Background: Polymeric micellar paclitaxel (pm-Pac) is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel. We aimed to compare the efficacy and safety between pm-Pac plus cisplatin and solvent-based paclitaxel (sb-Pac) plus cisplatin in advanced non-small-cell lung cancer (NSCLC). Patients and methods: A total of 448 stage IIIB to IV NSCLC patients were randomly assigned (2:1) to receive six 3-week cycles of either pm-Pac (230 mg/m 2 ) plus cisplatin (70 mg/m 2 ; n ¼ 300), followed by dose escalation of pm-Pac to 300 mg/m 2 from the second 3-week cycle if prespecified toxic effects were not observed after the first cycle, or sb-Pac (175 mg/m 2 ) plus cisplatin (70 mg/m 2 ; n ¼ 148). The primary end point was objective response rate (ORR) assessed by independent review committees (IRCs). The secondary end points included IRC-assessed progression-free survival (PFS), overall survival (OS), and safety. Results: Patients in the pm-Pac-plus-cisplatin group showed significant improvements in IRC-assessed ORR compared with those in the sb-Pac-plus-cisplatin group (50% versus 26%; rate ratio 1.91; P < 0.0001). Additionally, subgroup analysis showed that a higher ORR was consistently observed in both squamous and nonsquamous histological types. IRC-assessed median PFS was significantly higher in the pm-Pac-plus-cisplatin group than in the sb-Pac-pluscisplatin group (6.4-month versus 5.3-month; hazard ratio 0.63; P ¼ 0.0001). Median OS was not significantly

Background: Several actionable gene alterations, such as EGFR and KRAS mutations, for lung cancer are different in frequency between Caucasian and East Asian. NTRK fusions have been recently identified as a therapeutic target in a rare fraction of Caucasian patients with lung adenocarcinoma (3.3%). However, their frequency in East Asian has not yet been examined. Methods: A nationwide lung cancer genomic screening project in Japan (LC-SCRUM-Japan) was initiated from February 2013, and a total of 4118 lung cancer patients have been enrolled as of April 2017. A total of 2668 patients with lung cancer (non-squamous/squamous/small¼2088/275/305) were screened by using a next generation sequencing platform, Oncomine TM Focus Assay (OFA) for detecting NTRK1/2/3 fusions or Oncomine TM Comprehensive Assay (OCA) for detecting NTRK1/3 fusions. Results: Only one patient with ETV6-NTRK3 fusion (0.04%) was detected. The patient harboring ETV6-NTRK3 fusion was a 60-year-old man with a 35 pack-year smoking history, and pathologically diagnosed with adenocarcinoma. We also evaluated NTRK1 gene fusion-induced imbalances in the expression of the 5' and 3' regions of the transcripts using the OFA sequencing data, and there was no case with 5'/3' expression imbalances of NTRK1 gene transcripts. Conclusions: The frequency of NTRK fusions in Japanese patients with lung cancer is extremely rare (0.04%) compared with Caucasian.

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