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Shota Omori
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P19 - Locoregional and Oligometastatic Disease - Oligometastatic Disease (ID 129)
- Event: WCLC 2020
- Type: Posters
- Track: Locoregional and Oligometastatic Disease
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P19.02 - Association between Number of Residual Metastases and Patterns of Progression on EGFR TKI in EGFR mutated Non-Small Cell Lung Cancer. (ID 3000)
00:00 - 00:00 | Author(s): Shota Omori
- Abstract
Introduction
Local consolidative therapies (LAT) to all sites of disease are important for the treatment of oligometastatic EGFR-mutated non-small cell lung cancer (NSCLC). The distinctive feature of progressive disease (PD) in the initially involved sites alone suggests the presence of an oligometastatic state in NSCLC in which LAT can potentially be associated with clinical benefit. However, the association between the oligometastatic state (1–3 metastases) and patterns of initial PD after treatment with EGFR tyrosine kinase inhibitors (EGFR-TKIs) remains unclear in patients with EGFR-mutated NSCLC.
Methods
Patients with advanced EGFR-mutated NSCLC who were treated with EGFR-TKIs as the first-line therapy were retrospectively reviewed at the Shizuoka Cancer Center between January 2013 and December 2019. We evaluated the number of metastases at the start of EGFR-TKI treatment and the number of residual metastases at 12 weeks from the start of EGFR-TKI treatment. Logistic regression analyses were performed to identify the predictors of PD in the initially involved sites alone after treatment with EGFR-TKIs.
Results
Of the 415 consecutive patients, 168 who showed PD after treatment with EGFR-TKIs as the first-line therapy were finally included in the analyses. A total of 88 patients (52%) had PD in the initially involved sites alone. Totally, 16 patients (10%) showed 1–3 metastases at the start of EGFR-TKI treatment, and 51 patients (30%) showed 1–3 residual metastases at 12 weeks from the start of EGFR-TKI treatment. Multivariate logistic regression analyses of clinical factors at diagnosis revealed that the Eastern Cooperative Oncology Group performance status score of 0–1 (odds ratio [OR], 3.07; P = 0.003) and no initial central nervous system (CNS) metastases (OR, 2.43; P = 0.014) were independent predictors of PD in the initially involved sites alone. The 1–3 metastases at the start of EGFR-TKI treatment was not a predictor of PD in the initially involved sites alone (OR, 2.05; P = 0.297). Multivariate logistic regression analyses of the clinical factors at 12 weeks from the start of EGFR-TKI treatment revealed that 1–3 residual metastases (OR, 3.07; P = 0.003) and no residual CNS metastases (OR, 3.26; P = 0.014) were independent predictors of PD in the initially involved sites alone. Additional multivariate logistic regression analyses of the clinical factors at 12 weeks from the start of EGFR-TKI treatment revealed that 1–3 residual metastases (OR, 3.18; P = 0.002) and no residual CNS metastases (OR 2.77; P = 0.026) were independent predictors of PD in residually involved sites alone.
Conclusion
The results of this study showed that the initial 1–3 metastases at the start of EGFR-TKI treatment was not a predictor of PD in the initially involved sites alone, and that 1–3 residual metastases at 12 weeks from the start of EGFR-TKI treatment and no residual CNS metastases were independent predictors of PD in the residually involved sites alone in patients with EGFR-mutated NSCLC. Accordingly, the oligometastatic state at 12 weeks from the start of EGFR-TKI treatment might be a candidate for LAT to all sites of disease.
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P21 - Locoregional and Oligometastatic Disease - Treatment of Locally Advanced NSCLC (ID 131)
- Event: WCLC 2020
- Type: Posters
- Track: Locoregional and Oligometastatic Disease
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P21.01 - Phase I Study of Carboplatin/Nab-Paclitaxel and Concurrent TRT in Elderly Patients with Unresectable Locally Advanced NSCLC (ID 3062)
00:00 - 00:00 | Presenting Author(s): Shota Omori
- Abstract
Introduction
Low-dose carboplatin (CBDCA) and concurrent thoracic radiotherapy (TRT) is the standard treatment for elderly patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) in Japan. However, weekly CBDCA/paclitaxel (PTX) is often used for elderly patients without evaluating tolerability. A preclinical study has shown that nab-PTX is a more effective radiosensitizer than PTX. Based on these findings, we conducted a phase I study of CBDCA/nab-PTX (CnP) and concurrent TRT in elderly patients with LA-NSCLC.
Methods
The eligibility criteria included patients with unresectable stage III NSCLC, performance status (PS) of 0 or 1, and age ≥ 75 years. Eligible patients received 6 weeks of treatment with CnP and concurrent TRT 5 days a week with a total dose of 64 Gy in 32 fractions. CBDCA was fixed to AUC 2 mg/ml/min, and the recommended dose of nab-PTX was evaluated in the dose-escalation part (3 plus 3 design). Dose-limiting toxicity (DLT) included non-hematologic toxicities of grade 4, non-hematological toxicities of grade 3 lasting for three days or longer, neutropenia of grade 4 lasting eight days or longer, febrile neutropenia, thrombocytopenia of grade 4, skipping chemotherapy a total of two times, incompletion of radiotherapy by day 58, pneumonitis of grade 2 during study treatment or pneumonitis of grade 3 after study treatment. In addition, we evaluated tolerability at the recommended dose in the expansion part. We defined “treatment completion” as the receipt of 64 Gy of TRT within 58 days from the start of treatment plus at least five doses of CnP. The primary endpoint of the expansion part was treatment completion rate, and the expected and threshold values for the primary endpoint were 85 and 60%, respectively.
