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e21078 Background: Concurrent chemoradiotherapy (CCRT) is the standard treatment for patients with locally advanced non-small cell lung cell cancer (LA-NSCLC). We previously reported the phase I study of biweekly carboplatin and nab-paclitaxel (nab-PTX) with RT. Recommended dose for phase II study was carboplatin (AUC 4) and nab-PTX (100 mg/m2) (J Clin Oncol 2015 suppl; abstr 7529). Here we report the phase II part designed to assess the efficacy of biweekly carboplatin and nab-PTX with concurrent RT (UMIN000023802). Methods: Patients with inoperable stage Ⅲ NSCLC were treated with carboplatin (AUC 4) and nab-PTX 100 mg/m2 on days 1, 15, and 29. Thoracic radiotherapy was administered from day 1 to a total dose of 60 Gy in 30 fractions. Consolidation chemotherapy after CCRT was 2 cycles of carboplatin (AUC 6) on day 1 and nab-PTX 100 mg/m2 on days 1, 8, and 15. The primary endpoint for the phase II part is 2-year overall survival (OS) rate. Assuming an expected survival rate was 60% and a lower limit was 35% (alfa 0.05, beta 0.2). Secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), OS, and safety profile. Results: A total of 28 patients (median age 66 years, male 94%) were enrolled. Of the evaluable patients (n = 28), the rate of 2-year OS was 67.8% (95% CI: 49.3–82.1). The ORR was 96%, a median follow-up time was 33.2 months. Median PFS was 18.2 months (95% CI 13.1–not reached), and median OS was not reached (95% CI, 25.6–not reached). The most common toxicities of grade 3 or higher were neutropenia (60.5%), anemia (14.2%), thrombocytopenia (7.6%) and pneumonitis (3.6%). Conclusions: This study achieved the primary endpoint. Biweekly carboplatin and nab-PTX with concurrent RT therapy was well tolerated and promising systemic antitumor activity for patients with LA-NSCLC. Clinical trial information: 000023802 .

e21173Background: Afatinib is the second generation epidermal growth factor receptor (EGFR) - tyrosine kinase inhibitor (TKI) for mutant non-small cell lung cancer (NSCLC), and approved in Japan in...

Purpose Amrubicin, a new anthracycline agent, and topotecan are both active for previously treated small-cell lung cancer (SCLC). No comparative study of these agents has been reported. This randomized phase II study was conducted to select amrubicin or topotecan for future evaluation. Patients and Methods Patients with SCLC previously treated with platinum-containing chemotherapy were randomly assigned to receive amrubicin (40 mg/m2 on days 1 through 3) or topotecan (1.0 mg/m2 on days 1 through 5). Patients were stratified by Eastern Cooperative Oncology Group performance status (0, 1, or 2) and type of relapse (chemotherapy sensitive or refractory). The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival, and toxicity profile. Results From February 2004 to July 2007, 60 patients were enrolled, and 59 patients (36 patients with sensitive and 23 patients with refractory relapse) were assessable for efficacy and safety evaluation. Neutropenia was severe, and one treatment-related death owing to infection was observed in the amrubicin arm. ORRs were 38% (95% CI, 20% to 56%) for the amrubicin arm and 13% (95% CI, 1% to 25%) for the topotecan arm. In sensitive relapse, ORRs were 53% for the amrubicin arm and 21% for the topotecan arm. In refractory relapse, ORRs were 17% for the amrubicin arm and 0% for the topotecan arm. Median PFS was 3.5 months for patients in the amrubicin arm and 2.2 months for patients in the topotecan arm. Multivariate analysis revealed that amrubicin has more influence than topotecan on overall survival. Conclusion Amrubicin may be superior to topotecan with acceptable toxicity for previously treated patients with SCLC. Further evaluation of amrubicin for relapsed SCLC is warranted.

7520 Background: When this trial was planned, A was believed to be a promising new anthracycline agent for sensitive-relapsed SCLC. While re-challenge of P that had been used for the first-line tre...

7333 Background: The purpose of this study was to determine maximum tolerated dose (MTD) of a combination of GEM plus CBDCA administration on a biweekly schedule for inoperable NSCLC, and to assess...

7237 Background: The purpose of this study was to determine maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of a combination of gemcitabine plus carboplatin administration in a bi...