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153. Ondansetron compared with dexamethasone and metoclopramide as antiemetics in the chemotherapy of breast cancer with cyclophosphamide, methotrexate, and fluorouracil

Author

Levitt, Martin, Warr, David, Yelle, Louise, Rayner, Harry L., Lofters, Wycliffe S., Perrault, Danielle J., Wilson, Kenneth S., Latreille, Jean, Potvin, Martin, Warner, Ellen, Pritchard, Kathleen I., Palmer, Michael, Zee, Benny, and Pater, Joseph L.

Subjects
Ondansetron -- Evaluation, Dexamethasone -- Evaluation, Metoclopramide -- Evaluation, Chemotherapy -- Complications, Nausea -- Prevention, Vomiting -- Prevention
Abstract

Dexamethasone and metoclopramide appear to be as effective or slightly more effective than ondansetron in reducing vomiting and nausea associated with moderately emetogenic (causing vomiting) chemotherapy. Previous studies found ondansetron to be highly effective in reducing the nausea and vomiting in patients who took strongly emetogenic chemotherapy. Of 164 women with breast cancer who were about to receive moderately emetogenic chemotherapy, 84 took odansetron and 80 took dexamethasone and metoclopramide. Overall, about 66% of the women did not vomit in the seven days after chemotherapy. There were no significant differences between groups in the number of women who did not vomit. In the first day after chemotherapy, however, the women who took dexamethasone and metoclopramide experienced significantly less nausea than women who took ondansetron.

Published
1993

160. Influenza Vaccine Effectiveness Among Patients With Cancer: A Population-Based Study Using Health Administrative and Laboratory Testing Data From Ontario, Canada

Author

Blanchette, Phillip S., primary, Chung, Hannah, additional, Pritchard, Kathleen I., additional, Earle, Craig C., additional, Campitelli, Michael A., additional, Buchan, Sarah A., additional, Schwartz, Kevin L., additional, Crowcroft, Natasha S., additional, Gubbay, Jonathan B., additional, Karnauchow, Timothy, additional, Katz, Kevin, additional, McGeer, Allison J., additional, McNally, James D., additional, Richardson, David C., additional, Richardson, Susan E., additional, Rosella, Laura C., additional, Simor, Andrew, additional, Smieja, Marek, additional, Zahariadis, George, additional, Campigotto, Aaron, additional, and Kwong, Jeffrey C., additional

Published
2019
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161. Factors associated with endocrine therapy adherence among post-menopausal women treated for early-stage breast cancer in Ontario, Canada

Author

Blanchette, Phillip S., primary, Lam, Melody, additional, Richard, Lucie, additional, Allen, Britney, additional, Shariff, Salimah Z., additional, Vandenberg, Ted, additional, Pritchard, Kathleen I., additional, Chan, Kelvin K. W., additional, Louie, Alexander V., additional, Desautels, Danielle, additional, Raphael, Jacques, additional, and Earle, Craig C., additional

Published
2019
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163. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer

Author

Sparano, Joseph A., primary, Gray, Robert J., additional, Ravdin, Peter M., additional, Makower, Della F., additional, Pritchard, Kathleen I., additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Geyer, Charles E., additional, Dees, Elizabeth C., additional, Goetz, Matthew P., additional, Olson, John A., additional, Lively, Tracy, additional, Badve, Sunil S., additional, Saphner, Thomas J., additional, Wagner, Lynne I., additional, Whelan, Timothy J., additional, Ellis, Matthew J., additional, Paik, Soonmyung, additional, Wood, William C., additional, Keane, Maccon M., additional, Gomez Moreno, Henry L., additional, Reddy, Pavan S., additional, Goggins, Timothy F., additional, Mayer, Ingrid A., additional, Brufsky, Adam M., additional, Toppmeyer, Deborah L., additional, Kaklamani, Virginia G., additional, Berenberg, Jeffrey L., additional, Abrams, Jeffrey, additional, and Sledge, George W., additional

Published
2019
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164. Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx.

