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M. Yoshimura



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    MO08 - NSCLC - Early Stage (ID 117)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO08.10 - Efficacy of adjuvant chemotherapy for lung adenocarcinoma patients with pleural lavage cytology positive findings. (ID 174)

      17:10 - 17:15  |  Author(s): M. Yoshimura

      • Abstract
      • Presentation
      • Slides

      Background
      Pleural lavage cytology (PLC) is considered to be a prognostic factor for non-small cell lung cancer (NSCLC) patients. There has been no report describing the relationship between adjuvant chemotherapy and the presence of PLC.Backgroud: Pleural lavage cytology (PLC) is considered to be a prognostic factor for non-small cell lung cancer (NSCLC) patients. There has been no report describing the relationship between adjuvant chemotherapy and the presence of PLC.

      Methods
      From January 2000 to December 2009, we retrospectively reviewed the medical record of lung adenocarcinoma patients who underwent tumor resection and were positive for PLC immediately after thoracotomy.

      Results
      There were 53 patients (4.8%) out of 1114 lung adenocarcinoma patients had PLC positive findings, including 31 male and 22 female patients, with a mean age of 66.6 years. Median follow up period was 33.6 months. Adjuvant chemotherapy was administered intravenously to 24 patients and they were classified as adjuvant chemotherapy group. The rest of 29 patients were classified as surgery alone group. Pathological stage of I / II / III was 12 (41%) / 8 (28%) / 9 (31%) in surgery alone group and 7 (36%) / 8 (30%) / 9 (38%) in adjuvant chemotherapy group. The regimen of chemotherapy was as follows; 8 patients received cisplatin plus gemcitabine, 7 patients received carboplatin plus paclitaxel, 7 patients received gemcitabine, and 2 patients received others. 5-year survival rate was 50.3% and 29.7% (p=0.09) and 5-year recurrence free survival rate was 34.6% and 15.7% (p<0.01) in adjuvant chemotherapy group and surgery alone group. Even in stage I cases, there was a tendency that adjuvant chemotherapy group had better 5-year recurrence free survival than surgery alone group (60.1% and 29% p=0.11). In the COX proportional hazard multivariate analysis for recurrence free survival revealed that adjuvant chemotherapy (hazard ratio (HR) 0.45, p=0.03), tumor size >30mm (HR 2.23, p=0.02), and lymph node metastasis (HR 2.67, p<0.01) were significant independent prognostic factors.Figure 1

      Conclusion
      Adjuvant chemotherapy was considered to be effective for PLC positive lung adenocarcinoma patients. Even in stage I cases, our results implicated that adjuvant chemotherapy was beneficial.

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    MO13 - SCLC I (ID 118)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO13.08 - A pilot study of adjuvant chemotherapy with irinotecan and cisplatin for completely resected high grade pulmonary neuroendocrine carcinona (Large cell neuroendocrine carcinoma and small cell lung cancer) (ID 1562)

      11:15 - 11:20  |  Author(s): M. Yoshimura

      • Abstract
      • Presentation
      • Slides

      Background
      Large cell neuroendocrine carcinoma (LCNEC) and small cell lung cancer (SCLC) are recognized as high grade neuroendocrine carcinoma (HGNEC) of the lung. In patients with completely resected HGNEC, platinum-based adjuvant chemotherapy may be considered. However, the optimum chemotherapy regimen has not been determined. We conducted a multicenter single-arm phase II trial to evaluate irinotecan and cisplatin in postoperative adjuvant chemotherapy for HGNEC patients.

      Methods
      Patients with completely resected stage I- IIIA HGNEC received 4 cycles of irinotecan (60 mg/m[2], day 1, 8, 15) plus cisplatin (60 mg/m[2], day 1). This regimen was repeated every 4 weeks. Other eligibility criteria included ECOG PS 0–1, age 20, and <75 years old, adequate organ function, and no prior chemotherapy or radiotherapy. Patients with UGT1A1 polymorphisms (homozygous for *6 or *28, or simultaneously heterozygous *6 and *28), associated with irinotecan-related severe toxicity, were excluded. The primary endpoint was the rate of completion of chemotherapy (defined as underwent 3 or 4 cycles), and secondary endpoints were 3-year relapse free survival (RFS), rate of 3-year survival and toxicities.

      Results
      Forty patients were enrolled between September 2007 and April 2010. Patients’ characteristics were as follows: median age (range) 65 (45-73) years; male 85%; ECOG-PS 1 60%; LCNEC 57% and SCLC 43%; stage IA/IB/IIB/IIIA 32/35/8/5%; 95% received lobectomy. The rate of completion of chemotherapy was 83% (90% C.I.; 71-90%). The rate of overall survival at 3 years was estimated at 81%, and of RFS at 3 years was 74%. The rates of overall survival and RFS at 3 years were 86% and 74% among 23 LCNEC patients, and 74%, 76% among 17 SCLC patients, respectively. Nineteen patients (48%) experienced grade 3 or 4 neutrophils, but only five patients (13%) developed febrile neutropenia. Two patients (5%) developed grade 3 diarrhea, and 4 patients (10%) had grade 3 nausea. No treatment related deaths were observed in this study. All 40 specimens were also diagnosed as HGNEC at pathological central review among 7 pathologists. There were two specimens that showed the difference in between institutional diagnosis and central pathological diagnosis.

      Conclusion
      The combination of irinotecan and cisplatin as postoperative adjuvant chemotherapy was feasible and possibly efficacious for resected HGNEC.In Japan, a randomized phase III trial is ongoing to evaluate adjuvant chemotherapy of irinotecan and cisplatin, compared with etoposide and cisplatin, for completely resected HGNEC.

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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. Yoshimura

      • 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.