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In Reply:

Department of Oncology, Mayo Clinic, Rochester, MN

Kendrith Rowland

Carle Cancer Center, Urbana, IL

Shaker Dakhil

Cancer Center of Kansas, Wichita, KS

We thank Dr Davis for his comments on our article published in the June 15, 2004, issue of the Journal of Clinical Oncology,¹ in which we reported on our phase III trial that tested an eicosapentaenoic acid (EPA) nutritional supplement in cancer patients who were suffering from anorexia/weight loss syndrome.

To briefly summarize this study, the North Central Cancer Treatment Group (NCCTG) conducted a comparative trial of 421 patients, comparing an EPA nutritional supplement plus placebo versus megestrol acetate plus placebo versus both interventions. Although nonfluid weight gain was the primary end point, secondary end points included appetite, survival, quality of life, and adverse events. In contrast to what Dr Davis suggests in his letter, weight was not assessed only at 4 weeks, but indefinitely, for as long as a patient remained enrolled in the study. This trial showed that this EPA supplement provided no benefits over and above megestrol acetate alone. In view of this trial's large size, its double-dummy design, and its clinically relevant end points, which included survival and quality of life, we concluded that EPA is not a promising agent for the treatment of the cancer anorexia/weight loss syndrome.

We continue to stand by this conclusion. Two other major comparative studies provide confirmatory results. First, Bruera et al² published a 60-patient, negative, placebo-controlled trial. Second, Fearon et al³ observed, in a 200-patient, randomized, placebo-controlled trial of pancreatic cancer patients, that an EPA supplement was again ineffective.

Overall, more than 650 cancer patients have participated in negative phase III studies with EPA. Although the selection of study end points can be challenging, as discussed by Dr Davis, one would think that if EPA were benefiting patients in some way, at least some suggestion of a comparative advantage would have been observed by now in one of these three major trials. Furthermore, preliminary phase II data from Barber et al⁴ provided justification for the dose and manner of administration of the EPA supplement we tested, and presumably also for the supplement tested by Fearon et al. One might argue for additional preliminary evidence of efficacy before embarking on another major phase III trial with a higher dose or a different formulation of this agent.

We do agree with Dr Davis that further study of the cancer anorexia/weight loss syndrome is indicated. Marked by increasing debility, shortened survival, and a poor quality of life, this syndrome is devastating for cancer patients. There is no question that it merits further clinical investigation.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

REFERENCES

1. Jatoi A, Rowland K, Loprinzi CL, et al: An eicosapentaenoic acid supplement versus megestrol acetate versus both for patients with cancer-associated wasting: A North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort. J Clin Oncol 22:2469-2476, 2004[Abstract/Free Full Text]

2. Bruera E, Strasser F, Palmer JL, et al: Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: A double-blind, placebo-controlled study. J Clin Oncol 21:129-134, 2003[Abstract/Free Full Text]

3. Fearon KC, Von Meyenfeldt MF, Moses AG, et al: Effect of a protein and energy dense N-3 fatty acid enriched oral supplement on loss of weight and lean tissue in cancer cachexia: A randomised double blind trial. Gut 52:1479-1486, 2003[Abstract/Free Full Text]

4. Barber MD, Ross JA, Voss AC, et al: The effect of an oral nutritional supplement enriched fish oil on weight-loss in patients with pancreatic cancer. Br J Cancer 81:80-86, 1999[CrossRef][Medline]

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Related Correspondence

• Eicosapentaenoic Acid: The Answers Are Not All In
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