Author

Sparano, Joseph A., primary, Gray, Robert James, additional, Makower, Della F., additional, Lively, Tracy G., additional, Saphner, Thomas James, additional, Keane, Maccon M., additional, Gomez, Henry Leonidas, additional, Reddy, Pavan S., additional, Goggins, Timothy F., additional, Mayer, Ingrid A., additional, Toppmeyer, Deborah, additional, Brufsky, Adam, additional, Goetz, Matthew P., additional, Hayes, Daniel F., additional, Dees, Elizabeth Claire, additional, Pritchard, Kathleen I., additional, Geyer, Charles E., additional, Olson, John A., additional, Albain, Kathy S., additional, and Sledge, George W., additional

Published
2019
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165. Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37 298 women with early breast cancer in 26 randomised trials

Author

Gray, Richard, primary, Bradley, Rosie, additional, Braybrooke, Jeremy, additional, Liu, Zulian, additional, Peto, Richard, additional, Davies, Lucy, additional, Dodwell, David, additional, McGale, Paul, additional, Pan, Hongchao, additional, Taylor, Carolyn, additional, Barlow, William, additional, Bliss, Judith, additional, Bruzzi, Paolo, additional, Cameron, David, additional, Fountzilas, George, additional, Loibl, Sibylle, additional, Mackey, John, additional, Martin, Miguel, additional, Del Mastro, Lucia, additional, Möbus, Volker, additional, Nekljudova, Valentina, additional, De Placido, Sabino, additional, Swain, Sandra, additional, Untch, Michael, additional, Pritchard, Kathleen I, additional, Bergh, Jonas, additional, Norton, Larry, additional, Boddington, Clare, additional, Burrett, Julie, additional, Clarke, Mike, additional, Davies, Christina, additional, Duane, Fran, additional, Evans, Vaughan, additional, Gettins, Lucy, additional, Godwin, Jon, additional, Hills, Robert, additional, James, Sam, additional, Liu, Hui, additional, MacKinnon, Elizabeth, additional, Mannu, Gurdeep, additional, McHugh, Theresa, additional, Morris, Philip, additional, Read, Simon, additional, Wang, Yaochen, additional, Wang, Zhe, additional, Fasching, Peter, additional, Harbeck, Nadia, additional, Piedbois, Pascal, additional, Gnant, Michael, additional, Steger, Guenther, additional, Di Leo, Angelo, additional, Dolci, Stella, additional, Francis, Prue, additional, Larsimont, Denis, additional, Nogaret, Jean Marie, additional, Philippson, Catherine, additional, Piccart, Martine, additional, Linn, Sabine, additional, Peer, Petronella, additional, Tjan-Heijnen, Vivianne, additional, Vliek, Sonja, additional, Slamon, Dennis, additional, Bartlett, John, additional, Bramwell, Vivien H, additional, Chen, Bingshu, additional, Chia, Stephen, additional, Gelmon, Karen, additional, Goss, Paul, additional, Levine, Mark, additional, Parulekar, Wendy, additional, Pater, Joseph, additional, Rakovitch, Eileen, additional, Shepherd, Lois, additional, Tu, Dongsheng, additional, Whelan, Tim, additional, Berry, Don, additional, Broadwater, Gloria, additional, Cirrincione, Constance, additional, Muss, Hyman, additional, Weiss, Raymond, additional, Shan, Yi, additional, Shao, Yong Fu, additional, Wang, Xiang, additional, Xu, Binghe, additional, Zhao, Dong-Bing, additional, Bartelink, Harry, additional, Bijker, Nina, additional, Bogaerts, Jan, additional, Cardoso, Fatima, additional, Cufer, Tanja, additional, Julien, Jean-Pierre, additional, Poortmans, Philip, additional, Rutgers, Emiel, additional, van de Velde, Cornelis, additional, Carrasco, Eva, additional, Segui, Miguel Angel, additional, Blohmer, Jens Uwe, additional, Costa, Serban, additional, Gerber, Bernd, additional, Jackisch, Christian, additional, von Minckwitz, Gunter, additional, Giuliano, Mario, additional, De Laurentiis, Michele, additional, Bamia, Christina, additional, Koliou, Georgia-Angeliki, additional, Mavroudis, Dimitris, additional, A'Hern, Roger, additional, Ellis, Paul, additional, Kilburn, Lucy, additional, Morden, James, additional, Yarnold, John, additional, Sadoon, Mohammad, additional, Tulusan, Augustinus H, additional, Anderson, Stewart, additional, Bass, Gordon, additional, Costantino, Joe, additional, Dignam, James, additional, Fisher, Bernard, additional, Geyer, Charles, additional, Mamounas, Eleftherios P, additional, Paik, Soon, additional, Redmond, Carol, additional, Wickerham, D Lawrence, additional, Venturini, Marco, additional, Bighin, Claudia, additional, Pastorino, Simona, additional, Pronzato, Paolo, additional, Sertoli, Mario Roberto, additional, Foukakis, Theodorus, additional, Albain, Kathy, additional, Arriagada, Rodrigo, additional, Bergsten Nordström, Elizabeth, additional, Boccardo, Francesco, additional, Brain, Etienne, additional, Carey, Lisa, additional, Coates, Alan, additional, Coleman, Robert, additional, Correa, Candace, additional, Cuzick, Jack, additional, Davidson, Nancy, additional, Dowsett, Mitch, additional, Ewertz, Marianne, additional, Forbes, John, additional, Gelber, Richard, additional, Goldhirsch, Aron, additional, Goodwin, Pamela, additional, Hayes, Daniel, additional, Hill, Catherine, additional, Ingle, James, additional, Jagsi, Reshma, additional, Janni, Wolfgang, additional, Mukai, Hirofumi, additional, Ohashi, Yasuo, additional, Pierce, Lori, additional, Raina, Vinod, additional, Ravdin, Peter, additional, Rea, Daniel, additional, Regan, Meredith, additional, Robertson, John, additional, Sparano, Joseph, additional, Tutt, Andrew, additional, Viale, Giuseppe, additional, Wilcken, Nicholas, additional, Wolmark, Norman, additional, Wood, Wiliam, additional, and Zambetti, Milvia, additional

