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881 results on '"O'Shaughnessy, J."'

1. Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2− advanced breast cancer: final overall survival results of MONARCH 3

Author

Goetz, M.P., Toi, M., Huober, J., Sohn, J., Trédan, O., Park, I.H., Campone, M., Chen, S.-C., Manso, L.M., Paluch-Shimon, S., Freedman, O.C., O’Shaughnessy, J., Pivot, X., Tolaney, S.M., Hurvitz, S.A., Llombart-Cussac, A., André, V., Saha, A., van Hal, G., Shahir, A., Iwata, H., and Johnston, S.R.D.

Published
2024
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5. Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2− Advanced Breast Cancer

Author

Fasching PA, Delea TE, Lu YS, De Boer R, Hurvitz SA, Moynahan A, Chandiwana D, Lanoue B, Hu H, Thuerigen A, and O'Shaughnessy J

Subjects
monaleesa-3, paloma-1, overall survival, cdk4/6 inhibitor, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Peter A Fasching,1 Thomas E Delea,2 Yen-Shen Lu,3 Richard De Boer,4 Sara A Hurvitz,5 Aaron Moynahan,2 David Chandiwana,6 Brad Lanoue,6 Huilin Hu,6 Astrid Thuerigen,7 Joyce O’Shaughnessy8 1University Hospital Erlangen, Comprehensive Cancer Center Erlangen—EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen—Nuremberg, Erlangen, Germany; 2Policy Analysis Inc. (PAI), Brookline, MA, USA; 3National Taiwan University Hospital, Taipei, Taiwan; 4Peter MacCallum Cancer Centre, Victoria, Australia; 5University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA; 6Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 7Novartis Pharma AG, Basel, Switzerland; 8Department of Medical Oncology, Baylor University Medical Center, Texas Oncology and US Oncology Network, Dallas, TX, USACorrespondence: Peter A FaschingUniversity Hospital Erlangen, Comprehensive Cancer Center Erlangen—EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen, Maximiliansplatz 2, Erlangen, 91054, GermanyEmail peter.fasching@uk-erlangen.dePurpose: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus endocrine therapy are recommended for first-line treatment of hormone receptor–positive/human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC). However, not all CDK4/6i trials have reported significant overall survival (OS) benefit, and there have been no head-to-head trials. Two trials have reported OS outcomes in first-line patients: MONALEESA-3 reported significant OS benefit with first- or second-line ribociclib plus fulvestrant (RIB+FUL) versus placebo plus fulvestrant (PBO+FUL), while PALOMA-1 reported no significant OS benefit for palbociclib plus letrozole (PAL+LET) versus LET in first-line postmenopausal patients. Matched-adjusted indirect comparisons (MAICs) are an established method for comparing efficacy of treatments from different trials. We used an MAIC to compare first-line patients from MONALEESA-3 and PALOMA-1.Patients and Methods: An unanchored MAIC of progression-free survival (PFS) and OS in first-line patients with HR+/HER2− ABC treated with RIB+FUL versus PAL+LET was conducted using individual patient data from MONALEESA-3 and aggregated data from PALOMA-1. To match patients in PALOMA-1, patients in MONALEESA-3 were limited to those with no prior endocrine therapy for ABC and no (neo) adjuvant LET ≤ 12 months before enrollment. PFS and OS were compared using Kaplan–Meier estimators and Cox regression.Results: A total of 329 and 178 patients from RIB+FUL and PBO+FUL arms, respectively, of MONALEESA-3 were matched to 84 and 81 patients from PAL+LET and LET arms of PALOMA-1. After weighting, OS was significantly longer for RIB+FUL versus PAL+LET (hazard ratio [HR], 0.50; 95% CI, 0.32– 0.77; p = 0.0020). PFS favored RIB+FUL versus PAL+LET, although the difference was not statistically significant (HR, 0.77; 95% CI, 0.54– 1.10; p = 0.1553).Conclusion: Using MAIC to adjust for trial differences, OS comparisons favored RIB+FUL over PAL+LET as first-line treatment in postmenopausal patients with HR+/HER2− ABC. These exploratory results suggest a significant increase in OS benefit with RIB treatment compared with PAL.Keywords: MONALEESA-3, PALOMA-1, overall survival, CDK4/6 inhibitor

