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1. Abstract P1-14-01: Final results of NorBreast-231, a randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel as first-line chemotherapy in patients with advanced breast cancer

Author

Elżbieta Starosławska, R. De Freitas Junior, G. Villanova, L. Garcia Estevez, Aapro, M Groc, M. Ruiz Borrego, Saverio Cinieri, Roberto Hegg, H Hervieu, E. Szombara, and Serafin Morales

Subjects
Cancer Research, education.field_of_study, Chemotherapy, medicine.medical_specialty, Taxane, business.industry, medicine.medical_treatment, Population, Phases of clinical research, medicine.disease, Vinorelbine, Gastroenterology, Regimen, Breast cancer, Oncology, Internal medicine, medicine, business, education, Febrile neutropenia, medicine.drug
Abstract

Background: Single-agent chemotherapy (CT) is the standard treatment option in endocrine receptor (ER)-positive advanced breast cancer (ABC) after failure of endocrine therapy (ET) or in patients (pts) without visceral crisis. Both weekly paclitaxel (WP) and oral vinorelbine (OV) are among the recommended treatment options in this setting. The aim of this study was to evaluate the efficacy and safety profiles of OV and WP in a face to face study. Material and methods: Pts with ER-positive, HER2-negative ABC, with an age ≥18 years and with a documented locally recurrent or metastatic involvement previously untreated by CT were eligible. Pts were randomized to receive, as first-line CT, 3 weekly-cycles of either: ARM A: weekly OV, given as a 80 mg/m2 dose (following a first cycle at 60 mg/m2, dose escalation to 80 in the absence of grade 3 or 4 toxicity at cycle 1); ARM B: WP 80 mg/m2 per week. Primary endpoint was disease control rate (DCR). Pts were stratified according to prior taxane CT and visceral metastases. Results: 131 pts have been treated (OV: 66, WP: 65). Baseline pts characteristics (Arms OV/WP): median age 58/61 years; median number of prior ET: 2/2; prior (neo) adjuvant CT 74/72%; prior anthracycline 67/62%; prior taxane: 41/42%; >3 metastatic sites 42/48%; visceral metastases 79/79%. Median number of cycles (range): 6(1-55)/7(1-44); dose escalation of OV was performed in 75% of pts. Safety: most common non-hematological related G3/4 adverse events per pt were fatigue 8/2%, peripheral neuropathy 0/5%, nausea 3/0%, diarrhoea 3/2%, vomiting 3/0%, constipation 3/2%, alopecia (G2) 2/34%, no toxic deaths; febrile neutropenia was present in 2/0% of pts. Quality of life: over time, no major differences between both arms have been observed. Efficacy: DCR in the intent-to-treat population was [95%CI] 75.8 [63.6-85.5] /75.4 [63.1-85.2]%; overall response rate 20/40%; median progression-free survival: 5.5/6.4 months. Median overall survival was: OV 27.6/WP 22.3 months. Conclusion: Both OV and WP reached similar DCR rates of 75%. Each regimen presented a specific tolerance profile, with, in particular, a lower incidence of alopecia and peripheral neuropathy with OV. OV and WP are valid first-line CT options for ER-positive/HER2-negative pts with ABC. Citation Format: Aapro MS, Hegg R, Ruiz Borrego M, Staroslawska E, Morales S, Cinieri S, De Freitas Junior R, Garcia Estevez L, Szombara E, Hervieu H, Groc M, Villanova GR. Final results of NorBreast-231, a randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel as first-line chemotherapy in patients with advanced breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-14-01.

Published
2019
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2. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