Published
2019
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166. Bioinformatic analyses identifies novel protein-coding pharmacogenomic markers associated with paclitaxel sensitivity in NCI60 cancer cell lines

Author

Jarjanazi Hamdi, Ibrahim-zada Irada, Eng Lawson, Savas Sevtap, Meschian Mehran, Pritchard Kathleen I, and Ozcelik Hilmi

Subjects
Internal medicine, RC31-1245, Genetics, QH426-470
Abstract

Abstract Background Paclitaxel is a microtubule-stabilizing drug that has been commonly used in treating cancer. Due to genetic heterogeneity within patient populations, therapeutic response rates often vary. Here we used the NCI60 panel to identify SNPs associated with paclitaxel sensitivity. Using the panel's GI50 response data available from Developmental Therapeutics Program, cell lines were categorized as either sensitive or resistant. PLINK software was used to perform a genome-wide association analysis of the cellular response to paclitaxel with the panel's SNP-genotype data on the Affymetrix 125 k SNP array. FastSNP software helped predict each SNP's potential impact on their gene product. mRNA expression differences between sensitive and resistant cell lines was examined using data from BioGPS. Using Haploview software, we investigated for haplotypes that were more strongly associated with the cellular response to paclitaxel. Ingenuity Pathway Analysis software helped us understand how our identified genes may alter the cellular response to paclitaxel. Results 43 SNPs were found significantly associated (FDR < 0.005) with paclitaxel response, with 10 belonging to protein-coding genes (CFTR, ROBO1, PTPRD, BTBD12, DCT, SNTG1, SGCD, LPHN2, GRIK1, ZNF607). SNPs in GRIK1, DCT, SGCD and CFTR were predicted to be intronic enhancers, altering gene expression, while SNPs in ZNF607 and BTBD12 cause conservative missense mutations. mRNA expression analysis supported these findings as GRIK1, DCT, SNTG1, SGCD and CFTR showed significantly (p < 0.05) increased expression among sensitive cell lines. Haplotypes found in GRIK1, SGCD, ROBO1, LPHN2, and PTPRD were more strongly associated with response than their individual SNPs. Conclusions Our study has taken advantage of available genotypic data and its integration with drug response data obtained from the NCI60 panel. We identified 10 SNPs located within protein-coding genes that were not previously shown to be associated with paclitaxel response. As only five genes showed differential mRNA expression, the remainder would not have been detected solely based on expression data. The identified haplotypes highlight the role of utilizing SNP combinations within genomic loci of interest to improve the risk determination associated with drug response. These genetic variants represent promising biomarkers for predicting paclitaxel response and may play a significant role in the cellular response to paclitaxel.

