دورية أكاديمية
Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer
| العنوان: | Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer |
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| المؤلفون: | Andre F., Ciruelos E., Rubovszky G., Campone M., Loibl S., Rugo H. S., Iwata H., Conte P., Mayer I. A., Kaufman B., Yamashita T., Lu Y. -S., Inoue K., Takahashi M., Papai Z., Longin A. -S., Mills D., Wilke C., Hirawat S., Juric D. Rubovszky G, Kaufman B, Yamashita T, Lu YS, Ciruelos Gil EM, Inoue K, Takahashi M, Pápai Z, Arnedos M, Stemmer S, Cerda H, Campone M, Tesch H, Jurado JC, Toledano I, Rodriguez W, Delgado Mingorance JI, Safra T, Park YH, Krivorotko P, Forget F, Levy C, Masuda N, Lee KH, Melisko M, Huober J, Singer C, Mouret Reynier MA, Iwata H, Iwase H, Sohn J, Yamauchi T, Tomova A, Schenker M, Niikura N, Ungureanu A, Sriuranpong V, Kaen D, Henning JW, Borrego MR, Kurteva G, Deleu GFI, Popov V, Garcia Saenz JA, Timar-David M, Kim J, Lopez Lopez R, Perello Martorell A, Takano T, Kattan J, Wright G, Yañez E, Mundhenke C, Aggarwal L, Nakayama T, Airoldi M, Ludmila L, Alonso Romero JL, Arnaud A, Bianchi GV, Denduluri N, Shtivelband M, Kowalyszyn R, Chouinard E, Farhat F, Sevillano Fernandez E, Bermejo de Las Heras B, Perez Garcia JM, De Toro Salas R, Tseng LM, Sandri I, Barbeaux A, Brust L, Provencher L, Leheurteur M, Nusch A, Yousuf AF, Conte P, Gonzalez Cortijo L, Awada A, Schmidt M, Gopichand M, Lee KS, Vallejos C, Villman K, Aieta M, Rocca A, Takashima S, Van Dijk M, Martinez de Duenas E, Yardley D, Grossi M, Spazzapan S, Reinoso Toledo JG, Ahmed S, Volkov N, Dieterich M, Chiu J, Kaklamani V, Cuff K, Sagara Y, Casalnuovo M, Huizing M, Kohoutek M, Dalenc F, Figueroa Martinez P, Ponce Lorenzo J, Donev I, Brezden-Masley C, Derbel O, Welslau M, Berardi R, Akewanlop C, Dimopoulos M, Gupta S, Tonini G, Natoli C, van de Wouw A, Neciosup S, Margeli Vila M, Nilsson C, Toppmeyer D, Marx G, Holeckova P, Kisro J, Park-Simon TW, Erfan J, Matsumoto K, Kim SB, Overton L, Fontaine C, Priou F, Langanke D, Riseberg D, Juric D, Chap L, Dent S, Polikoff J, Varela M, Silva Melo Cruz FJ, Fernandez Abad M, Silverman P, Colangiovanni Girotto G, Fischer D, Allegrini G, Cunha Souza S, Karanikiotis H, Borrega Garcia P, Vukelja S, Northfelt D, Beck JT, Kozevnikovova R, Juhasz-Boess I, Geffen D, Karak FE, Zamora Aunon P, Hart L, Adams J, Santucci Alves da Silva B, Acevedo A, Christodoulou C, Mehta A, Pazzola A, Edlund P, Panwar U, Torrey M, Meyer A, Petzer A, Tournigand C, Heflik L, Mayer F, Gori S, Clement D, Shomova M, Law T, Horenkamp E, Rao R, Poncin R, Priester P, Baciuchka-Palmaro M, Mayeur D, Toledano A, Benasso M, Blasi L, Fujii T, Krie A, Pluard T, Cobb P, Kash J, Sanchez-Rivera I, McIntyre K, O'Rourke M, Mahmood T, Onwere I, Patel N, Zarwan C. |
| المساهمون: | Andre, F., Ciruelos, E., Rubovszky, G., Campone, M., Loibl, S., Rugo, H. S., Iwata, H., Conte, P., Mayer, I. A., Kaufman, B., Yamashita, T., Lu, Y. -S., Inoue, K., Takahashi, M., Papai, Z., Longin, A. -S., Mills, D., Wilke, C., Hirawat, S., Juric D., Rubovszky G, Kaufman, B, Yamashita, T, Lu, Y, Ciruelos Gil, Em, Inoue, K, Takahashi, M, Pápai, Z, Arnedos, M, Stemmer, S, Cerda, H, Campone, M, Tesch, H, Jurado, Jc, Toledano, I, Rodriguez, W, Delgado Mingorance, Ji, Safra, T, Park, Yh, Krivorotko, P, Forget, F, Levy, C, Masuda, N, Lee, Kh, Melisko, M, Huober, J, Singer, C, Mouret Reynier, Ma, Iwata, H, Iwase, H, Sohn, J, Yamauchi, T, Tomova, A, Schenker, M, Niikura, N, Ungureanu, A, Sriuranpong, V, Kaen, D, Henning, Jw, Borrego, Mr, Kurteva, G, Deleu, Gfi, Popov, V, Garcia Saenz, Ja, Timar-David, M, Kim, J, Lopez Lopez, R, Perello Martorell, A, Takano, T, Kattan, J, Wright, G, Yañez, E, Mundhenke, C, Aggarwal, L, Nakayama, T, Airoldi, M, Ludmila, L, Alonso Romero, Jl, Arnaud, A, Bianchi, Gv, Denduluri, N, Shtivelband, M, Kowalyszyn, R, Chouinard, E, Farhat, F, Sevillano Fernandez, E, Bermejo de Las Heras, B, Perez Garcia, Jm, De Toro Salas, R, Tseng, Lm, Sandri, I, Barbeaux, A, Brust, L, Provencher, L, Leheurteur, M, Nusch, A, Yousuf, Af, Conte, P, Gonzalez Cortijo, L, Awada, A, Schmidt, M |
