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1. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy—a sub-analysis of the ALTTO study

Author

Nader-Marta, Guilherme, Debien, Véronique, Eiger, Daniel, Tsourti, Zoi, Caparica, Rafael, Kassapian, Marie, Napoleone, Sylvia, Hultsch, Susanne, Korde, Larissa, Wang, Yingbo, Chumsri, Saranya, Pritchard, Kathleen I., Untch, Michael, Bellet-Ezquerra, Meritxell, Dornelles Rosa, Daniela, Moreno-Aspitia, Alvaro, Piccart, Martine, Dafni, Urania, and de Azambuja, Evandro

Published
2022
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2. Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials

Author

Braybrooke, Jeremy, Bradley, Rosie, Gray, Richard, Hills, Robert K, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Aihara, Tomohiko, Anderson, Stewart, Blum, Joanne, Cardoso, Fatima, Chen, Xiaosong, Crown, John P, Ejlertsen, Bent, Friedl, Thomas W P, Harbeck, Nadia, Janni, Wolfgang, Jensen, Maj-Britt, Mamounas, Eleftherios, Narui, Kazutaka, Nitz, Ulrike, Norton, Larry, O'Shaughnessy, Joyce, Piccart, Martine, Robert, Nicholas, Shao, Zhi-Ming, Slamon, Dennis, Sparano, Joseph, Watanabe, Toru, Yothers, Greg, Yu, Ke-Da, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Lui, Hui, Lui, Zulian, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Buzdar, Aman, Suman, Vera J, Hunt, Kelly K, Leonard, Robert C F, Mansi, Janine, Delbaldo, Catherine, Piedbois, Pascal, Quinaux, Emmanuel, Fesl, Christian, Gnant, Michael, Sölkner, Lidija, Steger, Guenther, Eikesdal, Hans Petter, Lønning, Per Eystein, Bee, Valerie, Fung, Helena, Mackey, John, Martin, Miguel, Press, Michael, De Azambuja, Evandro, Gelber, Richard, Regan, Meredith, Di Leo, Angelo, Van Dooren, Veerle, Nogaret, Jean Marie, Bartlett, John, Chen, Bingshu E, Gelmon, Karen, Goss, Paul E, Levine, Mark N, Parulekar, Wendy, Pritchard, Kathleen I, Shepherd, Lois, Berry, Donald, Cirrincione, Constance, Shulman, Lawrence N, Winer, Eric, Gelman, Rebecca S, Harris, Jay R, Henderson, Craig, Shapiro, Charles L, Christiansen, Peer, Ewertz, Marianne, Mouridsen, Henning T, Van Leeuwen, Elise, Linn, Sabine, Van Rossum, Annelot G J, Van Tinteren, Harm, Van Werkhoven, Erik, Goldstein, Lori, Gray, Robert, Eiermann, Wolfgang, Gianni, Luca, Valagussa, Pinuccia, Bogaerts, Jan, Bonnefoi, Herve, Poncet, Coralie, Huovinen, Riikka, Joensuu, Heikki, Bonneterre, Jacques, Fargeot, Pierre, Fumoleau, Pierre, Kerbrat, Pierre, Luporsi, Elisabeth, Namer, Moïse, Carrasco, Eva M, Segui, Miguel Angel, Meisner, Christoph, Loibl, Sibylle, Nekljudova, Valentina, Thomssen, Christoph, Von Minckwitz, Gunter, Kümmel, Sherko, Lopez, Massimo, Vici, Patrizia, Fountzilas, George, Koliou, Georgia, Mavroudis, Dimitrios, Saloustros, Emmanouil, Brain, Etienne, Delaloge, Suzette, Michiels, Stefan, Mathoulin-Pelissier, Simone, Bines, Jose, Sarmento, Roberta M B, Bonadonna, Gianni, Brambilla, Cristina, Rossi, Anna, Bliss, Judith, Coombes, Raoul Charles, Kilburn, Lucy, Marty, Michel, Amadori, Dino, Boccardo, Francesco, Nanni, Oriana, Rubagotti, Alessandra, Scarpi, Emanuela, Masuda, Norikazu, Toi, Masakazu, Ueno, Takayuki, Ishikawa, Takashi, Matsumoto, Koji, Takao, Shintaro, Sommer, Harald, Foroglou, Pericles, Giokas, George, Kondylis, D, Lissaios, Byron, Reinisch, Mattea, Lee, Keun Seok, Nam, Byung-Ho, Ro, Jung Sil, De Matteis, Andrea, Perrone, Francesco, Tang, Gong, Wolmark, Norman, Hozumi, Yasuo, Nomura, Yasuo, Earl, Helena, Hiller, Louise, Vallier, Anne-Laure, De Mastro, Lucia, Venturini, Macro, Delozier, Thierry, Lemonnier, Jerome, Martin, Anne-Laure, Roché, Henri, Spielmann, Marc, Chen, Xiasong, Shen, Kunwei, Albain, Kathy, Barlow, William, Budd, George T, Gralow, Julie, Hayes, Dan, Bartlett-Lee, Peter, Ellis, Paul, Bianco, Angelo Raffaele, De Laurentiis, Michelino, De Placido, Sabino, Wildiers, Hans, Hsu, Limin, Eremin, Oleg, Walker, Leslie G, Ahlgren, Johan, Blomqvist, Carl, Holmberg, Lars, Lindman, Henrik, Asmar, Lina, Jones, Stephen E, Gluz, Oleg, Liedtke, Cornelia, Arriagada, Rodrigo, Bergsten-Nordström, Elizabeth, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Dignam, James, Dowsett, Mitch, Francis, Prudence A, Goetz, Matthew P, Goodwin, Pam, Halpin-Murphy, Pat, Hill, Catherine, Jagsi, Reshma, Mukai, Hirofumi, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Salgado, Roberto, Spanic, Tanja, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2023
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3. Results of the phase I CCTG IND.231 trial of CX-5461 in patients with advanced solid tumors enriched for DNA-repair deficiencies