Published
2011
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172. Clinical cooperative trials of the National Cancer Institute of Canada Clinical Trials Group Breast Cancer Site Group

Author

Pritchard, Kathleen I.

Subjects
Breast cancer -- Adjuvant treatment, Chemotherapy -- Research, Health, National Cancer Institute of Canada -- Research
Abstract

For more than 10 years, the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Breast Cancer Site Group has focused primarily on trials of adjuvant therapy and of investigational new drugs (IND). Four trials of adjuvant therapy in node-positive women have been completed, are active, or are about to begin. Investigational new drug (IND) studies have included Phase II trials of intravenous and oral menagaril, 10-EDAM (edatrexate), taxotere, and mifepristone (RU-486) as well as a Phase I/II trial of 5-fluorouracil (5-FU), doxorubicin, and vinorelbine (FAN); a Phase 1/11 trial of 5-FU, leucovorin, doxorubicin, and vinorelbine (super-fan), all as first-line therapy for metastatic disease; and a Phase Ill study of vinorelbine plus doxorubicin versus doxorubicin alone as first- or second-line metastatic therapy. A proposed study with the European Organization for Research and Treatment of Cancer in locally advanced breast cancer will compare a standard NCIC CTG regimen of cyclophosphamide, epirubicin, and 5-FU (CEF) with epirubicin and cyclophosphamide granulocyte colony-stimulating factor (G-CSF), a more dose-intensive regimen. In addition, NCIC CTG is preparing a pilot of CEF with G-CSF to examine whether a substantially more intensive dosage can be given without added toxicity. NCIC CTG will also enter patients into a currently active Cancer and Leukemia Group B/Southwest Oncology Group randomized trial of intensive therapy versus more intensive therapy with bone marrow support in women younger than age 60 with 10 or more positive nodes. It is believed that optimizing the combination and timing of adjuvant hormonal and chemotherapy, exploring dose intensive approaches, developing investigational new drugs, studying the role of biologics, and tumor banking in conjunction with clinical trials remain important approaches for the future. Cancer 1994; 74:1150-5. Key words: breast cancer, clinical trials, adjuvant therapy, chemotherapy, tamoxifen, dose intensity, investigational new drugs, taxotere, mifepristone, 10-EDAM.

Published
1994

173. 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

Subjects
education
Abstract

The 14th St Gallen International Breast Cancer Conference (2015) reviewed new evidence on locoregional and systemic therapies for early breast cancer. This manuscript presents news and progress since the 2013 meeting, provides expert opinion on almost 200 questions posed to Consensus Panel members, and summarizes treatment-oriented classification of subgroups and treatment recommendations

Published
2017

174. Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor-positive breast cancer: NCIC CTG MA.27

Author

Lipton, Allan, Chapman, Judith-Anne W, Leitzel, Kim, Garg, Ashwani, Pritchard, Kathleen I, Ingle, James N, Budd, G Thomas, Ellis, Matthew J, Sledge, George W, Rabaglio, Manuela, Han, Lei, Elliott, Catherine R, Shepherd, Lois E, Goss, Paul E, and Ali, Suhail M

Subjects
610 Medicine & health
Abstract

BACKGROUND Breast cancer patients in the MA.27 trial had similar outcomes with steroidal aromatase inhibitor (AI) exemestane and nonsteroidal anastrozole. AIs increase the risk of osteoporosis. This study examined the effects of self-reported osteoporosis and osteoporosis therapy (OPT) on outcomes. METHODS The MA.27 phase 3 adjuvant trial enrolled 7576 postmenopausal women. The primary outcome was event-free survival (EFS), and the secondary outcome was distant disease-free survival (DDFS). Patients were permitted bisphosphonates to prevent or treat osteopenia/osteoporosis. In a multivariate, stratified Cox regression, factors were significant with a 2-sided Wald test P value ≤ .05. RESULTS Osteoporosis was reported at the baseline by 654 of the 7576 women (8.6%) and in total by 1294 patients. Oral OPT was received at the baseline by 815 of the 7576 women (10.8%) and in total by 2711 patients (36%). With a median follow-up of 4.1 years, 693 EFS events (9.15%) and 321 DDFS events (4.2%) occurred. Osteoporosis was not associated with EFS or DDFS. Few EFS events occurred before the initiation of OPT, with no substantive evidence of a time-differing effect on outcomes (nonproportional hazards). OPT (yes vs no) was significantly associated with improved EFS (hazard ratio [HR] for yes vs no, 0.67; 95% confidence interval [CI], 0.57-0.80; P < .001) and DDFS (HR, 0.57; 95% CI, 0.44-0.73; P