D. Miles, E. Ciruelos, A. Schneeweiss, F. Puglisi, T. Peretz-Yablonski, M. Campone, I. Bondarenko, Z. Nowecki, H. Errihani, S. Paluch-Shimon, A. Wardley, J.-L. Merot, P. Trask, Y. du Toit, C. Pena-Murillo, V. Revelant, D. Klingbiel, T. Bachelot, K. Bouzid, I. Desmoulins, B. Coudert, I. Glogowska, E. Ciruelos Gil, F. Dalenc, F. Ricci, V. Dieras, B. Kaufman, A. Ferreira, M. Mano, H. Kalofonos, C. Andreetta, F. Montemurro, S. Barrett, Q. Zhang, D. Mavroudis, J. Matus, C. Villarreal Garza, C. Beato, G. Ismael, X. Hu, H. Abdel Azeem, R. Gaafar, C. Perrin, P. Kerbrat, J. Ettl, S. Paepke, E. Hitre, I. Lang, M. Trudeau, S. Verma, H. Li, O. Hoffmann, B. Aktas, A. Cariello, G. Cruciani, A. Tienghi, C. Tondini, T. Al-Twegieri, N. Loman, R. Laing, E. Brain, P. Fasching, M. Lux, A. Frassoldati, Z. Aziz, J. Salas, J. Streb, K. Krzemieniecki, A. Wronski, J. Garcia Garcia, S. Menjon Beltran, I. Cicin, P. Schmid, C. Gallagher, N. Turner, Z. Tong, K. Boer, B. Juhász, Z. Horvath, G. Bianchini, L. Gianni, G. Curigliano, A. Juarez Ramiro, S. Susnjar, E. Matos, E. Sevillano, L. Garcia Estevez, E. Gokmen, R. Uslu, H. Wildiers, F. Schutz, M. Cruz, H. Bourgeois, R. von Schumann, S. Stemmer, A. Dominguez, F. Morales-Vásques, M. Wojtukiewicz, J. Trifunovic, M.J. Echarri Gonzalez, J. Illarramendi Mañas, E. Martinez De Dueñas, N. Voitko, J. Hicks, S. Waters, P. Barrett-Lee, D. Wheatley, R. De Boer, V. Cocquyt, G. Jerusalem, C. Barrios, L. Panasci, J. Mattson, M. Tanner, M. Gozy, G. Vasilopoulos, C. Papandreou, J. Revesz, N. Battelli, G. Benedetti, L. Latini, C. Gridelli, J. Lazaro Leon, J. Alarcón Company, A. Arance Fernandez, A. Barnadas Molins, I. Calvo Plaza, R. Bratos, A. Gonzalez Martin, Y. Izarzugaza Peron, L. Klint, A. Kovalev, N. McCarthy, B. Yeo, D. Kee, J. Thomson, S. White, R. Greil, S. Wang, X. Artignan, I. Juhasz-Böess, A. Rody, R. Ngan, F. Dourleshter, H. Goldberg, L. Doni, F. Di Costanzo, F. Ferraù, M. Drobniene, E. Aleknavicius, K. Rashid, L. Costa, L. de la Cruz Merino, J. Garcia Saenz, R. López, O. Del Val Munoz, O. Ozyilkan, F. Azribi, H. Jaafar, R. Baird, M. Verrill, J. Beith, A. Petzer, J. Moreira de Andrade, V. Bernstein, N. Macpherson, D. Rayson, I. Saad Eldin, M. Achille, P. Augereau, V. Müller, A. Rasco, E. Evron, D. Katz, R. Berardi, S. Cascinu, A. De Censi, A. Gennari, N. El-Saghir, M. Ghosn, H.M. Oosterkamp, J. Van den Bosch, M. Kukulska, E. Kalinka, J. Alonso, E. Dalmau Portulas, M. Del Mar Gordon Santiago, I. Pelaez Fernandez, S. Aksoy, K. Altundag, H. Senol Coskun, H. Bozcuk, Y. Shparyk, L. Barraclough, N. Levitt, U. Panwar, S. Kelly, A. Rigg, M. Varughese, C. Castillo, L. Fein, L. Malik, R. Stuart-Harris, C. Singer, H. Stoeger, H. Samonigg, J. Feng, M. Cedeño, J. Ruohola, J.-F. Berdah, A. Goncalves, H. Orfeuvre, E.-M. Grischke, E. Simon, S. Wagner, G. Koumakis, K. Papazisis, N. Ben Baruch, G. Fried, D. Geffen, N. Karminsky, T. Peretz, L. Cavanna, P. Pedrazzioli, D. Grasso, E. Ruggeri, G. D’Auria, L. Moscetti, E. Juozaityte, J. Rodriguez Cid, H. Roerdink, N. Siddiqi, J. Passos Coelho, A. Arcediano Del Amo, E. Garcia Garre, M. García Gonzalez, A. Garcia-Palomo Perez, C. Herenandez Perez, P. Lopez Alvarez, M.H. Lopez De Ceballos, N. Martínez Jañez, M. Mele Olive, K. McAdam, T. Perren, G. Dunn, A. Humphreys, W. Taylor, R. Vera, L. Kaen, J. Andel, G. Steger, J. De Grève, M. Huizing, R. Hegg, A. Joy, P. Kuruvilla, S. Sehdev, S. Smiljanic, R. Kütner, J. Alexandre, J. Grosjean, P. Laplaige, R. Largillier, P. Maes, P. Martin, V. Pottier, B. Christensen, F. Khandan, H.-J. Lück, D.-M. Zahm, G. Fountzilas, V. Karavasilis, T. Safra, M. Inbar, L. Ryvo, A. Bonetti, E. Seles, A. Giacobino, Y. Chavarri Guerra, F. de Jongh, A. van der Velden, L. van Warmerdam, S. Vrijaldenhoven, C.H. Smorenburg, M. Cavero, R. Andres Conejero, A. Oltra Ferrando, A. Redondo Sanchez, N. Ribelles Entrena, S. Saura Grau, G. Viñas Vilaro, K. Bachmeier, M. Beresford, M. Butt, J. Joffe, C. Poole, P. Woodings, P. Chakraborti, G. Yordi, N. Woodward, A. Nobre, G. Luiz Amorim, N. Califaretti, S. Fox, A. Robidoux, E. Li, N. Li, J. Jiang, T. Soria, P. Padrik, O. Lahdenpera, H. Barletta, N. Dohollou, D. Genet, K. Prulhiere, D. Coeffic, T. Facchini, S. Vieillot, S. Catala, L. Teixeira, T. Hesse, T. Kühn, A. Ober, R. Repp, W. Schröder, D. Pectasides, G. Bodoky, Z. Kahan, I. Jiveliouk, O. Rosengarten, V. Rossi, O. Alabiso, M. Pérez Martínez, A.J. van de Wouw, J. Smok-Kalwat, M. Damasecno, I. Augusto, G. Sousa, A. Saadein, N. Abdelhafiez, O. Abulkhair, A. Antón Torres, M. Corbellas Aparicio, R. Llorente Domenech, J. Florián Jerico, J. Garcia Mata, M. Gil Raga, A. Galan Brotons, A. Llombart Cussac, C. Llorca Ferrandiz, P. Martinez Del Prado, C. Olier Garate, C. Rodriguez Sanchez, R. Sanchez Gomez, M. Santisteban Eslava, J. Soberino, M. Vidal Losada Garcia, D. Soto de Prado, J. Torrego Garcia, E. Vicente Rubio, M. Garcia, A. Murias Rosales, H. Granstam Björneklett, U. Narbe, M. Jafri, D. Rea, J. Newby, A. Jones, S. Westwell, A. Ring, I. Alonso, R. Rodríguez, Miles, D., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Campone, M., Bondarenko, I., Nowecki, Z., Errihani, H., Paluch-Shimon, S., Wardley, A., Merot, J. -L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., Klingbiel, D., Bachelot, T., Bouzid, K., Desmoulins, I., Coudert, B., Glogowska, I., Ciruelos Gil, E., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhasz, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vasques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M. J., Illarramendi Manas, J., Martinez De Duenas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcon Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., Mccarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Boess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferrau, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., Lopez, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Muller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H. M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeno, M., Ruohola, J., Berdah, J. -F., Goncalves, A., Orfeuvre, H., Grischke, E. -M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D'Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., Garcia Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M. H., Martinez Janez, N., Mele Olive, M., Mcadam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Greve, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kutner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Luck, H. -J., Zahm, D. -M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C. H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Vinas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kuhn, T., Ober, A., Repp, R., Schroder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Perez Martinez, M., van de Wouw, A. J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Anton Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florian Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Bjorneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodriguez, R., Apollo - University of Cambridge Repository, Medical Genetics, Clinical sciences, and Laboratory for Medical and Molecular Oncology

