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M. Nakao



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    O07 - Supportive and Surgical Care (ID 136)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Surgery
    • Presentations: 1
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      O07.01 - Randomized phase III trial of aprepitant compared with dexamethasone for emesis induced by carboplatin (ID 1261)

      10:30 - 10:40  |  Author(s): M. Nakao

      • Abstract
      • Presentation
      • Slides

      Background
      Carboplatin (CBDCA) is used widely against various tumors,including non-small cell lung cancer, small cell lung cancer, which is classified a moderate emetic risk. 5-HT~3~ antagonist and corticosteroid had a great efficacy in patients (pts) treated with CBDCA containing chemotherapy. This randomized trial was conducted to evaluate the efficacy and safety of aprepitant (APR) compared with corticosteroid, based on granisetron (GRA) plus corticosteroid at the first day, in pts treated with CBDCA containing chemotherapy.

      Methods
      Pts treated with CBDCA (AUC 5 or 6) containing chemotherapy were entered on this trial. Major eligible criteria included more than 20 years old, and ECOG PS 0-2. Patients were randomized either A group (GRA 3 mg, iv, day 1, dexamethasone [DEX] 3.3 mg, iv, day 1, APR 125 mg , po, day 1, and APR 80 mg, po, days 2,3) or D group (GRA 3 mg, iv, day 1, D EX 6.6 mg, iv, day 1, and DEX 8 mg, po, days 2, 3). Randomization was stratified by gender and CBDCA AUC 5 or 6. Study period was 120 hours from administration of CBDCA. During this period, pts recorded the time and date of emetic episodes and severity of nausea by themselves in a survey form. Primary endpoint was complete response rate (CRR), defined as no emetic episodes and no rescue medications during the overall study period. Secondary endpoints included CRR during the acute (0-24 h) and the delayed (24-120 h) phases, no nausea rate, severity of nausea and safety. The planned sample size of 128 provided 80% power to detect a 20% improvement in the CRR at overall period with two-sided α of 0.1. This study was approved by the institutional review board in our institution. All pts provided written informed consent prior to enrollment.

      Results
      From October 2010 to August 2012, 128 pts were entered in this phase III trial. Three quarters of entered pts were male, and 63% were received CBDCA AUC 6. Baseline factors, such as age, gender, AUC of CBDCA, chemotherapy regimen, and PS, were well balanced between the two groups. The CRR during overall study period were 61.3% and 68.8% in A and D group, respectively (p=0.3799). There was no difference of CRR during both the acute phase (98.4% vs 98.4%) and the delayed (61.3% vs 68.8%). There was no adverse event due to the antiemetic therapy in both groups during the overall study period.

      Conclusion
      This randomized phase III trial failed to demonstrate that APR was superior to DEX for emesis induced by CBDCA containing chemotherapy which was classified a moderate emetic risk. Combination APR with DEX on days 2 and 3, or more was likely to increase an antiemetic efficacy during delayed phase. Further study was warranted.

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