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1. Image-based multiplex immune profiling of cancer tissues: translational implications. A report of the International Immuno-oncology Biomarker Working Group on Breast Cancer

Author

Jahangir, CA, Page, DB, Broeckx, G, Gonzalez, CA, Burke, C, Murphy, C, Reis-Filho, JS, Ly, A, Harms, PW, Gupta, RR, Vieth, M, Hida, A, Kahila, M, Kos, Z, van Diest, PJ, Verbandt, S, Thagaard, J, Khiroya, R, Abduljabbar, K, Haab, GA, Acs, B, Adams, S, Almeida, JS, Alvarado-Cabrero, I, Azmoudeh-Ardalan, F, Badve, S, Baharun, NB, Bellolio, ER, Bheemaraju, V, Blenman, KRM, Fujimoto, LBM, Burgues, O, Chardas, A, Cheang, MCU, Ciompi, F, Cooper, LAD, Coosemans, A, Corredor, G, Portela, FLD, Deman, F, Demaria, S, Dudgeon, SN, Elghazawy, M, Fernandez-Martin, C, Fineberg, S, Fox, SB, Giltnane, JM, Gnjatic, S, Gonzalez-Ericsson, P, Grigoriadis, A, Halama, N, Hanna, MG, Harbhajanka, A, Hart, SN, Hartman, J, Hewitt, S, Horlings, HM, Husain, Z, Irshad, S, Janssen, EAM, Kataoka, TR, Kawaguchi, K, Khramtsov, A, Kiraz, U, Kirtani, P, Kodach, LL, Korski, K, Akturk, G, Scott, E, Kovacs, A, Laenkholm, A-V, Lang-Schwarz, C, Larsimont, D, Lennerz, JK, Lerousseau, M, Li, X, Madabhushi, A, Maley, SK, Narasimhamurthy, VM, Marks, DK, McDonald, ES, Mehrotra, R, Michiels, S, Kharidehal, D, Minhas, FUAA, Mittal, S, Moore, DA, Mushtaq, S, Nighat, H, Papathomas, T, Penault-Llorca, F, Perera, RD, Pinard, CJ, Pinto-Cardenas, JC, Pruneri, G, Pusztai, L, Rajpoot, NM, Rapoport, BL, Rau, TT, Ribeiro, JM, Rimm, D, Vincent-Salomon, A, Saltz, J, Sayed, S, Hytopoulos, E, Mahon, S, Siziopikou, KP, Sotiriou, C, Stenzinger, A, Sughayer, MA, Sur, D, Symmans, F, Tanaka, S, Taxter, T, Tejpar, S, Teuwen, J, Thompson, EA, Tramm, T, Tran, WT, van Der Laak, J, Verghese, GE, Viale, G, Wahab, N, Walter, T, Waumans, Y, Wen, HY, Yang, W, Yuan, Y, Bartlett, J, Loibl, S, Denkert, C, Savas, P, Loi, S, Stovgaard, ES, Salgado, R, Gallagher, WM, Rahman, A, Jahangir, CA, Page, DB, Broeckx, G, Gonzalez, CA, Burke, C, Murphy, C, Reis-Filho, JS, Ly, A, Harms, PW, Gupta, RR, Vieth, M, Hida, A, Kahila, M, Kos, Z, van Diest, PJ, Verbandt, S, Thagaard, J, Khiroya, R, Abduljabbar, K, Haab, GA, Acs, B, Adams, S, Almeida, JS, Alvarado-Cabrero, I, Azmoudeh-Ardalan, F, Badve, S, Baharun, NB, Bellolio, ER, Bheemaraju, V, Blenman, KRM, Fujimoto, LBM, Burgues, O, Chardas, A, Cheang, MCU, Ciompi, F, Cooper, LAD, Coosemans, A, Corredor, G, Portela, FLD, Deman, F, Demaria, S, Dudgeon, SN, Elghazawy, M, Fernandez-Martin, C, Fineberg, S, Fox, SB, Giltnane, JM, Gnjatic, S, Gonzalez-Ericsson, P, Grigoriadis, A, Halama, N, Hanna, MG, Harbhajanka, A, Hart, SN, Hartman, J, Hewitt, S, Horlings, HM, Husain, Z, Irshad, S, Janssen, EAM, Kataoka, TR, Kawaguchi, K, Khramtsov, A, Kiraz, U, Kirtani, P, Kodach, LL, Korski, K, Akturk, G, Scott, E, Kovacs, A, Laenkholm, A-V, Lang-Schwarz, C, Larsimont, D, Lennerz, JK, Lerousseau, M, Li, X, Madabhushi, A, Maley, SK, Narasimhamurthy, VM, Marks, DK, McDonald, ES, Mehrotra, R, Michiels, S, Kharidehal, D, Minhas, FUAA, Mittal, S, Moore, DA, Mushtaq, S, Nighat, H, Papathomas, T, Penault-Llorca, F, Perera, RD, Pinard, CJ, Pinto-Cardenas, JC, Pruneri, G, Pusztai, L, Rajpoot, NM, Rapoport, BL, Rau, TT, Ribeiro, JM, Rimm, D, Vincent-Salomon, A, Saltz, J, Sayed, S, Hytopoulos, E, Mahon, S, Siziopikou, KP, Sotiriou, C, Stenzinger, A, Sughayer, MA, Sur, D, Symmans, F, Tanaka, S, Taxter, T, Tejpar, S, Teuwen, J, Thompson, EA, Tramm, T, Tran, WT, van Der Laak, J, Verghese, GE, Viale, G, Wahab, N, Walter, T, Waumans, Y, Wen, HY, Yang, W, Yuan, Y, Bartlett, J, Loibl, S, Denkert, C, Savas, P, Loi, S, Stovgaard, ES, Salgado, R, Gallagher, WM, and Rahman, A

