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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

7. 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

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, 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

9. 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, D.B., Jahangir, C.A., Verbandt, S., Kos, Z., Gupta, R., Khiroya, R., AbdulJabbar, K., Haab, G.A., Acs, B., Akturk, G., Almeida, J.S., Alvarado-Cabrero, I., Amgad, M., Azmoudeh-Ardalan, F., Badve, S., Baharun, N.B., Balslev, E., Bellolio, E.R., Bheemaraju, V., Blenman, K.R., Botinelly Mendonça Fujimoto, L., Bouchmaa, N., Burgues, O., Chardas, A., Chon U Cheang, M., Ciompi, F., Cooper, L.A., Coosemans, A., Corredor, G., Dahl, A.B., Dantas Portela, F.L., Deman, F., Demaria, S., Doré Hansen, J., Dudgeon, S.N., Ebstrup, T., Elghazawy, M., Fernandez-Martín, C., Fox, S.B., Gallagher, W.M., Giltnane, J.M., Gnjatic, S., Gonzalez-Ericsson, P.I., Grigoriadis, A., Halama, N., Hanna, M.G., Harbhajanka, A., Hart, S.N., Hartman, J., Hauberg, S., Hewitt, S., Hida, A.I., Horlings, H.M., Husain, Z., Hytopoulos, E., Irshad, S., Janssen, E.a, Kahila, M., Kataoka, T.R., Kawaguchi, K., Kharidehal, D., Khramtsov, A.I., Kiraz, U., Kirtani, P., Kodach, L.L., Korski, K., Kovács, A., Laenkholm, A.V., Lang-Schwarz, C., Larsimont, D., Lennerz, J.K., Lerousseau, M., Li, Xiaoxian, Ly, Amy, Madabhushi, A., Maley, S.K., Manur Narasimhamurthy, V., Marks, D.K., McDonald, E.S., Mehrotra, R., Michiels, S., Minhas, F.U.A.A., Mittal, S., Moore, D.A., Mushtaq, S., Nighat, H., Papathomas, T., Penault-Llorca, F., Perera, R.D., Pinard, C.J., Pinto-Cardenas, J.C., Pruneri, G., Pusztai, L., Rahman, A., Rajpoot, N.M., Rapoport, B.L., Rau, T.T., Reis-Filho, J.S., Ribeiro, J.M., Rimm, D., Roslind, A., Vincent-Salomon, A., Salto-Tellez, M., Saltz, J., Sayed, S., Scott, E., Siziopikou, K.P., Sotiriou, C., Stenzinger, A., Sughayer, M.A., Sur, D., Fineberg, S., Symmans, F., Tanaka, S., Taxter, T., Tejpar, S., Teuwen, J., Thompson, E.A., Tramm, T., Tran, W.T., Laak, J.A.W.M. van der, Diest, P.J. van, Verghese, G.E., Viale, G., Vieth, M., Wahab, N., Walter, T., Waumans, Y., Wen, H.Y., Yang, W, Yuan, Y., Zin, R.M., Adams, S., Bartlett, J., Loibl, S., Denkert, C., Savas, P., Loi, S., Salgado, R., Specht Stovgaard, E., Thagaard, J., Broeckx, G., Page, D.B., Jahangir, C.A., Verbandt, S., Kos, Z., Gupta, R., Khiroya, R., AbdulJabbar, K., Haab, G.A., Acs, B., Akturk, G., Almeida, J.S., Alvarado-Cabrero, I., Amgad, M., Azmoudeh-Ardalan, F., Badve, S., Baharun, N.B., Balslev, E., Bellolio, E.R., Bheemaraju, V., Blenman, K.R., Botinelly Mendonça Fujimoto, L., Bouchmaa, N., Burgues, O., Chardas, A., Chon U Cheang, M., Ciompi, F., Cooper, L.A., Coosemans, A., Corredor, G., Dahl, A.B., Dantas Portela, F.L., Deman, F., Demaria, S., Doré Hansen, J., Dudgeon, S.N., Ebstrup, T., Elghazawy, M., Fernandez-Martín, C., Fox, S.B., Gallagher, W.M., Giltnane, J.M., Gnjatic, S., Gonzalez-Ericsson, P.I., Grigoriadis, A., Halama, N., Hanna, M.G., Harbhajanka, A., Hart, S.N., Hartman, J., Hauberg, S., Hewitt, S., Hida, A.I., Horlings, H.M., Husain, Z., Hytopoulos, E., Irshad, S., Janssen, E.a, Kahila, M., Kataoka, T.R., Kawaguchi, K., Kharidehal, D., Khramtsov, A.I., Kiraz, U., Kirtani, P., Kodach, L.L., Korski, K., Kovács, A., Laenkholm, A.V., Lang-Schwarz, C., Larsimont, D., Lennerz, J.K., Lerousseau, M., Li, Xiaoxian, Ly, Amy, Madabhushi, A., Maley, S.K., Manur Narasimhamurthy, V., Marks, D.K., McDonald, E.S., Mehrotra, R., Michiels, S., Minhas, F.U.A.A., Mittal, S., Moore, D.A., Mushtaq, S., Nighat, H., Papathomas, T., Penault-Llorca, F., Perera, R.D., Pinard, C.J., Pinto-Cardenas, J.C., Pruneri, G., Pusztai, L., Rahman, A., Rajpoot, N.M., Rapoport, B.L., Rau, T.T., Reis-Filho, J.S., Ribeiro, J.M., Rimm, D., Roslind, A., Vincent-Salomon, A., Salto-Tellez, M., Saltz, J., Sayed, S., Scott, E., Siziopikou, K.P., Sotiriou, C., Stenzinger, A., Sughayer, M.A., Sur, D., Fineberg, S., Symmans, F., Tanaka, S., Taxter, T., Tejpar, S., Teuwen, J., Thompson, E.A., Tramm, T., Tran, W.T., Laak, J.A.W.M. van der, Diest, P.J. van, Verghese, G.E., Viale, G., Vieth, M., Wahab, N., Walter, T., Waumans, Y., Wen, H.Y., Yang, W, Yuan, Y., Zin, R.M., Adams, S., Bartlett, J., Loibl, S., Denkert, C., Savas, P., Loi, S., Salgado, R., and Specht Stovgaard, E.

Abstract

01 augustus 2023, Contains fulltext : 296181.pdf (Publisher’s version ) (Open Access), 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.

Published
2023

10. 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, D.B., Broeckx, G., Jahangir, C.A., Verbandt, S., Gupta, R.R., Thagaard, J., Khiroya, R., Kos, Z., AbdulJabbar, K., Acosta Haab, G., Acs, B., Akturk, G., Almeida, J.S., Alvarado-Cabrero, I., Azmoudeh-Ardalan, F., Badve, S., Baharun, N.B., Bellolio, E.R., Bheemaraju, V., Blenman, K.R., Botinelly Mendonça Fujimoto, L., Bouchmaa, N., Burgues, O., Cheang, M.C.U., Ciompi, F., Cooper, L.A., Coosemans, A., Corredor, G., Dantas Portela, F.L., Deman, F., Demaria, S., Dudgeon, S.N., Elghazawy, M., Ely, S., Fernandez-Martín, C., Fineberg, S., Fox, S.B., Gallagher, W.M., Giltnane, J.M., Gnjatic, S., Gonzalez-Ericsson, P.I., Grigoriadis, A., Halama, N., Hanna, M.G., Harbhajanka, A., Hardas, A., Hart, S.N., Hartman, J., Hewitt, S., Hida, A.I., Horlings, H.M., Husain, Z., Hytopoulos, E., Irshad, S., Janssen, E.a, Kahila, M., Kataoka, T.R., Kawaguchi, K., Kharidehal, D., Khramtsov, A.I., Kiraz, U., Kirtani, P., Kodach, L.L., Korski, K., Kovács, A., Laenkholm, A.V., Lang-Schwarz, C., Larsimont, D., Lennerz, J.K., Lerousseau, M., Li, Xiaoxian, Ly, Amy, Madabhushi, A., Maley, S.K., Manur Narasimhamurthy, V., Marks, D.K., McDonald, E.S., Mehrotra, R., Michiels, S., Minhas, F.U.A.A., Mittal, S., Moore, D.A., Mushtaq, S., Nighat, H., Papathomas, T., Penault-Llorca, F., Perera, R.D., Pinard, C.J., Pinto-Cardenas, J.C., Pruneri, G., Pusztai, L., Rahman, A., Rajpoot, N.M., Rapoport, B.L., Rau, T.T., Reis-Filho, J.S., Ribeiro, J.M., Rimm, D., Vincent-Salomon, A., Salto-Tellez, M., Saltz, J., Sayed, S., Siziopikou, K.P., Sotiriou, C., Stenzinger, A., Sughayer, M.A., Sur, D., Symmans, F., Tanaka, S., Taxter, T., Tejpar, S., Teuwen, J., Thompson, E.A., Tramm, T., Tran, W.T., Laak, J.A.W.M. van der, Diest, P.J. van, Verghese, G.E., Viale, G., Vieth, M., Wahab, N., Walter, T., Waumans, Y., Wen, H.Y., Yang, W, Yuan, Y., Adams, S., Bartlett, J.M.S., Loibl, S., Denkert, C., Savas, P., Loi, S., Salgado, R., Specht Stovgaard, E., Page, D.B., Broeckx, G., Jahangir, C.A., Verbandt, S., Gupta, R.R., Thagaard, J., Khiroya, R., Kos, Z., AbdulJabbar, K., Acosta Haab, G., Acs, B., Akturk, G., Almeida, J.S., Alvarado-Cabrero, I., Azmoudeh-Ardalan, F., Badve, S., Baharun, N.B., Bellolio, E.R., Bheemaraju, V., Blenman, K.R., Botinelly Mendonça Fujimoto, L., Bouchmaa, N., Burgues, O., Cheang, M.C.U., Ciompi, F., Cooper, L.A., Coosemans, A., Corredor, G., Dantas Portela, F.L., Deman, F., Demaria, S., Dudgeon, S.N., Elghazawy, M., Ely, S., Fernandez-Martín, C., Fineberg, S., Fox, S.B., Gallagher, W.M., Giltnane, J.M., Gnjatic, S., Gonzalez-Ericsson, P.I., Grigoriadis, A., Halama, N., Hanna, M.G., Harbhajanka, A., Hardas, A., Hart, S.N., Hartman, J., Hewitt, S., Hida, A.I., Horlings, H.M., Husain, Z., Hytopoulos, E., Irshad, S., Janssen, E.a, Kahila, M., Kataoka, T.R., Kawaguchi, K., Kharidehal, D., Khramtsov, A.I., Kiraz, U., Kirtani, P., Kodach, L.L., Korski, K., Kovács, A., Laenkholm, A.V., Lang-Schwarz, C., Larsimont, D., Lennerz, J.K., Lerousseau, M., Li, Xiaoxian, Ly, Amy, Madabhushi, A., Maley, S.K., Manur Narasimhamurthy, V., Marks, D.K., McDonald, E.S., Mehrotra, R., Michiels, S., Minhas, F.U.A.A., Mittal, S., Moore, D.A., Mushtaq, S., Nighat, H., Papathomas, T., Penault-Llorca, F., Perera, R.D., Pinard, C.J., Pinto-Cardenas, J.C., Pruneri, G., Pusztai, L., Rahman, A., Rajpoot, N.M., Rapoport, B.L., Rau, T.T., Reis-Filho, J.S., Ribeiro, J.M., Rimm, D., Vincent-Salomon, A., Salto-Tellez, M., Saltz, J., Sayed, S., Siziopikou, K.P., Sotiriou, C., Stenzinger, A., Sughayer, M.A., Sur, D., Symmans, F., Tanaka, S., Taxter, T., Tejpar, S., Teuwen, J., Thompson, E.A., Tramm, T., Tran, W.T., Laak, J.A.W.M. van der, Diest, P.J. van, Verghese, G.E., Viale, G., Vieth, M., Wahab, N., Walter, T., Waumans, Y., Wen, H.Y., Yang, W, Yuan, Y., Adams, S., Bartlett, J.M.S., Loibl, S., Denkert, C., Savas, P., Loi, S., Salgado, R., and Specht Stovgaard, E.

