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T. Naito



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    MA15 - Immunotherapy Prediction (ID 400)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Chemotherapy/Targeted Therapy/Immunotherapy
    • Presentations: 1
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      MA15.09 - Response to the Treatment Immediately before Nivolumab Monotherapy May Predict Clinical Response to Nivolumab (ID 4400)

      14:20 - 15:50  |  Author(s): T. Naito

      • Abstract
      • Slides

      Background:
      Nivolumab was approved in Japan on December 17, 2015 for previously treated non-small cell lung cancer (NSCLC). The expression of programmed death-ligand 1 (PD-L1) in tumor tissue is considered a predictive factor for clinical response to nivolumab. However, in Japan, there are no commercially available diagnostic kits for evaluating PD-L1 expression. In addition, little is known regarding other predictive factors of response to nivolumab monotherapy in patients with NSCLC. Therefore, we examined the relationships between the response to nivolumab monotherapy and clinical parameters in patients with NSCLC.

      Methods:
      Between December 2015 and April 2016, we performed a retrospective analysis of 50 patients with NSCLC treated with nivolumab monotherapy (3 mg/kg, every 2 weeks) at our Institution in the clinical setting.

      Results:
      Baseline characteristics of patients who received nivolumab monotherapy were: median age, 65 years [range:39–76]; 60% male; 26% ECOG-PS 0, 64% ECOG-PS 1; 38% smoker; 58% stage Ⅳ disease, 22% postoperative recurrence; 80% non-squamous (SQ) NSCLC; 36% non-SQ NSCLC patients had active EGFR mutations; 20% second-line, 18% third-line. The objective response rate (ORR) for all patients treated with nivolumab monotherapy was 18% (95%CI 10–31). Univariate analysis revealed that predictive factors of response to nivolumab monotherapy were associated with “SQ”, “response to the treatment immediately before nivolumab monotherapy”, “therapeutic line of nivolumab (second-line and third-line treatment)” and “smoker” categories (Table 1). In the multivariate logistic regression analysis, the independent predictive factors were “SQ” (P = 0.0069) and “response to the treatment immediately before nivolumab monotherapy” (P < 0.0001) (Table 1). Figure 1



      Conclusion:
      “Response to the treatment immediately before nivolumab monotherapy”, other than “SQ” histology may be predictors of clinical response to nivolumab in patients with NSCLC.

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    P2.02 - Poster Session with Presenters Present (ID 462)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P2.02-031 - Survival Data of Postoperative Adjuvant Chemotherapy of Cisplatin plus Vinorelbine for Completely Resected NSCLC: A Retrospective Study (ID 5032)

      14:30 - 15:45  |  Author(s): T. Naito

      • Abstract
      • Slides

      Background:
      Although the efficacy of postoperative adjuvant cisplatin (CDDP)-based chemotherapy, such as the combination of CDDP and vinorelbine (VNR) has been established for surgically resected non-small cell lung cancer (NSCLC), there has been some reports about the survival data of Asian patients treated with the combination of CDDP and VNR as adjuvant chemotherapy.

      Methods:
      We retrospectively have evaluated patient compliance and the safety of adjuvant chemotherapy with CDDP at 80 mg/m[2] administered on day 1 plus VNR at 25 mg/m[2] administered on days 1 and 8, every 3 weeks at the Shizuoka Cancer Center between February 2006 and October 2011 (Kenmotsu, et al. Respir Investig 2012). In this study, we evaluated survival data of these patients. Overall survival (OS) and relapse-free survival (RFS) after the start of adjuvant chemotherapy conducted by the Kaplan-Meier method to assess the time to death or relapse.

      Results:
      One hundred surgically resected NSCLC patients were included in this study. The characteristics of the patients were as follows: median age 63 years (range: 36–74); female 34%; never smokers 20 %; histology non-squamous/ squamous cell carcinoma 73%/ 27%; EGFR mutation mutant/ wild/ unknown 19%/23%/58%. Pathological stages IIA/IIB/IIIA were observed in 31/22/47%. The median time from surgical resection to the start of adjuvant chemotherapy was 44 days (range: 29–79 days). Median follow up was 5.6 years (range, 3.8 – 9.7 years). The five-year OS rate was 73% and the 2-year OS rate was 93%. The five-year RFS rate was 53% and the 2-year RFS rate was 62%. A univariate analysis of prognostic factors showed that patient characteristics (gender, histology, pathological stage) and dose intensity of cisplatin were not significantly associated with OS.

      Conclusion:
      Our results suggested that the prognosis of surgically resected NSCLC patients, who were treated with the combination of CDDP and VNR as adjuvant chemotherapy, might be better than previous results of adjuvant chemotherapies for NSCLC patients. This result can be influenced by the advances of diagnostic and surgical procedures, and the efficacy of chemotherapy including molecular target therapies.

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