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N. Masuda



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    MO06 - NSCLC - Chemotherapy I (ID 108)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO06.10 - Phase II study of bevacizumab, cisplatin and docetaxel plus maintenance bevacizumab as first line treatment for patients with advanced non-small cell lung cancer (n-Sq NSCLC) combined with exploratory analysis of circulating cells (CEC): Thoracic Oncology Research Group (TORG)1016 (ID 1211)

      16:15 - 17:45  |  Author(s): N. Masuda

      • Abstract
      • Presentation
      • Slides

      Background
      Bevacizumab has been shown to amplify efficacy against n-Sq NSCLC in combination with platinum doublet, especially taxane including regimens. Docetaxel is one of best taxane composition combined with cisplatin for first line treatment for NSCLC, and known to have anti-angiogenic effect and may act synergistically with VEGF inhibiting agent. The object of this study was to assess the efficacy and safety of bevacizumab, cisplatin and docetaxel combination treatment in patients with chemonaive n-Sq NSCLC patients. (Trial Registry: UMIN 000004368)

      Methods
      Eligible patients had advanced or recurrent n-Sq NSCLC with no prior chemotherapy. Patients having brain metastasis or history of hemoptysis were ineligible. Patients received 4 cycles of docetaxel (60mg/m[2]), cisplatin (80mg/m[2]) and bevacizumab (15mg/kg) on day1 every 3 weeks followed by Bev alone as maintenance every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was response rate (RR) and planned sample size of this phase II study was 47 patients (Simon's two-stage minimax design). We measured circulating endothelial cells (CEC) count day1 and 8 of first cycle for exploratory analysis of efficacy and safety prediction.

      Results
      From Oct 2010 to Apr 2012, 47 patients (28 males/ 19 females, median age, 61 years, 39-73) were enrolled. Stage IIIB/IV/recurrent: 5/39/3, ECOG PS 0/1: 31/16. All patients were adenocarcinoma, EGFR status: mutated/wild/unknown: 13/31/3. Bevacizumab maintenance were administered in 87% (41/47) of the patients and 9 was median number of delivered course, 4 course of induction and 5 course of maintenance. Dose reduction was required in 28% (13/47) of the patients. Thirty-five partial responses and 11 stable diseases were observed among 47 patients, yielding a RR of 74.5% (95% confidence interval: 59.7-86.1%) and disease control rate of 97.9% (88.7-99.9%), respectively. The median progression free survival duration in the patients was 9.0 (7.0-11.3) months. Grade 3/4 leukopenia, neutropenia, hypertension, nausea and febrile neutropenia were observed in 60, 96, 47, 13 and 9% of the patients, respectively. Alveolar hemorrhage (Grade 5) after 4 cycle occurred in one patient.

      Conclusion
      Bevacizumab, cisplatin and docetaxel combination followed by bevacizumab maintenance treatment was highly effective in patients with n-Sq NSCLC, with acceptable toxicity. Exploratory analysis of CEC is ongoing and will be presented.

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    P1.08 - Poster Session 1 - Radiotherapy (ID 195)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P1.08-007 - Outcomes and prognostic factors of stage I non-small cell lung cancer patients treated with stereotactic body radiotherapy or 3-dimentional conformal radiotherapy. (ID 780)

      09:30 - 16:30  |  Author(s): N. Masuda

      • Abstract

      Background
      Although stereotactic body radiotherapy (SBRT) has become a one of the preferred treatment options for patients with stage I non-small cell lung cancer, the patients are not always suitable for SBRT. The purpose of this study was to present the treatment outcomes and prognostic factors for stage I NSCLC treated with SBRT or 3-dimentional conformal radiotherapy (3DCRT).

      Methods
      The medical records of 77 patients with stage I NSCLC treated in our hospital were retrospectively reviewed. Forty-four patients were treated with SBRT which was delivered a total dose of 48Gy in 4 fractions　for one week. Thirty-three patients were treated with 3DCRT which was delivered a total dose of 60-66Gy in 20-30 fractions. SBRT was done with the real-time tumor-tracking system (RTRT) using 3 to 4 fiducial gold markers. 3DCRT was adapted to the patients who had difficulty of bronchoscopic implantation of fiducial markers, centrally located tumors or low performance status. In dose calculation for the majority of patients, inhomogeneity was corrected by the superposition method. Univariate and multivariate analysis were performed for predictive factors. .

      Results
      Median follow-up time was 30 months (range, 1 to 94 months). The 3-year local control (LC), disease-free survival (DFS), and overall survival rate (OS) of all patients were 69.2%, 57.1%, and 68.6%, respectively. There was no significant difference between the two groups in 3-year LC (SBRT, 78.6%; 3DCRT, 58.5%; p=0.146) and 3-year OS (SBRT, 66.4%; 3DCRT, 71.1%; p=0.83), but in 3-year DFS SBRT was superior to 3DCRT (SBRT, 66.2%; 3DCRT, 46.3%; p=0.039). Multivariate analysis detected pathological type and patient’s age as significant predictive factors for LC and DFS, respectively. Especially the histologic type of squamous cell carcinoma was detected as an adverse predictive factor for local control. The type of radiotherapy was not detected as a prognostic factor on multivariate analysis. No serious radiation morbidity was observed with either RT method.

      Conclusion
      Our results suggested that 3DCRT may be a good alternative treatment for patients who are not suitable for SBRT. Well-designed prospective studies investigating the optimal schedule of dose fractionation in early-stage lung cancer are warranted.

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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-020 - Dose adjustment of single agent amrubicin in lung cancer patients with impaired hepatic function (ID 1348)

      09:30 - 16:30  |  Author(s): N. Masuda

      • Abstract

      Background
      The pharmacokinetics (PK) of amrubicin (AMR) in lung cancer patients with impaired hepatic function have not been reported. The objectives of this study were to evaluate the PK of AMR and its major metabolite, amrubicinol (AMR-OH), in lung cancer patients with or without impaired hepatic function, and to assess the validity of dose adjustment of AMR based on hepatic function.

      Methods
      Eligibility criteria included the presence of histologically or cytologically proven lung cancer, an ECOG PS of 0 to 2, age 20 to 70 years old, and no evidence of hepatitis B virus infection. The dose was adjusted from 25 to 45 mg/m[2]/day (iv, days 1-3, q3w) based on the history of prior treatment and baseline values of total bilirubin (T-bil), AST and ALT (Table 1). Figure 1

      Results
      Five patients with impaired hepatic function (arm I) and 10 patients with normal hepatic function (arm N) were enrolled. Terminal half-life (t~1/2~) and clearance of AMR in plasma, and t~1/2~ of AMR-OH in blood did not differ between the two arms. Area under the curve (AUC~0-24~) of AMR in plasma and AUC~0-120~ of AMR-OH in blood in arm I were similar or lower compared to those in arm N (Table 2). The dose-adjusted AUCs of AMR and AMR-OH did not show a tendency to increase with increases in baseline T-bil, AST and ALT. Two deaths occurred in arm I (one due to disease progression, and the other due to an unspecified reason), but the toxicities in arm I were not severe compared with those in arm N. Figure 1

      Conclusion
      These data show the validity of dose adjustment of AMR in patients with impaired hepatic function.