Published
2021

6. Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer

Author

Bardia, A., Tolaney, S.M., Punie, K., Loirat, D., Oliveira, M., Kalinsky, K., Zelnak, A., Aftimos, P., Dalenc, F., Sardesai, S., Hamilton, E., Sharma, P., Recalde, S., Gil, E.C., Traina, T., O’Shaughnessy, J., Cortes, J., Tsai, M., Vahdat, L., Diéras, V., Carey, L.A., Rugo, H.S., Goldenberg, D.M., Hong, Q., Olivo, M., Itri, L.M., and Hurvitz, S.A.

Published
2021
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7. 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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8. Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial

Author

Bardia, A., Messersmith, W.A., Kio, E.A., Berlin, J.D., Vahdat, L., Masters, G.A., Moroose, R., Santin, A.D., Kalinsky, K., Picozzi, V., O'Shaughnessy, J., Gray, J.E., Komiya, T., Lang, J.M., Chang, J.C., Starodub, A., Goldenberg, D.M., Sharkey, R.M., Maliakal, P., Hong, Q., Wegener, W.A., Goswami, T., and Ocean, A.J.

Published
2021
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13. Hybrid capture-based genomic profiling of circulating tumor DNA from patients with estrogen receptor-positive metastatic breast cancer

Author

Chung, J.H., Pavlick, D., Hartmaier, R., Schrock, A.B., Young, L., Forcier, B., Ye, P., Levin, M.K., Goldberg, M., Burris, H., Gay, L.M., Hoffman, A.D., Stephens, P.J., Frampton, G.M., Lipson, D.M., Nguyen, D.M., Ganesan, S., Park, B.H., Vahdat, L.T., Leyland-Jones, B., Mughal, T.I., Pusztai, L., O’Shaughnessy, J., Miller, V.A., Ross, J.S., and Ali, S.M.

Published
2017
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16. 97P Efficacy and safety of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer: Long-term data from the PHranceSCa study

Author

O'Shaughnessy, J., primary, Sousa, S.P., additional, Jurado, J. Cruz, additional, Fallowfield, L.J., additional, Auvinen, P., additional, Pulido, C., additional, Cvetanovic, A.S., additional, Wilks, S.T., additional, Ribeiro, L.A., additional, Burotto, M., additional, Boulet, T., additional, Revelant, V., additional, Theron, N., additional, Trask, P., additional, Wahyudi, L.A., additional, Machackova, Z., additional, and Stamatovic, L., additional

Published
2023
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17. 196P Efficacy and safety of first-line (1L) ribociclib (RIB) + letrozole (LET) in patients (pts) with de novo metastatic disease and late recurrence from (neo)adjuvant therapy (tx) in MONALEESA (ML)-2

Author

O'Shaughnessy, J., primary, Beck, T., additional, Chia, S., additional, Isaacs, C., additional, De Laurentiis, M., additional, Kuemmel, S., additional, Jhaveri, K., additional, Janni, W., additional, Rugo, H.S., additional, Lteif, A., additional, Sopher, G., additional, Hu, H., additional, and Neven, P., additional

Published
2023
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18. 201P Trilaciclib combined with sacituzumab govitecan (SG) in metastatic triple-negative breast cancer (mTNBC): Preliminary phase II results

Author

Seneviratne, L., primary, Harnden, K.K., additional, Mardones, M., additional, Blau, S., additional, Gillespie-Twardy, A., additional, Danso, M.A., additional, Berz, D., additional, Guaqueta, D., additional, Schwerkoske, J., additional, O'Shaughnessy, J., additional, Patt, D., additional, Bardia, A., additional, Beelen, A., additional, Oyekunle, T., additional, Dell, V., additional, and Hurvitz, S.A., additional

