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Attend this session at the
2019 ASCO Annual Meeting!


Session: Symptoms and Survivorship

Type: Oral Abstract Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: S102

Olanzapine (OLN) versus aprepitant (APR) in patients receiving high-emetogenic chemotherapy: Final results of randomized phase II trial.

Sub-category:
Palliative Care and Symptom Management

Category:
Symptoms and Survivorship

Meeting:
2019 ASCO Annual Meeting

Abstract No:
11504

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 11504)

Author(s): Alexey Rumyantsev, Elena Glazkova, Rukhshona Nasyrova, Ekaterina Ignatova, Lia Chitia, Anna Popova, Dzhennet Chekini, Yaroslava Kochetkova, Sergei Kit, Kheda Elsnukaeva, Sophia Menshikova, Olga Sekhina, Ilya Pokataev, Alexandra Tyulyandina, Marina Stenina, Mona A. Frolova, Anatoly Bulanov, Mikhail Fedyanin, Alexey Tryakin, Sergei Tjulandin; Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology"оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russian Federation; National Medical Research Cancer CenterFederal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russian Federation; Federal State Budgetary Institution «N.N. Blokhin National Medical Research Center of Oncology»оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russian Federation; Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russian Federation; Federal State Budgetary Institution «N.N. Blokhin National Medical Research Center of Oncology»оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, Russia

Abstract Disclosures

Abstract:

Background: Management of chemotherapy-induced nausea and vomiting (CINV) remains challenging. OLN might provide several benefits over APR which is current standard of care – particularly in terms of nausea control and cost effectiveness. However, sedation associated with recommended doses of olanzapine precludes its wide use in oncology practice. Methods: This was randomized phase II single center study aimed to compare OLN and APR in CINV prophylaxis. Key inclusion criteria were: chemo- and radio-therapy naïve patients, planned administration of high-emetogenic chemotherapy (cisplatin, carboplatin AUC≥4, doxorubicin etc). Patients were randomized 1:1 ratio in the following arms: olanzapine 5 QD day 0-4 or aprepitant 125 mg day 1, 80 mg day 2,3. All patients received ondansetron 16 mg day 1 and dexamethasone 8 mg day 1-3. Primary endpoint was complete nausea control (no nausea and no rescue medication) 0-120 hours after chemotherapy. Complete response (no emesis and no rescue medication) was a key secondary end point. Nausea was assessed using MASCC Antiemesis Tool. Sample size: 94 patients to increase nausea control rate from 40 to 70% (α = 0.05; β = 0.80; 10% of estimated data loss).Results: We included in the analysis 93 patients who could be evaluated. The groups were well balanced, median age was 49 years, vast majority of patients (95.6%) were females. The proportion of patients with complete nausea control in OLN and APR groups was 44.2% and 24.0% respectively (RR 2.5; 95% CI 1.04-6.08; p = 0.039). Complete response was achieved in 74.4% and 54.0% patients respectively (RR 2.48; 95% CI 1.026-5.99; p = 0.041). No differences in rates of undesired sedations were detected. Conclusions: Our data suggests superiority of OLN regimen in terms of nausea control. This regimen deserves further investigation. Clinical trial information: NCT03478605

 
Other Abstracts in this Sub-Category:

 

1. A phase II RCT of high-dose vitamin D supplementation and exercise for cancer treatment-induced bone loss in breast cancer patients on aromatase inhibitors.

Meeting: 2019 ASCO Annual Meeting Abstract No: 11500 First Author: Luke Joseph Peppone
Category: Symptoms and Survivorship - Palliative Care and Symptom Management

 

2. A randomized trial comparing four-weekly versus 12-weekly administration of bone-targeted agents (denosumab, zoledronate, or pamidronate) in patients with bone metastases from either breast or castration-resistant prostate cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 11501 First Author: Mark J. Clemons
Category: Symptoms and Survivorship - Palliative Care and Symptom Management

 

3. A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: J-FORCE Study.

Meeting: 2019 ASCO Annual Meeting Abstract No: 11503 First Author: Hironobu Hashimoto
Category: Symptoms and Survivorship - Palliative Care and Symptom Management

 

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