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1. Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer.

Author

Harbeck, Nadia, Im, Seock-Ah, Gelmon, Karen, Lipatov, Oleg, Walshe, Janice, Martin, Miguel, Chavez-MacGregor, Mariana, Bananis, Eustratios, Gauthier, Eric, Lu, Dongrui, Kim, Sindy, Finn, Richard, Slamon, Dennis, Diéras, Véronique, and Rugo, Hope

Subjects
Humans, Female, Letrozole, Breast Neoplasms, Receptor, ErbB-2, Antineoplastic Combined Chemotherapy Protocols, Piperazines, Pyridines
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.PALOMA-2 demonstrated statistically and clinically significant improvement in progression-free survival with palbociclib plus letrozole versus placebo plus letrozole in estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (ABC). Here, we report results for the secondary end point overall survival (OS). Postmenopausal women (N = 666) with ER+/HER2- ABC without previous systemic therapy for ABC were randomly assigned 2:1 to palbociclib plus letrozole or placebo plus letrozole. After a median follow-up of 90.1 months, 405 deaths were observed and 155 patients were known to be alive. The median OS was 53.9 months (95% CI, 49.8 to 60.8) with palbociclib plus letrozole versus 51.2 months (95% CI, 43.7 to 58.9) with placebo plus letrozole (hazard ratio [HR], 0.96 [95% CI, 0.78 to 1.18]; stratified one-sided P = .34). An imbalance in the number of patients with unknown survival outcome between the treatment arms (13.3% v 21.2%, respectively) limited interpretation of OS results. With recovered survival data, the median OS was 53.8 (95% CI, 49.8 to 59.2) versus 49.8 months (95% CI, 42.3 to 56.4), respectively (HR, 0.92 [95% CI, 0.76 to 1.12]; one-sided P = .21). OS was not significantly improved with palbociclib plus letrozole compared with placebo plus letrozole.

Published
2024

2. Metastatic recurrence in women diagnosed with non-metastatic breast cancer: a systematic review and meta-analysis

Author

Morgan, Eileen, O’Neill, Colette, Shah, Richa, Langselius, Oliver, Su, Yaqi, Frick, Clara, Fink, Hanna, Bardot, Aude, Walsh, Paul M., Woods, Ryan R., Gonsalves, Lou, Nygård, Jan F., Negoita, Serban, Ramirez-Pena, Esmeralda, Gelmon, Karen, Antone, Nicoleta, Mutebi, Miriam, Siesling, Sabine, Cardoso, Fatima, Gralow, Julie, Soerjomataram, Isabelle, and Arnold, Melina

Published
2024
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3. Ultrasensitive plasma-based monitoring of tumor burden using machine-learning-guided signal enrichment

Author

Widman, Adam J., Shah, Minita, Frydendahl, Amanda, Halmos, Daniel, Khamnei, Cole C., Øgaard, Nadia, Rajagopalan, Srinivas, Arora, Anushri, Deshpande, Aditya, Hooper, William F., Quentin, Jean, Bass, Jake, Zhang, Mingxuan, Langanay, Theophile, Andersen, Laura, Steinsnyder, Zoe, Liao, Will, Rasmussen, Mads Heilskov, Henriksen, Tenna Vesterman, Jensen, Sarah Østrup, Nors, Jesper, Therkildsen, Christina, Sotelo, Jesus, Brand, Ryan, Schiffman, Joshua S., Shah, Ronak H., Cheng, Alexandre Pellan, Maher, Colleen, Spain, Lavinia, Krause, Kate, Frederick, Dennie T., den Brok, Wendie, Lohrisch, Caroline, Shenkier, Tamara, Simmons, Christine, Villa, Diego, Mungall, Andrew J., Moore, Richard, Zaikova, Elena, Cerda, Viviana, Kong, Esther, Lai, Daniel, Malbari, Murtaza S., Marton, Melissa, Manaa, Dina, Winterkorn, Lara, Gelmon, Karen, Callahan, Margaret K., Boland, Genevieve, Potenski, Catherine, Wolchok, Jedd D., Saxena, Ashish, Turajlic, Samra, Imielinski, Marcin, Berger, Michael F., Aparicio, Sam, Altorki, Nasser K., Postow, Michael A., Robine, Nicolas, Andersen, Claus Lindbjerg, and Landau, Dan A.

Published
2024
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5. Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY

Author

Balmaña, Judith, Fasching, Peter A., Couch, Fergus J., Delaloge, Suzette, Labidi-Galy, Intidhar, O’Shaughnessy, Joyce, Park, Yeon Hee, Eisen, Andrea F., You, Benoit, Bourgeois, Hughes, Gonçalves, Anthony, Kemp, Zoe, Swampillai, Angela, Jankowski, Tomasz, Sohn, Joo Hyuk, Poddubskaya, Elena, Mukhametshina, Guzel, Aksoy, Sercan, Timcheva, Constanta V., Park-Simon, Tjoung-Won, Antón-Torres, Antonio, John, Ellie, Baria, Katherine, Gibson, Isabel, and Gelmon, Karen A.

Published
2024
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6. A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer.

Author

Curigliano, Giuseppe, Shapiro, Geoffrey, Kristeleit, Rebecca, Abdul Razak, Albiruni, Leong, Stephen, Alsina, Maria, Giordano, Antonio, Gelmon, Karen, Stringer-Reasor, Erica, Vaishampayan, Ulka, Middleton, Mark, Olszanski, Anthony, Kern, Kenneth, Pathan, Nuzhat, Perea, Rachelle, Pierce, Kristen, Mutka, Sarah, Rugo, Hope, and Wainberg, Zev

Subjects
Humans, Triple Negative Breast Neoplasms, Cisplatin, Triazines, Morpholines, Antineoplastic Agents, Phosphoinositide-3 Kinase Inhibitors, Antineoplastic Combined Chemotherapy Protocols
Abstract

BACKGROUND: This Phase 1b study (B2151002) evaluated the PI3K/mTOR inhibitor gedatolisib (PF-05212384) in combination with other anti-tumour agents in advanced solid tumours. METHODS: Patients with various malignancies were administered gedatolisib (90‒310 mg intravenously every week [QW]) plus docetaxel (arm A) or cisplatin (arm B) (each 75 mg/m2 intravenously Q3W) or dacomitinib (30 or 45 mg/day orally). The safety and tolerability of combination therapies were assessed during dose escalation; objective response (OR) and safety were assessed during dose expansion. RESULTS: Of 110 patients enrolled, 107 received gedatolisib combination treatment. Seven of 70 (10.0%) evaluable patients had dose-limiting toxicities; the most common was grade 3 oral mucositis (n = 3). Based upon reprioritisation of the sponsors portfolio, dose expansion focused on arm B, gedatolisib (180 mg QW) plus cisplatin in patients (N = 22) with triple-negative breast cancer (TNBC). OR (95% CI) was achieved in four of ten patients in first-line (overall response rate 40.0% [12.2-73.8%]) and four of 12 in second/third-line (33.3% [9.9-65.1%]) settings. One patient in each TNBC arm (10%, first-line; 8.3%, second/third-line) achieved a complete response. CONCLUSIONS: Gedatolisib combination therapy showed an acceptable tolerability profile, with clinical activity at the recommended Phase 2 dose in patients with TNBC. CLINICAL TRIAL: ClinicalTrial.gov: NCT01920061.

