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2. Triterpene benzoates from the bark of Picramnia teapensis (Simaroubaceae)

Author

Rodríguez-Gamboa Tatiana, Fernandes João B., Rodrigues Filho Edson, Silva M. Fátima das G. F. da, Vieira Paulo C., Barrios Ch. Mariano, Castro-Castillo Oscar, Victor Sandra R., Pagnocca Fernando C., Bueno Odair C., and Hebling Maria J. A.

Subjects
Triterpene esters, lupanes, Picramnia teapensis, Atta sexdens, Leucoagaricus gongylophorus, Chemistry, QD1-999
Abstract

Two new benzoic acid esters of triterpene alcohols [lup-20(29)-en-28-oic acid 3alpha,7beta-dibenzoate and 3alpha-hydroxy-lup-20(29)-en-28-oic acid 7beta-benzoate] were isolated from the stem bark of Picramnia teapensis Tul. The structures of these compounds were established on the basis of spectral analyses. Other known compounds, beta-sitosterol, estigmasterol, lupeol and epilupeol, were identified in mixture by GC-MS. The triterpene esters have not shown in-vitro inhibitory effect on the growth of Leucoagaricus gongylophorus (Fisher), referred also as Leucocoprinus gongylophorus (Heim), syn Rozites gongylophora (Möller), the symbiotic fungus cultivated by the leaf-cutting ant Atta sexdens L.

Published
2001

3. IMpassion031: Efficacy, safety and patient (pts)-reported outcomes/quality of life (QoL) - Results from a Ph 3 study of neoadjuvant (neoadj) atezolizumab + chemo in early stage triple-negative breast cancer (eTNBC)

Author

Harbeck, N, additional, Zhang, H, additional, Barrios, CH, additional, Saji, S, additional, Jung, KH, additional, Hegg, R, additional, Köhler, A, additional, Sohn, J, additional, Iwata, H, additional, Telli, ML, additional, Ferrario, C, additional, Punie, K, additional, Penault-Llorca, F, additional, Patel, S, additional, Nguyen Duc, A, additional, Liste-Hermoso, M, additional, Maiya, V, additional, Molinero, L, additional, Chui, SY, additional, and Mittendorf, EA, additional

Published
2021
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4. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis (vol 32, pg 983, 2021)

Author

Emens, LA, Adams, S, Barrios, CH, Dieras, V, Iwata, H, Loi, S, Rugo, HS, Schneeweiss, A, Winer, EP, Patel, S, Henschel, V, Swat, A, Kaul, M, Molinero, L, Chui, SY, Schmid, P, Emens, LA, Adams, S, Barrios, CH, Dieras, V, Iwata, H, Loi, S, Rugo, HS, Schneeweiss, A, Winer, EP, Patel, S, Henschel, V, Swat, A, Kaul, M, Molinero, L, Chui, SY, and Schmid, P

Published
2021

5. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis

Author

Emens, LA, Adams, S, Barrios, CH, Dieras, V, Iwata, H, Loi, S, Rugo, HS, Schneeweiss, A, Winer, EP, Patel, S, Henschel, V, Swat, A, Kaul, M, Molinero, L, Chui, SY, Schmid, P, Emens, LA, Adams, S, Barrios, CH, Dieras, V, Iwata, H, Loi, S, Rugo, HS, Schneeweiss, A, Winer, EP, Patel, S, Henschel, V, Swat, A, Kaul, M, Molinero, L, Chui, SY, and Schmid, P

Abstract

BACKGROUND: Guidelines recommend atezolizumab plus nab-paclitaxel (A + nP) for first-line treatment of unresectable, locally advanced, or metastatic triple-negative breast cancer expressing programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (IC), based on IMpassion130. We report the final overall survival (OS) and safety of that study as per the prespecified analysis plan. PATIENTS AND METHODS: Patients were randomized to nP 100 mg/m2 (days 1, 8, and 15 of a 28-day cycle) with atezolizumab 840 mg (A + nP) or placebo (P + nP; days 1 and 15), until progression or unacceptable toxicity. Coprimary endpoints were progression-free survival [intention-to-treat (ITT) and PD-L1 IC-positive populations] and OS (tested hierarchically in the ITT population and, if significant, in the PD-L1 IC-positive population). RESULTS: Each arm comprised 451 patients; 666 (73.8%) had died by the final OS analysis cut-off (median follow-up, 18.8 months; interquartile range, 8.9-34.7 months). Median OS in the ITT population was 21.0 months [95% confidence interval (CI), 19.0-23.4 months] with A + nP, and 18.7 months (95% CI, 16.9-20.8 months) with P + nP [stratified hazard ratio (HR), 0.87; 95% CI, 0.75-1.02; P = 0.077]. Exploratory analysis in the PD-L1 IC-positive population showed a median OS of 25.4 months (95% CI, 19.6-30.7 months) with A + nP (n = 185) and 17.9 months (95% CI, 13.6-20.3 months) with P + nP (n = 184; stratified HR, 0.67; 95% CI, 0.53-0.86). Safety outcomes were consistent with previous analyses and the known toxicity profiles of each agent. Immune-mediated adverse events of special interest were reported in 58.7% and 41.6% of patients treated with A + nP and P + nP, respectively. CONCLUSION: Although the OS benefit in the ITT population was not statistically significant, precluding formal testing, clinically meaningful OS benefit was observed with A + nP in PD-L1 IC-positive patients, consistent with prior interim analyses. This combination remained saf

Published
2021

6. PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer

Author

Rugo, HS, Loi, S, Adams, S, Schmid, P, Schneeweiss, A, Barrios, CH, Iwata, H, Dieras, V, Winer, EP, Kockx, MM, Peeters, D, Chui, SY, Lin, JC, Duc, AN, Viale, G, Molinero, L, Emens, LA, Rugo, HS, Loi, S, Adams, S, Schmid, P, Schneeweiss, A, Barrios, CH, Iwata, H, Dieras, V, Winer, EP, Kockx, MM, Peeters, D, Chui, SY, Lin, JC, Duc, AN, Viale, G, Molinero, L, and Emens, LA

Abstract

BACKGROUND: In the phase III IMpassion130 study, atezolizumab plus nab-paclitaxel (A+nP) showed clinical benefit in advanced or metastatic triple-negative breast cancer patients who were programmed death-ligand 1 (PD-L1)+ (tumor-infiltrating immune cells [IC] ≥1%) using the SP142 immunohistochemistry assay. Here we evaluate 2 other PD-L1 assays for analytical concordance with SP142 and patient-associated clinical outcomes. METHODS: Samples from 614 patients (68.1% of intention-to-treat population) were centrally evaluated by immunohistochemistry for PD-L1 status on IC (VENTANA SP142, SP263, Dako 22C3) or as a combined positive score (CPS; 22C3). RESULTS: Using SP142, SP263, and 22C3 assays, PD-L1 IC ≥1% prevalence was 46.4% (95% confidence interval [CI] = 42.5% to 50.4%), 74.9% (95% CI = 71.5% to 78.3%), and 73.1% (95% CI = 69.6% to 76.6%), respectively; 80.9% were 22C3 CPS ≥1. At IC ≥1% (+), the analytical concordance between SP142 and SP263 and 22C3 was 69.2% and 68.7%, respectively. Almost all SP142+ cases were captured by other assays (double positive), but several SP263+ (29.6%) or 22C3+ (29.0%) cases were SP142- (single positive). A+nP clinical activity vs placebo+nP in SP263+ and 22C3+ patients (progression-free survival [PFS] hazard ratios [HRs] = 0.64 to 0.68; overall survival [OS] HRs = 0.75 to 0.79) was driven by double-positive cases (PFS HRs = 0.60 to 0.61; OS HRs = 0.71 to 0.75) rather than single-positive cases (PFS HRs = 0.68 to 0.81; OS HRs = 0.87 to 0.95). Concordance for harmonized cutoffs for SP263 (IC ≥4%) and 22C3 (CPS ≥10) to SP142 (IC ≥1%) was subpar (approximately 75%). CONCLUSIONS: 22C3 and SP263 assays identified more patients as PD-L1+ (IC ≥1%) than SP142. No inter-assay analytical equivalency was observed. Consistent improved A+nP efficacy was captured by the SP142 PD-L1 IC ≥1% subgroup nested within 22C3 and SP263 PD-L1+ (IC ≥1%) populations.

