Oxaliplatin induced neuropathy can be difficult to manage. Two recent phase II studies suggested that Cymbalta(duloxetine) is effective for oxapliplatin induced neuropathy. Both studies were in small number of patients and there was a significant monority of patients who did not tolerate treatment. Overall benefit was modest. Both studies concluded that using this drug is feasible. This was followed by an abstract at 2012 ASCO meeting of a phase III trial. This was a placebo controlled crossover trial. It found that there was no difference in duloxetine efficacy based on the specific neurotoxic agent received. Severe (Grade 3) non-hematologic toxicity was reported by 11%, and 41% reported moderate (Grade 2) toxicities. The incidence of Grade 2+ fatigue, the most commonly reported side effect, was significantly higher in the duloxetine arm as compared to placebo (11% vs. 3%, p = 0.029). It concluded that duloxetine 60mg daily is an efficacious and well-tolerated intervention for the treatment of taxane or platinum-related painful CIPN.
This trial raised more questions than it answers. It does not prove that Cymbalta is uniquely beneficial for oxaliplaitn induced neuropathy and toxicity was significant. It was a comparison against placebo, not another analgesic or anti-depressant. Clearly, comparative studies are needed before it can be considered standard of care.
C. Teng, H. Teng, Y. Yang, C. Yen, T. Lin, J. Lin, W. Chen, C. Tzeng, W. Wang; Department of Medicine, National Yang-Ming University Hospital and Taipei Veterans General Hospital, Yilan, Taiwan; Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Psychiatry, Taipei City Hospital Renai Branch, Taipei, Taiwan; Taipei Veterans General Hospital, Taipei, Taiwan; Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Medicine, National Yang-Ming University Hospital, Yilan, Taiwan Use of duloxetine for oxaliplatin-induced neuropathic pain in patients with colorectal cancer: An open-label pilot study. Clin Oncol 29: 2011 (suppl; abstr e19644)
Ya-Hsu Yang, Jen-Kou Lin, Wei-Shone Chen, Tzu-Chen Lin, Shung-Haur Yang, Jeng-Kai Jiang, Shih-Ching Chang, Yuan-Tzu Lan, Chun-Chi Lin, Chueh-Chuan Duloxetine improves oxaliplatin-induced neuropathy in patients with colorectal cancer: an open-label pilot study
Supportive Care in Cancer July 2012, Volume 20, Issue 7, pp 1491-1497 Ya-Hsu Yang, Jen-Kou Lin
Ellen M. Lavoie Smith, Herbert Pang, Constance Cirrincione, Stewart Barry Fleishman, Electra D. Paskett, Camilo E. Fadul, Chetaye Knox, Charles L. Shapiro, Paul Gilman, Cancer and Leukemia Group B; University of Michigan, Ann Arbor, MI; Duke University, Durham, NC; Alliance Statistical Center, Duke University, Durham, NC; Continuum Cancer Centers of New York, Beth Israel and St. Luke’s-Roosevelt, New York, NY; The Ohio State University Comprehensive Cancer Center, Columbus, OH; Dartmouth-Hitchcock Medical Center, Lebanon, NH; Illinois Oncology Research Association, Peoria, IL; The Ohio State University, Columbus, OH; Main Line Hematology and Oncology Associates, Wynnewood, PA CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). Citation:
J Clin Oncol 30, 2012 (suppl; abstr CRA9013)
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