Published
2023
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19. 198P Relationship of diarrhea and neutropenia events with outcomes in patients (pts) with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG): Post hoc analysis from the phase III ASCENT study

Author

de Azambuja, E., primary, Jacobs, F., additional, Lambertini, M., additional, Rugo, H.S., additional, Bardia, A., additional, Tolaney, S.M., additional, O'Shaughnessy, J., additional, Delaney, R.J., additional, Zha, S., additional, Liu, J., additional, Valdez, T., additional, Kalinsky, K., additional, and Agostinetto, E., additional

Published
2023
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20. P125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study

Author

Kümmel, S., primary, Schmid, P., additional, Harbeck, N., additional, Takahashi, M., additional, Untch, M., additional, Boileau, J.-F., additional, Cortes, J., additional, McArthur, H., additional, Dent, R., additional, O’Shaughnessy, J., additional, Pusztai, L., additional, Foukakis, T., additional, Park, Y.H., additional, Hui, R., additional, Cardoso, F., additional, Denkert, C., additional, Zhu, Y., additional, Pan, W., additional, Karantza, V., additional, and Fasching, P., additional

Published
2023
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21. P017 Abemaciclib + endocrine therapy (ET) for HR+, HER2-, node-positive, high-risk EBC: results from a pre-planned monarchE overall survival (OS) interim analysis (IA), including 4-year efficacy outcomes

Author

Johnston, S., primary, Toi, M., additional, O’Shaughnessy, J., additional, Rastogi, P., additional, Campone, M., additional, Neven, P., additional, Huang, C.S., additional, Huober, J., additional, Jaliffe, G. Garnica, additional, Cicin, I., additional, Tolaney, S., additional, Goetz, M.P., additional, Rugo, H., additional, Senkus, E., additional, Testa, L., additional, Del Mastro, L., additional, Shimizu, C., additional, Wei, R., additional, Shahir, A., additional, Munoz, M., additional, Antonio, B. San, additional, Andre, V., additional, Harbeck, N., additional, and Martín, M., additional

Published
2023
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22. A randomized adaptive phase II/III study of buparlisib, a pan-class I PI3K inhibitor, combined with paclitaxel for the treatment of HER2– advanced breast cancer (BELLE-4)

Author

Martín, M., Chan, A., Dirix, L., O’Shaughnessy, J., Hegg, R., Manikhas, A., Shtivelband, M., Krivorotko, P., Batista López, N., Campone, M., Ruiz Borrego, M., Khan, Q.J., Beck, J.T., Ramos Vázquez, M., Urban, P., Goteti, S., Di Tomaso, E., Massacesi, C., and Delaloge, S.

Published
2017
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24. Clinical effects of prior trastuzumab on combination eribulin mesylate plus trastuzumab as first-line treatment for human epidermal growth factor receptor 2 positive locally recurrent or metastatic breast cancer: results from a Phase II, single-arm, multicenter study

Author

Puhalla S, Wilks S, Brufsky AM, O'Shaughnessy J, Schwartzberg LS, Berrak E, Song J, and Vahdat L