Published
2021

7. Atezolizumab and nab-Paclitaxel in Advanced Triple-Negative Breast Cancer: Biomarker Evaluation of the IMpassion130 Study

Author

Emens, LA, Molinero, L, Loi, S, Rugo, HS, Schneeweiss, A, Dieras, V, Iwata, H, Barrios, CH, Nechaeva, M, Anh, N-D, Chui, SY, Husain, A, Winer, EP, Adams, S, Schmid, P, Emens, LA, Molinero, L, Loi, S, Rugo, HS, Schneeweiss, A, Dieras, V, Iwata, H, Barrios, CH, Nechaeva, M, Anh, N-D, Chui, SY, Husain, A, Winer, EP, Adams, S, and Schmid, P

Abstract

BACKGROUND: Understanding the impact of the tumor immune microenvironment and BRCA1/2-related DNA repair deficiencies on the clinical activity of immune checkpoint inhibitors may help optimize both patient and treatment selection in metastatic triple-negative breast cancer. In this substudy from the phase 3 IMpassion130 trial, immune biomarkers and BRCA1/2 alterations were evaluated for association with clinical benefit with atezolizumab and nab-paclitaxel (A+nP) vs placebo and nP in unresectable (P+nP) locally advanced or metastatic triple-negative breast cancer. METHODS: Patients were randomly assigned 1:1 to nab-paclitaxel 100 mg/m2 (days 1, 8, and 15 of a 28-day cycle) and atezolizumab 840 mg every 2 weeks or placebo until progression or toxicity. Progression-free survival and overall survival were evaluated based on programmed death-ligand 1 (PD-L1) expression on immune cells (IC) and tumor cells, intratumoral CD8, stromal tumor-infiltrating lymphocytes, and BRCA1/2 mutations. RESULTS: PD-L1 IC+ in either primary or metastatic tumor tissue was linked to progression-free survival and overall survival benefit with A+nP. PD-L1 IC+ low (26.9%; 243 of 902 patients) and high (13.9%; 125 of 902 patients) populations had improved outcomes that were comparable. Intratumoral CD8 and stromal tumor-infiltrating lymphocytes positivity (sTIL+) were associated with PD-L1 IC+ status; improved outcomes were observed with A+nP vs P+nP only in CD8+ and sTIL+ patients who were also PD-L1 IC+. BRCA1/2 mutations (occurring in 14.5% [89 of 612 patients]) were not associated with PD-L1 IC status, and PD-L1 IC+ patients benefited from A+nP regardless of BRCA1/2 mutation status. CONCLUSIONS: Although A+nP was more efficacious in patients with richer tumor immune microenvironment, clinical benefit was only observed in patients whose tumors were PD-L1 IC+.

Published
2021

8. Enhancing global access to cancer medicines

Author

Cortes J, Perez-García JM, Llombart-Cussac A, Curigliano G, El Saghir NS, Cardoso F, Barrios CH, Wagle S, Roman J, Harbeck N, Eniu A, Kaufman PA, Tabernero J, García-Estévez L, Schmid P, and Arribas J

Subjects
antineoplastic agents, health services accessibility, drug regulation, immunomodulation, research design, price
Abstract

Globally, cancer is the second leading cause of death, with numbers greatly exceeding those for human immunodeficiency virus/acquired immunodeficiency syndrome, tuberculosis, and malaria combined. Limited access to timely diagnosis, to affordable, effective treatment, and to high-quality care are just some of the factors that lead to disparities in cancer survival between countries and within countries. In this article, the authors consider various factors that prevent access to cancer medicines (particularly access to essential cancer medicines). Even if an essential cancer medicine is included on a national medicines list, cost might preclude its use, it might be prescribed or used inappropriately, weak infrastructure might prevent it being accessed by those who could benefit, or quality might not be guaranteed. Potential strategies to address the access problems are discussed, including universal health coverage for essential cancer medicines, fairer methods for pricing cancer medicines, reducing development costs, optimizing regulation, and improving reliability in the global supply chain. Optimizing schedules for cancer therapy could reduce not only costs, but also adverse events, and improve access. More and better biomarkers are required to target patients who are most likely to benefit from cancer medicines. The optimum use of cancer medicines depends on the effective delivery of several services allied to oncology (including laboratory, imaging, surgery, and radiotherapy). Investment is necessary in all aspects of cancer care, from these supportive services to technologies, and the training of health care workers and other staff.

Published
2020

9. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)

Author

Cardoso, F, Paluch-Shimon, S, Senkus, E, Curigliano, G, Aapro, MS, Andre, F, Barrios, CH, Bergh, J, Bhattacharyya, GS, Biganzoli, L, Boyle, F, Cardoso, M-J, Carey, LA, Cortes, J, El Saghir, NS, Elzayat, M, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Gligorov, J, Haidinger, R, Harbeck, N, Hu, X, Kaufman, B, Kaur, R, Kiely, BE, Kim, S-B, Lin, NU, Mertz, SA, Neciosup, S, Offersen, B, Ohno, S, Pagani, O, Prat, A, Penault-Llorca, F, Rugo, HS, Sledge, GW, Thomssen, C, Vorobiof, DA, Wiseman, T, Xu, B, Norton, L, Costa, A, Winer, EP, Cardoso, F, Paluch-Shimon, S, Senkus, E, Curigliano, G, Aapro, MS, Andre, F, Barrios, CH, Bergh, J, Bhattacharyya, GS, Biganzoli, L, Boyle, F, Cardoso, M-J, Carey, LA, Cortes, J, El Saghir, NS, Elzayat, M, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Gligorov, J, Haidinger, R, Harbeck, N, Hu, X, Kaufman, B, Kaur, R, Kiely, BE, Kim, S-B, Lin, NU, Mertz, SA, Neciosup, S, Offersen, B, Ohno, S, Pagani, O, Prat, A, Penault-Llorca, F, Rugo, HS, Sledge, GW, Thomssen, C, Vorobiof, DA, Wiseman, T, Xu, B, Norton, L, Costa, A, and Winer, EP

Published
2020

10. Safety and efficacy of sunitinib in patients from Latin America: subanalysis of an expanded access trial in metastatic renal cell carcinoma

Author

Barrios CH, Herchenhorn D, Chacón M, Cabrera-Galeana P, Sajben P, and Zhang K

Subjects
Latin America, tyrosine kinase inhibitor, sunitinib, expanded-access trial, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, metastatic renal cell carcinoma, lcsh:RC254-282
Abstract

Carlos H Barrios,1 Daniel Herchenhorn,2 Matías Chacón,3 Paula Cabrera-Galeana,4 Peter Sajben,5 Ke Zhang6 1Department of Medicine, PUCRS School of Medicine, Porto Alegre, 2Division of Clinical Oncology, Instituto Nacional do Câncer, Rio de Janeiro, Brazil; 3Clinical Oncology, Alexander Fleming Institute, Buenos Aires, Argentina; 4Department of Medical Oncology, Instituto Nacional de Cancerología, México, Centro Oncológico Issemym Edomex, México; 5Pfizer Oncology, New York, NY, 6Pfizer Oncology, La Jolla, CA, USA Background: Sunitinib is an approved treatment for metastatic renal cell carcinoma (mRCC). The safety profile and efficacy of sunitinib were confirmed in a global expanded access trial (ClinicalTrials.govidentifier: NCT00130897). This report presents a subanalysis of the final trial data from patients in Latin America.Methods: Treatment-naïve or previously treated mRCC patients aged ≥18 years received oral sunitinib at a starting dose of 50mg/day on a 4-weeks-on/2-weeks-off schedule. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. Safety was assessed regularly, and tumor measurements were scheduled per local practice (using Response Evaluation Criteria in Solid Tumors).Results: In total, 348 patients from Latin America received sunitinib. Overall, 75% of patients had two or more sites of metastatic disease, 28% were aged ≥65 years, 14% had an Eastern Cooperative Oncology Group performance status ≥2, 9% had brain metastases, 9% had no prior nephrectomy, and 5% had non-clear cell RCC. Median treatment duration was 8 months, and median follow-up was 15.1 months. In total, 326 patients (94%) discontinued treatment, primarily due to death (41%) or lack of efficacy (22%). Most treatment-related adverse events were of mild to moderate severity (grade 1/2). Mucosal inflammation (reported in 54% of patients), diarrhea (53%), and asthenia (41%) were the most common any-grade treatment-related adverse events. Asthenia (12%), neutropenia (10%), and fatigue and thrombocytopenia (both 9%) were the most common grade 3/4 treatment-related adverse events. In total, 311patients were included for tumor response, of whom eight (3%) had a complete response and 46 (15%) a partial response, yielding an objective response rate of 17%. Median duration of response, progression-free survival, and overall survival were 26.7, 12.1, and 16.9 months, respectively.Conclusion: The efficacy and safety profile of sunitinib in patients with mRCC from Latin America was comparable to that in the entire cohort of the global expanded access trial. Keywords: sunitinib, kidney cancer, expanded-access trial, Latin America, tyrosine kinase inhibitor

Published
2016

11. 4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)†

Author

Cardoso, F, Senkus, E., Costa, A, Papadopoulos, E, Aapro, M, André, F, Harbeck, N, Aguilar Lopez, B, Barrios, CH, Bergh, J, Prat, A, Boers-Doets, CB, Cardoso, MJ, Carey, LA, Cortés, J, Curigliano, G, Diéras, V, Saghir NS, EL, Eniu, A, Fallowfield, L, Francis, PA, Gelmon, K, Johnston, SRD, Kaufman, B, Koppikar, S, Krop, IE, Mayer, M, Nakigudde, G, Offersen, BV, Ohno, S, Pagani, O, Paluch-Shimon, S, Penault-Llorca, F, Prat, A., Rugo, HS, Sledge, GW, Spence, D, Thomssen, C, Vorobiof, DA, Xu, B., Norton, L, Winer, EP, Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland, Medical University of Gdansk, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
0301 basic medicine, Consensus Development Conferences as Topic, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Medical Oncology, 03 medical and health sciences, 0302 clinical medicine, Biomarkers, Tumor, Humans, Breast, Mastectomy, Societies, Medical, ComputingMilieux_MISCELLANEOUS, Neoplasm Staging, Clinical Trials as Topic, Integrative Medicine, Evidence-Based Medicine, Hematology, Chemoradiotherapy, Adjuvant, Neoadjuvant Therapy, 3. Good health, Europe, 030104 developmental biology, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Special article, Female, Biopsy, Large-Core Needle
Abstract

International audience

Published
2018
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12. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer A Randomized Clinical Trial

