Development and Validation of the Gene Expression Predictor of High-grade Serous Ovarian Carcinoma Molecular SubTYPE (PrOTYPE)
Standard
Development and Validation of the Gene Expression Predictor of High-grade Serous Ovarian Carcinoma Molecular SubTYPE (PrOTYPE). / Talhouk, Aline; George, Joshy; Wang, Chen; Budden, Timothy; Tan, Tuan Zea; Chiu, Derek S; Kommoss, Stefan; Leong, Huei San; Chen, Stephanie; Intermaggio, Maria P; Gilks, Blake; Nazeran, Tayyebeh M; Volchek, Mila; Elatre, Wafaa; Bentley, Rex C; Senz, Janine; Lum, Amy; Chow, Veronica; Sudderuddin, Hanwei; Mackenzie, Robertson; Leong, Samuel C Y; Liu, Geyi; Johnson, Dustin; Chen, Billy; Group, Aocs; Alsop, Jennifer; Banerjee, Susana N; Behrens, Sabine; Bodelon, Clara; Brand, Alison H; Brinton, Louise; Carney, Michael E; Chiew, Yoke-Eng; Cushing-Haugen, Kara L; Cybulski, Cezary; Ennis, Darren; Fereday, Sian; Fortner, Renée T; García-Donas, Jesús; Gentry-Maharaj, Aleksandra; Glasspool, Rosalind; Goranova, Teodora; Greene, Casey S; Haluska, Paul; Harris, Holly R; Hendley, Joy; Hernandez, Brenda Y; Herpel, Esther; Jimenez-Linan, Mercedes; Karpinskyj, Chloe; Kaufmann, Scott H; Keeney, Gary L; Kennedy, Catherine J; Köbel, Martin; Koziak, Jennifer M; Larson, Melissa C; Lester, Jenny; Lewsley, Liz-Anne; Lissowska, Jolanta; Lubiński, Jan; Luk, Hugh; Macintyre, Geoff; Mahner, Sven; McNeish, Iain A; Menkiszak, Janusz; Nevins, Nikilyn; Osorio, Ana; Oszurek, Oleg; Palacios, José; Hinsley, Samantha; Pearce, Celeste L; Pike, Malcolm C; Piskorz, Anna M; Ray-Coquard, Isabelle; Rhenius, Valerie; Rodriguez-Antona, Cristina; Sharma, Raghwa; Sherman, Mark E; De Silva, Dilrini; Singh, Naveena; Sinn, Peter; Slamon, Dennis; Song, Honglin; Steed, Helen; Stronach, Euan A; Thompson, Pamela J; Tołoczko, Aleksandra; Trabert, Britton; Traficante, Nadia; Tseng, Chiu-Chen; Widschwendter, Martin; Wilkens, Lynne R; Winham, Stacey J; Winterhoff, Boris; Beeghly-Fadiel, Alicia; Benitez, Javier; Berchuck, Andrew; Brenton, James D; Brown, Robert; Chang-Claude, Jenny; Chenevix-Trench, Georgia; deFazio, Anna; Fasching, Peter A; García, María J; Gayther, Simon A; Goodman, Marc T; Gronwald, Jacek; Henderson, Michelle J; Karlan, Beth Y; Kelemen, Linda E; Menon, Usha; Orsulic, Sandra; Pharoah, Paul D P; Wentzensen, Nicolas; Wu, Anna H; Schildkraut, Joellen M; Rossing, Mary Anne; Konecny, Gottfried E; Huntsman, David G; Huang, Ruby Yun-Ju; Goode, Ellen L; Ramus, Susan J; Doherty, Jennifer A; Bowtell, David D; Anglesio, Michael S.
