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1.16
Recently, a placebo-controlled multicenter study of 134
patients concluded that medroxyprogesterone acetate, another
progesterone analog similar to Megace, exhibits a mild side-effects
profile, has a beneficial effect on appetite, and may prevent
further weight loss. Beneficial effects were seen at both
6 and 12 week intervals from baseline. They further suggested
that the best result would be seen with weight-losing patients
who are still not cachectic (Simons
et al., 1996).
Quality
of life as measured by the multidimensional tool, the EORTC-QLQ-C30,
also showed improvement in appetite and a reduction in nausea
and vomiting.
1.17
In addition, a previous NCCTG trial (88-92-51) randomized
133 eligible patients with cancer anorexia/cachexia to receive
Megace (800 mg/d) or a placebo (Loprinzi
et al., 1990). In this trial the Megace significantly
increased patient appetite and led to a significant weight
gain in a portion of patients. A greater than 10% weight
gain over baseline was seen in 16% of Megace patients versus
0% of the placebo patients (p = .003). In addition, there
was significantly less reported nausea (38% vs 13%, p =
.001) and vomiting (25% vs 8%, p = .009) in the patients
assigned to Megace. Results from two other randomized, double-blind
trials are in concert with the findings from the above-described
trial (Bruera
et al., 1990; Techekmedyian
et al., 1990).
1.18
A total of 350 patients have been entered on an NCCTG trial
designed to look at the dose/response relationship of Megace
for cancer anorexia/cachexia (NCCTG 89-92-55). The results
of this trial demonstrate that a Megace dose of 800 mg/d
appears optimal for appetite stimulation (Loprinzi
et al.,1993).
1.19a
Thus, Megace is an effective agent for battling cancer anorexia/cachexia
and has become the standard of care at many institutions.
1.19b
Another drug that has been prospectively studied for patients
with disease-related anorexia/cachexia is Marinol (dronabinol).
This drug has been most extensively studied in patients
with AIDS-associated anorexia/cachexia. Here, a placebo-controlled,
randomized clinical trial demonstrated that Marinol statistically
significantly increased appetite (Beal
et al., 1995). This lead to FDA approval of Marinol
for AIDS-associated anorexia/cachexia. Marinol has also
been studied in a pilot fashion for cancer anorexia/cachexia
(Sacks
et al., 1990; Plasse et al.,
1991; Regelson et al., 1976).
These pilot reports suggest that Marinol also increases
appetite in patients with advanced cancer.
1.19c
Given the availability of two drugs that have been shown
to positively impact upon anorexia/cachexia, presumably
through disparate mechanisms of actions (although precise
mechanisms have not been clarified for either drug), it
appears appropriate to compare the benefits and toxicities
of these drugs alone or in combination in patients with
cancer anorexia/cachexia.
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