Predictors of the early discontinuation of anamorelin hydrochloride in gastrointestinal cancer-related cachexia: a multicenter retrospective cohort study (HGCSG2201).

PURPOSE: Anamorelin hydrochloride (ANAM), used to treat cancer cachexia, is often discontinued early in clinical practice. Herein, we explored the clinical factors associated with the early discontinuation (Ed) of ANAM and examined its effect on treatment outcomes.

METHODS

Clinical data of patients with gastrointestinal cancers who were administered ANAM between April and November 2021 from 16 institutions were retrospectively collected. Ed was defined as ANAM discontinuation within 4 weeks of initiation. ANAM efficacy was compared between the continuation (Co) and Ed groups.

RESULTS

Of the 123 patients, 50 had an Ed of ANAM. The most common reasons were cancer progression (36%), adverse events (30%), and insufficient efficacy (22%). Age ≥ 75 years (odds ratio [OR] 4.11, 95% confidence interval [CI] 1.418-11.952, p = 0.009), no concomitant anticancer chemotherapy (OR 8.84, 95% CI 1.900-41.151, p = 0.006), and modified Glasgow prognostic score 2 (OR 2.65, 95% CI 1.065-6.604, p = 0.036) were significant risk factors for Ed. At 3 ± 1 weeks after ANAM initiation, the number of patients with increased appetite (Co 50.8% vs Ed 14.3%, p = 0.012) and food intake (Co 59.2% vs Ed 20.0%, p = 0.002) were significantly higher in the Co group than in the Ed group.

CONCLUSION

Initiating ANAM while patients can still receive concurrent chemotherapy may help prevent Ed and achieve better therapeutic benefit. Trial registration The registration number in the UMIN Clinical Trial Registry is UMIN000051550. The date of registration is July 7, 2023.