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S. Kanda
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-005 - A Retrospective Study of Sequential Chemoradiotherapy for LD-SCLC Patients in Whom Concurrent Therapy is Not Indicated (ID 4066)
14:30 - 15:45 | Author(s): S. Kanda
- Abstract
Background:
The standard treatment for limited-disease small-cell lung cancer (LD-SCLC) is a combination of cisplatin-doublet chemotherapy and concurrent thoracic radiotherapy. However, sequential radiotherapy, rather than concurrent radiotherapy, is selected for some cases because of concerns regarding the irradiation field, patient age, comorbidities, or performance status. Nevertheless, the efficacy of sequential chemoradiotherapy in patients in whom concurrent chemoradiotherapy is contraindicated is not well known.
Methods:
We retrospectively analyzed 286 patients with LD-SCLC at the National Cancer Center Hospital and the NTT Medical Center in Japan between 2000 and 2014. We then compared the clinical characteristics and treatment outcomes of patients undergoing sequential radiotherapy with those undergoing concurrent radiotherapy.
Results:
One hundred and eighty-three patients received concurrent chemoradiotherapy and 30 received sequential chemoradiotherapy. The median age of the patients was 64 years (range, 18-81 years) for the concurrent group and 71.5 years (50-83 years) for the sequential group. The concurrent group contained 43 women (23%), while the sequential group contained 9 women (30%). The major reasons for the selection of sequential radiotherapy were patient age (13 patients), a large irradiation field (8 patients), and comorbidities (5 patients). In the sequential group, 23 (77%) received conventional radiotherapy, whereas 7 (23%) received accelerated hyperfractionated radiotherapy. The median overall survival period was 34.5 months for the concurrent group and 27.6 months for the sequential group (P = 0.39). The 2-, 3-, and 5-year survival rates were 71%, 50%, and 40% for the concurrent group and 56%, 56%, and 35% for the sequential group. Recurrence was seen in 149 patients (81%) in the concurrent group and 19 patients (63%) in the sequential group.
Conclusion:
We obtained treatment outcomes for patients who could not receive concurrent radiotherapy but could complete sequential radiotherapy that were comparable with the outcomes for those who received concurrent radiotherapy. For patients in whom concurrent chemoradiotherapy is not indicated, sequential chemoradiotherapy should be considered.
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-017 - Differences of Central Nerve System Metastasis during Gefitinib or Erlotinib Therapy in Patients with EGFR-Mutated Lung Adenocarcinoma (ID 4879)
14:30 - 15:45 | Author(s): S. Kanda
- Abstract
Background:
A few reports have suggested a difference in the incidences of new metastasis to the central nerve system (CNS) during gefitinib and erlotinib therapy. However, a direct comparison of these two therapies has not yet been reported. We planned a retrospective study to investigate the incidences of CNS metastasis progression (new CNS metastasis or progression of existing CNS metastasis) during gefitinib and erlotinib therapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR mutation.
Methods:
We retrospectively analyzed the incidences of CNS metastasis progression and the outcomes of NSCLC patients harboring EGFR mutation who received gefitinib or erlotinib as a first-line EGFR-TKI treatment at the National Cancer Center Hospital between 2008 and 2014.
Results:
A total of 175 patients were analyzed; 148 patients had received gefitinib, and 27 had received erlotinib. The median (range) ages were 64.5 (32-81) years and 62.0 (27-68) years, respectively; exon 19 deletion/L858R point mutations were present in 84/64 (56.7%/43.3%) and 17/10 (63.0%/37.0%) cases, respectively. The status of CNS metastasis before EGFR-TKI therapy was negative/positive in 105/43 (71.0%/29.0%) cases in the gefitinib group and 21/6 (77.8%/22.2%) cases in the erlotinib group, respectively. The incidence of CNS metastasis progression in the gefitinib group tended to be higher than that in the erlotinib group (29.0% vs. 11.1%; P = 0.051). In patients without CNS metastasis before EGFR-TKI therapy, the incidence of new CNS metastasis during EGFR-TKI treatment was significantly higher in the gefitinib group than in the erlotinib group (24.7% vs. 4.8%, P = 0.04). The progression-free survival (PFS) and overall survival (OS) periods of the patients who presented with CNS progression were shorter than those of the patients who presented without CNS progression (median PFS, 9.5 vs. 12.6 months, P = 0.034; median OS, 23.8 vs. 34.1 months, P = 0.002). Fifty-six patients underwent re-biopsy after the failure of EGFR-TKI therapy, but no difference in the incidences of EGFR T790M mutation was seen between patients with and those without CNS metastasis progression (40.0% for patients without CNS progression vs. 63.6% for patients with CNS metastasis progression, P = 0.19).
