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1. Impact of coadministration of proton-pump inhibitors and palbociclib in hormone receptor-positive/HER2-negative advanced breast cancer

Author

Di Cosimo, Serena, Pérez-García, José Manuel, Bellet, Meritxell, Dalenc, Florence, Gil Gil, Miguel J., Ruiz-Borrego, Manuel, Gavilá, Joaquín, Aguirre, Elena, Schmid, Peter, Marmé, Frederik, Gligorov, Joseph, Schneeweiss, Andreas, Albanell, Joan, Zamora, Pilar, Wheatley, Duncan, Martínez de Dueñas, Eduardo, Amillano, Kepa, Shimizu, Eileen, Sampayo-Cordero, Miguel, Cortés, Javier, and Llombart-Cussac, Antonio

Published
2024
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2. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03).

Author

Steger, Guenther, Hernando Fernández de Aránguiz, Blanca, Haddad, Tufia, Perelló, Antonia, Bellet, Meritxell, Fohler, Hannes, Metzger Filho, Otto, Jallitsch-Halper, Anita, Solomon, Kadine, Schurmans, Céline, Theall, Kathy, Lu, Dongrui, Tenner, Kathleen, Fesl, Christian, DeMichele, Angela, Mayer, Erica, Gnant, Michael, Dueck, Amylou, Frantal, Sophie, Martin, Miguel, Burstein, Hal, Greil, Richard, Fox, Peter, Wolff, Antonio, Chan, Arlene, Winer, Eric, Pfeiler, Georg, Miller, Kathy, Colleoni, Marco, Suga, Jennifer, Rubovsky, Gabor, Bliss, Judith, Mayer, Ingrid, Singer, Christian, Nowecki, Zbigniew, Hahn, Olwen, Thomson, Jacqui, Wolmark, Norman, Amillano, Kepa, and Rugo, Hope

Subjects
Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Female, Humans, Mastectomy, Middle Aged, Neoadjuvant Therapy, Neoplasm Staging, Piperazines, Progression-Free Survival, Prospective Studies, Protein Kinase Inhibitors, Pyridines, Time Factors
Abstract

PURPOSE: Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor-positive breast cancer has not been confirmed. PATIENTS AND METHODS: In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer-free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival. RESULTS: Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial. CONCLUSION: At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor-positive breast cancer.

Published
2022

3. Neoadjuvant eribulin in HER2-negative early-stage breast cancer (SOLTI-1007-NeoEribulin): a multicenter, two-cohort, non-randomized phase II trial

Author

Pascual, Tomás, Oliveira, Mafalda, Villagrasa, Patricia, Ortega, Vanesa, Paré, Laia, Bermejo, Begoña, Morales, Serafín, Amillano, Kepa, López, Rafael, Galván, Patricia, Canes, Jordi, Salvador, Fernando, Nuciforo, Paolo, Rubio, Isabel T., Llombart-Cussac, Antonio, Di Cosimo, Serena, Baselga, José, Harbeck, Nadia, Prat, Aleix, and Cortés, Javier

Published
2021
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4. 2837: Metabolic profiling of plasma and tissue in breast cancer patients: uncovering therapeutic response

Author

Jiménez-Franco, Andrea, Calderón, David, Jiménez-Aguilar, Juanma, Canela-Capdevila, Marta, García-Pablo, Raquel, Castañé, Helena, Araguas, Pablo, Malave, Bárbara, Acosta, Johana Cristina, Benavides, Rocío, Árquez, Miguel, Castaño, Fredy, Riu, Francesc, de la Flor, Miriam, Jordà, Coia, Melé, Mireia, Repkova, Jana, Amillano, Kepa, Camps, Jordi, Joven, Jorge, and Arenas, Meritxell

Published
2024
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5. Oral metronomic vinorelbine combined with endocrine therapy in hormone receptor-positive HER2-negative breast cancer: SOLTI-1501 VENTANA window of opportunity trial

Author

Adamo, Barbara, Bellet, Meritxell, Paré, Laia, Pascual, Tomás, Vidal, Maria, Pérez Fidalgo, José A., Blanch, Salvador, Martinez, Noelia, Murillo, Laura, Gómez-Pardo, Patricia, López-González, Ana, Amillano, Kepa, Canes, Jordi, Galván, Patricia, González-Farré, Blanca, González, Xavier, Villagrasa, Patricia, Ciruelos, Eva, and Prat, Aleix

Published
2019
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6. Abstract PD13-10: PD13-10 Impact of Proton Pump Inhibitors (PPI) on Palbociclib (PAL) Outcomes in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (HR+/HER2- ABC): Exploratory Analysis of the PARSIFAL Trial

Author

Cosimo, Serena Di, primary, Pérez-García, José Manuel, additional, Ezquerra, Meritxell Bellet, additional, Dalenc, Florence, additional, Gil, Miguel Gil, additional, Borrego, Manuel Ruiz, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, De Dueñas, Eduardo Martínez, additional, Carañana, Vicente, additional, Amillano, Kepa, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2023
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7. Abstract PD13-01: PD13-01 Elacestrant in postmenopausal women with estrogen receptor positive and HER2-negative early breast cancer: primary efficacy and safety analysis of the preoperative, window of opportunity SOLTI-1905-ELIPSE trial

Author

Vidal, Maria, primary, Pascual, Tomás, additional, Falato, Claudette, additional, Sanchez-Bayona, Rodrigo, additional, Muñoz, Montserrat, additional, Cerbrecos, Isaac, additional, Gonzalez-Farré, Xavier, additional, Cortadellas, Tomás, additional, Margelí, Mireia, additional, Luna, Miguel Angel, additional, Siso, Christian, additional, Amillano, Kepa, additional, Galván, Patricia, additional, Salvador, Fernando, additional, Espinosa, Alejandra, additional, Paré, Laia, additional, Sanfeliu, Esther, additional, Prat, Aleix, additional, and Ezquerra, Meritxell Bellet, additional

Published
2023
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8. SOLTI-1904 ACROPOLI TRIAL: efficacy of spartalizumab monotherapy across tumor-types expressing high levels of PD1 mRNA

