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1. Clinical Performance of the Consensus Immunoscore in Colon Cancer in the Asian Population from the Multicenter International SITC Study

Author

Mlecnik, B., Torigoe, T., Bindea, G., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Hirohashi, Y., Furuhata, T., Takemasa, I., Patel, P., Vora, H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Yili, Zhang, G., Yoshino, T., Taniguchi, H., Bifulco, C., Lugli, A., Lee, J.J., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, Elisa, Hartmann, A., Geppert, C.I., Kolwelter, J., Merkel, S., Grützmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Léonard, D., Remue, C., Wang, J., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Marliot, F., Fredriksen, T., Buttard, B., Lafontaine, L., Maby, P., Majdi, A., Hijazi, A., Sissy, C. El, Kirilovsky, A., Berger, A., Lagorce, C., Paustian, C., Ballesteros-Merino, C., Dijkstra, J.R., Water, C. van de, Lent-van Vliet, S. van, Knijn, N., Mușină, A.M., Scripcariu, D.V., Marincola, F.M., Ascierto, P.A., Fox, B.A., Pagès, F., Kawakami, Y., Galon, J., Mlecnik, B., Torigoe, T., Bindea, G., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Hirohashi, Y., Furuhata, T., Takemasa, I., Patel, P., Vora, H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Yili, Zhang, G., Yoshino, T., Taniguchi, H., Bifulco, C., Lugli, A., Lee, J.J., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, Elisa, Hartmann, A., Geppert, C.I., Kolwelter, J., Merkel, S., Grützmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Léonard, D., Remue, C., Wang, J., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Marliot, F., Fredriksen, T., Buttard, B., Lafontaine, L., Maby, P., Majdi, A., Hijazi, A., Sissy, C. El, Kirilovsky, A., Berger, A., Lagorce, C., Paustian, C., Ballesteros-Merino, C., Dijkstra, J.R., Water, C. van de, Lent-van Vliet, S. van, Knijn, N., Mușină, A.M., Scripcariu, D.V., Marincola, F.M., Ascierto, P.A., Fox, B.A., Pagès, F., Kawakami, Y., and Galon, J.

Abstract

Contains fulltext : 283495.pdf (Publisher’s version ) (Open Access), BACKGROUND: In this study, we evaluated the prognostic value of Immunoscore in patients with stage I-III colon cancer (CC) in the Asian population. These patients were originally included in an international study led by the Society for Immunotherapy of Cancer (SITC) on 2681 patients with AJCC/UICC-TNM stages I-III CC. METHODS: CD3+ and cytotoxic CD8+ T-lymphocyte densities were quantified in the tumor and invasive margin by digital pathology. The association of Immunoscore with prognosis was evaluated for time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS). RESULTS: Immunoscore stratified Asian patients (n = 423) into different risk categories and was not impacted by age. Recurrence-free rates at 3 years were 78.5%, 85.2%, and 98.3% for a Low, Intermediate, and High Immunoscore, respectively (HR[Low-vs-High] = 7.26 (95% CI 1.75-30.19); p = 0.0064). A High Immunoscore showed a significant association with prolonged TTR, OS, and DFS (p < 0.05). In Cox multivariable analysis stratified by center, Immunoscore association with TTR was independent (HR[Low-vs-Int+High] = 2.22 (95% CI 1.10-4.55) p = 0.0269) of the patient's gender, T-stage, N-stage, sidedness, and MSI status. A significant association of a High Immunoscore with prolonged TTR was also found among MSS (HR[Low-vs-Int+High] = 4.58 (95% CI 2.27-9.23); p ≤ 0.0001), stage II (HR[Low-vs-Int+High] = 2.72 (95% CI 1.35-5.51); p = 0.0052), low-risk stage-II (HR[Low-vs-Int+High] = 2.62 (95% CI 1.21-5.68); p = 0.0146), and high-risk stage II patients (HR[Low-vs-Int+High] = 3.11 (95% CI 1.39-6.91); p = 0.0055). CONCLUSION: A High Immunoscore is significantly associated with the prolonged survival of CC patients within the Asian population.