Abstract

01 augustus 2023, Contains fulltext : 296131.pdf (Publisher’s version ) (Closed access), 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.

Published
2023

14. The evaluation of tumor-infiltrating lymphocytes (TILs) in breast cancer: recommendations by an International TILs Working Group 2014

Author

Salgado, R., Denkert, C., Demaria, S., Sirtaine, N., Klauschen, F., Pruneri, G., Wienert, S., Van den Eynden, G., Baehner, F.L., Penault-Llorca, F., Perez, E.A., Thompson, E.A., Symmans, W.F., Richardson, A.L., Brock, J., Criscitiello, C., Bailey, H., Ignatiadis, M., Floris, G., Sparano, J., Kos, Z., Nielsen, T., Rimm, D.L., Allison, K.H., Reis-Filho, J.S., Loibl, S., Sotiriou, C., Viale, G., Badve, S., Adams, S., Willard-Gallo, K., and Loi, S.

Published
2015
Full Text
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15. Tumor infiltrating lymphocyte stratification of prognostic staging of early-stage triple negative breast cancer

Author

Loi, S, Salgado, R, Adams, S, Pruneri, G, Francis, PA, Lacroix-Triki, M, Joensuu, H, Dieci, MV, Badve, S, Demaria, S, Gray, R, Munzone, E, Drubay, D, Lemonnier, J, Sotiriou, C, Kellokumpu-Lehtinen, PL, Vingiani, A, Gray, K, Andre, F, Denkert, C, Piccart, M, Roblin, E, Michiels, S, Loi, S, Salgado, R, Adams, S, Pruneri, G, Francis, PA, Lacroix-Triki, M, Joensuu, H, Dieci, MV, Badve, S, Demaria, S, Gray, R, Munzone, E, Drubay, D, Lemonnier, J, Sotiriou, C, Kellokumpu-Lehtinen, PL, Vingiani, A, Gray, K, Andre, F, Denkert, C, Piccart, M, Roblin, E, and Michiels, S

Abstract

The importance of integrating biomarkers into the TNM staging has been emphasized in the 8th Edition of the American Joint Committee on Cancer (AJCC) Staging system. In a pooled analysis of 2148 TNBC-patients in the adjuvant setting, TILs are found to strongly up and downstage traditional pathological-staging in the Pathological and Clinical Prognostic Stage Groups from the AJJC 8th edition Cancer Staging System. This suggest that clinical and research studies on TNBC should take TILs into account in addition to stage, as for example patients with stage II TNBC and high TILs have a better outcome than patients with stage I and low TILs.

Published
2022

16. The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group

Author

El Bairi, K., Haynes, H. R., Blackley, E., Fineberg, S., Shear, J., Turner, S., de Freitas, J. R., Sur, D., Amendola, L. C., Gharib, M., Kallala, A., Arun, I., Azmoudeh-Ardalan, F., Fujimoto, L., Sua, L. F., Liu, S. -W., Lien, H. -C., Kirtani, P., Balancin, M., El Attar, H., Guleria, P., Yang, W., Shash, E., Chen, I. -C., Bautista, V., Do Prado Moura, J. F., Rapoport, B. L., Castaneda, C., Spengler, E., Acosta-Haab, G., Frahm, I., Sanchez, J., Castillo, M., Bouchmaa, N., Md Zin, R. R., Shui, R., Onyuma, T., Husain, Z., Willard-Gallo, K., Coosemans, A., Perez, E. A., Provenzano, E., Ericsson, P. G., Richardet, E., Mehrotra, R., Sarancone, S., Ehinger, A., Rimm, D. L., Bartlett, J. M. S., Viale, G., Denkert, C., Hida, A. I., Sotiriou, C., Loibl, S., Hewitt, S. M., Badve, S., Symmans, W. F., Kim, R. S., Pruneri, G., Goel, S., Francis, P. A., Inurrigarro, G., Yamaguchi, R., Garcia-Rivello, H., Horlings, H., Afqir, S., Salgado, R., Adams, S., Kok, M., Dieci, M. V., Michiels, S., Demaria, S., Loi, S., Schelfhout, V., Arbzadeh, E., Bondanar, A., Reyes, S. A. G., Ruz, J. R., Kang, J., Xiang, L., Zimovjanova, M., Togores, P., Ozturk, T., Patil, A., Corpa, M., Whitehouse, A., Tan, B., de Paula, A., Rossetti, C., Lang-Schwarz, C., Mahon, S., Giacometti, C., Linderholm, B., Deman, F., Montagna, G., Gong, G., Pavcovich, M., Chaer, Y., Cabrero, I. A., de Brito, M. L., Ilieva, N., Fulop, A., Souza, M., Bilancia, D., Idowu, M., Johri, R., Szpor, J., Bachani, L., Schmitt, F., Giannotti, M., Kurebayashi, Y., Ramirez, B. E. A., Salido, E., Bortesi, L., Bonetto, S., Elomina, K., Lopez, P., Sharma, V., Edirisinghe, A., Mathur, D., Sahay, A., Mouloud, M. A., Giang, C. H., Mukolwe, E., Kiruka, E., Samberg, N., Abe, N., Brown, M., Millar, E., X. B., Li, Yuan, Z., Pasupathy, A., Miele, R., Luff, R., e Porfirio, M. M. A., Ajemba, O., Soni, R., Orvieto, E., Dimaio, M., Thomas, J., Merard, R., Subramaniam, M. M., Apolinario, T., Preda, O., Preda, R., Makanga, A., Maior, M. S., Li, L., Saghatchian, M., Saurine, T., Janssen, E., Cochran, J., Vlada, N., Cappellesso, R., Elfer, K., Hollick, M., Desai, S., Oner, G., Schreurs, A., Liu, S., Perera, R., Mercurio, P., Garcia, F., Hosny, K., Matsumoto, H., van Deurzen, C., Bianchini, G., Coban, I., Jahangir, A., Rahman, A., Stover, D., Luz, P., Martel, A., Waumans, Y., Stenzinger, A., Cortes, J., Dimitrova, P., Nauwelaers, I., Velasco, M., Fan, F., Akturk, G., Firer, M., Roxanis, I., Schneck, M., Wen, H., Cockenpot, V., Konstantinov, A., Calatrava, A., Vidya, M. N., Choi, H. J., Jank, P., Ciinen, A. H., Sabanathan, D., Floris, G., Hoeflmayer, D., Hamada, T., Laudus, N., Grigoriadis, A., Porcellato, I., Acs, B., Miglietta, F., Parrodi, J., Clunie, D., Calhoun, B., F. -I., Lu, Lefevre, A., Tabbarah, S., Tran, W., Garcia-murillas, I., Jelinic, P., Boeckx, C., Souza, S., Cebollero, M. C., Felip, E., Rendon, J. L. S., El Gabry, E., Saltz, J., Bria, E., Garufi, G., Hartman, J., Sebastian, M., Olofsson, H., Kooreman, L., Cucherousset, J., Mathieu, M. -C., Ballesteros-Merino, C., Siziopikou, P., Fong, J., Klein, M., Qulis, I. R. I., Wesseling, J., Bellolio, E., Araya, J. C., Naber, S., Cheang, M., Castellano, I., Ales, A., Laenkholm, A. -V., Kulka, J., Quinn, C., Sapino, A., Amendoeira, I., Marchio, C., Braybrooke, J., Vincent-Salomon, A., Korski, K. P., Sofopoulos, M., Stovgaard, E. I. S., Bianchi, S., Bago-Horvath, Z., Yu, C., Regitnig, P., Hall, S., Kos, Z., Sant, S., Tille, J. -C., Gallas, B., Bethmann, D., Savas, P., Mendes, L., Soler, T., van Seijen, M., Gruosso, T., Quintana, A., Giltnane, J., Van den Eynden, G., Duregon, E., de Cabo, R., Recamo, P. C., Gaboury, L., Zimmerman, J., Pop, C. S., Wernicke, A., Williams, D., Gill, A., Solomon, B., Thapa, B., Farshid, G., Gilham, L., Christie, M., O'Toole, S., Hendry, S., Fox, S. B., Luen, S. J., Lakhani, S. R., Fuchs, T., John, T., Brcic, I., Hainfellner, J., Sigurd, L., Preusser, M., Poortmans, P., Decaluwe, A., Carey, C., Colpaert, C., Larsimont, D., Peeters, D., Broeckx, G., van de Vijver, K., Buisseret, L., Dirix, L., Hertoghs, M., Piccart, M., Ignatiadis, M., Van Bockstal, M., Sirtaine, N., Vermeulen, P., de Wind, R., Declercq, S., Gevaert, T., Haibe-Kans, B., Nelson, B. H., Watson, P. H., Leung, S., Nielsen, T., Shi, L., Balslev, E., Thagaard, J., Almangush, A., Makitie, A., Joensuu, H., Lundin, J., Drubay, D., Roblin, E., Andre, F., Penault-Llorca, F., Lemonnier, J., Adam, J., Lacroix-Triki, M., Ternes, N., Radosevic-Robin, N., Klaushen, F., Weber, K., Harbeck, N., Gluz, O., Wienert, S., Cserni, G., Vingiani, A., Criscitiello, C., Solinas, C., Curigliano, G., Konishi, E., Suzuki, E., Yoshikawa, K., Kawaguchi, K., Takada, M., Toi, M., Ishida, M., Shibata, N., Saji, S., Kogawa, T., Sakatani, T., Okamoto, T., Moriya, T., Kataoka, T., Shimoi, T., Sugie, T., Mukohara, T., Shu, Y., Kikawa, Y., Kozuka, Y., Sayed, S., Rahayu, R., Ramsaroop, R., Senkus-Konefka, E., Chmielik, E., Cardoso, F., Ribeiro, J., Chan, J., Dent, R., Martin, M., Hagen, C., Guerrero, A., Rojo, F., Comerma, L., Nuciforo, P., Serrano, V. V., Camaea, V. P., Steenbruggen, T., Ciompi, F., Nederlof, I., Jan, Hudecek, van der Laak, J., van den Berg, J., Voorwerk, L., van de Vijver, M., de Maaker, M., Linn, S., Mckenzie, H., Somaiah, N., Tutt, A., Swanton, C., Hiley, C., Moore, D. A., Hall, J. A., Le Quesne, J., Jabbar, K. A., al Bakir, M., Hills, R., Irshad, S., Yuan, Y., Li, Z., Liu, M., Klein, J., Fadare, O., Thompson, A., Lazar, A. J., Gown, A., Lo, A., Garrido Castro, A. C., Madabhushi, A., Moreira, A., Richardson, A., Beck, A. H., Bellizzi, A. M., Wolff, A., Harbhajanka, A., Sharma, A., Cimino-Mathews, A., Srinivasan, A., Singh, B., Chennubhotla, C. S., Chauhan, C., Dillon, D. A., Zardavas, D., Johnson, D. B., Thompson, A. E., Brogi, E., Reisenbichler, E., Huang, E., Hirsch, F. R., Mcarthur, H., Ziai, J., Brock, J., Kerner, J., Zha, J., Lennerz, J. K., Carter, J. M., Reis-Filho, J., Sparano, J., Balko, J. M., Pogue-Geile, K., Steele, K. E., Blenman, K. R. M., Allison, K. H., Pusztai, L., Cooper, L., Estrada, V. M., Flowers, M., Robson, M., Rebelatto, M. C., Hanna, M. G., Goetz, M. P., Khojasteh, M., Sanders, M. E., Regan, M. M., Misialek, M., Amgad, M., Tung, N., Singh, R., Huang, R., Pierce, R. H., Leon-Ferre, R., Swain, S., Ely, S., Kim, S. -R., Bedri, S., Paik, S., Schnitt, S., D'Alfons, T., Kurkure, U., Bossuyt, V., Tong, W., Wang, Y., Dos Anjos, C. H., Gaire, F., Van Diest, P. J., El Bairi, Khalid [0000-0002-8414-4145], de Freitas, Juliana Ribeiro [0000-0003-4978-7273], Sur, Daniel [0000-0002-0926-4614], Amendola, Luis Claudio [0000-0002-6404-450X], Azmoudeh-Ardalan, Farid [0000-0003-4701-0532], Kirtani, Pawan [0000-0002-2343-7016], Yang, Wenxian [0000-0002-5349-9680], Castillo, Miluska [0000-0002-0111-3176], Provenzano, Elena [0000-0003-3345-3965], Mehrotra, Ravi [0000-0001-9453-1408], Ehinger, Anna [0000-0001-9225-7396], Rimm, David L [0000-0001-5820-4397], Bartlett, John MS [0000-0002-0347-3888], Denkert, Carsten [0000-0002-2249-0982], Hida, Akira I [0000-0002-4486-8819], Sotiriou, Christos [0000-0002-5745-9977], Hewitt, Stephen M [0000-0001-8283-1788], Badve, Sunil [0000-0001-8861-9980], Symmans, William Fraser [0000-0002-1526-184X], Goel, Shom [0000-0001-8329-9084], Francis, Prudence A [0000-0002-7207-9286], Horlings, Hugo [0000-0003-4782-8828], Salgado, Roberto [0000-0002-1110-3801], Demaria, Sandra [0000-0003-4426-0499], Loi, Sherene [0000-0001-6137-9171], Apollo - University of Cambridge Repository, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anatomie pathologique, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), and UNICANCER