Subjects
oncology, breast neoplasms, advanced breast cancer, chemotherapy, eribulin mesylate, trastuzumab, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Shannon Puhalla,1 Sharon Wilks,2 Adam M Brufsky,1 Joyce O’Shaughnessy,3 Lee S Schwartzberg,4 Erhan Berrak,5 James Song,5 Linda Vahdat6 1Department of Hematology and Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, 2Department of Hematology Oncology, US Oncology-Cancer Care Centers of South Texas, San Antonio, TX, 3Department of Medical Oncology, Texas Oncology-Baylor Charles A. Sammons Cancer Center US Oncology, Dallas, TX, 4Department of Hematology/Oncology, West Cancer Center, University of Tennessee Health Science Center, Memphis, TN, 5Department of Medical Affairs, Formerly of Eisai Inc., Woodcliff Lake, NJ, 6Department of Medicine, Weill Cornell Medical College, New York, NY, USA Abstract: Eribulin mesylate, a novel nontaxane microtubule dynamics inhibitor in the halichondrin class of antineoplastic drugs, is indicated for the treatment of patients with metastatic breast cancer who previously received ≥2 chemotherapy regimens in the metastatic setting. Primary data from a Phase II trial for the first-line combination of ­eribulin plus trastuzumab in human epidermal growth factor receptor 2 positive patients showed a 71% objective response rate and tolerability consistent with the known profile of these agents. Here, we present prespecified analyses of efficacy of this combination based on prior trastuzumab use. Patients received eribulin mesylate 1.4 mg/m2 (equivalent to 1.23 mg/m2 eribulin [expressed as free base]) intravenously on days 1 and 8 plus trastuzumab (8 mg/kg intravenously/cycle 1, then 6 mg/kg) on day 1 of each 21-day cycle. Objective response rates, progression-free survival, and tolerability were assessed in patients who had and had not received prior adjuvant or neoadjuvant (neo/adjuvant) trastuzumab treatment. Fifty-two patients (median age: 59.5 years) received eribulin/trastuzumab for a median treatment duration of ~31 weeks; 40.4% (n=21) had been previously treated with neo/adjuvant trastuzumab prior to treatment with eribulin plus trastuzumab for metastatic disease (median time between neo/adjuvant and study treatment: 23 months). In trastuzumab-naïve patients (n=31) compared with those who had received prior trastuzumab, objective response rate was 77.4% versus 61.9%, respectively; duration of response was 11.8 versus 9.5 months, respectively; clinical benefit rate was 87.1% versus 81.0%, respectively; and median progression-free survival was 12.2 versus 11.5 months, respectively. The most common grade 3/4 treatment-emergent adverse events (occuring in ≥5% of patients) in patients who received prior trastuzumab versus trastuzumab naïve patients, respectively, were neutropenia (47.6% vs 32.3%), peripheral neuropathy (14.3% vs 25.8%), febrile neutropenia (14.3% vs 3.2%), fatigue (9.5% vs 6.5%), nausea (9.5% vs 0%), vomiting (9.5% vs 3.2%), and leukopenia (9.5% vs 3.2%). In patients with human epidermal growth factor receptor 2 positive metastatic breast cancer, first-line eribulin/trastuzumab treatment demonstrated substantial antitumor activity and was well tolerated, regardless of prior neo/adjuvant trastuzumab treatment. Keywords: oncology, breast neoplasms, advanced breast cancer, chemotherapy, eribulin mesylate, trastuzumab, HER2

Published
2016

27. Matching adjusted indirect comparison of PFS & OS comparing ribociclib + letrozole vs palbociclib + letrozole as first-line treatment of HR+/HER2− ABC: Analysis based on updated PFS & final OS results of MONALEESA-2 & PALOMA-2

Author

Jhaveri, K., primary, O’Shaughnessy, J., additional, Fasching, P., additional, Cardoso, F., additional, Tolaney, S., additional, Hamilton, E., additional, Sharma, V.K., additional, Biswas, C., additional, Haftchenary, S., additional, Pathak, P., additional, and Rugo, H., additional

Published
2022
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29. 273TiP ACE-Breast-03: A phase II study patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens treated with ARX788

Author

Hurvitz, S.A., primary, Kalinsky, K., additional, Tripathy, D., additional, Sledge, G., additional, Gradishar, W.J., additional, O'Shaughnessy, J., additional, Modi, S., additional, Park, H., additional, McCartney, A., additional, Frentzas, S., additional, Shannon, C., additional, Cuff, K., additional, Eek, R.W., additional, Martin Jimenez, M., additional, Curigliano, G., additional, Jerusalem, G., additional, Huang, C., additional, Press, M., additional, and Lu, J., additional