Published
2023

8. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7)

Author

Cardoso, Fatima, Paluch-Shimon, Shani, Schumacher-Wulf, Eva, Matos, Leonor, Gelmon, Karen, Aapro, Matti S., Bajpai, Jyoti, Barrios, Carlos H., Bergh, Jonas, Bergsten-Nordström, Elizabeth, Biganzoli, Laura, Cardoso, Maria João, Carey, Lisa A., Chavez-MacGregor, Mariana, Chidebe, Runcie, Cortés, Javier, Curigliano, Giuseppe, Dent, Rebecca A., El Saghir, Nagi S., Eniu, Alexandru, Fallowfield, Lesley, Francis, Prudence A., Franco Millan, Sandra X., Gilchrist, Jenny, Gligorov, Joseph, Gradishar, William J., Haidinger, Renate, Harbeck, Nadia, Hu, Xichun, Kaur, Ranjit, Kiely, Belinda, Kim, Sung-Bae, Koppikar, Smruti, Kuper-Hommel, Marion J.J., Lecouvet, Frédéric E., Mason, Ginny, Mertz, Shirley A., Mueller, Volkmar, Myerson, Claire, Neciosup, Silvia, Offersen, Birgitte V., Ohno, Shinji, Pagani, Olivia, Partridge, Ann H., Penault-Llorca, Frédérique, Prat, Aleix, Rugo, Hope S., Senkus, Elzbieta, Sledge, George W., Swain, Sandra M., Thomssen, Christoph, Vorobiof, Daniel A., Vuylsteke, Peter, Wiseman, Theresa, Xu, Binghe, Costa, Alberto, Norton, Larry, and Winer, Eric P.

Published
2024
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10. Patient-reported outcomes in high-risk HR+ /HER2- early breast cancer patients treated with endocrine therapy with or without palbociclib within the randomized PENELOPEB study

Author

García-Sáenz, José Angel, Marmé, Frederik, Untch, Michael, Bonnefoi, Hervé, Kim, Sung-Bae, Bear, Harry, Mc Carthy, Nicole, Gelmon, Karen, Martin, Miguel, Kelly, Catherine M., Reimer, Toralf, Toi, Masakazu, Law, Ernest, Bhattacharyya, Helen, Gnant, Michael, Makris, Andreas, Seiler, Sabine, Burchardi, Nicole, Nekljudova, Valentina, Loibl, Sibylle, and Rugo, Hope S.

Published
2024
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11. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer

Author

Tutt, Andrew NJ, Garber, Judy E, Kaufman, Bella, Viale, Giuseppe, Fumagalli, Debora, Rastogi, Priya, Gelber, Richard D, de Azambuja, Evandro, Fielding, Anitra, Balmaña, Judith, Domchek, Susan M, Gelmon, Karen A, Hollingsworth, Simon J, Korde, Larissa A, Linderholm, Barbro, Bandos, Hanna, Senkus, Elżbieta, Suga, Jennifer M, Shao, Zhimin, Pippas, Andrew W, Nowecki, Zbigniew, Huzarski, Tomasz, Ganz, Patricia A, Lucas, Peter C, Baker, Nigel, Loibl, Sibylle, McConnell, Robin, Piccart, Martine, Schmutzler, Rita, Steger, Guenther G, Costantino, Joseph P, Arahmani, Amal, Wolmark, Norman, McFadden, Eleanor, Karantza, Vassiliki, Lakhani, Sunil R, Yothers, Greg, Campbell, Christine, and Geyer, Charles E

Subjects
Digestive Diseases, Breast Cancer, Cancer, Clinical Research, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Adult, Antineoplastic Agents, Breast Neoplasms, Chemotherapy, Adjuvant, Disease-Free Survival, Double-Blind Method, Female, Genes, BRCA1, Genes, BRCA2, Germ-Line Mutation, Humans, Mastectomy, Middle Aged, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Receptor, ErbB-2, OlympiA Clinical Trial Steering Committee and Investigators, Receptor, erbB-2, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundPoly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with BRCA1 or BRCA2 germline mutation-associated early breast cancer.MethodsWe conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors who had received local treatment and neoadjuvant or adjuvant chemotherapy. Patients were randomly assigned (in a 1:1 ratio) to 1 year of oral olaparib or placebo. The primary end point was invasive disease-free survival.ResultsA total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P

Published
2021

13. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial

Author

Lin, Nancy U, Borges, Virginia, Anders, Carey, Murthy, Rashmi K, Paplomata, Elisavet, Hamilton, Erika, Hurvitz, Sara, Loi, Sherene, Okines, Alicia, Abramson, Vandana, Bedard, Philippe L, Oliveira, Mafalda, Mueller, Volkmar, Zelnak, Amelia, DiGiovanna, Michael P, Bachelot, Thomas, Chien, A Jo, O’Regan, Ruth, Wardley, Andrew, Conlin, Alison, Cameron, David, Carey, Lisa, Curigliano, Giuseppe, Gelmon, Karen, Loibl, Sibylle, Mayor, JoAl, McGoldrick, Suzanne, An, Xuebei, and Winer, Eric P

Subjects
Clinical Trials and Supportive Activities, Cancer, Clinical Research, Neurosciences, Breast Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Breast Neoplasms, Capecitabine, Disease Progression, Double-Blind Method, Female, Humans, Middle Aged, Oxazoles, Pyridines, Quinazolines, Receptor, ErbB-2, Trastuzumab, Young Adult, Receptor, erbB-2, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeIn the HER2CLIMB study, patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastases (BMs) showed statistically significant improvement in progression-free survival (PFS) with tucatinib. We describe exploratory analyses of intracranial efficacy and survival in participants with BMs.Patients and methodsPatients were randomly assigned 2:1 to tucatinib or placebo, in combination with trastuzumab and capecitabine. All patients underwent baseline brain magnetic resonance imaging; those with BMs were classified as active or stable. Efficacy analyses were performed by applying RECIST 1.1 criteria to CNS target lesions by investigator assessment. CNS-PFS (intracranial progression or death) and overall survival (OS) were evaluated in all patients with BMs. Confirmed intracranial objective response rate (ORR-IC) was evaluated in patients with measurable intracranial disease.ResultsThere were 291 patients with BMs: 198 (48%) in the tucatinib arm and 93 (46%) in the control arm. The risk of intracranial progression or death was reduced by 68% in the tucatinib arm (hazard ratio [HR], 0.32; 95% CI, 0.22 to 0.48; P < .0001). Median CNS-PFS was 9.9 months in the tucatinib arm versus 4.2 months in the control arm. Risk of death was reduced by 42% in the tucatinib arm (OS HR, 0.58; 95% CI, 0.40 to 0.85; P = .005). Median OS was 18.1 versus 12.0 months. ORR-IC was higher in the tucatinib arm (47.3%; 95% CI, 33.7% to 61.2%) versus the control arm (20.0%; 95% CI, 5.7% to 43.7%; P = .03).ConclusionIn patients with HER2-positive breast cancer with BMs, the addition of tucatinib to trastuzumab and capecitabine doubled ORR-IC, reduced risk of intracranial progression or death by two thirds, and reduced risk of death by nearly half. To our knowledge, this is the first regimen to demonstrate improved antitumor activity against BMs in patients with HER2-positive breast cancer in a randomized, controlled trial.

