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R. Jotte



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    P2.03a - Poster Session with Presenters Present (ID 464)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03a-039 - ABOUND.70+: Interim Quality of Life (QoL) Results of nab-Paclitaxel/Carboplatin Treatment of Elderly Patients With NSCLC (ID 4286)

      14:30 - 14:30  |  Author(s): R. Jotte

      • Abstract

      Background:
      QoL data in elderly patients with NSCLC receiving chemotherapy are limited, although these assessments can help inform treatment decisions. Interim QoL outcomes from the ongoing ABOUND.70+ study are reported here.

      Methods:
      Patients aged ≥ 70 years with locally advanced/metastatic NSCLC were randomized 1:1 to first-line nab-paclitaxel 100 mg/m[2] on days 1, 8, and 15 + carboplatin AUC 6 on day 1 every 21 days or the same nab-paclitaxel/carboplatin regimen with a 1-week break between cycles. The primary endpoint is the percentage of patients with grade ≥ 2 peripheral neuropathy or grade ≥ 3 myelosuppression adverse events. QoL (an exploratory endpoint) was assessed on day 1 of each cycle using the Lung Cancer Symptom Scale (LCSS) and EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L).

      Results:
      This analysis included 119 patients; 88 patients (74%) completed baseline + ≥ 1 postbaseline QoL assessments. The median age was 76 years (range, 70-93 years); 30% of patients were ≥ 80 years of age, 56% were male, and 99% had an ECOG PS 0-1. In general, LCSS symptom burden index and average total scores improved during cycles 1-4. The LCSS item of cough improved each cycle, with a mean change of 18.98 mm from baseline to end of cycle 4 on the visual analog scale (VAS; 95% CI, 8.42-29.54 mm). Fifty percent of patients had a clinically meaningful improvement (≥ 10 mm [VAS]) from baseline in the composite LCSS pulmonary symptom items of cough, shortness of breath, and hemoptysis. More than 80% of patients maintained/improved in each EQ-5D-5L dimension from baseline; complete resolution of baseline pain/discomfort, anxiety/depression, and self-care items was reported by ≥ 55% of patients (Table). Figure 1



      Conclusion:
      Clinically meaningful improvements in several QoL dimensions were observed in elderly patients with NSCLC treated with nab-paclitaxel/carboplatin. These data support the role of nab-paclitaxel/carboplatin in this patient population. NCT02151149

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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-038 - First-Line Atezolizumab plus Chemotherapy in Chemotherapy-Naïve Patients with Advanced NSCLC: A Phase III Clinical Program (ID 4956)

      14:30 - 14:30  |  Author(s): R. Jotte

      • Abstract

      Background:
      First-line treatments for patients with advanced NSCLC include targeted therapies and platinum-based doublet chemotherapy±bevacizumab and/or pemetrexed. Although immunotherapies targeting the PD-L1/PD-1 pathway are available for advanced NSCLC beyond the first line, chemotherapy is a key first-line option for patients, despite poor survival outcomes, highlighting the need for additional treatment options. Atezolizumab, a monoclonal anti–PD-L1 antibody, inhibits the binding of PD-L1 to its receptors PD-1 and B7.1, restoring tumor-specific T-cell immunity. Clinical efficacy has been reported with atezolizumab monotherapy in patients with squamous and nonsquamous NSCLC, with a survival benefit observed across all PD-L1 expression levels. Additionally, Phase Ib data showed the potential for chemotherapy to further enhance responses to atezolizumab, with tolerable safety, in patients with NSCLC. Bevacizumab in combination with atezolizumab may enhance efficacy in non-squamous NSCLC by inhibiting VEGF-mediated immunosuppression. Four global, Phase III, randomized, open-label trials are evaluating atezolizumab+platinum-based chemotherapy±bevacizumab in chemotherapy-naive patients with stage IV NSCLC.

      Methods:
      Eligible patients must have stage IV NSCLC, measurable disease (RECIST v1.1) and ECOG PS 0-1 and be chemotherapy naive. Exclusion criteria include untreated CNS metastases, autoimmune disease and prior exposure to immunotherapy. Patients will be enrolled regardless of PD-L1 expression status. Patients randomized to the experimental arm will receive atezolizumab 1200 mg with standard platinum-based chemotherapy in IMpower130 and 131 and also ±bevacizumab in IMpower150 for four or six 21-day cycles, then maintenance with atezolizumab in IMpower130 and 131 and atezolizumab+bevacizumab in IMpower150. In IMpower132, experimental-arm patients will receive atezolizumab+platinum-based chemotherapy+pemetrexed, then maintenance with atezolizumab+pemetrexed. Patients receiving atezolizumab may continue until loss of clinical benefit. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include objective response rate and safety. Evaluation of predictive biomarkers associated with efficacy will be performed.

      Trial IMpower130 IMpower131 IMpower132 IMpower150
      Histology Nonsquamous Squamous Nonsquamous Nonsquamous
      Planned enrollment(N) 650 1025 568 1200
      Experimental Atezolizuma +carboplatin +nab-paclitaxel Atezolizuma +carboplatin +paclitaxel or Atezolizumab +carboplatin +nab-paclitaxel Atezolizuma +carboplatin or cisplatin +pemetrexed Atezolizumab +carboplatin +paclitaxel or Atezolizumab +carboplatin +paclitaxel +bevacizumab
      Comparator Carboplatin +nab-paclitaxel Carboplatin +nab-paclitaxel Carboplatin or cisplatin +pemetrexed Carboplatin +paclitaxel +bevacizumab
      Stratification factors Sex Liver metastases Centrally assessed PD-L1 expression by IHC Sex Liver metastases Centrally assessed PD-L1 expression by IHC Sex ECOG PS Chemotherapy type (carboplatin vs cisplatin) Smoking status Sex Liver metastases Centrally assessed PD-L1 expression by IHC
      Identifier NCT02367781 NCT02367794 NCT02657434 NCT02366143
      ECOG PS, Eastern Cooperative Oncology Group performance status; IHC, immunohistochemistry.

      Results:
      Section not applicable

      Conclusion:
      Section not applicable