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K. Mori



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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      MO25.02 - Thoracic Radiotherapy With or Without Concurrent Daily Low-Dose Carboplatin in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer: Updated Results of the JCOG0301 and Pooled Analysis With the JCOG9812 Trial. (ID 734)

      10:35 - 10:40  |  Author(s): K. Mori

      • Abstract
      • Presentation
      • Slides

      Background
      The Japan Clinical Oncology Group (JCOG) undertook 2 randomized phase III trials (JCOG9812 and JCOG0301) to assess whether daily low-dose carboplatin plus radiotherapy could improve survival in elderly patients with stage III non-small cell lung cancer (NSCLC) when compared to radiotherapy alone. Although JCOG9812 was prematurely terminated because of a high incidence of treatment-related deaths (TRDs) and instances of protocol violation, especially with regard to radiotherapy planning, the trial regimen was assumed promising. Therefore, JCOG0301 was conducted for the same subjects using the same protocol regimen with modified inclusion criteria regarding pulmonary function and radiotherapy quality control (RTQC) measures. We then carried out a preplanned pooled analysis of these 2 studies.

      Methods
      The eligibility criteria for both trials were age of ≥71 years and unresectable stage III NSCLC. Patients were randomized to receive radiotherapy alone (60 Gy, RT arm) or chemoradiotherapy (radiotherapy, 60 Gy plus concurrent carboplatin, 30 mg/m[2] per fraction up to the first 20 fractions, CRT arm). The primary endpoint for both studies was overall survival (OS). The pooled analysis included OS, progression-free survival (PFS), response rate, and toxicities.

      Results
      In JCOG9812, 46 patients (RT arm, n=23; CRT arm, n=23) were enrolled from November 1999 to August 2001. In JCOG0301, 200 patients (RT arm, n=100; CRT arm, n=100) were enrolled from September 2003 to May 2010, and in total, 246 patients were included in the pooled analysis. Patient characteristics for the RT (n=123) and CRT (n=123) arms were as follows: median age, 77 years (range, 71–93) and 77 years (range, 71–89); stage IIIA/IIIB, 65/58 patients and 63/60 patients; performance status (PS) 0/1/2, 44/74/5 patients and 50/69/4 patients; men/women, 103/20 patients and 96/27 patients, respectively. The median OS for the RT (n=121) and CRT (n=122) arms were 16.3 months (95% CI, 13.4–18.6) and 20.7 months (95% CI, 16.3–26.9), respectively (HR, 0.672; 95%CI, 0.502–0.898, stratified log-rank test one-sided p=0.0034). The pooled HR for PFS was 0.671 (95%CI, 0.514–0.875, stratified log-rank test one-sided p=0.0015). Response rates for the RT and CRT arms were 46.3% and 53.3%, respectively. The number of patients with grade 3/4 hematological toxicities was higher in the CRT arm than in the RT arm: leucopenia (62.2% vs 1.7%), neutropenia (54.6% vs none), and thrombocytopenia (30.3% vs 3.3%). The incidence of grade 3/4 pneumonitis decreased from 4.4% (JCOG9812; RT, 4.5% and CRT, 4.3%) to 2.1% (JCOG0301; RT, 3.1% and CRT, 1.0%), and that of late lung toxicity, from 14.0% (JCOG9812; RT, 10.0% and CRT, 17.4%) to 5.9% (JCOG0301; RT, 5.3% and CRT, 6.5%). The incidence of TRD also decreased from 8.9% (JCOG9812; RT, 1 patient and CRT, 3 patients) to 3.6% (JCOG0301; RT, 4 patients and CRT, 3 patients). As per subgroup analyses, ≤75 years, stage IIIA, male, PS 0, and smoking history were associated with statistically significant improvement in OS in the CRT arm.

      Conclusion
      This combination chemoradiotherapy for elderly patients with locally advanced NSCLC provides clinically significant benefits and RTQC measures are imperative to improve treatment outcome.

