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Comparative Efficacy of Dronabinol and Megestrol Acetate

Bossier City, LA

To the Editor:The study by Jatoi et al¹ admits in its text a certain bias of intention in that it states a previous survey of "1,122 American oncologists (75% reply rate) found that as many as 30% would favor rescheduling marijuana for medical purposes....Our findings that dronabinol does little to promote appetite or weight gain among advanced cancer patients compared with megestrol acetate should dampen enthusiasm for the use of cannabinoids or their derivatives." Yet, there is also the admission that "few oncologists prescribe dronabinol." The enthusiasm the study wishes to dampen seems to be the enthusiasm for reclassifying marijuana to a Schedule II substance. The problem is, as everyone knows, the antiemetic effect of dronabinol is of little use if it cannot be properly absorbed, and the dose, as Roxane’s (Columbus, OH) own prescribing information shows, is widely variable. The 30% of the American oncologists cited in the study understand what the Mayo Clinic and Roxane never will: marijuana’s antiemetic and appetite-stimulating effects, when smoked, are rapid, powerful, and easily titrated by the patient, whereas the modest adverse effects of even the largest dose of the most potent smoked marijuana would be greatly outweighed if it weren’t for the fact that its relative purity cannot be assured because of its current legal status. I appreciate that the study admits the dose of dronabinol is questionable ("One might question the dose..."), but the explanation that other studies have shown "notable side effects" at higher dosing is woefully inadequate. Is Roxane rewriting the dosing instructions? If not, the dose in the study is inadequate to make the statement that "megestrol acetate provided superior palliation of anorexia in advanced cancer patients than dronabinol alone...." and, in my opinion, should be revised to indicate the dosages, which it does elsewhere in the text.

I do question the purpose of a study so conducted. It seems rather obvious the study’s authors believe marijuana is too unhealthy to use as a medicine for advanced cancer patients, and they seem to believe they have demonstrated such by conducting a study with dronabinol in a minimal dose. I find this presumptuous, but mostly, it is just wrong.

If the Mayo Clinic wants to back up their claims about cannabinoids, I am sure they can easily obtain the necessary permission from the government to do a large-scale study of smoked marijuana’s efficacy on advanced cancer anorexia and compare it with that of dronabinol and megestrol acetate. Until then, I suggest they be less dismissive about the obvious and more impartial about cannabinoids.

REFERENCES

1. Jatoi A, Windschitl HE, Loprinzi CL, et al: Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: A North Central Cancer Treatment Group Study. J Clin Oncol 20: 567-573, 2002[Abstract/Free Full Text]

Response

Mayo Clinic, Rochester, MN
CentraCare Clinic, St Cloud, MN

In Reply:We are pleased to respond to Mr Reynolds’ concerns. Mr Reynolds notes that our article¹ should be "revised to indicate the dosages." He also notes that our negative findings may have resulted from the dose of dronabinol used in this trial. First, in the Abstract, Patients and Methods, and Discussion sections of our article, we explicitly state the doses of dronabinol and megestrol acetate used in this study. Dosing is obviously an important issue in cancer care, and we have been as unambiguous as possible in informing readers of the doses tested in this trial. Second, we agree that our negative findings with respect to dronabinol as an orexigenic agent may have resulted from the dronabinol dose we tested. However, we have clearly stated the rationale for our choice of the dose 2.5 mg twice a day. If the sole purpose of an agent is appetite stimulation, we think it injudicious to substitute one symptom for a set of others. Because earlier data from Nelson et al² found an approximately 20% toxicity rate with a higher dose of dronabinol, we opted to test the lower dose of 2.5 mg twice a day. Of note, this decision on dronabinol dosing was made in concert with the manufacturers of dronabinol.

Finally, Mr Reynolds states in his letter, "the enthusiasm the study wishes to dampen seems to be the enthusiasm for reclassifying marijuana to a Schedule II substance." We are not opposed to the rigorous study of marijuana as a palliative or therapeutic agent for cancer patients. However, we did not test marijuana in our trial, nor do we claim to have tested it.

REFERENCES

1. Jatoi A, Windschitl HE, Loprinzi CL, et al: Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: A North Central Cancer Treatment Group Study. J Clin Oncol 20: 567-573, 2002[Abstract/Free Full Text]

2. Nelson K, Walsh D, Deeter P, et al: A phase II study of delta-9-tetrahydrocannabinol for appetite stimulation in cancer-associated anorexia. J Palliat Care 10: 14-18, 1994[Medline]

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