Author of

• 30601

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  P2.01 - Advanced NSCLC (ID 159)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Advanced NSCLC
  • Presentations: 1
  • Now Available
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 30708

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    P2.01-95 - Updated Data of KRSG 1302 Study: Nedaplatin and Nab-Paclitaxel for Patients with Previously Untreated Advanced Squamous Cell Lung Cancer (Now Available) (ID 136)

    10:15 - 18:15  |  Author(s): Mitsuo Nakayama
    • Abstract
    • Slides

    Background
    

    Background: Nedaplatin (N) and nab-paclitaxel (nab-P) are efficacious for the treatment of non-small cell lung cancer, especially advanced squamous cell lung cancer. Although a combination of N and nab-P is expected to result in the treatment of squamous cell lung cancer, no sufficient and reliable data have been reported yet.

    Method
    

    Patients and methods: The inclusion criteria were no prior chemotherapy; stage IIIB or stage IV squamous cell lung cancer; a performance status (PS) of 0–1; 75 > patients’ age > 20 years; and adequate major organ function. Patients received escalating doses of nab-P under a fixed dose of N (100 mg/m², 1st day) every 3 weeks in phase I. The initial dose of nab-P was 100 mg/m² on the 1st and 8th day (level 1), and the next dose was 100 mg/m² on the 1st, 8th, and 15th day (level 2). In phase II, the patients received the recommended dose of N/nab-P. The primary endpoint was tumor response, which was measured according to the revised version of response evaluation criteria in solid tumors.

    Result
    

    Results: In this study, 5 patients were enrolled in the phase I. Three patients in level 1 experienced no dose-limiting toxicities (DLTs); whereas, 2 patients in level 2 experienced DLTs. Therefore, level 1 was named the recommended dose. In addition, 23 patients were enrolled in phase II. Three and 23 patients in level 1 and phase II were evaluated, respectively. However, among them, 2 of 26 patients were not assessed due to pneumonia, and 1 of 26 patients was excluded from analysis due to patients’ refusal. Partial response, stable disease, and progressive disease were noted in 21, 0, and 2 patients, respectively, yielding a response rate of 91.3% [95% confidence interval (CI): 72.0–98.9]. The median progression-free survival (PFS) was 223 days (95%CI: 144–330), and the median overall survival (OS) was 358 days (95% CI: 255–950). The 1- and 2-year PFS rate were 17.8% and 12.0%. The 1- and 2-year OS rate were 50.0% and 43.8%, respectively. The grade 3 and grade 4 toxicities were manageable and there was no treatment-related death. These data were published in 2018 ESMO. We will report updated efficacy and safety of N/nab-P in KRSG 1302 study.

    Conclusion
    

    Conclusions: A combination of N (100 mg/m², 1st day) with nab-P (100 mg/m², 1st and 8th day) every 3 weeks demonstrated an effective therapeutic approach. Therefore, N/nab-P administration is to be safe and efficacious for patients with advanced squamous cell lung cancer.

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