Published
2017
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175. The role of bisphosphonates in early- and advanced-stage breast cancer: have we finally optimized care?

Author

Blanchette, Phillip S. and Pritchard, Kathleen I.

Subjects
Diphosphonates -- Health aspects, Patient care -- Methods, Breast cancer -- Care and treatment, Health
Abstract

Bisphosphonates have played an important role in the treatment of breast cancer, mainly in patients with bone metastasis, by reducing the risk of fracture, spinal cord compression, and hypercalcemia. Both oral and intravenous products are available and have strong supporting clinical evidence. Zoledronic acid, the most frequently used intravenous agent, has traditionally been given on a monthly dosing schedule. A novel every-12-weeks maintenance dosing schedule shows clinical equivalence and promises to improve safety, affordability, and quality of care. The Early Breast Cancer Trialists' Collaborative Group has recently helped clarify the controversial benefit of bisphosphonates in the adjuvant setting. Based on their meta-analysis, we now have strong evidence supporting the use of adjuvant bisphosphonates to help prevent the development of bone metastasis in postmenopausal breast cancer patients, which leads to a significant improvement in breast cancer-specific survival. We eagerly await the full publication of this practice-changing study, which continues the incremental advance of the treatment of patients with breast cancer., Introduction Bone is the primary site for breast cancer metastasis, representing a significant burden of disease and leading to fractures, spinal cord compression, pain, and hypercalcemia. [1] Breast cancer patients [...]

Published
2015

176. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

Author

Sparano, Joseph A., primary, Gray, Robert J., additional, Makower, Della F., additional, Pritchard, Kathleen I., additional, Albain, Kathy S., additional, Hayes, Daniel F., additional, Geyer, Charles E., additional, Dees, Elizabeth C., additional, Goetz, Matthew P., additional, Olson, John A., additional, Lively, Tracy, additional, Badve, Sunil S., additional, Saphner, Thomas J., additional, Wagner, Lynne I., additional, Whelan, Timothy J., additional, Ellis, Matthew J., additional, Paik, Soonmyung, additional, Wood, William C., additional, Ravdin, Peter M., additional, Keane, Maccon M., additional, Gomez Moreno, Henry L., additional, Reddy, Pavan S., additional, Goggins, Timothy F., additional, Mayer, Ingrid A., additional, Brufsky, Adam M., additional, Toppmeyer, Deborah L., additional, Kaklamani, Virginia G., additional, Berenberg, Jeffrey L., additional, Abrams, Jeffrey, additional, and Sledge, George W., additional

Published
2018
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178. TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score.

Author

Sparano, Joseph A., primary, Gray, Robert James, additional, Wood, William C., additional, Makower, Della F., additional, Lively, Tracy G., additional, Saphner, Thomas James, additional, Keane, Maccon M., additional, Gomez, Henry Leonidas, additional, Reddy, Pavan S., additional, Goggins, Timothy F, additional, Mayer, Ingrid A., additional, Toppmeyer, Deborah, additional, Brufsky, Adam, additional, Goetz, Matthew P., additional, Hayes, Daniel F., additional, Dees, Elizabeth Claire, additional, Pritchard, Kathleen I., additional, Geyer, Charles E., additional, Olson, John A., additional, and Sledge, George W., additional

Published
2018
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180. Effects of Celecoxib and Low-dose Aspirin on Outcomes in Adjuvant Aromatase Inhibitor–Treated Patients: CCTG MA.27

