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T. Suzuki



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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 2
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      P3.01-056 - Phase II Study of Carboplatin plus Weekly Nab-Paclitaxel in Elderly Patients with NSCLC: North Japan Lung Cancer Study Group Trial 1301 (ID 576)

      09:30 - 09:30  |  Author(s): T. Suzuki

      • Abstract
      • Slides

      Background:
      Recent IFCT-0501 trial demonstrated that carboplatin (CBDCA) combined with weekly paclitaxel (PTX) would be advantageous compared with monotherapy. Subsequently, CA031 trial suggested that weekly nab-paclitaxel (nab-PTX) was superior in efficacy and safety compared with 3-weekly PTX when combined with CBDCA. Since the subgroup analysis for elderly patients (pts) in CA031 showed very promising data (34% of overall response rate (ORR) and 8.0 months of progression-free survival (PFS)), we conducted this multicenter, non-randomized, open label, phase II trial to evaluate the efficacy and tolerability of CBDCA plus weekly nab-PTX regimen for elderly patients with advanced non-small cell lung cancer (NSCLC) prospectively.

      Methods:
      Eligible pts were aged 75 years or older with newly diagnosed clinical stage IIIB, IV, and postoperative recurrence NSCLC; ECOG performance status (PS) of 0-1; adequate organ function; written informed consent. Pts received CBDCA (AUC 6) on day 1 and nab-PTX (75mg/m[2]) on day1, 8, and 15, every 4 weeks. The primary endpoint was ORR and secondary endpoints were PFS, overall survival (OS), and toxicity profile. Assuming that ORR of 40% would be potential usefulness while ORR of 20% would be the lower limit of interest, 32 pts were required.

      Results:
      Between March 2013 and May 2014, 35 pts were enrolled and 32 pts were eligible. Median age was 78 years (range, 75-86), 84% (27/32) were male and 56% (18/32) were stage IV. 56% (18/32) had squamous cell carcinoma and 44% (14/32) had adenocarcinoma. Median treatment cycle was 4 (range, 1-6). ORR and DCR were 50% (95%CI: 33-67) and 94% (95%CI: 85-100), respectively. With a median follow-up of 9.1 months, median PFS was 6.4 months (95%CI: 4.8-8.0). Median OS had not been reached at the data cutoff point. Grade 3 or severer toxicities were as follows: neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). No febrile neutropenia and treatment-related deaths were observed.

      Conclusion:
      The combination of CBDCA and weekly nab-PTX demonstrated significant efficacy with acceptable toxicities in elderly patients with advanced NSCLC.

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      P3.01-071 - RAS Inhibitor Prevent Proteinuria of NSCLC Patients Who Received Bevasizumab Chemotherapy: NJLCG 1303 (ID 1204)

      09:30 - 09:30  |  Author(s): T. Suzuki

      • Abstract
      • Slides

      Background:
      Proteinuria caused by bevacizumab (BV) often becomes an obstacle to continuation of the treatment. Renin-angiotensin system inhibitor (RASI), angiotensin receptor blocker and angiotensin converting enzyme inhibitor, has demonstrated anti-proteinuria effect in diabetic nephropathy and nondiabetic kidney disease. This retrospective observational study was conducted to evaluate the anti-proteinuria effect of RASI for NSCLC patients (pts) who received BV chemotherapy.

      Methods:
      We reviewed the medical records of NSCLC pts between 2008 and 2014 at 11 hospitals. Eligible pts had a treatment of BV chemotherapy, no proteinuria, and no diabetes mellitus. Clinical characteristics, use of the antihypertensive drugs, change of the blood pressure, and proteinuria generation were investigated during first 6 courses of BV chemotherapy.

      Results:
      A total of 211 pts were enrolled. Pts characteristics were: male/female 121/90; median age 63 (range 35-88); ECOG performance status 0-1/2-3 199/12; stage Ⅳ/recurrent 189/22; dose of BV(/kg) 7.5mg/15mg 21/190; BV cycle 1-2/3-4/5-6 18/55/138; antihypertensive drugs RASI/non-RASI/none 59/44/108. Proteinuria was observed in 49 pts (23%) as grade 1/2/3 33/14/2. The rate of proteinuria generation was significantly lower in the RASI group than non-RASI group (17% vs. 41%, P=0.025). Multivariate analysis revealed that RASI significantly reduced proteinuria (HR=0.43, 95% CI=0.17-0.91, P=0.043).

      Conclusion:
      RASI demonstrated anti-proteinuria effect for NSCLC pts who received BV therapy.

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