Clinical utility of reflex testing using focused next-generation sequencing for management of patients with advanced lung adenocarcinoma.
Clinical utility of reflex testing using focused next-generation sequencing for management of patients with advanced lung adenocarcinoma.
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DOI：
10.1136/jclinpath-2018-205396
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发表时间：
2018-12
影响因子：
3.4
通讯作者：
Sadri N
中科院分区：
文献类型：
--
作者：
Miller TE;Yang M;Bajor D;Friedman JD;Chang RYC;Dowlati A;Willis JE;Sadri N
越来越多的基因组靶向疗法使基因组测试成为非小细胞肺癌患者护理的重要组成部分。然而，有限的组织可用性、成本和较长的周转时间可能会对有效的基因组测试和后续治疗造成障碍。需要采取有效的方法来减少这些障碍。使用混合 DNA/RNA NGS 组合对来自克利夫兰大学医院医学中心 (UHCMC) 连续患者的 302 例晚期肺腺癌进行了内部测试。样本测试反映了所有 III 期或 IV 期肿瘤的病理学结果。基因组改变根据其临床相关性进行分级，并用指南推荐的治疗进行报告。通过手动图表审查评估基因组测试结果的临床意义。样本队列由 64% 的活检、16% 的切除/切除和 20% 的细针抽吸组成，该检测结果可靠，成功率为 95%。从收到未染色的 FFPE 载玻片到报告的平均周转时间为 4.8±2.1 天，是建议 10 天的一半，与单基因测试相似。 18% 的病例发现 FDA 批准的或 NCCN 指南推荐的靶向治疗发生了改变。在该组中，60% 的患者接受了基因组驱动的治疗。我们发现我们的反射式内部 NGS 检测可靠、经济高效且高效。将反射测试与我们的 NGS 检测相结合，成功地扩展了所有指南推荐的改变的基因组分析，并且通过在我们的面板中包含更多数量的改变，我们在不改变成本或效率的情况下获得了指南之外的临床有用信息。这种方法使 UHCMC 临床医生能够有效地为肺腺癌患者启动基因组驱动的治疗。
The growing number of genomically-targeted therapies has made genomic testing an important part of the care for patients with non-small cell lung cancer. However, limited tissue availability, cost, and long turn-around times can create barriers to efficient genomic testing and subsequent treatment. Effective approaches to reduce these barriers are needed. 302 advanced lung adenocarcinomas from consecutive patients seen at University Hospitals Cleveland Medical Center (UHCMC) were tested in-house using a hybrid DNA/RNA NGS panel. Sample testing was reflexed from pathology for all stage III or IV tumors. Genomic alterations were tiered according to their clinical relevance and reported with guideline-recommended therapies. Clinical implications of genomic testing results was assessed by manual chart review. With a sample cohort consisting of 64% biopsies, 16% excisions/resections, and 20% fine-needle aspirations, the assay was reliable with a 95% success rate. The average turn-around time from receipt of unstained FFPE slides to reporting was 4.8±2.1 days, half of the recommended 10 days and similar to single gene testing. Alterations with FDA-approved or NCCN guideline-recommended targeted therapies were found in 18% of cases. Within this group, 60% of patients went on genomically-driven therapies. We found our reflexed in-house NGS assay to be reliable, cost-effective, and efficient. Incorporation of reflex testing with our NGS assay led to an expansion of successful genomic profiling for all guideline recommended alterations and by including an expanded number of alterations within our panel, we obtained clinically useful information outside the guidelines without changing cost or efficiency. This approach has enabled UHCMC clinicians to efficiently initiate genomically-driven therapies for patients with lung adenocarcinoma.
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影响因子：
46.9
作者：
Frampton GM;Fichtenholtz A;Otto GA;Wang K;Downing SR;He J;Schnall-Levin M;White J;Sanford EM;An P;Sun J;Juhn F;Brennan K;Iwanik K;Maillet A;Buell J;White E;Zhao M;Balasubramanian S;Terzic S;Richards T;Banning V;Garcia L;Mahoney K;Zwirko Z;Donahue A;Beltran H;Mosquera JM;Rubin MA;Dogan S;Hedvat CV;Berger MF;Pusztai L;Lechner M;Boshoff C;Jarosz M;Vietz C;Parker A;Miller VA;Ross JS;Curran J;Cronin MT;Stephens PJ;Lipson D;Yelensky R
通讯作者：
Yelensky R
影响因子：
45.3
作者：
Blumenthal, Gideon M.;Karuri, Stella W.;Pazdur, Richard
通讯作者：
Pazdur, Richard
DOI：
10.1056/nejmoa1612674
发表时间：
2017-02-16
期刊：
The New England journal of medicine
影响因子：
--
作者：
Mok TS;Wu Y-L;Ahn M-J;Garassino MC;Kim HR;Ramalingam SS;Shepherd FA;He Y;Akamatsu H;Theelen WS;Lee CK;Sebastian M;Templeton A;Mann H;Marotti M;Ghiorghiu S;Papadimitrakopoulou VA;AURA3 Investigators
通讯作者：
AURA3 Investigators
影响因子：
4.1
作者：
Lindeman, Neat I.;Cagle, Philip T.;Yatabe, Yasushi
通讯作者：
Yatabe, Yasushi
DOI：
10.1056/nejmoa1507643
发表时间：
2015-10-22
期刊：
The New England journal of medicine
影响因子：
--
作者：
Borghaei H;Paz-Ares L;Horn L;Spigel DR;Steins M;Ready NE;Chow LQ;Vokes EE;Felip E;Holgado E;Barlesi F;Kohlhäufl M;Arrieta O;Burgio MA;Fayette J;Lena H;Poddubskaya E;Gerber DE;Gettinger SN;Rudin CM;Rizvi N;Crinò L;Blumenschein GR Jr;Antonia SJ;Dorange C;Harbison CT;Graf Finckenstein F;Brahmer JR
通讯作者：
Brahmer JR