Author

Lee, Ay, Kamphuisen, Pw, Meyer, G, Bauersachs, R, Janas, Ms, Jarner, Mf, Khorana, Aa, Bella, Sr, Cerana, S, Zarbá, Jj, Johannes, A, Barrios, Ch, Borba, Ra, Cesario, F, de Azevedo, S, Ferreira Filho, Af, Franke, Fa, Padilha, S, Paiva, Qr, Pimenta, A, Rerin, J, Rigo, R, Rocha Van Eyll, Sb, Santos, Bg, Vacaro, G, Anastasov, V, Dragneva, T, Georgiev, G, Champion, P, Kuruvilla, P, Gonzalez, C, Ditl, P, Förster, J, Lubomir, B, Vydra, J, Abo El Hassan, R, Sabri, S, Allahloubi, N, Elzawawy, A, Ezzat, Ss, Sabry el, Km, Bacchus, L, Beyer Westendorf, J, Kamphausen, U, Niederwieser, D, Ostermann, H, Sosada, M, Anagnostopoulos, N, Fountzilas, G, Ioannou, C, Liapis, C, Barrios, Sf, Atilli, S, Balsubramanian, S, Bondarde, S, Desai, Sc, Deshmukh, C, Singh, Dp, Gharami, F, Goyal, L, Gupta, S, Gupte, S, Mukherjee, Kk, Krishnan, S, Kumar, K, Mehta, A, Mishra, K, Naik, R, Pawar, S, Rajnish, Vn, Warrier, N, Brenner, B, Gavish, I, Lugassy, G, Kolin, M, Enrico, B, Mazzucconi, Maria Gabriella, Visani, G, Awidi, A, Novikovs, N, Miscuks, J, Abigerges, D, Farhat, F, Khoueiry, P, Makarem, J, Alvarez Ordorica, O, Anaya Santacruz, E, Calderillo Ruiz, G, De la Concha Ureta, Hj, Pantigoso Wuilbert, Sr, Philco, M, Romero Pineda, A, Vargas Queszada, Ea, Gawrychowski, K, Witkiewicz, W, Macias, E, Teixeira, E, Ciuleanu, Te, Ligia, Cc, Lungulescu, D, Manolescu, Ig, Rodica, A, Volovat, C, Burov, Y, Katelnitsky, I, Svistov, D, Ahmad, K, Algahtani, F, Al Zahrani, H, Qari, M, Jovanovic, D, Milanovic, N, Perin, B, Stojanovic, V, Tomasic, L, Chovanec, J, Herman, O, Kissova, V, Sasvary, F, Špánik, S, Szentivanyi, M, Barón, F, Gallardo, E, Jiménez, D, Remedios, O, Sanchez, A, Engelbrecht, J, Jonas, N, Mcadam, G, Patel, M, Rapoport, B, Robertson, B, Oh, D, Kim, H, Kim, Hk, Kim, Hj, Kim, Hs, Ahn, Js, Chung, J, Jang, J, Park, Ku, Shin, Sw, Kim, Sh, Yoon, Ss, Kim, Yk, Chiu, Cf, Chang, Cs, Liu, Jh, Rau, Km, Chen, Sw, Chittima, S, Ekkapong, T, Nonglak, K, Pantep, A, Pramook, M, Thanakrit, S, Patrapim, S, Sumitra, T, Udomluck, C, Kobza, I, Nykonenko, O, Prasol, V, Vladychuk, I., Cardiovascular Centre (CVC), and Vascular Ageing Programme (VAP)

Subjects
Male, medicine.medical_specialty, Hemorrhage, DISEASE, law.invention, Tinzaparin, Randomized controlled trial, law, Recurrence, Internal medicine, Neoplasms, medicine, Humans, Cumulative incidence, International Normalized Ratio, cardiovascular diseases, Aged, Venous Thrombosis, MALIGNANCY, RISK, Heparin, business.industry, Medicine (all), Hazard ratio, Low-Molecular-Weight, Warfarin, Anticoagulants, General Medicine, Venous Thromboembolism, MOLECULAR-WEIGHT HEPARIN, Heparin, Low-Molecular-Weight, Middle Aged, medicine.disease, Thrombosis, Survival Analysis, PREVENTION, Surgery, Pulmonary embolism, Venous thrombosis, Female, business, Pulmonary Embolism, medicine.drug
Abstract

Importance Low-molecular-weight heparin is recommended over warfarin for the treatment of acute venous thromboembolism (VTE) in patients with active cancer largely based on results of a single, large trial. Objective To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute, symptomatic VTE in patients with active cancer. Design, Settings, and Participants A randomized, open-label study with blinded central adjudication of study outcomes enrolled patients in 164 centers in Asia, Africa, Europe, and North, Central, and South America between August 2010 and November 2013. Adult patients with active cancer (defined as histologic diagnosis of cancer and receiving anticancer therapy or diagnosed with, or received such therapy, within the previous 6 months) and objectively documented proximal deep vein thrombosis (DVT) or pulmonary embolism, with a life expectancy greater than 6 months and without contraindications for anticoagulation, were followed up for 180 days and for 30 days after the last study medication dose for collection of safety data. Interventions Tinzaparin (175 IU/kg) once daily for 6 months vs conventional therapy with tinzaparin (175 IU/kg) once daily for 5 to 10 days followed by warfarin at a dose adjusted to maintain the international normalized ratio within the therapeutic range (2.0-3.0) for 6 months. Main Outcomes and Measures Primary efficacy outcome was a composite of centrally adjudicated recurrent DVT, fatal or nonfatal pulmonary embolism, and incidental VTE. Safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and overall mortality. Results Nine hundred patients were randomized and included in intention-to-treat efficacy and safety analyses. Recurrent VTE occurred in 31 of 449 patients treated with tinzaparin and 45 of 451 patients treated with warfarin (6-month cumulative incidence, 7.2% for tinzaparin vs 10.5% for warfarin; hazard ratio [HR], 0.65 [95% CI, 0.41-1.03]; P = .07). There were no differences in major bleeding (12 patients for tinzaparin vs 11 patients for warfarin; HR, 0.89 [95% CI, 0.40-1.99]; P = .77) or overall mortality (150 patients for tinzaparin vs 138 patients for warfarin; HR, 1.08 [95% CI, 0.85-1.36]; P = .54). A significant reduction in clinically relevant nonmajor bleeding was observed with tinzaparin (49 of 449 patients for tinzaparin vs 69 of 451 patients for warfarin; HR, 0.58 [95% CI, 0.40-0.84]; P = .004). Conclusions and Relevance Among patients with active cancer and acute symptomatic VTE, the use of full-dose tinzaparin (175 IU/kg) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent VTE and was not associated with reductions in overall mortality or major bleeding, but was associated with a lower rate of clinically relevant nonmajor bleeding. Further studies are needed to assess whether the efficacy outcomes would be different in patients at higher risk of recurrent VTE. Trial Registration clinicaltrials.gov Identifier:NCT01130025

Published
2015

13. Abstract GS1-04: IMpassion130: Efficacy in immune biomarker subgroups from the global, randomized, double-blind, placebo-controlled, phase III study of atezolizumab + nab-paclitaxel in patients with treatment-naïve, locally advanced or metastatic triple-negative breast cancer

Author

Emens, LA, primary, Loi, S, additional, Rugo, HS, additional, Schneeweiss, A, additional, Diéras, V, additional, Iwata, H, additional, Barrios, CH, additional, Nechaeva, M, additional, Molinero, L, additional, Nguyen Duc, A, additional, Funke, R, additional, Chui, SY, additional, Husain, A, additional, Winer, EP, additional, Adams, S, additional, and Schmid, P, additional

Published
2019
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14. Abstract GS2-04: Efficacy results from CIBOMA/2004-01_GEICAM/2003-11 study: A randomized phase III trial assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer

Author

Martín, M, primary, Barrios, CH, additional, Torrecillas, L, additional, Ruiz-Borrego, M, additional, Bines, J, additional, Segalla, J, additional, Ruiz, A, additional, García-Sáenz, JA, additional, Torres, R, additional, de la Haba, J, additional, García, E, additional, Gómez, HL, additional, Llombart, A, additional, Rodríguez de la Borbolla, M, additional, Baena, JM, additional, Barnadas, A, additional, Calvo, L, additional, Pérez-Michel, L, additional, Ramos, M, additional, Castellanos, J, additional, Rodríguez-Lescure, A, additional, Cárdenas, J, additional, Vinholes, J, additional, Martínez de Dueñas, E, additional, Godes, MJ, additional, Seguí, MA, additional, Antón, A, additional, López-Álvarez, P, additional, Moncayo, J, additional, Amorim, G, additional, Villar, E, additional, Reyes, S, additional, Sampaio, C, additional, Cardemil, B, additional, Escudero, MJ, additional, Bezares, S, additional, Carrasco, E, additional, and Lluch, A, additional

Published
2019
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15. Abstract P4-12-01: Not presented

Author

Werutsky, G, primary, Villareal-Garza, C, additional, Moreno, HG, additional, Cartagena, AA, additional, Campos-Gomez, S, additional, Reyes, RO, additional, Lence, JJ, additional, Liedke, P, additional, Reinert, T, additional, Binotto, M, additional, Dybal, V, additional, Martinez-Mesa, J, additional, Freitas, RD, additional, Nunes Filho, PR, additional, Zaffaroni, F, additional, and Barrios, CH, additional

Published
2019
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16. Abstract P2-13-01: Efficacy of neratinib in hormone receptor-positive patients who initiated treatment within 1 year of completing trastuzumab-based adjuvant therapy in HER2+ early-stage breast cancer: Subgroup analyses from the phase III ExteNET trial