Published
2022
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30. 135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522

Author

Dent, R.A., primary, Cortés, J., additional, Pusztai, L., additional, McArthur, H.L., additional, Kuemmel, S., additional, Bergh, J., additional, Denkert, C., additional, Park, Y.H., additional, Hui, R., additional, Harbeck, N., additional, Takahashi, M., additional, Untch, M., additional, Fasching, P.A., additional, Cardoso, F., additional, Haiderali, A., additional, Jia, L., additional, Nguyen, A.M., additional, Pan, W., additional, O'Shaughnessy, J., additional, and Schmid, P., additional

Published
2022
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32. 205P Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials

Author

Yardley, D.A., primary, Yap, Y.S., additional, Azim, H.A., additional, De Boer, R.H., additional, Campone, M., additional, Ring, A., additional, De Laurentiis, M., additional, O'Shaughnessy, J., additional, Cortés, J., additional, Chattar, Y., additional, Thuerigen, A., additional, Zarate, J.P., additional, and Nusch, A., additional

Published
2022
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33. EE159 Cost Effectiveness of Pembrolizumab Combined with Chemotherapy Vs. Chemotherapy As First-Line Treatment for Metastatic TNBC That Expresses PD-L1 in the United States

Author

Huang, M, primary, Fasching, P, additional, Haiderali, A, additional, Pan, W, additional, Gray, E, additional, Zhou, J, additional, Hu, PH, additional, Le Bailly De Tilleghem, C, additional, Cappoen, N, additional, Chaudhuri, M, additional, and O'Shaughnessy, J, additional

Published
2022
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36. Adjuvant abemaciclib combined with endocrine therapy (ET): updated results from monarchE

Author

Harbeck, N., additional, O’Shaughnessy, J., additional, Rastogi, P., additional, Toi, M., additional, Hegg, R., additional, Sohn, J., additional, Guarneri, V., additional, Cortes, J., additional, Hamilton, E., additional, Wei, R., additional, Shahir, A., additional, San Antonio, B., additional, Nabinger, S., additional, Tolaney, S., additional, Martin, M., additional, and Johnston, S., additional

Published
2022
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37. 206TiP Randomized, multicenter, international phase III ARTEST study to evaluate enobosarm versus active control for the treatment of AR+ ER+ HER2- metastatic breast cancer in patients who previously received an estrogen-blocking agent and a CDK 4/6 inhibitor

Author

Brufsky, A., primary, Linden, H., additional, Rugo, H.S., additional, Vogel, C., additional, O'Shaughnessy, J., additional, Getzenberg, R.H., additional, Barnette, K.G., additional, Rodriguez, D., additional, Steiner, M.S., additional, and Mayer, E., additional

Published
2022
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38. 250TiP HER2-positive and HER2-low breast cancer patients in the ACE-Pan tumor-01 study: Phase I study evaluating ARX788 as monotherapy in advanced solid tumors with HER2 expression or mutation

Author

Lu, J., primary, Budd, G.T., additional, Frentzas, S., additional, Park, H., additional, Shannon, C., additional, Rugo, H.S., additional, O'Shaughnessy, J., additional, Demichele, A., additional, Tolaney, S.M., additional, Eek, R.W., additional, McCartney, A., additional, Cuff, K., additional, Esserman, L., additional, Alika, A., additional, Xu, D., additional, Li, M., additional, Le, T., additional, L'Heureux, D.Z., additional, Yan, J., additional, and Hurvitz, S.A., additional

Published
2022
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39. 168P Sacituzumab govitecan (SG) efficacy in patients with metastatic triple-negative breast cancer (mTNBC) by HER2 immunohistochemistry (IHC) status: Findings from the phase III ASCENT study

