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
497P - Sintilimab in combination with anlotinib in advanced NSCLC treated with first-line PD-1 antibodies: An open, single-arm, phase II trial
Presenter: Ying Jin
Session: Poster Display
Resources:
Abstract
498P - Frailty-adjusted life expectancy and survival in older lung cancer patients: A large-scale electronic health-record based study
Presenter: Thao Tu
Session: Poster Display
Resources:
Abstract
499P - Long-term survival and treatment (tx) patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC): Japanese cohort of a global real-world (rw) observational study
Presenter: Daichi Fujimoto
Session: Poster Display
Resources:
Abstract
500P - The effectiveness and safety of durvalumab after chemoradiotherapy for locoregional recurrence of completely resected non-small cell lung cancer: Real-world, multicenter, observational study (NEJ056)
Presenter: Hidehito Horinouchi
Session: Poster Display
Resources:
Abstract
501P - One-year survival outcomes of unresectable stage III non-small cell lung cancer patients who underwent PD-1 inhibitor plus chemo as induction therapy
Presenter: Xin Wang
Session: Poster Display
Resources:
Abstract
502P - Impact of sarcopenia on the outcome of patients with locally advanced non-small cell lung cancer treated with chemoradiotherapy followed by durvalumab
Presenter: Kentaro Tamura
Session: Poster Display
Resources:
Abstract
503P - Clinical outcomes by infusion timing of immune checkpoint inhibitors in patients with locally advanced NSCLC
Presenter: TSUYOSHI HIRATA
Session: Poster Display
Resources:
Abstract
504P - Real-world outcomes with induction systemic therapy for stage III in eligible for upfront local therapy: Pre vs post immunotherapy era in a tertiary referral centre
Presenter: Praveen Kumar Marimuthu
Session: Poster Display
Resources:
Abstract
505P - Neoadjuvant PD-1 inhibitor (tislelizumab) plus platinum–etoposide in patients with limited-stage small cell lung cancer: A phase II trial
Presenter: Junjie Hu
Session: Poster Display
Resources:
Abstract
506P - Intrathoracic progression is still the most dominant failure pattern after first-line chemo-immunotherapy in extensive-stage small-cell lung cancer: Implications for thoracic radiotherapy
Presenter: Byoung Hyuck Kim
Session: Poster Display
Resources:
Abstract