Author

Hilton, John, Gelmon, Karen, Bedard, Philippe L., Tu, Dongsheng, Xu, Hong, Tinker, Anna V., Goodwin, Rachel, Laurie, Scott A., Jonker, Derek, Hansen, Aaron R., Veitch, Zachary W., Renouf, Daniel J., Hagerman, Linda, Lui, Hongbo, Chen, Bingshu, Kellar, Deb, Li, Irene, Lee, Sung-Eun, Kono, Takako, Cheng, Brian Y. C., Yap, Damian, Lai, Daniel, Beatty, Sean, Soong, John, Pritchard, Kathleen I., Soria-Bretones, Isabel, Chen, Eric, Feilotter, Harriet, Rushton, Moira, Seymour, Lesley, Aparicio, Samuel, and Cescon, David W.

Published
2022
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4. Aromatase inhibitors versus tamoxifen in premenopausal women with oestrogen receptor-positive early-stage breast cancer treated with ovarian suppression: a patient-level meta-analysis of 7030 women from four randomised trials

Author

Bradley, Rosie, Braybrooke, Jeremy, Gray, Richard, Hills, Robert K, Liu, Zulian, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Francis, Prudence A, Gnant, Michael, Perrone, Francesco, Regan, Meredith M, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Jakesz, Raimund, Fesl, Christian, Pagani, Olivia, Gelber, Richard, De Laurentiis, Michelino, De Placido, Sabino, Gallo, Ciro, Albain, Kathy, Anderson, Stewart, Arriagada, Rodrigo, Bartlett, John, Bergsten-Nordström, Elizabeth, Bliss, Judith, Brain, Etienne, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Del Mastro, Lucia, Di Leo, Angelo, Dignam, James, Dowsett, Mitch, Ejlertsen, Bent, Goetz, Matthew, Goodwin, Pam, Halpin-Murphy, Pat, Hayes, Dan, Hill, Catherine, Jagsi, Reshma, Janni, Wolfgang, Loibl, Sibylle, Mamounas, Eleftherios P, Martín, Miguel, Mukai, Hirofumi, Nekljudova, Valentina, Norton, Larry, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Pritchard, Kathleen I, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Spanic, Tanja, Sparano, Joseph, Steger, Guenther, Tang, Gong, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Wolmark, Norman, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2022
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5. Implementing routine collection of EQ-5D-5L in a breast cancer outpatient clinic.

