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M. Okada



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    P2.09 - Poster Session 2 - Combined Modality (ID 213)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P2.09-016 - A feasibility study of neoadjuvant chemotherapy with cisplatin, pemetrexed and bevacizumab followed by surgery for nonsquamous non-small cell lung cancer (ID 2956)

      09:30 - 09:30  |  Author(s): M. Okada

      • Abstract

      Background
      Bevacizumab and pemetrexed/cisplatin improves the response and survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC); however, the role of these medications in the setting of induction therapy for NSCLC is not well defined. The purpose of this study was to evaluate the feasibility of induction combination therapy with cisplatin, pemetrexed and bevacizumab followed by surgery in patients with clinical stage II/IIIA nonsquamous NSCLC.

      Methods
      Patients with clinical stage II/IIIA nonsquamous NSCLC were enrolled. The induction chemotherapy consisted of three cycles of cisplatin (75 mg/m[2]), pemetrexed (500 mg/m[2]) and bevacizumab (15 mg/kg) on Day 1, administered every 21 days. At least six weeks after the last administration of bevacizumab, the patients underwent surgical resection. The primary endpoint was the complete resection rate after the completion of three cycles of induction chemotherapy. The sample size was set at 30. The feasibility of the treatment was considered to be confirmed if the complete resection rate was 80% (24/30) or more.

      Results
      A total of six institutions in Japan participated in this trial. The study was initiated in June 2010, and patient enrollment was completed in November 2012. Thirty-one patients were recruited, 30 of which were eligible. The median age was 64 years (range: 54-71), and the male/female ratio was 17/13. The PS0/PS1 ratio was 29/1, the adenocarcinoma/large cell carcinoma ratio was 30/0 and the clinical stage IIA/IIB/IIIA ratio was 5/3/22. Grade 3 toxicities included neutropenia (7%), nausea (7%), appetite loss (13%), hypertension (23%) and pulmonary embolism (3%). There were no grade 4 events, and 27 (90%) patients completed three cycles at the full dose of chemotherapy. All but one patient exhibited radiologic tumor reduction based on the RECIST criteria. The objective responses to chemotherapy was CR in 0% of the patients, PR in 37%, SD in 50% and PD in 10% (due to new lesions). The disease control rate (CR+PR+SD) was 87%. Five patients dropped out from the study before surgery due to the patient’s decision in one patient, adverse events in three and disease progression in one. The complete resection rate after the completion of three cycles of induction chemotherapy was 83% (25/80). Therefore, the results met our criterion for feasibility.

      Conclusion
      Induction chemotherapy using a combination of cisplatin, pemetrexed and bevacizumab in patients with resectable clinical stage II/IIIA nonsquamous NSCLC is therefore considered to be a feasible treatment modality. Figure 1

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    P2.14 - Poster Session 2 - Mesothelioma (ID 196)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P2.14-005 - Assessment of postoperative complications after the first all Japan multi-institutional trial of induction chemotherapy followed by extrapleural pneumonectomy for malignant pleural mesothelioma (ID 1517)

      09:30 - 09:30  |  Author(s): M. Okada

      • Abstract

      Background
      The first all Japan multi-institutional trial was completed to evaluate the feasibility of induction chemotherapy using pemetrexed plus cisplatin, followed by extrapleural pneumonectomy (EPP) and postoperative hemithoracic radiation in patients with resectable malignant pleural mesothelioma (MPM). The main results were presented at the ASCO 2013. In this study, we especially reviewed major postoperative complications and mortality of patients who underwent EPP and determined the risk factors responsible for adverse outcomes.

      Methods
      From 2008 to 2010, 42 patients with MPM were enrolled in this study. Thirty-nine patients received planed chemotherapy. Thirty-three patients proceeded to EPP, which was completed in 30 patients. These patients were candidates in this study. Major complications were defined by grade 3, 4, 5 events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Treatment-related death was defined as any death occurring within 84 days after operation. Logistic regression analysis was performed on preoperative variables for major adverse outcomes.

      Results
      A total of 17 institutions in Japan with certified specialists in oncology, surgery and radiation therapy participated in this trial. Thirty patients (29 male, 1 female; median age of 66 years, range 43–74) completed EPP (14 right-sided and 16 left-sided), and macroscopic complete resection was accomplished in all patients. Histology of the tumors was epithelial in 22, biphasic in 4, sarcomatous in 1, and others in 3. Median operation time and blood loss were 437 minutes (range, 335-655) and 1461 gram (range, 390-4530), respectively. Major postoperative complications developed in 73.3% of the patients, and treatment-related death occurred in 4 patients (13.3%), which causes were cardiac herniation (n = 1), ARDS (n = 2), bronchial fistula and ARDS (n = 1). There were no significant predictors for major postoperative complications and treatment related death in both univariate and multivariate analysis.

      Conclusion
      We cannot find the predictor of major adverse events and treatment related death in MPM patients treated with induction chemotherapy followed by EPP. Although that is why sample size is small, we also recognize that multimodality treatment including EPP for MPM has more than 10% mortality and should be included in a prospective trial at specialized centers.

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    P3.09 - Poster Session 3 - Combined Modality (ID 214)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P3.09-007 - Update data of biomarker analysis of WJOG4107 (A randomized phase II trial of adjuvant chemotherapy with S-1 versus CDDP+S-1 for resected stage II-IIIA non-small cell lung cancer (NSCLC)) (ID 1504)

      09:30 - 09:30  |  Author(s): M. Okada

      • Abstract

      Background
      We conducted a randomized phase II trial for patients with resected stage II-IIIA NSCLC comparing postoperative oral S-1 (80 mg/m2/day for consecutive 2 weeks q3w for 1 year) (S) (N=100) or cisplatin (CDDP) (60 mg/m2 day1) plus oral S-1, (80 mg/m2/day for 2 weeks) q3w for 4 cycles (PS)(N=100). We reported that disease free survival rate at 2 years (DFS@2) (95% confidence interval: CI), a primary endpoint, was 66 (55-74) % for S and 58 (48-67)% for PS. Here, we report the preliminary results of preplanned biomarker analysis, a co-primary endpoint, to identify molecules whose expression is significantly associated with patient outcome.

      Methods
      　cDNA extracted from macro-dissected formalin-fixed paraffin-embedded specimens were available for 197/200 patients. Thirty-one genes including those whose expressions have been potentially associated with　CDDP (e.g. ERCC1, XRCC1, BRCA1, GSTpi, HMG1, TBP) or fluorouracil (FU) sensitivity (TS, DHFR, DPD, UMPS, UPP1) were measured by QGE analysis (MassArray, Sequenom, CA). Additional analysis are being performed to assess ERCC1 isoform expression with an isoform-specific TaqMan probe (Applied Biosystems, CA). The expression of each gene was dichotomized according to its median value.

      Results
      Molecules such as ERCC1 and GSTpi whose expression have been previously associated with CDDP sensitivity did not emerge as predictive markers (P=0.7908, 0.6406, respectively). We quantitated ERCC1 by isotype (202 and 204 cannot be distinguished). There was a trend in patients with high 201 or 202/204, CDDP/S-1 was worse than S-1.

      Conclusion
      Quantitation of ERCC1 by isotype may define a patient subset that would benefit from postoperative platinum therapy.