Published
2022

2. SPORTS-RELATED VASCULAR INJURY OF THE NECK. A CLINICAL CASE OF VERTEBRAL THROMBOSIS AND STROKE DURING JIU-JITSU TRAINING.

Author

Deneva, V., Karakaneva, S., Naeva, D., Popivanova, B., and Mantarova-Valkova, S.

Subjects
YOUNG adults, CEREBROVASCULAR disease, VERTEBRAL artery, STROKE, NECK injuries
Abstract

Sports-related vascular injuries of the neck, such as dissection and thrombosis, are not common but are of great importance because of the high risk of developing stroke and disability in young people. Not only the direct traumatic damage to the vessel but also some genetic, anatomical, and physiological factors, as well as the specifics of motor activity in some sports, are essential for their development. The presence of hypoplastic arterial vessels, which increases the risk of thrombosis and related complications with repeated compressive effects, is significant. We present a clinical case of a 25-year-old man with a stroke due to congenital hypoplasia and thrombosis of the vertebral artery, with the main precipitating factor being compression of the neck while practicing jiu-jitsu. Given the increased incidence of reported vascular complications in this and other sports, our team strongly advocates for and supports clinical and neurosonographic evaluation of neck vessels as a routine preventive measure for cerebrovascular disorders in athletes. [ABSTRACT FROM AUTHOR]

Published
2024

3. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study

Author

Pages, F., Mlecnik, B., Marliot, F., Bindea, G., Ou, F.S., Bifulco, C., Lugli, A., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, E., Hartmann, A., Geppert, C., Kolwelter, J., Merkel, S., Grutzmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Leonard, D., Remue, C., Wang, J.Y., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E.K., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Fredriksen, T., Buttard, B., Angelova, M., Vasaturo, A., Maby, P., Church, S.E., Angell, H.K., Lafontaine, L., Bruni, D., Sissy, C. El, Haicheur, N., Kirilovsky, A., Berger, A., Lagorce, C., Meyers, J.P., Paustian, C., Feng, Z., Ballesteros-Merino, C., Dijkstra, J., Water, C. van de, Vliet, S. van, Knijn, N., Musina, A.M., Scripcariu, D.V., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Torigoe, T., Sato, N., Furuhata, T., Takemasa, I., Itoh, K., Patel, P.S., Vora, H.H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Y., Zhang, G., Kawakami, Y., Marincola, F.M., Ascierto, P.A., Sargent, D.J., Fox, B.A., Galon, J., Pages, F., Mlecnik, B., Marliot, F., Bindea, G., Ou, F.S., Bifulco, C., Lugli, A., Zlobec, I., Rau, T.T., Berger, M.D., Nagtegaal, I.D., Vink-Borger, E., Hartmann, A., Geppert, C., Kolwelter, J., Merkel, S., Grutzmann, R., Eynde, M. Van den, Jouret-Mourin, A., Kartheuser, A., Leonard, D., Remue, C., Wang, J.Y., Bavi, P., Roehrl, M.H.A., Ohashi, P.S., Nguyen, L.T., Han, S., MacGregor, H.L., Hafezi-Bakhtiari, S., Wouters, B.G., Masucci, G.V., Andersson, E.K., Zavadova, E., Vocka, M., Spacek, J., Petruzelka, L., Konopasek, B., Dundr, P., Skalova, H., Nemejcova, K., Botti, G., Tatangelo, F., Delrio, P., Ciliberto, G., Maio, M, Laghi, L., Grizzi, F., Fredriksen, T., Buttard, B., Angelova, M., Vasaturo, A., Maby, P., Church, S.E., Angell, H.K., Lafontaine, L., Bruni, D., Sissy, C. El, Haicheur, N., Kirilovsky, A., Berger, A., Lagorce, C., Meyers, J.P., Paustian, C., Feng, Z., Ballesteros-Merino, C., Dijkstra, J., Water, C. van de, Vliet, S. van, Knijn, N., Musina, A.M., Scripcariu, D.V., Popivanova, B., Xu, M., Fujita, T., Hazama, S., Suzuki, N., Nagano, H., Okuno, K., Torigoe, T., Sato, N., Furuhata, T., Takemasa, I., Itoh, K., Patel, P.S., Vora, H.H., Shah, B., Patel, J.B., Rajvik, K.N., Pandya, S.J., Shukla, S.N., Wang, Y., Zhang, G., Kawakami, Y., Marincola, F.M., Ascierto, P.A., Sargent, D.J., Fox, B.A., and Galon, J.