Author

Prat, Aleix, primary, Paz-Ares, Luis, additional, Juan, Manel, additional, Felip, Enriqueta, additional, Garralda, Elena, additional, González, Blanca, additional, Arance, Ana, additional, Martín-Liberal, Juan, additional, Gavilá, Joaquín, additional, López-González, Ana, additional, Cejalvo, Juan Miguel, additional, Izarzugaza, Yann, additional, Amillano, Kepa, additional, Corbacho, Javier García, additional, Saura, Cristina, additional, Racca, Fabricio, additional, Hierro, Cinta, additional, Sanfeliu, Esther, additional, Gonzalez, Xavier, additional, Canes, Jordi, additional, Villacampa, Guillermo, additional, Salvador, Fernando, additional, Pascual, Tomás, additional, Mesía, Ricard, additional, Cervantes, Andrés, additional, and Tabernero, Josep, additional

Published
2022
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9. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial

Author

Di Cosimo, Serena, primary, Pérez-García, José Manuel, additional, Bellet, Meritxell, additional, Dalenc, Florence, additional, Gil Gil, Miguel J, additional, Ruiz Borrego, Manuel, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, Martínez-De Dueñas, Eduardo, additional, Carañana, Vicente, additional, Amillano, Kepa, additional, Mina, Leonardo, additional, Malfettone, Andrea, additional, Cortés, Javier, additional, and Llombart-Cussac, Antonio, additional

Published
2022
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11. SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer

Author

Llombart-Cussac, Antonio, Bermejo, Begoña, Villanueva, Cristian, Delaloge, Suzette, Morales, Serafín, Balmaña, Judith, Amillano, Kepa, Bonnefoi, Hervé, Casas, Ana, Manso, Luis, Roché, Henri, Gonzalez-Santiago, Santiago, Gavilá, Joaquín, Sánchez-Rovira, Pedro, Di Cosimo, Serena, Harbeck, Nadia, Charpentier, Eric, Garcia-Ribas, Ignacio, Radosevic-Robin, Nina, Aura, Claudia, and Baselga, Jose

Published
2015
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13. Abstract P1-07-02: Primary results of ONAWA (SOLTI-1802) trial: A window of opportunity trial of onapristone in postmenopausal women with progesterone receptor-positive/HER2-negative early breast cancer (EBC)

Author

Bellet, Meritxell, primary, Morales, Serafin, additional, Gasol, Ariadna, additional, Amillano, Kepa, additional, Chic, Nuria, additional, González-Farré, Xavier, additional, Villagrasa, Patricia, additional, Paré, Laia, additional, Falato, Claudette, additional, Nuciforo, Paolo, additional, Martínez, Débora, additional, Ferrero-Cafiero, Juan M, additional, Pascual, Tomás, additional, Prat, Aleix, additional, Lange, Carol, additional, and Saura, Cristina, additional

Published
2022
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14. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial.

Author

Cosimo, Serena Di, Pérez-García, José Manuel, Bellet, Meritxell, Dalenc, Florence, Gil, Miguel J Gil, Borrego, Manuel Ruiz, Gavilá, Joaquín, Sampayo-Cordero, Miguel, Aguirre, Elena, Schmid, Peter, Marmé, Frederik, Gligorov, Joseph, Schneeweiss, Andreas, Albanell, Joan, Zamora, Pilar, Wheatley, Duncan, Dueñas, Eduardo Martínez-De, Carañana, Vicente, Amillano, Kepa, and Mina, Leonardo

Subjects
THERAPEUTIC use of antineoplastic agents, DRUG efficacy, LETROZOLE, DRUG tolerance, VEINS, LEUCOPENIA, DIARRHEA, PULMONARY embolism, PROTEIN kinase inhibitors, AGE distribution, FULVESTRANT, NEUTROPENIA, JOINT pain, INTERSTITIAL lung diseases, ASTHENIA, THROMBOEMBOLISM, ANEMIA, PROGRESSION-free survival, FATIGUE (Physiology), HORMONE receptor positive breast cancer, PATIENT safety, DISEASE risk factors, EVALUATION
Abstract

Background Palbociclib has gained a central role in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC). Despite its manageable toxicity profile, venous thromboembolism (VTE) or interstitial lung disease (ILD)/pneumonitis may infrequently occur. Therefore, we provide a comprehensive summary of the safety and tolerability of the combination of endocrine therapy and palbociclib among patients included in the randomized phase 2 PARSIFAL study. Materials and Methods Patients with endocrine-sensitive HR+/HER2- ABC and no prior therapy in an advanced setting (n  = 486) were randomly assigned 1:1 to receive fulvestrant–palbociclib (FP) or letrozole–palbociclib (LP). Laboratory tests and the incidence of adverse events (AEs) were recorded at baseline and day 1 of each cycle. Progression-free survival (PFS) was estimated for patients with and without VTE. Results A total of 483 patients were analyzed. Neutropenia, leukopenia, anemia, asthenia, arthralgia, fatigue, and diarrhea were the most frequent AEs in both groups. Febrile neutropenia occurred in 3 (1.2%) patients of the FP group and in 1 (0.4%) patient in the LP group. Six (2.5%; 0.4% grade 3) patients in the FP group and 6 patients (2.5%; 0.4% grade 3) in the LP group experienced ILD/pneumonitis. Pulmonary embolism was reported in 12 (5.0%) patients in the FP group and 6 (2.5%) patients in the LP group. Advanced age at baseline was the only factor significantly associated with an increased risk of pulmonary embolism (P  < .01). Conclusion The PARSIFAL data confirmed the favorable safety profile of both palbociclib regimens. VTE and ILD/pneumonitis were occasionally reported, and their early detection allowed patients to continue treatment effectively without detriment to efficacy. ClinicalTrials.gov Identifier NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983). [ABSTRACT FROM AUTHOR]

Published
2023
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15. Abstract PS10-17: Palbociclib (P) in combination with fulvestrant (F) or letrozole (L) in endocrine-sensitive patients (pts) with hormone receptor (HR)[+]/HER2[-] metastatic breast cancer (MBC): detailed safety analysis from a multicenter, randomized, open-label, phase II trial (PARSIFAL)

Author

Pérez-García, José Manuel, primary, Llombart-Cussac, Antonio, additional, Bellet, Meritxell, additional, Dalenc, Florence, additional, Gil, Miguel J. Gil, additional, Borrego, Manuel Ruiz, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Di Cosimo, Serena, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, Martínez-De Dueñas, Eduardo, additional, Carañana, Vicente, additional, Amillano, Kepa, additional, Malfettone, Andrea, additional, and Cortés, Javier, additional

Published
2021
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16. PARSIFAL: A randomized, multicenter, open-label, phase II trial to evaluate palbociclib in combination with fulvestrant or letrozole in endocrine-sensitive patients with estrogen receptor (ER)[+]/HER2[-] metastatic breast cancer.

