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Y. Ichinose



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    MO03 - Thymic Malignancies (ID 123)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO03.10 - A multicenter prospective study of carboplatin and paclitaxel for advanced thymic carcinoma: West Japan Oncology Group 4207L (ID 987)

      10:30 - 12:00  |  Author(s): Y. Ichinose

      • Abstract
      • Presentation
      • Slides

      Background
      Thymic carcinoma (TC) is a rare malignant tumor originated within the thymus gland and is associated with a poor prognosis, differing from thymoma which is the most common type of thymic malignant neoplasm. No results of clinical trials focusing on TC have been reported. This single-arm study evaluated carboplatin and paclitaxel (CbP) in previously untreated patients (pts) with advanced TC.

      Methods
      Pts with Masaoka’s stage III to IVb TC, ECOG PS 0 to 1, and more than 20 years old were eligible. The study treatment consisted of carboplatin (AUC 6) and paclitaxel (200 mg/m2) every 3 weeks for a maximum of 6 cycles. The primary endpoint was objective response rate (ORR) by extramural assessment. Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety. All pts were followed-up until 24 months (mo) after last enrollment. Based on the SWOG 2-stage design, the planned sample size of 40 pts was determined to reject the ORR of 20% under the expectation of 40% with a power of 0.85 and a type I error of 0.05.

      Results
      From May 2008 to November 2010, 40 pts were enrolled from 21 centers. Of 39 evaluable for analysis, the median age was 62 years (range, 36–84); 23/16 males/females; 3/10/26 with Masaoka’s stage III/IVa/IVb; 9/11/19 with squamous cell carcinoma/poorly differentiated neuroendocrine carcinoma/other types. The median number of cycles was 6. There was 1/13 complete/partial responses with an ORR of 36% (95% confidence interval [CI], 21-53%; P = 0.031). The median PFS was 7.5 mo (6.2-12.3 mo) while OS did not reach the median value. The 1-year and 2-year survival rates were 85% (95% CI, 69-93%) and 71% (95% CI, 54-83%), respectively. Major adverse event was grade 3-4 neutropenia in 34 pts (87%). Two cases (5%) of grade 3 febrile neutropenia, neuropathy, and arthralgia were observed, respectively. There was no treatment-related death.

      Conclusion
      CbP showed high efficacy in advanced TC. Our results established that CbP, one of the standard treatments for non-small cell lung cancer, also serves as a key chemotherapy regimen for TC.

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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.06 - Randomized Phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in Advanced Non-squamous, Non-small Cell Lung Cancer (LOGIK 0904). (ID 2235)

      10:30 - 12:00  |  Author(s): Y. Ichinose

      • Abstract
      • Presentation
      • Slides

      Background
      PARAMOUNT study confirmed the improvement of overall survival with continuation maintenance chemotherapy with pemetrexed (PEM) compared with placebo after 4 cycles of cisplatin plus PEM induction chemotherapy recently. JMEN study also showed the usefulness of switch maintenance with PEM after 4 cycles of platinum doublet without PEM. In this study, we conducted the randomized phase II study comparing switch or continuation maintenance chemotherapy with PEM after standard doublet regimen.

      Methods
      Histologically/cytologically confirmed stage IIIb or IV non-squamous NSCLC patients with mesurable disease, ECOG PS 0-1, age over 20 years and adequate organ function were eligible for the study. Randomization was stratified by gender and stage of disease. Patients received 3 cycles of PEM 500mg/m2 plus CB AUC6 (Arm 1) or PAC 200mg/m2 plus CB AUC6 (Arm 2). All patients with non-PD after induction chemotherapy continued PEM 500mg/m2 until PD. Primary endopoint is progression free survival (PFS).

      Results
      140 pts were enrolled and assigned to Arm1 or Arm2 randomly. The clinical data of 132 pts were used as full analysis set (median age 64.5 yrs (42-83), 85 male, 120 stage IV, 58 PS0, 127 adenocarcinoma, 46 never smoker). 42 pts had prior treatment including 9 sugery, 1 adjuvant chemotherapy, 24 radiotherapy and 8 others. In both arms, 50% of pts entered into the maintenance treatment with PEM after completion of 3 cycles induction chemotherapy. The median PFS was 113 days in Arm 1 and 143 days in Arm 2, respectively. Cox-proportinal Hazard ratio was1.047, and 95% HR confidential interval was 0.707-1.549. Stratified Log-Rank test showed no significant difference in both arms.

      Conclusion
      There was no significant difference for PFS in Arm 1(PEM plus CB followed by PEM) and Arm 2 (PAC plus CB followed by PEM).

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    P2.07 - Poster Session 2 - Surgery (ID 190)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P2.07-008 - Radiological-pathological correlation for resected small lung nodules with pure ground glass opacity detected by high-resolution computed tomography (ID 989)

      09:30 - 16:30  |  Author(s): Y. Ichinose

      • Abstract

      Background
      The term "ground glass opacity (GGO)" on high-resolution computed tomography (HRCT) is defined as “hazy increased attenuation in the lung that does not obliterate the bronchial and vascular margins” by Fleischner Society. The identification of small lung nodules of GGO on HRCT often implies lung cancer, especially well differentiated adenocarcinoma or atypical adenomatous hyperplasia; however, there is no objective definition of GGO, such as the computed tomography number.