Abstract

Contains fulltext : 193579.pdf (publisher's version ) (Closed access), BACKGROUND: The estimation of risk of recurrence for patients with colon carcinoma must be improved. A robust immune score quantification is needed to introduce immune parameters into cancer classification. The aim of the study was to assess the prognostic value of total tumour-infiltrating T-cell counts and cytotoxic tumour-infiltrating T-cells counts with the consensus Immunoscore assay in patients with stage I-III colon cancer. METHODS: An international consortium of 14 centres in 13 countries, led by the Society for Immunotherapy of Cancer, assessed the Immunoscore assay in patients with TNM stage I-III colon cancer. Patients were randomly assigned to a training set, an internal validation set, or an external validation set. Paraffin sections of the colon tumour and invasive margin from each patient were processed by immunohistochemistry, and the densities of CD3+ and cytotoxic CD8+ T cells in the tumour and in the invasive margin were quantified by digital pathology. An Immunoscore for each patient was derived from the mean of four density percentiles. The primary endpoint was to evaluate the prognostic value of the Immunoscore for time to recurrence, defined as time from surgery to disease recurrence. Stratified multivariable Cox models were used to assess the associations between Immunoscore and outcomes, adjusting for potential confounders. Harrell's C-statistics was used to assess model performance. FINDINGS: Tissue samples from 3539 patients were processed, and samples from 2681 patients were included in the analyses after quality controls (700 patients in the training set, 636 patients in the internal validation set, and 1345 patients in the external validation set). The Immunoscore assay showed a high level of reproducibility between observers and centres (r=0.97 for colon tumour; r=0.97 for invasive margin; p<0.0001). In the training set, patients with a high Immunoscore had the lowest risk of recurrence at 5 years (14 [8%] patients with a high Immunosc

Published
2018

5. Multicenter International Study of the Consensus Immunoscore for the Prediction of Relapse and Survival in Early-Stage Colon Cancer.

Author

Mlecnik B, Lugli A, Bindea G, Marliot F, Bifulco C, Lee JJ, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert CI, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard D, Remue C, Wang J, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Lafontaine L, Maby P, Majdi A, Hijazi A, El Sissy C, Kirilovsky A, Berger A, Lagorce C, Paustian C, Ballesteros-Merino C, Dijkstra J, van de Water C, Vliet SVL, Knijn N, Mușină AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Patel P, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Fox BA, Pagès F, and Galon J