Author

Strasser-Weippl, Kathrin, primary, Higgins, Michaela J, additional, Chapman, Judith-Anne W, additional, Ingle, James N, additional, Sledge, George W, additional, Budd, George T, additional, Ellis, Matthew J, additional, Pritchard, Kathleen I, additional, Clemons, Mark J, additional, Badovinac-Crnjevic, Tanja, additional, Han, Lei, additional, Gelmon, Karen A, additional, Rabaglio, Manuela, additional, Elliott, Catherine, additional, Shepherd, Lois E, additional, and Goss, Paul E, additional

Published
2018
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181. Quality of Life From Canadian Cancer Trials Group MA.17R: A Randomized Trial of Extending Adjuvant Letrozole to 10 Years

Author

Lemieux, Julie, primary, Brundage, Michael D., additional, Parulekar, Wendy R., additional, Goss, Paul E., additional, Ingle, James N., additional, Pritchard, Kathleen I., additional, Celano, Paul, additional, Muss, Hyman, additional, Gralow, Julie, additional, Strasser-Weippl, Kathrin, additional, Whelan, Kate, additional, Tu, Dongsheng, additional, and Whelan, Timothy J., additional

Published
2018
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182. Prospective Evaluation of the Impact of the 21-Gene Recurrence Score Assay on Adjuvant Treatment Decisions for Women with Node-Positive Breast Cancer in Ontario, Canada

Author

Torres, Sofia, primary, Trudeau, Maureen, additional, Gandhi, Sonal, additional, Warner, Ellen, additional, Verma, Sunil, additional, Pritchard, Kathleen I., additional, Petrella, Teresa, additional, Hew-Shue, Mark, additional, Chao, Calvin, additional, and Eisen, Andrea, additional

Published
2018
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184. Randomized Trial of Letrozole Following Tamoxifen as Extended Adjuvant Therapy in Receptor-Positive Breast Cancer: Updated Findings from NCIC CTG MA.17

Author

Goss, Paul E., Ingle, James N., Martino, Silvana, Robert, Nicholas J., Muss, Hyman B., Piccart, Martine J., Castiglione, Monica, Tu, Dongsheng, Shepherd, Lois E., Pritchard, Kathleen I., Livingston, Robert B., Davidson, Nancy E., Norton, Larry, Perez, Edith A., Abrams, Jeffrey S., Cameron, David A., Palmer, Michael J., Pater, Joseph L., Goss, Paul E., Ingle, James N., Martino, Silvana, Robert, Nicholas J., Muss, Hyman B., Piccart, Martine J., Castiglione, Monica, Tu, Dongsheng, Shepherd, Lois E., Pritchard, Kathleen I., Livingston, Robert B., Davidson, Nancy E., Norton, Larry, Perez, Edith A., Abrams, Jeffrey S., Cameron, David A., Palmer, Michael J., and Pater, Joseph L.

Abstract

Background: Most recurrences in women with breast cancer receiving 5 years of adjuvant tamoxifen occur after 5 years. The MA.17 trial, which was designed to determine whether extended adjuvant therapy with the aromatase inhibitor letrozole after tamoxifen reduces the risk of such late recurrences, was stopped early after an interim analysis showed that letrozole improved disease-free survival. This report presents updated findings from the trial. Methods: Postmenopausal women completing 5 years of tamoxifen treatment were randomly assigned to a planned 5 years of letrozole (n = 2593) or placebo (n = 2594). The primary endpoint was disease-free survival (DFS); secondary endpoints included distant disease-free survival, overall survival, incidence of contralateral tumors, and toxic effects. Survival was examined using Kaplan-Meier analysis and log-rank tests. Planned subgroup analyses included those by axillary lymph node status. All statistical tests were two-sided. Results: After a median follow-up of 30 months (range = 1.5-61.4 months), women in the letrozole arm had statistically significantly better DFS and distant DFS than women in the placebo arm (DFS: hazard ratio [HR] for recurrence or contralateral breast cancer = 0.58, 95% confidence interval [CI] = 0.45 to 0.76; P<.001; distant DFS: HR = 0.60, 95% CI = 0.43 to 0.84; P = .002). Overall survival was the same in both arms (HR for death from any cause = 0.82, 95% CI = 0.57 to 1.19; P = .3). However, among lymph node-positive patients, overall survival was statistically significantly improved with letrozole (HR = 0.61, 95% CI = 0.38 to 0.98; P = .04). The incidence of contralateral breast cancer was lower in women receiving letrozole, but the difference was not statistically significant. Women receiving letrozole experienced more hormonally related side effects than those receiving placebo, but the incidences of bone fractures and cardiovascular events were the same. Conclusion: Letrozole after tamoxifen is wel

Published
2017

185. Adjuvant endocrine therapy for breast cancer: longer therapy and the need for personalized treatment--should we treat beyond the data?

