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1. Lasofoxifene versus fulvestrant for ER+/HER2− metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial

Author

Goetz, M.P., Bagegni, N.A., Batist, G., Brufsky, A., Cristofanilli, M.A., Damodaran, S., Daniel, B.R., Fleming, G.F., Gradishar, W.J., Graff, S.L., Grosse Perdekamp, M.T., Hamilton, E., Lavasani, S., Moreno-Aspitia, A., O’Connor, T., Pluard, T.J., Rugo, H.S., Sammons, S.L., Schwartzberg, L.S., Stover, D.G., Vidal, G.A., Wang, G., Warner, E., Yerushalmi, R., Plourde, P.V., Portman, D.J., and Gal-Yam, E.N.

Published
2023
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2. Pregnancy After Breast Cancer in Young BRCA Carriers: An International Hospital-Based Cohort Study

Author

Lambertini, M, Blondeaux, E, Agostinetto, E, Hamy, A, Kim, H, Di Meglio, A, Molho, R, Hilbers, F, Pogoda, K, Carrasco, E, Punie, K, Bajpai, J, Ignatiadis, M, Moore, H, Phillips, K, Toss, A, Rousset-Jablonski, C, Peccatori, F, Renaud, T, Ferrari, A, Paluch-Shimon, S, Fruscio, R, Cui, W, Wong, S, Vernieri, C, Ruddy, K, Dieci, M, Matikas, A, Rozenblit, M, Villarreal-Garza, C, De Marchis, L, Del Mastro, L, Puglisi, F, Estevez-Diz, M, Rodriguez-Wallberg, K, Mrinakova, B, Meister, S, Livraghi, L, Clatot, F, Yerushalmi, R, De Angelis, C, Sanchez-Bayona, R, Meattini, I, Cichowska-Cwalinska, N, Berliere, M, Salama, M, De Giorgi, U, Sonnenblick, A, Chiodi, C, Lee, Y, Maria, C, Azim, H, Boni, L, Partridge, A, Lambertini M., Blondeaux E., Agostinetto E., Hamy A. -S., Kim H. J., Di Meglio A., Molho R. B., Hilbers F., Pogoda K., Carrasco E., Punie K., Bajpai J., Ignatiadis M., Moore H. C. F., Phillips K. -A., Toss A., Rousset-Jablonski C., Peccatori F. A., Renaud T., Ferrari A., Paluch-Shimon S., Fruscio R., Cui W., Wong S. M., Vernieri C., Ruddy K. J., Dieci M. V., Matikas A., Rozenblit M., Villarreal-Garza C., De Marchis L., Del Mastro L., Puglisi F., Estevez-Diz M. D. P., Rodriguez-Wallberg K. A., Mrinakova B., Meister S., Livraghi L., Clatot F., Yerushalmi R., De Angelis C., Sanchez-Bayona R., Meattini I., Cichowska-Cwalinska N., Berliere M., Salama M., De Giorgi U., Sonnenblick A., Chiodi C., Lee Y. -J., Maria C., Azim H. A., Boni L., Partridge A. H., Lambertini, M, Blondeaux, E, Agostinetto, E, Hamy, A, Kim, H, Di Meglio, A, Molho, R, Hilbers, F, Pogoda, K, Carrasco, E, Punie, K, Bajpai, J, Ignatiadis, M, Moore, H, Phillips, K, Toss, A, Rousset-Jablonski, C, Peccatori, F, Renaud, T, Ferrari, A, Paluch-Shimon, S, Fruscio, R, Cui, W, Wong, S, Vernieri, C, Ruddy, K, Dieci, M, Matikas, A, Rozenblit, M, Villarreal-Garza, C, De Marchis, L, Del Mastro, L, Puglisi, F, Estevez-Diz, M, Rodriguez-Wallberg, K, Mrinakova, B, Meister, S, Livraghi, L, Clatot, F, Yerushalmi, R, De Angelis, C, Sanchez-Bayona, R, Meattini, I, Cichowska-Cwalinska, N, Berliere, M, Salama, M, De Giorgi, U, Sonnenblick, A, Chiodi, C, Lee, Y, Maria, C, Azim, H, Boni, L, Partridge, A, Lambertini M., Blondeaux E., Agostinetto E., Hamy A. -S., Kim H. J., Di Meglio A., Molho R. B., Hilbers F., Pogoda K., Carrasco E., Punie K., Bajpai J., Ignatiadis M., Moore H. C. F., Phillips K. -A., Toss A., Rousset-Jablonski C., Peccatori F. A., Renaud T., Ferrari A., Paluch-Shimon S., Fruscio R., Cui W., Wong S. M., Vernieri C., Ruddy K. J., Dieci M. V., Matikas A., Rozenblit M., Villarreal-Garza C., De Marchis L., Del Mastro L., Puglisi F., Estevez-Diz M. D. P., Rodriguez-Wallberg K. A., Mrinakova B., Meister S., Livraghi L., Clatot F., Yerushalmi R., De Angelis C., Sanchez-Bayona R., Meattini I., Cichowska-Cwalinska N., Berliere M., Salama M., De Giorgi U., Sonnenblick A., Chiodi C., Lee Y. -J., Maria C., Azim H. A., Boni L., and Partridge A. H.

Abstract

(Abstracted from JAMA 2024;331(1):49-59 Individuals who are diagnosed with breast cancer at a young age are often carriers of a pathogenic variant in the BRCA1 or BRCA2 genes, and many young women in this situation are interested in preserving future fertility, if possible. Reproductive counseling in this situation can be complex due to the risk of passing on the variant, as well as the implications on their own fertility, as the mutation can impact ovarian reserve, fertility potential, and other factors.