Subjects
Oncology, medicine.medical_treatment, [SDV]Life Sciences [q-bio], TRASTUZUMAB, Improved survival, MICROENVIRONMENT, Review Article, SUBTYPES, NEOADJUVANT CHEMOTHERAPY, 0302 clinical medicine, Breast cancer, Ecology,Evolution & Ethology, PROGNOSTIC-SIGNIFICANCE, Medicine and Health Sciences, Pharmacology (medical), TUMOR-INFILTRATING LYMPHOCYTES, Stage (cooking), RC254-282, Chemical Biology & High Throughput, 0303 health sciences, Human Biology & Physiology, Genome Integrity & Repair, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, ASSOCIATION, 3. Good health, 030220 oncology & carcinogenesis, Biomarker (medicine), Life Sciences & Biomedicine, Genetics & Genomics, medicine.medical_specialty, chemical and pharmacologic phenomena, International Immuno-Oncology Biomarker Working Group, Predictive markers, 03 medical and health sciences, Signalling & Oncogenes, SDG 3 - Good Health and Well-being, Internal medicine, 692/53/2423, medicine, Radiology, Nuclear Medicine and imaging, In patient, 030304 developmental biology, Computational & Systems Biology, Science & Technology, IDENTIFICATION, business.industry, review-article, Cancer, 03.01. Általános orvostudomány, Immunotherapy, Tumour Biology, medicine.disease, PREDICTIVE-VALUE, 692/4028/67/1347, Programmed death 1, business, FREE SURVIVAL
Abstract

The advent of immune-checkpoint inhibitors (ICI) in modern oncology has significantly improved survival in several cancer settings. A subgroup of women with breast cancer (BC) has immunogenic infiltration of lymphocytes with expression of programmed death-ligand 1 (PD-L1). These patients may potentially benefit from ICI targeting the programmed death 1 (PD-1)/PD-L1 signaling axis. The use of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers has been under intense examination. Emerging data suggest that TILs are associated with response to both cytotoxic treatments and immunotherapy, particularly for patients with triple-negative BC. In this review from The International Immuno-Oncology Biomarker Working Group, we discuss (a) the biological understanding of TILs, (b) their analytical and clinical validity and efforts toward the clinical utility in BC, and (c) the current status of PD-L1 and TIL testing across different continents, including experiences from low-to-middle-income countries, incorporating also the view of a patient advocate. This information will help set the stage for future approaches to optimize the understanding and clinical utilization of TIL analysis in patients with BC. ispartof: NPJ BREAST CANCER vol:7 issue:1 ispartof: location:United States status: published

Published
2021
Full Text
View/download PDF

19. The tale of TILs in breast cancer: A report from The International Immuno-Oncology Biomarker Working Group

Author

El Bairi, K, Haynes, HR, Blackley, E, Fineberg, S, Shear, J, Turner, S, de Freitas, JR, Sur, D, Amendola, LC, Gharib, M, Kallala, A, Arun, I, Azmoudeh-Ardalan, F, Fujimoto, L, Sua, LF, Liu, S-W, Lien, H-C, Kirtani, P, Balancin, M, El Attar, H, Guleria, P, Yang, W, Shash, E, Chen, I-C, Bautista, V, Do Prado Moura, JF, Rapoport, BL, Castaneda, C, Spengler, E, Acosta-Haab, G, Frahm, I, Sanchez, J, Castillo, M, Bouchmaa, N, Zin, RRM, Shui, R, Onyuma, T, Husain, Z, Willard-Gallo, K, Coosemans, A, Perez, EA, Provenzano, E, Ericsson, PG, Richardet, E, Mehrotra, R, Sarancone, S, Ehinger, A, Rimm, DL, Bartlett, JMS, Viale, G, Denkert, C, Hida, AI, Sotiriou, C, Loibl, S, Hewitt, SM, Badve, S, Symmans, WF, Kim, RS, Pruneri, G, Goel, S, Francis, PA, Inurrigarro, G, Yamaguchi, R, Garcia-Rivello, H, Horlings, H, Afqir, S, Salgado, R, Adams, S, Kok, M, Dieci, MV, Michiels, S, Demaria, S, Loi, S, El Bairi, K, Haynes, HR, Blackley, E, Fineberg, S, Shear, J, Turner, S, de Freitas, JR, Sur, D, Amendola, LC, Gharib, M, Kallala, A, Arun, I, Azmoudeh-Ardalan, F, Fujimoto, L, Sua, LF, Liu, S-W, Lien, H-C, Kirtani, P, Balancin, M, El Attar, H, Guleria, P, Yang, W, Shash, E, Chen, I-C, Bautista, V, Do Prado Moura, JF, Rapoport, BL, Castaneda, C, Spengler, E, Acosta-Haab, G, Frahm, I, Sanchez, J, Castillo, M, Bouchmaa, N, Zin, RRM, Shui, R, Onyuma, T, Husain, Z, Willard-Gallo, K, Coosemans, A, Perez, EA, Provenzano, E, Ericsson, PG, Richardet, E, Mehrotra, R, Sarancone, S, Ehinger, A, Rimm, DL, Bartlett, JMS, Viale, G, Denkert, C, Hida, AI, Sotiriou, C, Loibl, S, Hewitt, SM, Badve, S, Symmans, WF, Kim, RS, Pruneri, G, Goel, S, Francis, PA, Inurrigarro, G, Yamaguchi, R, Garcia-Rivello, H, Horlings, H, Afqir, S, Salgado, R, Adams, S, Kok, M, Dieci, MV, Michiels, S, Demaria, S, and Loi, S

Abstract

The advent of immune-checkpoint inhibitors (ICI) in modern oncology has significantly improved survival in several cancer settings. A subgroup of women with breast cancer (BC) has immunogenic infiltration of lymphocytes with expression of programmed death-ligand 1 (PD-L1). These patients may potentially benefit from ICI targeting the programmed death 1 (PD-1)/PD-L1 signaling axis. The use of tumor-infiltrating lymphocytes (TILs) as predictive and prognostic biomarkers has been under intense examination. Emerging data suggest that TILs are associated with response to both cytotoxic treatments and immunotherapy, particularly for patients with triple-negative BC. In this review from The International Immuno-Oncology Biomarker Working Group, we discuss (a) the biological understanding of TILs, (b) their analytical and clinical validity and efforts toward the clinical utility in BC, and (c) the current status of PD-L1 and TIL testing across different continents, including experiences from low-to-middle-income countries, incorporating also the view of a patient advocate. This information will help set the stage for future approaches to optimize the understanding and clinical utilization of TIL analysis in patients with BC.

Published
2021

20. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer

Author

Kos, Z., Roblin, E., Kim, R. S., Michiels, S., Gallas, B. D., Chen, W., van de Vijver, K. K., Goel, S., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S., Denkert, C., Loibl, S., Luen, S. J., Bartlett, J. M. S., Savas, P., Pruneri, G., Dillon, D. A., Cheang, M. C. U., Tutt, A., Hall, J. A., Kok, M., Horlings, H. M., Madabhushi, A., van der Laak, J., Ciompi, F., Laenkholm, A. -V., Bellolio, E., Gruosso, T., Fox, S. B., Araya, J. C., Floris, G., Hudecek, J., Voorwerk, L., Beck, A. H., Kerner, J., Larsimont, D., Declercq, S., Van den Eynden, G., Pusztai, L., Ehinger, A., Yang, W., Abduljabbar, K., Yuan, Y., Singh, R., Hiley, C., Bakir, M., Lazar, A. J., Naber, S., Wienert, S., Castillo, M., Curigliano, G., Dieci, M. -V., Andre, F., Swanton, C., Reis-Filho, J., Sparano, J., Balslev, E., Chen, I. -C., Stovgaard, E. I. S., Pogue-Geile, K., Blenman, K. R. M., Penault-Llorca, F., Schnitt, S., Lakhani, S. R., Vincent-Salomon, A., Rojo, F., Braybrooke, J. P., Hanna, M. G., Soler-Monso, M. T., Bethmann, D., Castaneda, C. A., Willard-Gallo, K., Sharma, A., Lien, H. -C., Fineberg, S., Thagaard, J., Comerma, L., Gonzalez-Ericsson, P., Brogi, E., Loi, S., Saltz, J., Klaushen, F., Cooper, L., Amgad, M., Moore, D. A., Salgado, R., Hyytiainen, A., Hida, A. I., Thompson, A., Lefevre, A., Gown, A., Lo, A., Sapino, A., Moreira, A. M., Richardson, A., Vingiani, A., Bellizzi, A. M., Guerrero, A., Grigoriadis, A., Garrido-Castro, A. C., Cimino-Mathews, A., Srinivasan, A., Acs, B., Singh, B., Calhoun, B., Haibe-Kans, B., Solomon, B., Thapa, B., Nelson, B. H., Ballesteroes-Merino, C., Criscitiello, C., Boeckx, C., Colpaert, C., Quinn, C., Chennubhotla, C. S., Solinas, C., Drubay, D., Sabanathan, D., Peeters, D., Zardavas, D., Hoflmayer, D., Johnson, D. B., Thompson, E. A., Perez, E., Elgabry, E. A., Blackley, E. F., Reisenbichler, E., Chmielik, E., Gaire, F., F. -I., Lu, Azmoudeh-Ardalan, F., Peale, F., Hirsch, F. R., Acosta-Haab, G., Farshid, G., Broeckx, G., Koeppen, H., Haynes, H. R., Mcarthur, H., Joensuu, H., Olofsson, H., Cree, I., Nederlof, I., Frahm, I., Brcic, I., Chan, J., Ziai, J., Brock, J., Weseling, J., Giltnane, J., Lemonnier, J., Zha, J., Ribeiro, J., Lennerz, J. K., Carter, J. M., Hartman, J., Hainfellner, J., Le Quesne, J., Juco, J. W., van den Berg, J., Sanchez, J., Cucherousset, J., Adam, J., Balko, J. M., Saeger, K., Siziopikou, K., Sikorska, K., Weber, K., Steele, K. E., Emancipator, K., El Bairi, K., Allison, K. H., Korski, K., Buisseret, L., Shi, L., Kooreman, L. F. S., Molinero, L., Estrada, M. V., Van Seijen, M., Lacroix-Triki, M., Sebastian, M. M., Balancin, M. L., Mathieu, M. -C., van de Vijver, M., Rebelatto, M. C., Piccart, M., Goetz, M. P., Preusser, M., Khojasteh, M., Sanders, M. E., Regan, M. M., Barnes, M., Christie, M., Misialek, M., Ignatiadis, M., de Maaker, M., Van Bockstal, M., Harbeck, N., Tung, N., Laudus, N., Sirtaine, N., Burchardi, N., Ternes, N., Radosevic-Robin, N., Gluz, O., Grimm, O., Nuciforo, P., Jank, P., Kirtani, P., Watson, P. H., Jelinic, P., Francis, P. A., Russell, P. A., Pierce, R. H., Hills, R., Leon-Ferre, R., de Wind, R., Shui, R., Leung, S., Tabbarah, S., Souza, S. C., O'Toole, S., Swain, S., Dudgeon, S., Willis, S., Ely, S., Bedri, S., Irshad, S., Liu, S., Hendry, S., Bianchi, S., Braganca, S., Paik, S., Luz, S., Gevaert, T., D'Alfons, T., John, T., Sugie, T., Kurkure, U., Bossuyt, V., Manem, V., Camaea, V. P., Tong, W., Tran, W. T., Wang, Y., Allory, Y., Husain, Z., Bago-Horvath, Z., Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Gustave Roussy (IGR), Division of Pathology and Laboratory Medicine, Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Charité, Institute of Pathology, Translational Tumorpathology Unit, German Breast Group, University of the Sunshine Coast (USC), European Institute of Oncology [Milan] (ESMO), Breakthrough Breast Cancer Centre, London Institute of Cancer, Department of Pathology, The Netherlands Cancer Institute, Division of Experimental Therapy, The Netherlands Cancer Institute NKI/AvL, Odense University Hospital, Unité de génétique et biologie des cancers (U830), Université Paris Descartes - Paris 5 (UPD5)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Breast Medical Oncology [Houston], The University of Texas M.D. Anderson Cancer Center [Houston], Helsingborg Hospital, Division of Experimental Therapeutics [Milan, Italy], Département de médecine oncologique [Gustave Roussy], Cancer Research UK Lung Cancer Centre of Excellence [Londres, Royaume-Uni], University College of London [London] (UCL), Memorial Sloane Kettering Cancer Center [New York], Herlev and Gentofte Hospital, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Southern Queensland (USQ), Pharmacogenomics Unit [Paris], Department of Genetics [Paris], Institut Curie [Paris]-Institut Curie [Paris], Instituto de Física Teórica UAM/CSIC (IFT), Universidad Autonoma de Madrid (UAM)-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Ctr Biomol Struct & Org, University of Maryland [College Park], University of Maryland System-University of Maryland System, The University of Sydney, Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), Innovation North - Faculty of Information and Technology, Leeds Metropolitan University, Int Immuno-Oncology Biomarker, Graduate School, CCA - Cancer biology and immunology, Pathology, Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO), German Breast Group (GBG), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Universidad Autónoma de Madrid (UAM)-Consejo Superior de Investigaciones Científicas [Madrid] (CSIC), Gallas, Brandon D [0000-0001-7332-1620], van de Vijver, Koen K [0000-0002-2026-9790], Demaria, Sandra [0000-0003-4426-0499], Badve, Sunil S [0000-0001-8861-9980], Symmans, W Fraser [0000-0002-1526-184X], Rimm, David L [0000-0001-5820-4397], Savas, Peter [0000-0001-5999-428X], Hall, Jacqueline A [0000-0003-0708-1360], Horlings, Hugo M [0000-0003-4782-8828], van der Laak, Jeroen [0000-0001-7982-0754], Bellolio, Enrique [0000-0003-0079-5264], Araya, Juan Carlos [0000-0003-3501-8203], Floris, Giuseppe [0000-0003-2391-5425], Hudeček, Jan [0000-0003-1071-5686], Ehinger, Anna [0000-0001-9225-7396], Lazar, Alexander J [0000-0002-6395-4499], Castillo, Miluska [0000-0002-0111-3176], Curigliano, Giuseppe [0000-0003-1781-2518], Sparano, Joseph [0000-0002-9031-2010], Braybrooke, Jeremy P [0000-0003-1943-7360], Hanna, Matthew G [0000-0002-7536-1746], Willard-Gallo, Karen [0000-0002-1150-1295], Sharma, Ashish [0000-0002-1011-6504], Comerma, Laura [0000-0002-0249-4636], Gonzalez-Ericsson, Paula [0000-0002-6292-6963], Loi, Sherene [0000-0001-6137-9171], Cooper, Lee [0000-0002-3504-4965], Apollo - University of Cambridge Repository, Research Programs Unit, Heikki Joensuu / Principal Investigator, HUS Comprehensive Cancer Center, Department of Oncology, Medicum, Gallas, Brandon D. [0000-0001-7332-1620], van de Vijver, Koen K. [0000-0002-2026-9790], Badve, Sunil S. [0000-0001-8861-9980], Symmans, W. Fraser [0000-0002-1526-184X], Rimm, David L. [0000-0001-5820-4397], Hall, Jacqueline A. [0000-0003-0708-1360], Horlings, Hugo M. [0000-0003-4782-8828], Lazar, Alexander J. [0000-0002-6395-4499], Braybrooke, Jeremy P. [0000-0003-1943-7360], and Hanna, Matthew G. [0000-0002-7536-1746]