Author

Torres, Sofia, Bayoumi, Ahmed M., Abrahao, Ana B. K., Trudeau, Maureen, Pritchard, Kathleen I., Li, Chun Nim, Mitsakakis, Nicholas, Liu, Geoffrey, and Krahn, Murray

Subjects
CANCER patients, MEDICAL technology, BREAST cancer, DECISION making, HIGHER education
Abstract

Purpose: A cross-sectional study was conducted to investigate the feasibility of implementing routine collection of the Euro-Qol 5 dimensions (EQ-5D) questionnaire, to inform drug and health technology reimbursement decision making. Methods: Women with breast cancer were recruited during scheduled clinic visits to an academic cancer centre. EQ-5D-5L was self-administered using electronic tablets. Diagnostic and treatment data were abstracted from patient charts. Feasibility was assessed primarily by the proportion of patients who fully completed EQ-5D-5L and by their willingness to complete the instrument at each clinic visit. Results: 588 women were approached for study participation, 341 were enrolled. Fully completed EQ-5D-5L questionnaires were obtained in 323 participants (95% of participants, 95% CI 92–97%). Median time for EQ-5D-5L completion was 1.5 minutes (range:0.35 to 14.7). Mean age of participants was 58 years old. Most women who completed EQ-5D were White, born outside Canada and presented a high education level; one-quarter had metastatic disease. Most participants reported "No problems" in all EQ-5D-5L dimensions. Mean EQ-5D-5L index and mean EQ-5D-5L VAS values for all participants were respectively 0.83 (SD 0.13) and 75.7 (SD 17.45), with patients with metastatic disease scoring the lowest values. Seventy-eight percent of participants were willing to complete EQ-5D-5L at each clinic visit; lower Charlson comorbidity index and higher education level were predictors of willingness to continue to answer EQ-5D-5L. Conclusions: Tablet-based collection of EQ-5D-5L in the context of routine clinical practice proved to be feasible. However, many patients declined study participation or reported being in full health, raising concerns about whether this method of collecting EQ-5D adequately represents the health status of all breast cancer patients. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials

Author

Bradley, Rosie, Braybrooke, Jeremy, Gray, Richard, Hills, Robert, Liu, Zulian, Peto, Richard, Davies, Lucy, Dodwell, David, McGale, Paul, Pan, Hongchao, Taylor, Carolyn, Anderson, Stewart, Gelber, Richard, Gianni, Luca, Jacot, William, Joensuu, Heikki, Moreno-Aspitia, Alvaro, Piccart, Martine, Press, Michael, Romond, Edward, Slamon, Dennis, Suman, Vera, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Wang, Yaochen, Crown, John, de Azambuja, Evandro, Delaloge, Suzette, Fung, Helena, Geyer, Charles, Spielmann, Marc, Valagussa, Pinuccia, Albain, Kathy, Arriagada, Rodrigo, Bartlett, John, Bergsten-Nordström, Elizabeth, Bliss, Judith, Brain, Etienne, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Del Mastro, Lucia, Di Leo, Angelo, Dignam, James, Dowsett, Mitch, Ejlertsen, Bent, Francis, Prue, Gnant, Michael, Goetz, Matthew, Goodwin, Pam, Halpin-Murphy, Pat, Hayes, Dan, Hill, Catherine, Jagsi, Reshma, Janni, Wolfgang, Loibl, Sibylle, Mamounas, Eleftherios P, Martín, Miguel, Mukai, Hirofumi, Nekljudova, Valentina, Norton, Larry, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Regan, Meredith, Robertson, John, Rutgers, Emiel, Spanic, Tanja, Sparano, Joseph, Steger, Guenther, Tang, Gong, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Wolmark, Norman, Cameron, David, Bergh, Jonas, Pritchard, Kathleen I, and Swain, Sandra M

Published
2021
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8. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Results From BOLERO-2

Author

Hortobagyi, Gabriel N, Chen, David, Piccart, Martine, Rugo, Hope S, Burris, Howard A, Pritchard, Kathleen I, Campone, Mario, Noguchi, Shinzaburo, Perez, Alejandra T, Deleu, Ines, Shtivelband, Mikhail, Masuda, Norikazu, Dakhil, Shaker, Anderson, Ian, Robinson, Douglas M, He, Wei, Garg, Abhishek, McDonald, E Robert, Bitter, Hans, Huang, Alan, Taran, Tetiana, Bachelot, Thomas, Lebrun, Fabienne, Lebwohl, David, and Baselga, José