Author

Llombart-Cussac, Antonio, primary, Pérez-García, José Manuel, additional, Bellet, Meritxell, additional, Dalenc, Florence, additional, Gil Gil, Miguel J., additional, Ruiz Borrego, Manuel, additional, Gavilá, Joaquín, additional, Sampayo-Cordero, Miguel, additional, Aguirre, Elena, additional, Schmid, Peter, additional, Marmé, Frederik, additional, Di Cosimo, Serena, additional, Gligorov, Joseph, additional, Schneeweiss, Andreas, additional, Albanell, Joan, additional, Zamora, Pilar, additional, Wheatley, Duncan, additional, Martínez-De Dueñas, Eduardo, additional, Amillano, Kepa, additional, and Cortes, Javier, additional

Published
2020
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17. MOESM5 of Oral metronomic vinorelbine combined with endocrine therapy in hormone receptor-positive HER2-negative breast cancer: SOLTI-1501 VENTANA window of opportunity trial

Author

Adamo, Barbara, Meritxell Bellet, Paré, Laia, Pascual, Tomás, Vidal, Maria, Fidalgo, José Pérez, Blanch, Salvador, Martinez, Noelia, Murillo, Laura, Gómez-Pardo, Patricia, López-González, Ana, Amillano, Kepa, Canes, Jordi, Galván, Patricia, González-Farré, Blanca, González, Xavier, Villagrasa, Patricia, Ciruelos, Eva, and Aleix Prat

Abstract

Additional file 5: Table S2. Summary of the most frequent adverse events (AE).

Published
2019
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18. Stratification of cancer and diabetes based on circulating levels of formate and glucose

Author

Universitat Rovira i Virgili, Pietzke, Matthias; Fernandez Arroyo, Salvador; Sumpton, David; Mackay, Gillian M.; Martin-Castillo, Begona; Camps, Jordi; Joven, Jorge; Menendez, Javier A.; Vazquez, Alexei; Pernas, Sonia; Dorca, Joan; Alvarez-Lopez, Isabel; Martinez, Susana; Manuel Perez-Garcia, Jose; Batista Lopez, Norberto; Rodriguez-Sanchez, Cesar A.; Amillano, Kepa; Dominguez Fernandez, Severina; Luque-Cabal, Maria; Morilla, Idoia; Vinas, Gemma; Cortes, Javier;METTEN Study Grp, Universitat Rovira i Virgili, and Pietzke, Matthias; Fernandez Arroyo, Salvador; Sumpton, David; Mackay, Gillian M.; Martin-Castillo, Begona; Camps, Jordi; Joven, Jorge; Menendez, Javier A.; Vazquez, Alexei; Pernas, Sonia; Dorca, Joan; Alvarez-Lopez, Isabel; Martinez, Susana; Manuel Perez-Garcia, Jose; Batista Lopez, Norberto; Rodriguez-Sanchez, Cesar A.; Amillano, Kepa; Dominguez Fernandez, Severina; Luque-Cabal, Maria; Morilla, Idoia; Vinas, Gemma; Cortes, Javier;METTEN Study Grp

Abstract

BackgroundSerum and urine metabolites have been investigated for their use as cancer biomarkers. The specificity of candidate metabolites can be limited by the impact of other disorders on metabolite levels. In particular, the increasing incidence of obesity could become a significant confounding factor.MethodsHere we developed a multinomial classifier for the stratification of cancer, obesity and healthy phenotypes based on circulating glucose and formate levels. We quantified the classifier performance from the retrospective analysis of samples from breast cancer, lung cancer, obese individuals and healthy controls.ResultsWe discovered that circulating formate levels are significantly lower in breast and lung cancer patients than in healthy controls. However, the performance of a cancer classifier based on formate levels alone is limited because obese patients also have low serum formate levels. By introducing a multinomial classifier based on circulating glucose and formate levels, we were able to improve the classifier performance, reaching a true positive rate of 79% with a false positive rate of 8%.ConclusionsCirculating formate is reduced in HER2+ breast cancer, non-small cell lung cancer and highly obese patients relative to healthy controls. Further studies are required to determine the relevance of these observations in other cancer types and diseases.

Published
2019

19. The C Allele of ATM rs11212617 Associates With Higher Pathological Complete Remission Rate in Breast Cancer Patients Treated With Neoadjuvant Metformin

Author

Universitat Rovira i Virgili, Cuyas, Elisabet; Buxo, Maria; Ferri Iglesias, Maria Jose; Verdura, Sara; Pemas, Sonia; Dorca, Joan; Alvarez, Isabel; Martinez, Susana; Perez-Garcia, Jose Manuel; Batista-Lopez, Norberto; Rodriguez-Sanchez, Cesar A.; Amillano, Kepa; Dominguez, Severina; Luque, Maria; Morilla, Idoia; Stradella, Agostina; Vinas, Gemma; Cortes, Javier; Joven, Jorge; Brunet, Joan; Lopez-Bonet, Eugeni; Garcia, Margarita; Saidani, Samiha; Queralt Moles, Xavier; Martin-Castillo, Begona; Menendez, Javier A., Universitat Rovira i Virgili, and Cuyas, Elisabet; Buxo, Maria; Ferri Iglesias, Maria Jose; Verdura, Sara; Pemas, Sonia; Dorca, Joan; Alvarez, Isabel; Martinez, Susana; Perez-Garcia, Jose Manuel; Batista-Lopez, Norberto; Rodriguez-Sanchez, Cesar A.; Amillano, Kepa; Dominguez, Severina; Luque, Maria; Morilla, Idoia; Stradella, Agostina; Vinas, Gemma; Cortes, Javier; Joven, Jorge; Brunet, Joan; Lopez-Bonet, Eugeni; Garcia, Margarita; Saidani, Samiha; Queralt Moles, Xavier; Martin-Castillo, Begona; Menendez, Javier A.

