Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial
| العنوان: | Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial |
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| المؤلفون: | Ke-Da Yu, Miao Mo, Min He, Zhi-Ming Shao, Jing-Yu Ge, Spectrum Investigators, Xi-Yu Liu |
| المصدر: | J Natl Cancer Inst |
| بيانات النشر: | Oxford University Press (OUP), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Cancer Research, medicine.medical_specialty, Paclitaxel, medicine.medical_treatment, Population, Breast Neoplasms, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Pregnancy, Interquartile range, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, education, Cyclophosphamide, Epirubicin, education.field_of_study, Chemotherapy, Intention-to-treat analysis, business.industry, Editorials, medicine.disease, Chemotherapy regimen, Regimen, Treatment Outcome, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, business, medicine.drug |
| الوصف: | Background Chemotherapy-induced premature menopause leads to some consequences, including infertility. We initiated this randomized phase III trial to determine whether a cyclophosphamide-free adjuvant chemotherapy regimen would increase the likelihood of menses resumption and improve survival outcomes. Methods Young women with operable estrogen receptor-positive HER2-negative breast cancer after definitive surgery were randomly assigned to receive adjuvant epirubicin and cyclophosphamidefollowed by weekly paclitaxel (EC-wP) or epirubicin and paclitaxel followed by weekly paclitaxel (EP-wP). All patients received at least 5-year adjuvant endocrine therapy after chemotherapy. Two coprimary endpoints were the rate of menstrual resumption at 12 months after chemotherapy and 5-year disease-free survival in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT01026116). All statistical tests were 2-sided. Results Between January 2011 and December 2016, 521 patients (median age = 34 years; interquartile range = 31-38 years) were enrolled, with 261 in the EC-wP group and 260 in the EP-wP group. The rate of menstrual resumption at 12 months after chemotherapy was 48.3% in EC-wP (95% confidence interval [CI] = 42.2% to 54.3%) and 63.1% in EP-wP (95% CI = 57.2% to 68.9%), with an absolute difference of 14.8% (95% CI = 6.37% to 23.2%, P Conclusions The cyclophosphamide-free chemotherapy regimen might be associated with a higher probability of menses resumption. |
| تدمد: | 1460-2105 0027-8874 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fba592dcde09a4a09e5fa58db45e6b8f https://doi.org/10.1093/jnci/djab065 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....fba592dcde09a4a09e5fa58db45e6b8f |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14602105 00278874 |
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