in: CLIN CANCER RES, Jahrgang 26, Nr. 20, 15.10.2020, S. 5411-5423.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
Harvard
APA
Vancouver
Bibtex
}
RIS
TY - JOUR
T1 - Development and Validation of the Gene Expression Predictor of High-grade Serous Ovarian Carcinoma Molecular SubTYPE (PrOTYPE)
AU - Talhouk, Aline
AU - George, Joshy
AU - Wang, Chen
AU - Budden, Timothy
AU - Tan, Tuan Zea
AU - Chiu, Derek S
AU - Kommoss, Stefan
AU - Leong, Huei San
AU - Chen, Stephanie
AU - Intermaggio, Maria P
AU - Gilks, Blake
AU - Nazeran, Tayyebeh M
AU - Volchek, Mila
AU - Elatre, Wafaa
AU - Bentley, Rex C
AU - Senz, Janine
AU - Lum, Amy
AU - Chow, Veronica
AU - Sudderuddin, Hanwei
AU - Mackenzie, Robertson
AU - Leong, Samuel C Y
AU - Liu, Geyi
AU - Johnson, Dustin
AU - Chen, Billy
AU - Group, Aocs
AU - Alsop, Jennifer
AU - Banerjee, Susana N
AU - Behrens, Sabine
AU - Bodelon, Clara
AU - Brand, Alison H
AU - Brinton, Louise
AU - Carney, Michael E
AU - Chiew, Yoke-Eng
AU - Cushing-Haugen, Kara L
AU - Cybulski, Cezary
AU - Ennis, Darren
AU - Fereday, Sian
AU - Fortner, Renée T
AU - García-Donas, Jesús
AU - Gentry-Maharaj, Aleksandra
AU - Glasspool, Rosalind
AU - Goranova, Teodora
AU - Greene, Casey S
AU - Haluska, Paul
AU - Harris, Holly R
AU - Hendley, Joy
AU - Hernandez, Brenda Y
AU - Herpel, Esther
AU - Jimenez-Linan, Mercedes
AU - Karpinskyj, Chloe
AU - Kaufmann, Scott H
AU - Keeney, Gary L
AU - Kennedy, Catherine J
AU - Köbel, Martin
AU - Koziak, Jennifer M
AU - Larson, Melissa C
AU - Lester, Jenny
AU - Lewsley, Liz-Anne
AU - Lissowska, Jolanta
AU - Lubiński, Jan
AU - Luk, Hugh
AU - Macintyre, Geoff
AU - Mahner, Sven
AU - McNeish, Iain A
AU - Menkiszak, Janusz
AU - Nevins, Nikilyn
AU - Osorio, Ana
AU - Oszurek, Oleg
AU - Palacios, José
AU - Hinsley, Samantha
AU - Pearce, Celeste L
AU - Pike, Malcolm C
AU - Piskorz, Anna M
AU - Ray-Coquard, Isabelle
AU - Rhenius, Valerie
AU - Rodriguez-Antona, Cristina
AU - Sharma, Raghwa
AU - Sherman, Mark E
AU - De Silva, Dilrini
AU - Singh, Naveena
AU - Sinn, Peter
AU - Slamon, Dennis
AU - Song, Honglin
AU - Steed, Helen
AU - Stronach, Euan A
AU - Thompson, Pamela J
AU - Tołoczko, Aleksandra
AU - Trabert, Britton
AU - Traficante, Nadia
AU - Tseng, Chiu-Chen
AU - Widschwendter, Martin
AU - Wilkens, Lynne R
AU - Winham, Stacey J
AU - Winterhoff, Boris
AU - Beeghly-Fadiel, Alicia
AU - Benitez, Javier
AU - Berchuck, Andrew
AU - Brenton, James D
AU - Brown, Robert
AU - Chang-Claude, Jenny
AU - Chenevix-Trench, Georgia
AU - deFazio, Anna
AU - Fasching, Peter A
AU - García, María J
AU - Gayther, Simon A
AU - Goodman, Marc T
AU - Gronwald, Jacek
AU - Henderson, Michelle J
AU - Karlan, Beth Y
AU - Kelemen, Linda E
AU - Menon, Usha
AU - Orsulic, Sandra
AU - Pharoah, Paul D P
AU - Wentzensen, Nicolas
AU - Wu, Anna H
AU - Schildkraut, Joellen M
AU - Rossing, Mary Anne
AU - Konecny, Gottfried E
AU - Huntsman, David G
AU - Huang, Ruby Yun-Ju
AU - Goode, Ellen L
AU - Ramus, Susan J
AU - Doherty, Jennifer A
AU - Bowtell, David D
AU - Anglesio, Michael S
N1 - ©2020 American Association for Cancer Research.