Abstract

Background: The minor allele (C) of the single-nucleotide polymorphism (SNP) rs11212617, located near the ataxia telangiectasia mutated (ATM) gene, has been associated with an increased likelihood of treatment success with metformin in type 2 diabetes. We herein investigated whether the same SNP would predict clinical response to neoadjuvant metformin in women with early breast cancer (BC). Methods: DNA was collected from 79 patients included in the intention-to-treat population of the METTEN study, a phase 2 clinical trial of HER2-positive BC patients randomized to receive either metformin combined with anthracycline/taxane-based chemotherapy and trastuzumab or equivalent regimen without metformin, before surgery. SNP rs11212617 genotyping was assessed using allelic discrimination by quantitative polymerase chain reaction. Results: Logistic regression analyses revealed a significant relationship between the rs11212617 genotype and the ability of treatment arms to achieve a pathological complete response (pCR) in patients (odds ratio [OR](genotypexarm) = 10.33, 95% confidence interval [CI]: 1.29-82.89, p = 0.028). In the metformin-containing arm, patients bearing the rs11212617 C allele had a significantly higher probability of pCR (ORA/C,C/C = 7.94, 95% CI: 1.60-39.42, p = 0.011). Conversely, no association was found between rs11212617 and clinical response in the reference arm (ORA/C,C/C = 0.77, 95% CI: 0.20-2.92, p = 0.700). After controlling for tumor size and hormone receptor status, the rs11212617 C allele remained a significant predictor of pCR solely in the metformin-containing arm. Conclusions: If reproducible, the rs11212617 C allele might warrant consideration as a predictive clinical biomarker to inform the personalized use of metformin in BC patients.

Published
2019

20. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor–Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial.

Author

Llombart-Cussac, Antonio, Pérez-García, José Manuel, Bellet, Meritxell, Dalenc, Florence, Gil-Gil, Miguel, Ruíz-Borrego, Manuel, Gavilá, Joaquín, Sampayo-Cordero, Miguel, Aguirre, Elena, Schmid, Peter, Marmé, Frederik, Di Cosimo, Serena, Gligorov, Joseph, Schneeweiss, Andreas, Albanell, Joan, Zamora, Pilar, Wheatley, Duncan, Martínez-de Dueñas, Eduardo, Amillano, Kepa, and Malfettone, Andrea

Published
2021
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21. Total Tumor Load of mRNA Cytokeratin 19 in the Sentinel Lymph Node as a Predictive Value of Axillary Lymphadenectomy in Patients with Neoadjuvant Breast Cancer

Author

Karla B. Peña, Alba Cochs, Josep Gumà, Francesc Riu, Amillano Kepa, and David Parada

Subjects
0301 basic medicine, Metastasis, sentinel lymph node, 0302 clinical medicine, OSNA, Breast, Prospective Studies, Lymph node, Mastectomy, Genetics (clinical), Aged, 80 and over, medicine.diagnostic_test, Carcinoma, Ductal, Breast, Middle Aged, Neoadjuvant Therapy, Tumor Burden, nucleic acid amplification, medicine.anatomical_structure, Lymphatic Metastasis, 030220 oncology & carcinogenesis, Female, Radiology, Lymph, axillary lymphadenectomy, neoadjuvant chemotherapy, Adult, medicine.medical_specialty, lcsh:QH426-470, Axillary lymph nodes, Sentinel lymph node, Breast Neoplasms, Article, 03 medical and health sciences, Cytokeratin, breast cancer, Breast cancer, Predictive Value of Tests, Biopsy, Biomarkers, Tumor, Genetics, medicine, Humans, RNA, Messenger, Aged, Keratin-19, total tumor load, Sentinel Lymph Node Biopsy, business.industry, medicine.disease, lcsh:Genetics, 030104 developmental biology, Axilla, Lymph Node Excision, business
Abstract

Although sentinel lymph node biopsy (SLNB) has proved to be able to diagnose axillary lymph node status safely and reliably, there is still not enough evidence to suggest that it can be used in patients who have undergone neoadjuvant chemotherapy (NAC) for lymph node-sparing surgery. The present study used molecular approaches to determine whether SLNB can be reliably used in patients who have been treated with NAC before SLN surgery, and whether the total tumor load of the SLN can be used as a predictive factor in axillary lymphadenectomy (ALD). We used one-step nucleic acid amplification (OSNA) to analyze a total of 111 consecutive patients who presented operable invasive breast carcinomas and who had been treated with NAC. SLN was positive in 55 patients and the identification rate was 100%. In 9 of these 55 patients, ALD showed that other lymph nodes were also involved. In all of the other 46 patients, the only lymph node to be identified as positive was SLN. Metastasis was not found in any of the axillary lymph nodes in the isolated tumor cell group. The total tumor load, defined as the amount of cytokeratin 19 mRNA copy numbers in all positives SLN (copies/&micro, L), showed three risk groups related to the possibility of positive non-sentinel nodes. OSNA is a diagnostic technique that is highly sensitive, specific, and reproducible and it can be used to analyze sentinel lymph nodes after NAC. Total tumor load may be able to help predict additional metastases in axillary lymphadenectomy.

Published
2021
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22. Neoadjuvant Metformin Added to Systemic Therapy Decreases the Proliferative Capacity of Residual Breast Cancer

Author

Lopez-Bonet, Eugeni, primary, Buxó, Maria, additional, Cuyàs, Elisabet, additional, Pernas, Sonia, additional, Dorca, Joan, additional, Álvarez, Isabel, additional, Martínez, Susana, additional, Pérez-Garcia, Jose Manuel, additional, Batista-López, Norberto, additional, Rodríguez-Sánchez, César A., additional, Amillano, Kepa, additional, Domínguez, Severina, additional, Luque, Maria, additional, Morilla, Idoia, additional, Stradella, Agostina, additional, Viñas, Gemma, additional, Cortés, Javier, additional, Oliveras, Gloria, additional, Meléndez, Cristina, additional, Castillo, Laura, additional, Verdura, Sara, additional, Brunet, Joan, additional, Joven, Jorge, additional, Garcia, Margarita, additional, Saidani, Samiha, additional, Martin-Castillo, Begoña, additional, and Menendez, Javier A., additional

Published
2019
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23. Metformin induces a fasting- and antifolate-mimicking modification of systemic host metabolism in breast cancer patients

Author

Cuyàs, Elisabet, primary, Fernández-Arroyo, Salvador, additional, Buxó, Maria, additional, Pernas, Sonia, additional, Dorca, Joan, additional, Álvarez, Isabel, additional, Martínez, Susana, additional, Pérez-Garcia, Jose Manuel, additional, Batista-López, Norberto, additional, Rodríguez-Sánchez, César A., additional, Amillano, Kepa, additional, Domínguez, Severina, additional, Luque, Maria, additional, Morilla, Idoia, additional, Stradella, Agostina, additional, Viñas, Gemma, additional, Cortés, Javier, additional, Verdura, Sara, additional, Brunet, Joan, additional, López-Bonet, Eugeni, additional, Garcia, Margarita, additional, Saidani, Samiha, additional, Joven, Jorge, additional, Martin-Castillo, Begoña, additional, and Menendez, Javier A., additional