Results
From July 2014 to December 2018, 19 patients were enrolled at four institutions, all of whom were eligible and assessable. The baseline characteristics were as follows: median age (range), 81 (75–88) years; male/female, 17/2; PS 0/1, 14/5; IIIA/IIIB, 9/10; and adenocarcinoma/squamous cell carcinoma/other, 12/5/2. DLT was not observed in the first three patients treated at dose level 1 (nab-paclitaxel, 30mg/m2). Next, at dose level 2 (nab-paclitaxel, 40mg/m2), both of two enrolled patients experienced DLT (lung infection of grade 3 and pneumonitis of grade 3, respectively). The additional three patients enrolled at dose level 1 did not experience DLT. Therefore, the recommended nab-PTX dose was set at 30 mg/m2. In the expansion part, the treatment completion rate of the 17 analyzed patients at the recommended dose was 100% (90% CI, 83.8–100%). Eleven patients received all six cycles and six patients received five cycles of chemotherapy. After a median follow-up period of 13.3 months (range, 11.1–16.1 months) for censored cases, the median PFS was 13.4 months (95% CI, 4.2–21.4 months). The overall response rate was 76.5%. Common grade 3 or 4 toxicities included leukopenia (23.5%), neutropenia (17.6%), anemia (5.9%), and infection (5.9%). One treatment-related death due to pneumonitis was observed.
Conclusion
CBDCA/nab-PTX and concurrent TRT have shown a high treatment completion rate and exhibited promising efficacy in elderly patients with LA-NSCLC.
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P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P76.68 - The Impact of Eligibility for Anti-Angiogenic Treatment to the Prognosis of Patients with Non-Small Cell Lung Cancer Harboring EGFR Mutations (ID 3343)
00:00 - 00:00 | Author(s): Shota Omori
- Abstract
Introduction
Previous studies described the efficacy of erlotinib plus angiogenesis inhibitors (bevacizumab/ramucirumab) combination therapy compared with erlotinib monotherapy in epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC), regardless of EGFR activating mutation subtype. However, the impact of angiogenesis inhibitors’ eligibility criteria to progression free survival (PFS) and overall survival (OS) is still unclear. Hence, we evaluated the impact of angiogenesis inhibitors’ criteria in patients with NSCLC harboring EGFR activating mutation.
Methods
We retrospectively collected data of patients with EGFR mutation positive NSCLC who were treated with EGFR tyrosine kinase inhibitor (EGFR-TKI) monotherapy at Shizuoka Cancer Center between 2002 and 2019. Patients whose performance status (PS) was over 3, and those with symptomatic brain metastasis, were excluded from this study. Angiogenesis inhibitors ineligibility was defined as having at least one following conditions; 1) a history of bloody sputum or an exposure of tumor in bronchus, 2) radiologically identified major vessel invasion, 3) a history of cardiovascular disease and 4) history of chemoradiotherapy prior to EGFR-TKI treatment. They were divided into two groups, angiogenesis inhibitors eligible group (AI fit group) and ineligible group (unfit group).
Results
A total of 452 patients with NSCLC harboring EGFR activating mutation were included in this study. Among 452 patients, 207 patients had L858R mutation, and 245 patients had exon19 deletion. Median age of all patients was 71 years old (range 31-92), 35.0% were male, 43.1% had history of smoking, and majority of the patients were treated with gefitinib or erlotinib as a first EGFR-TKI (60.3％ and 18.8％). AI fit group included 339 patients; 152 patients (44.8%) had L858R and 187 patients (55.2%) had exon19 deletion. In baseline characteristics, patients with PS 2 were more frequently observed in AI unfit group compared with AI fit group. The median PFS of AI fit and unfit group were 12.9 month and 9.6 months (HR 0.72, 95%CI 0.57-0.92, p=0.007), and multivariate analysis indicated PS 2 and AI unfit were associated with shorter PFS. Also, OS was significantly longer in AI fit groups than in unfit group; median OS were 33.0 months and 18.5months, respectively (HR 0.58, 95%CI 0.45-0.74, p<0.001). Multivariate analysis indicated PS 2, AI unfit, EGFR exon 19 deletion, and age ≥75 as significant prognostic factors. Out of four AI eligibility definitions, bloody sputum or exposure of tumor in bronchus were significantly associated with poor PFS (HR 1.43, 95%CI 1.07-1.98 p=0.017) and OS (HR 1.67, 95%CI 1.18-2.36 p=0.004). There was no significant difference in PFS between EGFR mutation subtypes in AI fit group; median PFS were 11.5months in L858R mutation and 13.8months in exon19 deletion (HR 0.85, 95%CI 0.67-1.07 p=0.17).
Conclusion
In EGFR mutation positive NSCLC patients, the eligibility of AI was associated with longer PFS and OS, and resulted in insignificance of PFS between L858R and exon19 deletion group. Since these selection bias may have affected previous clinical trials data showing the efficacy of AI plus EGFR-TKI, the results of clinical trials should be carefully considered of its benefits.