Published
2024

3. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Zhang, Q., Xu, B., Shao, Z., Wang, X., Geng, C., Yan, X., Tong, Z., Shen, K., Yin, Y., Sun, T., Yang, J., Feng, J., Yan, M., Wang, Y., Liu, Q., Zhang, S., De Laurentiis, M., Santoro, A., Guarneri, V., Colleoni, M., Natoli, C., Cortesi, L., Placido, S., Gianni, L., Ferrau, F., Livi, L., Zambelli, A., Del Mastro, L., Tonini, G., Montemurro, F., Bianchi, G., Pedersini, R., Prete, S., Allegrini, G., Naso, G., Vici, P., Loirat, D., Mailliez, A., Priou, F., Tredan, O., Dalenc, F., Perrin, C., Gligorov, J., Timar David, M., Dohollou, N., Teixeira, L., Brocard, F., Arnaud, A., Delaloge, S., Spano, J.-P., Mansi, L., Andrade, L., Damian, F., Pedrini, J., Aleixo, S., Hegg, R., Junior, R., Reinisch, M., Schmidt, M., Wenzel, C., Grischke, E.-M., Schneeweiss, A., Just, M., Harbeck, N., Schumacher, C., Peters, U., Fischer, D., Forstbauer, H., Liersch, R., Warner, E., Bouganim, N., Doyle, C., Price Hiller, J., Vandenberg, T., Pavic, M., Robinson, A., Roldan Urgoiti, G., Califaretti, N., Alacacioglu, A., Gumus, M., Yalcin, B., Cicin, I., Kose, F., Uygun, K., Kaplan, M., Cubukcu, E., Wardley, A., Harries, M., Miles, D., Doval, D., Gupta, S., Mohapatra, P., Chatterjee, S., Ghadyalpatil, N., Singhal, M., Nag, S., Agarwal, A., Wolf, I., Gal Yam, E., Yerushalmi, R., Peretz, T., Fried, G., Ben Baruch, N., Katz, D., Hamilton, E., Kayali, F., Brufsky, A., Telli, M., Wright, G., Oyola, R., Rakowski, T., Graff, S., Tjulandin, S., Semiglazov, V., Aparicio, A., Ruiz Borrego, M., Merino, L., Guerra Martinez, J., Lopez, E., Yamashita, T., Ohtani, S., Inoue, K., Ito, Y., Niikura, N., Nakayama, T., Sagara, Y., Yanagita, Y., Kamada, Y., Kaneko, K., Kaen, D., Nervo, A., Eniu, A., Schenker, M., Priester, P., Melichar, B., Zimovjanova, M., Sormova, P., Sufliarsky, J., Kakalejcik, M., Belbaraka, R., Errihani, H., Le Than, D., Pham, D., Aravantinos, G., Papadimitriou, C., Koumakis, G., Papandreou, C., Podolski, P., Tabane, K., André, F., Cameron, D., Barrios, C., Patel, S., Patre, M., Morales, L., Patel, S.L., Kaul, M., Barata, T., and O’Shaughnessy, J.

Published
2021
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4. Pregnancy After Breast Cancer in Young BRCA Carriers

Author

Lambertini, M, Blondeaux, E, Agostinetto, E, Hamy, A-S, Kim, HJ, Di Meglio, A, Molho, RB, Hilbers, F, Pogoda, K, Carrasco, E, Punie, K, Bajpai, J, Ignatiadis, M, Moore, HCF, Phillips, K-A, Toss, A, Rousset-Jablonski, C, Peccatori, FA, Renaud, T, Ferrari, A, Paluch-Shimon, S, Fruscio, R, Cui, W, Wong, SM, Vernieri, C, Ruddy, KJ, Dieci, MV, Matikas, A, Rozenblit, M, Villarreal-Garza, C, De Marchis, L, Del Mastro, L, Puglisi, F, Estevez-Diz, MDP, Rodriguez-Wallberg, KA, Mrinakova, B, Meister, S, Livraghi, L, Clatot, F, Yerushalmi, R, De Angelis, C, Sanchez-Bayona, R, Meattini, I, Cichowska-Cwalinska, N, Berliere, M, Salama, M, De Giorgi, U, Sonnenblick, A, Chiodi, C, Lee, Y-J, Maria, C, Azim, HA, Boni, L, Partridge, AH, Lambertini, M, Blondeaux, E, Agostinetto, E, Hamy, A-S, Kim, HJ, Di Meglio, A, Molho, RB, Hilbers, F, Pogoda, K, Carrasco, E, Punie, K, Bajpai, J, Ignatiadis, M, Moore, HCF, Phillips, K-A, Toss, A, Rousset-Jablonski, C, Peccatori, FA, Renaud, T, Ferrari, A, Paluch-Shimon, S, Fruscio, R, Cui, W, Wong, SM, Vernieri, C, Ruddy, KJ, Dieci, MV, Matikas, A, Rozenblit, M, Villarreal-Garza, C, De Marchis, L, Del Mastro, L, Puglisi, F, Estevez-Diz, MDP, Rodriguez-Wallberg, KA, Mrinakova, B, Meister, S, Livraghi, L, Clatot, F, Yerushalmi, R, De Angelis, C, Sanchez-Bayona, R, Meattini, I, Cichowska-Cwalinska, N, Berliere, M, Salama, M, De Giorgi, U, Sonnenblick, A, Chiodi, C, Lee, Y-J, Maria, C, Azim, HA, Boni, L, and Partridge, AH

Abstract

IMPORTANCE: Young women with breast cancer who have germline pathogenic variants in BRCA1 or BRCA2 face unique challenges regarding fertility. Previous studies demonstrating the feasibility and safety of pregnancy in breast cancer survivors included limited data regarding BRCA carriers. OBJECTIVE: To investigate cumulative incidence of pregnancy and disease-free survival in young women who are BRCA carriers. DESIGN, SETTING, AND PARTICIPANTS: International, multicenter, hospital-based, retrospective cohort study conducted at 78 participating centers worldwide. The study included female participants diagnosed with invasive breast cancer at age 40 years or younger between January 2000 and December 2020 carrying germline pathogenic variants in BRCA1 and/or BRCA2. Last delivery was October 7, 2022; last follow-up was February 20, 2023. EXPOSURE: Pregnancy after breast cancer. MAIN OUTCOMES AND MEASURES: Primary end points were cumulative incidence of pregnancy after breast cancer and disease-free survival. Secondary end points were breast cancer-specific survival, overall survival, pregnancy, and fetal and obstetric outcomes. RESULTS: Of 4732 BRCA carriers included, 659 had at least 1 pregnancy after breast cancer and 4073 did not. Median age at diagnosis in the overall cohort was 35 years (IQR, 31-38 years). Cumulative incidence of pregnancy at 10 years was 22% (95% CI, 21%-24%), with a median time from breast cancer diagnosis to conception of 3.5 years (IQR, 2.2-5.3 years). Among the 659 patients who had a pregnancy, 45 (6.9%) and 63 (9.7%) had an induced abortion or a miscarriage, respectively. Of the 517 patients (79.7%) with a completed pregnancy, 406 (91.0%) delivered at term (≥37 weeks) and 54 (10.4%) had twins. Among the 470 infants born with known information on pregnancy complications, 4 (0.9%) had documented congenital anomalies. Median follow-up was 7.8 years (IQR, 4.5-12.6 years). No significant difference in disease-free survival was observed between patie