Published
2020

14. Gatekeeping in cancer clinical trials in Canada: The ethics of recruiting the ideal patient.

Author

Bell, Jennifer, Kelly, Mary, Gelmon, Karen, Chi, Kim, Ho, Anita, Rodney, Patricia, and Balneaves, Lynda

Subjects
clinical trials, oncology trials, research ethics, trial accrual, trial participants, Biomedical Research, Clinical Trials as Topic, Decision Making, Female, Gatekeeping, Humans, Informed Consent, Male, Neoplasms, Patient Participation, Patient Selection, Qualitative Research, Research Personnel, Surveys and Questionnaires
Abstract

BACKGROUND: Perspectives of clinical trial (CT) personnel on accrual to oncology CTs are relatively absent from the literature. This study explores CT personnels experience recruiting patients to oncology CTs. METHODS: A qualitative study design was utilized. In-depth, individual interviews with 12 oncology CT personnel were conducted, including six CT nurses and six physician-investigators. Interviews were digitally recorded and transcribed verbatim. Data were subjected to thematic and ethical analysis to identify key concepts and themes. RESULTS: CT personnel reported considering two ethical commitments in CT recruitment: maintaining trial integrity and ensuring patient autonomy through obtaining informed consent. The process of gatekeeping emerged as a way to navigate these ethical commitments during CT accrual. Gatekeeping was influenced by: (a) perceptions of patients personal suitability for a trial, and (b) healthcare resources and infrastructure. CT personnels discernment of personal suitability was influenced by patients cognitive and mental health status, language and cultural background, geographic location, family support, and disease status. Three structural factors impacted gatekeeping: complexity of CTs, consent process, and time limitations in the healthcare system. CT personnel experienced most factors as constraints to accrual and gaining patients informed consent. CONCLUSION: CT personnel discussed navigating ethical challenges in CT recruitment by offering enrollment to specific patient populations, exacerbating other ethical tensions. Systems-level strategies are needed to address barriers to ethical CT recruitment. Future research should investigate the role of policies and/or tools (eg, decision aids) to support patients and CT personnels discussions about CT participation, promote more ethical recruitment, and potentially increase accrual.

Published
2020

15. 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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16. Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis

Author

Timcheva, Constanta, Tomova, Antoaneta, Eisen, Andrea, Gelmon, Karen, Lemieux, Julie, Bazan, Fernando, Bourgeois, Hugues, Chakiba, Camille, Chehimi, Mohamad, Dalenc, Florence, De La Motte Rouge, Thibault, Frenel, Jean-Sébastien, Gonçalves, Anthony, Hardy-Bessard, Anne Claire, Lamy, Regine, Levy, Christelle, Lortholary, Alain, Mailliez, Audrey, Medioni, Jacques, Patsouris, Anne, Spaeth, Dominique, Teixeira, Luis, Tennevet, Isabelle, Villanueva, Cristian, You, Benoit, Ettl, Johannes, Gerber, Bernd, Hoffmann, Oliver, Park-Simon, Tjoung-Won, Reinisch, Mattea, Tio, Joke, Wimberger, Pauline, Boer, Katalin, Ballestrero, Alberto, Bianchini, Giampaolo, Biganzoli, Laura, Bordonaro, Roberto, Cognetti, Francesco, De Laurentiis, Michelino, De Placido, Sabino, Guarneri, Valentina, Montemurro, Filippo, Naso, Giuseppe, Santoro, Armando, Zamagni, Claudio, Kim, Seung-Jin, Nakamura, Seigo, Chae, Yee Soo, Cho, Eun Kyung, Hyun, Kim Jee, Im, Seock-Ah, Lee, Keun Seok, Park, Yeon Hee, Sohn, Joo Hyuk, Byrski, Tomasz, Huzarski, Tomasz, Kukielka-Budny, Bozena, Nowecki, Zbigniew, Szoszkiewicz, Renata, Tarnawski, Rafal, Dvornichenko, Viktoria, Moiseenko, Fedor, Mukhametshina, Guzel, Poddubskaya, Elena, Popova, Ekaterina, Tarasova, Anna, Vats, Anna, Adamo, Bárbara, Conejero, Raquel Andrés, Torres, Antonio Antón, Gelpi, Judith Balmaña, Fernández, Nieves Díaz, González, Alejandro Falcón, Garcia, Juan, Lorenzo-Lorenzo, Isabel, Antón, Fernando Moreno, Santisteban, Marta, Stradella, Agostina, Huang, Chiun-Sheng, Aksoy, Sercan, Arslan, Cagatay, Artac, Mehmet, Aydiner, Adnan, Ozyilkan, Ozgur, Sezer, Emel, Armstrong, Anne, Barrett, Sophie, Borley, Annabel, Kemp, Zoe, Michie, Caroline, Mukesh, Mukesh, Perren, Timothy, Swampillai, Angela, Young, Tammy, Gelmon, Karen A., Fasching, Peter A., Couch, Fergus J., Balmaña, Judith, Delaloge, Suzette, Labidi-Galy, Intidhar, Bennett, James, McCutcheon, Susan, Walker, Graham, and O'Shaughnessy, Joyce

Published
2021
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17. Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial.

Author

Diéras, Véronique, Harbeck, Nadia, Joy, Anil Abraham, Gelmon, Karen, Ettl, Johannes, Verma, Sunil, Lu, Dongrui R, Gauthier, Eric, Schnell, Patrick, Mori, Ave, Rugo, Hope S, and Finn, Richard S

Subjects
Humans, Breast Neoplasms, Piperazines, Pyridines, Receptor, erbB-2, Antineoplastic Combined Chemotherapy Protocols, Postmenopause, Female, Letrozole, Breast cancer, Hematologic, Neutropenia, Palbociclib, Safety, Receptor, ErbB-2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundPALOMA-2 confirmed that first-line palbociclib + letrozole improved progression-free survival (hazard ratio, 0.58; 95% confidence interval, 0.46-0.72) in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). This analysis evaluated palbociclib-associated hematologic adverse events (AEs) and provides insight on managing these AEs.Materials and methodsPostmenopausal women with ER+/HER2- ABC were randomly assigned 2:1 to letrozole (2.5 mg daily continuously) plus oral palbociclib (125 mg daily; 3 weeks on/1 week off) or placebo. Safety assessments were performed at baseline, days 1 and 15 (first two cycles) and day 1 of subsequent cycles, and included white blood cell, platelet, and absolute neutrophil count (ANC).ResultsPALOMA-2 randomized 666 women to palbociclib + letrozole (n = 444) or placebo + letrozole (n = 222). Neutropenia was the most common AE (95.3%) with palbociclib (grade 3, 55.6%; grade 4, 11.5%) and was managed by dose modifications; progression-free survival was similar between patients who experienced grade ≥ 3 neutropenia versus those who did not. Median (range) time to onset of neutropenia with palbociclib + letrozole was 15 (12-700) days (grade ≥ 3, 28.0 [12-854] days); median duration of each neutropenia episode grade ≥ 3 was 7.0 days. Asian ethnicity and low baseline ANC were associated with increased risk of grade 3/4 neutropenia with palbociclib (p < .001).ConclusionPalbociclib + letrozole was generally well tolerated. Neutropenia, the most frequently reported AE in women with ER+/HER2- ABC, was mostly transient and manageable by dose modifications in patients who experienced grade ≥ 3 neutropenia, without appearing to compromise efficacy. (Pfizer; NCT01740427) IMPLICATIONS FOR PRACTICE: Palbociclib demonstrated an acceptable safety profile in PALOMA-2 in women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) receiving first-line palbociclib + letrozole. Although hematologic adverse events (AEs) are typically expected with anticancer therapies and are often clinically significant, palbociclib-related hematologic AEs, particularly neutropenia (most frequent AE), were transient/manageable by dose reduction, interruption, or cycle delay, which is in contrast to the more profound neutropenia associated with chemotherapy. Palbociclib dose adjustments decreased hematologic AE severity without appearing to compromise efficacy, supporting palbociclib + letrozole as a first-line treatment for ER+/HER2- ABC.

