. Journal of Clinical Oncology, 16(4), 1310-1317.

Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer : Phase III randomized Intergroup study 0099. / Al-Sarraf, Muhyi; LeBlanc, Michael; Giri, P. G Shanker; Fu, Karen K.; Cooper, Jayo; Vuong, Te; Forastiere, Arlene A.; Adams, George; Sakr, Wael A.; Schuller, David E.; Ensley, John F.

In: Journal of Clinical Oncology, Vol. 16, No. 4, 04.1998, p. 1310-1317.

Research output: Contribution to journalArticle

Al-Sarraf, M, LeBlanc, M, Giri, PGS, Fu, KK, Cooper, J, Vuong, T, Forastiere, AA, Adams, G, Sakr, WA, Schuller, DE & Ensley, JF 1998, 'Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized Intergroup study 0099', Journal of Clinical Oncology, vol. 16, no. 4, pp. 1310-1317.
Al-Sarraf, Muhyi ; LeBlanc, Michael ; Giri, P. G Shanker ; Fu, Karen K. ; Cooper, Jayo ; Vuong, Te ; Forastiere, Arlene A. ; Adams, George ; Sakr, Wael A. ; Schuller, David E. ; Ensley, John F. / Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer : Phase III randomized Intergroup study 0099. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 4. pp. 1310-1317.
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title = "Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: Phase III randomized Intergroup study 0099",
abstract = "Purpose: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. Materials and Methods: Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during radiotherapy; postradiotheraphy, chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for throe courses. Patients wore stratified by tumor stage, nodal stage, performance status, and histology. Results: Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for flu chemoradiotheraphy group. The 3-year PFS rate was 24{\%} versus 69{\%}, respectively (P <.001). The median survival time was 34 months for the radiotherapy group and not reached for the chemoradiotherapy group, and the 3-year survival rate was 47{\%} versus 78{\%}, respectively (P= .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomized to radiotherapy was 46{\%}, and for the chomoradiotherapy group was 76{\%} (P <.001). Conclusion: We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.",
author = "Muhyi Al-Sarraf and Michael LeBlanc and Giri, {P. G Shanker} and Fu, {Karen K.} and Jayo Cooper and Te Vuong and Forastiere, {Arlene A.} and George Adams and Sakr, {Wael A.} and Schuller, {David E.} and Ensley, {John F.}",
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T2 - Phase III randomized Intergroup study 0099

AU - Al-Sarraf, Muhyi

AU - LeBlanc, Michael

AU - Giri, P. G Shanker

AU - Fu, Karen K.

AU - Cooper, Jayo

AU - Vuong, Te

AU - Forastiere, Arlene A.

AU - Adams, George

AU - Sakr, Wael A.

AU - Schuller, David E.

AU - Ensley, John F.

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N2 - Purpose: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. Materials and Methods: Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during radiotherapy; postradiotheraphy, chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for throe courses. Patients wore stratified by tumor stage, nodal stage, performance status, and histology. Results: Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for flu chemoradiotheraphy group. The 3-year PFS rate was 24% versus 69%, respectively (P <.001). The median survival time was 34 months for the radiotherapy group and not reached for the chemoradiotherapy group, and the 3-year survival rate was 47% versus 78%, respectively (P= .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomized to radiotherapy was 46%, and for the chomoradiotherapy group was 76% (P <.001). Conclusion: We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.

AB - Purpose: The Southwest Oncology Group (SWOG) coordinated an Intergroup study with the participation of Radiation Therapy Oncology Group (RTOG), and Eastern Cooperative Oncology Group (ECOG). This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. Materials and Methods: Radiotherapy was administered in both arms: 1.8- to 2.0-Gy/d fractions Monday to Friday for 35 to 39 fractions for a total dose of 70 Gy. The investigational arm received chemotherapy with cisplatin 100 mg/m2 on days 1, 22, and 43 during radiotherapy; postradiotheraphy, chemotherapy with cisplatin 80 mg/m2 on day 1 and fluorouracil 1,000 mg/m2/d on days 1 to 4 was administered every 4 weeks for throe courses. Patients wore stratified by tumor stage, nodal stage, performance status, and histology. Results: Of 193 patients registered, 147 (69 radiotherapy and 78 chemoradiotherapy) were eligible for primary analysis for survival and toxicity. The median progression-free survival (PFS) time was 15 months for eligible patients on the radiotherapy arm and was not reached for flu chemoradiotheraphy group. The 3-year PFS rate was 24% versus 69%, respectively (P <.001). The median survival time was 34 months for the radiotherapy group and not reached for the chemoradiotherapy group, and the 3-year survival rate was 47% versus 78%, respectively (P= .005). One hundred eighty-five patients were included in a secondary analysis for survival. The 3-year survival rate for patients randomized to radiotherapy was 46%, and for the chomoradiotherapy group was 76% (P <.001). Conclusion: We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.

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