      Methods
      A single institutional retrospective study. To access the correlation between radiological and pathological diagnosis of the patients with small pure GGO on HRCT. Thirty-nine consecutive surgically resected patients with pure GGO less than 30 mm detected by HRCT between July 2008 and March 2013 in our department were retrospectively examined. The median follow-up of these patients was 28.7 (1.9 - 92.7) months.

      Results
      The median age of the patients was 64 (range 42-82) years old, 19 patients were male and 20 were female. The median size of major axis of lung nodules was 11 (range 5-25) mm, and 29 (74.4%) were less than 15 mm and 10 were between 15 and 30 mm in diameter. Twenty-eight (71.8%) patients had a single nodule, whereas 11 patients had multiple nodules. Six of the 39 patients had a previous history of malignancy (three lung cancers and three other cancers). During the follow-up period, 22 patients had nodules that were stable in size or appearance, and five patients had nodules that either became enlarged or in which the opacity increased, as determined by HRCT. The other twelve patients were operated based on the findings of their first HRCT, basically by the attending surgeons’ decision. Partial resection was performed in seven patients, segmentectomy in 11 patients and lobectomy was performed in 21 patients. Histologically, thirty-seven patients had adenocarcinoma, one had small cell carcinoma and one had a benign tumor. Among the 37 patients with adenocarcinoma, 14 were adenocarcinoma in situ, five tumors were minimally invasive and 18 were invasive according to the IASLC/ATS/ERS classification. There was no postoperative recurrence during the follow-up period.

      Conclusion
      Even if the small pulmonary nodules present as pure GGO, they may still be adenocarcinoma with an invasive nature. The timing of surgery should be considered carefully so that a chance to achieve a cure of such patients is not missed.

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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.11-027 - The response of non-adenocarcinoma non-small-cell lung cancer patients with EGFR mutations to EGFR-TKI: A retrospective multicenter study (LOGIK 1104) (ID 2021)

      09:30 - 16:30  |  Author(s): Y. Ichinose

      • Abstract

      Background
      The epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such as gefitinib and erlotinib, are used to treat non-small cell lung cancer with EGFR sensitive mutations. The response rates to EGFR-TKI for mainly adenocarcinoma patients with EGFR mutations are very high, ranging from 62-85%, with a median progression-free survival (PFS) of 8.0-13.1 months and a median overall survival of 21.6-35.5 months. EGFR mutations can also be detected in a few non-adenocarcinoma tumors, however, the response of such cases to EGFR-TKIs is controversial. This study assessed the effectiveness of EGFR-TKIs in non-adenocarcinoma non-small cell lung cancer (non-adeno NSCLC) with EGFR mutations.

      Methods
      Nine institutions of the Lung Oncology Group in Kyushu (LOGIK) joined in this study. The primary endpoint was the response rate (RR), and the secondary endpoints were the disease control rate (DCR), overall survival, duration of disease control and the incidence of adverse events. A total of 43 cases of non-adeno NSCLC who were treated with EGFR-TKIs were retrospectively enrolled in this study.

      Results
      This study included 28 males and 15 females, and 18 of the 43 were never smokers. The ages of the patients ranged from 42 to 83 years, with a mean of 67 years. The pathological types were squamous cell carcinomas in 26 patients, adenosquamous cell carcinomas in six, large cell carcinomas in six, and others in five patients. Of these 43 cases, 18 with EGFR mutations were included in the analysis. The incidence of EGFR mutations was significantly higher in females than in males (80.0% vs. 21.4%, p<0.01), and in never smokers than in smokers (72.2% vs. 20.0%, p<0.01). The EGFR-TKIs administered were gefitinib in 27 patients and erlotinib in 16. In the patients with EGFR mutations, the RR and DCR were 83.8% and 93.8%, which were significantly superior to the rates in patients without EGFR mutations, which were 4.1% and 20.1%, respectively (p<0.01).

      Conclusion
      Even in patients with non-adeno NSCLC, the mutation of EGFR gene was a predictive factor for the response to EGFR-TKI treatment. In this meeting, we will show a detailed report based on the pathological analysis performed by the pathological committee of the LOGIK.

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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 - 16:30  |  Author(s): Y. Ichinose

      • 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.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-011 - Which do patients prefer as a first-line therapy, EGFR-TKI or chemotherapy, if they have NSCLC harboring EGFR mutation? A Vignettes study (LOGIK0903). (ID 1106)

      09:30 - 16:30  |  Author(s): Y. Ichinose

      • Abstract

      Background
      Treatment decision-making is associated with potential decisional conflict of patients. Aim of this study was to determine the preferences of advanced NSCLC patients for EGFR-TKI or chemotherapy as first-line therapy if they were in the situation of having a lung cancer harboring EGFR mutation, and to investigate the variables considered important to that preference.