Subjects
Oncology, [SDV]Life Sciences [q-bio], THERAPY, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Prognostic markers, 0302 clinical medicine, Breast cancer, Medicine and Health Sciences, Pharmacology (medical), Lymphocytes, Stromal tumor, health care economics and organizations, 0303 health sciences, CHEMOTHERAPY, Sciences bio-médicales et agricoles, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], PROGNOSTIC VALUE, Clinical Practice, 030220 oncology & carcinogenesis, Educational resources, Immunosurveillance, medicine.medical_specialty, 3122 Cancers, [SDV.CAN]Life Sciences [q-bio]/Cancer, IMMUNITY, lcsh:RC254-282, Article, Limfòcits, Càncer de mama, 03 medical and health sciences, Gastrointestinal cancer, SDG 3 - Good Health and Well-being, Internal medicine, 692/53/2422, medicine, Radiology, Nuclear Medicine and imaging, Càncer gastrointestinal, 030304 developmental biology, Predictive biomarker, Tumor-infiltrating lymphocytes, business.industry, Médecine pathologie humaine, medicine.disease, Cancérologie, Human medicine, business, SYSTEM, 631/67/580/1884
Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are important prognostic and predictive biomarkers in triple-negative (TNBC) and HER2-positive breast cancer. Incorporating sTILs into clinical practice necessitates reproducible assessment. Previously developed standardized scoring guidelines have been widely embraced by the clinical and research communities. We evaluated sources of variability in sTIL assessment by pathologists in three previous sTIL ring studies. We identify common challenges and evaluate impact of discrepancies on outcome estimates in early TNBC using a newly-developed prognostic tool. Discordant sTIL assessment is driven by heterogeneity in lymphocyte distribution. Additional factors include: technical slide-related issues; scoring outside the tumor boundary; tumors with minimal assessable stroma; including lymphocytes associated with other structures; and including other inflammatory cells. Small variations in sTIL assessment modestly alter risk estimation in early TNBC but have the potential to affect treatment selection if cutpoints are employed. Scoring and averaging multiple areas, as well as use of reference images, improve consistency of sTIL evaluation. Moreover, to assist in avoiding the pitfalls identified in this analysis, we developed an educational resource available at www.tilsinbreastcancer.org/pitfalls., info:eu-repo/semantics/published

Published
2020
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21. Consensus guidelines for the definition, detection and interpretation of immunogenic cell death

Author

Galluzzi, L., Vitale, I., Warren, S., Adjemian, S., Agostinis, P., Martinez, A.B., Chan, T.A., Coukos, G., Demaria, S., Deutsch, E., Draganov, D., Edelson, R.L., Formenti, S.C., Fucikova, J., Gabriele, L., Gaipl, U.S., Gameiro, S.R., Garg, A.D., Golden, E., Han, J., Harrington, K.J., Hemminki, A., Hodge, J.W., Hossain, DMS, Illidge, T., Karin, M., Kaufman, H.L., Kepp, O., Kroemer, G., Lasarte, J.J., Loi, S., Lotze, M.T., Manic, G., Merghoub, T., Melcher, A.A., Mossman, K.L., Prosper, F., Rekdal, Ø., Rescigno, M., Riganti, C., Sistigu, A., Smyth, M.J., Spisek, R., Stagg, J., Strauss, B.E., Tang, D., Tatsuno, K., van Gool, S.W., Vandenabeele, P., Yamazaki, T., Zamarin, D., Zitvogel, L., Cesano, A., Marincola, F.M., Department of Oncology, HUS Comprehensive Cancer Center, Research Programs Unit, TRIMM - Translational Immunology Research Program, University of Helsinki, and Helsinki University Hospital Area

Subjects
CALRETICULIN EXPOSURE, Consensus, Guidelines as Topic, Humans, Immunogenic Cell Death/genetics, Molecular Biology/methods, immunology, molecular biology, oncology, NOD-LIKE RECEPTORS, NF-KAPPA-B, 3122 Cancers, ANTICANCER CHEMOTHERAPY, IMMUNE CHECKPOINT BLOCKADE, ANTITUMOR IMMUNITY, ANTIGEN PRESENTATION, PATTERN-RECOGNITION RECEPTORS, APOPTOTIC CELLS, 3111 Biomedicine, CANCER-CELLS
Abstract

Cells succumbing to stress via regulated cell death (RCD) can initiate an adaptive immune response associated with immunological memory, provided they display sufficient antigenicity and adjuvanticity. Moreover, multiple intracellular and microenvironmental features determine the propensity of RCD to drive adaptive immunity. Here, we provide an updated operational definition of immunogenic cell death (ICD), discuss the key factors that dictate the ability of dying cells to drive an adaptive immune response, summarize experimental assays that are currently available for the assessment of ICD in vitro and in vivo, and formulate guidelines for their interpretation.

