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Hibiki Udagawa
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OA01 - Advanced Diagnostic Approaches for Intrathoracic Lymph Nodes and Peripheral Lung Tumors (ID 117)
- Event: WCLC 2019
- Type: Oral Session
- Track: Interventional Diagnostics/Pulmonology
- Presentations: 1
- Now Available
- Moderators:Marioara Simon, Tim Murgu
- Coordinates: 9/08/2019, 10:30 - 12:00, Melbourne (1991)
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OA01.05 - Cryobiopsy Compared with Forceps Biopsy in Pathological Diagnosis and Biomarker Research in Lung Cancer: A Prospective, Single-Arm Study (Now Available) (ID 1564)
10:30 - 12:00 | Author(s): Hibiki Udagawa
- Abstract
- Presentation
Background
Cryobiopsy is a novel transbronchial biopsy tool that enables the collection of larger samples than forceps biopsy. We evaluated the usefulness of cryobiopsy compared with forceps biopsy in pathological diagnosis and biomarker research in lung cancer.
Method
In this prospective single-arm study, 121 patients with or suspected of having lung cancer underwent concurrent transbronchial biopsy using a cryoprobe (ERBECRYO2) and forceps from the same lesion. Sample size and morphological classification were determined for patients whose cryobiopsy and forceps biopsy samples both contained tumor cells (n = 81). Patients diagnosed with non-small-cell lung carcinoma (NSCLC) with adequate samples from the two procedures (n = 65) were analyzed for programmed death ligand 1 (PD-L1) expression score (22C3). Genomic DNA and RNA were extracted from cryobiopsy and forceps biopsy formalin-fixed paraffin-embedded samples (20 NSCLC patients, 20 sections, 10 µm thick each) for whole-exome sequencing and RNA sequencing.
Result
Cryobiopsy samples were significantly larger than forceps biopsy samples (median 11.1 mm2[range: 3.3–135.0] vs. 2.0 mm2[0.7–6.6], p < 0.01). The confirmation rate of morphological classification of cryobiopsy samples was significantly higher than that of forceps biopsy samples (86% vs. 79%, p < 0.01, adenocarcinoma/squamous-cell carcinoma/small-cell carcinoma/other = 35/19/12/4 and 30/15/11/4, respectively). The success rate for evaluating PD-L1 score using cryobiopsy and forceps biopsy samples was 94% and 95%, respectively. A greater proportion of cryobiopsy samples tended to have PD-L1 > 1% than forceps biopsy samples (51% vs. 42%, p = 0.06). Significantly larger amounts of DNA (median 1.60μg vs. 0.58μg, p = 0.02) and RNA (median 0.62μg vs. 0.17μg, p < 0.01) were extracted from cryobiopsy samples than forceps biopsy samples. The success rate for whole-exome sequencing (90% vs. 15%, p < 0.01) and RNA sequencing (75% vs. 10%, p < 0.01) was higher for cryobiopsy samples than forceps biopsy samples. The median tumor-mutation burden in cryobiopsy samples was 84 (range 3–2396).
Conclusion
Cryobiopsy provided larger sample sizes compared with forceps biopsy, and were more useful for morphological classification, PD-L1 evaluation and genetic analysis.
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OA07 - Precision Medicine Involves Biology and Patients (ID 132)
- Event: WCLC 2019
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Silvia Novello, Fabrice Barlesi
- Coordinates: 9/09/2019, 11:00 - 12:30, Copenhagen (1980)
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OA07.03 - Clinical Outcome of Non-Small Cell Lung Cancer with EGFR/HER2 Exon 20 Insertions Identified in the LC-SCRUM-Japan (Now Available) (ID 629)
11:00 - 12:30 | Presenting Author(s): Hibiki Udagawa
- Abstract
- Presentation
Background
In-frame insertions in exon 20 (Ex20ins) of EGFR/HER2 occur in 2-5 % of non-small cell lung cancer (NSCLC). There is no approved targeted therapy for patients with these mutations. Historical control data would be valuable for the development of novel targeted therapies for these rare cancers.
Method
A nationwide genome screening project in Japan (LC-SCRUM-Japan) has been established for the development of molecular-targeted therapies for lung cancers. In this project, 161 cancer-related genes have been analyzed by a next-generation sequencing (NGS) system, Oncomine™ Comprehensive Assay. The therapeutic efficacy and survival of the patients with non-squamous (non-sq) NSCLC harboring EGFR/HER2 Ex20ins were evaluated using a large-scale clinico-genomic database in the LC-SCRUM-Japan.