Published
2019
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24. The C Allele of ATM rs11212617 Associates With Higher Pathological Complete Remission Rate in Breast Cancer Patients Treated With Neoadjuvant Metformin

Author

Cuyàs, Elisabet, primary, Buxó, Maria, additional, Ferri Iglesias, Maria José, additional, Verdura, Sara, additional, Pernas, Sonia, additional, Dorca, Joan, additional, Álvarez, Isabel, additional, Martínez, Susana, additional, Pérez-Garcia, Jose Manuel, additional, Batista-López, Norberto, additional, Rodríguez-Sánchez, César A., additional, Amillano, Kepa, additional, Domínguez, Severina, additional, Luque, Maria, additional, Morilla, Idoia, additional, Stradella, Agostina, additional, Viñas, Gemma, additional, Cortés, Javier, additional, Joven, Jorge, additional, Brunet, Joan, additional, López-Bonet, Eugeni, additional, Garcia, Margarita, additional, Saidani, Samiha, additional, Queralt Moles, Xavier, additional, Martin-Castillo, Begoña, additional, and Menendez, Javier A., additional

Published
2019
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25. A phase 2 trial of neoadjuvant metformin in combination with trastuzumab and chemotherapy in women with early HER2-positive breast cancer: the METTEN study

Author

Martin-Castillo, Begoña, primary, Pernas, Sonia, additional, Dorca, Joan, additional, Álvarez, Isabel, additional, Martínez, Susana, additional, Pérez-Garcia, Jose Manuel, additional, Batista-López, Norberto, additional, Rodríguez-Sánchez, César A., additional, Amillano, Kepa, additional, Domínguez, Severina, additional, Luque, Maria, additional, Stradella, Agostina, additional, Morilla, Idoia, additional, Viñas, Gemma, additional, Cortés, Javier, additional, Cuyàs, Elisabet, additional, Verdura, Sara, additional, Fernández-Ochoa, Álvaro, additional, Fernández-Arroyo, Salvador, additional, Segura-Carretero, Antonio, additional, Joven, Jorge, additional, Pérez, Elsa, additional, Bosch, Neus, additional, Garcia, Margarita, additional, López-Bonet, Eugeni, additional, Saidani, Samiha, additional, Buxó, Maria, additional, and Menendez, Javier A., additional

Published
2018
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26. Abstract CT165: A two-stage Simon Design phase II study for NOn-BRCA metastatic BReast cancer (MBC)patients with homologous recombination deficiency treated with OLAparib single agent.(NOBROLA study)

Author

Aguirre, Elena, primary, Amillano, Kepa, additional, Cortés, Alfonso, additional, Juan, María José, additional, Márquez, Antonia, additional, Ruiz, Manuel, additional, Servitja, Sonia, additional, Urrutikoetxea, Ander, additional, Llombart, Antonio, additional, Perez, José, additional, and Cortes, Javier, additional

Published
2018
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27. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial

Author

Colleoni, Marco, primary, Luo, Weixiu, additional, Karlsson, Per, additional, Chirgwin, Jacquie, additional, Aebi, Stefan, additional, Jerusalem, Guy, additional, Neven, Patrick, additional, Hitre, Erika, additional, Graas, Marie-Pascale, additional, Simoncini, Edda, additional, Kamby, Claus, additional, Thompson, Alastair, additional, Loibl, Sibylle, additional, Gavilá, Joaquín, additional, Kuroi, Katsumasa, additional, Marth, Christian, additional, Müller, Bettina, additional, O'Reilly, Seamus, additional, Di Lauro, Vincenzo, additional, Gombos, Andrea, additional, Ruhstaller, Thomas, additional, Burstein, Harold, additional, Ribi, Karin, additional, Bernhard, Jürg, additional, Viale, Giuseppe, additional, Maibach, Rudolf, additional, Rabaglio-Poretti, Manuela, additional, Gelber, Richard D, additional, Coates, Alan S, additional, Di Leo, Angelo, additional, Regan, Meredith M, additional, Goldhirsch, Aron, additional, Vandebroek, An, additional, Berliere, Martine, additional, Mitine, Carine, additional, Vuylsteke, Peter, additional, Borms, Marleen, additional, D'Hondt, Randal, additional, Glorieux, Philippe, additional, Mebis, Jeroen, additional, Verhoeven, Didier, additional, Coibion, Michael, additional, Forget, Frederic, additional, Duck, Lionel, additional, Wyendaele, Wim, additional, Barbeaux, Annelore, additional, Salmon, Jean-Paul, additional, Berteloot, Patrick, additional, Vermeij, Joanna, additional, Richard, Vincent, additional, Cinieri, Saverio, additional, Gianni, Lorenzo, additional, Clerico, Mario, additional, Pinotti, Graziella, additional, Bernardo, Antonio, additional, Biganzoli, Leo, additional, Gennari, Alessandra, additional, Graiff, Claudio, additional, Amadori, Dino, additional, Passalacqua, Rodolfo, additional, Forbes, John, additional, Francis, Prudence, additional, Foo, Serene, additional, Boyle, Frances, additional, Redfern, Andrew, additional, van der Westhuizen, Andre, additional, Lewis, Craig, additional, Sharma, Sharad, additional, Beale, Philip, additional, Byard, Ian, additional, Begbie, Stephen, additional, Sardelic, Frank, additional, Abdi, Ehtesham, additional, Clark, David, additional, Chindewere, Aaron, additional, Della-Fiorentina, Stephen, additional, Asghari, Ray, additional, Islam, Mohammed, additional, Na Teo, Lee, additional, White, Shane, additional, Gilbert, Linda, additional, Gardner, Katherine, additional, Uhlmann, Catarina, additional, Rauch, Daniel, additional, Mannhart, Meinrad, additional, Buser, Katharina, additional, Dedes, Konstantin, additional, Mueller, Andreas, additional, Rageth, Christoph, additional, Von Orelli, Stephanie, additional, Senn, Hans Joerg, additional, Pagani, Olivia, additional, Pedrazzini, Augusto, additional, Rochlitz, Christoph, additional, Bodmer, Alexandre, additional, Anchisi, Sandro, additional, Zaman, Khalil, additional, von Moos, Roger, additional, Betticher, Daniel, additional, Kralidas, Elena, additional, Popescu, Razven, additional, Fehr, Mathias, additional, Nyman, Per, additional, Jungquist, Anja, additional, Chamalidou, Chaido, additional, Foukakis, Theodoros, additional, Dabrosin, Charlotta, additional, Valachis, Antonis, additional, Lang, Istvan, additional, Kahan, Zsuzsanna, additional, Retamales, Javier, additional, Torres, Ulloa Roberto, additional, Fritis, Marcela, additional, Sole, Sebastian, additional, Torres, Soledad, additional, Letzkus, Jaime, additional, Escobar, Paula, additional, Vigneaux, Ines, additional, Arancibia, Jorge, additional, Cardemil, Juana Bernardita, additional, Huidobro, Patricio, additional, Gomez, Henry, additional, Wetter, Julie, additional, Vorobiof, Daniel, additional, McMichael, Gary, additional, Apffelstaedt, Justus, additional, Vorotnikov, Igor, additional, Schwartz, Joel, additional, Openshaw, Thomas, additional, Bonnefoi, Herve, additional, Jacquin, Jean-Philippe, additional, Bonichon-Lamichhane, Natalie, additional, Borstner, Simona, additional, Budrukkar, Ashwini, additional, Ewertz, Marianne, additional, Quispe, Oscar Zambrano, additional, Vestlev, Peter Michael, additional, Danø, Hella, additional, Nielsen, Ditte, additional, Jakobsen, Erik, additional, Hoejris, Inger, additional, Bogovic, Jurij Antonovic, additional, Jensen, Britta Bjerregaard, additional, Aage Møller, Knud, additional, Stenbygaard, Eric Lars, additional, Sharma, Ravi, additional, Bedi, Carolyn, additional, Bews-Hair, Maria, additional, Neades, Glyn, additional, McKirdy, Mike, additional, Barber, Matthew, additional, Alhasso, Abdulla, additional, Ritchie, Diana, additional, Fraser, Judith, additional, Scott, Lucy, additional, Yuille, Frances, additional, Lannigan, Alison, additional, Murphy, Dermot, additional, Shere, Mike, additional, Jackisch, Christian, additional, Tomé, Oliver, additional, Steer, Susanne, additional, Augustin, Doris, additional, Lübbe, Kristina, additional, Köcker-Korus, Heike, additional, Deuker, Jörg-Uwe, additional, Stefek, Andrea, additional, Just, Marianne, additional, Rhein, Uwe, additional, Bechtner, Christina, additional, Baerens, Dirk-Toralf, additional, Schrader, Iris, additional, Grischke, Eva-Maria, additional, Lorenz, Ralf, additional, Dietz, Wolfgang, additional, Thomalla, Jörg, additional, Schilling, Jörg, additional, Rempen, Andreas, additional, Graf, Heiko, additional, Doering, Gabriele, additional, Busch, Steffi, additional, Heinrich, Georg, additional, Tesch, Hans, additional, Uleer, Christoph, additional, Krabisch, Petra, additional, Rösel, Siegfried, additional, Kurbacher, Christian, additional, Ostertag, Horst, additional, Josten, Klaus-M, additional, Hielscher, Carsten, additional, Gröll, Isolde, additional, Mattner, Ute Marie, additional, Prechtl, Anita, additional, Lantzsch, Tilmann, additional, Ciruelos, Eva, additional, Garau, Isabel, additional, Bellet, Meritxell, additional, Climent, Miguel Angel, additional, López, Rafael, additional, Virizuela, Juan Antonio, additional, Bermejo, Begoña, additional, Janez, Noelia Martinez, additional, Amillano, Kepa, additional, Márquez, Raúl, additional, Dorca, Joan, additional, Godes, Maria Jose, additional, Gonzalez, Santiago, additional, Ohno, Shinji, additional, Aruga, Tomoyuki, additional, Yotsumoto, Daisuke, additional, Yamamoto, Yutaka, additional, Aihara, Tomohiko, additional, Morimoto, Takashi, additional, Bando, Hiroko, additional, Masuda, Norikazu, additional, Toi, Masakazu, additional, Aogi, Kenjiro, additional, Sato, Nobuaki, additional, Okada, Morihito, additional, Takahashi, Masato, additional, Tokunaga, Eriko, additional, Iwata, Hiroji, additional, Fujita, Takashi, additional, Fridrik, Michael, additional, Pristauz, Gunda, additional, Hackl, Claudia, additional, Singer, Christian, additional, Wette, Victor, additional, Gnant, Michael, additional, Thaler, Josef, additional, Greil, Richard, additional, Abendstein, Burghard, additional, Heck, Dietmar, additional, Manfreda, Diether, additional, Sevelda, Paul, additional, Thiel, Irene, additional, Tuttlies, Frank, additional, Stöger, Herbert, additional, Neunteufel, Walter, additional, Crown, John, additional, Kennedy, John, additional, Hill, Arnold, additional, McCaffrey, John, additional, Murphy, Conleth, additional, Coate, Linda, additional, Keane, Maccon, additional, Martin, Michael, additional, O'Connor, Miriam, additional, Duffy, Karen, additional, Ruepp, Barbara, additional, Piccart, Martine, additional, and Zardavas, Dimitrios, additional

Published
2018
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28. Time to definitive deterioration in patients with metastatic breast cancer subjected to second-line monochemotherapy.

Author

Seguí-Palmer, Miguel Angel, primary, Martinez Janez, Noelia, additional, Blanco, Esperanza, additional, Batista, J. Norberto, additional, Munoz, Montserrat, additional, Rodriguez, Cesar Augusto, additional, Fernandez, Isaura, additional, Jerez, Yolanda, additional, Garau, Isabel, additional, Amillano, Kepa, additional, Garcia, Carlos, additional, Perello, Antonia, additional, Santaballa, Ana, additional, Borrega, Pablo, additional, Salvador, Javier, additional, Garcia, Andres, additional, Ruiz, Manuel, additional, Pellin, Lorena, additional, and Andres, Raquel, additional

Published
2016
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30. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial.