Published
2024

6. Contraceptive use and the risk of ovarian cancer among women with a BRCA1 or BRCA2 mutation

Author

Xia, Y, Gronwald, J, Karlan, B, Lubinski, J, Mccuaig, J, Brooks, J, Moller, P, Eisen, A, Sun, S, Senter, L, Bordeleau, L, Neuhausen, S, Singer, C, Tung, N, Foulkes, W, Sun, P, Narod, S, Kotsopoulos, J, Yerushalmi, R, Fruscio, R, Rastelli, A, Zovato, S, Hyder, Z, Huzarski, T, Cybulski, C, Sweet, K, Wood, M, Mckinnon, W, Elser, C, Pal, T, Wiesner, G, Friedman, E, Meschino, W, Snyder, C, Metcalfe, K, Poll, A, Gojska, N, Warner, E, Kim, R, Rosen, B, Demsky, R, Ainsworth, P, Panabaker, K, Steele, L, Saal, H, Serfas, K, Panchal, S, Cullinane, A, Reilly, R, Blum, J, Kwong, A, Rayson, D, Isaacs, C, Ramón y Cajal, T, Dungan, J, Cohen, S, Xia Y. Y., Gronwald J., Karlan B., Lubinski J., McCuaig J. M., Brooks J., Moller P., Eisen A., Sun S., Senter L., Bordeleau L., Neuhausen S. L., Singer C. F., Tung N., Foulkes W. D., Sun P., Narod S. A., Kotsopoulos J., Yerushalmi R., Fruscio R., Rastelli A., Zovato S, Hyder Z., Huzarski T., Cybulski C, Sweet K., Wood M., McKinnon W., Elser C., Pal T., Wiesner G., Friedman E., Meschino W., Snyder C., Metcalfe K., Poll A., Gojska N., Warner E., Kim R. H., Rosen B., Demsky R., Ainsworth P., Panabaker K., Steele L., Saal H., Serfas K., Panchal S., Cullinane A., Reilly R. E., Blum J. L., Kwong A., Cybulski C., Rayson D., Isaacs C., Ramón y Cajal T., Dungan J., Cohen S., Xia, Y, Gronwald, J, Karlan, B, Lubinski, J, Mccuaig, J, Brooks, J, Moller, P, Eisen, A, Sun, S, Senter, L, Bordeleau, L, Neuhausen, S, Singer, C, Tung, N, Foulkes, W, Sun, P, Narod, S, Kotsopoulos, J, Yerushalmi, R, Fruscio, R, Rastelli, A, Zovato, S, Hyder, Z, Huzarski, T, Cybulski, C, Sweet, K, Wood, M, Mckinnon, W, Elser, C, Pal, T, Wiesner, G, Friedman, E, Meschino, W, Snyder, C, Metcalfe, K, Poll, A, Gojska, N, Warner, E, Kim, R, Rosen, B, Demsky, R, Ainsworth, P, Panabaker, K, Steele, L, Saal, H, Serfas, K, Panchal, S, Cullinane, A, Reilly, R, Blum, J, Kwong, A, Rayson, D, Isaacs, C, Ramón y Cajal, T, Dungan, J, Cohen, S, Xia Y. Y., Gronwald J., Karlan B., Lubinski J., McCuaig J. M., Brooks J., Moller P., Eisen A., Sun S., Senter L., Bordeleau L., Neuhausen S. L., Singer C. F., Tung N., Foulkes W. D., Sun P., Narod S. A., Kotsopoulos J., Yerushalmi R., Fruscio R., Rastelli A., Zovato S, Hyder Z., Huzarski T., Cybulski C, Sweet K., Wood M., McKinnon W., Elser C., Pal T., Wiesner G., Friedman E., Meschino W., Snyder C., Metcalfe K., Poll A., Gojska N., Warner E., Kim R. H., Rosen B., Demsky R., Ainsworth P., Panabaker K., Steele L., Saal H., Serfas K., Panchal S., Cullinane A., Reilly R. E., Blum J. L., Kwong A., Cybulski C., Rayson D., Isaacs C., Ramón y Cajal T., Dungan J., and Cohen S.

Abstract

Background BRCA1 and BRCA2 (BRCA) mutation carriers face a high lifetime risk of developing ovarian cancer. Oral contraceptives are protective in this population; however, the impact of other types of contraception (e.g. intrauterine devices, implants, injections) is unknown. We undertook a matched case-control study to evaluate the relationship between type of contraception and risk of ovarian cancer among women with BRCA mutations. Methods A total of 1733 matched pairs were included in this analysis. Women were matched according to year of birth, date of study entry, country of residence, BRCA mutation type and history of breast cancer. Detailed information on hormonal, reproductive and lifestyle exposures were collected from a routinely administered questionnaire. Conditional logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (CI) associated with each contraceptive exposure. Results Ever use of any contraceptive was significantly associated with reduced risk of ovarian cancer (OR = 0.62; 95% CI 0.52–0.75; P < 0.0001), which was driven by significant inverse associations with oral contraceptives (OR = 0.66; 95% CI 0.54–0.79; P < 0.0001) and contraceptive implants (OR = 0.30; 95% CI 0.12–0.73; P = 0.008). We observed a similar effect with use of injections (OR = 0.37; 95% CI 0.10–1.38; P = 0.14), but this did not achieve significance. No significant associations were observed between patterns of intrauterine device use and risk of ovarian cancer. Conclusions These findings support a protective effect of oral contraceptives and implants on risk of ovarian cancer among women with BRCA mutations. The possible protective effect of injections requires further evaluation.