PY - 2020/10/15
Y1 - 2020/10/15
N2 - PURPOSE: Gene expression-based molecular subtypes of high-grade serous tubo-ovarian cancer (HGSOC), demonstrated across multiple studies, may provide improved stratification for molecularly targeted trials. However, evaluation of clinical utility has been hindered by nonstandardized methods, which are not applicable in a clinical setting. We sought to generate a clinical grade minimal gene set assay for classification of individual tumor specimens into HGSOC subtypes and confirm previously reported subtype-associated features.EXPERIMENTAL DESIGN: Adopting two independent approaches, we derived and internally validated algorithms for subtype prediction using published gene expression data from 1,650 tumors. We applied resulting models to NanoString data on 3,829 HGSOCs from the Ovarian Tumor Tissue Analysis consortium. We further developed, confirmed, and validated a reduced, minimal gene set predictor, with methods suitable for a single-patient setting.RESULTS: Gene expression data were used to derive the predictor of high-grade serous ovarian carcinoma molecular subtype (PrOTYPE) assay. We established a de facto standard as a consensus of two parallel approaches. PrOTYPE subtypes are significantly associated with age, stage, residual disease, tumor-infiltrating lymphocytes, and outcome. The locked-down clinical grade PrOTYPE test includes a model with 55 genes that predicted gene expression subtype with >95% accuracy that was maintained in all analytic and biological validations.CONCLUSIONS: We validated the PrOTYPE assay following the Institute of Medicine guidelines for the development of omics-based tests. This fully defined and locked-down clinical grade assay will enable trial design with molecular subtype stratification and allow for objective assessment of the predictive value of HGSOC molecular subtypes in precision medicine applications.See related commentary by McMullen et al., p. 5271.
AB - PURPOSE: Gene expression-based molecular subtypes of high-grade serous tubo-ovarian cancer (HGSOC), demonstrated across multiple studies, may provide improved stratification for molecularly targeted trials. However, evaluation of clinical utility has been hindered by nonstandardized methods, which are not applicable in a clinical setting. We sought to generate a clinical grade minimal gene set assay for classification of individual tumor specimens into HGSOC subtypes and confirm previously reported subtype-associated features.EXPERIMENTAL DESIGN: Adopting two independent approaches, we derived and internally validated algorithms for subtype prediction using published gene expression data from 1,650 tumors. We applied resulting models to NanoString data on 3,829 HGSOCs from the Ovarian Tumor Tissue Analysis consortium. We further developed, confirmed, and validated a reduced, minimal gene set predictor, with methods suitable for a single-patient setting.RESULTS: Gene expression data were used to derive the predictor of high-grade serous ovarian carcinoma molecular subtype (PrOTYPE) assay. We established a de facto standard as a consensus of two parallel approaches. PrOTYPE subtypes are significantly associated with age, stage, residual disease, tumor-infiltrating lymphocytes, and outcome. The locked-down clinical grade PrOTYPE test includes a model with 55 genes that predicted gene expression subtype with >95% accuracy that was maintained in all analytic and biological validations.CONCLUSIONS: We validated the PrOTYPE assay following the Institute of Medicine guidelines for the development of omics-based tests. This fully defined and locked-down clinical grade assay will enable trial design with molecular subtype stratification and allow for objective assessment of the predictive value of HGSOC molecular subtypes in precision medicine applications.See related commentary by McMullen et al., p. 5271.
U2 - 10.1158/1078-0432.CCR-20-0103
DO - 10.1158/1078-0432.CCR-20-0103
M3 - SCORING: Journal article
C2 - 32554541
VL - 26
SP - 5411
EP - 5423
JO - CLIN CANCER RES
JF - CLIN CANCER RES
SN - 1078-0432
IS - 20
ER -