Published
2020

22. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Author

Hudecek, J., Voorwerk, L., van Seijen, M., Nederlof, I., de Maaker, M., van den Berg, J., van de Vijver, K. K., Sikorska, K., Adams, S., Demaria, S., Viale, G., Nielsen, T. O., Badve, S. S., Michiels, S., Symmans, W. F., Sotiriou, C., Rimm, D. L., Hewitt, S. M., Denkert, C., Loibl, S., Loi, S., Bartlett, J. M. S., Pruneri, G., Dillon, D. A., Cheang, M. C. U., Tutt, A., Hall, J. A., Kos, Z., Salgado, R., Kok, M., Horlings, H. M., Hyytiainen, A., Hida, A. I., Thompson, A., Lefevre, A., Lazar, A. J., Gown, A., Lo, A., Sapino, A., Madabhushi, A., Moreira, A., Richardson, A., Vingiani, A., Beck, A. H., Bellizzi, A. M., Guerrero, A., Grigoriadis, A., Ehinger, A., Garrido-Castro, A., Vincent-Salomon, A., Laenkholm, A. -V., Sharma, A., Cimino-Mathews, A., Srinivasan, A., Acs, B., Singh, B., Calhoun, B., Haibe-Kans, B., Solomon, B., Thapa, B., Nelson, B. H., Gallas, B. D., Castaneda, C., Ballesteros-Merino, C., Criscitiello, C., Boeckx, C., Colpaert, C., Quinn, C., Chennubhotla, C. S., Swanton, C., Solinas, C., Hiley, C., Drubay, D., Bethmann, D., Moore, D. A., Larsimont, D., Sabanathan, D., Peeters, D., Zardavas, D., Hoflmayer, D., Johnson, D. B., Thompson, E. A., Brogi, E., Perez, E., Elgabry, E. A., Stovgaard, E. S., Blackley, E. F., Roblin, E., Reisenbichler, E., Bellolio, E., Balslev, E., Chmielik, E., Gaire, F., Andre, F., F. -I., Lu, Azmoudeh-Ardalan, F., Rojo, F., Gruosso, T., Ciompi, F., Peale, F., Hirsch, F. R., Klauschen, F., Penault-Llorca, F., Acosta Haab, G., Farshid, G., van den Eynden, G., Curigliano, G., Floris, G., Broeckx, G., Gonzalez-Ericsson, Koeppen, H., Haynes, H. R., Mcarthur, H., Joensuu, H., Olofsson, H., Lien, H. -C., Chen, I. -C., Cree, I., Frahm, I., Brcic, I., Chan, J., Ziai, J., Brock, J., Wesseling, J., Giltnane, J., Kerner, J. K., Thagaard, J., Braybrooke, J. P., van der Laak, J. A. W. M., Lemonnier, J., Zha, J., Ribeiro, J., Lennerz, J. K., Carter, J. M., Saltz, J., Hartman, J., Hainfellner, J., Quesne, J. L., Juco, J. W., Reis-Filho, J., Sanchez, J., Sparano, J., Cucherousset, J., Araya, J. C., Adam, J., Balko, J. M., Saeger, K., Siziopikou, K., Willard-Gallo, K., Weber, K., Pogue-Geile, K. L., Steele, K. E., Emancipator, K., Abduljabbar, K., El Bairi, K., Blenman, K. R. M., Allison, K. H., Korski, K., Pusztai, L., Comerma, L., Buisseret, L., Cooper, L. A. D., Shi, L., Kooreman, L. F. S., Molinero, L., Estrada, M. V., Lacroix-Triki, M., Al Bakir, M., Sebastian, M. M., van de Vijver, M., Balancin, M. L., Dieci, M. V., Mathieu, M. -C., Rebelatto, M. C., Piccart, M., Hanna, M. G., Goetz, M. P., Preusser, M., Khojasteh, M., Sanders, M. E., Regan, M. M., Barnes, M., Christie, M., Misialek, M., Ignatiadis, M., van Bockstal, M., Castillo, M., Amgad, M., Harbeck, N., Tung, N., Laudus, N., Sirtaine, N., Burchardi, N., Ternes, N., Radosevic-Robin, N., Gluz, O., Grimm, O., Nuciforo, P., Jank, P., Gonzalez-Ericsson, P., Kirtani, P., Jelinic, P., Watson, P. H., Savas, P., Francis, P. A., Russell, P. A., Singh, R., Kim, R. S., Pierce, R. H., Hills, R., Leon-Ferre, R., de Wind, R., Shui, R., De Clercq, S., Leung, S., Tabbarah, S., Souza, S. C., O'Toole, S., Swain, S., Dudgeon, S., Willis, S., Ely, S., Kim, S. -R., Bedri, S., Irshad, S., Liu, S. -W., Goel, S., Hendry, S., Bianchi, S., Braganca, S., Paik, S., Wienert, S., Fox, S. B., Luen, S. J., Naber, S., Schnitt, S. J., Sua, L. F., Lakhani, S. R., Fineberg, S., Soler, T., Gevaert, T., D'Alfonso, T., John, T., Sugie, T., Kurkure, U., Bossuyt, V., Manem, V., Camara, V. P., Tong, W., Chen, W., Yang, W., Tran, W. T., Wang, Y., Yuan, Y., Allory, Y., Husain, Z., Bago-Horvath, Z., Division of Pathology and Laboratory Medicine, Università degli Studi di Milano [Milano] (UNIMI)-European Institute of Oncology [Milan] (ESMO), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Gustave Roussy (IGR), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Charité, Institute of Pathology, Translational Tumorpathology Unit, German Breast Group, Breast Cancer Translational Research Laboratory, Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB)-Faculté de Médecine [Bruxelles] (ULB), University of the Sunshine Coast (USC), European Institute of Oncology [Milan] (ESMO), Breakthrough Breast Cancer Centre, London Institute of Cancer, Department of Pathology, The Netherlands Cancer Institute, Division of Experimental Therapy, The Netherlands Cancer Institute NKI/AvL, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Hudeček, Jan [0000-0003-1071-5686], van de Vijver, Koen K [0000-0002-2026-9790], Demaria, Sandra [0000-0003-4426-0499], Badve, Sunil S [0000-0001-8861-9980], Symmans, William Fraser [0000-0002-1526-184X], Rimm, David L [0000-0001-5820-4397], Loi, Sherene [0000-0001-6137-9171], Hall, Jacqueline A [0000-0003-0708-1360], Horlings, Hugo M [0000-0003-4782-8828], Apollo - University of Cambridge Repository, van de Vijver, Koen K. [0000-0002-2026-9790], Badve, Sunil S. [0000-0001-8861-9980], Rimm, David L. [0000-0001-5820-4397], Hall, Jacqueline A. [0000-0003-0708-1360], Horlings, Hugo M. [0000-0003-4782-8828], Università degli Studi di Milano = University of Milan (UNIMI)-European Institute of Oncology [Milan] (ESMO), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, German Breast Group (GBG), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, [SDV]Life Sciences [q-bio], medicine.medical_treatment, MEDLINE, [SDV.CAN]Life Sciences [q-bio]/Cancer, Review Article, lcsh:RC254-282, 631/67/1857, Tumour biomarkers, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 03 medical and health sciences, 0302 clinical medicine, Breast cancer, 692/53, Internal medicine, Medicine and Health Sciences, medicine, Pharmacology (medical), Radiology, Nuclear Medicine and imaging, 692/4028/67/580, Stromal tumor, Biomarkers, Tumour immunology, business.industry, Risk management framework, review-article, Médecine pathologie humaine, 631/67/1347, Immunotherapy, Sciences bio-médicales et agricoles, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], 3. Good health, Review article, Clinical trial, Cancérologie, 030104 developmental biology, 030220 oncology & carcinogenesis, Biomarker (medicine), business
Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting., info:eu-repo/semantics/published

Published
2020
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23. Report on computational assessment of Tumor Infiltrating Lymphocytes from the International Immuno-Oncology Biomarker Working Group

Author

Amgad, M., Stovgaard, E.S., Balslev, E., Thagaard, J., Chen, W, Dudgeon, S., Sharma, A., Kerner, J.K., Denkert, C., Yuan, Y., AbdulJabbar, K., Wienert, S., Savas, P., Voorwerk, L., Beck, A.H., Madabhushi, A., Hartman, J., Sebastian, M.M., Horlings, H.M., Hudecek, J., Ciompi, F., Moore, D.A.J., Singh, R., Roblin, E., Balancin, M.L., Mathieu, M.C., Lennerz, J.K., Kirtani, P., Chen, I.C., Braybrooke, J.P., Pruneri, G., Demaria, S., Adams, S., Schnitt, S.J., Lakhani, S.R., Rojo, F., Comerma, L., Badve, S.S., Khojasteh, M., Symmans, W.F., Sotiriou, C., Gonzalez-Ericsson, P., Pogue-Geile, K.L., Kim, R.S., Rimm, D.L., Viale, G., Hewitt, S.M., Bartlett, J.M.S., Penault-Llorca, F., Goel, S., Lien, H.C., Loibl, S., Kos, Z., Loi, S., Hanna, M.G., Michiels, S., Kok, M., Nielsen, T.O., Lazar, A.J., Bago-Horvath, Z., Kooreman, L.F., Laak, J.A.W.M. van der, Saltz, J., Gallas, B.D., Kurkure, U., Barnes, M., Salgado, R., Cooper, L.A.D., Amgad, M., Stovgaard, E.S., Balslev, E., Thagaard, J., Chen, W, Dudgeon, S., Sharma, A., Kerner, J.K., Denkert, C., Yuan, Y., AbdulJabbar, K., Wienert, S., Savas, P., Voorwerk, L., Beck, A.H., Madabhushi, A., Hartman, J., Sebastian, M.M., Horlings, H.M., Hudecek, J., Ciompi, F., Moore, D.A.J., Singh, R., Roblin, E., Balancin, M.L., Mathieu, M.C., Lennerz, J.K., Kirtani, P., Chen, I.C., Braybrooke, J.P., Pruneri, G., Demaria, S., Adams, S., Schnitt, S.J., Lakhani, S.R., Rojo, F., Comerma, L., Badve, S.S., Khojasteh, M., Symmans, W.F., Sotiriou, C., Gonzalez-Ericsson, P., Pogue-Geile, K.L., Kim, R.S., Rimm, D.L., Viale, G., Hewitt, S.M., Bartlett, J.M.S., Penault-Llorca, F., Goel, S., Lien, H.C., Loibl, S., Kos, Z., Loi, S., Hanna, M.G., Michiels, S., Kok, M., Nielsen, T.O., Lazar, A.J., Bago-Horvath, Z., Kooreman, L.F., Laak, J.A.W.M. van der, Saltz, J., Gallas, B.D., Kurkure, U., Barnes, M., Salgado, R., and Cooper, L.A.D.

Abstract

Contains fulltext : 220833.pdf (publisher's version ) (Open Access), Assessment of tumor-infiltrating lymphocytes (TILs) is increasingly recognized as an integral part of the prognostic workflow in triple-negative (TNBC) and HER2-positive breast cancer, as well as many other solid tumors. This recognition has come about thanks to standardized visual reporting guidelines, which helped to reduce inter-reader variability. Now, there are ripe opportunities to employ computational methods that extract spatio-morphologic predictive features, enabling computer-aided diagnostics. We detail the benefits of computational TILs assessment, the readiness of TILs scoring for computational assessment, and outline considerations for overcoming key barriers to clinical translation in this arena. Specifically, we discuss: 1. ensuring computational workflows closely capture visual guidelines and standards; 2. challenges and thoughts standards for assessment of algorithms including training, preanalytical, analytical, and clinical validation; 3. perspectives on how to realize the potential of machine learning models and to overcome the perceptual and practical limits of visual scoring.

Published
2020

24. The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice

Author

Gonzalez-Ericsson, P, Stovgaard, ES, Sua, LF, Reisenbichler, E, Kos, Z, Carter, JM, Michiels, S, Le Quesne, J, Nielsen, TO, Laenkholm, A-V, Fox, SB, Adam, J, Bartlett, JMS, Rimm, DL, Quinn, C, Peeters, D, Dieci, M, Vincent-Salomon, A, Cree, I, Hida, A, Balko, JM, Haynes, HR, Frahm, I, Acosta-Haab, G, Balancin, M, Bellolio, E, Yang, W, Kirtani, P, Sugie, T, Ehinger, A, Castaneda, CA, Kok, M, McArthur, H, Siziopikou, K, Badve, S, Fineberg, S, Gown, A, Viale, G, Schnitt, SJ, Pruneri, G, Penault-Llorca, F, Hewitt, S, Thompson, EA, Allison, KH, Symmans, WF, Bellizzi, AM, Brogi, E, Moore, DA, Larsimont, D, Dillon, DA, Lazar, A, Lien, H, Goetz, MP, Broeckx, G, El Bairi, K, Harbeck, N, Cimino-Mathews, A, Sotiriou, C, Adams, S, Liu, S-W, Loibl, S, Chen, I-C, Lakhani, SR, Juco, JW, Denkert, C, Blackley, EF, Demaria, S, Leon-Ferre, R, Gluz, O, Zardavas, D, Emancipator, K, Ely, S, Loi, S, Salgado, R, Sanders, M, Gonzalez-Ericsson, P, Stovgaard, ES, Sua, LF, Reisenbichler, E, Kos, Z, Carter, JM, Michiels, S, Le Quesne, J, Nielsen, TO, Laenkholm, A-V, Fox, SB, Adam, J, Bartlett, JMS, Rimm, DL, Quinn, C, Peeters, D, Dieci, M, Vincent-Salomon, A, Cree, I, Hida, A, Balko, JM, Haynes, HR, Frahm, I, Acosta-Haab, G, Balancin, M, Bellolio, E, Yang, W, Kirtani, P, Sugie, T, Ehinger, A, Castaneda, CA, Kok, M, McArthur, H, Siziopikou, K, Badve, S, Fineberg, S, Gown, A, Viale, G, Schnitt, SJ, Pruneri, G, Penault-Llorca, F, Hewitt, S, Thompson, EA, Allison, KH, Symmans, WF, Bellizzi, AM, Brogi, E, Moore, DA, Larsimont, D, Dillon, DA, Lazar, A, Lien, H, Goetz, MP, Broeckx, G, El Bairi, K, Harbeck, N, Cimino-Mathews, A, Sotiriou, C, Adams, S, Liu, S-W, Loibl, S, Chen, I-C, Lakhani, SR, Juco, JW, Denkert, C, Blackley, EF, Demaria, S, Leon-Ferre, R, Gluz, O, Zardavas, D, Emancipator, K, Ely, S, Loi, S, Salgado, R, and Sanders, M

Published
2020

25. Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Author

Hudecek, 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, Hudecek, 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, and Horlings, HM

Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting.