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Genetics, Clinical Trials and Supportive Activities, Clinical Research, Breast Cancer, Cancer, 2.1 Biological and endogenous factors, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aetiology, Aged, Aromatase Inhibitors, Biomarkers, Tumor, Breast Neoplasms, Everolimus, Female, Follow-Up Studies, High-Throughput Nucleotide Sequencing, Humans, Immunoenzyme Techniques, Middle Aged, Mutation, Neoplasm Invasiveness, Neoplasm Metastasis, Neoplasm Staging, Postmenopause, Prognosis, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone, Survival Rate, Receptor, erbB-2, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeTo explore the genetic landscape of tumors from patients enrolled on the BOLERO-2 trial to identify potential correlations between genetic alterations and efficacy of everolimus treatment. The BOLERO-2 trial has previously demonstrated that the addition of everolimus to exemestane prolonged progression-free survival by more than twofold in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer previously treated with nonsteroidal aromatase inhibitors.Patients and methodsNext-generation sequencing was used to analyze genetic status of cancer-related genes in 302 archival tumor specimens from patients representative of the BOLERO-2 study population. Correlations between the most common somatic alterations and degree of chromosomal instability, and treatment effect of everolimus were investigated.ResultsProgression-free survival benefit with everolimus was maintained regardless of alteration status of PIK3CA, FGFR1, and CCND1 or the pathways of which they are components. However, quantitative differences in everolimus benefit were observed between patient subgroups defined by the exon-specific mutations in PIK3CA (exon 20 v 9) or by different degrees of chromosomal instability in the tumor tissues.ConclusionThe data from this exploratory analysis suggest that the efficacy of everolimus was largely independent of the most commonly altered genes or pathways in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. The potential impact of chromosomal instabilities and low-frequency genetic alterations on everolimus efficacy warrants further investigation.

Published
2016

10. A four gene signature predicts benefit from anthracyclines: evidence from the BR9601 and MA.5 clinical trials

Author

Spears, Melanie, Yousif, Fouad, Lyttle, Nicola, Boutros, Paul C, Munro, Alison F, Twelves, Chris, Pritchard, Kathleen I, Levine, Mark N, Shepherd, Lois, and Bartlett, John MS

Subjects
Breast Cancer, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Genetics, 4.2 Evaluation of markers and technologies, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Anthracyclines, Antibiotics, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Breast Neoplasms, Chromosomal Instability, Female, Follow-Up Studies, Gene Expression Profiling, Gene Expression Regulation, Neoplastic, Humans, Middle Aged, Neoplasm Grading, Neoplasm Recurrence, Local, Neoplasm Staging, Prognosis, Proportional Hazards Models, RNA, Messenger, Real-Time Polymerase Chain Reaction, Reverse Transcriptase Polymerase Chain Reaction, Signal Transduction, Survival Rate, breast cancer, anthracycline, chromosome instability, predictive biomarker, Oncology and Carcinogenesis
Abstract

Chromosome instability (CIN) in solid tumours results in multiple numerical and structural chromosomal aberrations and is associated with poor prognosis in multiple tumour types. Recent evidence demonstrated CEP17 duplication, a CIN marker, is a predictive marker of anthracycline benefit. An analysis of the BR9601 and MA.5 clinical trials was performed to test the role of existing CIN gene expression signatures as predictive markers of anthracycline sensitivity in breast cancer. Univariate analysis demonstrated, high CIN25 expression score was associated with improved distant relapse free survival (DRFS) (HR: 0.74, 95% CI 0.54-0.99, p = 0.046). High tumour CIN70 and CIN25 scores were associated with aggressive clinicopathological phenotype and increased sensitivity to anthracycline therapy compared to low CIN scores. However, in a prospectively planned multivariate analysis only pathological grade, nodal status and tumour size were significant predictors of outcome for CIN25/CIN70. A limited gene signature was generated, patients with low tumour CIN4 scores benefited from anthracycline treatment significantly more than those with high CIN4 scores (HR 0.37, 95% CI 0.20-0.56, p = 0.001). In multivariate analyses the treatment by marker interaction for CIN4/anthracyclines demonstrated hazard ratio of 0.35 (95% CI 0.15-0.80, p = 0.012) for DRFS. This data shows CIN4 is independent predictor of anthracycline benefit for DRFS in breast cancer.

Published
2015

13. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis.

Author

Yardley, Denise A, Noguchi, Shinzaburo, Pritchard, Kathleen I, Burris, Howard A, Baselga, José, Gnant, Michael, Hortobagyi, Gabriel N, Campone, Mario, Pistilli, Barbara, Piccart, Martine, Melichar, Bohuslav, Petrakova, Katarina, Arena, Francis P, Erdkamp, Frans, Harb, Wael A, Feng, Wentao, Cahana, Ayelet, Taran, Tetiana, Lebwohl, David, and Rugo, Hope S

Subjects
Humans, Bone Neoplasms, Breast Neoplasms, Liver Neoplasms, Lung Neoplasms, Sirolimus, Androstadienes, Receptors, Estrogen, Receptors, Progesterone, Antineoplastic Combined Chemotherapy Protocols, Disease-Free Survival, Treatment Outcome, Double-Blind Method, Postmenopause, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Everolimus, Advanced breast cancer, Exemestane, Hormone receptor positive, Nonsteroidal aromatase inhibitors, Oncology, Postmenopausal, Progression-free survival, Receptors, Estrogen, Progesterone, and over, Pharmacology and Pharmaceutical Sciences, General Clinical Medicine
Abstract

