453P - Palonosetron plus megestrol acetate verses palonosetron plus dexamethasone in preventing moderately emetogenic chemotherapy-induced nausea and vomiting: A randomized, multicenter, crossover, phase II trial

Background

Evidence shows megestrol acetate (MA) may be a potential antiemetics for preventing chemotherapy-induced nausea and vomiting (CINV). While no persuasive clinic trails were performed to validate the efficacy and safety of MA. Here we designed a phase II trial to assess the efficacy of palonosetron plus megestrol acetate versus palonosetron plus dexamethasone (DEX) in preventing chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy (MEC) regimens.

Methods

This was a multicenter, randomized, crossover, phases II clinical trial at West China hospital and West China Fourth hospital of Sichuan University. The eligible patients were recruited to the DEX-MA group and MA-DEX group by using computer-generated random number table. DEX-MA group received palonosetron and dexamethasone for first chemotherapy circle and then received palonosetron and megestrol acetate for second circle. The MA-DEX group received the treatment in the reverse order. Evaluating efficacy and quality of life of patients of these two regimens relatively. The primary endpoint was complete response (CR). This trial has registered with Chinese Clinical Trial Register (ChiCTR2000037447).

Results

Between June 2020 and March 2021, sixty-one patients were eventually evaluated in the study. Thirty-two patients were randomized in the DEX-MA group and 29 in the MA-DEX group. Of all subjects, 56% were male, and 44% were female. CR rates showed no significant difference in acute phase (DEX vs. MA, 85.25% vs. 85.25%, P=1.000), delayed phase (DEX vs. MA, 81.97% vs. 83.61%, P=0.810), overall phase (DEX vs. MA, 75.41% vs. 73.77%, P=0.835). Quality of life (QOL) showed significant differences in dyspnea symptom (P=0.000) and appetite loss symptom (P=0.021).

Conclusions

Megestrol acetate may have equivalent efficacy to dexamethasone in the treatment of moderately emetogenic regimen chemotherapy induced nausea and vomiting, and no obvious adverse reactions occurred. Compared with dexamethasone, megestrol acetate can significantly improve the quality of life, especially in terms of decreasing the dyspnea and appetite loss.

Clinical trial identification

ChiCTR2000037447, 2020-08-28.

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.