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T. Yamanaka



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    OA08 - Targeted Therapies in Brain Metastases (ID 381)

    • Event: WCLC 2016
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      OA08.02 - Phase II Study of Erlotinib in Advanced Non-Small Cell Lung Cancer Patients with Leptomeningeal Metastasis (LOGIK1101) (ID 5099)

      16:00 - 17:30  |  Author(s): T. Yamanaka

      • Abstract
      • Presentation
      • Slides

      Background:
      Leptomeningeal metastases (LM) occur in almost 5% of non-small cell lung cancer (NSCLC) patients (pts) and are associated with a poor prognosis. To date, no prospective study has identified active chemotherapy for NSCLC pts with LM. In retrospective studies, EGFR-TKI treatment is reported to be effective in the treatment of LM. We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of erlotinib in pts with LM.

      Methods:
      NSCLC pts with cytologically confirmed LM were eligible and received erlotinib 150mg daily. Overall cytological response rate (ORR; defined “number of pts who achieves complete remission in CSF / number of all pts”), time to LM progression (TTP), overall survival (OS) and pharmacokinetics were analyzed. Under the null hypothesis, the regimen would be rejected if confirmed ORR was 5% or less. This study was closed because of low accrual with only 21 of required 32 pts (66 %) accrued.

      Results:
      From Dec 2011 to May 2015, 21 pts (17 pts with EGFR mutation) were enrolled. CSFs available for EGFR mutation analysis (N=17) were all EGFR T790M negative. ORR was 30 % (95%CI 12 -54 %). Median TTP was 2.3 months. Median OS was 3.1 months. Significantly longer TTP and OS were observed in EGFR-mutant than in EGFR-wild type (P=0.0054 and P<0.0001, respectively). Seven pts survived longer than 6 months. CSF penetration rate (Mean + SD) was 3.3 + 0.8 %. There was no correlation between CSF concentration and clinical efficacy.

      Conclusion:
      Erlotinib treatment for LM is active, especially in EGFR-mutant. Our findings suggest that erlotinib could represent a treatment option for EGFR mutated pts. CSF penetration in LM patients is equivalent to those in previous reports. Table1. Summary of ORR, TPP and OS

      ORR (%) mTTP (M) mOS (M)
      All (N=20) 30 2.3 3.1
      EGFR mutant (N=17) 35 2.7 4.0
      EGFR wild (N=3) 0 0.7 0.8
      P value (mt vs. wt) - 0.0054 <0.0001


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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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      P2.02-027 - A Randomized Phase II Trial of S-1 plus Cisplatin or Docetaxel plus Cisplatin with Concurrent Thoracic Radiotherapy for Stage III NSCLC: TORG1018 (ID 4164)

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

      • Abstract

      Background:
      Concurrent chemoradiotherapy (CCRT) is the current standard treatment for inoperable stage III non-small cell lung cancer (NSCLC), and a clearly superior regimen has not yet been identified. This study was conducted to evaluate cisplatin with S-1 (SP) or docetaxel (DP) with concurrent thoracic radiotherapy in patients with inoperable stage III NSCLC.

      Methods:
      In this open-label, non-comparative phase II trial, patients with inoperable stage IIIA/B NSCLC were randomized (1:1) to SP (S-1 40 mg/m[2] twice a day on days 1-14 and 29-42, and cisplatin 60 mg/m[2] on days 1 and 29) or DP (docetaxel 50 mg/m[2] and cisplatin 60 mg/m[2 ]on days 1 and 29), stratified by institution, gender, histology, and stage. In both arms, concurrent radiotherapy was started on day 1 (total 60 Gy in 30 fractions). After CCRT, patients in each group received two additional cycles of consolidation chemotherapy with the same regimen as that for the CCRT part. The primary endpoint was the 2-year overall survival (OS) rate, and secondary endpoints were OS, progression-free survival (PFS), toxicity profile, dose intensity and objective response rate (ORR).