IntroductionEffective treatments for hormone-receptor-positive (HR(+)) breast cancer (BC) following relapse/progression on nonsteroidal aromatase inhibitor (NSAI) therapy are needed. Initial Breast Cancer Trials of OraL EveROlimus-2 (BOLERO-2) trial data demonstrated that everolimus and exemestane significantly prolonged progression-free survival (PFS) versus placebo plus exemestane alone in this patient population.MethodsBOLERO-2 is a phase 3, double-blind, randomized, international trial comparing everolimus (10 mg/day) plus exemestane (25 mg/day) versus placebo plus exemestane in postmenopausal women with HR(+) advanced BC with recurrence/progression during or after NSAIs. The primary endpoint was PFS by local investigator review, and was confirmed by independent central radiology review. Overall survival, response rate, and clinical benefit rate were secondary endpoints.ResultsFinal study results with median 18-month follow-up show that median PFS remained significantly longer with everolimus plus exemestane versus placebo plus exemestane [investigator review: 7.8 versus 3.2 months, respectively; hazard ratio = 0.45 (95% confidence interval 0.38-0.54); log-rank P < 0.0001; central review: 11.0 versus 4.1 months, respectively; hazard ratio = 0.38 (95% confidence interval 0.31-0.48); log-rank P < 0.0001] in the overall population and in all prospectively defined subgroups, including patients with visceral metastases, [corrected] and irrespective of age. The incidence and severity of adverse events were consistent with those reported at the interim analysis and in other everolimus trials.ConclusionThe addition of everolimus to exemestane markedly prolonged PFS in patients with HR(+) advanced BC with disease recurrence/progression following prior NSAIs. These results further support the use of everolimus plus exemestane in this patient population. ClinicalTrials.gov #NCT00863655.

Published
2013

14. Effect of Everolimus on Bone Marker Levels and Progressive Disease in Bone in BOLERO-2

Author

Gnant, Michael, Baselga, Jose, Rugo, Hope S, Noguchi, Shinzaburo, Burris, Howard A, Piccart, Martine, Hortobagyi, Gabriel N, Eakle, Janice, Mukai, Hirofumi, Iwata, Hiroji, Geberth, Matthias, Hart, Lowell L, Hadji, Peyman, El-Hashimy, Mona, Rao, Shantha, Taran, Tetiana, Sahmoud, Tarek, Lebwohl, David, Campone, Mario, and Pritchard, Kathleen I

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Estrogen, Clinical Research, Cancer, Aging, Clinical Trials and Supportive Activities, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Alkaline Phosphatase, Androstadienes, Antineoplastic Agents, Aromatase Inhibitors, Bone Density, Bone Density Conservation Agents, Bone Neoplasms, Bone Remodeling, Bone Resorption, Breast Neoplasms, Collagen Type I, Confounding Factors, Epidemiologic, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Everolimus, Female, Follow-Up Studies, Fractures, Spontaneous, Humans, Middle Aged, Odds Ratio, Osteogenesis, Postmenopause, Procollagen, Proportional Hazards Models, Receptors, Estrogen, Sirolimus, TOR Serine-Threonine Kinases, Treatment Failure, Treatment Outcome, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundBreast Cancer Trials of Oral Everolimus 2 (BOLERO-2), a phase III study in postmenopausal women with estrogen receptor-positive breast cancer progressing despite nonsteroidal aromatase inhibitor therapy, showed statistically significant benefits with adding everolimus to exemestane. Moreover, in preclinical studies, mammalian target of rapamycin inhibition was associated with decreased osteoclast survival and activity. Exploratory analyses in BOLERO-2 evaluated the effect of everolimus on bone marker levels and progressive disease in bone.MethodsPatients were treated with exemestane (25mg/day) and randomized (2:1) to everolimus (10mg/day; combination) or placebo (exemestane only). Exploratory endpoints included changes in bone turnover marker levels vs baseline and progressive disease in bone, defined as unequivocal progression of a preexisting bone lesion or the appearance of a new bone lesion.ResultsBaseline disease characteristics were well balanced between arms (N = 724); baseline bisphosphonate use was not (43.9% combination vs 54.0% exemestane only). At a median of 18 months of follow-up, median progression-free survival (primary endpoint) was statistically significantly longer with the combination vs exemestane only (Cox proportional hazard ratio = 0.45, 95% confidence interval = 0.38 to 0.54; log-rank, 1-sided P < .0001). Bone marker levels at 6 and 12 weeks increased with exemestane only, as expected, but decreased with the combination. The cumulative incidence rate of progressive disease in bone was lower in the combination arm. Bone-related adverse events occurred with similar frequency in both arms (3.3% combination vs 4.2% exemestane only).ConclusionThese exploratory analyses suggest that everolimus has beneficial effects on bone turnover and progressive disease in bone in patients receiving exemestane for hormone receptor-positive breast cancer progressing during/after nonsteroidal aromatase inhibitor therapy.