Author

Gnant, M, primary, Martin, M, additional, Holmes, F-A, additional, Jackisch, C, additional, Chia, SK, additional, Iwata, H, additional, Moy, B, additional, Martinez, N, additional, Mansi, J, additional, Morales, S, additional, Ruiz-Borrego, M, additional, von Minckwitz, G, additional, Buyse, M, additional, Delaloge, S, additional, Bhandari, M, additional, Murias Rosales, A, additional, Galeano, T, additional, Fujita, T, additional, Luczak, A, additional, Barrios, CH, additional, Saura, C, additional, Rugo, HS, additional, Chien, J, additional, Johnston, SR, additional, Spencer, M, additional, Xu, F, additional, Barnett, B, additional, Chan, A, additional, and Ejlertsen, B, additional

Published
2019
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17. Abstract P1-13-03: Effects of neratinib after trastuzumab-based adjuvant therapy in hormone receptor-positive HER2+ early-stage breast cancer: Exploratory analyses from the phase III ExteNET trial

Author

Chia, SKL, primary, Martin, M, additional, Iwata, H, additional, Moy, B, additional, Lalani, AS, additional, Holmes, FA, additional, Mansi, J, additional, von Minckwitz, G, additional, Buyse, M, additional, Delaloge, S, additional, Ejlertsen, B, additional, Yao, B, additional, Murias Rosales, A, additional, Hellerstedt, B, additional, Cold, S, additional, Inoue, K, additional, Shen, Z-Z, additional, Galeano, T, additional, Barrios, CH, additional, and Chan, A, additional

Published
2018
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19. Abstract P4-10-17: Survival outcomes related to health care coverage in metastatic breast cancer in Brazil: A sub-analysis from the LACOG-0312 study

Author

Werutsky, G, primary, Zaffaroni, F, additional, Uema, D, additional, Cronenberger, E, additional, Cordeiro de Lima, VC, additional, de Sant'ana, RO, additional, Bines, J, additional, Santi, PX, additional, Goés, RS, additional, Liedke, P, additional, Batista, MLM, additional, Dybal, V, additional, Nerón, YV, additional, Beato, CA, additional, Borges, G, additional, Giacomazzi, J, additional, dos Santos, LV, additional, Ismael, G, additional, Rosa, DD, additional, Azambuja, A, additional, Andrade, D, additional, Martinez-Mesa, J, additional, Debiasi, M, additional, and Barrios, CH, additional

Published
2018
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20. Abstract P1-17-10: Survival outcomes related to health care coverage in breast cancer patients with brain metastases in Brazil: A sub-analysis from the LACOG-0312 study

Author

Albuquerque, C, primary, Debiasi, M, additional, Werutsky, G, additional, Uema, D, additional, Cronenberger, E, additional, Cordeiro de Lima, VC, additional, de Sant'ana, RO, additional, Bines, J, additional, Santi, PX, additional, Goés, RS, additional, Liedke, P, additional, Batista, MLM, additional, Dybal, V, additional, Nerón, YV, additional, Beato, CA, additional, Borges, G, additional, Giacomazzi, J, additional, dos Santos, LV, additional, Ismael, G, additional, Rosa, DD, additional, Azambuja, A, additional, Andrade, D, additional, Martinez-Mesa, J, additional, Zaffaroni, F, additional, and Barrios, CH, additional

Published
2018
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21. Abstract OT1-01-01: IMpassion131: A phase III study comparing 1L atezolizumab with paclitaxel vs placebo with paclitaxel in treatment-naive patients with inoperable locally advanced or metastatic triple negative breast cancer (TNBC)

Author

Miles, D, primary, André, F, additional, Gligorov, J, additional, Verma, S, additional, Xu, B, additional, Cameron, D, additional, Barrios, CH, additional, Schneeweiss, A, additional, Easton, V, additional, Ghazi, Y, additional, and O'Shaughnessy, J, additional

Published
2018
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22. Abstract PD3-12: PIK3CA alterations and benefit with neratinib after trastuzumab-based adjuvant therapy in early-stage HER2+ breast cancer: Correlative analyses of the phase III ExteNET trial

Author

Chia, SKL, primary, Martin, M, additional, Holmes, FA, additional, Ejlertsen, B, additional, Delaloge, S, additional, Moy, B, additional, Iwata, H, additional, von Minckwitz, G, additional, Mansi, J, additional, Barrios, CH, additional, Gnant, M, additional, Tomašević, Z, additional, Denduluri, N, additional, Šeparović, R, additional, Kim, S-B, additional, Hugger Jakobsen, E, additional, Harvey, V, additional, Robert, N, additional, Smith, J, additional, Harker, G, additional, Lalani, AS, additional, Zhang, B, additional, Eli, LD, additional, Buyse, M, additional, and Chan, A, additional

Published
2018
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23. Utilization and Treatment Patterns Among Patients with Advanced Non-Small Cell Lung Cancer Receiving Predictive Molecular Biomarker (BMX) Tests

Author

Kothari, S, primary, Arunachalam, A, additional, Tsao, M, additional, Lee, DH, additional, Kambartel, K, additional, Isobe, H, additional, Huang, M, additional, Escosteguy Barrios, CH, additional, Khattak, A, additional, de Marinis, F, additional, Cao, X, additional, Burke, T, additional, Lopez, MA, additional, and De Castro, J, additional

Published
2017
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24. 3rd ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3).

Author

Cardoso, F, Costa, A, Senkus, E, Aapro, M, André, F, Barrios, CH, Bergh, J, Bhattacharyya, G, Biganzoli, L, Cardoso, MJ, Carey, L, Corneliussen-James, D, Curigliano, G, Dieras, V, El Saghir, N, Eniu, A, Fallowfield, L, Fenech, D, Francis, P, Gelmon, K, Gennari, A, Harbeck, N, Hudis, C, Kaufman, B, Krop, I, Mayer, M, Meijer, H, Mertz, S, Ohno, S, Pagani, O, Papadopoulos, E, Peccatori, F, Penault-Llorca, F, Piccart, MJ, Pierga, JY, Rugo, H, Shockney, L, Sledge, G, Swain, S, Thomssen, C, Tutt, A, Vorobiof, D, Xu, B, Norton, L, Winer, E, Cardoso, F, Costa, A, Senkus, E, Aapro, M, André, F, Barrios, CH, Bergh, J, Bhattacharyya, G, Biganzoli, L, Cardoso, MJ, Carey, L, Corneliussen-James, D, Curigliano, G, Dieras, V, El Saghir, N, Eniu, A, Fallowfield, L, Fenech, D, Francis, P, Gelmon, K, Gennari, A, Harbeck, N, Hudis, C, Kaufman, B, Krop, I, Mayer, M, Meijer, H, Mertz, S, Ohno, S, Pagani, O, Papadopoulos, E, Peccatori, F, Penault-Llorca, F, Piccart, MJ, Pierga, JY, Rugo, H, Shockney, L, Sledge, G, Swain, S, Thomssen, C, Tutt, A, Vorobiof, D, Xu, B, Norton, L, and Winer, E

Published
2017

25. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Martin, M, Holmes, F, Ejlertsen, B, Delaloge, S, Moy, B, Iwata, H, von Minckwitz, G, Chia, S, Mansi, J, Barrios, C, Gnant, M, Tomasevic, Z, Denduluri, N, Separovic, R, Gokmen, E, Bashford, A, Borrego, M, Kim, S, Jakobsen, E, Ciceniene, A, Inoue, K, Overkamp, F, Heijns, J, Armstrong, A, Link, J, Abraham, A, Bryce, J, Wong, A, Moran, S, Yao, B, Xu, F, Auerbach, A, Buyse, M, Chan, A, Bidoli, P, Holmes, FA, Chia, SKL, Barrios, CH, Borrego, MR, Kim, SB, Jakobsen, EH, Heijns, JB, Armstrong, AC, Link, JS, Bryce, JR, Martin, M, Holmes, F, Ejlertsen, B, Delaloge, S, Moy, B, Iwata, H, von Minckwitz, G, Chia, S, Mansi, J, Barrios, C, Gnant, M, Tomasevic, Z, Denduluri, N, Separovic, R, Gokmen, E, Bashford, A, Borrego, M, Kim, S, Jakobsen, E, Ciceniene, A, Inoue, K, Overkamp, F, Heijns, J, Armstrong, A, Link, J, Abraham, A, Bryce, J, Wong, A, Moran, S, Yao, B, Xu, F, Auerbach, A, Buyse, M, Chan, A, Bidoli, P, Holmes, FA, Chia, SKL, Barrios, CH, Borrego, MR, Kim, SB, Jakobsen, EH, Heijns, JB, Armstrong, AC, Link, JS, and Bryce, JR

Abstract

Background ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings. Methods In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1–3c (modified to stage 2–3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1–3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants. Findings Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1–5·3), patients

Published
2017

26. Abstract P6-16-04: Real World data and patterns of care of metastatic breast cancer (MBC) in Brazil: First results of LACOG 0312 retrospective study

Author

Barrios, CH, primary, Uema, D, additional, Cronenberger, E, additional, Lima, V, additional, Bines, J, additional, de Sant'ana, RO, additional, Batista, ML, additional, Dybal, V, additional, Liedke, P, additional, Beato, C, additional, Nerón, YV, additional, Giacomazzi, J, additional, dos Santos, L, additional, Ismael, G, additional, Azambuja, A, additional, Andrade, D, additional, Rosa, DD, additional, Borges, G, additional, Mano, M, additional, Martinez-Mesa, J, additional, Zaffaroni, F, additional, and Werutsky, G, additional