Published
2022

7. 192MO DESTINY-Breast04 subgroup analyses of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with human epidermal growth factor 2 (HER2)-low, estrogen-receptor (ER) expression immunohistochemistry (IHC) 0-10% metastatic breast cancer (mBC)

Author

Cameron, D.A.A., primary, Jacot, W., additional, Yamashita, T., additional, Losada, M.J. Vidal, additional, Schmid, P., additional, Lee, K.S., additional, De Laurentiis, M., additional, Zagouri, F., additional, Ueno, N.T., additional, Prat, A., additional, Harbeck, N., additional, Yerushalmi, R., additional, Lu, Y-S., additional, Gombos, A., additional, Orbegoso, C.M.A., additional, Cheng, F-C., additional, Yung, L., additional, Rajagopalan, R., additional, Tsurutani, J., additional, and Modi, S., additional

Published
2023
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8. 186O Patient-reported outcomes (PROs) from DESTINY-Breast02, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2–positive (HER2+) metastatic breast cancer (mBC)

Author

Fehm, T.N., primary, Cottone, F., additional, Dunton, K., additional, André, F., additional, Krop, I., additional, Park, Y.H., additional, De Laurentiis, M., additional, Miyoshi, Y., additional, Armstrong, A., additional, Borrego, M. Ruiz, additional, Yerushalmi, R., additional, Duhoux, F.P., additional, Takano, T., additional, Lu, W., additional, Livings, C., additional, Egorov, A., additional, and Kim, S-B., additional

Published
2023
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9. P169 Clinical outcomes in patients (pts) with estrogen receptor (ER)+ stage I breast cancer (BC) and Recurrence Score (RS) 26–30: Real-world data

Author

Rotem, O., primary, Peretz, I., additional, Leviov, M., additional, Kuchuk, I., additional, Itay, A., additional, Tokar, M., additional, Paluch-Shimon, S., additional, Maimon, O., additional, Yerushalmi, R., additional, Drumea, K., additional, Evron, E., additional, Sonnenblick, A., additional, Gal-Yam, E., additional, Goldvaser, H., additional, Yosef, S., additional, Merose, R., additional, Bareket-Samish, A., additional, Soussan-Gutman, L., additional, and Stemmer, S.M., additional

Published
2023
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10. Evaluation of European-based polygenic risk score for breast cancer in Ashkenazi Jewish women in Israel

Author

Levi, H, Carmi, S, Rosset, S, Yerushalmi, R, Zick, A, Yablonski-Peretz, T, Wang, Q, Bolla, MK, Dennis, J, Michailidou, K, Lush, M, Ahearn, T, Andrulis, IL, Anton-Culver, H, Antoniou, AC, Arndt, V, Augustinsson, A, Auvinen, P, Freeman, LB, Beckmann, M, Behrens, S, Bermisheva, M, Bodelon, C, Bogdanova, NV, Bojesen, SE, Brenner, H, Byers, H, Camp, N, Castelao, J, Chang-Claude, J, Chirlaque, M-D, Chung, W, Clarke, C, Collee, MJ, Colonna, S, Couch, F, Cox, A, Cross, SS, Czene, K, Daly, M, Devilee, P, Dork, T, Dossus, L, Eccles, DM, Eliassen, AH, Eriksson, M, Evans, G, Fasching, P, Fletcher, O, Flyger, H, Fritschi, L, Gabrielson, M, Gago-Dominguez, M, Garcia-Closas, M, Garcia-Saenz, JA, Genkinger, J, Giles, GG, Goldberg, M, Guenel, P, Hall, P, Hamann, U, He, W, Hillemanns, P, Hollestelle, A, Hoppe, R, Hopper, J, Jakovchevska, S, Jakubowska, A, Jernstrom, H, John, E, Johnson, N, Jones, M, Vijai, J, Kaaks, R, Khusnutdinova, E, Kitahara, C, Koutros, S, Kristensen, V, Kurian, AW, Lacey, J, Lambrechts, D, Le Marchand, L, Lejbkowicz, F, Lindblom, A, Loibl, S, Lori, A, Lubinski, J, Mannermaa, A, Manoochehri, M, Mavroudis, D, Menon, U, Mulligan, A, Murphy, R, Nevelsteen, I, Newman, WG, Obi, N, O'Brien, K, Offit, K, Olshan, A, Plaseska-Karanfilska, D, Olson, J, Panico, S, Park-Simon, T-W, Patel, A, Peterlongo, P, Rack, B, Radice, P, Rennert, G, Rhenius, V, Romero, A, Saloustros, E, Sandler, D, Schmidt, MK, Schwentner, L, Shah, M, Sharma, P, Simard, J, Southey, M, Stone, J, Tapper, WJ, Taylor, J, Teras, L, Toland, AE, Troester, M, Truong, T, van der Kolk, LE, Weinberg, C, Wendt, C, Yang, XR, Zheng, W, Ziogas, A, Dunning, AM, Pharoah, P, Easton, DF, Ben-Sachar, S, Elefant, N, Shamir, R, Elkon, R, Levi, H, Carmi, S, Rosset, S, Yerushalmi, R, Zick, A, Yablonski-Peretz, T, Wang, Q, Bolla, MK, Dennis, J, Michailidou, K, Lush, M, Ahearn, T, Andrulis, IL, Anton-Culver, H, Antoniou, AC, Arndt, V, Augustinsson, A, Auvinen, P, Freeman, LB, Beckmann, M, Behrens, S, Bermisheva, M, Bodelon, C, Bogdanova, NV, Bojesen, SE, Brenner, H, Byers, H, Camp, N, Castelao, J, Chang-Claude, J, Chirlaque, M-D, Chung, W, Clarke, C, Collee, MJ, Colonna, S, Couch, F, Cox, A, Cross, SS, Czene, K, Daly, M, Devilee, P, Dork, T, Dossus, L, Eccles, DM, Eliassen, AH, Eriksson, M, Evans, G, Fasching, P, Fletcher, O, Flyger, H, Fritschi, L, Gabrielson, M, Gago-Dominguez, M, Garcia-Closas, M, Garcia-Saenz, JA, Genkinger, J, Giles, GG, Goldberg, M, Guenel, P, Hall, P, Hamann, U, He, W, Hillemanns, P, Hollestelle, A, Hoppe, R, Hopper, J, Jakovchevska, S, Jakubowska, A, Jernstrom, H, John, E, Johnson, N, Jones, M, Vijai, J, Kaaks, R, Khusnutdinova, E, Kitahara, C, Koutros, S, Kristensen, V, Kurian, AW, Lacey, J, Lambrechts, D, Le Marchand, L, Lejbkowicz, F, Lindblom, A, Loibl, S, Lori, A, Lubinski, J, Mannermaa, A, Manoochehri, M, Mavroudis, D, Menon, U, Mulligan, A, Murphy, R, Nevelsteen, I, Newman, WG, Obi, N, O'Brien, K, Offit, K, Olshan, A, Plaseska-Karanfilska, D, Olson, J, Panico, S, Park-Simon, T-W, Patel, A, Peterlongo, P, Rack, B, Radice, P, Rennert, G, Rhenius, V, Romero, A, Saloustros, E, Sandler, D, Schmidt, MK, Schwentner, L, Shah, M, Sharma, P, Simard, J, Southey, M, Stone, J, Tapper, WJ, Taylor, J, Teras, L, Toland, AE, Troester, M, Truong, T, van der Kolk, LE, Weinberg, C, Wendt, C, Yang, XR, Zheng, W, Ziogas, A, Dunning, AM, Pharoah, P, Easton, DF, Ben-Sachar, S, Elefant, N, Shamir, R, and Elkon, R