Published
2020

26. Report on computational assessment of Tumor Infiltrating Lymphocytes from the International Immuno-Oncology Biomarker Working Group

Author

Amgad, M, Stovgaard, ES, Balslev, E, Thagaard, J, Chen, W, Dudgeon, S, Sharma, A, Kerner, JK, Denkert, C, Yuan, Y, AbdulJabbar, K, Wienert, S, Savas, P, Voorwerk, L, Beck, AH, Madabhushi, A, Hartman, J, Sebastian, MM, Horlings, HM, Hudecek, J, Ciompi, F, Moore, DA, Singh, R, Roblin, E, Balancin, ML, Mathieu, M-C, Lennerz, JK, Kirtani, P, Chen, I-C, Braybrooke, JP, Pruneri, G, Demaria, S, Adams, S, Schnitt, SJ, Lakhani, SR, Rojo, F, Comerma, L, Badve, SS, Khojasteh, M, Symmans, WF, Sotiriou, C, Gonzalez-Ericsson, P, Pogue-Geile, KL, Kim, RS, Rimm, DL, Viale, G, Hewitt, SM, Bartlett, JMS, Penault-Llorca, F, Goel, S, Lien, H-C, Loibl, S, Kos, Z, Loi, S, Hanna, MG, Michiels, S, Kok, M, Nielsen, TO, Lazar, AJ, Bago-Horvath, Z, Kooreman, LFS, van der Laak, JAWM, Saltz, J, Gallas, BD, Kurkure, U, Barnes, M, Salgado, R, Cooper, LAD, Amgad, M, Stovgaard, ES, Balslev, E, Thagaard, J, Chen, W, Dudgeon, S, Sharma, A, Kerner, JK, Denkert, C, Yuan, Y, AbdulJabbar, K, Wienert, S, Savas, P, Voorwerk, L, Beck, AH, Madabhushi, A, Hartman, J, Sebastian, MM, Horlings, HM, Hudecek, J, Ciompi, F, Moore, DA, Singh, R, Roblin, E, Balancin, ML, Mathieu, M-C, Lennerz, JK, Kirtani, P, Chen, I-C, Braybrooke, JP, Pruneri, G, Demaria, S, Adams, S, Schnitt, SJ, Lakhani, SR, Rojo, F, Comerma, L, Badve, SS, Khojasteh, M, Symmans, WF, Sotiriou, C, Gonzalez-Ericsson, P, Pogue-Geile, KL, Kim, RS, Rimm, DL, Viale, G, Hewitt, SM, Bartlett, JMS, Penault-Llorca, F, Goel, S, Lien, H-C, Loibl, S, Kos, Z, Loi, S, Hanna, MG, Michiels, S, Kok, M, Nielsen, TO, Lazar, AJ, Bago-Horvath, Z, Kooreman, LFS, van der Laak, JAWM, Saltz, J, Gallas, BD, Kurkure, U, Barnes, M, Salgado, R, and Cooper, LAD

Abstract

Assessment of tumor-infiltrating lymphocytes (TILs) is increasingly recognized as an integral part of the prognostic workflow in triple-negative (TNBC) and HER2-positive breast cancer, as well as many other solid tumors. This recognition has come about thanks to standardized visual reporting guidelines, which helped to reduce inter-reader variability. Now, there are ripe opportunities to employ computational methods that extract spatio-morphologic predictive features, enabling computer-aided diagnostics. We detail the benefits of computational TILs assessment, the readiness of TILs scoring for computational assessment, and outline considerations for overcoming key barriers to clinical translation in this arena. Specifically, we discuss: 1. ensuring computational workflows closely capture visual guidelines and standards; 2. challenges and thoughts standards for assessment of algorithms including training, preanalytical, analytical, and clinical validation; 3. perspectives on how to realize the potential of machine learning models and to overcome the perceptual and practical limits of visual scoring.

Published
2020

27. Consensus guidelines for the definition, detection and interpretation of immunogenic cell death

Author

Galluzzi, L, Vitale, I, Warren, S, Adjemian, S, Agostinis, P, Buque Martinez, A, Chan, TA, Coukos, G, Demaria, S, Deutsch, E, Draganov, D, Edelson, RL, Formenti, SC, Fucikova, J, Gabriele, L, Gaipl, US, Gameiro, SR, Garg, AD, Golden, E, Han, J, Harrington, KJ, Hemminki, A, Hodge, JW, Hossain, DMS, Illidge, T, Karin, M, Kaufman, HL, Kepp, O, Kroemer, G, Lasarte, JJ, Loi, S, Lotze, MT, Manic, G, Merghoub, T, Melcher, AA, Mossman, KL, Prosper, F, Rekdal, O, Rescigno, M, Riganti, C, Sistigu, A, Smyth, MJ, Spisek, R, Stagg, J, Strauss, BE, Tang, D, Tatsuno, K, van Gool, SW, Vandenabeele, P, Yamazaki, T, Zamarin, D, Zitvogel, L, Cesano, A, Marincola, FM, Galluzzi, L, Vitale, I, Warren, S, Adjemian, S, Agostinis, P, Buque Martinez, A, Chan, TA, Coukos, G, Demaria, S, Deutsch, E, Draganov, D, Edelson, RL, Formenti, SC, Fucikova, J, Gabriele, L, Gaipl, US, Gameiro, SR, Garg, AD, Golden, E, Han, J, Harrington, KJ, Hemminki, A, Hodge, JW, Hossain, DMS, Illidge, T, Karin, M, Kaufman, HL, Kepp, O, Kroemer, G, Lasarte, JJ, Loi, S, Lotze, MT, Manic, G, Merghoub, T, Melcher, AA, Mossman, KL, Prosper, F, Rekdal, O, Rescigno, M, Riganti, C, Sistigu, A, Smyth, MJ, Spisek, R, Stagg, J, Strauss, BE, Tang, D, Tatsuno, K, van Gool, SW, Vandenabeele, P, Yamazaki, T, Zamarin, D, Zitvogel, L, Cesano, A, and Marincola, FM

Abstract

Cells succumbing to stress via regulated cell death (RCD) can initiate an adaptive immune response associated with immunological memory, provided they display sufficient antigenicity and adjuvanticity. Moreover, multiple intracellular and microenvironmental features determine the propensity of RCD to drive adaptive immunity. Here, we provide an updated operational definition of immunogenic cell death (ICD), discuss the key factors that dictate the ability of dying cells to drive an adaptive immune response, summarize experimental assays that are currently available for the assessment of ICD in vitro and in vivo, and formulate guidelines for their interpretation.

Published
2020

28. Pitfalls in assessing stromal tumor infiltrating lymphocytes (sTILs) in breast cancer

Author

Kos, Z, Roblin, E, Kim, RS, Michiels, S, Gallas, BD, Chen, W, van de Vijver, KK, Goel, S, Adams, S, Demaria, S, Viale, G, Nielsen, TO, Badve, SS, Symmans, WF, Sotiriou, C, Rimm, DL, Hewitt, S, Denkert, C, Loibl, S, Luen, SJ, Bartlett, JMS, Savas, P, Pruneri, G, Dillon, DA, Cheang, MCU, Tutt, A, Hall, JA, Kok, M, Horlings, HM, Madabhushi, A, van der Laak, J, Ciompi, F, Laenkholm, A-V, Bellolio, E, Gruosso, T, Fox, SB, Araya, JC, Floris, G, Hudecek, J, Voorwerk, L, Beck, AH, Kerner, J, Larsimont, D, Declercq, S, Van den Eynden, G, Pusztai, L, Ehinger, A, Yang, W, AbdulJabbar, K, Yuan, Y, Singh, R, Hiley, C, al Bakir, M, Lazar, AJ, Naber, S, Wienert, S, Castillo, M, Curigliano, G, Dieci, M-V, Andre, F, Swanton, C, Reis-Filho, J, Sparano, J, Balslev, E, Chen, I-C, Stovgaard, EIS, Pogue-Geile, K, Blenman, KRM, Penault-Llorca, F, Schnitt, S, Lakhani, SR, Vincent-Salomon, A, Rojo, F, Braybrooke, JP, Hanna, MG, Soler-Monso, MT, Bethmann, D, Castaneda, CA, Willard-Gallo, K, Sharma, A, Lien, H-C, Fineberg, S, Thagaard, J, Comerma, L, Gonzalez-Ericsson, P, Brogi, E, Loi, S, Saltz, J, Klaushen, F, Cooper, L, Amgad, M, Moore, DA, Salgado, R, Kos, Z, Roblin, E, Kim, RS, Michiels, S, Gallas, BD, Chen, W, van de Vijver, KK, Goel, S, Adams, S, Demaria, S, Viale, G, Nielsen, TO, Badve, SS, Symmans, WF, Sotiriou, C, Rimm, DL, Hewitt, S, Denkert, C, Loibl, S, Luen, SJ, Bartlett, JMS, Savas, P, Pruneri, G, Dillon, DA, Cheang, MCU, Tutt, A, Hall, JA, Kok, M, Horlings, HM, Madabhushi, A, van der Laak, J, Ciompi, F, Laenkholm, A-V, Bellolio, E, Gruosso, T, Fox, SB, Araya, JC, Floris, G, Hudecek, J, Voorwerk, L, Beck, AH, Kerner, J, Larsimont, D, Declercq, S, Van den Eynden, G, Pusztai, L, Ehinger, A, Yang, W, AbdulJabbar, K, Yuan, Y, Singh, R, Hiley, C, al Bakir, M, Lazar, AJ, Naber, S, Wienert, S, Castillo, M, Curigliano, G, Dieci, M-V, Andre, F, Swanton, C, Reis-Filho, J, Sparano, J, Balslev, E, Chen, I-C, Stovgaard, EIS, Pogue-Geile, K, Blenman, KRM, Penault-Llorca, F, Schnitt, S, Lakhani, SR, Vincent-Salomon, A, Rojo, F, Braybrooke, JP, Hanna, MG, Soler-Monso, MT, Bethmann, D, Castaneda, CA, Willard-Gallo, K, Sharma, A, Lien, H-C, Fineberg, S, Thagaard, J, Comerma, L, Gonzalez-Ericsson, P, Brogi, E, Loi, S, Saltz, J, Klaushen, F, Cooper, L, Amgad, M, Moore, DA, and Salgado, R

Abstract

Stromal tumor-infiltrating lymphocytes (sTILs) are important prognostic and predictive biomarkers in triple-negative (TNBC) and HER2-positive breast cancer. Incorporating sTILs into clinical practice necessitates reproducible assessment. Previously developed standardized scoring guidelines have been widely embraced by the clinical and research communities. We evaluated sources of variability in sTIL assessment by pathologists in three previous sTIL ring studies. We identify common challenges and evaluate impact of discrepancies on outcome estimates in early TNBC using a newly-developed prognostic tool. Discordant sTIL assessment is driven by heterogeneity in lymphocyte distribution. Additional factors include: technical slide-related issues; scoring outside the tumor boundary; tumors with minimal assessable stroma; including lymphocytes associated with other structures; and including other inflammatory cells. Small variations in sTIL assessment modestly alter risk estimation in early TNBC but have the potential to affect treatment selection if cutpoints are employed. Scoring and averaging multiple areas, as well as use of reference images, improve consistency of sTIL evaluation. Moreover, to assist in avoiding the pitfalls identified in this analysis, we developed an educational resource available at www.tilsinbreastcancer.org/pitfalls.

Published
2020

32. Tumor mutational burden is a determinant of immune-mediated survival in breast cancer

Author

Miller, L.D., Routh, E.D., Wang, E., Su, J., Jones, W.D., Black, M.A., Hoadley, K.A., Triozzi, P., Print, C., Pullikuth, A., Bedognetti, D., Thomas, A., Chou, J.W., Jin, G., Gatza, M.L., Demaria, S., Perou, C.M., Mehta, G.A., Knowlton, N, and Page, D.B.

Abstract

Mounting evidence supports a role for the immune system in breast cancer outcomes. The ability to distinguish highly immunogenic tumors susceptible to anti-tumor immunity from weakly immunogenic or inherently immune-resistant tumors would guide development of therapeutic strategies in breast cancer. Genomic, transcriptomic and clinical data from The Cancer Genome Atlas (TCGA) and Molecular Taxonomy of Breast Cancer International Consortium (METABRIC) breast cancer cohorts were used to examine statistical associations between tumor mutational burden (TMB) and the survival of patients whose tumors were assigned to previously-described prognostic immune subclasses reflecting favorable, weak or poor immune-infiltrate dispositions (FID, WID or PID, respectively). Tumor immune subclasses were associated with survival in patients with high TMB (TMB-Hi, P < 0.001) but not in those with low TMB (TMB-Lo, P = 0.44). This statistical relationship was confirmed in the METABRIC cohort (TMB-Hi, P = 0.047; TMB-Lo, P = 0.39), and also found to hold true in the more-indolent Luminal A tumor subtype (TMB-Hi, P = 0.011; TMB-Lo, P = 0.91). In TMB-Hi tumors, the FID subclass was associated with prolonged survival independent of tumor stage, molecular subtype, age and treatment. Copy number analysis revealed the reproducible, preferential amplification of chromosome 1q immune-regulatory genes in the PID immune subclass. These findings demonstrate a previously unappreciated role for TMB as a determinant of immune-mediated survival of breast cancer patients and identify candidate immune-regulatory mechanisms associated with immunologically cold tumors. Immune subtyping of breast cancers may offer opportunities for therapeutic stratification.