Published
2024

2. Pitfalls in machine learning-based assessment of tumor-infiltrating lymphocytes in breast cancer: a report of the international immuno-oncology biomarker working group

Author

Thagaard, J, Broeckx, G, Page, DB, Jahangir, CA, Verbandt, S, Kos, Z, Gupta, R, Khiroya, R, Abduljabbar, K, Acosta Haab, G, Acs, B, Akturk, G, Almeida, JS, Alvarado-Cabrero, I, Amgad, M, Azmoudeh-Ardalan, F, Badve, S, Baharun, NB, Balslev, E, Bellolio, ER, Bheemaraju, V, Blenman, KRM, Botinelly Mendonca Fujimoto, L, Bouchmaa, N, Burgues, O, Chardas, A, Cheang, MU, Ciompi, F, Cooper, LAD, Coosemans, A, Corredor, G, Dahl, AB, Dantas Portela, FL, Deman, F, Demaria, S, Dore Hansen, J, Dudgeon, SN, Ebstrup, T, Elghazawy, M, Fernandez-Martin, C, Fox, SB, Gallagher, WM, Giltnane, JM, Gnjatic, S, Gonzalez-Ericsson, P, Grigoriadis, A, Halama, N, Hanna, MG, Harbhajanka, A, Hart, SN, Hartman, J, Hauberg, S, Hewitt, S, Hida, A, Horlings, HM, Husain, Z, Hytopoulos, E, Irshad, S, Janssen, EAM, Kahila, M, Kataoka, TR, Kawaguchi, K, Kharidehal, D, Khramtsov, A, Kiraz, U, Kirtani, P, Kodach, LL, Korski, K, Kovacs, A, Laenkholm, A-V, Lang-Schwarz, C, Larsimont, D, Lennerz, JK, Lerousseau, M, Li, X, Ly, A, Madabhushi, A, Maley, SK, Manur Narasimhamurthy, V, Marks, DK, McDonald, ES, Mehrotra, R, Michiels, S, Minhas, FUAA, Mittal, S, Moore, DA, Mushtaq, S, Nighat, H, Papathomas, T, Penault-Llorca, F, Perera, RD, Pinard, CJ, Pinto-Cardenas, JC, Pruneri, G, Pusztai, L, Rahman, A, Rajpoot, NM, Rapoport, BL, Rau, TT, Reis-Filho, JS, Ribeiro, JM, Rimm, D, Roslind, A, Vincent-Salomon, A, Salto-Tellez, M, Saltz, J, Sayed, S, Scott, E, Siziopikou, KP, Sotiriou, C, Stenzinger, A, Sughayer, MA, Sur, D, Fineberg, S, Symmans, F, Tanaka, S, Taxter, T, Tejpar, S, Teuwen, J, Thompson, EA, Tramm, T, Tran, WT, van Der Laak, J, van Diest, PJ, Verghese, GE, Viale, G, Vieth, M, Wahab, N, Walter, T, Waumans, Y, Wen, HY, Yang, W, Yuan, Y, Zin, RM, Adams, S, Bartlett, J, Loibl, S, Denkert, C, Savas, P, Loi, S, Salgado, R, Specht