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, medicine.medical_treatment, chemistry.chemical_compound, paclitaxel, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, skin and connective tissue diseases, HER2 positive, hormone receptor, metastatic breast cancer, overall survival, pertuzumab, Hematology, Metastatic breast cancer, Receptor, ErbB-2/genetics, Neoplasm Recurrence, Local/drug therapy, Treatment Outcome, Docetaxel, Paclitaxel, 030220 oncology & carcinogenesis, Female, Taxoids, Pertuzumab, medicine.drug, medicine.medical_specialty, Taxoids/therapeutic use, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast Neoplasms/drug therapy, Internal medicine, medicine, Humans, Trastuzumab/adverse effects, neoplasms, Chemotherapy, Taxane, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, medicine.disease, 030104 developmental biology, chemistry, Neoplasm Recurrence, Local, business
Abstract

Background The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Published
2021

3. Abstract P6-14-03: Randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor positive, HER2-negative patients with advanced breast cancer (NorBreast-231 trial)

Author

Matti Aapro, Serafin Morales, Roberto Hegg, Elżbieta Starosławska, L. Garcia Estevez, M. Ruiz Borrego, E. Szombara, H Hervieu, Saverio Cinieri, G. Villanova, R. De Freitas Junior, and M Groc

Subjects
Cancer Research, education.field_of_study, medicine.medical_specialty, Chemotherapy, Taxane, business.industry, medicine.medical_treatment, Population, Cancer, Phases of clinical research, medicine.disease, Vinorelbine, Gastroenterology, Regimen, Breast cancer, Oncology, Internal medicine, medicine, education, business, medicine.drug
Abstract

Rationale: Quality of Life is of prime importance in Advanced Breast Cancer (ABC), a mostly non-curable disease. Both paclitaxel (P) and vinorelbine as single-agent chemotherapy (CT) are recommended treatment options in the management of ABC non-responsive to hormone therapy (HT) and with no visceral crisis. These agents are active with a good tolerance profile. The benefits and safety of oral vinorelbine (OV) and weekly P have however never been evaluated in a face to face trial. Methods: Main eligibility criteria included: age ≥18 years, documented locally recurrent or metastatic involvement previously untreated by CT, estrogen receptor positive disease previously treated by at least one HT, HER2-negative status, Karnofsky PS ≥70 and presence of at least one measurable lesion. Study treatment (until progression): Arm A, OV 80 mg/m2 weekly (following a first cycle at 60 mg/m2 and dose escalation to 80 in the absence of grade 3 or 4 toxicity); Arm B: paclitaxel 80 mg/m2 weekly. One cycle was defined as three weeks of treatment. Patients were stratified according to prior taxane (yes/no) and visceral metastases (yes/no). Primary endpoint was disease control rate (DCR), defined as confirmed complete response/partial response/stable disease of a minimum duration of 6 weeks. Results: 131 pts have been randomized (OV 66; P 65). Baseline patient characteristics (Arms A/B): median age 58/61 years; median number of previous HT 2/2; prior (neo)adjuvant CT 74/72%; prior anthracycline 64/62%; prior taxane 39/42%; >3 metastatic sites 42/48%; visceral metastases 80/78%. Safety: the most common non-haematological related G3/4 adverse events (≥3% patients) were: fatigue 7.6/1.5%, peripheral neuropathy 0/4.6%, nausea 3/0%, diarrhoea 3/1.5%, vomiting 3/0%, constipation 3/1.5%; alopecia (G2) was present in 1.5/33.8%; no toxic deaths observed. Efficacy: DCR in the intent-to-treat population was [95%CI] 75.8 [63.6-85.5]/75.4 [63.1-85.2] %; overall response was 20/40%; stable disease was 56/35% respectively. Treatment exposure, other efficacy / safety parameters and quality of life results will be presented during the meeting. Conclusion: Both OV and P reached similar DCR rates of 75%. As expected, each regimen presented a specific tolerance profile, with, in particular, a lower incidence of alopecia and peripheral neuropathy with OV. Citation Format: Aapro M, Ruiz Borrego M, Staroslawska E, Morales S, Cinieri S, De Freitas Junior R, Garcia Estevez L, Szombara E, Hervieu H, Groc M, Villanova G, Hegg R. Randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor positive, HER2-negative patients with advanced breast cancer (NorBreast-231 trial) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-14-03.

