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Yuki Akazawa
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FP02 - Health Services Research/Health Economics (ID 120)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP02.04 - NSCLC with TPS>90% could have Higher Possibility of Causing Severe irAE; Retrospective Investigation in one Institution (ID 869)
00:00 - 00:00 | Presenting Author(s): Yuki Akazawa
- Abstract
Introduction
Recently, immune checkpoint inhibitors (ICI) have been introduced into clinical treatment strategy for advanced or recurrent NSCLC. However, little is known about the relation between the risk of irAE and patients’ clinical backgrounds. In this research, we attempted to reveal which types of clinical backgrounds are likely associated with the development of severe irAE when they were treated with ICI.
Methods
We have treated over 300 advanced or recurrent NSCLC with ICI in our institute since January 2016, and the results of TPS were obtained in 240 patients. We retrospectively analyzed the relationship between patients’ clinical backgrounds and severe irAE which caused discontinuation of treatment.
We excluded patients who were treated with durvalmab because it has different treatment strategy from other ICIs.
Results
Patients' background is shown below. We defined TPS>90% as ultra-high TPS, because those patients are shown to have preferable response to ICI. All the patients with EGFR mutation received EGFR-TKI before ICI.
first-line group second or later-line group 95 145 charasteristic Age, years median 71.9 70.2 range (95% C.I.) 70.2-73.6 68.9-71.6 Sex female 18 ( 18.9%) 56 ( 38.6%) male 77 ( 81.1%) 89 ( 61.4%) Histologic diagnosis adenocarcinoma 48 ( 50.5%) 89 ( 61.4%) squamouscarcinoma 38 ( 40.0%) 37 ( 25.5%) others 9 ( 9.5%) 19 ( 13.1%) ECOG performance status good (0 or 1) 80 ( 84.2%) 96 ( 76.8%) poor (2 -4) 15 ( 15.9%) 29 ( 23.2%) TPS high expression (>50%) 67 (70.5%) 40 (27.6%) low expression (1-49%) 22 (23.2%) 56 (38.6%) negative (<1%) 6 ( 6.3%) 49 (33.8%) ultra-high expression (>90%) 32 ( 33.7%) 19 ( 13.1%) Driver mutation no 92 ( 96.8%) 105 ( 72.4%) yes 3 ( 3.2%) 40 ( 27.6%) EGFR / KRAS / HER2 / others 0 / 2 / 1 / 0 36 / 1 / 2 / 1 ICI pembrolizumab 84 ( 88.4%) 57 ( 39.3%) nivolumab 0 ( 0%) 62 ( 42.8%) atezolizumab 11 ( 11.6%) 26 ( 17.9%) Forty-six had severe irAE of any grade of ILD or >Grade3 AE, and most of them were treated with steroids. Nineteen of them received ICI subsequently.
Univariate analysis indicated that TPS>50%, first-line treatment and administration of pembrolizumab showed significantly higher possibility of severe irAE (p<0.05, p<0.001, p<0.05, respectively). Furthermore, patients with ultra-high TPS was likely to experience severe irAE compared to other groups (p<0.01). When we examine the patients in first-line treatment, only ultra-high TPS showed statistically higher tendency of irAE (p<0.05). However, in second or later-line patients, no clinical backgrounds indicated the higher risk of irAE.
No difference was observed in response rate between ultra-high and other group in first-line treatment (71.9%, 61.9% respectively, p=1.0). In later-line, ultra-high group showed better response rate than others (52.6%, 19.8% respectively, p=0.032). However, no differences were observed in time to treatment failure and OS between ultra-high and others.
In 1st-line patients, TTF of ultra-high and others was 207days and 175days (p=0.306), OS was 727days and 742days, respectively (p=0.74). In later-line, TTF was 107days and 70days(p=0.109),and OS was 511days and 308days (p=0.448).
Conclusion
Patients with ultra-high TPS had higher possibility of irAE especially when they received ICI for first-line. However, no difference was observed in OS between two groups. In our investigation, survival was not translated from better response in ultra-high group.
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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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P76.79 - Osimertinib in Poor PS Patients with T790M-Positive Advanced NSCLC after Progression of EGFR TKI Treatments (NEJ032B) (ID 3492)
00:00 - 00:00 | Author(s): Yuki Akazawa
- Abstract
Introduction
Osimertinib has already been reported to be highly effective in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) -resistant patients with T790M mutation-positive advanced non-small-cell lung cancer (NSCLC). However, its effectiveness and safety in those patients with poor performance status (PS) are unknown.
Methods
After progression by a treatment of gefitinib, elrotinib and/or afatinib patients who had T790M mutation, a Stage IIIB, IV or recurrence disease, and PS 2-4 were enrolled in this study. Osimertinib at a dose of 80 mg/day was orally administered. The primary endpoint of this phase II study was response rate (RR), and the secondary endpoints were progression free survival (PFS), overall survival (OS) and safety.
Results
Thirty-three patients were enrolled from February 2017 to May 2019. All patients met the eligibility criteria. Their median age was 72 years (range: 47–89). Women accounted for 81.8% of the patients, and 69.7% and 24.2% of the patients had a PS of 2 and 3, respectively. For 32 patients except for a patient with a protocol violation, the RR was 53.1% (95% confidence interval: 34.7-70.9%), and the disease control rate was 75.0%. The PFS was 4.8 months, and the OS was 11.1 months. Interstitial lung disease (ILD) at all grades and grade 3-5 were observed in 15.1% (5/33) and 6.1% (2/33), respectively, and treatment-related death by ILD occurred in one patient.
Conclusion
As the primary endpoint, we verified that osimertinib was sufficiently effective in EGFR TKI-resistant, poor PS patients with T790M mutation-positive advanced NSCLC. However, physicians should pay attention to relatively short PFS and adverse events such as ILD.
Clinical trial information: jRCTs061180018.