Published
2017
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27. Abstract S5-02: Neratinib after trastuzumab-based adjuvant therapy in early-stage HER2+ breast cancer: 3-year analysis from a phase 3 randomized, placebo-controlled, double-blind trial (ExteNET)

Author

Chan, A, primary, Delaloge, S, additional, Holmes, FA, additional, Moy, B, additional, Iwata, H, additional, Harker, G, additional, Masuda, N, additional, Neskovic Konstantinovic, ZB, additional, Petrakova, K, additional, Guerrero Zotano, AL, additional, Iannotti, N, additional, Rodriguez, GI, additional, Tassone, P, additional, von Minckwitz, G, additional, Ejlertsen, B, additional, Chia, SKL, additional, Mansi, J, additional, Barrios, CH, additional, Buyse, M, additional, Wong, A, additional, Bryce, R, additional, Ye, Y, additional, and Martin, M, additional

Published
2016
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29. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2)

Author

Cardoso, F, Costa, A, Norton, L, Senkus, E, Aapro, M, Andre, F, Barrios, CH, Bergh, J, Biganzoli, L, Blackwell, KL, Cardoso, MJ, Cufer, T, El Saghir, N, Fallowfield, L, Fenech, D, Francis, P, Gelmon, K, Giordano, SH, Gligorov, J, Goldhirsch, A, Harbeck, N, Houssami, N, Hudis, C, Kaufman, B, Krop, I, Kyriakides, S, Lin, UN, Mayer, M, Merjaver, SD, Nordstrom, EB, Pagani, O, Partridge, A, Penault-Llorca, F, Piccart, MJ, Rugo, H, Sledge, G, Thomssen, C, van't Veer, L, Vorobiof, D, Vrieling, C, West, N, Xu, B, Winer, E, Cardoso, F, Costa, A, Norton, L, Senkus, E, Aapro, M, Andre, F, Barrios, CH, Bergh, J, Biganzoli, L, Blackwell, KL, Cardoso, MJ, Cufer, T, El Saghir, N, Fallowfield, L, Fenech, D, Francis, P, Gelmon, K, Giordano, SH, Gligorov, J, Goldhirsch, A, Harbeck, N, Houssami, N, Hudis, C, Kaufman, B, Krop, I, Kyriakides, S, Lin, UN, Mayer, M, Merjaver, SD, Nordstrom, EB, Pagani, O, Partridge, A, Penault-Llorca, F, Piccart, MJ, Rugo, H, Sledge, G, Thomssen, C, van't Veer, L, Vorobiof, D, Vrieling, C, West, N, Xu, B, and Winer, E

Published
2014

30. Triterpene benzoates from the bark of Picramnia teapensis (Simaroubaceae)

Author

João B. Fernandes, Odair Correa Bueno, M. J. A. Hebling, Paulo C. Vieira, Sandra R. Victor, Edson Rodrigues Filho, Tatiana Rodrı́guez-Gamboa, Mariano Barrios Ch., Fernando Carlos Pagnocca, M. Fátima das G. F. da Silva, Oscar Castro-Castillo, Universidade Federal de São Carlos (UFSCar), Univ Nacl, and Universidade Estadual Paulista (Unesp)

Subjects
Stereochemistry, Picramnia, Leucoagaricus, lupanes, gongylophorus, lcsh:Chemistry, Triterpene, Picramnia teapensis, chemistry.chemical_classification, Leucoagaricus gongylophorus, biology, Traditional medicine, Chemistry, General Chemistry, Triterpene esters, biology.organism_classification, Atta sexdens, Benzoates, lcsh:QD1-999, visual_art, visual_art.visual_art_medium, Simaroubaceae, Bark
Abstract

Submitted by Guilherme Lemeszenski (guilherme@nead.unesp.br) on 2014-02-26T17:11:36Z No. of bitstreams: 1 WOS000168799700010.pdf: 88717 bytes, checksum: 8004b75a4fa11c8aff67badab46865e7 (MD5) Made available in DSpace on 2014-02-26T17:11:36Z (GMT). No. of bitstreams: 1 WOS000168799700010.pdf: 88717 bytes, checksum: 8004b75a4fa11c8aff67badab46865e7 (MD5) Previous issue date: 2001-05-01 Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-20T13:12:47Z No. of bitstreams: 1 WOS000168799700010.pdf: 88717 bytes, checksum: 8004b75a4fa11c8aff67badab46865e7 (MD5) Made available in DSpace on 2014-05-20T13:12:47Z (GMT). No. of bitstreams: 1 WOS000168799700010.pdf: 88717 bytes, checksum: 8004b75a4fa11c8aff67badab46865e7 (MD5) Previous issue date: 2001-05-01 Two new benzoic acid esters of triterpene alcohols [lup-20 (29)-en-28-oic acid 3 alpha, 7 beta -dibenzoate and 3 alpha -hydroxy-lup-20(29)-en-28-ic acid 7 beta -benzoate] were isolated from the stem bark of Picramnia teapensis Tul. The structures of these compounds were established on the basis of spectral analyses. Other known compounds, beta -sitosterol, estigmasterol, lupeol and epilupeol, were identified in mixture by GC-MS. The triterpene esters have not shown in-vitro inhibitory effect on the growth of Leucoagaricus gongylophorus (Fisher), referred also as Leucocoprinus gongylophorus (Heim), syn Rozites gongylophora (Moller), the symbiotic fungus cultivated by the leaf-cutting ant Atta sexdens L. Univ Fed Sao Carlos, Dept Quim, BR-13565905 Sao Carlos, SP, Brazil Univ Nacl, Dept Quim, Heredia, Costa Rica Univ Estadual Paulista Julio de Mesquita, Ctr Estudo Insetos Sociais, BR-13506900 Rio Claro, SP, Brazil Univ Estadual Paulista Julio de Mesquita, Ctr Estudo Insetos Sociais, BR-13506900 Rio Claro, SP, Brazil

Published
2001

31. Abstract P4-12-26: A phase II randomized study of lapatinib in combination with capecitabine, vinorelbine or gemcitabine as first or second line-therapy in patients with HER2 positive metastatic breast cancer progressing after taxane (LACOG 0801)

Author

Gomez, H, primary, Neciosup, S, additional, Tosello, C, additional, Mano, M, additional, Bines, J, additional, Ismael, G, additional, Santi, PX, additional, Pinczowsky, H, additional, Neron, Y, additional, Fanelli, M, additional, Fein, L, additional, Sampaio, C, additional, Lerzo, G, additional, Capo, A, additional, Zarba, JJ, additional, Blajman, C, additional, Varela, MS, additional, Martínez-Mesa, J, additional, Werutsky, G, additional, and Barrios, CH, additional

Published
2013
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32. Abstract OT2-6-02: Denosumab versus placebo as adjuvant treatment for women with early-stage breast cancer at high risk of disease recurrence (D-CARE): A global, placebo-controlled, randomized, double-blind, phase 3 clinical trial

Author

Goss, PE, primary, Barrios, CH, additional, Chan, A, additional, Finkelstein, DM, additional, Iwata, H, additional, Martin, M, additional, Braun, A, additional, Zhou, Y, additional, Maniar, T, additional, and Coleman, RE, additional

Published
2013
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34. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.

Author

Piccart-Gebhart, Martine, Procter, Marion, Leyland-Jones, Brian, Goldhirsch, Aron, Untch, M., Smith, Ian, Gianni, L., Baselga, J, Bell, Richard H, Jackisch, C., Cameron, David A, Dowsett, Mitch, Barrios, CH, Steger, G., Huang, C.-S., Andersson, M, Inbar, M., Lichinitser, Michail, Lang, Istvan, Nitz, U., Iwata, Hiroji, Thomssen, C., Lohrisch, C, Suter, T., Rüschoff, Josef, Sütö, T., Greatorex, V., Ward, David, Straehle, Carolyn, McFadden, E., Dolci, Stella, Gelber, R D, HERA study team, Piccart-Gebhart, Martine, Procter, Marion, Leyland-Jones, Brian, Goldhirsch, Aron, Untch, M., Smith, Ian, Gianni, L., Baselga, J, Bell, Richard H, Jackisch, C., Cameron, David A, Dowsett, Mitch, Barrios, CH, Steger, G., Huang, C.-S., Andersson, M, Inbar, M., Lichinitser, Michail, Lang, Istvan, Nitz, U., Iwata, Hiroji, Thomssen, C., Lohrisch, C, Suter, T., Rüschoff, Josef, Sütö, T., Greatorex, V., Ward, David, Straehle, Carolyn, McFadden, E., Dolci, Stella, Gelber, R D, and HERA study team

Abstract

BACKGROUND: Trastuzumab, a recombinant monoclonal antibody against HER2, has clinical activity in advanced breast cancer that overexpresses HER2. We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy. METHODS: This international, multicenter, randomized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy. RESULTS: Data were available for 1694 women randomly assigned to two years of treatment with trastuzumab, 1694 women assigned to one year of trastuzumab, and 1693 women assigned to observation. We report here the results only of treatment with trastuzumab for one year or observation. At the first planned interim analysis (median follow-up of one year), 347 events (recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant disease, or death) were observed: 127 events in the trastuzumab group and 220 in the observation group. The unadjusted hazard ratio for an event in the trastuzumab group, as compared with the observation group, was 0.54 (95 percent confidence interval, 0.43 to 0.67; P<0.0001 by the log-rank test, crossing the interim analysis boundary), representing an absolute benefit in terms of disease-free survival at two years of 8.4 percentage points. Overall survival in the two groups was not significantly different (29 deaths with trastuzumab vs. 37 with observation). Severe cardiotoxicity developed in 0.5 percent of the women who were treated with trastuzumab. CONCLUSIONS: One year of treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer. (ClinicalTrials.gov number, NCT00045032.), Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

Published
2005

35. Abstract OT2-3-03: Denosumab versus placebo as adjuvant treatment for women with early-stage breast cancer at high risk of disease recurrence (D-CARE): An international, randomized, double-blind, placebo-controlled phase 3 clinical trial

Author

Goss, PE, primary, Barrios, CH, additional, Chan, A, additional, Finkelstein, DM, additional, Iwata, H, additional, Martin, M, additional, Braun, A, additional, Ke, C, additional, Maniar, T, additional, and Coleman, RE, additional

Published
2012
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36. OT1-01-03: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Comparing Denosumab with Placebo as Adjuvant Treatment for Women with Early-Stage Breast Cancer Who Are at High Risk of Disease Recurrence (D-CARE).

