Abstract 1854P
Background
Evaluated the efficacy and safety of reduced dose of olanzapine(5mg)(OLN) with full dose of olanzapine(10mg) and addition of aprepitant(APR) in achieving complete response(no emetic episodes and no use of rescue medicine) in patients on highly emetogenic chemotherapy.(HEC).
Methods
Randomized-controlled trial done in patients on HEC to OLN 5mg v/s 10mg with dexamethasone(DEX)polensetron/granisetron(POL/GRAN)) on control of vomiting. 280 patients randomly assigned in 1:1:1:1 in 4 arms receiving OLN5mg, POL/GRAN and DEX(O5PD),OLN10mg, POL/GRAN and DEX(O10PD),APR OLN 5mg,POL/GRAN and DEX(AO5PD) and APR,OLN10mg,POL/GRAN and DEXA(AO10PD) arms.Nausea prevention in patients on HEC at acute (0-24 hrs post chemotherapy), delayed(25-50 hrs post chemotherapy) and overall periods(0-120 hrs post chemotherapy) were primary end points and complete response(CR) as secondary end point.
Results
CR rates 78.5%,80%,81.4% and 84.3% in O5PD,O10PD,AO5PD and AO10PD arms respectively.Patients without nausea O5PD:84.3% acute,80% delayed and 78.6% overall periods, for O5PD: 87.1% acute,82.9% delayed and 80% overall periods, for AO5PD: 87.1% acute,81.4% delayed and 80% overall periods,For AO10PD:88.5% acute,85.7% delayed and 84.3% overall periods.O5PD was comparable to O10 PD in control of CINV. The differences between the two arms were not significant with respect to CR rates and control of nausea and vomiting in both acute and delayed phases.(p>0.05), addition of APR was not significant(AO5PD and AO10PD) with respect to emesis and nausea in both acute and delayed periods when compared to OPD5 and OPD10 arms(p>0.05). The most common treatment related adverse event with olanzapine was sedation seen in 54 patients(19.2%). 17 patients(6.07%) received olanzapine dose 5mg and 37 patients received olanzapine dose of 10 mg shows grade1/2 sedation(p<0.05).
Conclusions
Reduced dose OLN 5mg comparable to OLN 10 mg with respect to efficacy but 10 mg dose olanzapine causes increased risk of sedation. Addition of apripitant does not cause significant impact on efficacy of olanzapine in combination of dexamethasone and polensetron/granisetron.
Clinical trial identification
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.