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Yukihisa Hatakeyama



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-48 - Nab-Paclitaxel Plus Gemcitabine in Advanced NSCLC After Platinum-Based Chemotherapy: Final ResultsĀ and Caveolin-1 Expression (ID 12872)

      16:45 - 18:00  |  Author(s): Yukihisa Hatakeyama

      • Abstract
      • Slides

      Background

      Nab-Paclitaxel (PTX) plus gemcitabine significantly improved overall survival, progression-free survival, and response rate in patients with metastatic pancreatic adenocarcinoma. Anti-tumor synergy between nab-PTX and gemcitabine was recently demonstrated in mouse model. Combination treatment increases intra-tumoral gemcitabine levels attributable to a decrease in the primary gemcitabine metabolizing enzyme, cytidine deaminase. Higher caveolin-1 expression in tumor-associated stroma was associated with improved overall survival and response rate in patients with advanced non-small-cell lung cancer (NSCLC) treated with nab-PTX. Based on these data, we planned to assess the efficacy and safety of combination with nab-PTX plus gemcitabine in patients with NSCLC previously treated with platinum-based chemotherapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function were eligible. Treatment consisted of nab-PTX (100 mg/m2) plus gemcitabine (1000 mg/m2) on days 1 and 8 of each 3-week cycle until progression disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Archived tumor blocks, if available, were collected for caveolin-1 expression analysis using immunohistochemistry.

      4c3880bb027f159e801041b1021e88e8 Result

      Of the 28 patients enrolled, 28 were evaluable for response and toxicity. The median age was 68 years (range 47-79), 23 males and 5 females. Histology subtypes were: adenocarcinoma 19 patients, squamous cell carcinoma 9 patients. Seventeen patients had ECOG PS 1 and 11 patients had PS 0. Twenty-four patients were 2nd line and 4 patients were 3rd line. The median number of cycles administered was 4 (range 1-10). The overall response rate was 17.9%. The disease control rate was 67.9%. The median progression-free survival was 3.1 months (95% confidence interval [CI] = 1.6-4.1). The median overall survival was 11.7 months (95% CI = 8.0-19.3). Five patients (17.9%) had grade 4 neutropenia, 4 patients (14.3%) had grade 3 anemia, 3 patients (10.7%) had grade 3 thrombocytopenia. However, no patients developed febrile neutropenia. Remarkable non-hematologic toxicity was interstitial pneumonia with grade 3 in 4 patients (14.3%), neuropathy with grade 3 in 2 patients (7.1%) and infections with grade 3 in 2 patients (7.1%). Caveolin-1 expression analysis will be presented at the meeting.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The efficacy of nab-Paclitaxel in combination with gemcitabine in advanced second or third-line NSCLC patients was limited and the high onset of interstitial pneumonia was unacceptable.

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