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Supportive care for the prevention of nausea, vomiting and anorexia in a phase 1B study of selinexor in advanced cancer patients: an exploratory study

Authors :
Funda Meric-Bernstam
Siqing Fu
Jordi Rodon Ahnert
Timothy A. Yap
Aung Naing
Daniel D. Karp
Shalini Dalal
Laura Rubin
David Hui
Sarina Anne Piha-Paul
Apostolia Maria Tsimberidou
Abdulrazzak Zarifa
Rony Dev
Aya Albittar
Linda L. Zhong
Suyu Liu
Source :
Investigational new drugs. 40(1)
Publication Year :
2021

Abstract

Introduction. Clinical observations of cancer patients treated with selinexor have reported high incidence of nausea and anorexia. The study objective was to investigate the adoption of prophylactic olanzapine for the prevention of nausea, vomiting and anorexia in cancer patients receiving selinexor and standard chemotherapy. Methods. We retrospectively reviewed supportive care interventions in patients receiving selinexor and recorded frequency of adverse events (NCI-CTAE). Association between categorical variables were analyzed using Fisher’s exact tests; repeated measures analysis was performed to assess weight changes over time. Results. Of 124 evaluable patients, 83 (66.9%) were female, 93 were white (75.0%), and the most common cancer was ovarian (N = 30, 24.2%). One hundred and four patients (83.9%) received olanzapine, of which 93 (89.4%) were prophylactically treated, the majority (86.5%) receiving low 2.5 mg daily dose. Other anti-emetics included ondansetron in 90 patients (72.6%), dexamethasone prescribed in 50 patients (40.3%) and metoclopramide in 49 patients (39.5%), while aprepitant/fosaprepitant (N = 2, 1.6%) were prescribed infrequently. Cancer patients receiving prophylactic olanzapine (N = 93) compared to patients who never received olanzapine (N = 20) had more Grade 1 + anorexia (31.2% vs 20.0%), less nausea (53.8% vs 70.0%), less vomiting (33.3% vs 40.0%), and increased hyperglycemia (29.0% vs 10.0%), but differences were non-statistically significant. In addition, there was minimal weight loss over time in both groups and no statistically significant differences in weight loss between groups. Conclusion. Prophylactic olanzapine decreased nausea, vomiting and maintained weight over 3 months but did not prevent anorexia in patients receiving selinexor and chemotherapy. Low dose olanzapine was well tolerated but associated with hyperglycemia.

Details

ISSN :
15730646
Volume :
40
Issue :
1
Database :
OpenAIRE
Journal :
Investigational new drugs
Accession number :
edsair.doi.dedup.....030ec489a93c1c30a6ae60cc938e6479