Abstract 4021
Background
In the recent years, there has been an increased incorporation of research biopsies in clinical trials and translational research. However, limited information is available on the determinants of sample quality, which could help identifying parameters for successful biopsy ascertainment.
Methods
Data from all consecutive patients who had one or more research biopsies at our institution as part of a phase I-III trials and/or translational research projects approved by Ethics Committee from January 2017 to December 2018 were extracted and analyzed.
Results
A total of 1517 procedures were performed in 979 consenting patients, reaching in total 3811 tissue samples (71% at screening and 29% on-treatment or at progression) with an average of 2.5 samples per procedure. Tumor biopsies were obtained under ultrasound (60%), computed tomography (12%) guidance or non-guided (28%). Samples were formalin-fixed and paraffin embedded (FFPE, 48%), snap frozen (20%) or alternatively stabilized (32%) according to study protocol. Tumor content (TC) was determined in 1514 FFPE samples: 90% of them had tumor cells, 81% showed more than 10% TC and 59% more than 50% TC. No significant difference in TC was found between screening and on-treatment biopsies (p = 0.12). Sample quality was negatively affected by biopsy site (<10% TC rates in non-visceral vs visceral were 26% vs 14%, respectively, p<.0001), method (non-guided vs guided, 37% vs 17%, p<.0001), and operator expertise (<50 vs > 50 biopsies x year, 31% vs 16.5%, p<.0001). In a multivariate logistic model, biopsy site and method were independent determinants of poor sample quality (<10% TC). Within the same biopsy procedure, inter-sample variability was low with 77% of samples showing between 0% to 30% difference in TC. Among 134 intra-trial sequential biopsies with available TC assessment, only 25% pairs were not suitable for performing downstream comparative analyses (<10% TC).
Conclusions
Our experience provides important information to improve research biopsy effectiveness in a biomarker program linked to clinical trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
P.G. Nuciforo: Honoraria (self): Bayer; Honoraria (self): Novartis; Honoraria (self): MSD. C. Saura: Advisory / Consultancy: AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Roche, Genomic health, Novartis, Pfizer, Pierre Fabre, Puma, Synthon and Sanofi; Travel / Accommodation / Expenses: AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Roche, Genomic health, Novartis, Pfizer, Pierre Fabre, Puma, Synthon and Sanofi. E. Elez: Honoraria (self): Hoffman La-Roche, Bristol Myers Squibb, Servier, Amgen, Merck Serono, Array, Sanofi; Advisory / Consultancy: Hoffman La-Roche, Bristol Myers Squibb, Servier, Amgen, Merck Serono, Array, Sanofi; Research grant / Funding (self): Hoffman La-Roche, Bristol Myers Squibb, Servier, Amgen, Merck Serono, Array, Sanofi; Honoraria (institution): Array, MSD, Abbvie, Amgen, GSK, AstraZeneca, Bristol Myers Squibb, Novartis, Boehringer, Ingelheim, Hoffman La-Roche.. E. Felip: Speaker Bureau / Expert testimony: AbbVie, AstraZeneca, Blueprint medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Medscape, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Touchtime.; Advisory / Consultancy: AbbVie, AstraZeneca, Blueprint medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Guardant Health, Janssen, Medscape, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Touchtime.; Research grant / Funding (institution): Fundación Merck Salud, Grant for Oncology Innovation EMD Serono. A. Oaknin: Advisory / Consultancy: Roche, AstraZeneca, PharmaMar, Clovis Oncology, Tesaro, Inmunogen and Genmab; Travel / Accommodation / Expenses: Roche, AstraZeneca, and PharmaMar. E. Muñoz-Couselo: Advisory / Consultancy: Amgen, Bristol-Myers Squibb, Merck, Sharp & Dohme, Novartis, Pierre Fabre, and Roche; Honoraria (self): Amgen, Bristol-Myers Squibb, Merck, Sharp & Dohme, Novartis, Pierre Fabre, Sanofi and Roche ; Leadership role, Clinical trial participation (principal investigator): Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Sharp & Dohme, Novartis, Pierre Fabre, and Roche. T. Macarulla Mercade: Advisory / Consultancy: Shire Pharmaceuticals, Roche, Tesaro, Batxer, Sanofi, Celgene, QED Therapeutics, Genzyme