Published
2019

18. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer

Author

Diéras, Véronique, Rugo, Hope S, Schnell, Patrick, Gelmon, Karen, Cristofanilli, Massimo, Loi, Sherene, Colleoni, Marco, Lu, Dongrui R, Mori, Ave, Gauthier, Eric, Bartlett, Cynthia Huang, Slamon, Dennis J, Turner, Nicholas C, and Finn, Richard S

Subjects
Clinical Research, Breast Cancer, Clinical Trials and Supportive Activities, Cancer, Patient Safety, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Follow-Up Studies, Fulvestrant, Humans, Letrozole, Middle Aged, Piperazines, Prognosis, Pyridines, Receptor, ErbB-2, Receptors, Estrogen, Receptor, erbB-2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundPalbociclib administered with endocrine therapy was tolerable when the overall incidence of toxicities was assessed separately for three PALOMA studies. This study analyzed pooled, longer-term PALOMA safety data longitudinally.MethodsData were pooled from three randomized phase II and III studies (ClinicalTrials.gov: NCT00721409, NCT01740427, NCT01942135) of hormone receptor-positive/human epidermal growth factor receptor 2‒negative advanced breast cancer patients. Front-line patients were randomly assigned to receive letrozole with/without palbociclib (PALOMA-1) or letrozole plus palbociclib/placebo (PALOMA-2). In PALOMA-3, patients with prior endocrine resistance received fulvestrant plus palbociclib/placebo. The cumulative event rates of adverse events (AEs), reporting up to 50 months of treatment, were assessed over time.ResultsPatients who received endocrine therapy (n = 1343) were included in this pooled analysis (872 were also treated with palbociclib, and 471 were not). The most common AEs with palbociclib plus endocrine therapy were neutropenia and infections (any grade, 80.6% and 54.7%, respectively), which were higher than in the endocrine monotherapy arm (any grade, 5.3% and 36.9%). The most common hematologic AEs (≥15.0% in the palbociclib arm) were more likely to be reported in the initial months of the study, after which time the cumulative event rate did not substantially increase. With palbociclib plus endocrine therapy, any grade AEs leading to permanent discontinuation over three years occurred in only 8.3% of patients.ConclusionsBased on these long-term safety analyses, there is no evidence of specific cumulative or delayed toxicities with palbociclib plus endocrine therapy, supporting the ongoing investigation of palbociclib plus endocrine therapy in early breast cancer (NCT02513394).