Author

Hurvitz, S.A., primary, Bardia, A., additional, Punie, K., additional, Kalinsky, K., additional, Cortés, J., additional, O'Shaughnessy, J., additional, Carey, L.A., additional, Rugo, H.S., additional, Yoon, O.K., additional, Pan, Y., additional, Delaney, R.J., additional, Hofsess, S., additional, Hodgkins, P., additional, Phan, S-C., additional, and Dieras, V., additional

Published
2022
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40. 99P Cost effectiveness of pembrolizumab in combination with chemotherapy as neoadjuvant therapy and continued as a single agent as adjuvant therapy for high-risk early-stage TNBC in the United States

Author

Fasching, P.A., primary, Huang, M., additional, Haiderali, A., additional, Xue, W., additional, Pan, W., additional, Zhou, Z-Y., additional, Hu, P., additional, Chaudhuri, M., additional, Le Bailly De Tilleghem, C., additional, Cappoen, N., additional, and O'Shaughnessy, J., additional

Published
2022
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42. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial

Author

Geyer, C.E., primary, Sikov, W.M., additional, Huober, J., additional, Rugo, H.S., additional, Wolmark, N., additional, O’Shaughnessy, J., additional, Maag, D., additional, Untch, M., additional, Golshan, M., additional, Lorenzo, J. Ponce, additional, Metzger, O., additional, Dunbar, M., additional, Symmans, W.F., additional, Rastogi, P., additional, Sohn, J.H., additional, Young, R., additional, Wright, G.S., additional, Harkness, C., additional, McIntyre, K., additional, Yardley, D., additional, and Loibl, S., additional

Published
2022
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43. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study

Author

Rugo, H S, O'Shaughnessy, J, Boyle, F, Toi, M, Broom, R, Blancas, I, Gumus, M, Yamashita, T, Im, Y-H, Rastogi, P, Zagouri, F, Song, C, Campone, M, San Antonio, B, Shahir, A, Hulstijn, M, Brown, J, Zimmermann, A, Wei, R, Johnston, S R D, Reinisch, M, Tolaney, S M, and monarchE Committee Members

Subjects
safety, Diarrhea, Receptor, ErbB-2, HER2 negative, Aminopyridines, HR positive, Breast Neoplasms, Hematology, abemaciclib, monarchE, Oncology, Antineoplastic Combined Chemotherapy Protocols, Quality of Life, Humans, Benzimidazoles, Female, Patient Reported Outcome Measures, early breast cancer, Neoplasm Recurrence, Local
Abstract

In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile.

Published
2022

45. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase 3 trial

Author

Geyer CE Jr, Sikov WM, Huober J, Rugo HS, Wolmark N, O'Shaughnessy J, Maag D, Untch M, Golshan M, Ponce Lorenzo J, Metzger O, Dunbar M, Symmans WF, Rastogi P, Sohn J, Young R, Wright GS, Harkness C, McIntyre K, Yardley D, and Loibl S

Subjects
phase 3, triple-negative breast cancer, veliparib, carboplatin [(max 6)], neoadjuvant chemotherapy
Abstract

