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: 1
  • Moderators:
  • Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)

  • 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): T. Berry
    • 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.

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