Published
2018
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4. 357TiP SGNLVA-002: Single arm, open-label, phase Ib/II study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer

Author

Jane L. Meisel, Yinghui Wang, L. Manso Sánchez, Valentina Boni, Rachel Wuerstlein, Carlos Alemany, Johannes Ettl, Sami Diab, HS Han, Zejing Wang, Ursa Brown-Glaberman, L. Garcia Estevez, R. Villanueva Vazquez, S. Kuemmel, Mafalda Oliveira, J. Cortés, Reva Basho, Timothy J. Pluard, Y.W. Moon, and Rajni Sinha

Subjects
First line treatment, Oncology, medicine.medical_specialty, business.industry, Internal medicine, medicine, Phase (waves), Hematology, Pembrolizumab, Open label, business, Triple-negative breast cancer
Published
2020
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6. NorBreast-231 trial: a randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor positive, HER2-negative patients with advanced breast cancer

Author

Saverio Cinieri, M Groc, L. Garcia Estevez, G. Villanova, H Hervieu, Roberto Hegg, M. Ruiz Borrego, Matti Aapro, Serafin Morales, R. De Freitas Junior, Elżbieta Starosławska, and E. Szombara

Subjects
Oncology, Cancer Research, medicine.medical_specialty, business.industry, Advanced breast, HER2 negative, Weekly paclitaxel, Cancer, Estrogen receptor, Phases of clinical research, medicine.disease, Vinorelbine, Internal medicine, medicine, business, medicine.drug
Published
2018
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7. 1802 Overall survival (OS) from the phase 2 study of enzalutamide (ENZA), an androgen receptor (AR) signaling inhibitor, in AR+ advanced triple-negative breast cancer (aTNBC)

Author

Peter Schmid, Amy C. Peterson, Denise A. Yardley, T.A. Traina, Iulia Cristina Tudor, J. Cortes, Ahmad Awada, Joyce Steinberg, Kurt Miller, Steve Chan, Luca Gianni, Clifford A. Hudis, L. Garcia-Estevez, Noelia Martínez-Jañez, John Crown, Hirdesh Uppal, and Martha Elizabeth Blaney

Subjects
Androgen receptor, Cancer Research, chemistry.chemical_compound, Oncology, chemistry, business.industry, Overall survival, Cancer research, Medicine, Phases of clinical research, Enzalutamide, business, Triple-negative breast cancer
Published
2015
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8. Randomised Phase Ii Study Evaluating, As First-Line Chemotherapy, Weekly Oral Vinorelbine As a Single-Agent Versus Weekly Paclitaxel As a Single-Agent in Estrogen Receptor Positive, Her2-Negative Patients with Advanced Breast Cancer (Norbreast-231 Trial)

Author

Serafin Morales, Nicole Tubiana-Mathieu, Roberto Hegg, M. Wojtukiewicz, Rodolfo Passalacqua, O. Garrone, Elżbieta Starosławska, H. Simon, M. Ruiz Borrego, A. Ardizzoia, G. Villanova, L. Fein, Christelle Levy, E. Richardet, M. Morand, E. Szombara, L. Garcia Estevez, Matti Aapro, J. Egreteau, and Saverio Cinieri

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, Randomization, Taxane, business.industry, medicine.medical_treatment, Phases of clinical research, Cancer, Hematology, medicine.disease, Vinorelbine, Chemotherapy regimen, Breast cancer, Internal medicine, medicine, business, medicine.drug
Abstract

Background: Chemotherapy (CT) is widely used in the management of estrogen receptor (ER) positive breast cancer patients (pts) pre-treated by hormone therapy (HT) . Single-agent CT in this setting has been validated in guidelines of management of the disease. Both paclitaxel and vinorelbine are recommended among the standard available CT agents for advanced breast cancer (ABC). Weekly paclitaxel (P) and oral vinorelbine (OV) as single agents are active with a good tolerance profile for these pts. Oral CT offers significant advantages over intravenous CT because of its greatest convenience, its ease of administration and reduced need for hospitalisation. Since the benefits and safety profile of OV and weekly P have never been compared in a face to face trial, this study will provide key clinical data regarding the optimal management of this patient population: ER positive and HER2-negative disease previously treated by a HT. Trial design: In this open-label study, pts are randomized to receive: OV 60 mg/m2/week (day 1, 8, 15) for the first cycle, then increased to 80 mg/m2/week from the second cycle in the absence of grade 3 or 4 toxicity or weekly P 80 mg/m2/week (day 1, 8, 15) intravenously. Treatments are continued until disease progression, unacceptable toxicity or pt's refusal. Main eligibility criteria include: age ≥18 years, documented locally recurrent or metastatic disease previously untreated by CT, ER positive disease previously treated by at least one HT, HER2-negative disease, Karnofsky PS ≥70. Primary objective: disease-control rate (defined as objective response or stable disease for a minimum of 6 weeks). Secondary objectives: other efficacy parameters, evaluation of safety profiles of both arms and quality of life assessment. Statistical methods: the one-sample multiple testing procedure for phase II clinical trials described by Fleming is used. This procedure employs the standard single stage test procedure at the last one of 2 pre-specified testings, while both allowing for early termination (should extreme results be seen) and essentially preserving the size and power of the single stage procedure. 124 pts will be enrolled in this randomized phase II study (62 per treatment arm). Randomisation is stratified according to prior taxane (yes or no) and presence of visceral metastases (yes or no). Disclosure: M. Aapro: Advisory Board Member, Pierre Fabre; M. Morand: Employee of Pierre Fabre Medicament; G.R. Villanova: Employee of Pierre Fabre Medicament. All other authors have declared no conflicts of interest.

