Biomarker testing for personalized, first-line therapy in advanced nonsquamous non-small cell lung cancer patients in the real world setting in Japan: a retrospective, multicenter, observational study (the BRAVE study)

Shimizu, Junichi; Masago, Katsuhiro; Saito, Haruhiro; Nishino, Kazumi; Kurata, Takeshi; Itoh, Yoshio; Yoshimura, Yoko; Yabuki, Yutaka; Dosaka‐Akita, Hirotoshi

doi:10.1177/1758835920904522

Cited by 23 publications

(28 citation statements)

References 7 publications

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“…Moreover, it takes more time before ordering Oncomine Dx because a pathological check is still required to assess the quality of tissue samples, unlike Cobas EGFR. A previous study reported the median time from the confirmation of NSCLC diagnosis to the initiation of first‐line treatment was 19 days 7 . Therefore, 13 days as the median TAT of Oncomine Dx is relatively long.…”

Section: Discussionmentioning

confidence: 94%

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Feasibility of next‐generation sequencing test for patients with advanced NSCLC in clinical practice

et al. 2020

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Background The usefulness of the Oncomine Dx Target test (Oncomine Dx), a next‐generation sequencing (NGS) test, has already been proven in clinical trials. However, NGS requires high‐quality tumor samples and takes a long time to generate results. The feasibility of NGS for use in advanced non‐small cell lung cancer (NSCLC) patients in clinical practice has not yet been determined. Methods Patients serially diagnosed with advanced NSCLC were evaluated in our hospital. The Oncomine Dx, Cobas EGFR mutation test (Cobas EGFR), and ALK‐IHC were performed. The patients were divided into four sets: the full analysis set (FAS) that referred to patients diagnosed with NSCLC, the intent to perform companion diagnostics (CDx) set (IPS) that referred to patients in which CDx had been ordered regardless of sample quality, the per‐performed CDx set (PPS) that referred to patients who could undergo CDx regardless of the results, and the per‐completed CDx set (CCS) that referred to patients in which informative results were received from the CDx. Results The total number of patients analyzed in the study was 167. The IPS/FAS of Oncomine Dx (80.2%) was lower than that of the ALK‐IHC (85.0%) and Cobas EGFR (92.8%). The CCS/FAS of Oncomine Dx (65.9%) was lower than that of the ALK‐IHC (82.0%) and Cobas EGFR (92.2%). PPS/IPS and CCS/PPS of the Oncomine Dx with nonsurgical biopsy ranged between 78.6% and 90.9%, which was lower than those patients who underwent surgical resection (95.0% and 100%). Conclusions The feasibility of Oncomine Dx in clinical practice was lower than the other CDx. The feasibility of Oncomine Dx will increase by improving the biopsy procedure. Key points Significant study findings The usefulness of a next‐generation sequencing (NGS) test has been proven in clinical trials. The feasibility of NGS is lower than other diagnostics in clinical practice especially with regard to nonsurgical biopsy. What this study adds It is necessary to improve the feasibility of NGS in clinical practice. To improve NGS feasibility, turnaround time must be shortened, and larger samples must be obtained during surgical procedures.

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Section: Discussionmentioning

confidence: 94%

“…Therefore, performing several singleplex CDx became necessary to select the precise treatment for each patient. This led to increasing tissue consumption and longer turnaround time (TAT) before starting first‐line chemotherapy 6,7 …”

Section: Introductionmentioning

confidence: 99%

Feasibility of next‐generation sequencing test for patients with advanced NSCLC in clinical practice

et al. 2020

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“…A recent study reported PD-L1 TPS ≥50% rates of 29 and 26.2% in tested nonsquamous and squamous patients, respectively [30]. In the overall population testing rates for EGFR, ALK and ROS1 were 87, 66 and 47%, respectively (data not shown), slightly lower than another study which found 98% testing rate for EGFR and 88% for ALK [31], and of those with a positive genomic aberration, 93% received TKI treatment. The percentage of patients with an EGFR (19%) or ALK (4%) aberrations were similar to a recently published study [32].…”

