1. Aprepitant in conjunction with palonosetron and dexamethasone is associated with increased antiemetic efficacy during FOLFOX or FOLFIRI chemotherapy in women.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Approximately 40% of the population worldwide will be diagnosed with cancer at some point during their lifetimes. Chemotherapy, in its many modalities, is a therapeutic and palliative treatment for cancer. Chemotherapy-associated nausea and vomiting (CINV) remains one of the most common and distressing side effects of this treatment regime, affecting countless individuals worldwide. The FOLFOX (fluorouracil, leucovorin, and oxaliplatin) and FOLFIRI (fluorouracil, leucovorin, and irinotecan) are chemotherapy regimens used widely in treatment of gastrointestinal cancers. This phase 3, double-blind, placebo-controlled randomized clinical trial investigated the antiemetic efficacy of Aprepitatnt, a neurokinin-1 (NK-1) RA, in combination of palonosetron and dexamethasone in young women with gastrointestinal cancer receiving FOLFOX or FOLFIRI chemotherapy from August 4, 2015, to March 31, 2020. Aprepitant in conjunction with palonosetron and dexamethasone was shown to have increased antiemetic efficacy during FOLFOX or FOLFIRI chemotherapy in women with a history of little or no alcohol consumption and gastrointestinal cancer. One strength of this study is utilizing a double-blind, placebo-controlled randomized clinical trial design. By focusing on population at higher risk for CINV, younger age, female, with little or no alcohol consumption also allows for effective examination of the efficacy of Aprepitant in combination with palonosetron and dexamethasone. However, the trial only examined the effect of Aprepitant during the first course of chemotherapy. The efficacy for complete chemotherapy treatment duration remains unknown. The relatively small sample size also decreases the power of the study and further investigation with a large sample size is needed.
In-Depth [randomized controlled trial]: In this phase 3, double-blind, placebo-controlled randomized clinical trial, women younger than 50 years of age with little or no alcohol consumption in China when treated with Aprepitant were shown to have a higher no-vomiting rates and less nausea while on FOLFOX therapy. 65.9% of the patient receiving the Aprepitant regimen had no nausea while only 49.2% of the placebo group had no nausea (P =0.08) with a striking 16.9 percentage point difference. Notably, the participants in the Aprepitant group tolerated the treatment reasonably well without significant adverse events.
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