Published
2013

17. Bone-Targeted Therapy in Early Breast Cancer

Author

Jerzak, Katarzyna J., Raphael, Jacques, Desautels, Danielle N., Blanchette, Phillip S., Tyono, Ivan, and Pritchard, Kathleen I.

Subjects
Aromatase inhibitors -- Dosage and administration, Bones -- Health aspects, Breast cancer -- Drug therapy -- Complications and side effects, Fractures (Injuries) -- Risk factors, Postmenopausal women, Cancer treatment, Osteoporosis, Adjuvant chemotherapy, Androgens, Phenols (Class of compounds), Sex hormones, Recurrence (Disease), Enzymes, Algorithms, Tamoxifen, Estrogens, Retirement benefits, Cancer recurrence, Hormones, Health
Abstract

Aromatase inhibitors (AIs) play an important role in the adjuvant treatment of hormone receptor-positive breast cancer, but they are associated with bone loss and increased fracture risk. Although several guidelines for the management of osteoporosis and osteopenia exist, their algorithms do not account for the use of AIs. In this article, we describe the role of bone-targeted therapies, specifically for managing early breast cancer, by reviewing their bone-specific and cancer-specific benefits., IntroductionAromatase inhibitors (AIs) play an important role in the adjuvant treatment of estrogen receptor-positive (ER+) breast cancer. By inhibiting the aromatase enzyme responsible for the peripheral conversion of androgens to [...]

Published
2018

18. Supplementary Figure S2 from Genetic Polymorphisms in the Long Noncoding RNA MIR2052HG Offer a Pharmacogenomic Basis for the Response of Breast Cancer Patients to Aromatase Inhibitor Therapy

Author

Ingle, James N., primary, Xie, Fang, primary, Ellis, Matthew J., primary, Goss, Paul E., primary, Shepherd, Lois E., primary, Chapman, Judith-Anne W., primary, Chen, Bingshu E., primary, Kubo, Michiaki, primary, Furukawa, Yoichi, primary, Momozawa, Yukihide, primary, Stearns, Vered, primary, Pritchard, Kathleen I., primary, Barman, Poulami, primary, Carlson, Erin E., primary, Goetz, Matthew P., primary, Weinshilboum, Richard M., primary, Kalari, Krishna R., primary, and Wang, Liewei, primary

Published
2023
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21. Supplementary Tables 1-2 from A 50-Gene Intrinsic Subtype Classifier for Prognosis and Prediction of Benefit from Adjuvant Tamoxifen

Author

Chia, Stephen K., primary, Bramwell, Vivien H., primary, Tu, Dongsheng, primary, Shepherd, Lois E., primary, Jiang, Shan, primary, Vickery, Tammi, primary, Mardis, Elaine, primary, Leung, Samuel, primary, Ung, Karen, primary, Pritchard, Kathleen I., primary, Parker, Joel S., primary, Bernard, Philip S., primary, Perou, Charles M., primary, Ellis, Matthew J., primary, and Nielsen, Torsten O., primary

Published
2023
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23. Supplementary Tables 1-2 from Responsiveness of Intrinsic Subtypes to Adjuvant Anthracycline Substitution in the NCIC.CTG MA.5 Randomized Trial

Author

Cheang, Maggie C.U., primary, Voduc, K. David, primary, Tu, Dongsheng, primary, Jiang, Shan, primary, Leung, Samuel, primary, Chia, Stephen K., primary, Shepherd, Lois E., primary, Levine, Mark N., primary, Pritchard, Kathleen I., primary, Davies, Sherri, primary, Stijleman, Inge J., primary, Davis, Carole, primary, Ebbert, Mark T.W., primary, Parker, Joel S., primary, Ellis, Matthew J., primary, Bernard, Philip S., primary, Perou, Charles M., primary, and Nielsen, Torsten O., primary