Conclusion:
The incidence of the progression of CNS metastasis during gefitinib therapy was higher than that during erlotinib therapy. In addition, the difference in this incidence was more remarkable among patients who had not developed CNS metastasis prior to the start of EGFR-TKI therapy.
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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
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-023 - A Phase III Study Comparing Gefitinib and Inserted Cisplatin plus Pemetrexed with Gefitinib for EGFR-Mutated Advanced Non-Squamous NSCLC (ID 4587)
14:30 - 15:45 | Author(s): S. Kanda
- Abstract
Background:
Overcoming and prevention of acquired resistance to EGFR-TKIs in the treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC) is a critical issue. Although third-generation EGFR-TKIs, such as osimertinib, which are potent against EGFR carrying the T790M mutation, have been developed, they are insufficient to overcome other resistance mechanisms. We hypothesized that the insertion of platinum-doublet chemotherapy with EGFR-TKIs might prevent the emergence of acquired resistance to EGFR-TKIs and prolong the patient survival. An early phase II study of inserted cisplatin and docetaxel with gefitinib showed promising outcomes, including a median progression-free survival of 19.5 months and median survival time of 48.0 months.
Methods:
Figure 1 This study (JCOG1404 / WJOG8214L: AGAIN study) is an intergroup, multicenter, randomized phase III study conducted by the Japan Clinical Oncology Group (JCOG) and the West Japan Oncology Group (WJOG). The objective of this study is to confirm the superiority, in terms of the overall survival, of the study treatment, described below, over gefitinib monotherapy. As the study treatment, gefitinib are administered on days 1-56. Then, after a two-week drug-free period, three cycles of cisplatin and pemetrexed are administered on days 71, 92, and 113. Thereafter, gefitinib is re-started on day 134 and continued until disease progression. The secondary endpoints are progression-free survival, response rate, adverse events, severe adverse events and proportion of EGFR T790M mutation positive in the tumor samples at disease progression. The key eligibility criteria are: patients with advanced or recurrent non-squamous NSCLC harboring EGFR activating mutations (exon 19 deletion or exon21 L858R), age 20 to 74 years, and PS 0 or 1. This study was started in December 2015, and a total of 500 patients will be enrolled over a period of 3 years. This trial has been registered at UMIN-CTR[umin.ac.jp/ctr/] as UMIN000020242.
Results:
Section not applicable
Conclusion:
Section not applicable
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-097 - Nivolumab in Elderly or Poor Performance Status Patients with Advanced Non-Small Cell Lung Cancer (ID 4213)
14:30 - 15:45 | Author(s): S. Kanda
- Abstract
Background:
Nivolumab showed durable antitumor activity and survival benefit in previously treated patients with advanced non-small cell lung cancer (NSCLC). The aim of this study was to evaluate the efficacy and safety of nivolumab in elderly (≥75 year old) or poor performance status (PS; ≥2) patients with NSCLC, most of who have been excluded from clinical trials.
Methods:
This was a retrospective cohort study investigating the outcome of patients with advanced or post-operative recurrence NSCLC who received nivolumab from January to April 2016 in the National Cancer Center Hospital. Patient characteristics, the efficacy of nivolumab, survival, and adverse events were analyzed. Immunohistochemical (IHC) expression of programmed cell death ligand 1 (PD-L1) in pretreatment tissue (10 biopsy and 3 operation specimens) was assessed using the rabbit monoclonal PD-L1 antibody (clone 28-8; Abcam). Staining of ≥1% of tumor cells was considered as the cut-off value of positive PD-L1 expression.
Results:
A total of 20 patients, including 10 elderly patients with non-squamous NSCLC and 10 poor PS patients (7 with non-squamous and 3 with squamous NSCLC), received nivolumab. Objective responses were observed in 6 patients: 4 (40%) elderly and 2 (20%) poor PS patients. The median progression-free survival was 2.8 months and 1.7 months in the elderly and poor PS groups, respectively. Of 13 cases with quantifiable IHC results, 10 cases were positive for PD-L1. PD-L1 expression was not predictive of a response, which occurred in 4 of 10 (40%) patients with PD-L1-postive tumors, 1 of 3 (33%) patients with PD-L1-negative tumors, and 1 of 7 (14%) patients with an unknown PD-L1 status (p = 0.52). Treatment-related adverse events led to discontinuation of nivolumab in 6 patients (1 elderly and 5 poor PS patients). Figure 1
Conclusion:
Nivolumab had a clinically meaningful response for elderly or poor PS advanced NSCLC patients, but toxicity led to the discontinuation of nivolumab.