Published
2019

20. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Author

Sevelda, Paul, Haslbauer, Ferdinand, Penzinger, Monika, Öhler, Leopold, Tinchon, Christoph, Greil, Richard, Heibl, Sonja, Bartsch, Rupert, Wette, Viktor, Singer, Christian F., Pasterk, Claudia, Helfgott, Ruth, Pristauz-Telsnigg, Gunda, Stöger, Herbert, Weltermann, Angsar, Egle, Daniel, Thiel, Irene, Fuchs, David, Rumpold, Holger, Strasser-Weippl, Kathrin, Rautenberg, Beate, Müller, Volkmar, Schmidt, Marcus, Paepke, Stefan, Aydogdu, Mustafa, Thomssen, Christoph, Rom, Joachim, Mau, Christine, Fasching, Peter, Göhring, Uwe-Jochen, Kühn, Thorsten, Noeding, Stefanie, Kümmel, Sherko, Hackmann, John, Stickeler, Elmar, Joshi, Abhishek, Dewar, Joanna, Friedlander, Michael, Phillips, Kelly-Anne, Antill, Yoland, Woodward, Natasha, Abdi, Ehtesham, Tiley, Susan, George, Mathew, Boadle, David, Goodwin, Annabel, van der Westhuizen, Andre, Kannourakis, George, Murray, Nicholas, McCarthy, Nicole, Kroep, Judith, de Boer, Maaike, Heijns, Joan, Jager, Agnes, Erdkamp, Franciscus, Bakker, Sandra, Sonke, Gabe S., Sami, Amer, Mackey, John, Prady, Catherine, Eisen, Andrea, Desbiens, Christine, Patocskai, Erica, Ferrario, Cristiano, Gelmon, Karen, Bordeleau, Louise, Chalchal, Haji, Niraula, Saroj, ido wolf, Senkus, Elżbieta, Duhoux, François, Randal d’Hondt, Luce, Sylvie, Roodenbeke, Daphné t’Kint de, Papadimitriou, Konstantinos, Borms, Marleen, Quaghebeur, Claire, Jacot, William, Brain, Etienne, Venat-Bouvet, Laurence, Lortholary, Alain, Nowecki, Zbigniew, Cardoso, Fátima, Hayward, Richard, Bella, Santiago, Lazzaro, Mauricio Fernández, Pilnik, Norma, Fein, Luis E., Blajman, Cesar, Lerzo, Guillermo, Varela, Mirta, Zarba, Juan Jose, Kaen, Diego, Constanzo, Maria Victoria, Tio, Joke, Siggelkow, Wulf, Jackisch, Christian, Grischke, Eva Maria, Zahm, Dirk, Tato-Varela, Sara, Schmatloch, Sabine, Klare, Peter, Stefek, Andrea, Rhiem, Kerstin, Hoffmann, Oliver, Deryal, Mustafa, Gröll, Isolde, Ledwon, Peter, Uleer, Christoph, Krabisch, Petra, Potenberg, Jochem, Darsow, Maren, Park-Simon, Tjoung-Won, Höffkes, Heinz-Gert, Emde, Till-Oliver, Graffunder, Gerd, Tomé, Oliver, Forstmeyer, Dirk, Terhaag, Jürgen, Salat, Christoph, Kast, Karin, Weniger, Steffi, Schreiber, Carsten, Heinrich, Bernhard, Dieterich, Max, Wüllner, Michaela Penelope, Conejero, Raquel Andrés, García Sáenz, José Ángel, Martinez, Lourdes Calvo, Lanza, Angels Arcusa, Murillo, Serafín Morales, Carrasco, Fernando Henao, Tormo, Salvador Blanch, López, Isabel Álvarez, Delgado Mingorance, Juan Ignacio, Gomez, Elena Álvarez, Santisteban, Marta, Jurado, Josefina Cruz, Quiroga, Vanesa, Borrego, Manuel Ruiz, Martínez de Dueñas, Eduardo, Alés Martínez, Jose Enrique, De la Haba, Juan, Jañez, Noelia Martínez, Lescure, Álvaro Rodríguez, Torres, Antonio Antón, Crusades, Gema Llort, González-Santiago, Santiago, Aragones, Antonia Marquez, Ortega, Ana Laura, Molins, Agusti Barnadas, Chacón López-Muñiz, José Ignacio, Jiménez, Miguel Martín, Bertrán, Ana Santaballa, Rodríguez, César, Cortijo, Lucía González, Cretella, Elisabetta, Cortesi, Laura, Ruggeri, Enzo Maria, Verusio, Claudio, Gori, Stefania, Bonetti, Andrea, Mosconi, Anna Maria, Johannsson, Oskar, Jerusalem, Guy, Neven, Patrick, Nagy, Tünde, Pinotti, Graziella, Colleoni, Marco A., Bernardo, Antonio, Gianni, Lorenzo, Bucci, Eraldo, Biganzoli, Laura, Dedes, Konstantin, Novak, Urban, Zaman, Khalil, Braybrooke, Jeremy, Winter, Matthew, Rea, Daniel, Kelleher, Muireann, Barrett, Sophie, Chan, Stephen, Hickish, Tamas, Hurwitz, Jane, Conibear, John, Jegannathen, Apurna, Parton, Marina, Tutt, Andrew, Allerton, Rozenn, Borley, Annabel, Armstrong, Anne, Copson, Ellen, Levitt, Nicola, Abraham, Jean, Perren, Timothy, Roylance, Rebecca, Ishida, Kazushige, Toyama, Tatsuya, Masuda, Norikazu, Watanabe, Junichiro, Tokunaga, Eriko, Kinoshita, Takayuki, Rai, Yoshiaki, Takada, Masahiro, Yanagita, Yasuhiro, Nakamura, Rikiya, Nakayama, Takahiro, Naoi, Yasuto, Iwata, Hiroji, Nakamura, Seigo, Takahashi, Masato, Aogi, Kenjiro, Tsugawa, Koichiro, Mukai, Hirofumi, Takano, Toshimi, Osaki, Akihiko, Sato, Nobuaki, Yamauchi, Hideko, Tokuda, Yutaka, Ito, Mitsuya, Sugimoto, Takeki, Bahadur, Shakeela W., Ganz, Patricia A., Lu, Min J., Mita, Monica M., Waisman, James, Polikoff, Jonathan A., Telli, Melinda L., Seaward, Samantha A., Suga, J. Marie, Durna, Lara N., Carney, Jennifer Fu, Menter, Alex, Puthillath, Ajithkumar, Rohatgi, Nitin, Feusner, James H., Bobolis, Kristie A., Eisenberg, Peter D., Wong, Derrick, Borges, Virginia F., Urquhart, Alexander T., Hofstatter, Erin W., McCarron, Edward C., Isaacs, Claudine, Herbolsheimer, Pia, Varadarajan, Ramya, Raben, Adam, Deveras, Ruby Anne E., Valdes-Albini, Frances, Mahtani, Reshma L., Meisel, Jane L., Sumrall, Bradley T., Jones, Cheryl F., Ofori, Samuel N., Sumida, Kenneth N.M., Karwal, Mark, Wilbur, Deborah W., Singh, (Joe), Spector, David M., Schallenkamp, John, Merkel, Douglas E., Lo, Shelly S., Khosla, Pam G., Cristofanilli, Massimo, Flaum, Lisa, Hoskins, Kent F., Cobleigh, Melody A., Lambiase, Elyse A., Hahn, Olwen M., Oliff, Ira A., Faller, Bryan A., Wade, James L., Burhani, Nafisa D., Gil, Amaryllis, Einhorn, Harvey E., Storniolo, Anna M.V., Chang, Brian K., Kalra, Maitri, Robin, Erwin L., Ansari, Bilal, Sharma, Priyanka, Dakhil, Shaker R., Deming, Richard L., Cole, John T., Hanson, David S., Ochoa, Augusto C., Garber, Judy E., Zimbler, Harvey, Armstrong, Deborah K., Tkaczuk, Katherine H.R., Riseberg, David A., O'Connor, Brian M., Openshaw, Thomas H., Zakalik, Dana, Vakhariya, Cynthia M., Schott, Anne F., Simon, Michael S., Doyle, Thomas J., Al Baghdadi, Tareq, VanderWoude, Amy, Flynn, Patrick J., Zera, Richard T., Friday, Bret E.B., Ruddy, Kathryn J., Smith, Ron, Ademuyiwa, Olabisi, Foluso, Ellis, Robert, Carlson, Jay W., Marchello, T, Benjamin, Levine, Edward A., Marcom, Paul K., Harkness, Cameron B., Tan, Antoinette R., Charles, William J., Kuzma, Charles S., Asaad, Shonda, Radford, James E., Steen, Preston D., Unnikrishnan, Madhu, Seeger, Grant R., Leu, Kirsten M.H., Copur, Mehmet S., Hauke, Ralph J., Soori, Gamini S., Arrick, Bradley A., Reeder, Jennifer G., Toppmeyer, Deborah L., Dayao, Zoneddy R., Adams, Sylvia, Andreopoulou, Eleni, Allison, Magnuson, Anampa Mesias, Jesus D., Sharma, Ruby, Ramaswamy, Bhuvaneswari, Gerds, Aaron T., Shenk, Robert R., Gross, Howard M., Trehan, Shruti, Razaq, Wajeeha, Mansoor, Abdul H., Hilton, Christie J., Brufsky, Adam M., Huynh, Chanh, Chowdhury, Nabila, Domchek, Susan M., Sigurdson, Elin R., Cescon, Terrence P., Rovito, Marc A., DeNittis, Albert S., Vogel, Victor G., Julian, Thomas B., Boyle, L.E., Baez-Diaz, Luis, Brescia, Frank J., Doster, John E., Siegel, Robert D., Wong, Lucas, Patel, Tejal, Nangia, Julie R., Jones, Catherine A., Cannon, George M., Bear, Harry D., Vachhani, Hetal, Wilkinson, Mary, Wood, Marie E., Yan, Fengting, Sui, Xingwei, van Haelst, Carol M., Specht, Jennifer M., Zhuo, Ying, Qamar, Rubina, Ryan, Matthew L., Stockham, Abigail, Virani, Shamsuddin, Gayle, Arlene A., Jubelirer, Steven J., Kurian, Sobha, Salkeni, Mohamad A., Loman, Niklas, Linderholm, Barbro, Silander, Gustav, Hallbeck, Anna-Lotta, von Wachenfeldt Väppling, Anna, Curtit, Elsa, Cardoso, Catarina, Braga, Sofia, Abreu, Miguel, Casa-Nova, Mafalda, Nave, Mónica, Ciruelos Gil, Eva María, Gelpi, Judith Balmaña, Ortega, Adela Fernández, Padró, Josep Gumà, Bermejo de las Heras, Begoña, Cao, María González, Bañuelos, Juan Cueva, Company, Jesús Alarcon, Villaró, Gemma Viñas, Estevez, Laura García, Huober, Jens, Busch, Steffi, Fehm, Tanja, Hahn, Antje, Grafe, Andrea, Noesselt, Thomas, Dewitz, Thomas, Wagner, Harald, Bechtner, Christina, Weigel, Michael, Kolberg, Hans-Christian, Decker, Thomas, Thomalla, Jörg, Hesse, Tobias, Harbeck, Nadia, Jens-Uwe Blohmer, Jan Schröder, Wolf Sütterlin, Marc, Altena, Renske, Chiu, Chang-Fang, Chen, Shin-Cheh, Hou, Ming-Feng, Chang, Yuan-Ching, Chen, Shang-Hung, Chen, Shou-Tung, Huang, Chiun-Sheng, Yeh, Dah-Cherng, Yu, Jyh-Cherng, Tseng, Ling-Ming, Chung, Wei-Pang, Mailliez, Audrey, Petit, Thierry, Delaloge, Suzette, Lévy, Christelle, Dalivoust, Philippe, Extra, Jean-Marc, Mouret-Reynier, Marie-Ange, Hardy-Bessard, Anne-Claire, Simon, Hélène, L'Haridon, Tiffenn, Mege, Alice, Giacchetti, Sylvie, Chakiba-Brugere, Camille, Gratet, Alain, Pottier, Virginie, Ferrero, Jean-Marc, Tennevet, Isabelle, Perrin, Christophe, Canon, Jean-Luc, Joris, Sofie, Shao, Zhimin, Xu, Binghe, Jiang, ZeFei, Sun, Qiang, Shen, Kunwei, Pang, Da, Zhang, Jin, Wang, Shui, Yang, Hongjian, Liao, Ning, Zheng, Hong, Fu, Peifen, Song, Chuangui, Wang, Yongsheng, Fan, Zhimin, Geng, Cuizhi, Tredan, Olivier, Landherr, László, Kaufman, Bella, Yerushalmi, Rinat, Uziely, Beatrice, Conte, Pierfranco, Zamagni, Claudio, Bianchini, Giampaolo, De Laurentiis, Michelino, Tondini, Carlo, Gebbia, Vittorio, Ciccarese, Mariangela, Sarosiek, Tomasz, Mackiewicz, Jacek, Słowińska, Anna, Kalinka, Ewa, Huzarski, Tomasz, Im, Seock-Ah, Jung, Kyung Hae, Sohn, Joo Hyuk, Kim, Jee Hyun, Lee, Keun Seok, Park, Yeon Hee, Lee, Kyoung Eun, Chae, Yee Soo, Cho, Eun Kyung, Geyer, C.E., Jr., Garber, J.E., Gelber, R.D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A.C., Arnedos, M., Balmaña, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S.M., Eisen, A., Elsafy, F., Fein, L.E., Fielding, A., Ford, J.M., Friedman, S., Gelmon, K.A., Gianni, L., Gnant, M., Hollingsworth, S.J., Im, S.-A., Jager, A., Jóhannsson, Ó. Þ, Lakhani, S.R., Janni, W., Linderholm, B., Liu, T.-W., Loman, N., Korde, L., Loibl, S., Lucas, P.C., Marmé, F., Martinez de Dueñas, E., McConnell, R., Phillips, K.-A., Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C.F., Španić, T., Stickeler, E., Toi, M., Traina, T.A., Viale, G., Zoppoli, G., Park, Y.H., Yerushalmi, R., Yang, H., Pang, D., Jung, K.H., Mailliez, A., Fan, Z., Tennevet, I., Zhang, J., Nagy, T., Sonke, G.S., Sun, Q., Parton, M., Colleoni, M.A., Schmidt, M., Brufsky, A.M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., and Tutt, A.N.J.

