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Y. Takeda



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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)

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

      • 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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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-019 - A prospective cohort study of non-squamous non-small cell lung cancer patients treated with bevacizumab (ID 1288)

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

      • Abstract

      Background
      In several clinical trials, first line combination chemotherapies with bevacizumab (Bev) have been reported to improve clinical outcomes in patients with advanced non-squamous non-small cell lung cancer (non-sq NSCLC). Although Bev was approved for NSCLC in autumn of 2009 in Japan, there are not enough data regarding the efficacy and toxicity with Bev treatment in real-world clinical practice in Japan. We have evaluated the efficacy and safety of the combination chemotherapy with Bev in patients with non-sq NSCLC at four major hospitals in Shinjuku area, Tokyo, Japan.

      Methods
      From August 2010 to July 2012, 102 patients planned to treat with Bev was prospectively enrolled in this study with written informed consent. Eligible patients were histlogically or cytologically documented non-sq NSCLC with advanced stage (IIIB-IV) or recurrence, ECOG-PS 0-2, and adequate organ function for cytotoxic chemotherapy. Patients received Bev (15mg/kg, every 3 weeks) plus any chemotherapy (physician’s choice) followed by maintenance Bev. The primary endpoints were safety and efficacy (PFS). Patients were treated at four major hospitals (three university hospitals and one national center) participating in Shinjuku Thoracic Oncology Group (STOG).

      Results
      Patients characteristics: median age (range) 64 (36-85) years, male/female = 60/42, clinical staging: IIIB/IV/post-operation recurrence/others ＝ 8/77/15/1, ECOG-PS 0/1/2 = 66/34/2, adenocarcinoma/others = 98/4, non-smoker/smoker = 40/60, EGFR mutation (+)/(-)/unknown ＝ 43/56/3, 1[st ]line /2[nd] line />=3[rd] line ＝ 56/23/23, Bev combination regimen: CBDCA+PEM/ CDDP+PEM/ CBDCA+PTX/ others ＝ 40/22/18/22. At the time of April 2013, median Bev administration number (range) was 7 (1-29) in total; 7.5 (1-29) in 1[st] line, 8 (1-24) in 2[nd] line, 7 (1-21) in >= 3[rd] line. With evaluable 102 cases, response rate (RR) was 39.2%, disease control rate (DCR) was 90.2%, median PFS was 321 (95%CI: 195-410) days (10.6 months (M)). Median overall survival was not reached. RR, DCR, and PFS were 46.4%, 96.4%, 10.9M with 1[st] line, 39.1%, 87.0%, 9.1M with 2[nd] line, 21.7%, 78.3%, 9.3M with >= 3[rd] line. Hematological toxicities (>=G3): leucocytopenia 24%, neutropenia 40%, anemia 8%, thrombocytopenia 5%, febrile neutropenia 3%. Bev related adverse events (>=G3): Hypertension 28%, proteinuria 5%, thromboembolism 5%, hemosputum 1%. There was no treatment related death.

      Conclusion
      Combination chemotherapy with Bev was effective for the patients with non-sq NSCLC in real-world clinical practice in Japan, as similar or superior efficacy as clinical trials. Also, adverse events were well tolerated. The efficacy was good at 1[st] line and also at 2[nd] line and thereafter.