|
Advertisement |
|
|
||
 |
|
|||||
|
|||||
|
 |
||||||
|
||||||
|
||||||
|
Journal of Clinical Oncology, Vol 25, No 7 (March 1), 2007: pp. 918 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2006.09.3948
More Thoughts on the Reporting of Adverse Events in Cancer Clinical TrialsSenior Adult Oncology, Moffitt Cancer Center, Tampa, FL To the Editor: In an article in the August 20, 2006, issue of the Journal of Clinical Oncology, Scharf and Colevas1 described the variability in the reporting of adverse events (AEs) in phase II trials. In the accompanying editorial, Anderson2 deplored the "inconsistent and incomplete characterization and reporting of high-grade AEs." Scharf and Colevas do not distinguish between hematologic and nonhematologic AEs. My research has led me to pay considerable attention to AE reporting, and one of the areas in which AEs are reported especially inconsistently is hematologic toxicity. For example, in the same period covered by Scharf and Colevas’s series, two randomized studies published in the same year in this very journal reported on the doxorubicin-cyclophosphamide regimen; one reported an incidence of grade 3/4 neutropenia of 6.3%,3 the other reported an incidence of 88%.4 Most likely, the difference lays chiefly on the emphasis that investigators did or did not place on the collection of nadir CBCs. We chose an extreme example, in which the difference is obvious to the reader. However, the frequency of CBCs is rarely reported when toxicity is detailed in publications. The reader might therefore be misled as to the level of toxicity of a given regimen. This heterogeneity in data-gathering also defeats the standardizing purpose of the National Cancer Institute Common Toxicity Criteria (CTC) regarding hematologic toxicity reporting. I would like to suggest several solutions to harmonize the reporting of hematologic toxicity in cancer trials. At the very least, reports should mention how hematologic toxicity was monitored, preferably at the bottom of the toxicity table (eg, weekly CBCs v CBC required only at the beginning of a cycle). Large numbers of patients are usually enrolled onto adjuvant trials, and relatively well-known regimens are administered. In such trials, the requirement of weekly CBCs may safely be traded off for study purposes, in order to ease compliance and free resources to assess key prognostic factors, such as comorbidity and functional status. In contrast, phase II trials explore new single-agent and combination regimens for which only preliminary toxicity information is available from phase I trials. Not controlling weekly CBCs would lead to fictitiously low reports of hematologic toxicity and might provide patients and practitioners with a false sense of security about the infectious risk involved. A compromise solution for large trials could be to mandate weekly CBCs during the first cycle of chemotherapy, since most hematologic toxicities occur during this cycle.5 If we want to make the tremendous efforts invested into the design of the CTC criteria fruitful, we need to make the reader fully able to assess the quality and meaning of the hematologic toxicity data collection. AUTHOR’S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author indicated no potential conflicts of interest. REFERENCES
1. Scharf O, Colevas AD: Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 24:3933-3938, 2006 2. Anderson SJ: Some thoughts on the reporting of adverse events in phase II cancer clinical trials. J Clin Oncol 24:3821-3822, 2006 3. Bear HD, Anderson S, Brown A, et al: The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: Preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 21:4165-4174, 2003 4. Nabholtz JM, Falkson C, Campos D, et al: Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: Results of a randomized, multicenter, phase III trial. J Clin Oncol 21:968-975, 2003 5. Gómez H, Hidalgo M, Casanova L, et al: Risk factors for treatment-related death in elderly patients with aggressive non-Hodgkin’s lymphoma: Results of a multivariate analysis. J Clin Oncol 16:2065-2069, 1998[Abstract] Related Reply
Related Article
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||
|
|||||||||||
|
|
Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|