Published
2022
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21. Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HER2+ Breast Cancer in Both the Early and Metastatic Setting.

Author

Manna, Mita, Gelmon, Karen A., Boileau, Jean-François, Brezden-Masley, Christine, Cao, Jeffrey Q., Jerzak, Katarzyna J., Prakash, Ipshita, Sehdev, Sandeep, Simmons, Christine, Bouganim, Nathaniel, Brackstone, Muriel, Cescon, David W., Chia, Stephen, Dayes, Ian S., Edwards, Scott, Hilton, John, Joy, Anil Abraham, Laing, Kara, Webster, Marc, and Henning, Jan-Willem

Subjects
*HER2 positive breast cancer, *EPIDERMAL growth factor receptors, *BREAST cancer, *CANCER patients, *HORMONE receptor positive breast cancer
Abstract

Human epidermal growth factor receptor 2-positive (HER2+) breast cancer is an aggressive subtype of breast cancer associated with a poor prognosis when sub-optimally treated. Recent advances include new and effective targeted therapies that have significantly improved outcomes for patients. Despite these advances, there are significant gaps across Canada, underscoring the need for evidence-based consensus guidance to inform treatment decisions. Addressing these gaps is crucial to ensuring that effective therapies are integrated into clinical practice, so as to improve the lives of patients affected by this aggressive form of breast cancer. The Research Excellence, Active Leadership (REAL) Canadian Breast Cancer Alliance is a standing nucleus committee of clinical-academic oncologists across Canada and Breast Cancer Canada, a patient organization. The mandate of this group is to provide evidence-based guidance on best practices in the management of patients with breast cancer. These consensus recommendations were developed using a modified Delphi process with up to three rounds of anonymous voting. Consensus was defined a priori as ≥75% of voters agreeing with the recommendation as written. There are 9 recommendations in the early setting; 7 recommendations in the metastatic setting; and 10 recommendations for patients with brain metastases. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for Clinical Staging of Patients Newly Diagnosed with Breast Cancer.

Author

Cao, Jeffrey Q., Surgeoner, Brae, Manna, Mita, Boileau, Jean-François, Gelmon, Karen A., Brackstone, Muriel, Brezden-Masley, Christine, Jerzak, Katarzyna J., Prakash, Ipshita, Sehdev, Sandeep, Wong, Stephanie M., Bouganim, Nathaniel, Cescon, David W., Chia, Stephen, Dayes, Ian S., Joy, Anil Abraham, and Henning, Jan-Willem

Subjects
MEDICAL personnel, ASYMPTOMATIC patients, BREAST cancer, PHYSICIAN practice patterns, SURGICAL margin
Abstract

The accurate staging of breast cancer is fundamental for guiding treatment decisions and predicting patient outcomes. However, there can be considerable variation in routine clinical practice based on individual interpretation of guidelines and depending on the healthcare provider initially involved in working up patients newly diagnosed with breast cancer, ranging from primary care providers, triage nurses, surgeons, and/or oncologists. The optimal approach for clinical staging, particularly in asymptomatic patients presenting with intermediate-risk disease, remains a topic of dialogue among clinicians. Given this area of uncertainty, the Research Excellence, Active Leadership (REAL) Canadian Breast Cancer Alliance conducted a modified Delphi process to assess the level of agreement among Canadian expert clinicians on various staging recommendations. In total, 20 items were drafted covering staging based on biological status, the utilization of localization clips, both for the axilla during diagnosis and primary surgical site for margins and radiation therapy planning, and the use of advanced imaging for the investigation of distant metastases. Overall, the consensus threshold among all participants (i.e., ≥75% agreement) was reached in 20/20 items. Differences in clinical practice and recent findings from the literature are provided in the discussion. These consensus recommendations are meant to help standardize breast cancer staging practices in Canada, ensuring accurate diagnosis and optimal treatment planning. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Comparative biomarker analysis of PALOMA-2/3 trials for palbociclib

Author

Zhu, Zhou, Turner, Nicholas C., Loi, Sherene, André, Fabrice, Martin, Miguel, Diéras, Véronique, Gelmon, Karen A., Harbeck, Nadia, Zhang, Cathy, Cao, Joan Q., Yan, Zhengming, Lu, Dongrui R., Wei, Ping, VanArsdale, Todd L., Rejto, Paul A., Huang, Xin, Rugo, Hope S., Loibl, Sibylle, Cristofanilli, Massimo, Finn, Richard S., and Liu, Yuan

Published
2022
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25. 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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26. Accurate determination of CRISPR-mediated gene fitness in transplantable tumours

Author

Eirew, Peter, O’Flanagan, Ciara, Ting, Jerome, Salehi, Sohrab, Brimhall, Jazmine, Wang, Beixi, Biele, Justina, Algara, Teresa, Lee, So Ra, Hoang, Corey, Yap, Damian, McKinney, Steven, Bates, Cherie, Kong, Esther, Lai, Daniel, Beatty, Sean, Andronescu, Mirela, Zaikova, Elena, Funnell, Tyler, Ceglia, Nicholas, Chia, Stephen, Gelmon, Karen, Mar, Colin, Shah, Sohrab, Roth, Andrew, Bouchard-Côté, Alexandre, and Aparicio, Samuel

Published
2022
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28. Preservation of quality of life in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial)

Author

Mueller, Volkmar, Wardley, Andrew, Paplomata, Elisavet, Hamilton, Erika, Zelnak, Amelia, Fehrenbacher, Louis, Jakobsen, Erik, Curtit, Elsa, Boyle, Frances, Harder Brix, Eva, Brenner, Andrew, Crouzet, Laurence, Ferrario, Cristiano, Muñoz-Mateu, Montserrat, Arkenau, Hendrik-Tobias, Iqbal, Nayyer, Aithal, Sramila, Block, Margaret, Cold, Soeren, Cancel, Mathilde, Hahn, Olwen, Poosarla, Teja, Stringer-Reasor, Erica, Colleoni, Marco, Cameron, David, Curigliano, Giuseppe, Siadak, Muriel, DeBusk, Kendra, Ramos, Jorge, Feng, Wentao, and Gelmon, Karen

Published
2021
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31. Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2

Author

Rugo, Hope S., Finn, Richard S., Gelmon, Karen, Joy, Anil A., Harbeck, Nadia, Castrellon, Aurelio, Mukai, Hirofumi, Walshe, Janice M., Mori, Ave, Gauthier, Eric, Lu, Dongrui Ray, Bananis, Eustratios, Martin, Miguel, and Diéras, Véronique