Published
2014
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9. Biologic study of the effects of lapatinib in PI3K/akt- and ras/raf/MAK-signaling pathways in HER2-positive ductal breast carcinoma in situ (DCIS)

Author

L. Garcia-Estevez

Subjects
Oncology, In situ, Cancer Research, medicine.medical_specialty, medicine.drug_class, business.industry, Lapatinib, Tyrosine-kinase inhibitor, body regions, Ductal Breast Carcinoma, Internal medicine, medicine, Her2 receptor, Signal transduction, skin and connective tissue diseases, business, neoplasms, Protein kinase B, PI3K/AKT/mTOR pathway, medicine.drug
Abstract

e13581 Background: DCIS is a heterogeneous disease, with increasing incidence. Up to 37% of DCIS overexpress HER2. Lapatinib is a tyrosine kinase inhibitor that directly inhibits HER2 receptor sign...

Published
2011
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10. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).

Author

Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, and DeMichele A

Subjects
Antineoplastic Agents, Hormonal adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms enzymology, Breast Neoplasms pathology, Chemotherapy, Adjuvant, Disease-Free Survival, Female, Humans, Neoplasm Staging, Piperazines adverse effects, Protein Kinase Inhibitors adverse effects, Pyridines adverse effects, Risk Factors, Time Factors, Antineoplastic Agents, Hormonal therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Piperazines therapeutic use, Protein Kinase Inhibitors therapeutic use, Pyridines therapeutic use, Receptor, ErbB-2 analysis, Receptors, Estrogen analysis, Receptors, Progesterone analysis
Abstract