Section: Discussionmentioning

confidence: 73%

Real-World Study of PD-L1 Testing Patterns and Treatment Distribution in Patients with Metastatic Non-Small-Cell Lung Cancer in Israel

et al. 2021

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Aim: We describe PD-L1 testing patterns and first-line treatment for patients with metastatic non-small-cell lung cancer in a 2.3 million-member state-mandated health service in Israel. Materials & methods: Newly diagnosed stage IV non-small-cell lung cancer patients initiating systemic anticancer treatment from 1 January 2017 until 31 December 2018 were identified from the national cancer registry and Maccabi Healthcare Service database and followed until 30 June 2019. Results: The cohort consisted of 410 patients; 58% males, median age 68 years, 70% current/former smokers, 81% adenocarcinoma, 14% had brain metastases, and Eastern Cooperative Oncology Group performance status was 46/17/37% for 0–1/2–4/unknown, respectively. A total of 80% tested for PD-L1 expression, of which 47% had tumor proportion score (TPS) ≥ 50%. A total of 95% with TPS ≥ 50% and no known tumor aberrations (including EGFR mutations, and translocations in ALK and ROS1) received first-line PD-1/PD-L1-inhibitor monotherapy, and 80% of untested/TPS < 50% received platinum doublets. Conclusion: Fast uptake of testing was observed, and treatment patterns showed high adherence to guidelines.

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“…This is concerning given that the Japan Lung Cancer Society recommends simultaneous testing of multiple diagnostic biomarkers. 5,11 The higher frequency of simultaneous testing in the BRAVE study (31.7% for EGFR/ALK/ROS1/ PD-L1) 11 may suggest that simultaneous testing is more common in larger, specialized centers than in the smaller hospitals included from a nationwide perspective. The use of single biomarker versus simultaneous testing may be an important testing barrier in which different individual biomarkers are prioritized in a situation influenced by limited tissue sample availability.…”

Section: Discussionmentioning

confidence: 99%

“…Data from the observational BRAVE study in Japan also revealed that the testing rate for first-line treatment decisions for NSCLC in 2017 was highest for EGFR (97.5%) and lowest for ROS1 (67.3%), although the testing rates were similar for ALK (88.1%) and PD-L1 (87.1%). 11 Low testing rates for ROS1 may be due to some centers only testing for ROS1 if results for EGFR and ALK are negative, as these biomarkers are mutually exclusive. 11 However, the BRAVE study focused on clinical records from a relatively small number of patients (N = 202) from 11 medical centers in Japan, 11 whereas ours is a larger study using nationwide claims data over a longer time period (June 2017 to November 2018, compared with January 2018 to May 2018 in the BRAVE study 11 ), and is therefore more likely to provide a broader view reflecting real-world practice throughout Japan.…”

Section: Discussionmentioning

confidence: 99%

Real-World Evidence of Diagnostic Testing for Driver Oncogene Mutations in Lung Cancer in Japan

Yatabe

Yoshiki

Matsumura

et al. 2021

JTO Clinical and Research Reports

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Introduction: Diagnostic testing is important in determining appropriate treatment for individuals with lung cancer. In 2018, testing of five biomarkers (EGFR, ALK, ROS1, BRAF, programmed cell death-ligand 1 [PD-L1]) was approved in Japan. Information is lacking regarding realworld testing patterns.Methods: This descriptive, retrospective observational study used the Japan Medical Data Vision Co., Ltd. (MDV), database (June 2017-November 2018) and covered data for EGFR, ALK, ROS1, and PD-L1; records on BRAF testing were not yet available. Adults diagnosed with having lung cancer (International Classification of Diseases-10 C34) with record of any biomarker test ordered were included.Results: Of 8323 patients with any biomarker test, 83.2% were tested for EGFR, 55.3% for ALK, 32.2% ROS1, and 77.2% PD-L1. Combinations of EGFR with other biomarkers accounted for approximately 80% of the testing patterns; 1427 patients (17.1%) had combination testing ordered for EGFR/ALK/ROS1/PD-L1, but some biomarker combinations were tested in less than 1% of the cases. Median time from first testing order to treatment order was 22 (range: 2-525) days overall and increased with number of testing instances: 21 (2-509) days for patients with one, 28 (3-525) days for patients with two, and 30 (9-502) days for patients with three. A 7-day pattern of peaks was observed in the test order date and time to treatment.Conclusions: This real-world evidence revealed variations in diagnostic testing patterns, which could affect time to treatment in Japan. Variations are likely influenced by individual biomarker prioritization considering limited tissue samples in clinical practice.

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Biomarker testing for personalized, first-line therapy in advanced nonsquamous non-small cell lung cancer patients in the real world setting in Japan: a retrospective, multicenter, observational study (the BRAVE study)

Cited by 23 publications

References 7 publications

Feasibility of next‐generation sequencing test for patients with advanced NSCLC in clinical practice

Feasibility of next‐generation sequencing test for patients with advanced NSCLC in clinical practice

Real-World Study of PD-L1 Testing Patterns and Treatment Distribution in Patients with Metastatic Non-Small-Cell Lung Cancer in Israel

Real-World Evidence of Diagnostic Testing for Driver Oncogene Mutations in Lung Cancer in Japan

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