Abstract 453P
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.
Resources from the same session
451P - The real-world efficacy and safety of anamorelin hydrochloride for Japanese unresectable non-small cell lung cancer patients with cachexia
Presenter: Daisuke Arai
Session: Poster Display
Resources:
Abstract
452P - The relationship between BCG immunotherapy and oxidative stress parameters in patients with non-muscle invasive bladder cancer
Presenter: Mukul Singh
Session: Poster Display
Resources:
Abstract
454P - A multicenter randomized open-label phase II study investigating optimal antiemetic therapy for patients with advanced/recurrent gastric cancer treated with trastuzumab deruxtecan (T-DXd): EN-hance study
Presenter: Akira Ooki
Session: Poster Display
Resources:
Abstract
455P - Assessing model-predicted neurokinin-1 (NK1) receptor occupancy (RO) of netupitant to support efficacy over an extended time period
Presenter: Matti Aapro
Session: Poster Display
Resources:
Abstract
456P - Oxycodone/naloxone in moderate-to-severe cancer pain: A phase III study in China
Presenter: Ping Lu
Session: Poster Display
Resources:
Abstract
457P - Anticoagulation for terminal cancer patients with cancer associated venous thromboembolism
Presenter: Sang Bo Oh
Session: Poster Display
Resources:
Abstract
458P - Association between TSPAN15 and SLC44A2 genetic polymorphisms and venous thromboembolism in cancer patients
Presenter: Alshimaa Al Hanafy
Session: Poster Display
Resources:
Abstract
459P - Association between national health screening program and undertreatment of dyslipidemia in cancer survivors: A cross-sectional study
Presenter: Sujeong Shin
Session: Poster Display
Resources:
Abstract
460P - Group to grow: A systematic review of group-based interventions for post-traumatic growth on cancer patients
Presenter: Dyta William
Session: Poster Display
Resources:
Abstract
461P - A randomized controlled trial of yoga in locally advanced non-small cell lung cancer patients receiving chemoradiotherapy
Presenter: Indranil Khan
Session: Poster Display
Resources:
Abstract