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A. Hata



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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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      P1.10-019 - Differential efficacy of EGFR-TKI according to variants of exon 19 deletional mutation in non-small cell lung cancer (ID 1177)

      09:30 - 09:30  |  Author(s): A. Hata

      • Abstract

      Background
      Deletional mutations in exon 19 (Del-19) and L858R point mutation in exon 21 are the most common mutations in the epidermal growth factor receptor (EGFR) gene. In Del-19, several variants actually exist, consisting of different amino acid positions or different sizes. Little evidence has been described whether the variation of Del-19 mutation affects EGFR-tyrosine kinase inhibitor (TKI) sensitivity.

      Methods
      Between December 2005 and March 2013, we screened 111 patients harboring Del-19 who had received EGFR-TKIs. Efficacies of EGFR-TKI such as response rate (RR), progression-free survival (PFS), and overall survival (OS) were retrospectively evaluated among various patient characteristics (age, gender, ECOG performance status [PS], smoking status, clinical stage, histology, treatment line, types of TKI, initial site of deletion, and presence of insertion). We also performed a multivariate analysis with the proportional hazards model to exclude several confounds. A backward stepwise approach was adopted as our variable selection method for multivariate analyses.

      Results
      Among these 111 patients with exon 19 deletion mutations, 83 (75%) patients had a deletion from E746 (⊿E746 group), and a deletion from L747 (⊿L747 group) 28 (25%). PFS of ⊿E746 group (12.0 months, 95% confidence interval [CI] 9.27-15.63) was significantly longer than ⊿L747 group (10.0 months, 95% CI 6.43-14.27) (p = 0.0129). Insertion mutations were found in 20 patients (18%), and 91 patients (82%) were without insertions. PFS without insertions (12.0 months, 95% CI 9.27-15.17) was significantly longer than with insertions (10.0 months, 95% CI 3.97-12.67) (p = 0.0173). No relationships were found for RR in all patient characteristics. In univariate analysis, PS (0-1 vs 2-4, p = 0.0001), clinical stage (ⅢB/Ⅳ vs recurrence, p = 0.0408), treatment line (1st line vs after 2nd line, p = 0.0122), initial site of deletion, and presence of insertion were statistically significant factors for longer PFS. PS (p <0.0001), histology (Adeno vs Squamous, p = 0.0134) and treatment line (p = 0.0052) were statistically significant factors for longer OS. In multivariate analysis, PS (hazards ratio [HR] 0.580, 95% CI 0.43-0.80, p = 0.0009) and initial site of deletion (HR 0.696, 95% CI 0.55-0.89, p = 0.0047) remained as significant factors for longer PFS. PS (HR 0.525, 95% CI 0.35-0.78, p = 0.0016), gender (Female vs Male, HR 0.701, 95% CI 0.53-0.93, p = 0.0140) and histology (HR 0.479, 95% CI 0.30-0.83, p = 0.0120) were selected as significant factors for longer OS.

      Conclusion
      Our data indicated better efficacy of EGFR-TKI in ⊿E746 group than ⊿L747 group. Deletional locations may affect the sensitivity to EGFR-TKI.

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    P2.21 - Poster Session 2 - Diagnosis and Staging (ID 170)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P2.21-007 - Computed tomography-guided needle aspiration and biopsy of pulmonary lesions: a single-center experience on 750 biopsies in Japan (ID 3288)

      09:30 - 09:30  |  Author(s): A. Hata

      • Abstract

      Background
      Computed tomography (CT)-guided fine needle aspiration (FNA) and biopsy is a well-established diagnostic method for pulmonary lesion.The aim of our study was to update the diagnostic outcomes and the safety profile of CT-guided lung biopsies.

      Methods
      We retrospectively analyzed the results of the CT -guided FNA and biopsies for 750 pulmonary lesions in 696 patients, and investigated the diagnostic yield, and complication rates.The independent risk factors for the diagnostic failure (ie, nondiagnostic, false-positive, and false-negative results) and the complications (severe pneumothorax) were determined using multivariate logistic regression analysis.