Abstract

Background: The prognostic value of Immunoscore was evaluated in Stage II/III colon cancer (CC) patients, but it remains unclear in Stage I/II, and in early-stage subgroups at risk. An international Society for Immunotherapy of Cancer (SITC) study evaluated the pre-defined consensus Immunoscore in tumors from 1885 AJCC/UICC-TNM Stage I/II CC patients from Canada/USA (Cohort 1) and Europe/Asia (Cohort 2). METHODS: Digital-pathology is used to quantify the densities of CD3+ and CD8+ T-lymphocyte in the center of tumor (CT) and the invasive margin (IM). The time to recurrence (TTR) was the primary endpoint. Secondary endpoints were disease-free survival (DFS), overall survival (OS), prognosis in Stage I, Stage II, Stage II-high-risk, and microsatellite-stable (MSS) patients. RESULTS: High-Immunoscore presented with the lowest risk of recurrence in both cohorts. In Stage I/II, recurrence-free rates at 5 years were 78.4% (95%-CI, 74.4−82.6), 88.1% (95%-CI, 85.7−90.4), 93.4% (95%-CI, 91.1−95.8) in low, intermediate and high Immunoscore, respectively (HR (Hi vs. Lo) = 0.27 (95%-CI, 0.18−0.41); p < 0.0001). In Cox multivariable analysis, the association of Immunoscore to outcome was independent (TTR: HR (Hi vs. Lo) = 0.29, (95%-CI, 0.17−0.50); p < 0.0001) of the patient’s gender, T-stage, sidedness, and microsatellite instability-status (MSI). A significant association of Immunoscore with survival was found for Stage II, high-risk Stage II, T4N0 and MSS patients. The Immunoscore also showed significant association with TTR in Stage-I (HR (Hi vs. Lo) = 0.07 (95%-CI, 0.01−0.61); P = 0.016). The Immunoscore had the strongest (69.5%) contribution χ2 for influencing survival. Patients with a high Immunoscore had prolonged TTR in T4N0 tumors even for patients not receiving chemotherapy, and the Immunoscore remained the only significant parameter in multivariable analysis. CONCLUSION: In early CC, low Immunoscore reliably identifies patients at risk of relapse for whom a more intensive surveillance program or adjuvant treatment should be considered.

Published
2023
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6. Clinical Performance of the Consensus Immunoscore in Colon Cancer in the Asian Population from the Multicenter International SITC Study.

Author

Mlecnik B, Torigoe T, Bindea G, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Hirohashi Y, Furuhata T, Takemasa I, Patel P, Vora H, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Yoshino T, Taniguchi H, Bifulco C, Lugli A, Lee JJ, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert CI, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard D, Remue C, Wang J, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson E, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Marliot F, Fredriksen T, Buttard B, Lafontaine L, Maby P, Majdi A, Hijazi A, El Sissy C, Kirilovsky A, Berger A, Lagorce C, Paustian C, Ballesteros-Merino C, Dijkstra J, Van de Water C, van Lent-van Vliet S, Knijn N, Mușină AM, Scripcariu DV, Marincola FM, Ascierto PA, Fox BA, Pagès F, Kawakami Y, and Galon J

Abstract

BACKGROUND: In this study, we evaluated the prognostic value of Immunoscore in patients with stage I−III colon cancer (CC) in the Asian population. These patients were originally included in an international study led by the Society for Immunotherapy of Cancer (SITC) on 2681 patients with AJCC/UICC-TNM stages I−III CC. METHODS: CD3+ and cytotoxic CD8+ T-lymphocyte densities were quantified in the tumor and invasive margin by digital pathology. The association of Immunoscore with prognosis was evaluated for time to recurrence (TTR), disease-free survival (DFS), and overall survival (OS). RESULTS: Immunoscore stratified Asian patients (n = 423) into different risk categories and was not impacted by age. Recurrence-free rates at 3 years were 78.5%, 85.2%, and 98.3% for a Low, Intermediate, and High Immunoscore, respectively (HR[Low-vs-High] = 7.26 (95% CI 1.75−30.19); p = 0.0064). A High Immunoscore showed a significant association with prolonged TTR, OS, and DFS (p < 0.05). In Cox multivariable analysis stratified by center, Immunoscore association with TTR was independent (HR[Low-vs-Int+High] = 2.22 (95% CI 1.10−4.55) p = 0.0269) of the patient’s gender, T-stage, N-stage, sidedness, and MSI status. A significant association of a High Immunoscore with prolonged TTR was also found among MSS (HR[Low-vs-Int+High] = 4.58 (95% CI 2.27−9.23); p ≤ 0.0001), stage II (HR[Low-vs-Int+High] = 2.72 (95% CI 1.35−5.51); p = 0.0052), low-risk stage-II (HR[Low-vs-Int+High] = 2.62 (95% CI 1.21−5.68); p = 0.0146), and high-risk stage II patients (HR[Low-vs-Int+High] = 3.11 (95% CI 1.39−6.91); p = 0.0055). CONCLUSION: A High Immunoscore is significantly associated with the prolonged survival of CC patients within the Asian population.