Stovgaard, E, Thagaard, J, Broeckx, G, Page, DB, Jahangir, CA, Verbandt, S, Kos, Z, Gupta, R, Khiroya, R, Abduljabbar, K, Acosta Haab, G, Acs, B, Akturk, G, Almeida, JS, Alvarado-Cabrero, I, Amgad, M, Azmoudeh-Ardalan, F, Badve, S, Baharun, NB, Balslev, E, Bellolio, ER, Bheemaraju, V, Blenman, KRM, Botinelly Mendonca Fujimoto, L, Bouchmaa, N, Burgues, O, Chardas, A, Cheang, MU, Ciompi, F, Cooper, LAD, Coosemans, A, Corredor, G, Dahl, AB, Dantas Portela, FL, Deman, F, Demaria, S, Dore Hansen, J, Dudgeon, SN, Ebstrup, T, Elghazawy, M, Fernandez-Martin, C, Fox, SB, Gallagher, WM, Giltnane, JM, Gnjatic, S, Gonzalez-Ericsson, P, Grigoriadis, A, Halama, N, Hanna, MG, Harbhajanka, A, Hart, SN, Hartman, J, Hauberg, S, Hewitt, S, Hida, A, Horlings, HM, Husain, Z, Hytopoulos, E, Irshad, S, Janssen, EAM, Kahila, M, Kataoka, TR, Kawaguchi, K, Kharidehal, D, Khramtsov, A, Kiraz, U, Kirtani, P, Kodach, LL, Korski, K, Kovacs, A, Laenkholm, A-V, Lang-Schwarz, C, Larsimont, D, Lennerz, JK, Lerousseau, M, Li, X, Ly, A, Madabhushi, A, Maley, SK, Manur Narasimhamurthy, V, Marks, DK, McDonald, ES, Mehrotra, R, Michiels, S, Minhas, FUAA, Mittal, S, Moore, DA, Mushtaq, S, Nighat, H, Papathomas, T, Penault-Llorca, F, Perera, RD, Pinard, CJ, Pinto-Cardenas, JC, Pruneri, G, Pusztai, L, Rahman, A, Rajpoot, NM, Rapoport, BL, Rau, TT, Reis-Filho, JS, Ribeiro, JM, Rimm, D, Roslind, A, Vincent-Salomon, A, Salto-Tellez, M, Saltz, J, Sayed, S, Scott, E, Siziopikou, KP, Sotiriou, C, Stenzinger, A, Sughayer, MA, Sur, D, Fineberg, S, Symmans, F, Tanaka, S, Taxter, T, Tejpar, S, Teuwen, J, Thompson, EA, Tramm, T, Tran, WT, van Der Laak, J, van Diest, PJ, Verghese, GE, Viale, G, Vieth, M, Wahab, N, Walter, T, Waumans, Y, Wen, HY, Yang, W, Yuan, Y, Zin, RM, Adams, S, Bartlett, J, Loibl, S, Denkert, C, Savas, P, Loi, S, Salgado, R, and Specht Stovgaard, E

Published
2023

3. Spatial analyses of immune cell infiltration in cancer: current methods and future directions. A report of the International Immuno-Oncology Biomarker Working Group on Breast Cancer