Abstract

BACKGROUND: Polygenic risk score (PRS), calculated based on genome-wide association studies (GWASs), can improve breast cancer (BC) risk assessment. To date, most BC GWASs have been performed in individuals of European (EUR) ancestry, and the generalisation of EUR-based PRS to other populations is a major challenge. In this study, we examined the performance of EUR-based BC PRS models in Ashkenazi Jewish (AJ) women. METHODS: We generated PRSs based on data on EUR women from the Breast Cancer Association Consortium (BCAC). We tested the performance of the PRSs in a cohort of 2161 AJ women from Israel (1437 cases and 724 controls) from BCAC (BCAC cohort from Israel (BCAC-IL)). In addition, we tested the performance of these EUR-based BC PRSs, as well as the established 313-SNP EUR BC PRS, in an independent cohort of 181 AJ women from Hadassah Medical Center (HMC) in Israel. RESULTS: In the BCAC-IL cohort, the highest OR per 1 SD was 1.56 (±0.09). The OR for AJ women at the top 10% of the PRS distribution compared with the middle quintile was 2.10 (±0.24). In the HMC cohort, the OR per 1 SD of the EUR-based PRS that performed best in the BCAC-IL cohort was 1.58±0.27. The OR per 1 SD of the commonly used 313-SNP BC PRS was 1.64 (±0.28). CONCLUSIONS: Extant EUR GWAS data can be used for generating PRSs that identify AJ women with markedly elevated risk of BC and therefore hold promise for improving BC risk assessment in AJ women.

Published
2023

11. 149P Clinical outcomes in ER+ breast cancer patients with recurrence score 26-30-guided therapy: Real-world data

Author

Rotem, O., primary, Peretz, I., additional, Leviov, M., additional, Kuchuk, I., additional, Itay, A., additional, Tokar, M., additional, Paluch-Shimon, S., additional, Maimon, O., additional, Yerushalmi, R., additional, Drumea, K., additional, Evron, E., additional, Sonnenblick, A., additional, Nili Gal Yam, E., additional, Goldvaser, H., additional, Yosef, S.G., additional, Merose, R., additional, Bareket-Samish, A., additional, Soussan-Gutman, L., additional, and Stemmer, S., additional

Published
2022
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12. 152P Molecular characterization by the 21-gene breast cancer (BC) Recurrence Score (RS) test of BRCA1/2 mutation carriers (mBRCA1/2) versus the general BC patient (pt) population

Author

Yerushalmi, R., primary, Pomerantz, A., additional, Lewin, R., additional, Paluch-Shimon, S., additional, Soussan-Gutman, L., additional, Baehner, F.L., additional, Voet, H., additional, Bareket-Samish, A., additional, Kedar, I., additional, and Kaduri, L., additional

Published
2022
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14. Breast cancer risk after age 60 among BRCA1 and BRCA2 mutation carriers

