Author of

• 18973

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  P2.01 - Advanced NSCLC (ID 618)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 2
  • Moderators:
  • Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)

  • 23127

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    P2.01-004 - Safety and Efficacy of Nab-Paclitaxel plus Carboplatin in Elderly Patients with NSCLC (ABOUND.70+) (ID 7561)

    09:00 - 09:00  |  Author(s): C.S.R. Dakhil
    • Abstract
    • Slides

    Background:
    A subanalysis 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 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/m[2] 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 analyses 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 = 71; Arm B, n = 72). Primary endpoint results are presented in the table. Overall, confirmed ORR was 23.9% vs 40.3% (P = 0.038), median PFS was 3.6 vs 7.0 months (HR 0.48 [95% CI, 0.30-0.76]; P = 0.002), and median OS was 15.2 vs 16.2 months (HR 0.72 [95% CI, 0.44-1.19]; P = 0.197). Among patients who received second-line therapy across treatment arms (n = 61), median OS from start of first-line 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

    Primary Endpoint
    Event, n (%)	Arm A n = 68	Arm B n = 70
    Patients with either grade ≥ 2 peripheral neuropathy or grade ≥ 3 myelosuppression	52 (76.5)	54 (77.1)
    Grade ≥ 2 peripheral neuropathy	25 (36.8)	25 (35.7)
    Grade ≥ 3 myelosuppression	48 (70.6)	45 (64.3)
    Neutropenia	39 (57.4)	39 (55.7)
    Anemia	14 (20.6)	17 (24.3)
    Thrombocytopenia	17 (25.0)	12 (17.1)

    
    
    

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  • 23136

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    P2.01-013 - Nab-Paclitaxel/Carboplatin in Elderly Patients with NSCLC (ABOUND.70+): Analysis of Safety and Quality of Life (QoL) by Cycle (ID 8185)

    09:00 - 09:00  |  Author(s): C.S.R. Dakhil
    • Abstract

    Background:
    ABOUND.70+ evaluated 2 schedules of first-line nab-paclitaxel/carboplatin in patients ≥70 years with advanced NSCLC to determine whether a 1-week break can improve tolerability. Safety and QoL by cycle are reported.
    
    Method:
    Patients ≥70 years with locally advanced/metastatic NSCLC were randomized to first-line nab-paclitaxel 100mg/m[2] on d1, 8, 15 and carboplatin AUC 6 on d1 of a 21-d cycle (Arm A) or the same regimen with a 1-week break between cycles (Arm B). Primary endpoint: percentage of patients with grade ≥2 peripheral neuropathy (PN) or grade ≥3 myelosuppression (laboratory values). QoL (exploratory endpoint) was assessed using Lung Cancer Symptom Scale (LCSS) on d1 of each cycle. Safety analyses included patients receiving ≥1 dose of study medication. AEs/QoL were analyzed at each of the first 6 cycles.
    
    Result:
    At interim evaluation, primary endpoint was similar across arms, resulting in early closure of enrollment. Of 143 randomized patients, 68 and 70 in Arms A and B received ≥1 dose of study drug. Table lists primary endpoint and key safety results by cycle. Grade ≥2 PN occurred earlier in Arm A. Incidence of grade ≥3 myelosuppression was highest in the first 2 cycles, progressively declining after cycle 3 (both arms). Dose reductions occurred in earlier cycles for Arm A; at the start of cycle 4, 36% vs 47% of patients received the maximum dose (100mg/m[2]) of nab-paclitaxel in Arms A and B. Generally, QoL was maintained throughout treatment. LCSS item of cough improved with each cycle; mean change from baseline at the end of cycle 6 was 25.4 and 13.8mm (visual analog scale).
    
    Conclusion:
    Although the overall rate of grade ≥2 PN and grade ≥3 myelosuppression was similar between arms, analysis by cycle showed that grade ≥2 PN and dose reductions occurred earlier in Arm A. QoL was maintained in both arms. NCT02151149

    	Arm A n = 68		Arm B n = 70
    Safety
    Primary endpoint, %	76		77
    P value	0.9258
    Peripheral neuropathy, %	Grade ≥ 2[a]	Grade ≥ 3[a]	Grade ≥ 2[a]	Grade ≥ 3[a]
    All cycles	37	13	36	17
    Cycle 1	6	0	0	0
    Cycle 2	6	4	1	0
    Cycle 3	7	4	9	1
    Cycle 4	4	0	7	1
    Cycle 5	6	3	4	1
    Cycle 6	4	1	4	9
    Myelosuppression, %	Grade ≥ 3		Grade ≥ 3
    All cycles	71		64
    Cycle 1	35		37
    Cycle 2	22		10
    Cycle 3	3		10
    Cycle 4	6		1
    Cycle 5	1		3
    Cycle 6	3		3
    [a ]Calculated by first occurrence of adverse event of respective grade.

    .