Author

Page, DB, Broeckx, G, Jahangir, CA, Jahangir, C, Verbandt, S, Gupta, RR, Thagaard, J, Khiroya, R, Kos, Z, Abduljabbar, K, Acosta Haab, G, Acs, B, Almeida, JS, Alvarado-Cabrero, I, Azmoudeh-Ardalan, F, Badve, S, Baharun, NB, Bellolio, ER, Bheemaraju, V, Blenman, KRM, Botinelly Mendonca Fujimoto, L, Burgues, O, Cheang, MCU, Ciompi, F, Cooper, LAD, Coosemans, A, Corredor, G, Dantas Portela, FL, Deman, F, Demaria, S, Dudgeon, SN, Elghazawy, M, Ely, S, Fernandez-Martin, C, Fineberg, S, Fox, SB, Gallagher, WM, Giltnane, JM, Gnjatic, S, Gonzalez-Ericsson, P, Grigoriadis, A, Halama, N, Hanna, MG, Harbhajanka, A, Hardas, A, Hart, SN, Hartman, J, Hewitt, S, Hida, A, Horlings, HM, Husain, Z, Hytopoulos, E, Irshad, S, Janssen, EAM, Kahila, M, Kataoka, TR, Kawaguchi, K, Kharidehal, D, Khramtsov, A, Kiraz, U, Kirtani, P, Kodach, LL, Korski, K, Kovacs, A, Laenkholm, A-V, Lang-Schwarz, C, Larsimont, D, Lennerz, JK, Lerousseau, M, Li, X, Ly, A, Madabhushi, A, Maley, SK, Manur Narasimhamurthy, V, Marks, DK, McDonald, ES, Mehrotra, R, Michiels, S, Minhas, FUAA, Mittal, S, Moore, DA, Mushtaq, S, Nighat, H, Papathomas, T, Penault-Llorca, F, Perera, RD, Pinard, CJ, Pinto-Cardenas, JC, Pruneri, G, Pusztai, L, Rahman, A, Rajpoot, NM, Rapoport, BL, Rau, TT, Reis-Filho, JS, Ribeiro, JM, Rimm, D, Salomon, A-V, Salto-Tellez, M, Saltz, J, Sayed, S, Siziopikou, KP, Sotiriou, C, Stenzinger, A, Sughayer, MA, Sur, D, Symmans, F, Tanaka, S, Taxter, T, Tejpar, S, Teuwen, J, Thompson, EA, Tramm, T, Tran, WT, van Der Laak, J, van Diest, PJ, Verghese, GE, Viale, G, Vieth, M, Wahab, N, Walter, T, Waumans, Y, Wen, HY, Yang, W, Yuan, Y, Adams, S, Bartlett, JMS, Loibl, S, Denkert, C, Savas, P, Loi, S, Salgado, R, Specht Stovgaard, E, Akturk, G, Bouchmaa, N, Page, DB, Broeckx, G, Jahangir, CA, Jahangir, C, Verbandt, S, Gupta, RR, Thagaard, J, Khiroya, R, Kos, Z, Abduljabbar, K, Acosta Haab, G, Acs, B, Almeida, JS, Alvarado-Cabrero, I, Azmoudeh-Ardalan, F, Badve, S, Baharun, NB, Bellolio, ER, Bheemaraju, V, Blenman, KRM, Botinelly Mendonca Fujimoto, L, Burgues, O, Cheang, MCU, Ciompi, F, Cooper, LAD, Coosemans, A, Corredor, G, Dantas Portela, FL, Deman, F, Demaria, S, Dudgeon, SN, Elghazawy, M, Ely, S, Fernandez-Martin, C, Fineberg, S, Fox, SB, Gallagher, WM, Giltnane, JM, Gnjatic, S, Gonzalez-Ericsson, P, Grigoriadis, A, Halama, N, Hanna, MG, Harbhajanka, A, Hardas, A, Hart, SN, Hartman, J, Hewitt, S, Hida, A, Horlings, HM, Husain, Z, Hytopoulos, E, Irshad, S, Janssen, EAM, Kahila, M, Kataoka, TR, Kawaguchi, K, Kharidehal, D, Khramtsov, A, Kiraz, U, Kirtani, P, Kodach, LL, Korski, K, Kovacs, A, Laenkholm, A-V, Lang-Schwarz, C, Larsimont, D, Lennerz, JK, Lerousseau, M, Li, X, Ly, A, Madabhushi, A, Maley, SK, Manur Narasimhamurthy, V, Marks, DK, McDonald, ES, Mehrotra, R, Michiels, S, Minhas, FUAA, Mittal, S, Moore, DA, Mushtaq, S, Nighat, H, Papathomas, T, Penault-Llorca, F, Perera, RD, Pinard, CJ, Pinto-Cardenas, JC, Pruneri, G, Pusztai, L, Rahman, A, Rajpoot, NM, Rapoport, BL, Rau, TT, Reis-Filho, JS, Ribeiro, JM, Rimm, D, Salomon, A-V, Salto-Tellez, M, Saltz, J, Sayed, S, Siziopikou, KP, Sotiriou, C, Stenzinger, A, Sughayer, MA, Sur, D, Symmans, F, Tanaka, S, Taxter, T, Tejpar, S, Teuwen, J, Thompson, EA, Tramm, T, Tran, WT, van Der Laak, J, van Diest, PJ, Verghese, GE, Viale, G, Vieth, M, Wahab, N, Walter, T, Waumans, Y, Wen, HY, Yang, W, Yuan, Y, Adams, S, Bartlett, JMS, Loibl, S, Denkert, C, Savas, P, Loi, S, Salgado, R, Specht Stovgaard, E, Akturk, G, and Bouchmaa, N

Published
2023

5. NSABP FB-10: a phase Ib/II trial evaluating ado-trastuzumab emtansine (T-DM1) with neratinib in women with metastatic HER2-positive breast cancer.