Published
2020
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32. Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer

Author

Slamon, Dennis J., primary, Diéras, Véronique, additional, Rugo, Hope S., additional, Harbeck, Nadia, additional, Im, Seock-Ah, additional, Gelmon, Karen A., additional, Lipatov, Oleg N., additional, Walshe, Janice M., additional, Martin, Miguel, additional, Chavez-MacGregor, Mariana, additional, Bananis, Eustratios, additional, Gauthier, Eric, additional, Lu, Dongrui R., additional, Kim, Sindy, additional, and Finn, Richard S., additional

Published
2024
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33. Correction to: A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer

Author

Curigliano, Giuseppe, Shapiro, Geoffrey I., Kristeleit, Rebecca S., Abdul Razak, Albiruni R., Leong, Stephen, Alsina, Maria, Giordano, Antonio, Gelmon, Karen A., Stringer-Reasor, Erica, Vaishampayan, Ulka N., Middleton, Mark, Olszanski, Anthony J., Rugo, Hope S., Kern, Kenneth A., Pathan, Nuzhat, Perea, Rachelle, Pierce, Kristen J., Mutka, Sarah C., and Wainberg, Zev A.

Published
2023
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35. Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials

Author

Finn, Richard S., Cristofanilli, Massimo, Ettl, Johannes, Gelmon, Karen A., Colleoni, Marco, Giorgetti, Carla, Gauthier, Eric, Liu, Yuan, Lu, Dongrui R., Zhang, Zhe, Bartlett, Cynthia Huang, Slamon, Dennis J., Turner, Nicholas C., and Rugo, Hope S.

Published
2020
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39. Effect of metformin versus placebo on metabolic factors in the MA.32 randomized breast cancer trial

Author

Goodwin, Pamela J., Dowling, Ryan J. O., Ennis, Marguerite, Chen, Bingshu E., Parulekar, Wendy R., Shepherd, Lois E., Burnell, Margot J., Vander Meer, Rachel, Molckovsky, Andrea, Gurjal, Anagha, Gelmon, Karen A., Ligibel, Jennifer A., Hershman, Dawn L., Mayer, Ingrid A., Whelan, Timothy J., Hobday, Timothy J., Rastogi, Priya, Rabaglio-Poretti, Manuela, Lemieux, Julie, Thompson, Alastair M., Rea, Daniel W., and Stambolic, Vuk

Published
2021
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41. Clonal Decomposition and DNA Replication States Defined by Scaled Single-Cell Genome Sequencing

Author

Hannon, Gregory J., Battistoni, Giorgia, Bressan, Dario, Cannell, Ian, Casbolt, Hannah, Jauset, Cristina, Kovačević, Tatjana, Mulvey, Claire, Nugent, Fiona, Ribes, Marta Paez, Pearsall, Isabella, Qosaj, Fatime, Sawicka, Kirsty, Wild, Sophia, Williams, Elena, Aparicio, Samuel, Laks, Emma, Li, Yangguang, O’Flanagan, Ciara, Smith, Austin, Ruiz, Teresa, Balasubramanian, Shankar, Lee, Maximillian, Bodenmiller, Bernd, Burger, Marcel, Kuett, Laura, Tietscher, Sandra, Windager, Jonas, Boyden, Edward, Alon, Shahar, Cui, Yi, Emenari, Amauche, Goodwin, Dan, Karagiannis, Emmanouil, Sinha, Anubhav, Wassie, Asmamaw T., Caldas, Carlos, Bruna, Alejandra, Callari, Maurizio, Greenwood, Wendy, Lerda, Giulia, Lubling, Yaniv, Marti, Alastair, Rueda, Oscar, Shea, Abigail, Harris, Owen, Becker, Robby, Grimaldi, Flaminia, Harris, Suvi, Vogl, Sara, Joyce, Johanna A., Hausser, Jean, Watson, Spencer, Shah, Sorhab, McPherson, Andrew, Vázquez-García, Ignacio, Tavaré, Simon, Dinh, Khanh, Fisher, Eyal, Kunes, Russell, Walton, Nicolas A., Al Sa’d, Mohammad, Chornay, Nick, Dariush, Ali, Solares, Eduardo Gonzales, Gonzalez-Fernandez, Carlos, Yoldas, Aybuke Kupcu, Millar, Neil, Zhuang, Xiaowei, Fan, Jean, Lee, Hsuan, Duran, Leonardo Sepulveda, Xia, Chenglong, Zheng, Pu, Zahn, Hans, Lai, Daniel, Steif, Adi, Brimhall, Jazmine, Biele, Justina, Wang, Beixi, Masud, Tehmina, Ting, Jerome, Grewal, Diljot, Nielsen, Cydney, Leung, Samantha, Bojilova, Viktoria, Smith, Maia, Golovko, Oleg, Poon, Steven, Eirew, Peter, Kabeer, Farhia, Ruiz de Algara, Teresa, Lee, So Ra, Taghiyar, M. Jafar, Huebner, Curtis, Ngo, Jessica, Chan, Tim, Vatrt-Watts, Spencer, Walters, Pascale, Abrar, Nafis, Chan, Sophia, Wiens, Matt, Martin, Lauren, Scott, R. Wilder, Underhill, T. Michael, Chavez, Elizabeth, Steidl, Christian, Da Costa, Daniel, Ma, Yussanne, Coope, Robin J.N., Corbett, Richard, Pleasance, Stephen, Moore, Richard, Mungall, Andrew J., Mar, Colin, Cafferty, Fergus, Gelmon, Karen, Chia, Stephen, Marra, Marco A., Hansen, Carl, and Shah, Sohrab P.

Published
2019
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42. 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, Bradley, Rosie, Braybrooke, Jeremy, Liu, Zulian, Peto, Richard, Davies, Lucy, Dodwell, David, McGale, Paul, Pan, Hongchao, Taylor, Carolyn, Barlow, William, Bliss, Judith, Bruzzi, Paolo, Cameron, David, Fountzilas, George, Loibl, Sibylle, Mackey, John, Martin, Miguel, Del Mastro, Lucia, Möbus, Volker, Nekljudova, Valentina, De Placido, Sabino, Swain, Sandra, Untch, Michael, Pritchard, Kathleen I, Bergh, Jonas, Norton, Larry, Boddington, Clare, Burrett, Julie, Clarke, Mike, Davies, Christina, Duane, Fran, Evans, Vaughan, Gettins, Lucy, Godwin, Jon, Hills, Robert, James, Sam, Liu, Hui, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Wang, Yaochen, Wang, Zhe, Fasching, Peter, Harbeck, Nadia, Piedbois, Pascal, Gnant, Michael, Steger, Guenther, Di Leo, Angelo, Dolci, Stella, Francis, Prue, Larsimont, Denis, Nogaret, Jean Marie, Philippson, Catherine, Piccart, Martine, Linn, Sabine, Peer, Petronella, Tjan-Heijnen, Vivianne, Vliek, Sonja, Slamon, Dennis, Bartlett, John, Bramwell, Vivien H, Chen, Bingshu, Chia, Stephen, Gelmon, Karen, Goss, Paul, Levine, Mark, Parulekar, Wendy, Pater, Joseph, Rakovitch, Eileen, Shepherd, Lois, Tu, Dongsheng, Whelan, Tim, Berry, Don, Broadwater, Gloria, Cirrincione, Constance, Muss, Hyman, Weiss, Raymond, Shan, Yi, Shao, Yong Fu, Wang, Xiang, Xu, Binghe, Zhao, Dong-Bing, Bartelink, Harry, Bijker, Nina, Bogaerts, Jan, Cardoso, Fatima, Cufer, Tanja, Julien, Jean-Pierre, Poortmans, Philip, Rutgers, Emiel, van de Velde, Cornelis, Carrasco, Eva, Segui, Miguel Angel, Blohmer, Jens Uwe, Costa, Serban, Gerber, Bernd, Jackisch, Christian, von Minckwitz, Gunter, Giuliano, Mario, De Laurentiis, Michele, Bamia, Christina, Koliou, Georgia-Angeliki, Mavroudis, Dimitris, A'Hern, Roger, Ellis, Paul, Kilburn, Lucy, Morden, James, Yarnold, John, Sadoon, Mohammad, Tulusan, Augustinus H, Anderson, Stewart, Bass, Gordon, Costantino, Joe, Dignam, James, Fisher, Bernard, Geyer, Charles, Mamounas, Eleftherios P, Paik, Soon, Redmond, Carol, Wickerham, D Lawrence, Venturini, Marco, Bighin, Claudia, Pastorino, Simona, Pronzato, Paolo, Sertoli, Mario Roberto, Foukakis, Theodorus, Albain, Kathy, Arriagada, Rodrigo, Bergsten Nordström, Elizabeth, Boccardo, Francesco, Brain, Etienne, Carey, Lisa, Coates, Alan, Coleman, Robert, Correa, Candace, Cuzick, Jack, Davidson, Nancy, Dowsett, Mitch, Ewertz, Marianne, Forbes, John, Gelber, Richard, Goldhirsch, Aron, Goodwin, Pamela, Hayes, Daniel, Hill, Catherine, Ingle, James, Jagsi, Reshma, Janni, Wolfgang, Mukai, Hirofumi, Ohashi, Yasuo, Pierce, Lori, Raina, Vinod, Ravdin, Peter, Rea, Daniel, Regan, Meredith, Robertson, John, Sparano, Joseph, Tutt, Andrew, Viale, Giuseppe, Wilcken, Nicholas, Wolmark, Norman, Wood, Wiliam, and Zambetti, Milvia