Published
2018
Full Text
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40. Assessing Tumor-Infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method from the International Immuno-Oncology Biomarkers Working Group: Part 2: TILs in Melanoma, Gastrointestinal Tract Carcinomas, Non-Small Cell Lung Carcinoma and Mesothelioma, Endometrial and Ovarian Carcinomas, Squamous Cell Carcinoma of the Head and Neck, Genitourinary Carcinomas, and Primary Brain Tumors.

Author

Hendry, Shona, Salgado, Roberto, Gevaert, Thomas, Russell, PA, John, T, Thapa, B, Christie, M, Van De Vijver, Kristin Inneke, Estrada, Mónica Valeria, Gonzales-Ericsson, PI, Sanders, Melinda M.E., Solomon, B, Solinas, Cinzia, Van den Eynden, Gert, Allory, Y, Preusser, Matthias, Hainfellner, J, Pruneri, Giancarlo, Vingiani, Andrea, Demaria, S, Symmans, Fraser, Nuciforo, Paolo, Comerma, L, Thompson, E A, Lakhani, Sunil S.R., Kim, Su Ryang, Schnitt, S, Colpaert, S, Sotiriou, Christos, Ignatiadis, Michail, Badve, S, Pierce, RH, Viale, G, Sirtaine, N., Pénault-Llorca, Frederique, Sugie, T, Fineberg, Daniel, Paik, Soon, Srinivasa, A, Richardson, A L, Wang, Y, Chmielik, E, Johnson, Douglas D.B., Balko, Justin J.M., Wienert, S, Bossuyt, V, Michiels, S, Ternest, N, Burchardi, N, Luen, SJ, Savas, P, Klauschen, F, Watson, PH, Nelson, BH, Criscitiello, Carmen, O'Toole, S, Larsimont, Denis, De Wind, Roland, Curigliano, G, André, F, Lacroix-Triki, M, Van de Vijver, Marc J, Rojo Fernandez, José Manuel, Floris, Giuseppe, Svatos, Bedrich, Sparano, Joseph, Rimm, David D.L., Nielsen, T, Kos, Z, Hewitt, Stephen M, Singh, Bal Ram, Farshid, G, Loibl, Sibylle, Allison, K H, Tung Ngu, Chan, Adams, S., Willard-Gallo, Karen, Horlings, HM, Gandhi, L, Moreira, A., Hirsch, F, Dieci, Maria V, Urbanowicz, M, Brcic, I, Korski, K, Gaire, F, Koeppen, A.H., Lo, A., Giltnane, Jennifer J.M., Rebelatto, MC, Steele, KE, Zha, J, Emancipator, K, Juco, JW, Denkert, Carsten, Reis-Filho, Jorge Sergio, Loi, Sherene, Fox, Stephen B, Hendry, Shona, Salgado, Roberto, Gevaert, Thomas, Russell, PA, John, T, Thapa, B, Christie, M, Van De Vijver, Kristin Inneke, Estrada, Mónica Valeria, Gonzales-Ericsson, PI, Sanders, Melinda M.E., Solomon, B, Solinas, Cinzia, Van den Eynden, Gert, Allory, Y, Preusser, Matthias, Hainfellner, J, Pruneri, Giancarlo, Vingiani, Andrea, Demaria, S, Symmans, Fraser, Nuciforo, Paolo, Comerma, L, Thompson, E A, Lakhani, Sunil S.R., Kim, Su Ryang, Schnitt, S, Colpaert, S, Sotiriou, Christos, Ignatiadis, Michail, Badve, S, Pierce, RH, Viale, G, Sirtaine, N., Pénault-Llorca, Frederique, Sugie, T, Fineberg, Daniel, Paik, Soon, Srinivasa, A, Richardson, A L, Wang, Y, Chmielik, E, Johnson, Douglas D.B., Balko, Justin J.M., Wienert, S, Bossuyt, V, Michiels, S, Ternest, N, Burchardi, N, Luen, SJ, Savas, P, Klauschen, F, Watson, PH, Nelson, BH, Criscitiello, Carmen, O'Toole, S, Larsimont, Denis, De Wind, Roland, Curigliano, G, André, F, Lacroix-Triki, M, Van de Vijver, Marc J, Rojo Fernandez, José Manuel, Floris, Giuseppe, Svatos, Bedrich, Sparano, Joseph, Rimm, David D.L., Nielsen, T, Kos, Z, Hewitt, Stephen M, Singh, Bal Ram, Farshid, G, Loibl, Sibylle, Allison, K H, Tung Ngu, Chan, Adams, S., Willard-Gallo, Karen, Horlings, HM, Gandhi, L, Moreira, A., Hirsch, F, Dieci, Maria V, Urbanowicz, M, Brcic, I, Korski, K, Gaire, F, Koeppen, A.H., Lo, A., Giltnane, Jennifer J.M., Rebelatto, MC, Steele, KE, Zha, J, Emancipator, K, Juco, JW, Denkert, Carsten, Reis-Filho, Jorge Sergio, Loi, Sherene, and Fox, Stephen B

