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S. Blum

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    Best abstracts selected from submissions 5 (ID 6)

    • Event: ACLC 2018
    • Type: Oral Session
    • Track:
    • Presentations: 1
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      OA10 - CheckMate 078: Patient-Reported Outcomes (PROs) With Nivolumab vs Docetaxel in Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 150)

      16:20 - 17:00  |  Author(s): S. Blum

      • Abstract

      Nivolumab is approved in China for treatment of previously treated advanced NSCLC without EGFR/ALK alterations based on the findings of CheckMate 078 (NCT02613507), a randomized, open-label phase 3 study in a predominantly Chinese population that demonstrated superior overall survival with nivolumab versus docetaxel. Patients were randomized 2:1 to receive nivolumab 3 mg/kg Q2W or docetaxel 75 mg/m2 Q3W until disease progression or unacceptable toxicity. The results mirrored previous findings in the similar CheckMate 017/057 studies, which included few Asian patients. PROs in CheckMate 017/057 showed reductions in disease-related symptom burden and improvement in health-related quality of life (HRQOL). This study investigated whether similar improvements occurred in CheckMate 078.

      Symptom burden was assessed using the Lung Cancer Symptom Scale (LCSS) average symptom burden index (ASBI). HRQOL was assessed using the LCSS 3-item global index (3-IGI) and EQ-5D-3L utility index (UI) and visual analog scale (VAS). Assessments for nivolumab and docetaxel occurred at baseline and every 4 and 3 weeks, respectively, up to week 24, and thereafter every 6 weeks for both treatments.

      Of 504 randomized patients, 458 (91%) had evaluable PROs with baseline assessment and ?1 post-baseline assessment (90.4% were Asian and 60.0% had non-squamous tumor histology). Compliance was ?83% for all on-treatment PRO assessments. Ten or more patients remained on nivolumab and docetaxel until week 72 and 30, respectively. Time to first deterioration (TTD) was significantly prolonged with nivolumab vs docetaxel for all PRO measures; hazard ratios (95% confidence interval) were 0.47 (0.35?0.64) for LCSS-ASBI, 0.62 (0.47?0.83) for LCSS-3-IGI, and 0.56 (0.44?0.71) for both EQ-5D-3L VAS and UI. Deterioration rates at week 12 were significantly lower with nivolumab (LCSS, n=313; EQ-5D-3L, n=312) than docetaxel (LCSS, n=137; EQ-5D-3L, n=142) for LCSS-ASBI (31.6% vs 46.7%), EQ-5D-3L VAS (46.8% vs 58.5%), and EQ-5D-3L UI (36.5% vs 51.4%). Patients treated with nivolumab demonstrated clinically meaningful improvements for most LCSS-ASBI assessments after week 30 and all LCSS-3-IGI assessments after week 16; no clinically meaningful improvements were observed with docetaxel (descriptive). HRQOL improvements with nivolumab were observed with the EQ-5D-3L UI (weeks 20?72) and VAS (weeks 16?54), but most were not clinically meaningful.

      HRQOL and symptom burden improved with nivolumab vs docetaxel in CheckMate 078. Deterioration rates up to week 12 decreased and TTD was delayed with nivolumab vs docetaxel. Patients treated with nivolumab showed clinically meaningful improvement in symptom burden from baseline. These findings are consistent with those from CheckMate 017/057.