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Y. Enomoto



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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P2.10-023 - Feasibility study of pemetrexed (PEM) plus bevacizumab (BV) as the first-line treatment for elderly advanced or recurrent non-squamous (non-Sq) non-small cell lung cancer (NSCLC): TORG1015. (ID 1487)

      09:30 - 09:30  |  Author(s): Y. Enomoto

      • Abstract

      Background
      The addition of BV to cytotoxic agent(s) prolonged survival for non-Sq NSCLC patients (pts). However, there is no definitive evidence for the cytotoxic agent(s) plus BV is superior to the cytotoxic agent(s) alone for elderly non-Sq NSCLC. We conducted the feasibility study of PEM plus BV as the first-line treatment for elderly advanced or recurrent non-Sq NSCLC.

      Methods
      Major eligibility and exclusion criteria were followings; chemotherapy-naïve; unfit for bolus combination chemotherapy; stage III/IV or relapsed non-Sq NSCLC; age≥70; PS 0-1; no evidence of brain metastasis; no history of hemoptysis and irradiation for thorax. PEM (500mg/m[2]) and BV (15mg/kg) were administrated intravenously on day 1 every 3 weeks. The primary endpoint was toxicity and the secondary endpoints were objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and the percentage of pts who completed more than 3 cycles.

      Results
      From November 2010 to April 2012, total 12 pts were enrolled. Patients characteristics were following; Male/Female=6/6; Median age (range) 78 (72-81); Histology was all adenocarcinoma; Activating EGFR mutation No/Yes/unknown=9/2/1; Stage IIIB/IV/Recurrence=2/8/2; ECOG PS 0/1=6/6; Smoking History Yes/No=6/6. Severe toxicities (Grade 3≥) were leukopenia (25%), neutropenia (25%), anemia (8%), thrombocytopenia (8%), febrile neutropenia (8%), anorexia (8%), hypertension (8%), fatigue (8%), nausea (8%), and perforation (colon) (8%). No dose-limiting toxicity and treatment-related death was occurred. Three patients achieved PR and the ORR was 25%. The median PFS and OS were 5.6 months (mo) (95% C.I. 1.1-7.9 mo) and 10.3 mo (95% C.I. 6.9-15.6 mo) in 11 evaluated pts, respectively. The 1-year survival rate was 49% (95% C.I. 12-79%). Seven of 12 pts (58%) received more than 3 cycles.

      Conclusion
      PEM plus BV as first-line treatment for elderly non-Sq NSCLC was well tolerable and promising.

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      P2.10-050 - Efficacy of Denosumab in patients with metastatic lung cancer with EGFR mutations (ID 3285)

      09:30 - 09:30  |  Author(s): Y. Enomoto

      • Abstract

      Background
      Denosumab, a fully human monoclonal antibody to RANKL, is expected to improve overall survival better than zoledronic acid when administered in the treatment of bone metastasis from lung cancer. Although the mechanism of prolongation of survival by denosumab for lung cancer patients is unknown, denosumab may have an additional effect other than bone-protective effects. We examined relevance between efficacy of denosumab and EGFR mutation status which is tend to be causal of multiple bone metastasis.

      Methods
      Patients treated by Denosumab with metastatic lung cancer were eligible for the study. We retrospectively analyzed their histological type, EGFR mutation status, chemotherapy, the change of primary lesion and bone metastasis before and after treatment of denosumab.

      Results
      From July 2012 to June 2013, there were 18 patients matched in the analysis.Patients’ characteristics: median age 68.5 years, male/female 9/9, PS0/1/2/3 2/10/4/2, adenocarcinoma/others 15/3, EGFR mutation status Ex19del./L858R/wt or unknown 9/2/7). Seven patients were treated by gefitinib, and in the three of them, reossifications by computed tomography were observed without ostalgia.In none of 11 patients treated by other anticancer drug or followed-up, reossification was seen. Figure 1Figure 2

      Conclusion
      Patients treated with gefitinib may be beneficial by denosumab treatment. Further investigation exploring synergistic effect of denosumab and gefitinib is warranted.