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Yuki Sato
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FP14 - Targeted Therapy - Clinically Focused (ID 252)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP14.16 - Phase 2 Trial of the Alternating Therapy with Osimertinib and Afatinib for Treatment-Naive Patients with EGFR-Mutated Advanced Non–Small Cell Lung Cancer (WJOG10818L/Alt Trial) (ID 3084)
00:00 - 00:00 | Author(s): Yuki Sato
- Abstract
- Presentation
Introduction
First-line therapy with an EGFR tyrosine kinase inhibitor (TKI) is standard of care for patients with EGFR-mutated NSCLC. Whereas osimertinib is sensitive to the acquired mutation T790M in 1st/2nd generation EGFR-TKI resistant patient, afatinib overcomes the resistance of osimertinib due to highly express HER2/HER3 or C797S mutations. Osimertinib and afatinib may deliver drug efficacy in a complement manner, therefore, we conducted the phase II clinical trial to evaluate the efficacy of alternative treatment strategy of osimertinib and afatinib.
Methods
Patients with treatment-naive stage IV EGFR-mutated (L858R or del19) NSCLC were enrolled. Orally osimertinib 80 mg once a day for 8 weeks, followed by afatinib 20 mg once a day for 8 weeks, which was repeated alternately. Primary endpoint was one-year PFS rate evaluated by investigators based on RECIST 1.1. A minimum of 36 evaluable patients were required for the lower limit of 60% confidence interval for 1 year PFS rate to be more than the threshold of 64% with power of 80%, where the expected was assumed to be 77%.
Results
From Nov 2018 to Feb 2019, 46 pts were enrolled and treated with study therapy. One-year PFS rate was 70.18% (60% CI: 63.9%-75.59%, 95% CI: 54.22%-81.48%), which didn’t meet primary endpoint. Thus, the actual 60% CI lower limit is 63.9% thus very close to the threshold. The ORR and one-year survival rate were 69.6% (95% CI: 54.2%-82.3%) and 93.48% (95% CI: 81.13%-97.85%), respectively. The most common treatment-related adverse effects (TRAEs) (% any grade, % grade 3) were diarrhea (73.9%, 4.3%), rash acneiform (63.0%, 2.2%) and paronychia (52.2%, 0%). Pneumonitis was observed in 5 patients, all of whom were being treated with osimertinib. Baseline heregulin level was not correlated with the efficacy. Plasma EGFR determined by digital PCR is under evaluation.
Conclusion
Although current study didn’t meet the primary endpoint of one-year PFS rate, alteration therapy with osimertinib and afatinib demonstrated promising efficacy and tolerability for first-line treatment of EGFR-mutated NSCLC. Clinical trial information: jRCTs051180009
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P37 - Pathology - Biomarker Testing (ID 107)
- Event: WCLC 2020
- Type: Posters
- Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P37.29 - Clinical Characteristics that Affect the Success Rate of BRAF-V600E Oncomine Dx Target Test (ID 1489)
00:00 - 00:00 | Presenting Author(s): Yuki Sato
- Abstract
Introduction
BRAF-V600E is detected in 1-2% of lung adenocarcinoma, and dabrafenib plus trametinib combination therapy exhibited robust efficacy in clinical trials. In Japan, the companion diagnostic (CDx) for BRAF-V600E is Oncomine Dx Target Test, that utilizes NGS platform. However, the success rate is unsatisfactory for routine clinical use. Herein, we conducted a retrospective study to investigate the characteristics that affect the success rate of BRAF-V600E Oncomine Dx Target Test.
Methods
We retrospectively analyzed patients whose tumor specimens were submitted for BRAF-V600E Oncomine Dx Target Test at our institute between July 2018 and October 2019. Clinical data including specimen types, tumor cell number on HE slides, tumor content on HE slides, and FFPE storage time were collected.
Results
In total, 118 patients were included in this study. Overall success rate was 85%. The reason of failure was low amount of DNA (8%, n=10) and NGS analysis error (7%, n=8). By specimen types, success rate was 100% for surgically resected specimens, 76% for TBB specimens, and 89% for TBNA specimens. As for tumor cell number on HE slides, success rate of specimens with >200 tumor cells was 90%, whereas that of specimens with ≦200 tumor cells was 59% (p=0.001). As for tumor content on HE slides, success rate of specimens with ≧30% tumor content was 84%, and that of specimens with ＜30% tumor content was 65% (p=0.082). FFPE storage time did not affect the success rate.
Conclusion
Tumor specimens with ≦200 tumor cells on HE slides might be unsuitable for BRAF-V600E Oncomine Dx Target Test.