Author

Di Cosimo S, Pérez-García JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavilá J, Sampayo-Cordero M, Aguirre E, Schmid P, Marmé F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martínez-De Dueñas E, Carañana V, Amillano K, Mina L, Malfettone A, Cortés J, and Llombart-Cussac A

Subjects
Female, Humans, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Fulvestrant therapeutic use, Letrozole therapeutic use, Receptor, ErbB-2 metabolism, Receptors, Estrogen metabolism, Breast Neoplasms, Pulmonary Embolism etiology, Venous Thromboembolism etiology
Abstract

Background: Palbociclib has gained a central role in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Despite its manageable toxicity profile, venous thromboembolism (VTE) or interstitial lung disease (ILD)/pneumonitis may infrequently occur. Therefore, we provide a comprehensive summary of the safety and tolerability of the combination of endocrine therapy and palbociclib among patients included in the randomized phase 2 PARSIFAL study., Materials and Methods: Patients with endocrine-sensitive HR+/HER2- ABC and no prior therapy in an advanced setting (n = 486) were randomly assigned 1:1 to receive fulvestrant-palbociclib (FP) or letrozole-palbociclib (LP). Laboratory tests and the incidence of adverse events (AEs) were recorded at baseline and day 1 of each cycle. Progression-free survival (PFS) was estimated for patients with and without VTE., Results: A total of 483 patients were analyzed. Neutropenia, leukopenia, anemia, asthenia, arthralgia, fatigue, and diarrhea were the most frequent AEs in both groups. Febrile neutropenia occurred in 3 (1.2%) patients of the FP group and in 1 (0.4%) patient in the LP group. Six (2.5%; 0.4% grade 3) patients in the FP group and 6 patients (2.5%; 0.4% grade 3) in the LP group experienced ILD/pneumonitis. Pulmonary embolism was reported in 12 (5.0%) patients in the FP group and 6 (2.5%) patients in the LP group. Advanced age at baseline was the only factor significantly associated with an increased risk of pulmonary embolism (P < .01)., Conclusion: The PARSIFAL data confirmed the favorable safety profile of both palbociclib regimens. VTE and ILD/pneumonitis were occasionally reported, and their early detection allowed patients to continue treatment effectively without detriment to efficacy., Clinicaltrials.gov Identifier: NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983)., (© The Author(s) 2022. Published by Oxford University Press.)

Published
2023
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31. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03).

Author

Gnant M, Dueck AC, Frantal S, Martin M, Burstein HJ, Greil R, Fox P, Wolff AC, Chan A, Winer EP, Pfeiler G, Miller KD, Colleoni M, Suga JM, Rubovsky G, Bliss JM, Mayer IA, Singer CF, Nowecki Z, Hahn O, Thomson J, Wolmark N, Amillano K, Rugo HS, Steger GG, Hernando Fernández de Aránguiz B, Haddad TC, Perelló A, Bellet M, Fohler H, Metzger Filho O, Jallitsch-Halper A, Solomon K, Schurmans C, Theall KP, Lu DR, Tenner K, Fesl C, DeMichele A, and Mayer EL

Subjects
Antineoplastic Agents, Hormonal adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms mortality, Breast Neoplasms pathology, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Female, Humans, Mastectomy, Middle Aged, Neoplasm Staging, Piperazines adverse effects, Progression-Free Survival, Prospective Studies, Protein Kinase Inhibitors adverse effects, Pyridines adverse effects, Time Factors, Antineoplastic Agents, Hormonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Neoadjuvant Therapy adverse effects, Neoadjuvant Therapy mortality, Piperazines therapeutic use, Protein Kinase Inhibitors therapeutic use, Pyridines therapeutic use
Abstract

