Abstract 5146
Background
Chemotherapy Induced Nausea and Vomiting (CINV) is a common phenomenon and various modalities are being looked to reduce this adverse event. Though these modalities better control emesis, nausea is still a problem that is not optimally controlled, thus requiring newer methods to control the same.
Methods
In this study, various combinations of Olanzapine (O), Aprepitant (A), Dexamethasone (D) and 5-HT3 Antagonist (H) were randomized to three groups - standard (AHD), combined (AHDO) & olanzapine (HDO) and compared for efficacy to address the problem of CINV. Patients who had never had any previous chemotherapy and receiving cisplatin, cyclophosphamide–doxorubicin & any other Highly Emetogenic Chemotheraphy (HEC) as per guidelines were enrolled. The standard doses of the concomitant drugs were administered before and after chemotherapy. The two groups receiving Olanzapine were administered 10 mg orally daily on days 1 through 4. Nausea prevention & complete response (no emesis, no use of rescue medication) were primary end points. The toxicity profile and quality of life were secondary end points.
Results
Total of 209 subjects were included in this study (68 in standard (A), 70 in combined (B) & 71 in olanzapine (C) arm). The proportion of patients with no chemotherapy induced nausea was significantly greater in group B than in C & A arm for first 24 hours after chemotherapy (80% (B) v/s 63.23% & 58.9% (A&C); p < 0.01), the delayed period (25-120 hours) after chemotherapy (75.71% (B) v/s 59.23% & 64% (A&C); p < 0.05) and the overall 120-hour period (74% (C) v/s 48% & 52% (A&C); p < 0.01). The complete response rate for vomiting was also significantly increased with group B during the three periods – (85.71% (B) v/s 69.1% & 62% (A&C); p < 0.05), (81 % (B) v/s 70.5% & 68.3% (A&C); p = 0.09, and 77.14% (B) v/s 60.29% & 59.3% (A&C); p < 0.05) respectively. Although there were no significant differences between QTc intervals & blood sugar levels, 5% patients receiving olanzapine had increased sedation (grade 2).
Conclusions
Addition of Olanzapine to the standard arm significantly improved nausea prevention, as well as the complete response for vomiting. This modality may be further studied to determine its efficacy in lower doses so as to negate the effect of sedation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Kidwai Cancer Institute.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2182 - Evaluating the prevalence of the expression of PD-L1 in NSCLC specimens with short-duration formalin fixation using IHC 22C3 pharmDx
Presenter: Keiichi Ota
Session: Poster Display session 1
Resources:
Abstract
5255 - [18F]-FDG PET/CT in predicting PD-L1 status in nasopharyngeal carcinoma
Presenter: Liang Zhao
Session: Poster Display session 1
Resources:
Abstract
4910 - Expression of PD-L1 in Chinese Patients with Common Cancers
Presenter: Min Zheng
Session: Poster Display session 1
Resources:
Abstract
4227 - The clearance of EGF by tumor-associated macrophages is suppressed by chemotherapeutic agent cisplatin
Presenter: Irina Larionova
Session: Poster Display session 1
Resources:
Abstract
5222 - VHIO-300 and a thousand one nights, a tale of Precision Medicine
Presenter: Ginevra Caratù
Session: Poster Display session 1
Resources:
Abstract
5668 - Matched Whole-Genome Sequencing and Whole-Exome Sequencing with Circulating Tumor DNA (ctDNA) Analysis are complementary modalities in clinical practice
Presenter: Robin Imperial
Session: Poster Display session 1
Resources:
Abstract
5772 - Exploring the role of genes associated with familial cancer syndromes on the development of multiple primary tumors
Presenter: Atanaska Mitkova
Session: Poster Display session 1
Resources:
Abstract
4784 - Doxorubicin resistance: early and advanced tumors can use two different strategies based on initial and profound abnormalities in microRNA expression signature
Presenter: Volodymyr Halytskiy
Session: Poster Display session 1
Resources:
Abstract
3456 - From tumor transcriptomes to underlying cell type proportions to better predict prognosis and response to treatments
Presenter: Yuna Blum
Session: Poster Display session 1
Resources:
Abstract
4976 - Optimization of automated germline DNA extraction from non-tumoral formalin-fixed paraffin embedded (FFPE) tissues
Presenter: Omar Youssef
Session: Poster Display session 1
Resources:
Abstract