Author

Blanchette, Phillip S. and Pritchard, Kathleen I.

Subjects
Cancer -- Adjuvant treatment, Hormone therapy -- Patient outcomes, Breast cancer -- Care and treatment, Health
Abstract

Women with hormone receptor (HR)-positive breast cancer carry an ongoing risk of disease recurrence despite our best current management. In fact, 50% of recurrences occur 6 to 15 years after [...]

Published
2013

187. Updated results from the phase III ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L) or their combination (L+T) in the adjuvant treatment of HER2-positive early breast cancer.

Author

Moreno-Aspitia, Alvaro, primary, Holmes, Eileen McCormick, additional, Jackisch, Christian, additional, De Azambuja, Evandro, additional, Boyle, Frances M., additional, Hillman, David W., additional, Korde, Larissa A., additional, Fumagalli, Debora, additional, Izquierdo, Miguel A., additional, McCullough, Ann E., additional, Wolff, Antonio C., additional, Pritchard, Kathleen I., additional, Untch, Michael, additional, Lang, Istvan, additional, Xu, Binghe, additional, Smith, Ian E., additional, Barrios, Carlos H., additional, Gelber, Richard D., additional, Baselga, Jose, additional, and Piccart-Gebhart, Martine J., additional

Published
2017
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188. Osteoporosis therapy and outcomes for postmenopausal patients with hormone receptor–positive breast cancer: NCIC CTG MA.27

Author

Lipton, Allan, primary, Chapman, Judith‐Anne W., additional, Leitzel, Kim, additional, Garg, Ashwani, additional, Pritchard, Kathleen I., additional, Ingle, James N., additional, Budd, G. Thomas, additional, Ellis, Matthew J., additional, Sledge, George W., additional, Rabaglio, Manuela, additional, Han, Lei, additional, Elliott, Catherine R., additional, Shepherd, Lois E., additional, Goss, Paul E., additional, and Ali, Suhail M., additional

Published
2017
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189. Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor–Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation (FACE) Trial

Author

Smith, Ian, primary, Yardley, Denise, additional, Burris, Howard A., additional, De Boer, Richard, additional, Amadori, Dino, additional, McIntyre, Kristi, additional, Ejlertsen, Bent, additional, Gnant, Michael, additional, Jonat, Walter, additional, Pritchard, Kathleen I., additional, Dowsett, Mitch, additional, Hart, Lowell, additional, Poggio, Susan, additional, Comarella, Lisa, additional, Salomon, Herve, additional, Wamil, Barbara, additional, and O’Shaughnessy, Joyce, additional

Published
2017
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193. A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer.

Author

Robertson, John F. R., Jiang, Zefei, Di Leo, Angelo, Ohno, Shinji, Pritchard, Kathleen I., Ellis, Matthew, Bradbury, Ian, and Campbell, Christine

Abstract

Background: Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC). Methods: Meta-analysis of randomized controlled trials (RCTs) evaluating fulvestrant 500 mg in postmenopausal hormone receptor-positive ABC, to evaluate differences in clinical benefit rate (CBR; proportion of patients experiencing best overall response of complete response, partial response, or stable disease for ≥ 24 weeks) between fulvestrant 500 mg and comparator endocrine therapies. Odds ratios (OR) and 95% confidence intervals (CI) for CBR were calculated; fixed effects (FE) models were constructed (first- and second-line data, alone and combined). Results: Six RCTs were included. Four studies evaluated fulvestrant 500 mg vs. fulvestrant 250 mg; two evaluated fulvestrant 500 mg vs. anastrozole 1 mg. In total, 1054 and 534 patients were included (first- and second-line treatment, respectively). Analysis of OR and 95% CI of CBR by therapy line favored fulvestrant 500 mg vs. comparator therapy. Assessing all results combined in the FE model indicated significant improvement in CBR with fulvestrant 500 mg vs. comparator treatments (OR 1.33; 95% CI 1.13–1.57; p = 0.001). Restricting the FE model to therapy line demonstrated significant improvement in CBR vs. comparator treatments (OR 1.33; 95% CI 1.02–1.73; p = 0.035) for first-line, and a trend to improvement vs. comparator treatments (OR 1.27; 95% CI 0.90–1.79; p = 0.174) for second-line. Conclusions: In postmenopausal patients with hormone receptor-positive ABC, fulvestrant 500 mg first-line was associated with significantly greater CBR (more patients benefiting from treatment) vs. comparator endocrine therapy. [ABSTRACT FROM AUTHOR]