Author

Stjepanovic, N, Lubinski, J, Moller, P, Randall Armel, S, Foulkes, W, Tung, N, Neuhausen, S, Kotsopoulos, J, Sun, P, Sun, S, Eisen, A, Narod, S, Senter, L, Couch, C, Fruscio, R, Weitzel, J, Olopade, O, Singer, C, Pal, T, Huzarski, T, Cybulski, C, Sweet, K, Zakalik, D, Wood, M, Mckinnon, W, Elser, C, Wiesner, G, Friedman, E, Meschino, W, Snyder, C, Metcalfe, K, Poll, A, Warner, E, Kim, R, Demsky, R, Ainsworth, P, Steele, L, Saal, H, Serfas, K, Panchal, S, Cullinane, C, Reilly, R, Blum, J, Kwong, A, Rayson, D, Cajal, T, Dungan, J, Yerushalmi, R, Ginsburg, O, Schraeder, I, Cohen, S, Lemirelemire, E, Zovato, S, Rastelli, A, Gronwald, J, Mccuaig, J, Karlan, B, Bordeleau, L, Stjepanovic N., Lubinski J., Moller P., Randall Armel S., Foulkes W. D., Tung N., Neuhausen S. L., Kotsopoulos J., Sun P., Sun S., Eisen A., Narod S. A., Senter L., Couch C. E. F., Fruscio R., Weitzel J. N., Olopade O., Singer C. F., Pal T., Huzarski T., Cybulski C., Sweet K., Zakalik D., Wood M., McKinnon W., Elser C., Wiesner G., Friedman E., Meschino W., Snyder C., Metcalfe K., Poll A., Warner E., Kim R., Demsky R., Ainsworth P., Steele L., Saal H., Serfas K., Panchal S., Cullinane C. A., Reilly R. E., Blum J. L., Kwong A., Rayson D., Cajal T. R., Dungan J., Yerushalmi R., Ginsburg O., Schraeder I., Cohen S., LemireLemire E., Zovato S., Rastelli A., Gronwald J., McCuaig J., Karlan B., Bordeleau L., Stjepanovic, N, Lubinski, J, Moller, P, Randall Armel, S, Foulkes, W, Tung, N, Neuhausen, S, Kotsopoulos, J, Sun, P, Sun, S, Eisen, A, Narod, S, Senter, L, Couch, C, Fruscio, R, Weitzel, J, Olopade, O, Singer, C, Pal, T, Huzarski, T, Cybulski, C, Sweet, K, Zakalik, D, Wood, M, Mckinnon, W, Elser, C, Wiesner, G, Friedman, E, Meschino, W, Snyder, C, Metcalfe, K, Poll, A, Warner, E, Kim, R, Demsky, R, Ainsworth, P, Steele, L, Saal, H, Serfas, K, Panchal, S, Cullinane, C, Reilly, R, Blum, J, Kwong, A, Rayson, D, Cajal, T, Dungan, J, Yerushalmi, R, Ginsburg, O, Schraeder, I, Cohen, S, Lemirelemire, E, Zovato, S, Rastelli, A, Gronwald, J, Mccuaig, J, Karlan, B, Bordeleau, L, Stjepanovic N., Lubinski J., Moller P., Randall Armel S., Foulkes W. D., Tung N., Neuhausen S. L., Kotsopoulos J., Sun P., Sun S., Eisen A., Narod S. A., Senter L., Couch C. E. F., Fruscio R., Weitzel J. N., Olopade O., Singer C. F., Pal T., Huzarski T., Cybulski C., Sweet K., Zakalik D., Wood M., McKinnon W., Elser C., Wiesner G., Friedman E., Meschino W., Snyder C., Metcalfe K., Poll A., Warner E., Kim R., Demsky R., Ainsworth P., Steele L., Saal H., Serfas K., Panchal S., Cullinane C. A., Reilly R. E., Blum J. L., Kwong A., Rayson D., Cajal T. R., Dungan J., Yerushalmi R., Ginsburg O., Schraeder I., Cohen S., LemireLemire E., Zovato S., Rastelli A., Gronwald J., McCuaig J., Karlan B., and Bordeleau L.

Abstract

Purpose: It is not known whether the risk of breast cancer among BRCA1 and BRCA2 mutation carriers after age 60 is high enough to justify intensive screening or prophylactic surgery. Thus, we conducted a prospective analysis of breast cancer risk in BRCA1 and BRCA2 mutation carriers from age 60 until age 80. Methods: Subjects had no history of cancer and both breasts intact at age 60 (n = 699). Women were followed until a breast cancer diagnosis, prophylactic bilateral mastectomy or death. We calculated the annual cancer rate and cumulative incidence of breast cancer (invasive and in situ) from age 60 to age 80. We assessed the associations between hormone replacement therapy, family history of breast cancer and bilateral oophorectomy and breast cancer risk. Results: Over a mean follow-up of 7.9 years, 61 invasive and 20 in situ breast cancers were diagnosed in the cohort. The mean annual rate of invasive breast cancer was 1.8% for BRCA1 mutation carriers and 1.7% for BRCA2 mutation carriers. The cumulative risk of invasive breast cancer from age 60 to 80 was 20.1% for women with a BRCA1 mutation and was 17.3% for women with a BRCA2 mutation. Hormone replacement therapy, family history and oophorectomy were not associated with breast cancer risk. Conclusions: Findings from this large prospective study indicate that the risk of developing breast cancer remains high after age 60 in both BRCA1 and BRCA2 mutation carriers. These findings warrant further evaluation of the role of breast cancer screening in older mutation carriers.

Published
2021

19. P1108: HIGH COMPLETE RESPONSE RATE FOLLOWING POINT-OF-CARE ANTI CD19 CAR T-CELL THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA

Author

Fried, S., primary, Besser, M. J., additional, Shkury, E., additional, Yerushalmi, R., additional, Shem-Tov, N., additional, Danylesko, I., additional, Jacoby, E., additional, Itzhaki, O., additional, Shouval, R., additional, Kedmi, M., additional, Shimoni, A., additional, Nagler, A., additional, and Avigdor, A., additional

Published
2022
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20. Overall survival in the OlympiA phase Ill trial of adjuvant olaparib in patients with germime pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Author

Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., Johannsson, O. Th, Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., and Johannsson, O. Th

Abstract

Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. Patients and methods: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. Results: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Delta 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Delta 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Delta 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. Conclusion: With 35 years of median follow-up, OlympiA demonstrates statistical

Published
2022

22. VP1-2022: Pre-specified event driven analysis of Overall Survival (OS) in the OlympiA phase III trial of adjuvant olaparib (OL) in germline BRCA1/2 mutation (gBRCAm) associated breast cancer

Author

Tutt, A.N.J., primary, Garber, J., additional, Gelber, R.D., additional, Phillips, K-A., additional, Eisen, A., additional, Johannsson, O.T., additional, Rastogi, P., additional, Cui, K.Y., additional, Im, S-A., additional, Yerushalmi, R., additional, Brufsky, A.M., additional, Taboada, M., additional, Rossi, G., additional, Yothers, G., additional, Singer, C., additional, Fein, L.E., additional, Loman, N., additional, Cameron, D., additional, Campbell, C., additional, and Geyer, C.E., additional

Published
2022
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23. Breast cancer risk after age 60 among BRCA1 and BRCA2 mutation carriers