      Results:
      Between May 2011 and August 2014, 110 patients from 19 institutions were enrolled. Finally, 106 patients (56 in each arm) were evaluable for efficacy and safety. The patient characteristics were: male/female, 83/23; median age, 65 (range 42-74) yr; performance status 0/1, 59/47; IIIA/IIIB, 59/47. After a median follow-up of 23.1 months, ORR and median PFS were 71.7% (95%CI: 57.7-83.2) and 11.5 months (95%: 9.00-14.1) in the SP arm, and 67.9% (95%CI: 53.7-80.1) and 17.2 months (95%: 9.62-24.0) in the DP arm, respectively. Grade 3-4 leukopenia (34.0%/62.3%) and neutropenia (28.3%/56.6%) were significantly higher in the DP arm than in the SP arm. Incidences of non-hematological toxicity including febrile neutropenia, anorexia, nausea, diarrhea, radiation pneumonitis and esophagitis tended to be high in the DP arm. No treatment-related death occurred.

      Conclusion:
      At this preliminary stage, it appears that although the DP arm may have more toxic effects than the SP arm, it has a favorable PFS. The OS data will be available soon.

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    P2.06 - Poster Session with Presenters Present (ID 467)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
    • Presentations: 1
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      P2.06-037 - A Feasibility Study of Concurrent Chemoradiation Followed by Surgery for Pathologically-Proven Clinical IIIA-N2 Non-Small Cell Lung Cancer (ID 4700)

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

      • Abstract
      • Slides

      Background:
      The standard treatment for stage IIIA-N2 non-small cell lung cancer (NSCLC) is definitive chemoradiotherapy. However, the strategy for resectable IIIA-N2 disease remains controversial. This phase II multi-institutional trial (WJOG5308L) was designed to evaluate the feasibility for neoadjuvant chemoradiotherapy followed by surgery (tri-modality) in patients with pathologically-proven N2 NSCLC.

      Methods:
      Patients with resectable IIIA-N2 (pathologically proven N2) were eligible. Neoadjuvant chemotherapy consisted of weekly paclitaxel (40mg/m2) plus carboplatin (AUC 2) for 5 weeks. Concurrent radiotherapy (RT) was prescribed with 50 Gy in 25 fractions to the mediastinum and primary tumor. Patients underwent surgical resection, unless PD disease, followed by two courses of paclitaxel plus carboplatin consolidation chemotherapy. The primary endpoint was complete resection (R0) rate. Secondary endpoints were progression-free survival, overall survival, response rate, protocol completion rate and morbidity/mortality.

      Results:
      From December 2011 to November 2013, 40 patients were enrolled. The median follow-up time was 33.97 (7.2-46.3) months. The radiological responses to neoadjuvant chemoradiotherapy were as follows: no complete response, 23 (57.5%) partial response, 16 (40.0%) stable disease and one (2.5%) progression. 34 of 40 patients underwent surgery. Reasons for not receiving surgery were radiation pneumonitis (n=4), PD (n=1) and delay of protocol (n=1). Of 34 resections, twenty-eight were lobectomies, three were bilobectomies, two were pneumonectomies, and one was exploratory thoracotomy. Six patients underwent sleeve lobectomy, without any complication. Thirty-two patients achieved the primary endpoint, complete resection (R0) rate 80% (32/40). Pathological complete response (PCR) rate was 30.3%. Finally, 20 patients (50%) completed all planned tri-modality treatment. The 2-year progression-free and overall survival rates for all patients were 62.5% and 75.0%, respectively. The 2-year recurrence-free survival for patients who received R0 was 61.5%. Neutropenia was the main grade 3/4 morbidity and tolerable. 30-days mortality rate was 0 %. Two treat-related deaths (late bronchial fistula) occurred. Sites of first disease recurrences were mediastinal lymphnodes (n=9, 22.5%), lung (n=8, 20%), and brain (n=4, 10%).

      Conclusion:
      Tri-modality treatment, neoadjuvant chemoradiotherapy followed by surgery, for resectable IIIA-N2 NSCLC seems feasible and promising.

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