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jueves, 29 de julio de 2010
Randomized Trial of Radiotherapy Plus Concurrent-Adjuvant Chemotherapy vs Radiotherapy Alone for Regionally Advanced Nasopharyngeal Carcinoma -- Lee et al., 10.1093/jnci/djq258 -- JNCI Journal of the National Cancer Institute
Journal of the National Cancer Institute Advance Access published online on July 15, 2010 JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djq258
Randomized Trial of Radiotherapy Plus Concurrent–Adjuvant Chemotherapy vs Radiotherapy Alone for Regionally Advanced Nasopharyngeal Carcinoma Anne W. M. Lee, Stewart Y. Tung, Daniel T. T. Chua, Roger K. C. Ngan, Rick Chappell, Raymond Tung, Lillian Siu, W. T. Ng, W. K. Sze, Gordon K. H. Au, Stephen C. K. Law, Brian O'Sullivan, T. K. Yau, T. W. Leung, Joseph S. K. Au, W. M. Sze, C. W. Choi, K. K. Fung, Joseph T. Lau, W. H. Lau
Affiliations of authors: Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong, China (AWML, WTN, TKY, WMS); Department of Clinical Oncology, Tuen Mun Hospital, Hong Kong, China (SYT, WKS, TWL); Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China (DTTC, GKHA); Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, China (RKCN, SCKL, JSKA, WHL); Hong Kong Cancer Fund, Hong Kong, China (RT); Hong Kong Anti-Cancer Society, Hong Kong, China (CWC, KKF); Center for Epidemiology and Biostatistics, Chinese University of Hong Kong, Hong Kong, China (JTL); Department of Biostatistics, Wisconsin Medical School, Madison, WI (RC); Ontario Cancer Institute, Princess Margaret Hospital, Toronto, ON, Canada (LS, BOS)
Correspondence to: Anne W. M. Lee, MD, Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Rd, Chai Wan, Hong Kong (e-mail: email@example.com).
Background: 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.
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