Published
2022
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7. Multicenter International Society for Immunotherapy of Cancer Study of the Consensus Immunoscore for the Prediction of Survival and Response to Chemotherapy in Stage III Colon Cancer.

Author

Mlecnik B, Bifulco C, Bindea G, Marliot F, Lugli A, Lee JJ, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Lafontaine L, Bruni D, Lanzi A, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Paustian C, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Muşină AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Fox BA, Pagès F, and Galon J

Subjects
Aged, Aged, 80 and over, CD3 Complex metabolism, Chemotherapy, Adjuvant, Colonic Neoplasms genetics, Colonic Neoplasms pathology, Disease-Free Survival, Female, Humans, Lymphocyte Count, Lymphocytes, Tumor-Infiltrating, Male, Microsatellite Instability, Middle Aged, Mutation, Neoplasm Staging, Predictive Value of Tests, Survival Rate, Time Factors, Antineoplastic Agents therapeutic use, CD8-Positive T-Lymphocytes metabolism, Colonic Neoplasms drug therapy, Colonic Neoplasms immunology, Neoplasm Recurrence, Local immunology
Abstract

Purpose: The purpose of this study was to evaluate the prognostic value of Immunoscore in patients with stage III colon cancer (CC) and to analyze its association with the effect of chemotherapy on time to recurrence (TTR)., Methods: An international study led by the Society for Immunotherapy of Cancer evaluated the predefined consensus Immunoscore in 763 patients with American Joint Committee on Cancer/Union for International Cancer Control TNM stage III CC from cohort 1 (Canada/United States) and cohort 2 (Europe/Asia). CD3+ and cytotoxic CD8+ T lymphocyte densities were quantified in the tumor and invasive margin by digital pathology. The primary end point was TTR. Secondary end points were overall survival (OS), disease-free survival (DFS), prognosis in microsatellite stable (MSS) status, and predictive value of efficacy of chemotherapy., Results: Patients with a high Immunoscore presented with the lowest risk of recurrence, in both cohorts. Recurrence-free rates at 3 years were 56.9% (95% CI, 50.3% to 64.4%), 65.9% (95% CI, 60.8% to 71.4%), and 76.4% (95% CI, 69.3% to 84.3%) in patients with low, intermediate, and high immunoscores, respectively (hazard ratio [HR; high v low], 0.48; 95% CI, 0.32 to 0.71; P = .0003). Patients with high Immunoscore showed significant association with prolonged TTR, OS, and DFS (all P < .001). In Cox multivariable analysis stratified by participating center, Immunoscore association with TTR was independent (HR [high v low], 0.41; 95% CI, 0.25 to 0.67; P = .0003) of patient's sex, T stage, N stage, sidedness, and microsatellite instability status. Significant association of a high Immunoscore with prolonged TTR was also found among MSS patients (HR [high v low], 0.36; 95% CI, 0.21 to 0.62; P = .0003). Immunoscore had the strongest contribution χ2 proportion for influencing survival (TTR and OS). Chemotherapy was significantly associated with survival in the high-Immunoscore group for both low-risk (HR [chemotherapy v no chemotherapy], 0.42; 95% CI, 0.25 to 0.71; P = .0011) and high-risk (HR [chemotherapy v no chemotherapy], 0.5; 95% CI, 0.33 to 0.77; P = .0015) patients, in contrast to the low-Immunoscore group ( P > .12)., Conclusion: This study shows that a high Immunoscore significantly associated with prolonged survival in stage III CC. Our findings suggest that patients with a high Immunoscore will benefit the most from chemotherapy in terms of recurrence risk.

