P2.01-004 Safety and Efficacy of Nab-Paclitaxel plus Carboplatin in Elderly Patients with NSCLC (ABOUND.70+)

S2070 Background: We aimed to determine whether Astragalus membranaceus root extract (AmE), which has immunomodulatory activities mainly on macrophages and Th1 type immune response, improve the overall survival (OS) of patients with metastatic non-small cell lung cancer (NSCLC). Method: The medical charts of 117 patients with metastatic NSCLC were retrospectively assessed. Thirty-four patients (A group) using AmE during systemic anti-cancer treatment were compared with 83 controls (C group) who did not use AmE following the diagnosis of NSCLC. The histological subtype, performance status, age, gender, smoking status, comorbidities, chemotherapeutics (CT), and erlotinib that were received in any line of treatment were recorded. We compared the OS of the patients in the A and C groups. Result: The median (±SD) age of the patients was 61(±7) years and all patients were administered systemic treatment (CT or erlotinib). The histological subtype, performance status, age, gender, smoking status, comorbidities, usage of different type of CT agents and erlotinib were similar in the A and C groups. The median follow-up period was longer for the A group than the C group (18 vs 11 months, p <0.001). At the time of the analysis, 83.8% of the patients had died. In the univariate analysis, the median OS (±SE) was significantly longer in the A group compared with the C group (21±4.2 vs 11 ±0.9 months, p¼ 0.004) (Fig 1). In addition to AmE usage, female gender, smoking status, presence of hypertension and erlotinib usage had also significant impact on OS (p <0.05 for all). In the multivariate analysis, only AmE (HR: 0.46, 95% CI: 0.27-0.76, p¼ 0.003) and erlotinib (HR: 0.45, 95% CI: 0.22-0.89, p¼ 0.02) usage had significant benefit on OS. Conclusion: The use of AmE during systemic anti-cancer treatment may significantly prolong OS of patients with metastatic NSCLC. Keywords: non-small cell lung cancer, overall survival, Astragalus membranaceus

Journal of Thoracic Oncology

Vol. 12 No. 11S2

advanced NSCLC. ABOUND.70+ evaluated 2 schedules of nab-paclitaxel/carboplatin to determine whether a 1-week break could improve tolerability. Method: Patients 70 years with locally advanced/metastatic NSCLC were randomized to receive first-line nab-paclitaxel 100mg/m2 on days 1, 8, 15 and carboplatin AUC 6 on day 1 of a 21-d cycle (Arm A) or the same regimen with a 1-week break between cycles (Arm B). Primary endpoint: the percentage of patients with grade 2 peripheral neuropathy or grade 3 myelosuppression; key secondary endpoints: progression-free survival (PFS), overall survival (OS), and overall response rate (ORR), for which statistical analyzes did not control for type I error (P values unadjusted). Result: At interim evaluation, the primary endpoint was similar across treatment arms leading to early closure of enrollment. Baseline characteristics were well balanced between arms (Arm A, n ¼ 71; Arm B, n ¼ 72). Primary endpoint results are presented in the table. Overall, confirmed ORR was 23.9% vs 40.3% (P ¼ 0.038), median PFS was 3.6 vs 7.0 months (HR 0.48 [95% CI, 0.30-0.76]; P ¼ 0.002), and median OS was 15.2 vs 16.2 months (HR 0.72 [95% CI, 0.44-1.19]; P ¼ 0.197). Among patients who received second-line therapy across treatment arms (n ¼ 61), median OS from start of firstline treatment was 22.7 months (95% CI, 11.79-not estimable [NE]) and 16.4 months (95% CI, 12.12-NE) in patients receiving chemotherapy and immunotherapy, respectively. Conclusion: nab-Paclitaxel/carboplatin was well tolerated and efficacious in elderly patients with advanced NSCLC. Incidence of grade 2 peripheral neuropathy or grade 3 myelosuppression (primary endpoint) was similar in both treatment arms. A signal of improvement was observed in PFS and ORR in Arm B. NCT02151149 Keywords: elderly, NSCLC, nab-paclitaxel

Primary Endpoint

Event, n (%) Patients with either grade  2 peripheral neuropathy or grade  3 myelosuppression Grade  2 peripheral neuropathy Grade  3 myelosuppression Neutropenia Anemia Thrombocytopenia

Fig 1. The Kaplan-Meier curves of OS according to AmE usage.

P2.01-004 Safety and Efficacy of Nab-Paclitaxel plus Carboplatin in Elderly Patients with NSCLC (ABOUND.70+) C. Langer,1 E. Anderson,2 R. Jotte,3 J.W. Goldman,4 D. Haggstrom,5 D. Smith,6 C. Dakhil,7 K. Konduri,8 E. Kim,5 T.J. Ong,9 A. Sanford,9 K. Amiri,9 J. Weiss10 1Abramson Cancer Center, University of Pennsylvania, Philadelphia/PA/US, 2Knight Cancer Institute, Oregon Health and Science University, Portland/OR/US, 3Rocky Mountain Cancer Centers, Denver/CO/US, 4David Geffen School of Medicine at UCLA, Los Angeles/CA/US, 5Levine Cancer Institute; Carolinas Healthcare System, Charlotte/NC/US, 6Compass Oncology, Vancouver/CA, 7Cancer Center of Kansas, Wichita/KS/US, 8Baylor Charles A. Sammons Cancer Center; Texas Oncology Pa, Dallas/TX/US, 9Celgene Corporation, Summit/NJ/US, 10 Unc Lineberger Comprehensive Cancer Center, Chapel Hill/NC/US Background: A sub analysis of a phase III registrational trial demonstrated a 9.5-month survival benefit with nab-paclitaxel/carboplatin vs paclitaxel/carboplatin for patients 70 years with

Arm A n ¼ 68

Arm B n ¼ 70

52 (76.5)

54 (77.1)

25 48 39 14 17

25 45 39 17 12

(36.8) (70.6) (57.4) (20.6) (25.0)

(35.7) (64.3) (55.7) (24.3) (17.1)

P2.01-005 A Randomized Phase II Trial of Erlotinib vs S-1 in Patients with NSCLC as Third- or Fourth-Line Therapy (HOT1002) Y. Kawai,1 H. Asahina,2 Y. Ikezawa,1 S. Oizumi,3 T. Ogi,4 M. Watanabe,3 T. Amano,5 H. Dosaka-Akita,5 H. Isobe,6 M. Nishimura2 1Respiratory Medicine, Oji General Hospital, Tomakomai City, Hokkaido/JP, 2First Department of Medicine, Hokkaido University Hospital, Sapporo, Hokkaido/JP, 3Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapppro/JP, 4 Department of Respiratory Medicine, Obihiro-Kosei General Hospital, Obihiro City, Hokkaido/JP, 5Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido/JP, 6Department of Medical Oncology, Kkr Sapporo Medical Center, Sapporo/JP Background: Because of the improved efficacy of first and second-line therapy in patients (pts) with non-small cell lung cancer (NSCLC) with wild type EGFR, a high proportion of patients receive third-line therapy and beyond. When this study was planned, erlotinib, an EGFR tyrosine kinase inhibitor, was recommended as standard second-line therapy, irrespective of EGFR status, based on the results of BR 21 study. We