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    O20 - Staging and Advanced Disease (ID 102)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Surgery
    • Presentations: 1
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      O20.07 - Local therapy for limited distant metastasis in patients with completely resected NSCLC (ID 1262)

      17:20 - 17:30  |  Author(s): K. Mori

      • Abstract
      • Presentation
      • Slides

      Background
      In general, distant metastasis is regarded as an incurable systemic disease. Therefore, local therapies including metastasectomy or radiotherapy are rarely applied, and the treatment goals are disease control using chemotherapy or palliation. There are, however, several reports in which local therapy can contribute to long-term survival in patients with metastatic disease, especially for brain metastasis or adrenal metastasis in patients with NSCLC.

      Methods
      Between 1986 and 2009, among 1548 patients who underwent surgical resection for NSCLC in our institution, we identified 405 patients who experienced recurrence after R0 resection, without history of other malignancy, and detailed recurrence information available. We investigated the recurrent mode, number of metastatic focus and organ, treatment for metastasis, and prognosis.

      Results
      Among 405 patients, 245 patients had distant metastasis without local recurrence, 115 had local recurrence, and 45 had both local and distant metastasis. We focused on the 245 patients with distant metastasis without local recurrence, including 215 patients who had only single organ metastasis and 93 patients who had only solitary metastasis. The treatments for distant metastasis and the 5-year survival rates were shown in the Table 1. The number of organ involved and metastatic focus were significantly associated with prolonged survival. Local therapy were mainly applied for limited metastases, and associated with higher survival rates. The number of patients and the 5-year survival rates according to the metastatic organ in patients with solitary metastasis are shown in Table 2. Other metastatic organ included soft tissue in 3 patients, kidney in 3, and trachea, intestine, and abdominal lymph node in 1.Finally, 6 patients survived more than 5 years with disease-free status; these included 2 brains, 2 lungs, 1 bone, and 1 subcutaneous metastasis.

      Table 1
      Multiple organ Single organ Multiple Single
      Treatment Number of pts 5y OS (%) Number of pts 5y OS (%) Number of pts 5y OS (%) Number of pts 5y OS (%)
      BSC 8 0 48 6.4 43 7.1 5 0
      Chemo Tx 3 0 32 16.3 30 17.7 2 0
      Radio Tx 19 5.7 101 11.8 43 0 58 21.4
      Surgery 0 - 34 38.0 6 66.7 28 33.4
      Total 30 3.5 215 15.2 122 8.9 93 23.3
      Table 2
      Organ Number of pts 5y OS (%)
      Brain 36 19.2
      Bone 24 16.7
      Lung 18 32.4
      Adrenal gland 6 0
      Other 9 55.6

      Conclusion
      Prolonged survival can be achieved using local therapy in patients with limited distant metastasis irrespective of metastatic organ.

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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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      P3.10-021 - Phase II Multicenter Trial of Erlotinib for Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Mutations (ID 1417)

      09:30 - 09:30  |  Author(s): K. Mori

      • Abstract

      Background
      Erlotinib is effective for non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and also recommended in NCCN guidelines. However, there has been a few study done on second-line therapy in NSCLC with EGFR mutations in Japan. The aim of this phase II study was to evaluate the efficacy and safety of erlotinib therapy as second-line treatment in EGFR-mutated NSCLC who was previously treated with platinum doublet.

      Methods
      NSCLC patients with EGFR mutations (exon19 or 21) who were treated with platinum doublet previously as first-line therapy were treated with daily erlotinib (150mg/ day). The primary endpoint in this phase II study was response rate (RR), and the secondary endpoints were progression-free survival time (PFS), overall survival time (OS), and safety.

      Results
      From August 2009 to February 2012, 31 NSCLC patients were eligible in this phase II study. The patient’s demographics were a median age of 65 years (range 50-75 years), 21 men and 10 women, 30 adenocarcinomas and 1 other type of cancer, 9 never-smokers and 22 former smokers, PS (ECOG) were 0 in 15, 1 in 14, 2 in 2 patients, exon19 mutation in 15 and exon21 mutation in 16, respectively. Total RR of erlotinib treatment was 61.3%. The disease control rate was 93.5%. Median PFS was 308 days and OS was not reached. Toxicities such as acne, rush and diarrhea were less than Grade 2. Treatment-related death caused by pneumonitis in one patient.

      Conclusion
      Erlotinib therapy as second-line treatment in EGFR-mutated NSCLC patients who were treated with platinum doublet previously was effective with an acceptable toxicity profile.