Published
2019
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43. Primary Results of ROSE/TRIO-12, a Randomized Placebo-Controlled Phase III Trial Evaluating the Addition of Ramucirumab to First-Line Docetaxel Chemotherapy in Metastatic Breast Cancer

Author

Mackey, John R, Ramos-Vazquez, Manuel, Lipatov, Oleg, McCarthy, Nicole, Krasnozhon, Dmitriy, Semiglazov, Vladimir, Manikhas, Alexey, Gelmon, Karen A, Konecny, Gottfried E, Webster, Marc, Hegg, Roberto, Verma, Sunil, Gorbunova, Vera, Abi Gerges, Dany, Thireau, Francois, Fung, Helena, Simms, Lorinda, Buyse, Marc, Ibrahim, Ayman, and Martin, Miguel

Subjects
Cancer, Clinical Research, Clinical Trials and Supportive Activities, Breast Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Disease-Free Survival, Docetaxel, Double-Blind Method, Drug Administration Schedule, Fatigue, Febrile Neutropenia, Female, Hand-Foot Syndrome, Humans, Hypertension, Immunoglobulin G, Kaplan-Meier Estimate, Middle Aged, Neoplasm Recurrence, Local, Stomatitis, Taxoids, Treatment Outcome, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeCurrently, antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival (PFS) but not improved quality or duration of survival, warranting evaluation of new agents in a placebo-controlled setting. Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation. The ROSE/TRIO-012 trial evaluated ramucirumab with docetaxel in unresectable, locally recurrent, or metastatic breast cancer.Patients and methodsIn this double-blind, placebo-controlled, randomized, multinational phase III trial, 1,144 patients with human epidermal growth factor receptor 2 (HER2) -negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting were randomly assigned at a two-to-one ratio to receive docetaxel 75 mg/m(2) plus ramucirumab 10 mg/kg or docetaxel 75 mg/m(2) plus placebo once every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria. Patients were stratified by previous taxane therapy, visceral metastasis, hormone receptor status, and geographic region. An independent data monitoring committee oversaw the trial. The primary end point was investigator-assessed PFS.ResultsMedian PFS in patients treated with ramucirumab plus docetaxel was 9.5 months, compared with 8.2 months in patients who received placebo plus docetaxel (hazard ratio [HR], 0.88; P = .077). Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel, compared with 27.2 months in patients who received placebo plus docetaxel (HR, 1.01; P = .915). Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue, hypertension, febrile neutropenia, palmar-plantar erythrodysesthesia syndrome, and stomatitis.ConclusionAddition of ramucirumab to docetaxel in HER2-negative advanced breast cancer did not meaningfully improve important clinical outcomes.

Published
2015

44. Circulating tumour mutation detection in triple-negative breast cancer as an adjunct to tissue response assessment

Author

Zaikova, Elena, primary, Cheng, Brian Y. C., additional, Cerda, Viviana, additional, Kong, Esther, additional, Lai, Daniel, additional, Lum, Amy, additional, Bates, Cherie, additional, den Brok, Wendie, additional, Kono, Takako, additional, Bourque, Sylvie, additional, Chan, Angela, additional, Feng, Xioalan, additional, Fenton, David, additional, Gurjal, Anagha, additional, Levasseur, Nathalie, additional, Lohrisch, Caroline, additional, Roberts, Sarah, additional, Shenkier, Tamara, additional, Simmons, Christine, additional, Taylor, Sara, additional, Villa, Diego, additional, Miller, Ruth, additional, Aguirre-Hernandez, Rosalia, additional, Aparicio, Samuel, additional, and Gelmon, Karen, additional

Published
2024
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46. Improving Care for Older Adults with Cancer in Canada: A Call to Action.

Author

Cook, Sarah, Alibhai, Shabbir, Mehta, Rajin, Savard, Marie-France, Mariano, Caroline, LeBlanc, Dominique, Desautels, Danielle, Pezo, Rossanna, Zhu, Xiaofu, Gelmon, Karen A., and Hsu, Tina

Subjects
OLDER people, CANCER patients, GERIATRIC oncology, MEDICAL personnel, GERIATRIC nursing, ONCOLOGY nursing, TUMOR growth
Abstract

Most patients diagnosed with and dying from cancer in Canada are older adults, with aging contributing to the large projected growth in cancer incidence. Older adults with cancer have unique needs, and on a global scale increasing efforts have been made to address recognized gaps in their cancer care. However, in Canada, geriatric oncology remains a new and developing field. There is increasing recognition of the value of geriatric oncology and there is a growing number of healthcare providers interested in developing the field. While there is an increasing number of dedicated programs in geriatric oncology, they remain limited overall. Developing novel methods to delivery geriatric care in the oncology setting and improving visibility is important. Formal incorporation of a geriatric oncology curriculum into training is critical to both improve knowledge and demonstrate its value to healthcare providers. Although a robust group of dedicated researchers exist, increased collaboration is needed to capitalize on existing expertise. Dedicated funding is critical to promoting clinical programs, research, and training new clinicians and leaders in the field. By addressing challenges and capitalizing on opportunities for improvement, Canada can better meet the unique needs of its aging population with cancer and ultimately improve their outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Vitamin D Levels, Vitamin D Receptor Polymorphisms, and Inflammatory Cytokines in Aromatase Inhibitor-Induced Arthralgias: An Analysis of CCTG MA.27

Author

Niravath, Polly, Chen, Bingshu, Chapman, Judy-Anne W., Agarwal, Sandeep K., Welschhans, Robert L., Bongartz, Tim, Kalari, Krishna R., Shepherd, Lois E., Bartlett, John, Pritchard, Kathleen, Gelmon, Karen, Hilsenbeck, Susan G., Rimawi, Mothaffar F., Osborne, C. Kent, Goss, Paul E., and Ingle, James N.

Published
2018
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