Author

Jacobs SA, Wang Y, Abraham J, Feng H, Montero AJ, Lipchik C, Finnigan M, Jankowitz RC, Salkeni MA, Maley SK, Puhalla SL, Piette F, Quinn K, Chang K, Nagy RJ, Allegra CJ, Vehec K, Wolmark N, Lucas PC, Srinivasan A, and Pogue-Geile KL

Subjects
Humans, Female, Middle Aged, Aged, Adult, Circulating Tumor DNA genetics, Circulating Tumor DNA blood, Biomarkers, Tumor genetics, Mutation, Aged, 80 and over, Trastuzumab therapeutic use, Trastuzumab administration & dosage, Treatment Outcome, Neoplasm Metastasis, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Breast Neoplasms pathology, Breast Neoplasms mortality, Breast Neoplasms metabolism, Receptor, ErbB-2 metabolism, Receptor, ErbB-2 genetics, Ado-Trastuzumab Emtansine therapeutic use, Quinolines therapeutic use, Quinolines administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects
Abstract

Background: We previously reported our phase Ib trial, testing the safety, tolerability, and efficacy of T-DM1 + neratinib in HER2-positive metastatic breast cancer patients. Patients with ERBB2 amplification in ctDNA had deeper and more durable responses. This study extends these observations with in-depth analysis of molecular markers and mechanisms of resistance in additional patients., Methods: Forty-nine HER2-positive patients (determined locally) who progressed on-treatment with trastuzumab + pertuzumab were enrolled in this phase Ib/II study. Mutations and HER2 amplifications were assessed in ctDNA before (C1D1) and on-treatment (C2D1) with the Guardant360 assay. Archived tissue (TP0) and study entry biopsies (TP1) were assayed for whole transcriptome, HER2 copy number, and mutations, with Ampli-Seq, and centrally for HER2 with CLIA assays. Patient responses were assessed with RECIST v1.1, and Molecular Response with the Guardant360 Response algorithm., Results: The ORR in phase II was 7/22 (32%), which included all patients who had at least one dose of study therapy. In phase I, the ORR was 12/19 (63%), which included only patients who were considered evaluable, having received their first scan at 6 weeks. Central confirmation of HER2-positivity was found in 83% (30/36) of the TP0 samples. HER2-amplified ctDNA was found at C1D1 in 48% (20/42) of samples. Patients with ctHER2-amp versus non-amplified HER2 ctDNA determined in C1D1 ctDNA had a longer median progression-free survival (PFS): 480 days versus 60 days (P = 0.015). Molecular Response scores were significantly associated with both PFS (HR 0.28, 0.09-0.90, P = 0.033) and best response (P = 0.037). All five of the patients with ctHER2-amp at C1D1 who had undetectable ctDNA after study therapy had an objective response. Patients whose ctHER2-amp decreased on-treatment had better outcomes than patients whose ctHER2-amp remained unchanged. HER2 RNA levels show a correlation to HER2 CLIA IHC status and were significantly higher in patients with clinically documented responses compared to patients with progressive disease (P = 0.03)., Conclusions: The following biomarkers were associated with better outcomes for patients treated with T-DM1 + neratinib: (1) ctHER2-amp (C1D1) or in TP1; (2) Molecular Response scores; (3) loss of detectable ctDNA; (4) RNA levels of HER2; and (5) on-treatment loss of detectable ctHER2-amp. HER2 transcriptional and IHC/FISH status identify HER2-low cases (IHC 1+ or IHC 2+ and FISH negative) in these heavily anti-HER2 treated patients. Due to the small number of patients and samples in this study, the associations we have shown are for hypothesis generation only and remain to be validated in future studies. Clinical Trials registration NCT02236000., (© 2024. The Author(s).)

Published
2024
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6. Image-based multiplex immune profiling of cancer tissues: translational implications. A report of the International Immuno-oncology Biomarker Working Group on Breast Cancer.

