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
4811 - Comprehensive genomic profiling of thymic carcinoma in a sample Chinese population
Presenter: Baohui Han
Session: Poster Display session 1
Resources:
Abstract
2045 - The analysis of treatment sequences and clinical outcomes of thymic carcinoma
Presenter: Arakaki Motoko
Session: Poster Display session 1
Resources:
Abstract
4785 - Transcriptomic Difference of Thymoma and Thymic Carcinoma
Presenter: Naixin Liang
Session: Poster Display session 1
Resources:
Abstract
2864 - A Phase II Trial of Preoperative Chemoradiotherapy and Pembrolizumab for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Presenter: Seoyoung Lee
Session: Poster Display session 1
Resources:
Abstract
5015 - The study of tumor associated exosomes in crosstalk between esophageal carcinoma and lymphatic endothelial cells
Presenter: Weimin Mao
Session: Poster Display session 1
Resources:
Abstract
1339 - Up-regulation of IBSP expression predicts poor prognosis of Esophageal Squamous Cell Carcinoma patients
Presenter: Mingyue Wang
Session: Poster Display session 1
Resources:
Abstract
4083 - PD-L1 expression in primary tumour vs metastatic samples in the Phase 3 MYSTIC study in first-line metastatic (m) NSCLC
Presenter: Niels Reinmuth
Session: Poster Display session 1
Resources:
Abstract
5113 - Assessing the impact of subsequent checkpoint inhibitor (CPI) treatment on overall survival: post hoc analyses from the phase 3 JAVELIN Lung 200 study of avelumab vs docetaxel in platinum-treated locally advanced/metastatic non-small cell lung cancer (NSCLC)
Presenter: Fabrice Barlesi
Session: Poster Display session 1
Resources:
Abstract
4256 - Long-term avelumab treatment in patients with advanced non-small cell lung cancer (NSCLC): post hoc analyses from JAVELIN Solid Tumor
Presenter: Borys Hrinczenko
Session: Poster Display session 1
Resources:
Abstract
4305 - Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: Updated survival and subgroup analysis from the real-world EVIDENS study
Presenter: Fabrice Barlesi
Session: Poster Display session 1
Resources:
Abstract