Author

Goss, PE, primary, Barrios, CH, additional, Bell, R, additional, Finkelstein, D, additional, Iwata, H, additional, Martin, M, additional, Braun, A, additional, Ke, C, additional, Maniar, T, additional, Braun, S, additional, Dansey, R, additional, and Coleman, RE, additional

Published
2011
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39. P1-17-01: Figitumumab Plus Exemestane Versus Exemestane as First-Line Treatment of Postmenopausal Hormone Receptor-Positive Advanced Breast Cancer: A Randomized, Open-Label Phase II Trial.

Author

Ryan, PD, primary, Neven, P, additional, Blackwell, KL, additional, Dirix, LY, additional, Barrios, CH, additional, Miller, WH, additional, Fein, LE, additional, Fenton, D, additional, Benner, RJ, additional, Meech, SJ, additional, Paccagnella, L, additional, Sleight, B, additional, Yee, D, additional, and Goss, PE, additional

Published
2011
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42. Randomized phase II study of dacomitinib (PF-00299804), an irreversible pan-human epidermal growth factor receptor inhibitor, versus erlotinib in patients with advanced non-small-cell lung cancer.

Author

Ramalingam SS, Blackhall F, Krzakowski M, Barrios CH, Park K, Bover I, Seog Heo D, Rosell R, Talbot DC, Frank R, Letrent SP, Ruiz-Garcia A, Taylor I, Liang JQ, Campbell AK, O'Connell J, Boyer M, Ramalingam, Suresh S, Blackhall, Fiona, and Krzakowski, Maciej

Published
2012
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44. Breast cancer in Brazil: present status and future goals.

Author

Lee BL, Liedke PE, Barrios CH, Simon SD, Finkelstein DM, and Goss PE

Abstract

Breast cancer is the most common cancer in women worldwide and 70% of breast cancer deaths occur in women from low-income and middle-income countries. Latin America has about 115000 new cases of disease every year, with about 50000 arising in Brazil. We examined the present status of breast cancer in Brazil as an example of the health effects of geographical, ethnic, and socioeconomic diversities on delivery of care. Our goal was to identify deficiencies that could be responsible for disparities in survival from breast cancer. We searched the English and Portuguese published work and reviewed national databases and Brazilian publi-cations. Although the availability of publications specific to Brazil is low in general, we identified several factors that could account for disparities: delays in diagnosis due to low cancer awareness and implementation of mammography screening, unknown quality of surgery, and restricted access to radiotherapy and modern systemic therapies. [ABSTRACT FROM AUTHOR]

Published
2012

46. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer.

Author

Bardia A, Hu X, Dent R, Yonemori K, Barrios CH, O'Shaughnessy JA, Wildiers H, Pierga JY, Zhang Q, Saura C, Biganzoli L, Sohn J, Im SA, Lévy C, Jacot W, Begbie N, Ke J, Patel G, and Curigliano G

Subjects
Adult, Aged, Female, Humans, Middle Aged, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Camptothecin administration & dosage, Camptothecin adverse effects, Camptothecin analogs & derivatives, Kaplan-Meier Estimate, Progression-Free Survival, Receptors, Estrogen analysis, Receptors, Estrogen metabolism, Aged, 80 and over, Treatment Outcome, Antineoplastic Agents, Hormonal administration & dosage, Antineoplastic Agents, Hormonal adverse effects, Antineoplastic Agents, Immunological administration & dosage, Antineoplastic Agents, Immunological adverse effects, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Breast Neoplasms mortality, Immunoconjugates administration & dosage, Immunoconjugates adverse effects, Receptor, ErbB-2 analysis, Receptor, ErbB-2 metabolism, Trastuzumab administration & dosage, Trastuzumab adverse effects
Abstract

Background: Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy in patients with metastatic breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) after previous chemotherapy., Methods: We conducted a phase 3, multicenter, open-label trial involving patients with hormone receptor-positive metastatic breast cancer with low HER2 expression (a score of 1+ or 2+ on immunohistochemical [IHC] analysis and negative results on in situ hybridization) or ultralow HER2 expression (IHC 0 with membrane staining) who had received one or more lines of endocrine-based therapy and no previous chemotherapy for metastatic breast cancer. Patients were randomly assigned in a 1:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival (according to blinded independent central review) among the patients with HER2-low disease. Secondary end points included progression-free survival among all the patients who had undergone randomization, overall survival, and safety., Results: Of the 866 patients who underwent randomization, 713 had HER2-low disease, and 153 had HER2-ultralow disease. Among the patients with HER2-low disease, the median progression-free survival was 13.2 months (95% confidence interval [CI], 11.4 to 15.2) in the trastuzumab deruxtecan group and 8.1 months (95% CI, 7.0 to 9.0) in the chemotherapy group (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75; P<0.001); the results were consistent in the exploratory HER2-ultralow population. Data for overall survival were immature. Adverse events of grade 3 or higher occurred in 52.8% of the patients in the trastuzumab deruxtecan group and in 44.4% of those in the chemotherapy group. Adjudicated interstitial lung disease or pneumonitis occurred in 49 patients (11.3%; three events were grade 5 in severity) and in 1 patient (0.2%; grade 2), respectively., Conclusions: Among patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who had received one or more lines of endocrine-based therapy, treatment with trastuzumab deruxtecan resulted in longer progression-free survival than chemotherapy. No new safety signals were identified. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast06 ClinicalTrials.gov number, NCT04494425.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2024
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48. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7).

Author

Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro MS, Bajpai J, Barrios CH, Bergh J, Bergsten-Nordström E, Biganzoli L, Cardoso MJ, Carey LA, Chavez-MacGregor M, Chidebe R, Cortés J, Curigliano G, Dent RA, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Franco Millan SX, Gilchrist J, Gligorov J, Gradishar WJ, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim SB, Koppikar S, Kuper-Hommel MJJ, Lecouvet FE, Mason G, Mertz SA, Mueller V, Myerson C, Neciosup S, Offersen BV, Ohno S, Pagani O, Partridge AH, Penault-Llorca F, Prat A, Rugo HS, Senkus E, Sledge GW, Swain SM, Thomssen C, Vorobiof DA, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, and Winer EP

Subjects
Humans, Female, Consensus, Practice Guidelines as Topic, Breast Neoplasms therapy, Breast Neoplasms pathology, Palliative Care standards
Abstract

