التفاصيل البيبلوغرافية
| العنوان: |
6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial |
| المؤلفون: |
Earl HM, Hiller L, Vallier A-L, Loi S, McAdam K, Hughes-Davies L, Harnett AN, Ah-See M-L, Simcock R, Rea D, Raj S, Woodings P, Harries M, Howe D, Raynes K, Higgins HB, Wilcox M, Plummer C, Mansi J, Gounaris I, Mahler-Araujo B, Provenzano E, Chhabra A, Abraham JE, Caldas C, Hall PS, McCabe C, Hulme C, Miles D, Wardley AM, Cameron DA, Dunn JA, Agarwal R, Algurafi H, Allerton R, Archer C, Armstrong A, Bale C, Barraclough L, Barthakur U, Bedi C, Benstead K, Bloomfield D, Bowen R, Bradley C, Brown J, Butt M, Churn M, Cleator S, Cliff J, Crellin P, Daly M, De Silva-Minor S, Dhadda A, Din O, Down S, Earl H, Eaton D, Eichholz A, Epurescu D, Goh C, Goodman A, Grieve R, Hadaki M, Harper-Wynne C, Hayward L, Humphreys A, Innes H, Jafri M, Jegannathen A, Kelleher M, Kristeleit H, Lee D, Lupton S, MacGregor C, Malik Z, Marshall J, McGolick T, Mehra R, Mithal N, Moss C, Moss A, Mukesh M, Neal A, Nelmes D, Neville-Webbe H, Newby J, O'Reilly S, Ostler P, Persic M, Pettit L, Raja F, Reed C, Rigg A, Roe H, Shah N, Simmonds P, Sims E, Smith S, Storey N, Taylor W, Thanvi N, Tipples K, Vaidya J, Varughese M, Vinayan A, Walji N, Waters S, Wright K, Yahya S |
| المصدر: |
The Lancet, 29 June - 5 July 2019 |
| بيانات النشر: |
Lancet Publishing Group |
| سنة النشر: |
2019 |
| المجموعة: |
Newcastle University Library ePrints Service |
| الوصف: |
© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is non-inferior to the standard 12-month treatment regarding disease-free survival. Methods: This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered every 3 weeks intravenously (loading dose of 8 mg/kg followed by maintenance doses of 6 mg/kg) or subcutaneously (600 mg), given in combination with chemotherapy (concurrently or sequentially). The primary endpoint was disease-free survival, analysed by intention to treat, with a non-inferiority margin of 3% for 4-year disease-free survival. Safety was analysed in all patients who received trastuzumab. This trial is registered with EudraCT (number 2006–007018–39), ISRCTN (number 52968807), and ClinicalTrials.gov (number NCT00712140). Findings: Between Oct 4, 2007, and July 31, 2015, 2045 patients were assigned to 12-month trastuzumab treatment and 2044 to 6-month treatment (one patient was excluded because they were double randomised). Median follow-up was 5·4 years (IQR 3·6–6·7) for both treatment groups, during which a disease-free survival event occurred in 265 (13%) of 2043 patients in the 6-month group and 247 (12%) of 2045 patients in the 12-month group. 4-year disease-free survival was 89·4% (95% CI 87·9–90·7) in the 6-month group and 89·8% (88·3–91·1) in the 12-month group (hazard ratio 1·07 [90% CI 0·93–1·24], non-inferiority ... |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| الإتاحة: |
https://eprint.ncl.ac.uk/fulltext.aspx?url=258584/8EB34366-D8C9-4498-9728-D2D1595C4BA9.pdf&pub_id=258584Test |
| رقم الانضمام: |
edsbas.F8D6B098 |
| قاعدة البيانات: |
BASE |