Abstract

info:eu-repo/semantics/published

Published
2017

46. Melanoma and immunotherapy bridge 2015 : Naples, Italy. 1-5 December 2015.

Author

Nanda, VGY, Peng, W, Hwu, P, Davies, MA, Ciliberto, G, Fattore, L, Malpicci, D, Aurisicchio, L, Ascierto, PA, Croce, CM, Mancini, R, Spranger, S, Gajewski, TF, Wang, Y, Ferrone, S, Vanpouille-Box, C, Wennerberg, E, Pilones, KA, Formenti, SC, Demaria, S, Tang, H, Fu, Y-X, Dummer, R, Puzanov, I, Tarhini, A, Chauvin, J-M, Pagliano, O, Fourcade, J, Sun, Z, Wang, H, Sanders, C, Kirkwood, JM, Chen, T-HT, Maurer, M, Korman, AJ, Zarour, HM, Stroncek, DF, Huber, V, Rivoltini, L, Thurin, M, Rau, T, Lugli, A, Pagès, F, Camarero, J, Sancho, A, Jommi, C, de Coaña, YP, Wolodarski, M, Yoshimoto, Y, Gentilcore, G, Poschke, I, Masucci, GV, Hansson, J, Kiessling, R, Scognamiglio, G, Sabbatino, F, Marino, FZ, Anniciello, AM, Cantile, M, Cerrone, M, Scala, S, D’alterio, C, Ianaro, A, Cirin, G, Liguori, G, Bott, G, Chapman, PB, Robert, C, Larkin, J, Haanen, JB, Ribas, A, Hogg, D, Hamid, O, Testori, A, Lorigan, P, Sosman, JA, Flaherty, KT, Yue, H, Coleman, S, Caro, I, Hauschild, A, McArthur, GA, Sznol, M, Callahan, MK, Kluger, H, Postow, MA, Gordan, R, Segal, NH, Rizvi, NA, Lesokhin, A, Atkins, MB, Burke, MM, Ralabate, A, Rivera, A, Kronenberg, SA, Agunwamba, B, Ruisi, M, Horak, C, Jiang, J, Wolchok, J, Liszkay, G, Maio, M, Mandalà, M, Demidov, L, Stoyakovskiy, D, Thomas, L, de la Cruz-Merino, L, Atkinson, V, Dutriaux, C, Garbe, C, Wongchenko, M, Chang, I, Koralek, DO, Rooney, I, Yan, Y, Dréno, B, Sullivan, R, Patel, M, Hodi, S, Amaria, R, Boasberg, P, Wallin, J, He, X, Cha, E, Richie, N, Ballinger, M, Smith, DC, Bauer, TM, Wasser, JS, Luke, JJ, Balmanoukian, AS, Kaufman, DR, Zhao, Y, Maleski, J, Leopold, L, Gangadhar, TC, Long, GV, Michielin, O, VanderWalde, A, Andtbacka, RHI, Cebon, J, Fernandez, E, Malvehy, J, Olszanski, AJ, Gause, C, Chen, L, Chou, J, Stephen Hodi, F, Brady, B, Mortier, L, Hassel, JC, Rutkowski, P, McNeil, C, Kalinka-Warzocha, E, Lebbé, C, Ny, L, Chacon, M, Queirolo, P, Loquai, C, Cheema, P, Berrocal, A, Eizmendi, KM, Bar-Sela, G, Hardy, H, Weber, JS, Grob, J-J, Marquez-Rodas, I, Schmidt, H, Briscoe, K, Baurain, J-F, Wolchok, JD, Pinto, R, De Summa, S, Garrisi, VM, Strippoli, S, Azzariti, A, Guida, G, Guida, M, Tommasi, S, Jacquelot, N, Enot, D, Flament, C, Pitt, JM, Vimond, N, Blattner, C, Yamazaki, T, Roberti, M-P, Vetizou, M, Daillere, R, Poirier-Colame, V, la Semeraro, M, Caignard, A, Slingluff, CL, Sallusto, F, Rusakiewicz, S, Weide, B, Marabelle, A, Kohrt, H, Dalle, S, Cavalcanti, A, Kroemer, G, Di Giacomo, AM, Wong, P, Yuan, J, Umansky, V, Eggermont, A, Zitvogel, L, Anna, P, Marco, T, Stefania, S, Francesco, M, Mariaelena, C, Gabriele, M, Antonio, AP, Franco, S, Roberti, MP, Enot, DP, Semeraro, M, Jégou, S, Flores, C, Kwon, BS, Anderson, AC, Borg, C, Aubin, F, Ayyoub, M, De Presbiteris, AL, Cordaro, FG, Camerlingo, R, Fratangelo, F, Mozzillo, N, Pirozzi, G, Patriarca, EJ, Caputo, E, Motti, ML, Falcon, R, Miceli, R, Capone, M, Madonna, G, Mallardo, D, Carrier, MV, Panza, E, De Cicco, P, Armogida, C, Ercolano, G, Botti, G, Cirino, G, Sandru, A, Blank, M, Balatoni, T, Olasz, J, Farkas, E, Szollar, A, Savolt, A, Godeny, M, Csuka, O, Horvath, S, Eles, K, Shoenfeld, Y, Kasler, M, Costantini, S, Capone, F, Moradi, F, Berglund, P, Leandersson, K, Linnskog, R, Andersson, T, Prasad, CP, Nigro, CL, Lattanzio, L, Proby, C, Syed, N, Occelli, M, Cauchi, C, Merlano, M, Harwood, C, Thompson, A, Crook, T, Bifulco, K, Ingangi, V, Minopoli, M, Ragone, C, Pessi, A, Mannavola, F, D’Oronzo, S, Felici, C, Tucci, M, Doronzo, A, Silvestris, F, Ferretta, A, Guida, S, Maida, I, Cocco, T, Passarelli, A, Quaresmini, D, Franzese, O, Palermo, B, Di Donna, C, Sperduti, I, Foddai, M, Stabile, H, Gismondi, A, Santoni, A, Nisticò, P, Sponghini, AP, Platini, F, Marra, E, Rondonotti, D, Alabiso, O, Fierro, MT, Savoia, P, Stratica, F, Quaglino, P, Di Monta, G, Corrado, C, Di Marzo, M, Ugo, M, Di Cecilia, ML, Nicola, M, Fusciello, C, Marra, A, Guarrasi, R, Baldi, C, Russo, R, Di Giulio, G, Faiola, V, Zeppa, P, Pepe, S, Gambale, E, Carella, C, Di Paolo, A, De Tursi, M, Marra, L, De Murtas, F, Sorrentino, V, Voinea, S, Panaitescu, E, Bolovan, M, Stanciu, A, Cinca, S, Botti, C, Aquino, G, Anniciello, A, Fortes, C, Mastroeni, S, Caggiati, A, Passarelli, F, Zappalà, A, Capuano, M, Bono, R, Nudo, M, Marino, C, Michelozzi, P, De Biasio, V, Battarra, VC, Formenti, S, Ascierto, ML, McMiller, TL, Berger, AE, Danilova, L, Anders, RA, Netto, GJ, Xu, H, Pritchard, TS, Fan, J, Cheadle, C, Cope, L, Drake, CG, Pardoll, DM, Taube, JM, Topalian, SL, Gnjatic, S, Nataraj, S, Imai, N, Rahman, A, Jungbluth, AA, Pan, L, Venhaus, R, Park, A, Lehmann, FF, Lendvai, N, Cohen, AD, Cho, HJ, Daniel, S, Hirsh, V, Nanda, VGY, Peng, W, Hwu, P, Davies, MA, Ciliberto, G, Fattore, L, Malpicci, D, Aurisicchio, L, Ascierto, PA, Croce, CM, Mancini, R, Spranger, S, Gajewski, TF, Wang, Y, Ferrone, S, Vanpouille-Box, C, Wennerberg, E, Pilones, KA, Formenti, SC, Demaria, S, Tang, H, Fu, Y-X, Dummer, R, Puzanov, I, Tarhini, A, Chauvin, J-M, Pagliano, O, Fourcade, J, Sun, Z, Wang, H, Sanders, C, Kirkwood, JM, Chen, T-HT, Maurer, M, Korman, AJ, Zarour, HM, Stroncek, DF, Huber, V, Rivoltini, L, Thurin, M, Rau, T, Lugli, A, Pagès, F, Camarero, J, Sancho, A, Jommi, C, de Coaña, YP, Wolodarski, M, Yoshimoto, Y, Gentilcore, G, Poschke, I, Masucci, GV, Hansson, J, Kiessling, R, Scognamiglio, G, Sabbatino, F, Marino, FZ, Anniciello, AM, Cantile, M, Cerrone, M, Scala, S, D’alterio, C, Ianaro, A, Cirin, G, Liguori, G, Bott, G, Chapman, PB, Robert, C, Larkin, J, Haanen, JB, Ribas, A, Hogg, D, Hamid, O, Testori, A, Lorigan, P, Sosman, JA, Flaherty, KT, Yue, H, Coleman, S, Caro, I, Hauschild, A, McArthur, GA, Sznol, M, Callahan, MK, Kluger, H, Postow, MA, Gordan, R, Segal, NH, Rizvi, NA, Lesokhin, A, Atkins, MB, Burke, MM, Ralabate, A, Rivera, A, Kronenberg, SA, Agunwamba, B, Ruisi, M, Horak, C, Jiang, J, Wolchok, J, Liszkay, G, Maio, M, Mandalà, M, Demidov, L, Stoyakovskiy, D, Thomas, L, de la Cruz-Merino, L, Atkinson, V, Dutriaux, C, Garbe, C, Wongchenko, M, Chang, I, Koralek, DO, Rooney, I, Yan, Y, Dréno, B, Sullivan, R, Patel, M, Hodi, S, Amaria, R, Boasberg, P, Wallin, J, He, X, Cha, E, Richie, N, Ballinger, M, Smith, DC, Bauer, TM, Wasser, JS, Luke, JJ, Balmanoukian, AS, Kaufman, DR, Zhao, Y, Maleski, J, Leopold, L, Gangadhar, TC, Long, GV, Michielin, O, VanderWalde, A, Andtbacka, RHI, Cebon, J, Fernandez, E, Malvehy, J, Olszanski, AJ, Gause, C, Chen, L, Chou, J, Stephen Hodi, F, Brady, B, Mortier, L, Hassel, JC, Rutkowski, P, McNeil, C, Kalinka-Warzocha, E, Lebbé, C, Ny, L, Chacon, M, Queirolo, P, Loquai, C, Cheema, P, Berrocal, A, Eizmendi, KM, Bar-Sela, G, Hardy, H, Weber, JS, Grob, J-J, Marquez-Rodas, I, Schmidt, H, Briscoe, K, Baurain, J-F, Wolchok, JD, Pinto, R, De Summa, S, Garrisi, VM, Strippoli, S, Azzariti, A, Guida, G, Guida, M, Tommasi, S, Jacquelot, N, Enot, D, Flament, C, Pitt, JM, Vimond, N, Blattner, C, Yamazaki, T, Roberti, M-P, Vetizou, M, Daillere, R, Poirier-Colame, V, la Semeraro, M, Caignard, A, Slingluff, CL, Sallusto, F, Rusakiewicz, S, Weide, B, Marabelle, A, Kohrt, H, Dalle, S, Cavalcanti, A, Kroemer, G, Di Giacomo, AM, Wong, P, Yuan, J, Umansky, V, Eggermont, A, Zitvogel, L, Anna, P, Marco, T, Stefania, S, Francesco, M, Mariaelena, C, Gabriele, M, Antonio, AP, Franco, S, Roberti, MP, Enot, DP, Semeraro, M, Jégou, S, Flores, C, Kwon, BS, Anderson, AC, Borg, C, Aubin, F, Ayyoub, M, De Presbiteris, AL, Cordaro, FG, Camerlingo, R, Fratangelo, F, Mozzillo, N, Pirozzi, G, Patriarca, EJ, Caputo, E, Motti, ML, Falcon, R, Miceli, R, Capone, M, Madonna, G, Mallardo, D, Carrier, MV, Panza, E, De Cicco, P, Armogida, C, Ercolano, G, Botti, G, Cirino, G, Sandru, A, Blank, M, Balatoni, T, Olasz, J, Farkas, E, Szollar, A, Savolt, A, Godeny, M, Csuka, O, Horvath, S, Eles, K, Shoenfeld, Y, Kasler, M, Costantini, S, Capone, F, Moradi, F, Berglund, P, Leandersson, K, Linnskog, R, Andersson, T, Prasad, CP, Nigro, CL, Lattanzio, L, Proby, C, Syed, N, Occelli, M, Cauchi, C, Merlano, M, Harwood, C, Thompson, A, Crook, T, Bifulco, K, Ingangi, V, Minopoli, M, Ragone, C, Pessi, A, Mannavola, F, D’Oronzo, S, Felici, C, Tucci, M, Doronzo, A, Silvestris, F, Ferretta, A, Guida, S, Maida, I, Cocco, T, Passarelli, A, Quaresmini, D, Franzese, O, Palermo, B, Di Donna, C, Sperduti, I, Foddai, M, Stabile, H, Gismondi, A, Santoni, A, Nisticò, P, Sponghini, AP, Platini, F, Marra, E, Rondonotti, D, Alabiso, O, Fierro, MT, Savoia, P, Stratica, F, Quaglino, P, Di Monta, G, Corrado, C, Di Marzo, M, Ugo, M, Di Cecilia, ML, Nicola, M, Fusciello, C, Marra, A, Guarrasi, R, Baldi, C, Russo, R, Di Giulio, G, Faiola, V, Zeppa, P, Pepe, S, Gambale, E, Carella, C, Di Paolo, A, De Tursi, M, Marra, L, De Murtas, F, Sorrentino, V, Voinea, S, Panaitescu, E, Bolovan, M, Stanciu, A, Cinca, S, Botti, C, Aquino, G, Anniciello, A, Fortes, C, Mastroeni, S, Caggiati, A, Passarelli, F, Zappalà, A, Capuano, M, Bono, R, Nudo, M, Marino, C, Michelozzi, P, De Biasio, V, Battarra, VC, Formenti, S, Ascierto, ML, McMiller, TL, Berger, AE, Danilova, L, Anders, RA, Netto, GJ, Xu, H, Pritchard, TS, Fan, J, Cheadle, C, Cope, L, Drake, CG, Pardoll, DM, Taube, JM, Topalian, SL, Gnjatic, S, Nataraj, S, Imai, N, Rahman, A, Jungbluth, AA, Pan, L, Venhaus, R, Park, A, Lehmann, FF, Lendvai, N, Cohen, AD, Cho, HJ, Daniel, S, and Hirsh, V

Abstract

MELANOMA BRIDGE 2015 KEYNOTE SPEAKER PRESENTATIONS Molecular and immuno-advances K1 Immunologic and metabolic consequences of PI3K/AKT/mTOR activation in melanoma Vashisht G. Y. Nanda, Weiyi Peng, Patrick Hwu, Michael A. Davies K2 Non-mutational adaptive changes in melanoma cells exposed to BRAF and MEK inhibitors help the establishment of drug resistance Gennaro Ciliberto, Luigi Fattore, Debora Malpicci, Luigi Aurisicchio, Paolo Antonio Ascierto, Carlo M. Croce, Rita Mancini K3 Tumor-intrinsic beta-catenin signaling mediates tumor-immune avoidance Stefani Spranger, Thomas F. Gajewski K4 Intracellular tumor antigens as a source of targets of antibody-based immunotherapy of melanoma Yangyang Wang, Soldano Ferrone Combination therapies K5 Harnessing radiotherapy to improve responses to immunotherapy in cancer Claire Vanpouille-Box, Erik Wennerberg, Karsten A. Pilones, Silvia C. Formenti, Sandra Demaria K6 Creating a T cell-inflamed tumor microenvironment overcomes resistance to checkpoint blockade Haidong Tang, Yang Wang, Yang-Xin Fu K7 Biomarkers for treatment decisions? Reinhard Dummer K8 Combining oncolytic therapies in the era of checkpoint inhibitors Igor Puzanov K9 Immune checkpoint blockade for melanoma: should we combine or sequence ipilimumab and PD-1 antibody therapy? Michael A. Postow News in immunotherapy K10 An update on adjuvant and neoadjuvant therapy for melanom Ahmad Tarhini K11 Targeting multiple inhibitory receptors in melanoma Joe-Marc Chauvin, Ornella Pagliano, Julien Fourcade, Zhaojun Sun, Hong Wang, Cindy Sanders, John M. Kirkwood, Tseng-hui Timothy Chen, Mark Maurer, Alan J. Korman, Hassane M. Zarour K12 Improving adoptive immune therapy using genetically engineered T cells David F. Stroncek Tumor microenvironment and biomarkers K13 Myeloid cells and tumor exosomes: a crosstalk for assessing immunosuppression? Veronica Huber, Licia Rivoltini K14 Update on the SITC biomarker taskforce: progress and challenges Magdalena Thurin World-wide immunosc

Published
2016

47. Society for immunotherapy of cancer (SITC) statement on the proposed changes to the common rule

Author

Kaufman, HL, Butterfield, LH, Coulie, PG, Demaria, S, Ferris, RL, Galon, J, Khleif, SN, Mellman, I, Ohashi, PS, Overwijk, WW, Topalian, SL, Marincola, FM, Kaufman, HL, Butterfield, LH, Coulie, PG, Demaria, S, Ferris, RL, Galon, J, Khleif, SN, Mellman, I, Ohashi, PS, Overwijk, WW, Topalian, SL, and Marincola, FM

Abstract

The Common Rule is a set of ethical principles that provide guidance on the management of human subjects taking part in biomedical and behavioral research in the United States. The elements of the Common Rule were initially developed in 1981 following a revision of the Declaration of Helsinki in 1975. Most academic facilities follow the Common Rule in the regulation of clinical trials research. Recently, the government has suggested a revision of the Common Rule to include more contemporary and streamlined oversight of clinical research. In this commentary, the leadership of the Society for Immunotherapy of Cancer (SITC) provides their opinion on this plan. While the Society recognizes the considerable contribution of clinical research in supporting progress in tumor immunotherapy and supports the need for revisions to the Common Rule, there is also some concern over certain elements which may restrict access to biospecimens and clinical data at a time when high throughput technologies, computational biology and assay standardization is allowing major advances in understanding cancer biology and providing potential predictive biomarkers of immunotherapy response. The Society values its professional commitment to patients for improving clinical outcomes with tumor immunotherapy and supports continued discussion with all stakeholders before implementing changes to the Common Rule in order to ensure maximal patient protections while promoting continued clinical research at this historic time in cancer research.

Published
2016

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