Published
2023
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24. Supplementary Figures 1-2 from A 50-Gene Intrinsic Subtype Classifier for Prognosis and Prediction of Benefit from Adjuvant Tamoxifen

Author

Chia, Stephen K., primary, Bramwell, Vivien H., primary, Tu, Dongsheng, primary, Shepherd, Lois E., primary, Jiang, Shan, primary, Vickery, Tammi, primary, Mardis, Elaine, primary, Leung, Samuel, primary, Ung, Karen, primary, Pritchard, Kathleen I., primary, Parker, Joel S., primary, Bernard, Philip S., primary, Perou, Charles M., primary, Ellis, Matthew J., primary, and Nielsen, Torsten O., primary

Published
2023
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26. Supplementary Figure 2 from Responsiveness of Intrinsic Subtypes to Adjuvant Anthracycline Substitution in the NCIC.CTG MA.5 Randomized Trial

Author

Cheang, Maggie C.U., primary, Voduc, K. David, primary, Tu, Dongsheng, primary, Jiang, Shan, primary, Leung, Samuel, primary, Chia, Stephen K., primary, Shepherd, Lois E., primary, Levine, Mark N., primary, Pritchard, Kathleen I., primary, Davies, Sherri, primary, Stijleman, Inge J., primary, Davis, Carole, primary, Ebbert, Mark T.W., primary, Parker, Joel S., primary, Ellis, Matthew J., primary, Bernard, Philip S., primary, Perou, Charles M., primary, and Nielsen, Torsten O., primary

Published
2023
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27. Data from Genetic Polymorphisms in the Long Noncoding RNA MIR2052HG Offer a Pharmacogenomic Basis for the Response of Breast Cancer Patients to Aromatase Inhibitor Therapy

Author

Ingle, James N., primary, Xie, Fang, primary, Ellis, Matthew J., primary, Goss, Paul E., primary, Shepherd, Lois E., primary, Chapman, Judith-Anne W., primary, Chen, Bingshu E., primary, Kubo, Michiaki, primary, Furukawa, Yoichi, primary, Momozawa, Yukihide, primary, Stearns, Vered, primary, Pritchard, Kathleen I., primary, Barman, Poulami, primary, Carlson, Erin E., primary, Goetz, Matthew P., primary, Weinshilboum, Richard M., primary, Kalari, Krishna R., primary, and Wang, Liewei, primary

Published
2023
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28. Supplementary Material from Genetic Polymorphisms in the Long Noncoding RNA MIR2052HG Offer a Pharmacogenomic Basis for the Response of Breast Cancer Patients to Aromatase Inhibitor Therapy

Author

Ingle, James N., primary, Xie, Fang, primary, Ellis, Matthew J., primary, Goss, Paul E., primary, Shepherd, Lois E., primary, Chapman, Judith-Anne W., primary, Chen, Bingshu E., primary, Kubo, Michiaki, primary, Furukawa, Yoichi, primary, Momozawa, Yukihide, primary, Stearns, Vered, primary, Pritchard, Kathleen I., primary, Barman, Poulami, primary, Carlson, Erin E., primary, Goetz, Matthew P., primary, Weinshilboum, Richard M., primary, Kalari, Krishna R., primary, and Wang, Liewei, primary

Published
2023
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29. Supplementary Figure Legends 1-2 from Responsiveness of Intrinsic Subtypes to Adjuvant Anthracycline Substitution in the NCIC.CTG MA.5 Randomized Trial

Author

Cheang, Maggie C.U., primary, Voduc, K. David, primary, Tu, Dongsheng, primary, Jiang, Shan, primary, Leung, Samuel, primary, Chia, Stephen K., primary, Shepherd, Lois E., primary, Levine, Mark N., primary, Pritchard, Kathleen I., primary, Davies, Sherri, primary, Stijleman, Inge J., primary, Davis, Carole, primary, Ebbert, Mark T.W., primary, Parker, Joel S., primary, Ellis, Matthew J., primary, Bernard, Philip S., primary, Perou, Charles M., primary, and Nielsen, Torsten O., primary

Published
2023
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30. Supplementary Figure 1 from Responsiveness of Intrinsic Subtypes to Adjuvant Anthracycline Substitution in the NCIC.CTG MA.5 Randomized Trial

Author

Cheang, Maggie C.U., primary, Voduc, K. David, primary, Tu, Dongsheng, primary, Jiang, Shan, primary, Leung, Samuel, primary, Chia, Stephen K., primary, Shepherd, Lois E., primary, Levine, Mark N., primary, Pritchard, Kathleen I., primary, Davies, Sherri, primary, Stijleman, Inge J., primary, Davis, Carole, primary, Ebbert, Mark T.W., primary, Parker, Joel S., primary, Ellis, Matthew J., primary, Bernard, Philip S., primary, Perou, Charles M., primary, and Nielsen, Torsten O., primary