      Results
      The study included 417 male patients and 279 female patients, with a mean age of 71 years.The mean lesion size was 2.0 cm in maximal diameter.The biopsy results were nondiagnostic in 1.4% of the lesions (11 of 750 cases).The diagnostic accuracy was 92.6% (685/739cases).The sensitivity and specificity for the diagnosis of malignancy was 91.7% (534 of 582 cases) and 99.3% (156 of 157 cases), respectively.The significant independent risk factor for diagnostic failure was Lesions measuring < 2.0 cm (OR, 3.94; p <0.0001).Pneumothorax was the most common complication, and occurred in 36% (272 cases), pneumothorax requiring temporal drainage or chest tube insertion in 7.3% (55 cases), and tension pneumothorax, in 0.2% (2 cases).There were 27 cases (3.6%) with pulmonary hemorrhage, 63 cases (8.4%) with hemoptysis, 2 cases (0.2%) with air embolism , 5 cases (0.6%) with hypertension requiring antihypertensive treatment , 1 case (0.1%) with posterior reversible encephalopathy syndrome（PRES）, and 8 cases (1.0%) with others, including pain, shock, subcutaneous emphysema, subcutaneous hematoma, epilepsy, and bradycardia or tachycardia spell.From a total of 13 patients with severe complications, 12 patients recovered without sequela, however 1 patient recovered but developed paraplegia due to spinal cord infarction; there were no fatalities.The significant independent risk factors for pneumothorax requiring drainage were the depth from pleura < 3.0 cm (OR, 3.60; p <0.001), lesions in the middle lobe (OR, 2.25; p 0.0284),　and COPD patients(OR, 4.38; p <0.001).

      Conclusion
      CT-guided lung FNA and biopsy have a high diagnostic yield, but factors such as the acquisition of lesions measuring <2.0 cm significantly increased the rate of diagnostic failure.The complication rates were acceptable and comparable to previously published figures.The rate of pneumothorax requiring drainage was correlated with the depth from pleura < 3.0 cm, lesions in the middle lobe, and COPD patients.

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    P3.08 - Poster Session 3 - Radiotherapy (ID 199)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      P3.08-001 - Feasibility of stereotactic body radiation therapy with concurrent chemotherapy for patients over 75 years old with Stage I non-small-cell lung cancer. (ID 241)

      09:30 - 09:30  |  Author(s): A. Hata

      • Abstract

      Background
      Stereotactic body radiation therapy (SBRT) is now the standard treatment for elderly patients with inoperable Stage I non-small-cell lung cancer (NSCLC). However SBRT with concurrent chemotherapy may be feasible and effective to selected elderly patients with NSCLC. This retrospective study was aimed to evaluate the safety and tolerability of concurrent SBRT and chemotherapy in patients aged 75 years or older.

      Methods
      We reviewed the records of 11 NSCLC patients who were 75 years or older when treated with SBRT and concurrent chemotherapy with curative intent from 2009 to 2012. Five patients had T1 tumor, the others had T2 tumors. The median age was 81 years with a range of 76 to 88 years. Eight (72%) patients had chronic obstructive pulmonary disease. The median number of Eastern Cooperative Oncology Group (ECOG) performance status of the cases in the beginning of treatment was 1 with a range from 0 to 2. The median delivered radiation dose was 48 Gy in 4 fractions. Concurrent chemotherapy regimen was carboplatin plus paclitaxel, carboplatin plus docetaxel, paclitaxel alone, pemetrexed alone, and S1 alone.

      Results
      All patients received SBRT on schedule. Out of 11 patients, concurrent chemotherapy was successfully accomplished as originally planned in 8 (72%) patients. Initial effect of SBRT plus chemotherapy could be evaluated in all cases. Complete local remission was achieved in 10 patients. One patient alone had local recurrence. Distant metastases observed in 4 patients. In 2 patients, chemotherapy was intermitted due to grade 3 neutrophil count decreased and anemia (Common Terminology Criteria for Adverse Events version 4.0). In another, chemotherapy was broken off because of Grade 2 radiation pneumonitis. During the treatment, no other adverse event was shown. No treatment-related death was observed.

      Grade 2 Grade 3
      Neutrophil count decreased 6 (55%) 1 (9%)
      Anemia 1 (9%) 2 (10%)
      Radiation pneumonitis 1 (9%) 0

      Conclusion
      SBRT plus concurrent chemotherapy might be feasible in selected patients aged 75 years or older with Stage I NSCLC.