BACKGROUND: Most clinical trials for acute leukemia have reported results after 2-3 years of follow-up. Comparisons between the original data and longer-term follow-up data may be of interest, particularly with regard to promising new therapies. METHODS: In 1996, survival data were updated from three prospective, randomized comparisons of idarubicin and daunorubicin that began in 1984 and 1985. These were trials of the Memorial Sloan-Kettering Cancer Center (MSKCC), the U.S. Multicenter Study Group, and the Southeastern Cancer Study Group (SEG). The original results of these trials were reported in 1991 and 1992. RESULTS: The original results of the SEG trial demonstrated no significant difference between idarubicin and daunorubicin. The updated survival analysis showed similar results. The MSKCC trial revealed a significant advantage of idarubicin compared with daunorubicin in both the original and the updated analyses. The U.S. Multicenter trial found a significant difference favoring idarubicin in the original analysis, but the difference was not significant in the updated analysis. CONCLUSIONS: It is essential that the median length of follow-up be clearly stated in any clinical trial. When the results obtained with a particularly promising new drug or procedure are presented early in the course of study (within 1-2 years), the investigators should strongly consider a repeat evaluation after an additional 3-5 years of follow-up.
RCT Entities:
BACKGROUND: Most clinical trials for acute leukemia have reported results after 2-3 years of follow-up. Comparisons between the original data and longer-term follow-up data may be of interest, particularly with regard to promising new therapies. METHODS: In 1996, survival data were updated from three prospective, randomized comparisons of idarubicin and daunorubicin that began in 1984 and 1985. These were trials of the Memorial Sloan-Kettering Cancer Center (MSKCC), the U.S. Multicenter Study Group, and the Southeastern Cancer Study Group (SEG). The original results of these trials were reported in 1991 and 1992. RESULTS: The original results of the SEG trial demonstrated no significant difference between idarubicin and daunorubicin. The updated survival analysis showed similar results. The MSKCC trial revealed a significant advantage of idarubicin compared with daunorubicin in both the original and the updated analyses. The U.S. Multicenter trial found a significant difference favoring idarubicin in the original analysis, but the difference was not significant in the updated analysis. CONCLUSIONS: It is essential that the median length of follow-up be clearly stated in any clinical trial. When the results obtained with a particularly promising new drug or procedure are presented early in the course of study (within 1-2 years), the investigators should strongly consider a repeat evaluation after an additional 3-5 years of follow-up.
Authors: Franklin Souza-Silva; Saulo Cabral Bourguignon; Bernardo Acácio Santini Pereira; Luzia Monteiro de Castro Côrtes; Luiz Filipe Gonçalves de Oliveira; Andrea Henriques-Pons; Lea Cysne Finkelstein; Vitor Francisco Ferreira; Paula Fernandes Carneiro; Rosa Teixeira de Pinho; Ernesto Raul Caffarena; Carlos Roberto Alves Journal: Antimicrob Agents Chemother Date: 2015-01-12 Impact factor: 5.191
Authors: John Gregory; Haesook Kim; Todd Alonzo; Rob Gerbing; William Woods; Howard Weinstein; Lois Shepherd; Charles Schiffer; Frederick Appelbaum; Cheryl Willman; Peter Wiernik; Jacob Rowe; Martin Tallman; James Feusner Journal: Pediatr Blood Cancer Date: 2009-12 Impact factor: 3.167
Authors: Piyanuch Kongtim; Uday Popat; Antonio Jimenez; Sameh Gaballa; Riad El Fakih; Gabriela Rondon; Julianne Chen; Carlos Bueso-Ramos; Gautam Borthakur; Naveen Pemmaraju; Guillermo Garcia-Manero; Hagop Kantarjian; Amin Alousi; Chitra Hosing; Paolo Anderlini; Issa F Khouri; Partow Kebriaei; Borje S Andersson; Betul Oran; Katayoun Rezvani; David Marin; Elizabeth J Shpall; Richard E Champlin; Stefan O Ciurea Journal: Biol Blood Marrow Transplant Date: 2015-09-04 Impact factor: 5.742