PracticeUpdate: Oncology - Winter 2018

CONFERENCE COVERAGE 28

PatientsWith Advanced Cancer May Not Have to Accept Anorexia as Inevitable Study showed some evidence for megestrol acetate as a treatment option By the PracticeUpdate Editorial Team A lthough not statistically significant, results from a study demonstrated that megestrol acetate showed a trend in improving symptoms of anorexia in patients with advanced

The multisite, double-blind, phase III effectiveness study com- pared megestrol acetate 480 mg/day (n=61), dexamethasone 4 mg/day (n=67) and placebo (n=62) for 4 weeks on their net short- term effect on appetite and quality of life. The study population included both inpatients and outpatients with advanced cancer who had anorexia for ≥2 weeks and a score ≤4 on a 0–10 numeric rating scale in which 0 = no appetite and 10 = best possible appe- tite. Patients were assessed for their change in appetite score at 1 week, with response defined as a 25% increase in the baseline score (primary endpoint). At week 1, 79.3% of participants in the megestrol acetate group, 65.5% in the dexamethasone group, and 58.5% in the placebo group were responders (P = .067). Furthermore, there were no dif- ferences in weight, performance status or quality of life reported at 1 week (secondary endpoints). Regarding the lack of statistical significance of these results, Dr. Currow commented, “People in the placebo arm did sur- prisingly well.…I don’t think that’s a placebo response, I think it’s regression to the mean.” Although there was little difference between treatment groups for the primary and secondary effectiveness endpoints, there was a consistent trend in secondary endpoints favoring megestrol ace- tate than dexamethasone or placebo. Subgroup analyses indicate megestrol acetate may be more effective in maintaining body weight for subjects whose appetite responded. The study also found that treatment-emergent adverse events occurred in the majority of participants (90.4%) and included altered mood and insomnia; hyperglycemia was specifically more frequent in patients taking dexamethasone. According to Dr. Cur- row, “What we didn’t see in this study was an increase in the rates of deep vein thrombosis or coronary emboli, which…was a concern for people entering the study.” He said the design of the study was predicated on concerns about toxicity over the potential benefit of treatment. Patients were assessed each week across the 4 weeks in order for them to continue in the study, and that was specifically because of concerns of deep vein thrombosis for patients taking megestrol acetate. This was an important limitation of the study. Dr. Currow hopes that these results will start to change the belief in clinical practice that anorexia is simply part of living with advanced cancer. “I think the big challenge is when we feel as clinicians that we don’t have something to offer, we don’t even take a full his- tory for that particular symptom.” These results, which will soon be published, show that there is something that can be done for these patients. www.practiceupdate.com/c/69126 " I think the big challenge is when we feel as clinicians that we don’t have something to offer, we don’t even take a full history for that particular symptom. "

cancer, with lower rates of certain side effects than was antici- pated by the study investigators, according to a poster presented at the ASCO 2018. Anorexia affects the majority of patients with advanced cancer, and there currently is not enough evidence indicating which treatment is best to improve symptoms. “[Anorexia] is not only [a problem] for the patients themselves—the impact on the families and caregivers is substantial. It is very hard to sit at the dinner table when someone is just not eating and the others still eat,” said David Christopher Currow, BMed, PhD, FAHMS, from the University of Technology, Sydney, Australia in an interview to Elsevier’s PracticeUpdate . According to Dr. Currow, there is wide variation in clinical prac- tice for treating anorexia in patients with advanced cancer, and although megestrol acetate has been shown to be of clinical bene- fit, it has not been evaluated head-to-head with the most frequently used therapy in parts of the world, dexamethasone.

© ASCO/Scott Morgan 2018

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