Virtual Library

 x 
My Library Virtual Library FAQ

Start Your Search

O.J. Vidal



Author of

  • +

    OA11 - Angiogenesis in Advanced Lung Cancer (ID 387)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • +

      OA11.02 - Randomized Phase 1b/3 Study of Erlotinib plus Ramucirumab in First-Line EGFR Mut + Stage IV NSCLC: Phase 1b Safety Results (ID 3827)

      12:10 - 12:20  |  Author(s): O.J. Vidal

      • Abstract
      • Presentation
      • Slides

      Background:
      Ramucirumab, an antiangiogenic IgG1 VEGFR2-targeted monoclonal antibody, and erlotinib, an EGFR tyrosine kinase inhibitor, are both active in advanced NSCLC. This global phase 1b/3 study (NCT02411448) will assess safety, tolerability and efficacy of the combination of ramucirumab with erlotinib in previously untreated patients with EGFR mutation-positive stage IV NSCLC. Here we report phase 1b safety results.

      Methods:
      Eligible patients with ECOG PS 0-1, an activating EGFR mutation, and previously untreated stage IV NSCLC received ramucirumab 10 mg/kg intravenously on day 1 of repeating 14-day (± 3 days) cycle and erlotinib 150 mg orally daily. Treatment continued until disease progression or unacceptable toxicity. The primary objective of part A was to assess the safety and tolerability, in terms of dose limiting toxicities (DLT), of adding the recommended dose of ramucirumab for phase 3 (part B) to standard dose erlotinib. Data were analyzed separately for Japan (JP) (cohort 1) and US/EU (cohort 2). The DLT assessment occurred during the first 2 cycles (approximately 28 days).

      Results:
      As of Dec 16th, 2015, 14 patients were treated in the phase 1b part of this trial and 12 were DLT evaluable (6 JP; 6 US/EU). Overall, 6 grade (Gr) 3 treatment-emergent adverse events (TEAE) were noted, with at least one TEAE in 5 patients; no serious adverse events or Gr 4-5 TEAEs occurred. In the JP cohort the median age was 73 (64-79), 57% had ECOG PS 1 and 29% had a history of smoking. Four patients (57%) experienced a Gr 3 TEAE, of which one was a DLT (elevation of alanine aminotransferase) while the others (hypertension [n=2], dermatitis acneiform, and diarrhea) were not DLTs. In the US/EU cohort the median age was 71 (31-83), 86% had ECOG PS 1, and no patients had a history of smoking. One patient experienced Gr 3 TEAE of rash; no DLTs were observed in this cohort.

      Conclusion:
      Enrollment on the phase 1b portion of this trial is complete and the safety results were consistent with previous combinations of antiangiogenic/erlotinib in this patient population. No unexpected toxicities were identified. Phase 3 enrollment has been initiated maintaining the dose of ramucirumab at 10 mg/kg Q2W.

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.

  • +

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

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
    • +

      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): O.J. Vidal

      • 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