Author

Jahangir CA, Page DB, Broeckx G, Gonzalez CA, Burke C, Murphy C, Reis-Filho JS, Ly A, Harms PW, Gupta RR, Vieth M, Hida AI, Kahila M, Kos Z, van Diest PJ, Verbandt S, Thagaard J, Khiroya R, Abduljabbar K, Acosta Haab G, Acs B, Adams S, Almeida JS, Alvarado-Cabrero I, Azmoudeh-Ardalan F, Badve S, Baharun NB, Bellolio ER, Bheemaraju V, Blenman KR, Botinelly Mendonça Fujimoto L, Burgues O, Chardas A, Cheang MCU, Ciompi F, Cooper LA, Coosemans A, Corredor G, Dantas Portela FL, Deman F, Demaria S, Dudgeon SN, Elghazawy M, Fernandez-Martín C, Fineberg S, Fox SB, Giltnane JM, Gnjatic S, Gonzalez-Ericsson PI, Grigoriadis A, Halama N, Hanna MG, Harbhajanka A, Hart SN, Hartman J, Hewitt S, Horlings HM, Husain Z, Irshad S, Janssen EA, Kataoka TR, Kawaguchi K, Khramtsov AI, Kiraz U, Kirtani P, Kodach LL, Korski K, Akturk G, Scott E, Kovács A, Laenkholm AV, Lang-Schwarz C, Larsimont D, Lennerz JK, Lerousseau M, Li X, Madabhushi A, Maley SK, Manur Narasimhamurthy V, Marks DK, McDonald ES, Mehrotra R, Michiels S, Kharidehal D, Minhas FUAA, Mittal S, Moore DA, Mushtaq S, Nighat H, Papathomas T, Penault-Llorca F, Perera RD, Pinard CJ, Pinto-Cardenas JC, Pruneri G, Pusztai L, Rajpoot NM, Rapoport BL, Rau TT, Ribeiro JM, Rimm D, Vincent-Salomon A, Saltz J, Sayed S, Hytopoulos E, Mahon S, Siziopikou KP, Sotiriou C, Stenzinger A, Sughayer MA, Sur D, Symmans F, Tanaka S, Taxter T, Tejpar S, Teuwen J, Thompson EA, Tramm T, Tran WT, van der Laak J, Verghese GE, Viale G, Wahab N, Walter T, Waumans Y, Wen HY, Yang W, Yuan Y, Bartlett J, Loibl S, Denkert C, Savas P, Loi S, Specht Stovgaard E, Salgado R, Gallagher WM, and Rahman A

Subjects
Humans, Female, Biomarkers, Tumor genetics, Prognosis, Phenotype, United Kingdom, Tumor Microenvironment, Breast Neoplasms
Abstract

Recent advances in the field of immuno-oncology have brought transformative changes in the management of cancer patients. The immune profile of tumours has been found to have key value in predicting disease prognosis and treatment response in various cancers. Multiplex immunohistochemistry and immunofluorescence have emerged as potent tools for the simultaneous detection of multiple protein biomarkers in a single tissue section, thereby expanding opportunities for molecular and immune profiling while preserving tissue samples. By establishing the phenotype of individual tumour cells when distributed within a mixed cell population, the identification of clinically relevant biomarkers with high-throughput multiplex immunophenotyping of tumour samples has great potential to guide appropriate treatment choices. Moreover, the emergence of novel multi-marker imaging approaches can now provide unprecedented insights into the tumour microenvironment, including the potential interplay between various cell types. However, there are significant challenges to widespread integration of these technologies in daily research and clinical practice. This review addresses the challenges and potential solutions within a structured framework of action from a regulatory and clinical trial perspective. New developments within the field of immunophenotyping using multiplexed tissue imaging platforms and associated digital pathology are also described, with a specific focus on translational implications across different subtypes of cancer. © 2024 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland., (© 2024 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland.)