Result
A total of 3441 advanced non-sq NSCLC patients were successfully analyzed from 2015 to 2018. EGFR Ex20ins were detected in 73 patients (2%; M766_A767insASV/A767_S768insSVD/H773_V774insH/D770_N771insNPH/N771_P772insPH/others=22/17/5/4/4/21) and HER2 Ex20ins were detected in 128 patients (4%; A775_G776insYVMA/G776delinsVC/P780_Y781insGSP/others=95/16/10/7). The median age of the patients was 62 (range, 33-90) years. Eighty-one patients (40%) were male and 114 (57%) were never smoker. Two-hundred patients (99%) were diagnosed as adenocarcinoma and 1 as adenosquamous-cell carcinoma. Based on our database, the median overall survivals in patients with EGFR Ex20ins were 22.4 (95%CI, 15.3-36.8) months, and those with HER2 Ex20ins were 18.8 (13.6-30.3) months. In the patients with EGFR/HER2 Ex20ins, the objective response rate (ORR) and median progression-free survivals (mPFS) of 1st-line platinum-containing chemotherapies were 32% and 6.0 (5.7-7.0) months, respectively. The ORR and mPFS of docetaxel with or without ramucirumab were 26% and 5.1 (3.8-5.9) months, respectively. The ORR and mPFS of PD-1 inhibitor were 0% and 2.0 (1.6-2.6) months, respectively. No significant difference in the therapeutic efficacy of these drugs was observed between the patients with EGFR Ex20ins and HER2 Ex20ins. In 19 patients with EGFR Ex20ins treated with 1st/2nd generation EGFR-TKIs, the ORR was 5% (a M766_A767insASV-positive tumor responded to afatinib) and the mPFS was 2.1 (1.3-4.2) months.
Conclusion
The patients with EGFR/HER2 Ex20ins-positive NSCLC showed poor responses to PD-1 inhibitors and 1st/2nd generation EGFR-TKIs. These historical data are highly informative in evaluating the efficacy of novel targeted therapies for EGFR/HER2 Ex20ins-positive NSCLC.
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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.04-72 - Clinical Feature and Management of Acquired Resistance to PD-1 Inhibitor in Advanced NSCLC (ID 1343)
10:15 - 18:15 | Author(s): Hibiki Udagawa
- Abstract
Background
Programmed cell death-1(PD-1) inhibitors have emerged as a standard treatment for patients with advanced non-small cell lung cancer (NSCLC). However, the patterns of disease progression (PD) after an initial response (acquired resistance) to a PD-1 inhibitor and the efficacy of continuous PD-1 inhibitor therapy beyond PD remain unclear.
Method
We retrospectively reviewed medical charts of advanced NSCLC patients treated with nivolumab or pembrolizumab as any line treatment at National Cancer Center Hospital East between January 2016 and October 2017. Acquired resistance was defined as disease progression after 6 months or more of treatment with a PD-1 inhibitor. Isolated disease progression was defined as progression in 1 site or organ, whereas systemic progression involved >1 site or organ. The clinical feature, PD pattern of acquired resistance, subsequent treatment and survival after acquired resistance were investigated.
Result
Fifty-nine patients were treated with a PD-1 inhibitor for 6 months or more, of whom 27 patients (46%) had acquired resistance. Only 1 patient received a PD-1 inhibitor as fist-line treatment. Twelve patients were diagnosed as adenocarcinoma, 4 as squamous-cell carcinoma and 11 as NSCLC-NOS. The response at 6 months of treatment was partial response in 17 patients (63%) and stable disease in 10 patients (37%). The median time to acquired resistance was 12.2 (95%CI 9.3-17.8) months. Progression in the lesion identified at baseline was observed in 16 patients (59%), new lesions appeared in 4 patients (15%) and both of them occurred in 7 patients (26%). Overall, the most frequent progression site was lung (n=14, 52%), followed by thoracic lymph node (n=7, 26%), pleura (n=6, 22%) and brain (n=4, 15%). The median number of progressed lesions was 2 and 67% of patients had progression limited to one (30%) or two (37%) lesions. Ten patients (37%) had isolated disease progression in lung (n=3), brain (n=3), thoracic lymph node (n=2), neck lymph node (n=1) and adrenal (n=1). In 11 patients, PD-1 inhibitor therapy was continued beyond PD with (n=4) or without local radiotherapy (n=7). The median OS after acquired resistance in patients with or without continuous PD-1 inhibitor therapy beyond PD was 9.9 months and 10.7 months, respectively.
Conclusion
Our results suggest that the most common pattern of acquired resistance to a PD-1 inhibitor was progression of thoracic lesion identified at baseline. One-third of the patients had isolated disease progression. The efficacy of continuous PD-1 inhibitor therapy beyond PD might be limited.