Published
2023
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32. Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015

Author

Coates, A.S., Winer, E.P., Goldhirsch, A., Gelber, R.D., Gnant, M., Piccart-Gebhart, M., Thürlimann, B., Senn, H.-J., André, Fabrice, Baselga, José, Bergh, Jonas, Bonnefoi, Hervé, Burstein, Harold, Cardoso, Fatima, Castiglione-Gertsch, Monica, Coates, Alan S., Colleoni, Marco, Curigliano, Giuseppe, Davidson, Nancy E., Di Leo, Angelo, Ejlertsen, Bent, Forbes, John F., Galimberti, Viviana, Gelber, Richard D., Gnant, Michael, Goldhirsch, Aron, Goodwin, Pamela, Harbeck, Nadia, Hayes, Daniel F., Huober, Jens, Hudis, Clifford A., Ingle, James N., Jassem, Jacek, Jiang, Zefei, Karlsson, Per, Morrow, Monica, Orecchia, Roberto, Kent Osborne, C., Partridge, Ann H., de la Peña, Lorena, Piccart-Gebhart, Martine J., Pritchard, Kathleen I., Rutgers, Emiel J.T., Sedlmayer, Felix, Semiglazov, Vladimir, Shao, Zhi-Ming, Smith, Ian, Thürlimann, Beat, Toi, Masakazu, Tutt, Andrew, Viale, Giuseppe, von Minckwitz, Gunter, Watanabe, Toru, Whelan, Timothy, Winer, Eric P., and Xu, Binghe

Published
2015
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33. Effects of metformin versus placebo on vitamin B12 metabolism in non-diabetic breast cancer patients in CCTG MA.32

Author

Lohmann, Ana Elisa, Liebman, Mira F., Brien, William, Parulekar, Wendy R., Gelmon, Karen A., Shepherd, Lois E., Ligibel, Jennifer A., Hershman, Dawn L., Rastogi, Priya, Mayer, Ingrid A., Hobday, Timothy J., Lemieux, Julie, Thompson, Alastair Mark, Pritchard, Kathleen I., Whelan, Timothy Joseph, Mukherjee, Som D., Chalchal, Haji I., Bernstein, Vanessa, Stambolic, Vuk, Chen, Bingshu E., Goodwin, Pamela Jean, and From the CCTG, Alliance, SWOG, ECOG, NSABP Cooperative Groups

Published
2017
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36. Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial

Author

Goss, Paul E, Hershman, Dawn L, Cheung, Angela M, Ingle, James N, Khosla, Sundeep, Stearns, Vered, Chalchal, Haji, Rowland, Kendrith, Muss, Hyman B, Linden, Hannah M, Scher, Judite, Pritchard, Kathleen I, Elliott, Catherine R, Badovinac-Crnjevic, Tanja, St Louis, Jessica, Chapman, Judith-Anne W, and Shepherd, Lois E

Published
2014
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43. Safety and Efficacy of Everolimus With Exemestane vs. Exemestane Alone in Elderly Patients With HER2-Negative, Hormone Receptor–Positive Breast Cancer in BOLERO-2

Author

Pritchard, Kathleen I., Burris, Howard A., III, Ito, Yoshinori, Rugo, Hope S., Dakhil, Shaker, Hortobagyi, Gabriel N., Campone, Mario, Csöszi, Tibor, Baselga, José, Puttawibul, Puttisak, Piccart, Martine, Heng, Daniel, Noguchi, Shinzaburo, Srimuninnimit, Vichien, Bourgeois, Hugues, Gonzalez Martin, Antonio, Osborne, Karen, Panneerselvam, Ashok, Taran, Tetiana, Sahmoud, Tarek, and Gnant, Michael

Published
2013
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49. Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial

Author

Goss, Paul E, Smith, Ian E, O'Shaughnessy, Joyce, Ejlertsen, Bent, Kaufmann, Manfred, Boyle, Frances, Buzdar, Aman U, Fumoleau, Pierre, Gradishar, William, Martin, Miguel, Moy, Beverly, Piccart-Gebhart, Martine, Pritchard, Kathleen I, Lindquist, Deborah, Chavarri-Guerra, Yanin, Aktan, Gursel, Rappold, Erica, Williams, Lisa S, and Finkelstein, Dianne M

Published
2013
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