Author

Stjepanovic N., Lubinski J., Moller P., Randall Armel S., Foulkes W. D., Tung N., Neuhausen S. L., Kotsopoulos J., Sun P., Sun S., Eisen A., Narod S. A., Senter L., Couch C. E. F., Fruscio R., Weitzel J. N., Olopade O., Singer C. F., Pal T., Huzarski T., Cybulski C., Sweet K., Zakalik D., Wood M., McKinnon W., Elser C., Wiesner G., Friedman E., Meschino W., Snyder C., Metcalfe K., Poll A., Warner E., Kim R., Demsky R., Ainsworth P., Steele L., Saal H., Serfas K., Panchal S., Cullinane C. A., Reilly R. E., Blum J. L., Kwong A., Rayson D., Cajal T. R., Dungan J., Yerushalmi R., Ginsburg O., Schraeder I., Cohen S., LemireLemire E., Zovato S., Rastelli A., Gronwald J., McCuaig J., Karlan B., Bordeleau L., Stjepanovic, N, Lubinski, J, Moller, P, Randall Armel, S, Foulkes, W, Tung, N, Neuhausen, S, Kotsopoulos, J, Sun, P, Sun, S, Eisen, A, Narod, S, Senter, L, Couch, C, Fruscio, R, Weitzel, J, Olopade, O, Singer, C, Pal, T, Huzarski, T, Cybulski, C, Sweet, K, Zakalik, D, Wood, M, Mckinnon, W, Elser, C, Wiesner, G, Friedman, E, Meschino, W, Snyder, C, Metcalfe, K, Poll, A, Warner, E, Kim, R, Demsky, R, Ainsworth, P, Steele, L, Saal, H, Serfas, K, Panchal, S, Cullinane, C, Reilly, R, Blum, J, Kwong, A, Rayson, D, Cajal, T, Dungan, J, Yerushalmi, R, Ginsburg, O, Schraeder, I, Cohen, S, Lemirelemire, E, Zovato, S, Rastelli, A, Gronwald, J, Mccuaig, J, Karlan, B, and Bordeleau, L

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Heterozygote, medicine.medical_treatment, Ovariectomy, Genes, BRCA2, Genes, BRCA1, Breast Neoplasms, 03 medical and health sciences, Breast cancer screening, 0302 clinical medicine, Breast cancer, Internal medicine, medicine, Humans, Cumulative incidence, Genetic Predisposition to Disease, Prospective Studies, skin and connective tissue diseases, Prospective cohort study, Mastectomy, Aged, Aged, 80 and over, BRCA2 Protein, medicine.diagnostic_test, business.industry, BRCA1 Protein, Incidence, Oophorectomy, Cancer, Hormone replacement therapy (menopause), Middle Aged, BRCA1, medicine.disease, BRCA2, Prophylactic Surgery, 3. Good health, Prospective, 030104 developmental biology, 030220 oncology & carcinogenesis, Mutation, Female, business
Abstract

Purpose: It is not known whether the risk of breast cancer among BRCA1 and BRCA2 mutation carriers after age 60 is high enough to justify intensive screening or prophylactic surgery. Thus, we conducted a prospective analysis of breast cancer risk in BRCA1 and BRCA2 mutation carriers from age 60 until age 80. Methods: Subjects had no history of cancer and both breasts intact at age 60 (n = 699). Women were followed until a breast cancer diagnosis, prophylactic bilateral mastectomy or death. We calculated the annual cancer rate and cumulative incidence of breast cancer (invasive and in situ) from age 60 to age 80. We assessed the associations between hormone replacement therapy, family history of breast cancer and bilateral oophorectomy and breast cancer risk. Results: Over a mean follow-up of 7.9years, 61 invasive and 20 in situ breast cancers were diagnosed in the cohort. The mean annual rate of invasive breast cancer was 1.8% for BRCA1 mutation carriers and 1.7% for BRCA2 mutation carriers. The cumulative risk of invasive breast cancer from age 60 to 80 was 20.1% for women with a BRCA1 mutation and was 17.3% for women with a BRCA2 mutation. Hormone replacement therapy, family history and oophorectomy were not associated with breast cancer risk. Conclusions: Findings from this large prospective study indicate that the risk of developing breast cancer remains high after age 60 in both BRCA1 and BRCA2 mutation carriers. These findings warrant further evaluation of the role of breast cancer screening in older mutation carriers.

Published
2020

26. Do alternative methods of measuring tumor size, including consideration of multicentric/multifocal disease, enhance prognostic information beyond TNM staging in women with early stage breast cancer: an analysis of the NCIC CTG MA.5 and MA.12 clinical trials

Author

Hilton, J. F., Bouganim, N., Dong, B., Chapman, J. W., Arnaout, A., O’Malley, F., Gelmon, K. A., Yerushalmi, R., Levine, M. N., Bramwell, V. H. C., Whelan, T. J., Pritchard, K. I., Shepherd, L. E., and Clemons, M.

Published
2013
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29. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer

