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
540P - Phase III study of serplulimab plus chemotherapy as first-line therapy for advanced squamous non-small cell lung cancer: ASTRUM-004 Asian subgroup
Presenter: Caicun Zhou
Session: Poster Display
Resources:
Abstract
541P - Integrated analysis of randomized controlled trials IMpower130 and IMpower132 for advanced non-squamous non-small cell lung cancer (NSCLC)
Presenter: Hibiki Udagawa
Session: Poster Display
Resources:
Abstract
542P - First-line HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy in advanced/recurrent squamous non-small cell lung cancer: A phase II study
Presenter: Zhen Wang
Session: Poster Display
Resources:
Abstract
543P - A multicenter retrospective study to investigate risk factors for immune checkpoint inhibitor-induced pneumonitis in non-small cell lung cancer patients with comorbid interstitial pneumonia
Presenter: Yuriko Ishida
Session: Poster Display
Resources:
Abstract
544P - Single cell level investigation of blood cells representing immune checkpoint inhibitor response in lung adenocarcinoma patients
Presenter: Juyong Seong
Session: Poster Display
Resources:
Abstract
545P - Completion of pembrolizumab in advanced non-small cell lung cancer: Real-world outcomes after two years of therapy (COPILOT)
Presenter: Andrew Fantoni
Session: Poster Display
Resources:
Abstract
546P - Combination therapy with anti-PD-1 antibody plus angiokinase inhibitor exerts synergistic antitumor effect against malignant mesothelioma via tumor microenvironment modulation
Presenter: Akio Tada
Session: Poster Display
Resources:
Abstract
547P - Immunotherapy outcome in advanced/metastatic lung cancer patients in real-world experience: Indian data
Presenter: Naveen K
Session: Poster Display
Resources:
Abstract
548P - B-Myb acts as a mentor instant promoter in non-small cell lung cancer by modifying the PD-1/PD-L1 axis
Presenter: Pan Xu
Session: Poster Display
Resources:
Abstract
549P - Drug-induced interstitial lung disease in patients with non-small cell lung cancer treated with immunotherapy for postoperative recurrence: Evaluation of CT findings and histopathological findings of the background lung
Presenter: shodai fujimoto
Session: Poster Display
Resources:
Abstract