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153 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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14. 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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15. 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

33. 4 Oral - Neoadjuvant pembrolizumab or placebo + chemotherapy, followed by adjuvant pembrolizumab or placebo plus endocrine therapy for early-stage high-risk ER+/HER2– breast cancer: Results from the phase 3 KEYNOTE-756 study.

Author

Cardoso, F., O'Shaughnessy, J., McArthur, H., Schmid, P., Cortes, J., Harbeck, N., Telli, M.L., Cescon, D.W., Fasching, P., Shao, Z., Loirat, D., Park, Y.H., Gonzalez Fernandez, M., Rubovszky, G., Im, S.A., Hui, R., Takano, T., André, F., Yasojima, H., and Liu, Z.

Subjects
*BREAST tumor risk factors, *BREAST tumors, *TREATMENT effectiveness, *CONFERENCES & conventions, *MONOCLONAL antibodies, *ADJUVANT chemotherapy, *COMBINED modality therapy, *HORMONE therapy, *EVALUATION
Published
2024
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37. 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., Schmid, P., Harbeck, N., Takahashi, M., Untch, M., Boileau, J.-F., Cortes, J., McArthur, H., Dent, R., O'Shaughnessy, J., Pusztai, L., Foukakis, T., Park, Y.H., Hui, R., Cardoso, F., Denkert, C., Zhu, Y., Pan, W., Karantza, V., and Fasching, P.

Subjects
PEMBROLIZUMAB, PLACEBOS, CANCER chemotherapy
Published
2023
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38. 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., Toi, M., O'Shaughnessy, J., Rastogi, P., Campone, M., Neven, P., Huang, C.S., Huober, J., Jaliffe, G. Garnica, Cicin, I., Tolaney, S., Goetz, M.P., Rugo, H., Senkus, E., Testa, L., Del Mastro, L., Shimizu, C., Wei, R., Shahir, A., and Munoz, M.

Subjects
TREATMENT effectiveness, HORMONE therapy, OVERALL survival
Published
2023
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39. 3 Oral - 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., O'Shaughnessy, J., Fasching, P., Cardoso, F., Tolaney, S., Hamilton, E., Sharma, V.K., Biswas, C., Haftchenary, S., Pathak, P., and Rugo, H.

Subjects
*THERAPEUTIC use of antineoplastic agents, *LETROZOLE, *CONFERENCES & conventions, *TREATMENT effectiveness, *BREAST tumors
Published
2022
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41. Bovine besnoitiosis (Besnoitia besnoiti) in an Irish dairy herd.

Author

Ryan, E. G., Lee, A., Carty, C., O'Shaughnessy, J., Kelly, P., Cassidy, J. P., Sheehan, M., Johnson, A., and de Waal, T.

Subjects
BESNOITIOSIS, APICOMPLEXA, ANIMAL disease control, INFECTIOUS disease transmission, VETERINARY medicine
Abstract

Bovine besnoitiosis, caused by the apicomplexan protozoan parasite Besnoitia besnoiti, was diagnosed in an Irish dairy herd. This is the first diagnosis of besnoitiosis in Ireland or the UK and the most northerly European outbreak yet described. The diagnosis occurred following a farm investigation in June 2015 into an unusual dermatological problem that had been ongoing since 2010. On an annual basis, 1-2 per cent of cows in the herd exhibited clinical signs, including skin thickening, alopecia, weight loss and poor performance. Others displayed pyrexia, limb oedema, respiratory distress and reduced milk yield. Histopathological examination of skin revealed granulomatous and eosinophilic dermatitis, with characteristic intradermal protozoal cysts, consistent with cutaneous besnoitiosis. Follow-up serological testing and clinical examination of cattle (n=228) on the farm found that 68 per cent (144/212) were seropositive for B. besnoiti. In addition, 51 per cent (117/228) had characteristic scleral conjunctival cysts and 68 per cent (134/198) had vulval cysts. Postmortem examination of a severely affected animal revealed typical gross and histopathological lesions of B. besnoiti infection. These results confirmed endemic infection with B. besnoiti. The identification of this exotic disease highlights the importance of veterinary surveillance at both local and national level, particularly in relation to emerging diseases. [ABSTRACT FROM AUTHOR]

Published
2016
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43. 258P Analysis of patients (pts) without an initial triple-negative breast cancer (TNBC) diagnosis (Dx) in the phase III ASCENT study of sacituzumab govitecan (SG) in brain metastases-negative (BMNeg) metastatic TNBC (mTNBC).

Author

O'Shaughnessy, J., Brufsky, A., Rugo, H.S., Tolaney, S.M., Diab, S., Punie, K., Sardesai, S., Hamilton, E., Loirat, D., Traina, T.A., Leon-Ferre, R., Hurvitz, S.A., Kalinsky, K., Bardia, A., Henry, S., Mayer, I., Hong, Q., Phan, S., and Cortés, J.

Subjects
*TRIPLE-negative breast cancer, *DIAGNOSIS, *METASTASIS
Published
2021
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50. Acceptance of change in the healthcare paradigm from reductionism to holism.

Author

Kubsch S, O'Shaughnessy J, Carrick J, Willihnganz T, Henricks-Soderberg L, and Sloan SA

Abstract

The purpose of this study was to examine acceptance of change of the healthcare paradigm from reductionism to holism among consumers of healthcare, physicians, and registered nurses. Inaccuracy in perception of acceptance of the holistic paradigm can limit conversation about and use of complementary therapies. Study results did not show a significant difference in acceptance of change between the 3 groups. [ABSTRACT FROM AUTHOR]

Published
2007
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