      Methods
      Three vignettes were designed to assess the patients’, the physicians’ or medical staff members’ preferences for treatment decision-making and the reasons classified into five category such as “evidence level”, “type of drug administration”, “therapeutic efficacy”, “adverse events”, and “influence to ordinary life” behind the decision. HADS, FACT-L and characteristics of participants including gender, age, and performance status (PS) are also investigated in this analysis.

      Results
      Total 377 individuals containing 100 patients, 100 physicians, and 177 medical staff members were analyzed in this study, and 322 participants (85.4%) preferred to EGFR-TKI than chemotherapy as a first-line therapy. Preference rate of EGFR-TKI in patients was statistically significantly lower than those in physicians and medical staffs, 73%, 88% and 91%, respectively. Among the reasons we investigated, “therapeutic efficacy” was the only marginal significant reason for preference in patients (odds ratio: 3.88, p=0.06). In addition to “therapeutic efficacy”, “type of drug administration” and “influence to ordinary life” was the significant reasons for their preference in physicians (odds ratio: 11.57, 22.57 and 20.5, respectively). In pre-planned analysis, we found the difference of value between the patients and the physicians in “influence to ordinary life”.

      Conclusion
      If the patients have an advanced lung cancer with EGFR mutation, they may prefer EGFR-TKI as a first-line therapy to chemotherapy as well as physicians and medical staff members. However the reasons of those preferences among them may be different. We should consider continuation of patients’ ordinary life when we discuss about treatment decision-making with patients.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-007 - Preliminary safety results of MONET-A: A Prospective, Asian Phase 3, Randomized, Placebo-controlled, Double-blind Trial of the Investigational agent Motesanib in Combination with Paclitaxel and Carboplatin for Asian patients of Advanced Non-squamous Non-small Cell Lung Cancer (ID 889)

      09:30 - 16:30  |  Author(s): Y. Ichinose

      • Abstract

      Background
      Inhibition of the vascular endothelial growth factor receptor (VEGFR) pathway appears to be an effective treatment strategy for frontline non-small cell lung cancer (NSCLC), but small molecule VEGFR kinase inhibitors have failed to show survival benefit. Motesanib is an orally administrated small molecule antagonist of VEGFR 1, 2, and 3, platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor (c-kit). In a subgroup analysis of Asian patients (n = 227) from the global phase 3 study (MONET-1), treatment of motesanib in combination with paclitaxel and carboplatin demonstrated significant improvements in overall survival (HR, 0.65; 95% CI, 0.46-0.91), progression free survival (HR, 0.59; 95% CI, 0.44-0.79), and overall response rate compared to placebo. To prospectively evaluate efficacy and safety of motesanib in Asian patients with NSCLC, this phase 3 study has initiated.

      Methods
      Stage IV/recurrent non-squamous NSCLC patients without prior chemotherapy receive oral motesanib (125 mg) or placebo once daily in combination with paclitaxel (200 mg/m[2]) and carboplatin (AUC = 6) every 3 weeks up to 6 cycles and continue motesanib or placebo until disease progression, consent withdrawal, or unmanageable adverse event. ECOG performance status 0 or 1 are eligible for this study regardless of epidermal growth factor receptor (EGFR) mutation status. Patients with untreated or symptomatic central nervous system metastases are excluded. Approximately 400 patients will be randomized in a double-blind 1:1 ratio to motesanib or placebo. Stratification factors include EGFR mutation status, weight loss of ≥ 5% in the previous 6 months, and region. This MONET-A trial will be assessed twice by the Independent Data Monitoring Committee (IDMC), at the time 50 and 150 patients complete their first cycle for unblinded safety data.

      Results
      This study initiated in July 2012 and is being conducted in Japan, Korea, Taiwan, and Hong Kong. The enrollment is ongoing. First evaluation by IDMC was performed using the data as of 26 December 2012. A total of 64 patients were enrolled and 63 patients (63 Japanese; median age, 64.5 years) received study treatment. All the blinded patients who received study treatment experienced adverse events (AEs); Grade 3 to 5 AEs were reported in 38 patients (60.3%). Common AEs included alopecia (63.5%), peripheral sensory neuropathy (57.1%), and decreased appetite (50.8%). 7 patients had 8 serious AEs (SAEs). SAEs considered to be related to blinded study drug were cholecystitis in 2 patients, gastric ulcer haemorrhage, nausea, and upper gastrointestinal haemorrhage in 1 patient. A treatment-related fatal AE (interstitial lung disease) was reported in one patient (blinded). AEs leading to permanent discontinuation of unblindedunblinded study drug (motesanib or placeco) were cholecystitis (Grade 2), liver injury (Grade 3), purpura (Grade 2), rash (Grade 3), eye haemorrhage (Grade 2), upper gastrointestinal haemorrhage (Grade 3), and gamma-glutamyltransferase increased (Grade 4).

      Conclusion
      The first IDMC recommended continuation of the study after the review of unblinded data of 63 patients. Updated safety data will be presented after the second IDMC (JapicCTI-121887).