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Article: Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma

TitleRandomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma
Authors
Issue Date2010
Citation
Journal of the National Cancer Institute, 2010, v. 102, n. 15, p. 1188-1198 How to Cite?
AbstractBackground Current practice of adding concurrent-adjuvant chemotherapy to radiotherapy (CRT) for treating advanced nasopharyngeal carcinoma is based on the Intergroup-0099 Study published in 1998. However, the outcome for the radiotherapy-alone (RT) group in that trial was substantially poorer than those in other trials, and there were no data on late toxicities. Verification of the long-term therapeutic index of this regimen is needed. Methods Patients with nonkeratinizing nasopharyngeal carcinoma staged T1-4N2-3M0 were randomly assigned to RT (176 patients) or to CRT (172 patients) using cisplatin (100 mg/m2) every 3 weeks for three cycles in concurrence with radiotherapy, followed by cisplatin (80 mg/m2) plus fluorouracil (1000 mg per m2 per day for 4 days) every 4 weeks for three cycles. Primary endpoints included overall failure-free rate (FFR) (the time to first failure at any site) and progression-free survival. Secondary endpoints included overall survival, locoregional FFR, distant FFR, and acute and late toxicity rates. All statistical tests were two-sided. Results The two treatment groups were well balanced in all patient characteristics, tumor factors, and radiotherapy parameters. Adding chemotherapy statistically significantly improved the 5-year FFR (CRT vs RT: 67% vs 55%; P =. 014) and 5-year progression-free survival (CRT vs RT: 62% vs 53%; P =. 035). Cumulative incidence of acute toxicity increased with chemotherapy by 30% (CRT vs RT: 83% vs 53%; P <. 001), but the 5-year late toxicity rate did not increase statistically significantly (CRT vs RT: 30% vs 24%; P =. 30). Deaths because of disease progression were reduced statistically significantly by 14% (CRT vs RT: 38% vs 24%; P =. 008), but 5-year overall survival was similar (CRT vs RT: 68% vs 64%; P =. 22; hazard ratio of CRT = 0.81, 95% confidence interval = 0.58 to 1.13) because deaths due to toxicity or incidental causes increased by 7% (CRT vs RT: 1.7% vs 0, and 8.1% vs 3.4%, respectively; P =. 015). Conclusions Adding concurrent-adjuvant chemotherapy statistically significantly reduced failure and cancer-specific deaths when compared with radiotherapy alone. Although there was no statistically significant increase in major late toxicity, increase in noncancer deaths narrowed the resultant gain in overall survival. © 2010 The Author. Published by Oxford University Press. All rights reserved.
Persistent Identifierhttp://hdl.handle.net/10722/213936
ISSN
2015 Impact Factor: 11.37
2015 SCImago Journal Rankings: 6.192

 

DC FieldValueLanguage
dc.contributor.authorLee, Anne W M-
dc.contributor.authorTung, Stewart Y.-
dc.contributor.authorChua, Daniel T T-
dc.contributor.authorNgan, Roger K C-
dc.contributor.authorChappell, Rick-
dc.contributor.authorTung, Raymond-
dc.contributor.authorSiu, Lillian-
dc.contributor.authorNg, W. T.-
dc.contributor.authorSze, W. K.-
dc.contributor.authorAu, Gordon K H-
dc.contributor.authorLaw, Stephen C K-
dc.contributor.authorO'Sullivan, Brian-
dc.contributor.authorYau, T. K.-
dc.contributor.authorLeung, T. W.-
dc.contributor.authorAu, Joseph S K-
dc.contributor.authorSze, W. M.-
dc.contributor.authorChoi, C. W.-
dc.contributor.authorFung, K. K.-
dc.contributor.authorLau, Joseph T.-
dc.contributor.authorLau, W. H.-
dc.date.accessioned2015-08-19T13:41:17Z-
dc.date.available2015-08-19T13:41:17Z-
dc.date.issued2010-
dc.identifier.citationJournal of the National Cancer Institute, 2010, v. 102, n. 15, p. 1188-1198-
dc.identifier.issn0027-8874-
dc.identifier.urihttp://hdl.handle.net/10722/213936-
dc.description.abstractBackground Current practice of adding concurrent-adjuvant chemotherapy to radiotherapy (CRT) for treating advanced nasopharyngeal carcinoma is based on the Intergroup-0099 Study published in 1998. However, the outcome for the radiotherapy-alone (RT) group in that trial was substantially poorer than those in other trials, and there were no data on late toxicities. Verification of the long-term therapeutic index of this regimen is needed. Methods Patients with nonkeratinizing nasopharyngeal carcinoma staged T1-4N2-3M0 were randomly assigned to RT (176 patients) or to CRT (172 patients) using cisplatin (100 mg/m2) every 3 weeks for three cycles in concurrence with radiotherapy, followed by cisplatin (80 mg/m2) plus fluorouracil (1000 mg per m2 per day for 4 days) every 4 weeks for three cycles. Primary endpoints included overall failure-free rate (FFR) (the time to first failure at any site) and progression-free survival. Secondary endpoints included overall survival, locoregional FFR, distant FFR, and acute and late toxicity rates. All statistical tests were two-sided. Results The two treatment groups were well balanced in all patient characteristics, tumor factors, and radiotherapy parameters. Adding chemotherapy statistically significantly improved the 5-year FFR (CRT vs RT: 67% vs 55%; P =. 014) and 5-year progression-free survival (CRT vs RT: 62% vs 53%; P =. 035). Cumulative incidence of acute toxicity increased with chemotherapy by 30% (CRT vs RT: 83% vs 53%; P <. 001), but the 5-year late toxicity rate did not increase statistically significantly (CRT vs RT: 30% vs 24%; P =. 30). Deaths because of disease progression were reduced statistically significantly by 14% (CRT vs RT: 38% vs 24%; P =. 008), but 5-year overall survival was similar (CRT vs RT: 68% vs 64%; P =. 22; hazard ratio of CRT = 0.81, 95% confidence interval = 0.58 to 1.13) because deaths due to toxicity or incidental causes increased by 7% (CRT vs RT: 1.7% vs 0, and 8.1% vs 3.4%, respectively; P =. 015). Conclusions Adding concurrent-adjuvant chemotherapy statistically significantly reduced failure and cancer-specific deaths when compared with radiotherapy alone. Although there was no statistically significant increase in major late toxicity, increase in noncancer deaths narrowed the resultant gain in overall survival. © 2010 The Author. Published by Oxford University Press. All rights reserved.-
dc.languageeng-
dc.relation.ispartofJournal of the National Cancer Institute-
dc.titleRandomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma-
dc.typeArticle-
dc.description.natureLink_to_subscribed_fulltext-
dc.identifier.doi10.1093/jnci/djq258-
dc.identifier.pmid20634482-
dc.identifier.scopuseid_2-s2.0-77955445967-
dc.identifier.hkuros266198-
dc.identifier.volume102-
dc.identifier.issue15-
dc.identifier.spage1188-
dc.identifier.epage1198-
dc.identifier.eissn1460-2105-
dc.identifier.f10005793956-

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