Purpose: The PALLAS study investigated whether the addition of palbociclib, an oral CDK4/6 inhibitor, to adjuvant endocrine therapy (ET) improves invasive disease-free survival (iDFS) in early hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In this analysis, we evaluated palbociclib exposure and discontinuation in PALLAS., Methods: Patients with stage II-III HR+, HER2- disease were randomly assigned to 2 years of palbociclib with adjuvant ET versus ET alone. The primary objective was to compare iDFS between arms. Continuous monitoring of toxicity, dose modifications, and early discontinuation was performed. Association of baseline covariates with time to palbociclib reduction and discontinuation was analyzed with multivariable competing risk models. Landmark and inverse probability weighted per-protocol analyses were performed to assess the impact of drug persistence and exposure on iDFS., Results: Of the 5,743 patient analysis population (2,840 initiating palbociclib), 1,199 (42.2%) stopped palbociclib before 2 years, the majority (772, 27.2%) for adverse effects, most commonly neutropenia and fatigue. Discontinuation of ET did not differ between arms. Discontinuations for non-protocol-defined reasons were greater in the first 3 months of palbociclib, and in the first calendar year of accrual, and declined over time. No significant relationship was seen between longer palbociclib duration or ≥ 70% exposure intensity and improved iDFS. In the weighted per-protocol analysis, no improvement in iDFS was observed in patients receiving palbociclib versus not (hazard ratio 0.89; 95% CI, 0.72 to 1.11)., Conclusion: Despite observed rates of discontinuation in PALLAS, analyses suggest that the lack of significant iDFS difference between arms was not directly related to inadequate palbociclib exposure. However, the discontinuation rate illustrates the challenge of introducing novel adjuvant treatments, and the need for interventions to improve persistence with oral cancer therapies., Competing Interests: Erica L. MayerConsulting or Advisory Role: Lilly, Novartis, AstraZeneca, Gilead SciencesResearch Funding: Pfizer (Inst) Christian FeslResearch Funding: Pfizer (Inst) Dominik HlauschekResearch Funding: Pfizer (Inst) Laura Garcia-EstevezConsulting or Advisory Role: Daiichi Sankyo/Astra Zeneca, Palex, Seattle GeneticsResearch Funding: Roche/Genentech (Inst) Nicholas ZdenkowskiHonoraria: Roche, Pfizer, EisaiConsulting or Advisory Role: Lilly, AstraZeneca, EisaiResearch Funding: Roche (Inst), Pfizer (Inst)Travel, Accommodations, Expenses: Roche, Amgen, Novartis Kathy D. MillerThis author is the Senior Deputy Editor of 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) Marija BalicConsulting or Advisory Role: Amgen, AstraZeneca, Daiichi Sankyo/Astra Zeneca, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, SamsungSpeakers' Bureau: Amgen, AstraZeneca, Daiichi Sankyo/Astra Zeneca, Lilly, Novartis, Pierre Fabre, Pfizer, Roche, Seattle GeneticsResearch Funding: Lilly (Inst), Novartis (Inst), Pfizer (Inst)Travel, Accommodations, Expenses: MSD 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) David CameronConsulting or Advisory Role: Lilly (Inst), Novartis (Inst), Novartis (Inst), Research Triangle Institute RTI Health Solutions (Inst), Daiichi Sankyo (Inst), Prima BioMed (Inst), Merck Sharp & Dohme (Inst), Zymeworks (Inst), Eisai (Inst), Puma Biotechnology (Inst), Pfizer (Inst), Oncolytics (Inst), Roche (Inst), Roche (Inst), Samsung Bioepis (Inst), Seattle Genetics (Inst), Synthon (Inst), Clarity Pharmaceuticals (Inst), Bexon/Zymeworks (Inst), Sanofi (Inst)Research Funding: Roche (Inst), Novartis (Inst), AstraZeneca (Inst) Eric P. WinerHonoraria: Genentech/Roche, Genomic HealthConsulting 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 José Juan Ponce LorenzoHonoraria: Seattle Genetics, Novartis, Pfizer, AstraZeneca/Daiichi Sankyo, Lilly, RocheConsulting or Advisory Role: Seattle Genetics, Novartis, AstraZeneca/Daiichi Sankyo, Roche Tufia C. HaddadResearch Funding: Takeda (Inst) Hiroji IwataHonoraria: Chugai Pharma, AstraZeneca, Eisai, Pfizer, Daiichi Sankyo, Lilly Japan, Kyowa Hakko Kirin, Taiho PharmaceuticalConsulting or Advisory Role: Chugai Pharma, Daiichi Sankyo, Pfizer, AstraZeneca, Lilly Japan, Kyowa Hakko Kirin, NovartisResearch Funding: MSD (Inst), AstraZeneca (Inst), Kyowa Hakko Kirin (Inst), Daiichi Sankyo (Inst), Chugai Pharma (Inst), Nihonkayaku (Inst), Lilly Japan (Inst), Novartis (Inst), Bayer (Inst), Pfizer (Inst), Boehringer Ingelheim (Inst), Sanofi (Inst) Matthew GoetzConsulting or Advisory Role: Lilly, bioTheranostics, Genomic Health, Novartis, Eisai, Sermonix Pharmaceuticals, Context Therapeutics, Pfizer, BiovicaResearch Funding: Lilly (Inst), Pfizer (Inst), Sermonix Pharmaceuticals (Inst)Patents, Royalties, Other Intellectual Property: Methods and Materials for Assessing Chemotherapy Responsiveness and Treating Cancer, Methods and Materials for Using Butyrylcholinesterases to Treat Cancer, Development of Human Tumor Xenografts from Women with Breast Cancer Treated with Neoadjuvant Chemotherapy (Inst)Travel, Accommodations, Expenses: Lilly Fatima CardosoConsulting or Advisory Role: Roche, Novartis, Pfizer, AstraZeneca, Teva, Astellas Pharma, Merus, Celgene, Eisai, Daiichi Sankyo, Genentech, Merck Sharp & Dohme, Sanofi, Pierre Fabre, Macrogenics, Amgen, GE Healthcare, GlaxoSmithKline, Mylan, Mundipharma, Seattle Genetics, Samsung Bioepis, Medscape, Prime OncologyTravel, Accommodations, Expenses: Pfizer, Roche, AstraZeneca Tiffany A. TrainaConsulting or Advisory Role: Genentech/Roche, Pfizer, AstraZeneca, Merck, Puma Biotechnology, Athenex, Daiichi Sankyo, Ionis Pharmaceuticals, Seattle Genetics, Eisai, Exact Sciences, Foundation Medicine, Ayala Pharmaceuticals, Gilead Sciences, Blueprint Medicines, Ellipses Pharma, Fuji Pharma, ITeos Therapeutics, AgendiaResearch Funding: Eisai (Inst), Pfizer (Inst), Novartis (Inst), Innocrin Pharma (Inst), AstraZeneca (Inst), Astellas Pharma (Inst), Immunomedics (Inst), Genentech/Roche (Inst), Daiichi Sankyo (Inst), Carrick Pharm (Inst), Ayala Pharmaceuticals (Inst) Urs BreitensteinConsulting or Advisory Role: AstraZeneca (Inst), Elie Lilly (Inst), Novartis (Inst), Pierre Fabre (Inst), Roche (Inst) Kerstin AckerlResearch Funding: Pfizer (Inst) Otto Metzger FilhoHonoraria: 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 Karin ZehetnerResearch Funding: Pfizer (Inst) Kadine SolomonEmployment: Alliance Foundation TrialsStock and Other Ownership Interests: Pfizer, Merck, Moderna Therapeutics Sarra El-AbedEmployment: Astellas Pharma (I), argenx (I)Research Funding: Novartis (Inst), Roche/Genentech (Inst), Pfizer (Inst) Kathy Puyana TheallEmployment: Pfizer (I)Stock and Other Ownership Interests: Pfizer (I)Honoraria: PfizerTravel, Accommodations, Expenses: Pfizer Dongrui Ray LuEmployment: PfizerStock and Other Ownership Interests: Pfizer Amylou DueckPatents, Royalties, Other Intellectual Property: Royalties from licensing fees for a patient symptom questionnaire (MPN-SAF) Michael GnantEmployment: Sandoz (I)Honoraria: Amgen, Novartis, AstraZeneca, LillyConsulting or Advisory Role: Daiichi-Sankyo, Veracyte, Tolmar, LifeBrain, Lilly Angela DeMicheleResearch Funding: Pfizer (Inst), Genentech (Inst), Calithera Biosciences (Inst), Novartis (Inst)No other potential conflicts of interest were reported.

