Risk of oral and gastrointestinal mucosal injury among patients receiving selected targeted agents: a meta-analysis
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ORIGINAL ARTICLE
Risk of oral and gastrointestinal mucosal injury among patients receiving selected targeted agents: a meta-analysis Linda S. Elting & Yu-Chia Chang & Pratibha Parelkar & Christine B. Boers-Doets & Marisol Michelet & Guido Hita & Tanya Rouleau & Catherine Cooksley & Josiah Halm & Madhuri Vithala & Paolo Bossi & Carmen Escalante & Michael T. Brennan & On behalf of the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO)
Received: 18 December 2012 / Accepted: 11 April 2013 # Springer-Verlag Berlin Heidelberg 2013
Abstract Purpose The purpose of this study was to estimate the risk and severity of oral and gastrointestinal mucosal toxicities associated with selected targeted agents. Methods We searched the English-language literature in February 2011 for reports of randomized clinical trials comparing a FDA-approved targeted agent to a standard of care regimens. Long-term follow-up and secondary reports of trials were excluded, leaving 85 studies for analysis. Using metaanalytic methods, we calculated the relative risks of oral and gastrointestinal toxicities, adjusting for sample size using the inverse variance technique. For each targeted agent and each side effect, we calculated the number needed to harm, the
number of patients that, if treated with the more toxic regimen, would produce one additional episode of the toxicity. Results Oral mucositis was significantly more frequent among patients treated with bevacizumab, erlotinib, sorafenib, or sunitinib, although this difference was confined to low-grade mucositis. The clinical significance of these findings is unclear given its low incidence and mild severity. In contrast, diarrhea was significantly more frequent with most of the targeted agents studied, with adjusted relative risks between 1.5 and 4.5. An additional patient with diarrhea will be observed for every three to five patients treated with these targeted agents, compared with conventional regimens.
L. S. Elting (*) : Y.-C. Chang : P. Parelkar Department of Health Services Research, The University of Texas MD Anderson Cancer Center, 1400 Pressler St., Unit 1444, Houston, TX 77030-4009, USA e-mail: [email protected]
C. Cooksley Department of Internal Medicine, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555-0177, USA
C. B. Boers-Doets Department of Clinical Oncology, Leiden University Medical Centre, PO Box 9600, 2300 RC( Leiden, The Netherlands
M. Vithala Division of Medical Oncology, Duke University Medical Center/Durham VA Medical Center, 508 Fulton St., Durham, NC 27705, USA
M. Michelet Oral Medicine Department, FUNDALEU-Foundation to Fight against Leukemia, Hospitalization and Clinical Research Center, José E. Uriburu 1450, Buenos Aires, Argentina
P. Bossi Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, Milan, Italy
G. Hita : J. Halm Department of General Internal Medicine, The University of Texas MD Anderson C
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