2110P - Palonosetron plus megestrol acetate verses dexamethasone in preventing nausea and vomiting following moderately emetogenic chemotherapy: A randomized, multicenter, self-controlled, phase II trial

Background

Chemotherapy-induced nausea and vomiting (CINV) is the most common side effect following chemotherapy. For medium emetic chemotherapy (MEC), guidelines recommend dexamethasone （DEX） for the prevention and treatment of CINV. But the usage of DEX can cause a variety of adverse reactions. DEX-free regimens are being actively explored. Megestrol acetate （MA） was suggested as an antiemetic therapy gradually. Accordingly, the present phase II trial was designed to test the hypothesis that the efficacy of MA plus palonosetron regimen against CINV is non-inferior to a DEX regimen.

Methods

This was a randomized, self-controlled phase II study. Patients enrolled were scheduled to receive primary chemotherapy that contained oxaliplatin and fluorouracil every 3 weeks and randomized to the MA-DEX group or DEX-MA group. MA-DEX group received palonosetron (0.25 mg intravenously, d1) and MA （160 mg orally, d1-5）for first cycle and then received palonosetron and DEX (6 mg orally, d1-4) for second cycle. The DEX-MA group received the antiemetic treatment in the reverse order. The primary endpoint was complete response (CR). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint. All subjects have signed the informed consent, and this trial has registered with Chinese Clinical Trial Register (ChiCTR2000037447).

Results

61 patients were eventually evaluated in the study 32 included in the DEX-MA group and 29 in the MA-DEX group. Overall CR rates were 82.25% for those administered MA on day 1 (acute phase) (n = 52), and 83.61% on days 2 -5 (delayed phase) (n = 51), 72.13% on days 1-7 (whole phase). According to CR rates，the MA regimen is non-inferior to DEX regimen during the acute, delayed and whole phase. Compared with DEX, the quality of life (QOL) of MA regimen was higher with respect to dyspnea (P=0.000) and appetite (P=0.021).

Conclusions

In this trial, MA is non-inferior to dexamethasone in the treatment of CINV induced by MEC regimens, and no obvious adverse reactions occurred. Compared with DEX, MA led to a milder dyspnea and appetite decrease, and better quality of life after chemotherapy.

Clinical trial identification

ChiCTR2000037447, 2020/08/27.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.