Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099

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 c...

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Veröffentlicht in:Journal of clinical oncology 1998-04, Vol.16 (4), p.1310-1317
Hauptverfasser: M Al-Sarraf, M LeBlanc, P G Giri, K K Fu, J Cooper, T Vuong, A A Forastiere, G Adams, W A Sakr, D E Schuller, J F Ensley
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container_end_page 1317
container_issue 4
container_start_page 1310
container_title Journal of clinical oncology
container_volume 16
creator M Al-Sarraf
M LeBlanc
P G Giri
K K Fu
J Cooper
T Vuong
A A Forastiere
G Adams
W A Sakr
D E Schuller
J F Ensley
description 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. 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; postradiotherapy, 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 three courses. Patients were stratified by tumor stage, nodal stage, performance status, and histology. 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 the chemo-radiotherapy 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 chemo-radiotherapy 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 chemoradiotherapy group was 76% (P < .001). We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.
doi_str_mv 10.1200/JCO.1998.16.4.1310
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This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. 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; postradiotherapy, 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 three courses. Patients were stratified by tumor stage, nodal stage, performance status, and histology. 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 the chemo-radiotherapy group. The 3-year PFS rate was 24% versus 69%, respectively (P &lt; .001). The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy 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 chemoradiotherapy group was 76% (P &lt; .001). We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.1998.16.4.1310</identifier><identifier>PMID: 9552031</identifier><language>eng</language><publisher>Baltimore, MD: American Society of Clinical Oncology</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - mortality ; Carcinoma, Squamous Cell - radiotherapy ; Cisplatin - administration &amp; dosage ; Cisplatin - adverse effects ; Combined Modality Therapy ; Combined treatments (chemotherapy of immunotherapy associated with an other treatment) ; Female ; Fluorouracil - administration &amp; dosage ; Fluorouracil - adverse effects ; Humans ; Male ; Medical sciences ; Middle Aged ; Nasopharyngeal Neoplasms - drug therapy ; Nasopharyngeal Neoplasms - mortality ; Nasopharyngeal Neoplasms - radiotherapy ; Neoplasm Recurrence, Local ; Pharmacology. 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The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy 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 chemoradiotherapy group was 76% (P &lt; .001). We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - mortality</subject><subject>Carcinoma, Squamous Cell - radiotherapy</subject><subject>Cisplatin - administration &amp; dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Combined Modality Therapy</subject><subject>Combined treatments (chemotherapy of immunotherapy associated with an other treatment)</subject><subject>Female</subject><subject>Fluorouracil - administration &amp; dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nasopharyngeal Neoplasms - drug therapy</subject><subject>Nasopharyngeal Neoplasms - mortality</subject><subject>Nasopharyngeal Neoplasms - radiotherapy</subject><subject>Neoplasm Recurrence, Local</subject><subject>Pharmacology. 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This randomized phase III trial compared chemoradiotherapy versus radiotherapy alone in patients with nasopharyngeal cancers. 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; postradiotherapy, 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 three courses. Patients were stratified by tumor stage, nodal stage, performance status, and histology. 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 the chemo-radiotherapy group. The 3-year PFS rate was 24% versus 69%, respectively (P &lt; .001). The median survival time was 34 months for the radiotherapy group and not reached for the chemo-radiotherapy 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 chemoradiotherapy group was 76% (P &lt; .001). We conclude that chemoradiotherapy is superior to radiotherapy alone for patients with advanced nasopharyngeal cancers with respect to PFS and overall survival.</abstract><cop>Baltimore, MD</cop><pub>American Society of Clinical Oncology</pub><pmid>9552031</pmid><doi>10.1200/JCO.1998.16.4.1310</doi><tpages>8</tpages></addata></record>
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subjects Adolescent
Adult
Aged
Aged, 80 and over
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - mortality
Carcinoma, Squamous Cell - radiotherapy
Cisplatin - administration & dosage
Cisplatin - adverse effects
Combined Modality Therapy
Combined treatments (chemotherapy of immunotherapy associated with an other treatment)
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Humans
Male
Medical sciences
Middle Aged
Nasopharyngeal Neoplasms - drug therapy
Nasopharyngeal Neoplasms - mortality
Nasopharyngeal Neoplasms - radiotherapy
Neoplasm Recurrence, Local
Pharmacology. Drug treatments
Radiation-Sensitizing Agents - administration & dosage
Radiation-Sensitizing Agents - adverse effects
Survival Analysis
title Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099
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