Published
2024
Full Text
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7. Pitfalls in machine learning-based assessment of tumor-infiltrating lymphocytes in breast cancer: A report of the International Immuno-Oncology Biomarker Working Group on Breast Cancer

Author

Thagaard J, Broeckx G, Page DB, Jahangir CA, Verbandt S, Kos Z, Gupta R, Khiroya R, Abduljabbar K, Acosta Haab G, Acs B, Akturk G, Almeida JS, Alvarado-Cabrero I, Amgad M, Azmoudeh-Ardalan F, Badve S, Baharun NB, Balslev E, Bellolio ER, Bheemaraju V, Blenman KR, Botinelly Mendonça Fujimoto L, Bouchmaa N, Burgues O, Chardas A, Chon U Cheang M, Ciompi F, Cooper LA, Coosemans A, Corredor G, Dahl AB, Dantas Portela FL, Deman F, Demaria S, Doré Hansen J, Dudgeon SN, Ebstrup T, Elghazawy M, Fernandez-Martín C, Fox SB, Gallagher WM, Giltnane JM, Gnjatic S, Gonzalez-Ericsson PI, Grigoriadis A, Halama N, Hanna MG, Harbhajanka A, Hart SN, Hartman J, Hauberg S, Hewitt S, Hida AI, Horlings HM, Husain Z, Hytopoulos E, Irshad S, Janssen EA, Kahila M, Kataoka TR, Kawaguchi K, Kharidehal D, Khramtsov AI, Kiraz U, Kirtani P, Kodach LL, Korski K, Kovács A, Laenkholm AV, Lang-Schwarz C, Larsimont D, Lennerz JK, Lerousseau M, Li X, Ly A, Madabhushi A, Maley SK, Manur Narasimhamurthy V, Marks DK, McDonald ES, Mehrotra R, Michiels S, Minhas FUAA, Mittal S, Moore DA, Mushtaq S, Nighat H, Papathomas T, Penault-Llorca F, Perera RD, Pinard CJ, Pinto-Cardenas JC, Pruneri G, Pusztai L, Rahman A, Rajpoot NM, Rapoport BL, Rau TT, Reis-Filho JS, Ribeiro JM, Rimm D, Roslind A, Vincent-Salomon A, Salto-Tellez M, Saltz J, Sayed S, Scott E, Siziopikou KP, Sotiriou C, Stenzinger A, Sughayer MA, Sur D, Fineberg S, Symmans F, Tanaka S, Taxter T, Tejpar S, Teuwen J, Thompson EA, Tramm T, Tran WT, van der Laak J, van Diest PJ, Verghese GE, Viale G, Vieth M, Wahab N, Walter T, Waumans Y, Wen HY, Yang W, Yuan Y, Zin RM, Adams S, Bartlett J, Loibl S, Denkert C, Savas P, Loi S, Salgado R, and Specht Stovgaard E

Subjects
Humans, Animals, Lymphocytes, Tumor-Infiltrating, Biomarkers, Machine Learning, Triple Negative Breast Neoplasms, Mammary Neoplasms, Animal
Abstract

The clinical significance of the tumor-immune interaction in breast cancer is now established, and tumor-infiltrating lymphocytes (TILs) have emerged as predictive and prognostic biomarkers for patients with triple-negative (estrogen receptor, progesterone receptor, and HER2-negative) breast cancer and HER2-positive breast cancer. How computational assessments of TILs might complement manual TIL assessment in trial and daily practices is currently debated. Recent efforts to use machine learning (ML) to automatically evaluate TILs have shown promising results. We review state-of-the-art approaches and identify pitfalls and challenges of automated TIL evaluation by studying the root cause of ML discordances in comparison to manual TIL quantification. We categorize our findings into four main topics: (1) technical slide issues, (2) ML and image analysis aspects, (3) data challenges, and (4) validation issues. The main reason for discordant assessments is the inclusion of false-positive areas or cells identified by performance on certain tissue patterns or design choices in the computational implementation. To aid the adoption of ML for TIL assessment, we provide an in-depth discussion of ML and image analysis, including validation issues that need to be considered before reliable computational reporting of TILs can be incorporated into the trial and routine clinical management of patients with triple-negative breast cancer. © 2023 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland., (© 2023 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland.)

Published
2023
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8. Spatial analyses of immune cell infiltration in cancer: current methods and future directions: A report of the International Immuno-Oncology Biomarker Working Group on Breast Cancer.