Author

Miles, D., primary, Gligorov, J., additional, André, F., additional, Cameron, D., additional, Schneeweiss, A., additional, Barrios, C., additional, Xu, B., additional, Wardley, A., additional, Kaen, D., additional, Andrade, L., additional, Semiglazov, V., additional, Reinisch, M., additional, Patel, S., additional, Patre, M., additional, Morales, L., additional, Patel, S.L., additional, Kaul, M., additional, Barata, T., additional, O’Shaughnessy, J., additional, Zhang, Q., additional, Shao, Z., additional, Wang, X., additional, Geng, C., additional, Yan, X., additional, Tong, Z., additional, Shen, K., additional, Yin, Y., additional, Sun, T., additional, Yang, J., additional, Feng, J., additional, Yan, M., additional, Wang, Y., additional, Liu, Q., additional, Zhang, S., additional, De Laurentiis, M., additional, Santoro, A., additional, Guarneri, V., additional, Colleoni, M., additional, Natoli, C., additional, Cortesi, L., additional, Placido, S., additional, Gianni, L., additional, Ferrau, F., additional, Livi, L., additional, Zambelli, A., additional, Del Mastro, L., additional, Tonini, G., additional, Montemurro, F., additional, Bianchi, G., additional, Pedersini, R., additional, Prete, S., additional, Allegrini, G., additional, Naso, G., additional, Vici, P., additional, Loirat, D., additional, Mailliez, A., additional, Priou, F., additional, Tredan, O., additional, Dalenc, F., additional, Perrin, C., additional, Timar David, M., additional, Dohollou, N., additional, Teixeira, L., additional, Brocard, F., additional, Arnaud, A., additional, Delaloge, S., additional, Spano, J.-P., additional, Mansi, L., additional, Damian, F., additional, Pedrini, J., additional, Aleixo, S., additional, Hegg, R., additional, Junior, R., additional, Schmidt, M., additional, Wenzel, C., additional, Grischke, E.-M., additional, Just, M., additional, Harbeck, N., additional, Schumacher, C., additional, Peters, U., additional, Fischer, D., additional, Forstbauer, H., additional, Liersch, R., additional, Warner, E., additional, Bouganim, N., additional, Doyle, C., additional, Price Hiller, J., additional, Vandenberg, T., additional, Pavic, M., additional, Robinson, A., additional, Roldan Urgoiti, G., additional, Califaretti, N., additional, Alacacioglu, A., additional, Gumus, M., additional, Yalcin, B., additional, Cicin, I., additional, Kose, F., additional, Uygun, K., additional, Kaplan, M., additional, Cubukcu, E., additional, Harries, M., additional, Miles, D., additional, Doval, D., additional, Gupta, S., additional, Mohapatra, P., additional, Chatterjee, S., additional, Ghadyalpatil, N., additional, Singhal, M., additional, Nag, S., additional, Agarwal, A., additional, Wolf, I., additional, Gal Yam, E., additional, Yerushalmi, R., additional, Peretz, T., additional, Fried, G., additional, Ben Baruch, N., additional, Katz, D., additional, Hamilton, E., additional, Kayali, F., additional, Brufsky, A., additional, Telli, M., additional, Wright, G., additional, Oyola, R., additional, Rakowski, T., additional, Graff, S., additional, Tjulandin, S., additional, Aparicio, A., additional, Ruiz Borrego, M., additional, Merino, L., additional, Guerra Martinez, J., additional, Lopez, E., additional, Yamashita, T., additional, Ohtani, S., additional, Inoue, K., additional, Ito, Y., additional, Niikura, N., additional, Nakayama, T., additional, Sagara, Y., additional, Yanagita, Y., additional, Kamada, Y., additional, Kaneko, K., additional, Nervo, A., additional, Eniu, A., additional, Schenker, M., additional, Priester, P., additional, Melichar, B., additional, Zimovjanova, M., additional, Sormova, P., additional, Sufliarsky, J., additional, Kakalejcik, M., additional, Belbaraka, R., additional, Errihani, H., additional, Le Than, D., additional, Pham, D., additional, Aravantinos, G., additional, Papadimitriou, C., additional, Koumakis, G., additional, Papandreou, C., additional, Podolski, P., additional, and Tabane, K., additional

Published
2021
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31. 388P Subgroup analysis of patients (pts) with HER2-low metastatic breast cancer (mBC) with brain metastases (BMs) at baseline from DESTINY-Breast04, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC)

Author

Tsurutani, J., Jacot, W., Yamashita, T., Riaz, F., Yerushalmi, R., Im, S-A., Niikura, N., Halser-Strub, U., Cortés, J., Wennstig, A-K., Chae, Y., Wang, X., Li, W., Simon, H., Masci, G., Tamburini, E., Aguilar, C. Orbegoso, Tecson, K., Yung, L., and Modi, S.

Published
2023
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37. National comprehensive cancer network recommendations for drugs without US food and drug administration approval in metastatic breast cancer: A cross-sectional study

Author

Etan, T, Amir, E, Tibau, A, Yerushalmi, R, Moore, A, Shepshelovich, D, and Goldvaser, H

Subjects
Off-label, Metastatic breast cancer, Anti-cancer drugs, FDA, NCCN
Abstract

Background: National Comprehensive Cancer Network (NCCN) guidelines can include recommendations for off label use of anti-cancer drugs. Here, we evaluate NCCN recommendations not supported by US Food and Drug Administration (FDA) approval and explore associations with such recommendations. Methods: All NCCN recommendations for MBC and their supporting data were identified. Drug labels were reviewed to determine whether recommendations are FDA approved. Logistic regression was used to compare FDA approved and off-label recommendations for pre-specified categories, including drug type, tumor subtype, level of recommendation and line of therapy. Results: Of 124 recommendations identified, 68 (55%) were off-label. Chemotherapy and human epidermal growth factor receptor 2 (HER2) targeted drugs were associated with lower odds of FDA approval (OR = 0.28, p = 0.001 and OR = 0.29, 95% p = 0.005, respectively). Recommendations for endocrine therapy (OR = 3.44, p = 0.009) and non-HER2 targeted treatment (OR = 10.0, p < 0.001) were more commonly FDA approved indications. Compared to combination therapies, monotherapies were more likely to be FDA approved (OR = 3.45, p = 0.001) as were category 1 (OR = 7.63, p = 0.001) and preferred NCCN recommendations (OR = 4.07, p < 0.001). Compared to off-label recommendations, NCCN recommendations of approved drugs were based on significantly higher sample size (mean 477 vs. 342 patients, p = 0.02) and were non-significantly associated with availability of randomized data (OR = 2.0, 95% CI 0.89-4.49, p = 0.09). Conclusion: More than half of all NCCN recommendations for MBC are off-label, mostly involving chemotherapy containing regimes for HER2 negative disease and combinations which include HER2-targeted drugs. Improved transparency of NCCN guidelines may result from reporting of the strength of the evidence supporting recommendations for MBC.

Published
2020

49. BASELINE CLINICAL AND PET-CT TUMOR BURDEN PARAMETERS DO NOT PREDICT OUTCOME OF RELAPSE/REFRACTORY AGGRESSIVE B CELL LYMPHOMA PATIENTS TREATED WITH ANTI-CD19 CAR T-CELLS

Author

Avigdor, A., primary, Davidson, T., additional, Shimoni, A., additional, Yerushalmi, R., additional, Shem-Tov, N., additional, Danylesko, I., additional, Itzhaki, O., additional, Toren, A., additional, Jacoby, E., additional, Besser, M., additional, and Nagler, A., additional

Published
2019
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