Evaluation: Continued Need for Randomized Trials
Authors: Roy A. Beveridge, David H. Regan, Grant Swanson, Eva Stump
Journal: Journal of Clinical Oncology (2000)

Article Tools SPECIAL DEPARTMENTS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2000.18.18.3321 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 10986068 Evaluation: Continued Need for Randomized Trials Roy A. BeveridgexRoy A. BeveridgeSearch for articles by this author , David H. ReganxDavid H. ReganSearch for articles by this author Grant SwansonxGrant SwansonSearch for articles by this author , Eva StumpxEva StumpSearch for articles by this author Show More Inova Fairfax Hospital Falls Church, VAMonterey Bay Oncology and Genetics Center, Monterey, CAiKnowmed, Berkeley, CA https://doi.org/10.1200/JCO.2000.18.18.3321 First Page Full Text PDF Figures and Tables © 2000 by American Society of Clinical OncologyjcoJ Clin OncolJournal of Clinical OncologyJCO0732-183X1527-7755American Society of Clinical OncologyResponse18092000In Reply:The letter by Beveridge and Regan contains several inaccuracies that need to be clarified. Our study1 was not a randomized trial, as was clearly stated in the Patients and Methods section. Beveridge and Regan are incorrect when they write that our conclusions state that it was.We agree strongly with their point that a definitive randomized evaluation of the comparitive efficacy of different growth factors must include comparable chemotherapy regimens in the two treatment arms. Unfortunately, the studies cited2-4 failed to do this and hence fall short of providing clear evidence of therapeutic equivalence. In addition, the efficacy trial cited3 initiated growth factors at the WBC nadir, a practice now known to have little if any clinical impact and not recommended by current American Society of Clinical Oncology guidelines. It is not surprising, therefore, that no significant difference in outcomes was noted in that study. The abstract by Bennett5 was, of course, not available at the time our manuscript was completed, and we look forward to seeing the study in its entirety.Finally, although we share the enthusiasm of Beveridge and Regan for the role of the randomized trial, it is of interest to note that several studies6,7 have called into question the previously unassailable view of the superiority of the randomized trial over observational studies.1. Swanson G, Bergstrom K, Stump E, et al: Growth factor usage patterns in outcomes of the community setting: Collection through a practice-based computerized clinical information system. J Clin Oncol 18:: 1764,2000-1770, Link, Google Scholar2. Beveridge RA, Miller JA, Kehls AN, et al: Randomized trial comparing the tolerability of sargramostim (yeast-derived RhuG-CSF) and filgrastim (bacteria-derived RhuG-CSF) in cancer patients receiving myelosuppressive chemotherapy. Support Care Cancer 5:: 289,1997-298, Crossref, Medline, Google Scholar3. Beveridge RA, Miller JA, Kehls AN, et al: A comparison of efficacy of sargramostim (yeast-derived RhuG-CSF) and filgrastim (bacteria-derived RhuG-CSF) in the therapeutic setting of chemotherapy-induced myelosuppression. Cancer Invest 16:: 366,1998-373, Crossref, Medline, Google Scholar4. Regan DH: Prospective study comparing the safety and efficacy of sargramostim (RhuG-CSF) with filgrastim (RhuG-CSF) for prevention of primary and secondary chemotherapy-induced neutropenia. Proc Am Soc Clin Oncol 18:: 605a,,1999 (abstr 2336) Google Scholar5. Bennett CL: A double-blind, randomized trial of toxicity, resource use and cost for filgrastim and sargramostim. Proc Am Soc Clin Oncol 18:: 437a,,2000 (abstr 1712) Link, Google Scholar6. Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:: 1887,2000-1892, Crossref, Medline, Google Scholar7. Benson K, Hartz AJ: A comparison of observational studies and randomized, controlled trials. N Engl J Med 342:: 1878,2000-1886, Crossref, Medline, Google Scholar