Author

Page DB, Broeckx G, Jahangir CA, Verbandt S, Gupta RR, Thagaard J, Khiroya R, Kos Z, Abduljabbar K, Acosta Haab G, Acs B, Akturk G, Almeida JS, Alvarado-Cabrero I, Azmoudeh-Ardalan F, Badve S, Baharun NB, Bellolio ER, Bheemaraju V, Blenman KR, Botinelly Mendonça Fujimoto L, Bouchmaa N, Burgues O, Cheang MCU, Ciompi F, Cooper LA, Coosemans A, Corredor G, Dantas Portela FL, Deman F, Demaria S, Dudgeon SN, Elghazawy M, Ely S, Fernandez-Martín C, Fineberg S, Fox SB, Gallagher WM, Giltnane JM, Gnjatic S, Gonzalez-Ericsson PI, Grigoriadis A, Halama N, Hanna MG, Harbhajanka A, Hardas A, Hart SN, Hartman J, Hewitt S, Hida AI, Horlings HM, Husain Z, Hytopoulos E, Irshad S, Janssen EA, Kahila M, Kataoka TR, Kawaguchi K, Kharidehal D, Khramtsov AI, Kiraz U, Kirtani P, Kodach LL, Korski K, Kovács A, Laenkholm AV, Lang-Schwarz C, Larsimont D, Lennerz JK, Lerousseau M, Li X, Ly A, Madabhushi A, Maley SK, Manur Narasimhamurthy V, Marks DK, McDonald ES, Mehrotra R, Michiels S, Minhas FUAA, Mittal S, Moore DA, Mushtaq S, Nighat H, Papathomas T, Penault-Llorca F, Perera RD, Pinard CJ, Pinto-Cardenas JC, Pruneri G, Pusztai L, Rahman A, Rajpoot NM, Rapoport BL, Rau TT, Reis-Filho JS, Ribeiro JM, Rimm D, Vincent-Salomon A, Salto-Tellez M, Saltz J, Sayed S, Siziopikou KP, Sotiriou C, Stenzinger A, Sughayer MA, Sur D, Symmans F, Tanaka S, Taxter T, Tejpar S, Teuwen J, Thompson EA, Tramm T, Tran WT, van der Laak J, van Diest PJ, Verghese GE, Viale G, Vieth M, Wahab N, Walter T, Waumans Y, Wen HY, Yang W, Yuan Y, Adams S, Bartlett JMS, Loibl S, Denkert C, Savas P, Loi S, Salgado R, and Specht Stovgaard E

Subjects
Humans, Biomarkers, Benchmarking, Lymphocytes, Tumor-Infiltrating, Spatial Analysis, Tumor Microenvironment, Colonic Neoplasms
Abstract

Modern histologic imaging platforms coupled with machine learning methods have provided new opportunities to map the spatial distribution of immune cells in the tumor microenvironment. However, there exists no standardized method for describing or analyzing spatial immune cell data, and most reported spatial analyses are rudimentary. In this review, we provide an overview of two approaches for reporting and analyzing spatial data (raster versus vector-based). We then provide a compendium of spatial immune cell metrics that have been reported in the literature, summarizing prognostic associations in the context of a variety of cancers. We conclude by discussing two well-described clinical biomarkers, the breast cancer stromal tumor infiltrating lymphocytes score and the colon cancer Immunoscore, and describe investigative opportunities to improve clinical utility of these spatial biomarkers. © 2023 The Pathological Society of Great Britain and Ireland., (© 2023 The Pathological Society of Great Britain and Ireland.)

Published
2023
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9. Dorsal Spinal Intradural Intramedullary Epidermoid Cyst: A Rare Case Report and Review of Literature.

Author

Musali SR, Mohammed I, Gollapudi PR, and Maley SK

Abstract

Epidermoid cysts are commonly seen intracranial lesions but their occurrence in the spine is rare. They account for <1% of all the benign tumors of the spine. These are benign epithelial-lined cysts filled with keratin. They are classified into two types: congenital or acquired. Congenital epidermoid cysts are more commonly associated with spinal dysraphic states such as syringomyelia, dermal sinus and spina bifida whereas the acquired cysts are associated with repeated lumbar punctures. Based on the location, they can be extradural, intradural, extramedullary, or intramedullary. Most of the epidermoids are intradural extramedullary. Intramedullary epidermoid cysts are very uncommon. We report a case of a 6-year-old female patient with dorsal epidermoid cyst with neurological deficits. Magnetic resonance imaging of the spine showed a well-defined lesion from D9 to D12 which was hypointense on T1W1 and heterogeneously hyperintense on T2W2. Surgery was performed to excise the lesion and to decompress the spinal cord. Histopathological examination of the excised lesion confirmed it as an epidermoid cyst., Competing Interests: There are no conflicts of interest.

Published
2019
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