2020
Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
Hudeček J, Voorwerk L, van Seijen M, Nederlof I, de Maaker M, van den Berg J, van de Vijver KK, Sikorska K, Adams S, Demaria S, Viale G, Nielsen TO, Badve SS, Michiels S, Symmans WF, Sotiriou C, Rimm DL, Hewitt SM, Denkert C, Loibl S, Loi S, Bartlett JMS, Pruneri G, Dillon DA, Cheang MCU, Tutt A, Hall JA, Kos Z, Salgado R, Kok M, Horlings HM. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials. Npj Breast Cancer 2020, 6: 15. PMID: 32436923, PMCID: PMC7217941, DOI: 10.1038/s41523-020-0155-1.Peer-Reviewed Original ResearchStromal tumor-infiltrating lymphocytesTriple-negative breast cancerMetastatic triple-negative breast cancerTumor-infiltrating lymphocytesClinical trialsBiomarker-driven clinical trialsPotential predictive biomarkersPotential risk factorsImmunotherapy trialsImmunotherapy responsePredictive biomarkersRisk factorsBreast cancerStratification factorsSpecific trialsIntegral biomarkerTrialsLymphocytesBiomarkersReliable assessmentReviewCancer
2019
Reanalysis of the NCCN PD-L1 companion diagnostic assay study for lung cancer in the context of PD-L1 expression findings in triple-negative breast cancer
Rimm DL, Han G, Taube JM, Yi ES, Bridge JA, Flieder DB, Homer R, Roden AC, Hirsch FR, Wistuba II, Pusztai L. Reanalysis of the NCCN PD-L1 companion diagnostic assay study for lung cancer in the context of PD-L1 expression findings in triple-negative breast cancer. Breast Cancer Research 2019, 21: 72. PMID: 31196152, PMCID: PMC6567382, DOI: 10.1186/s13058-019-1156-6.Peer-Reviewed Original ResearchConceptsPD-L1 expressionImmune cell PD-L1 expressionLung cancerImmune cellsTriple-negative breast cancerEasy scoring methodCompanion diagnostic testsPD-L1Immune therapyBreast cancerImmunohistochemical testsBetter outcomesLarger studyTumor cellsDiagnostic testsCancerExpression findingsCellsExpressionPoor agreementScoring methodTherapyTrialsCorrections to “Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial”
Shi W, Jiang T, Nuciforo P, Hatzis C, Holmes E, Harbeck N, Sotiriou C, Peña L, Loi S, Rosa DD, Chia S, Wardley A, Ueno T, Rossari J, Eidtmann H, Armour A, Piccart-Gebhart M, Rimm DL, Baselga J, Pusztai L. Corrections to “Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial”. Annals Of Oncology 2019, 30: 1018. PMID: 30624555, PMCID: PMC6594454, DOI: 10.1093/annonc/mdy530.Peer-Reviewed Original ResearchAddressing the dichotomy between individual and societal approaches to personalised medicine in oncology
Salgado R, Solit DB, Rimm DL, Bogaerts J, Canetta R, Lively T, Lyerly K, Span PN, Bateman-House A, Makady A, Bergmann L, Nagai S, Smith C, Robson M, Savage M, Voest E, Sweeney C, Lambin P, Thomas M, Harris L, Lacombe D, Massard C, Bernards R, Bogaerts J, Canetta R, Sullivan R, Tejpar S, Lukinova N, Lyerly H, Moore H, Smith M, Yee L, DuBois R, Hahn W, Janne P, Solit D, Willman C, Rimm D, Bateman-House A, Makady A, Bergmann L, Nagai S, Thomas M, Cree I, Hegde P, Hopper S, Smith C, Robson M, Savage M, Voest E, Sweeney C, Ingelman-Sundberg M, Nichols G, Maignen F, Besse B, Swierzewski R, Lambin P, Kiermaier A, Lacombe D, Lively T, Massard C, Caliguri M, Velculescu V, Foggi P, Hahn W, Lukinova N, Salgado R, Golfinopoulos V. Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology. European Journal Of Cancer 2019, 114: 128-136. PMID: 31060925, DOI: 10.1016/j.ejca.2019.03.025.Peer-Reviewed Original ResearchConceptsReal-world evidenceClinical trialsSystemic therapeutic interventionsNovel clinical trialsNovel trial designsCancer clinical researchComprehensive tumor profilingHealth care delivery systemTumor-derived DNAIndividual molecular profileCancer drug developmentGold standard approachPatient tumorsClinical utilityTrial designTherapeutic interventionsTumor profilingPatient advocatesClinical researchMolecular profileDrug developmentTrialsPhysician autonomyDelivery systemPatients
2018
correction to: Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial
Shi W, Jiang T, Nuciforo P, Hatzis C, Holmes E, Harbeck N, Sotiriou C, Peña L, Loi S, Rosa DD, Chia S, Wardley A, Ueno T, Rossari J, Eidtmann H, Armour A, Piccart-Gebhart M, Rimm DL, Baselga J, Pusztai L. correction to: Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial. Annals Of Oncology 2018, 29: 2152. PMID: 29701764, PMCID: PMC6225898, DOI: 10.1093/annonc/mdx805.Peer-Reviewed Original Research
2016
PD-L1 Expression in Lung Cancer
Yu H, Boyle TA, Zhou C, Rimm D, Hirsch FR. PD-L1 Expression in Lung Cancer. Journal Of Thoracic Oncology 2016, 11: 964-975. PMID: 27117833, PMCID: PMC5353357, DOI: 10.1016/j.jtho.2016.04.014.Peer-Reviewed Original ResearchConceptsPD-L1Lung cancerAnti-PD-1 drugsDifferent PD-L1 antibodiesPD-L1 protein expressionImmunotherapy clinical trialsAdvanced lung cancerPD-L1 expressionPD-L1 antibodiesSubset of patientsDeath ligand 1PD-L1 detectionBetter patient careClinical trialsPatient careProtein expressionHistory of useImmunohistochemistry platformBiomarkersImmunotherapyLigand 1PatientsCancerExpressionTrials
2011
p16 protein status and response to treatment in a prospective clinical trial (ECOG 2303) of patients with head and neck squamous cell carcinoma (HNSCC).
Psyrri A, Ghebremichael M, Pectasides E, Dimou A, Burtness B, Rimm D, Wanebo H, Forastiere A. p16 protein status and response to treatment in a prospective clinical trial (ECOG 2303) of patients with head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2011, 29: e16032-e16032. DOI: 10.1200/jco.2011.29.15_suppl.e16032.Peer-Reviewed Original ResearchCancer and Leukemia Group B Pathology Committee Guidelines for Tissue Microarray Construction Representing Multicenter Prospective Clinical Trial Tissues
Rimm DL, Nielsen TO, Jewell SD, Rohrer DC, Broadwater G, Waldman F, Mitchell KA, Singh B, Tsongalis GJ, Frankel WL, Magliocco AM, Lara JF, Hsi ED, Bleiweiss IJ, Badve SS, Chen B, Ravdin PM, Schilsky RL, Thor A, Berry DA. Cancer and Leukemia Group B Pathology Committee Guidelines for Tissue Microarray Construction Representing Multicenter Prospective Clinical Trial Tissues. Journal Of Clinical Oncology 2011, 29: 2282-2290. PMID: 21519016, PMCID: PMC3107745, DOI: 10.1200/jco.2010.33.2023.Peer-Reviewed Original ResearchConceptsMulti-institutional clinical trialsPractice-changing evidenceProportion of patientsCooperative Oncology GroupCooperative group studiesCompanion diagnostic testsCollection of tissuesOncology GroupClinical trialsPathology CommitteeStudy populationCommittee guidelinesSuch trialsDiagnostic testsBiomarker studiesGroup studyPrecious tissuePatientsCancerTissueNumber of assaysTrialsFacility directorsGuidelines