Author of

• 17556

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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
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17628

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    P2.03a-072 - Interim Results from ABOUND.Sqm: Safety of nab-Paclitaxel/Carboplatin Induction Therapy in Squamous (SCC) NSCLC (ID 4391)

    14:30 - 14:30  |  Author(s): M.D.I. Casado
    • Abstract

    Background:
    Improving tolerability of chemotherapy for patients with SCC NSCLC remains an important aspect of care. Induction therapy with nab-paclitaxel/carboplatin followed by nab-paclitaxel maintenance therapy could be an effective treatment option for this patient population. Interim safety results from the induction part of the ongoing ABOUND.sqm study are reported here.
    
    Methods:
    Patients with advanced SCC NSCLC who had no prior chemotherapy for metastatic disease received induction therapy with nab-paclitaxel 100 mg/m[2] on days 1, 8, and 15 + carboplatin AUC 6 on day 1 (21-day cycles) for 4 cycles. Patients not progressing after 4 cycles were randomized 2:1 to maintenance nab-paclitaxel 100 mg/m[2] on days 1 and 8 of each 21-day cycle + best supportive care (BSC) or BSC alone until progression/unacceptable toxicity. Progression-free survival from randomization into the maintenance part of the study is the primary endpoint. Secondary endpoints include safety (analyzed as treatment-emergent adverse events [TEAEs], overall survival, overall response rate, and disease control rate.
    
    Results:
    212 patients receiving induction treatment were evaluable in this analysis. Median age was 68 years; 66% of patients were male, 87% were white, and 99% had an Eastern Cooperative Oncology Group performance status of 0-1. Discontinuations were observed in 94/212 patients (44%) during induction. Of these, 35/94 (37%) discontinued due to disease progression, 23/94 (24%) due to AEs, 11/94 (12%) due to other reasons, 10/94 (11%) due to death, 9/94 (10%) due to patient decision, and 6/94 (6%) due to symptomatic deterioration. The median percentage of per-protocol dose of nab-paclitaxel was 75%, and median dose intensity was 74.87 mg/m[2]/week. At least 1 nab-paclitaxel dose reduction, missed dose, or dose delay occurred in 41%, 51%, and 58% of treated patients, respectively. Grade 3/4 TEAEs were mainly hematologic and included neutropenia (86/212; 41%), anemia (52/212; 25%), and thrombocytopenia (33/212; 16%). Grade 3/4 peripheral neuropathy occurred in 8/212 patients (4%).
    
    Conclusion:
    This interim report from the ABOUND.sqm study demonstrates that the tolerability profile of nab-paclitaxel/carboplatin was consistent with that reported in the phase III study, and no new safety signals were observed. Updated results will be presented at the meeting. NCT02027428