This manuscript describes the Advanced Breast Cancer (ABC) international consensus guidelines updated at the last two ABC international consensus conferences (ABC 6 in 2021, virtual, and ABC 7 in 2023, in Lisbon, Portugal), organized by the ABC Global Alliance. It provides the main recommendations on how to best manage patients with advanced breast cancer (inoperable locally advanced or metastatic), of all breast cancer subtypes, as well as palliative and supportive care. These guidelines are based on available evidence or on expert opinion when a higher level of evidence is lacking. Each guideline is accompanied by the level of evidence (LoE), grade of recommendation (GoR) and percentage of consensus reached at the consensus conferences. Updated diagnostic and treatment algorithms are also provided. The guidelines represent the best management options for patients living with ABC globally, assuming accessibility to all available therapies. Their adaptation (i.e. resource-stratified guidelines) is often needed in settings where access to care is limited., Competing Interests: Declaration of competing interest Matti S. Aapro: Consultant for Accord Pharmaceuticals, Amgen, BMS, Celgene, Clinigen Group, Daiichi Sankyo, Eisai Co.Ltd, Eli Lilly, Genomic Health (Exact Sciences), G1 Therapeutics, Inc., GlaxoSmithKline (GSK), Helsinn Healthcare SA, Hospira (Pfizer), Johnson & Johnson, Merck, Merck Serono (Merck KGaA), Mundipharma International Limited, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Tesaro (GSK), Teva Pharmaceuticals Industries Ltd., Vifor Pharma. Received honoraria for lectures at symposia of Accord Pharmaceuticals, Amgen, Astellas, Bayer HealthCare Pharmaceuticals (Schering), Biocon, Boeringer Ingelheim, Cephalon, Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo, Eisai Co., Ltd., Dr Reddy's Laboratories, Genomic Health (Exact Sciences), Glenmark Pharmaceuticals Limited, GSK, Helsinn Healthcare SA, Hospira (Pfizer), Ipsen, Janssen Biotech, Kyowa Kirin Group, Merck, Merck Serono (Merck KGaA), Mundipharma International Limited, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Sanofi, Tesaro (GSK), Taiho Pharmaceutical, Teva Pharmaceutical Industries Ltd., Vifor Pharma. Grant/Research supports: Amgen, Eisai, Genomic Health (Exact Sciences), Helsinn, Hospira, Novartis, Merck, Mundipharma, Pfizer, Roche, Sandoz, Tesaro, Teva, Vifor. Jyoti Bajpai: Institutional financial interests for conducting research: Eli Lilly, MSD, Novartis, Roche, Paxman Coolers Ltd, Samsung Bioepis co. Ltd, Sun Pharma. Carlos H. Barrios: Receipt of grants/research supports: (to the institution) Nektar, Pfizer, Polyphor, Amgen, Daiichi Sankyo, Sanofi, Exelixis, Regeneron, Novartis, GSK, Janssen, OBI Pharma, Lilly, Seagen, Roche, BMS, MSD, Merck Serono, AstraZeneca, Novocure, Aveo Oncology, Takeda, TRIO, PharmaMar, Celgene, PPD, Syneos Health, Labcorp, ICON, IQVIA, Parexel, Nuvisan, PSI, Worldwide, Gilead Sciences, Bayer, Servier. Receipt of honoraria or consultation fees: Advisory Boards and Consulting: Boehringer-Ingelheim, GSK, Novartis, Pfizer, Roche/Genentech, Eisai, Bayer, MSD, AstraZeneca, Zodiac, Lilly, Sanofi, Daiichi. Stock shareholder: Ownership or stocks: Tummi, MEDSir. Jonas Bergh: Receipt of grants/research supports: Research grants from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche & Sanofi-Aventis to Karolinska Institutet and/or University Hospital. No personal payments. Other support: Payment for a chapter in UpToDate on breast cancer prediction to Asklepios Medicin HB. Laura Biganzoli: Personal financial interests (Honoraria, consultancy or advisory role): Amgen, AstraZeneca, Boehringer-Ingelheim, Daiichi-Sankyo, Eisai, Exact Sciences, Gilead, Lilly, Menarini, Novartis, Pfizer, Pierre Fabre, Roche, Sanofi, SeaGen. Institutional financial interests: Celgene, Genomic Health, Novartis. Travel grants: AstraZeneca, Daiichi-Sankyo. Fatima Cardoso: Receipt of honoraria or consultation fees: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi-Sankyo, Eisai, GE Oncology, Genentech, Gilead, GlaxoSmithKline, Iqvia, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, prIME Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva, Touchime. Maria-Joao Cardoso: Receipt of honoraria or consultation fees: AstraZeneca, Merck-Sharp, Novartis and Roche. Lisa A. Carey: Other support: Research funding (institution): NanoString Technologies, Seagen, Veracyte, AstraZeneca. Uncompensated relationships: Lilly, Seagen, Novartis, Genentech/Roche, GlaxoSmithKline. Mariana Chavez-MacGregor: Receipt of grants/research supports: BCRF, Susan G Komen. Receipt of honoraria or consultation fees: Astra Zeneca, Pfizer, Lilly, Roche, Merck. Javier Cortés: Receipt of grants/research supports: Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp&Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies. Receipt of honoraria or consultation fees: Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo, Astrazeneca. Stock shareholder: MedSIR, Nektar Pharmaceuticals, Leuko (relative). Other support: Research funding to the Institution: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London. Travel, accommodation, expenses: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo, Astrazeneca, Gilead. Patents: Pharmaceutical Combinations of a Pi3k Inhibitor and A Microtubule Destabilizing Agent. Javier Cortés Castán, Alejandro Piris Giménez, Violeta Serra Elizalde. WO 2014/199294 A. ISSUED. Her2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy. Aleix Prat, Antonio Llombart, Javier Cortés.US 2019/0338368 A1. LICENSED. Giuseppe Curigliano: Receipt of grants/research supports: Merck. Receipt of honoraria or consultation fees: Merck, Lilly, Pfizer, Daichi Sankyo, Seagen, Novartis, Roche, Astra Zeneca, Ellipsis. Participation in a sponsored speakers' bureau: Seagen, Novartis, Lilly, Pfizer, Daichii Sankyo. Rebecca A. Dent: Receipt of grants/research supports: AstraZeneca, Roche. Receipt of honoraria or consultation fees: AstraZeneca, DKSH, Eisai, Merck, Novartis, Pfizer, Roche. Nagi S. El Saghir: Receipt of honoraria or consultation fees: Roche, Novartis, Lilly. Alexandru Eniu: Receipt of honoraria or consultation fees: Astra Zeneca, Daiichi Sankyo, Gilead, Janssen, MSD, Novartis, SeaGen. Receipt of grants/research supports: AstraZeneca. Full or part-time employment: European School of Oncology (ESO). Lesley Fallowfield: Receipt of grants/research supports: Novartis, Bristol-Myers Squibb, Lilly. Receipt of honoraria or consultation fees: Voluntis, Genomic Health, NanoString Technologies, Novartis, Pfizer, MSD, Novartis, Abbvie, Clovis Oncology, Puma Biotechnology, AstraZeneca, Takeda, Genomic Health/Exact Sciences, Lilly, Seagen, Roche. Sandra X. Franco Millan: Receipt of honoraria or consultation fees: Novartis, Pfizer, Eli Lilly. Participation in a sponsored speakers' bureau: Novartis, Pfizer, Eli Lilly. Karen Gelmon: Receipt of grants/research supports: Pfizer, AstraZeneca. Receipt of honoraria or consultation fees: Pfizer, Lilly, Novartis, AstraZeneca, Merck, Gilead, Seagen. Jenny Gilchrist: Receipt of honoraria or consultation fees: Eli-Lilly, AstraZeneca, Novartis, Pfizer, MSD, Gilead, Juniper Biologics. Joseph Gligorov: Receipt of grants/research supports: Eisai, Exact Science, Guardant, Roche Genentech. Receipt of honoraria or consultation fees: Astra Zeneca, Daiichi, Eisai, Evapharma, Exact Science, Gilead, Guardant Lilly, Merck, Novartis, Onxeo, Pfizer, Roche Genentech, Seattle Genetics. Participation in a sponsored speakers' bureau: Eisai, Eva Pharm, Novartis, Roche Genentech, Seattle Genetics. Other support (please specify): Institutional: Institut Universitaire de Cancérologie AP-HP Sorbonne Université; French breast cancer guidelines St Paul. Nadia Harbeck: Receipt of grants/research supports: all to institution. Receipt of honoraria or consultation fees: AstraZeneca, Daiichi-Sankyo, Gilead, Lilly, MSD, Novartis, PierreFabre, Pfizer, Roche, Sandoz, Seagen, Viatris, Zuelligpharma. Participation on a sponsored speakers' bureau: EPG Communication, MEDSCAPE, Springer. Stock shareholder: WSG minority ownership. Spouse/Partner: Consulting for WSG. Ranjit Kaur: Receipt of grants/research supports: Novartis, Roche, Pfizer, Astrazeneca. Receipt of honoraria or consultation fees: Novartis, Roche, Pfizer, Astrazeneca. Participation in a sponsored speakers' bureau: Novartis, Roche, Pfizer, Astrazeneca. Belinda Kiely: Receipt of honoraria or consultation fees: Speakers fees: Novartis, Eisai. Advisory boards: Roche, Gilead, Novartis. Other support (please specify): meeting registrations fees: Novartis, Pfizer, MSD. Sung-Bae Kim: Receipt of grants/research supports: Novartis, Sanofi-Aventis, and DongKook Pharm Co. Receipt of honoraria or consultation fees: Novartis, AstraZeneca, Lilly, Dae Hwa Pharmaceutical Co. Ltd, ISU Abxis, OBI pharma, Beigene and Daiichi-Sankyo. Stock shareholder: Genopeaks. Smruti Koppikar: Receipt of honoraria or consultation fees: Eli Lilly, Novartis, Cipla, Roche. Participation in a sponsored speakers' bureau: Eli Lilly, Novartis, Cipla, Roche. Marion Kuper-Hommel: Receipt of honoraria or consulting fees: Astra Zeneca. Ginny Mason: Participation in a sponsored speakers' bureau: Novartis. Volkmar Mueller: Receipt of grants/research supports: Institutional research support from Novartis, Roche, Seagen, Genentech, Astra Zeneca. Receipt of honoraria or consultation fees: Speaker honoraria: Astra Zeneca, Daiichi-Sankyo, Eisai, GSK, Pfizer, MSD, Medac, Novartis, Roche, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead, Pierre Fabre. Consultancy honoraria from Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, DaiichiSankyo, Eisai, Lilly, Sanofi, Seagen, Gilead, Stemline, ClinSol. Other support (please specify): Travel grants: Roche, Pfizer, Daiichi Sankyo, Gilead. Claire Myerson: Receipt of honoraria or consultation fees: Novartis Pharma. Silvia Neciosup: Receipt of grants/research supports: Roche, Pfizer. Participation in a sponsored speakers' bureau: Tecnofarma, AZ, Roche, Pfizer. Larry Norton: Receipt of honoraria or consultation fees: Blackrock QLS Advisors, Cold Spring Harbor Laboratory, UNC Breast Spore EAB Meeting, Codagenix Scientific Advisory Board Meeting, Martell Diagnostic Laboratories, Inc., Celgene, Agenus, Immix Biopharma, Inc. Shinji Ohno: Participation in a sponsored speakers' bureau: Chugai, Lilly, MSD, Nippon Kayaku. Shani Paluch-Shimon: Receipt of grants/research supports: Pfizer. Receipt of honoraria or consultation fees: Pfizer, Lily, Novartis, Astra Zeneca, Roche, MSD, Gilead, Rhenium/Exact Sciences, Stemline, Daichi Sankyo. Participation in a sponsored speakers' bureau: Pfizer, Lily, Novartis, Astra Zeneca, Roche, MSD, Gilead. Ann H. Partridge: Uptodate Royalties. Aleix Prat: Receipt of grants/research supports: Boehringer, Novartis, Roche, Nanostring, Sysmex Europa GmbH, Medica Scientia inno. Research, SL, Celgene, Astellas and Pzifer. Receipt of honoraria or consultation fees: Roche, Pfizer, Novartis, Amgen, BMS, Puma, Oncolytics Biotech, MSD, Guardan Health, Peptomyc and Lilly, Nanostring Technologies and Daiichi Sankyo. Other support: Clinical trials: Boehringer, Lilly, Roche, Novartis, Amgen and Daiichi Sankyo. Hope S. Rugo: Receipt of grants/research supports: Astellas Pharma Inc.; AstraZeneca; Daiichi Sankyo, Inc.; F. Hoffmann-La Roche AG/Genentech, Inc.; Gilead Sciences, Inc.; GlaxoSmithKline; Lilly; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Pfizer; Pionyr Immunotherapeutics; Sermonix Pharmaceuticals Inc.; Taiho Oncology, Inc. and Veru Inc. Receipt of honoraria or consultation fees: Puma, NAPO, Blueprint, and Scorpion Therapeutics Daichi Sankyo. Elzbieta Senkus: Receipt of honoraria or consultation fees: AstraZeneca, Curio Science, Egis, Eli Lilly, Gilead, high5md, MSD, Novartis, Pfizer, Roche, Swixx. Other support: travel support: AstraZeneca, Egis, Gilead, Novartis, Roche. Contracted research: Amgen, AstraZeneca, Eli Lilly, Gilead, Novartis, OBI Pharma, Roche, Samsung, Seagen. Medical writing: AstraZeneca, Eli Lilly. Royalties: Springer. Sandra M. Swain: Receipt of grants/research supports: Kailos Genetics, Genentech/Roche. Receipt of honoraria or consultation fees: Athenex, AstraZeneca, Biotheranostics, Natera, Exact Sciences, Lilly, Merck, Genentech/Roche, Sanofi, Daiichi Sankyo, Molecular Templates, Napo Pharmaceuticals. Stock shareholder: SEAGEN. Other support: CO- PI of INAVO 122 Genentech/Roche with in-kind travel to investigator meetings, Travel related expenses in kind Sanofi and Daiichi Sankyo. Peter Vuylsteke: Receipt of grants/research supports: UICC grant. Receipt of honoraria or consultation fees: Roche, Novartis and MSD. Theresa Wiseman: Receipt of grants/research supports: Receiver of SPCC Pfizer grant. Binghe Xu: Receipt of grants/research supports: sponsored research to my institution from Roche, AstraZeneca and Pfizer. Receipt of honoraria or consultation fees: advisory or consultancy fees from Novartis and Roche. Participation in a sponsored speakers' bureau: speakers’ bureau fees from AstraZeneca, Pfizer, Roche, Eisai. Elizabeth Bergsten-Nordström, Alberto Costa, Runcie C. W. Chidebe, Prudence A. Francis, Xichun Hu, Renate Haidinger, Leonor Matos, Shirley A. Mertz, Birgitte V. Offersen, Olivia Pagani, Eva Schumacher-Wulf, Daniel A. Vorobiof, Frédéric E. Lecouvet, and Eric P. Winer reported no significant relationships. William J. Gradishar, George W. Sledge and Christoph Thomssen have not submitted a disclosure of interests’ form., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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49. The impact of a breast cancer diagnosis on marital outcomes and factors associated with divorce and separation.