BACKGROUND: Primary analyses of the phase 3 BrighTNess trial showed addition of carboplatin with/without veliparib to neoadjuvant chemotherapy significantly improved pathological complete response (pCR) rates with manageable acute toxicity in patients with triple-negative breast cancer (TNBC). Here, we report 4.5-year follow-up data from the trial. DESIGN: Women with untreated stage II-III TNBC were randomized (2:1:1) to paclitaxel (weekly for 12 doses) plus either: (a) carboplatin (every 3 weeks for four cycles) plus veliparib (twice daily); (b) carboplatin plus veliparib placebo; or (c) carboplatin placebo plus veliparib placebo. All patients then received doxorubicin and cyclophosphamide (AC) every 2?3 weeks for four cycles. The primary endpoint was pCR. Secondary endpoints included event-free survival (EFS), overall survival (OS), and safety. Since the co-primary endpoint of increased pCR with carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel was not met, secondary analyses are descriptive. RESULTS: Of 634 patients, 316 were randomized to carboplatin plus veliparib with paclitaxel, 160 to carboplatin with paclitaxel, and 158 to paclitaxel. With median follow-up of 4.5 years, the hazard ratio [HR] for EFS for carboplatin plus veliparib with paclitaxel versus paclitaxel was 0.63 (95% confidence interval [CI] 0.43?0.92, P=0.02), but 1.12 (95% CI 0.72?1.72, P=0.62) for carboplatin plus veliparib with paclitaxel versus carboplatin with paclitaxel. In post hoc analysis, HR for EFS was 0.57 (95% CI 0.36?0.91, P=0.02) for carboplatin with paclitaxel versus paclitaxel. OS did not differ significantly between treatment arms, nor did rates of myelodysplastic syndromes, acute myeloid leukemia, or other secondary malignancies. CONCLUSION: Improvement in pCR with addition of carboplatin was associated with long-term EFS benefit with a manageable safety profile, and without increasing the risk of second malignancies, while adding veliparib did not impact EFS. These findings support the addition of carboplatin to weekly paclitaxel followed by AC neoadjuvant chemotherapy for early stage TNBC.

Published
2022

46. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study

Author

Rugo, H.S. O'Shaughnessy, J. Boyle, F. Toi, M. Broom, R. Blancas, I. Gumus, M. Yamashita, T. Im, Y.-H. Rastogi, P. Zagouri, F. Song, C. Campone, M. San Antonio, B. Shahir, A. Hulstijn, M. Brown, J. Zimmermann, A. Wei, R. Johnston, S.R.D. Reinisch, M. Tolaney, S.M. monarchE Committee Members

Abstract

BACKGROUND: In monarchE, abemaciclib plus endocrine therapy (ET) as adjuvant treatment of hormone receptor-positive, human epidermal growth factor 2-negative, high-risk, early breast cancer (EBC) demonstrated a clinically meaningful improvement in invasive disease-free survival versus ET alone. Detailed safety analyses conducted at a median follow-up of 27 months and key patient-reported outcomes (PROs) are presented. PATIENTS AND METHODS: The safety population included all patients who received at least one dose of study treatment (n = 5591). Safety analyses included incidence, management, and outcomes of common and clinically relevant adverse events (AEs). Patient-reported health-related quality of life, ET symptoms, fatigue, and side-effect burden were assessed. RESULTS: The addition of abemaciclib to ET resulted in higher incidence of grade ≥3 AEs (49.7% versus 16.3% with ET alone), predominantly laboratory cytopenias [e.g. neutropenia (19.6%)] without clinical complications. Abemaciclib-treated patients experienced more serious AEs (15.2% versus 8.8%). Discontinuation of abemaciclib and/or ET due to AEs occurred in 18.5% of patients, mainly due to grade 1/2 AEs (66.8%). AEs were managed with comedications (e.g. antidiarrheals), abemaciclib dose holds (61.7%), and/or dose reductions (43.4%). Diarrhea was generally low grade (grade 1/2: 76%); grade 2/3 events were highest in the first month (20.5%), most were short-lived (≤7 days) and did not recur. Venous thromboembolic events (VTEs) were higher with abemaciclib + ET (2.5%) versus ET (0.6%); in the abemaciclib arm, increased VTE risk was observed with tamoxifen versus aromatase inhibitors (4.3% versus 1.8%). PROs were similar between arms, including being 'bothered by side-effects of treatment', except for diarrhea. At ≥3 months, most patients reporting diarrhea reported 'a little bit' or 'somewhat'. CONCLUSIONS: In patients with high-risk EBC, adjuvant abemaciclib + ET has an acceptable safety profile and tolerability is supported by PRO findings. Most AEs were reversible and manageable with comedications and/or dose modifications, consistent with the known abemaciclib toxicity profile. Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

Published
2022

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