Europe, Baxalta, Bayer, Incyte, Genzyme ; Travel / Accommodation / Expenses: from Merck, H3 Biomedicine, Bayer, Sanofi. M. Alsina Maqueda: Advisory / Consultancy: Servier, Lilly, BMS and MS. Honoraria for speaking issues from Servier, BMS, MSD, Lilly, Roche and Amge; Travel / Accommodation / Expenses: Servier, Roche, Amgen and Lilly. J. Carles: Advisory / Consultancy: Bayer / Johnson & Johnson / Bristol-Myers Squibb / Astellas Pharma / Pfizer / Sanofi / MSD Oncology / Roche/ AstraZéneca; Speaker Bureau / Expert testimony: Bayer / Johnson & Johnson / Asofarma / Astellas Pharma; Research grant / Funding (institution): AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, INC, Astellas Pharma., AstraZeneca AB, Aveo Pharmaceuticals INC, Bayer AG, Blueprint Medicines Corporation, BN Immunotherapeutics INC, Boehringer Ingelheim España, S.A., Bristol-Myers Squibb Inter. R. Dienstmann: Advisory / Consultancy: Roche; Research grant / Funding (self): Merck. J. Tabernero: Advisory / Consultancy: Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Part. E. Garralda: Advisory / Consultancy: F.Hoffmann-La Roche, Ellipses Pharma, Neomed Therapeutics1 Inc, Boehringer Ingelheim, Janssen Global Services, ; Speaker Bureau / Expert testimony: Bristol-Mayers Squibb ; Travel / Accommodation / Expenses: Merck Sharp & Dohme, Glycotope, Menarini; Research grant / Funding (self), Scitron Project - VHIO Technology : Novartis; Research grant / Funding (institution), Clinical Trial Principal Investigator: Principia Biopharma Inc, Lilly, S.A, Novartis, Genentech, Loxo Oncologi Inc, F.Hoffmann-La Roche Ltd, Symphogen A/S, Merck, Sharp & Dohme de España, S.A, Incyte Biosciences International, Pharma Mar, S.A.U, Kura Oncology Inc, Macrogenics Inc, Glycotope G; Leadership role: ESMO Women for Oncology - W4O. All other authors have declared no conflicts of interest.
Resources from the same session
1242 - Monalizumab in combination with cetuximab in patients (pts) with recurrent or metastatic (R/M) head and neck cancer (SCCHN) previously treated or not with PD-(L)1 inhibitors (IO): 1-year survival data.
Presenter: Roger Cohen
Session: Poster Display session 3
Resources:
Abstract
4703 - Updated results of a phase II study evaluating accelerator-based boron neutron capture therapy (AB-BNCT) with borofalan(10B) (SPM-011) in recurrent squamous cell carcinoma (R-SCC-HN) and recurrent and locally advanced non-SCC (R/LA-nSCC-HN) of the head and neck
Presenter: Katsumi Hirose
Session: Poster Display session 3
Resources:
Abstract
3638 - Phase 3 KEYNOTE-048 Study of First-Line (1L) Pembrolizumab (P) for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC): Asia vs Non-Asia Subgroup (subgrp) Analysis
Presenter: Makoto Tahara
Session: Poster Display session 3
Resources:
Abstract
2954 - Integrated data review evaluating safety, pharmacokinetics (PK) and immunogenicity of RM-1929 photoimmunotherapy (PIT) in subjects with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC).
Presenter: Jennifer Johnson
Session: Poster Display session 3
Resources:
Abstract
3629 - First line versus second line immunotherapy in recurrent/metastatic squamous cell carcinoma of the head and neck
Presenter: Caroline Even
Session: Poster Display session 3
Resources:
Abstract
767 - Sensitizing HRAS overexpressing head and neck squamous cell carcinoma (HNSCC) to chemotherapy
Presenter: Theodoros Rampias
Session: Poster Display session 3
Resources:
Abstract
4985 - A Single-Arm, Open-Label, Multicenter, Phase IIIb Clinical Trial with Nivolumab in Subjects with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck.
Presenter: Paolo Bossi
Session: Poster Display session 3
Resources:
Abstract
1564 - Long-term Results of Phase 2 Trial of Reduced Modified Clinical Target Volume in Low-risk Nasopharyngeal Carcinoma Treated with Intensity Modulated Radiotherapy
Presenter: Jingjing Miao
Session: Poster Display session 3
Resources:
Abstract
3356 - To compare two oral mucosa contouring methods in predicting acute oral mucocitis in nasopharyngeal carcinoma treated with helical tomotherapy
Presenter: Yuan-Yuan Chen
Session: Poster Display session 3
Resources:
Abstract
1984 - Induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT) in nasopharyngeal carcinoma (NPC)
Presenter: Gizem Kaval
Session: Poster Display session 3
Resources:
Abstract