Author

Werutsky G, Lopes M, de Jesus RG, Gazola AA, Pellegrini RA, Rebelatto TF, Freitas LVW, Heck AP, da Silva AF, Rodrigues MF, Gössling G, Giacomazzi J, Rocha MS, Rosa DD, Barrios CH, Cronemberger EH, Queiroz GS, Bines J, Simon SD, and Fay AP

Subjects
Humans, Female, Retrospective Studies, Middle Aged, Adult, Brazil epidemiology, Marital Status, Socioeconomic Factors, Aged, Risk Factors, Cancer Survivors statistics & numerical data, Divorce statistics & numerical data, Breast Neoplasms diagnosis, Breast Neoplasms surgery
Abstract

Objective: To analyze marital outcomes, divorce or separation, and its association with demographic, socioeconomic, and clinicopathological factors among breast cancer (BC) survivors after 2-years of diagnosis., Methods: We performed a retrospective analysis of marital status at baseline and at years 1 and 2 of follow-up of women aged ≥ 18 years diagnosed with invasive BC participating in the AMAZONA III (GBECAM0115) study. The BC diagnosis occurred between January 2016 and March 2018 at 23 institutions in Brazil., Results: Of the 2974 women enrolled in AMAZONA III, 599 were married or living under common law at baseline. Divorce or separation occurred in 35 (5.8%) patients at 2 years of follow-up. In the multivariate analysis, public health insurance coverage was associated with a higher risk of marital status change (8.25% vs. 2.79%, RR 3.09, 95% CI 1.39 - 7.03, p = 0.007). Women who underwent mastectomy, adenomastectomy or skin-sparing mastectomy were associated with a higher risk of divorce or separation (8.1% vs. 4.49%, RR 1.97, 95 CI 1.04 - 3.72, p = 0.0366) than those who underwent breast-conserving surgery., Conclusion: Women covered by the public health system and those who underwent mastectomy, adenomastectomy or skin-sparing mastectomy were associated with a higher risk of divorce or separation. This evidence further supports the idea that long-term marital stability is associated with a complex interplay between socioeconomic conditions and stressors, such as BC diagnosis and treatment. ClinicalTrials Registration: NCT02663973., Competing Interests: Conflicts to interest: none to declare

Published
2024
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50. The somatic mutation profile of estrogen receptor-positive HER2-negative metastatic breast cancer in Brazilian patients.

Author

Reinert T, do Rego FO, Silva MCE, Rodrigues AM, Koyama FC, Gonçalves AC, Pauletto MM, de Carvalho Oliveira LJ, de Resende CAA, Landeiro LCG, Barrios CH, Mano MS, and Dienstmann R

Abstract

Background: Breast cancer is the leading cause of cancer death among women worldwide. Studies about the genomic landscape of metastatic breast cancer (MBC) have predominantly originated from developed nations. There are still limited data on the molecular epidemiology of MBC in low- and middle-income countries. This study aims to evaluate the prevalence of mutations in the PI3K-AKT pathway and other actionable drivers in estrogen receptor (ER)+/HER2- MBC among Brazilian patients treated at a large institution representative of the nation's demographic diversity., Methods: We conducted a retrospective observational study using laboratory data (OC Precision Medicine). Our study included tumor samples from patients with ER+/HER2- MBC who underwent routine tumor testing from 2020 to 2023 and originated from several Brazilian centers within the Oncoclinicas network. Two distinct next-generation sequencing (NGS) assays were used: GS Focus (23 genes, covering PIK3CA , AKT1 , ESR1 , ERBB2 , BRCA1 , BRCA2 , PALB2 , TP53 , but not PTEN ) or GS 180 (180 genes, including PTEN, tumor mutation burden [TMB] and microsatellite instability [MSI])., Results: Evaluation of tumor samples from 328 patients was undertaken, mostly (75.6%) with GS Focus. Of these, 69% were primary tumors, while 31% were metastatic lesions. The prevalence of mutations in the PI3K-AKT pathway was 39.3% (95% confidence interval, 33% to 43%), distributed as 37.5% in PIK3CA and 1.8% in AKT1 . Stratification by age revealed a higher incidence of mutations in this pathway among patients over 50 (44.5% vs 29.1%, p=0.01). Among the PIK3CA mutations, 78% were canonical (included in the alpelisib companion diagnostic non-NGS test), while the remaining 22% were characterized as non-canonical mutations (identifiable only by NGS test). ESR1 mutations were detected in 6.1%, exhibiting a higher frequency in metastatic samples (15.1% vs 1.3%, p=0.003). Additionally, mutations in BRCA1, BRCA2 , or PALB2 were identified in 3.9% of cases, while mutations in ERBB2 were found in 2.1%. No PTEN mutations were detected, nor were TMB high or MSI cases., Conclusion: We describe the genomic landscape of Brazilian patients with ER+/HER2- MBC, in which the somatic mutation profile is comparable to what is described in the literature globally. These data are important for developing precision medicine strategies in this scenario, as well as for health systems management and research initiatives., Competing Interests: Authors TR, AG, MP, LO, CR, LL, CB, MM, & RD were employed by the company Oncoclínicas & Co. TR – Research funding: AstraZeneca, Libbs. Speaker honoraria/advisory board: AstraZeneca, Daichi-Sankyo, Novartis, MSD, Lilly, Libbs. RD declares advisory role for Roche, Foundation Medicine, received a speaker’s fee from Roche, Ipsen, Amgen, Servier, Sanofi, Libbs, Merck Sharp & Dohme, Lilly, AstraZeneca, Janssen, Takeda, Bristol Myers Squibb, GlaxoSmithKline, Gilead, research grants from Merck, Novartis, Daiichi-Sankyo, GlaxoSmithKline and AstraZeneca, and is investor in Trialing Health, S.L. CB - Stock and Other Ownership Interests: Biomarker, MedSIR, Tummi. Speaker Honoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, Eisai. Consulting or Advisory Role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai,Pfizer, AstraZeneca, Libbs, MSD Oncology, United Medical. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Reinert, do Rego, Silva, Rodrigues, Koyama, Gonçalves, Pauletto, de Carvalho Oliveira, de Resende, Landeiro, Barrios, Mano and Dienstmann.)

Published
2024
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