Purpose: Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor-positive breast cancer has not been confirmed., Patients and Methods: In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer-free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival., Results: Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial., Conclusion: At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor-positive breast cancer., Competing Interests: Michael GnantEmployment: Sandoz (I)Honoraria: Amgen, Novartis, AstraZeneca, LillyConsulting or Advisory Role: Daiichi Sankyo, Veracyte, Tolmar¸ LifeBrain, Lilly Amylou C. DueckPatents, Royalties, Other Intellectual Property: Royalties from licensing fees for a patient symptom questionnaire (MPN-SAF) Miguel MartinHonoraria: Roche/Genentech, Lilly, Pfizer, Novartis, Pierre FabreConsulting or Advisory Role: Roche/Genentech, Novartis, Pfizer, Lilly, AstraZeneca, Taiho Pharmaceutical, PharmaMarSpeakers' Bureau: Lilly/ImClone, Roche/Genentech, Pierre FabreResearch Funding: Novartis (Inst), Roche (Inst)¸ Puma Biotechnology (Inst)Other Relationship: Roche, Novartis Hal J. BursteinThis author is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of this manuscript. Richard GreilHonoraria: Celgene, Roche, Merck, Takeda, AstraZeneca, Novartis, Amgen, Bristol Myers Squibb, MSD¸ Sandoz, AbbVie, Gilead Sciences, Daiichi SankyoConsulting or Advisory Role: Celgene, Novartis, Roche, Bristol Myers Squibb, Takeda, AbbVie, AstraZeneca, Janssen, MSD, Merck, Gilead Sciences, Daiichi SankyoResearch Funding: Celgene (Inst), Merck (Inst), Takeda (Inst), AstraZeneca (Inst), Novartis (Inst), Amgen (Inst), Bristol Myers Squibb (Inst), MSD (Inst), Sandoz (Inst), Gilead Sciences (Inst), Roche (Inst)Travel, Accommodations, Expenses: Roche, Amgen, Janssen-Cilag, AstraZeneca, Novartis, MSD, Celgene, Gilead Sciences, Bristol Myers Squibb, AbbVie, Daiichi Sankyo Antonio C. WolffThis author is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of this manuscript.Consulting or Advisory Role: Ionis PharmaceuticalsPatents, Royalties, Other Intellectual Property: A.C.W. has been named as an inventor on one or more issued patents or pending patent applications related to methylation in breast cancer, has assigned his rights to JHU, and participates in a royalty sharing agreement with JHUOpen Payments Link: https://openpaymentsdata.cms.gov/physician/357301/summary Arlene ChanHonoraria: Novartis, LillyConsulting or Advisory Role: LillyResearch Funding: Eisai Eric P. WinerHonoraria: Genomic Health, Genentech/RocheConsulting or Advisory Role: Leap Therapeutics, Seattle Genetics, Jounce Therapeutics, GlaxoSmithKline, Carrick Therapeutics, Lilly, G1 Therapeutics, Syros Pharmaceuticals, Genentech/Roche, Gilead Sciences, Zymeworks, AthenexResearch Funding: Genentech (Inst)Other Relationship: InfiniteMD Georg PfeilerHonoraria: Amgen, Roche/Genentech, Pfizer¸ Lilly, AstraZeneca/Merck, AstraZeneca/Daiichi Sankyo, Novartis, UCB, Accord HealthcareConsulting or Advisory Role: Pfizer¸ Amgen¸ Lilly, Novartis, AstraZeneca/Merck, AstraZeneca/Daiichi Sankyo, UCB, Roche/GenentechSpeakers' Bureau: Roche/Genentech, Pfizer, Lilly, Novartis, UCB, AstraZeneca/Merck, AstraZeneca/Daiichi Sankyo, Accord Healthcare, Amgen, Accord HealthcareResearch Funding: Pfizer, Roche/GenentechTravel, Accommodations, Expenses: Novartis, Lilly, Roche/Genentech, Lilly, AstraZeneca/Daiichi Sankyo Kathy MillerThis author is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of this manuscript.Consulting or Advisory Role: Merck, Genentech/Roche, Athenex, AstraZeneca, Bristol Myers Squibb/CelgeneResearch Funding: Taiho Pharmaceutical (Inst), Novartis (Inst), Seattle Genetics (Inst), Pfizer (Inst), Astex Pharmaceuticals (Inst), British Biotech (Inst), CytomX Therapeutics (Inst), Alphamab (Inst) Marco ColleoniResearch Funding: Roche (Inst) Gabor RubovskyConsulting or Advisory Role: Pfizer, Novartis, Roche, Gilead SciencesTravel, Accommodations, Expenses: Amgen Judith M. BlissResearch Funding: AstraZeneca (Inst), Merck Sharp & Dohme (Inst), Puma Biotechnology (Inst), Pfizer (Inst), Roche (Inst), GlaxoSmithKline/Novartis (Inst), Lilly (Inst), Janssen-Cilag (Inst), Clovis Oncology (Inst)Travel, Accommodations, Expenses: Pfizer Ingrid A. MayerConsulting or Advisory Role: Novartis, AstraZeneca, Lilly, Genentech, GlaxoSmithKline, Immunomedics, MacroGenics, Pfizer, AbbVie, Seattle Genetics, Puma Biotechnology, Cyclacel, Blueprint Medicines, SanofiResearch Funding: Novartis (Inst), Pfizer (Inst), Genentech (Inst) Christian SingerHonoraria: Novartis, AstraZeneca/MedImmune, Daiichi Sankyo Europe GmbHConsulting or Advisory Role: AstraZeneca/MedImmune, Daiichi-Sankyo, Gilead Sciences, Sanofi/Aventis, NovartisSpeakers' Bureau: Novartis, AstraZeneca/MedImmuneResearch Funding: Novartis, Sanofi, Myriad Genetics, Roche, AstraZeneca/MedImmuneTravel, Accommodations, Expenses: Roche, Novartis Zbigniew NoweckiTravel, Accommodations, Expenses: Roche/Genentech Olwen HahnLeadership: Via OncologyStock and Other Ownership Interests: Teleflex MedicalHonoraria: Cardinal Health (I)Consulting or Advisory Role: Pfizer, hmpglobal.comTravel, Accommodations, Expenses: Cardinal Health (I) Jacqui ThomsonHonoraria: MSD Oncology, Roche/Genentech Norman WolmarkOpen Payments Link: https://openpaymentsdata.cms.gov/physician/159597 Hope S. RugoHonoraria: Puma Biotechnology, MylanConsulting or Advisory Role: SamsungResearch Funding: MacroGenics (Inst), OBI Pharma (Inst), Eisai (Inst), Pfizer (Inst), Novartis (Inst), Lilly (Inst), Genentech (Inst), Merck (Inst), Immunomedics (Inst), Odonate Therapeutics (Inst), Daiichi Sankyo (Inst), Seattle Genetics (Inst), Sermonix Pharmaceuticals (Inst), AstraZeneca (Inst)Travel, Accommodations, Expenses: Pfizer, Novartis, Mylan, AstraZeneca Spain, MerckOpen Payments Link: https://openpaymentsdata.cms.gov/summary Guenther G. StegerHonoraria: Pfizer, Lilly, Novartis, Roche, AstraZeneca/Daiichi Sankyo, Teva, Pfizer, Lilly, NovartisTravel, Accommodations, Expenses: Roche, Teva Blanca Hernando Fernández de AránguizHonoraria: GlaxoSmithKline, PharmaMar, Clovis OncologyTravel, Accommodations, Expenses: Pfizer, MSD Oncology, Roche Tufia C. HaddadResearch Funding: Takeda (Inst) Meritxell Bellet EzquerraConsulting or Advisory Role: Pfizer, Lilly, NovartisSpeakers' Bureau: Lilly, Pfizer, Novartis Hannes FohlerEmployment: Takeda (I)Research Funding: Pfizer (Inst) Otto MetzgerHonoraria: Grupo Oncoclinicas, RocheResearch Funding: Susan G. Komen for the Cure (Inst), Pfizer (Inst), Roche/Genentech (Inst), Eisai (Inst), Cascadian Therapeutics (Inst), AbbVie (Inst)Travel, Accommodations, Expenses: Grupo Oncoclinicas Anita Jallitsch-HalperResearch Funding: Pfizer (Inst) Kadine SolomonEmployment: Alliance Foundation TrialsStock and Other Ownership Interests: Pfizer, Merck, Moderna Therapeutics Céline SchurmansResearch Funding: Pfizer (Inst), Roche/Genentech (Inst), AstraZeneca (Inst), Novartis (Inst), Servier (Inst), Pfizer (Inst), Sanofi (Inst)Patents, Royalties, Other Intellectual Property: My organization receives royalties from Agendia Kathy P. TheallEmployment: PfizerStock and Other Ownership Interests: PfizerHonoraria: PfizerTravel, Accommodations, Expenses: Pfizer Dongrui R. LuEmployment: PfizerStock and Other Ownership Interests: Pfizer Kathleen TennerStock and Other Ownership Interests: Merck Christian FeslResearch Funding: Pfizer (Inst) Angela DeMicheleResearch Funding: Pfizer (Inst), Genentech (Inst), Calithera Biosciences (Inst), Novartis (Inst) Erica L. MayerConsulting or Advisory Role: Lilly, Novartis, AstraZeneca, Gilead SciencesResearch Funding: Pfizer (Inst)No other potential conflicts of interest were reported.

Published
2022
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