Published
2022
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11. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor-Positive Breast Cancer.

Author

Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly CM, Winer E, and Yardley DA

Subjects
Adult, Aged, Aged, 80 and over, Androstadienes administration & dosage, Benzamides administration & dosage, Breast Neoplasms metabolism, Breast Neoplasms pathology, Double-Blind Method, Female, Follow-Up Studies, Humans, Middle Aged, Nitriles administration & dosage, Phenylthiohydantoin administration & dosage, Prognosis, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Receptor, ErbB-2 metabolism, Receptors, Estrogen metabolism, Receptors, Progesterone metabolism
Abstract

Purpose: To determine whether the androgen receptor (AR) inhibitor, enzalutamide, improves effectiveness of endocrine therapy (ET) in hormone receptor-positive (HR + ) breast cancer., Patients and Methods: In this phase II trial, patients with HR + /HER2 normal advanced/metastatic breast cancer were randomized 1:1 to exemestane 25 mg with placebo or exemestane 50 mg with enzalutamide 160 mg daily (NCT02007512). Two parallel cohorts enrolled patients with 0 (cohort 1) or 1 (cohort 2) prior ET for advanced disease. Progression-free survival (PFS) was the primary endpoint in the intent-to-treat (ITT) population of each cohort. Biomarkers were evaluated in an exploratory analysis., Results: Overall, 247 patients were randomized (cohort 1, n = 127 and cohort 2, n = 120). PFS was not improved in either cohort of the ITT population [HR, 0.82 (95% confidence interval (CI), 0.54-1.26); P = 0.3631 for cohort 1 and HR, 1.02 (95% CI, 0.66-1.59); P = 0.9212 for cohort 2]. In cohort 1, high levels of AR mRNA were associated with greater benefit of enzalutamide ( P interaction = 0.0048). This effect was particularly apparent in patients with both high levels of AR mRNA and low levels of ESR1 mRNA [HR, 0.24 (95% CI, 0.10-0.60); P = 0.0011]. The most common any grade adverse events in the enzalutamide arms were nausea (39%) in cohort 1 and fatigue (37%) in cohort 2., Conclusions: Enzalutamide with exemestane was well tolerated. While PFS was not improved by the addition of enzalutamide to exemestane in an unselected population, ET-naïve patients with high AR mRNA levels, particularly in combination with low ESR1 mRNA levels, may benefit from enzalutamide with exemestane., (©2020 American Association for Cancer Research.)

Published
2020
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12. Randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor-positive, HER2-negative patients with advanced breast cancer (NorBreast-231 trial).

Author

Aapro M, Ruiz-Borrego M, Hegg R, Kukielka-Budny B, Morales S, Cinieri S, Freitas-Junior R, Garcia-Estevez L, Szombara E, Borges GS, Passalacqua R, Hervieu H, Groc M, and Villanova G

Subjects
Adult, Aged, Aged, 80 and over, Breast Neoplasms metabolism, Drug Administration Schedule, Female, Humans, Middle Aged, Receptor, ErbB-2 metabolism, Receptors, Estrogen metabolism, Treatment Outcome, Antineoplastic Agents, Phytogenic administration & dosage, Breast Neoplasms drug therapy, Paclitaxel administration & dosage, Vinorelbine administration & dosage
Abstract

Background: Single-agent paclitaxel and vinorelbine are recommended treatments for advanced breast cancer (ABC) non-responsive to hormone therapy and without visceral crisis. This phase II trial compared first-line oral vinorelbine versus weekly paclitaxel for ABC., Methods: Eligible female patients had measurable locally recurrent/metastatic estrogen receptor-positive HER2-negative breast cancer and had received prior endocrine therapy (any setting) but no chemotherapy for ABC. Patients were stratified by prior taxane and visceral metastases and randomized to either oral vinorelbine 80 mg/m 2 (first cycle at 60 mg/m 2 , escalated to 80 mg/m 2 in the absence of grade 3/4 toxicity) or intravenous paclitaxel 80 mg/m 2 on days 1, 8, and 15 every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was disease control rate (DCR; confirmed complete or partial response, or stable disease for ≥6 weeks)., Results: The 131 randomized patients had received a median of 2 prior endocrine therapies; >70% had prior (neo)adjuvant chemotherapy and 79% visceral metastases. DCR was 75.8% (95% confidence interval: 63.6-85.5%) with vinorelbine and 75.4% (63.1-85.2%) with paclitaxel. The most common grade 3/4 adverse events were neutropenia (52%), fatigue (11%), and vomiting (5%) with vinorelbine, and neutropenia (17%), dyspnea (6%), hypertension (6%), and peripheral sensory neuropathy (5%) with paclitaxel. Grade 2 alopecia occurred in 2% of vinorelbine-treated and 34% of paclitaxel-treated patients. Neither arm showed relevant global health status changes., Conclusion: Oral vinorelbine and paclitaxel demonstrated similar DCRs (∼75%). Safety profiles differed and, together with administration route and convenience, may influence treatment choice (EudraCT number, 2012-003530-16)., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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13. Updating the role of obesity and cholesterol in breast cancer.