| سنة النشر: | 2019 |
| المجموعة: | ARUd'A - Archivio Istituzionale della ricerca dell'università Chieti-Pescara (IRIS) |
| مصطلحات موضوعية: | Adult, Aged, 80 and over, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocol, Breast Neoplasm, Class I Phosphatidylinositol 3-Kinase, Diarrhea, Female, Fulvestrant, Human, Male, Middle Aged, Mutation, Progression-Free Survival, Receptor, ErbB-2, Receptors, Estrogen, Progesterone, Thiazoles |
| الوصف: | BACKGROUND: PIK3CA mutations occur in approximately 40% of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The PI3Kα-specific inhibitor alpelisib has shown antitumor activity in early studies. METHODS: In a randomized, phase 3 trial, we compared alpelisib (at a dose of 300 mg per day) plus fulvestrant (at a dose of 500 mg every 28 days and once on day 15) with placebo plus fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously. Patients were enrolled into two cohorts on the basis of tumor-tissue PIK3CA mutation status. The primary end point was progression-free survival, as assessed by the investigator, in the cohort with PIK3CA-mutated cancer; progression-free survival was also analyzed in the cohort without PIK3CA-mutated cancer. Secondary end points included overall response and safety. RESULTS: A total of 572 patients underwent randomization, including 341 patients with confirmed tumor-tissue PIK3CA mutations. In the cohort of patients with PIK3CA-mutated cancer, progression-free survival at a median follow-up of 20 months was 11.0 months (95% confidence interval [CI], 7.5 to 14.5) in the alpelisib-fulvestrant group, as compared with 5.7 months (95% CI, 3.7 to 7.4) in the placebo-fulvestrant group (hazard ratio for progression or death, 0.65; 95% CI, 0.50 to 0.85; P<0.001); in the cohort without PIK3CA-mutated cancer, the hazard ratio was 0.85 (95% CI, 0.58 to 1.25; posterior probability of hazard ratio <1.00, 79.4%). Overall response among all the patients in the cohort without PIK3CA-mutated cancer was greater with alpelisib-fulvestrant than with placebo-fulvestrant (26.6% vs. 12.8%); among patients with measurable disease in this cohort, the percentages were 35.7% and 16.2%, respectively. In the overall population, the most frequent adverse events of grade 3 or 4 were hyperglycemia (36.6% in the alpelisib-fulvestrant group vs. 0.7% in the placebo-fulvestrant ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | ELETTRONICO |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/31091374; info:eu-repo/semantics/altIdentifier/wos/WOS:000468059200011; volume:380; issue:20; firstpage:1929; lastpage:1940; numberofpages:12; journal:NEW ENGLAND JOURNAL OF MEDICINE; http://hdl.handle.net/11564/704663Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85065812556; http://www.nejm.org/medical-indexTest |
| DOI: | 10.1056/NEJMoa1813904 |
| الإتاحة: | https://doi.org/10.1056/NEJMoa1813904Test http://hdl.handle.net/11564/704663Test http://www.nejm.org/medical-indexTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.2FD493E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1056/NEJMoa1813904 |
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