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A. Gu



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    P1.03 - Poster Session with Presenters Present (ID 455)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P1.03-062 - Lung Cancer Screening with Low-Dose CT in China: Study Design and Baseline Results from the First Round Screening Arm (ID 5639)

      14:30 - 14:30  |  Author(s): A. Gu

      • Abstract

      Background:
      Lung cancer screening with low-dose CT (LDCT) was shown to reduce lung cancer mortality by 20% in the National Lung Screening Trial. However, several other trails have reported that there was no reduction in lung cancer mortality with a LDCT screening strategy. Meanwhile, whether LDCT screens could decrease healthcare costs is yet insufficiently explored. The objectives of the present study was to investigate whether LDCT screening is capable to reduce the lung cancer mortality by at least 20% and analyze the healthcare costs of the lung cancer LDCT screening in China.

      Methods:
      The present study is a randomized controlled trial of LDCT screening for lung cancer versus usual care. Eligible participants were those aged 45–70 years, and with either of the following risk factors: 1) history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years; 2) malignant tumors history in immediate family members; 3) personal cancer history; 4) professional exposure to carcinogens; 5) long term exposure to second-hand smoke; 6) long term exposure to cooking oil fumes. All the participants were randomized into a screening arm with three rounds of alternate years LDCT screens and a control arm with three rounds of alternate years questionnaire inquiries. Management of positive screening test was carried out by a prespecified protocol.

      Results:
      From November 2013 to November 2014, 5933 participants were enrolled in our trail, of which 2933 were assigned to LDCT screening arm, and 3000 to control arm. In the first screening round, 2892 participants (98.6%) undergo LDCT after randomization. At baseline 742 subjects (25.7%) showed noncalcified nodules (NCN) larger than 4 mm. 69 cases were highly suspected of lung cancer according to the suggestion of three experienced experts. The highly suspected cases were accounting for 9.30% of all NCN subjects and 2.39% of all the screening arm participants. By March 2016, 26 cases underwent surgical resections, including 23 lung adenocarcinoma, 1 lung squamous cell carcinoma and 2 benign lesions, representing a positive lung cancer detection rate with low-dose CT screening of 0.83%(24/2892). Among all the lung cancer cases, 23/24 (95.8%) had stage I disease, and 1/24 (4.2%) had stage II disease. The second round screening was still ongoing since May 2016.

      Conclusion:
      Screening with LDCT increases the detection rate of early stage lung cancers (stage I and II) in a high risk population.

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    P2.06 - Poster Session with Presenters Present (ID 467)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
    • Presentations: 1
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      P2.06-020 - A Open-Label Randomised Controlled Trial of First-Line Genexol-PM/ CrEL-Based Paclitaxel plus Cisplatin in Advanced NSCLC Patients (ID 4569)

      14:30 - 14:30  |  Author(s): A. Gu

      • Abstract

      Background:
      Genexol-PM is a novel Cremophor EL(CrEL)-free polymeric micelle formation of paclitaxel.This multicentre study was designed to compare Genexol-PM and CrEL-based paclitaxel in combination with cisplatin in terms of efficacy and safety as first-line therapy in advanced non-small cell lung cancer.

      Methods:
      Chemonaive patients aged from 18 to 70 years with histologically or cytologically confirmed, locally advanced, metastatic or recurrent advanced NSCLC and an ECOG performance status of 0–1 were randomised 2:1 to the treatment group (Genexol-PM+ cisplatin ) and the controll group (paclitaxel+cisplatin) .Patients were treated with Genexol-PM 230mg/m2 intravenously without premedication or paclitaxel 175mg/m2 intravenously with premedication plus cisplatin 70mg/m2 on day 1 of a 3-week cycle for up to six cycles. Intrapatient dose escalation of Genexol-PM to 300mg/m2 was carried out in treatment group from the second cycle if the prespecified toxic effects were not observed after the first cycle.

      Results:
      170 patients were randomised into the study. PFS and OS data are not yet mature.

      Conclusion:
      This multicentre study is in progress.