Published
2020
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8. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study.

Author

Pagès F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Börger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grützmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Léonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Mușină AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, and Galon J

Subjects
Adult, Aged, Colonic Neoplasms immunology, Female, Humans, Lymphocytes, Tumor-Infiltrating, Male, Middle Aged, Neoplasm Staging, Prognosis, Proportional Hazards Models, Reproducibility of Results, Colonic Neoplasms classification, Colonic Neoplasms diagnosis, Neoplasm Recurrence, Local etiology
Abstract

Background: The estimation of risk of recurrence for patients with colon carcinoma must be improved. A robust immune score quantification is needed to introduce immune parameters into cancer classification. The aim of the study was to assess the prognostic value of total tumour-infiltrating T-cell counts and cytotoxic tumour-infiltrating T-cells counts with the consensus Immunoscore assay in patients with stage I-III colon cancer., Methods: An international consortium of 14 centres in 13 countries, led by the Society for Immunotherapy of Cancer, assessed the Immunoscore assay in patients with TNM stage I-III colon cancer. Patients were randomly assigned to a training set, an internal validation set, or an external validation set. Paraffin sections of the colon tumour and invasive margin from each patient were processed by immunohistochemistry, and the densities of CD3+ and cytotoxic CD8+ T cells in the tumour and in the invasive margin were quantified by digital pathology. An Immunoscore for each patient was derived from the mean of four density percentiles. The primary endpoint was to evaluate the prognostic value of the Immunoscore for time to recurrence, defined as time from surgery to disease recurrence. Stratified multivariable Cox models were used to assess the associations between Immunoscore and outcomes, adjusting for potential confounders. Harrell's C-statistics was used to assess model performance., Findings: Tissue samples from 3539 patients were processed, and samples from 2681 patients were included in the analyses after quality controls (700 patients in the training set, 636 patients in the internal validation set, and 1345 patients in the external validation set). The Immunoscore assay showed a high level of reproducibility between observers and centres (r=0·97 for colon tumour; r=0·97 for invasive margin; p<0·0001). In the training set, patients with a high Immunoscore had the lowest risk of recurrence at 5 years (14 [8%] patients with a high Immunoscore vs 65 (19%) patients with an intermediate Immunoscore vs 51 (32%) patients with a low Immunoscore; hazard ratio [HR] for high vs low Immunoscore 0·20, 95% CI 0·10-0·38; p<0·0001). The findings were confirmed in the two validation sets (n=1981). In the stratified Cox multivariable analysis, the Immunoscore association with time to recurrence was independent of patient age, sex, T stage, N stage, microsatellite instability, and existing prognostic factors (p<0·0001). Of 1434 patients with stage II cancer, the difference in risk of recurrence at 5 years was significant (HR for high vs low Immunoscore 0·33, 95% CI 0·21-0·52; p<0·0001), including in Cox multivariable analysis (p<0·0001). Immunoscore had the highest relative contribution to the risk of all clinical parameters, including the American Joint Committee on Cancer and Union for International Cancer Control TNM classification system., Interpretation: The Immunoscore provides a reliable estimate of the risk of recurrence in patients with colon cancer. These results support the implementation of the consensus Immunoscore as a new component of a TNM-Immune classification of cancer., Funding: French National Institute of Health and Medical Research, the LabEx Immuno-oncology, the Transcan ERAnet Immunoscore European project, Association pour la Recherche contre le Cancer, CARPEM, AP-HP, Institut National du Cancer, Italian Association for Cancer Research, national grants and the Society for Immunotherapy of Cancer., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Published
2018
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