Published
2019
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194. 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, 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, Baselga, José, Hortobagyi, Gabriel N, 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

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

196. Adjuvant endocrine therapy for breast cancer: a commentary

Author

Pritchard, Kathleen I. and Ruste, Athena S.

Subjects
Cancer -- Adjuvant treatment, Hormone therapy -- Usage -- Health aspects, Breast cancer -- Research -- Care and treatment, Health
Abstract

The review by Drs. Ruta Rao and Melody Cobleigh in this issue of ONCOLOGY summarizes the state-of-the-art adjuvant hormonal therapy for breast cancer concisely and appropriately. However, there are some [...]

Published
2012

197. Adjuvant hormonal therapy for premenopausal breast cancer: incorporating clinical experience

Author

Nasim, Saira and Pritchard, Kathleen I.

Subjects
Cancer -- Adjuvant treatment, Menopause -- Care and treatment, Ablation (Surgery), Breast cancer -- Care and treatment, Health, American Society of Clinical Oncology
Abstract

The article 'Adjuvant Hormonal Therapy in Premenopausal Women With Operable Breast Cancer: Not-So-Peripheral Perspectives' by Richard Love, published in this issue of ONCOLOGY, raises a number of important practice issues [...]

Published
2010

198. Overdiagnosing overdiagnosis

Author

Yaffe, Martin J. and Pritchard, Kathleen I.

Subjects
Controversies in Oncology:Breast Cancer, Cancer Research, Oncology, Commentary, Humans, Breast Neoplasms, Female, Early Detection of Cancer, Mammography
Abstract

Solid evidence shows that screening mammography contributes to a substantial reduction in mortality from breast cancer, but it is far from a perfect test. Estimates of overdetection of breast cancer, based on extrapolation of SEER data, may suffer from considerable uncertainty because of major assumptions required in such calculations and the difficulty in correcting for confounding factors such as lead time and demographic variations. Some of the charged language used and the extreme positions taken in the discussion of screening distract from coherent communication of the complex issues surrounding this topic. More balanced discussion would better serve the public.

Published
2014

199. Ovarian suppression/ablation in premenopausal ER-positive breast cancer patients: issues and recommendations

Author

Pritchard, Kathleen I.

Subjects
Roche Holding AG, Pfizer Inc., Breast cancer -- Care and treatment, Metastasis -- Care and treatment, Menopause -- Care and treatment, Cancer patients -- Care and treatment, Cancer -- Chemotherapy, Pharmaceutical industry, Estrogen, Chemotherapy, Methotrexate, Cyclophosphamide, Tamoxifen, Progesterone
Abstract

Endocrine therapy remains pivotal in the adjuvant therapy of premenopausal women with hormone receptor positive breast cancer. Ovarian ablation, used alone, is effective in delaying recurrence and increasing survival in such women. When added to chemotherapy, it is less clear that this technique is effective, perhaps because of the endocrine ablative effect of chemotherapy. Adjuvant trials comparing ovarian ablation with or without tamoxifen to CMF-type chemotherapy (cyclophosphamide, methotrexate, fluorouracil) suggest that the endocrine therapy is equivalent to or better than this chemotherapy in women whose tumors express estrogen and/or progesterone receptors. Endocrine therapy with ovarian ablation, tamoxifen, or the combination is also useful in the metastatic setting in premenopausal women., Developed over a century ago,[1] endocrine therapy remains the most effective and the most clearly targeted form of systemic therapy for breast cancer. Endocrine treatments work best in women whose [...]

Published
2009

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

Published
2016
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