Author

Garcia-Estevez L and Moreno-Bueno G

Subjects
Body Weight physiology, Breast Neoplasms blood, Breast Neoplasms epidemiology, Breast Neoplasms prevention & control, Female, Humans, Obesity blood, Risk Factors, Weight Loss physiology, Breast Neoplasms etiology, Cholesterol blood, Life Style, Obesity complications
Abstract

Background: Breast cancer is the second most common cause of cancer-related death among women. Advances in our understanding of the disease have translated into better diagnostics and more effective therapeutics, leading to earlier detection and improved outcomes. Several studies have pointed at lifestyle and environmental factors as contributory for the onset and progression of the disease. Obesity and cholesterol stand out for their potential causal relationship with breast cancer and ease of modification., Main Text: Obesity and cholesterol represent risk factors for breast cancer, but their impact is largely affected by cofounding variables including menopausal status, disease subtype, and inflammation. Establishing a causal relationship between lifestyle factors and clinical outcomes may be challenging. Epidemiological studies and meta-analyses have rendered conflicting or sometimes contradictory results, possibly owing to the multifactorial nature of the disease. We discuss the supporting evidence and limitations in our understanding of obesity and cholesterol as risk factors for breast cancer., Conclusions: There is sufficient evidence that obesity and cholesterol impact clinical outcomes. Physicians are advised to take steps to help patients with their weight, such as recommending dietary and lifestyle interventions.

Published
2019
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14. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer.

Author

Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, and Cortes J

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Benzamides, Female, Humans, Immunohistochemistry, Kaplan-Meier Estimate, Middle Aged, Neoplasm Metastasis, Nitriles, Phenylthiohydantoin administration & dosage, Phenylthiohydantoin adverse effects, Progression-Free Survival, Triple Negative Breast Neoplasms pathology, Phenylthiohydantoin analogs & derivatives, Receptors, Androgen biosynthesis, Triple Negative Breast Neoplasms drug therapy, Triple Negative Breast Neoplasms metabolism
Abstract

Purpose Studies suggest that a subset of patients with triple-negative breast cancer (TNBC) have tumors that express the androgen receptor (AR) and may benefit from an AR inhibitor. This phase II study evaluated the antitumor activity and safety of enzalutamide in patients with locally advanced or metastatic AR-positive TNBC. Patients and Methods Tumors were tested for AR with an immunohistochemistry assay optimized for breast cancer; nuclear AR staining > 0% was considered positive. Patients received enzalutamide 160 mg once per day until disease progression. The primary end point was clinical benefit rate (CBR) at 16 weeks. Secondary end points included CBR at 24 weeks, progression-free survival, and safety. End points were analyzed in all enrolled patients (the intent-to-treat [ITT] population) and in patients with one or more postbaseline assessment whose tumor expressed ≥ 10% nuclear AR (the evaluable subgroup). Results Of 118 patients enrolled, 78 were evaluable. CBR at 16 weeks was 25% (95% CI, 17% to 33%) in the ITT population and 33% (95% CI, 23% to 45%) in the evaluable subgroup. Median progression-free survival was 2.9 months (95% CI, 1.9 to 3.7 months) in the ITT population and 3.3 months (95% CI, 1.9 to 4.1 months) in the evaluable subgroup. Median overall survival was 12.7 months (95% CI, 8.5 months to not yet reached) in the ITT population and 17.6 months (95% CI, 11.6 months to not yet reached) in the evaluable subgroup. Fatigue was the only treatment-related grade 3 or higher adverse event with an incidence of > 2%. Conclusion Enzalutamide demonstrated clinical activity and was well tolerated in patients with advanced AR-positive TNBC. Adverse events related to enzalutamide were consistent with its known safety profile. This study supports additional development of enzalutamide in advanced TNBC.

Published
2018
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15. Impact of chemotherapy on telomere length in sporadic and familial breast cancer patients.

Author

Benitez-Buelga C, Sanchez-Barroso L, Gallardo M, Apellániz-Ruiz M, Inglada-Pérez L, Yanowski K, Carrillo J, Garcia-Estevez L, Calvo I, Perona R, Urioste M, Osorio A, Blasco MA, Rodriguez-Antona C, and Benitez J

Subjects
Adult, Aged, Aged, 80 and over, Breast Neoplasms drug therapy, Case-Control Studies, Cross-Sectional Studies, Female, Genes, BRCA1, Genes, BRCA2, Humans, Longitudinal Studies, Middle Aged, Mutation, Risk Factors, Telomere metabolism, Telomere Shortening, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms genetics, Telomere genetics
Abstract

Recently, we observed that telomeres of BRCA1/2 mutation carriers were shorter than those of controls or sporadic breast cancer patients, suggesting that mutations in these genes might be responsible for this event. Given the contradictory results reported in the literature, we tested whether other parameters, such as chemotherapy, could be modifying telomere length (TL). We performed a cross-sectional study measuring leukocyte TL of 266 sporadic breasts cancer patients treated with first-line chemotherapy, with a median follow-up of 240 days. Additionally, we performed both cross-sectional and longitudinal studies in a series of 236 familial breast cancer patients that included affected and non-affected BRCA1/2 mutation carriers. We have measured in leukocytes from peripheral blood: the TL, percentage of short telomeres (<3 kb), telomerase activity levels and the annual telomere shortening speed. In sporadic cases we found that chemotherapy exerts a transient telomere shortening effect (around 2 years) that varies depending on the drug combination. In familial cases, only patients receiving treatment were associated with telomere shortening but they recovered normal TL after a period of 2 years. Chemotherapy affects TL and should be considered in the studies that correlate TL with disease susceptibility.

Published
2015
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