دورية أكاديمية
EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer
| العنوان: | EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer |
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| المؤلفون: | Biganzoli L., Cinieri S., Berardi R., Pedersini R., McCartney A., Minisini A. M., Caremoli E. R., Spazzapan S., Magnolfi E., Brunello A., Risi E., Palumbo R., Leo S., Colleoni M., Donati S., De Placido S., Orlando L., Pistelli M., Parolin V., Mislang A., Becheri D., Puglisi F., Sanna G., Zafarana E., Boni L., Mottino G. |
| المساهمون: | Biganzoli, L., Cinieri, S., Berardi, R., Pedersini, R., Mccartney, A., Minisini, A. M., Caremoli, E. R., Spazzapan, S., Magnolfi, E., Brunello, A., Risi, E., Palumbo, R., Leo, S., Colleoni, M., Donati, S., De Placido, S., Orlando, L., Pistelli, M., Parolin, V., Mislang, A., Becheri, D., Puglisi, F., Sanna, G., Zafarana, E., Boni, L., Mottino, G. |
| سنة النشر: | 2020 |
| المجموعة: | Università degli Studi di Udine: CINECA IRIS |
| مصطلحات موضوعية: | Breast cancer, Functional decline, Metastatic, Nab-paclitaxel, Older adult, Toxicity |
| الوصف: | Background: Limited data are available regarding the use of nab-paclitaxel in older patients with breast cancer. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population. Methods: EFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m2 (arm A) or 125 mg/m2 (arm B) on days 1, 8, and 15 on a 28-day cycle, as first-line treatment for advanced disease. The primary endpoint was event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death. In each arm, the null hypothesis that the median EFS would be ≤ 7 months was tested against a one-sided alternative according to the Brookmeyer Crowley test. Secondary endpoints included objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety. Results: After a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9-8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2-9.7, p = 0.078) in arm B. Progression-free survival, overall survival, and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B. The most frequently reported non-haematological AEs were fatigue (grade [G] 2-3 toxicity occurrence in arm A vs B, 43% and 51%, respectively) and peripheral neuropathy (G2-3 arm A vs B, 19% and 38%, respectively). Conclusion: Pre-specified outcomes were similar in both treatment arms. However, 100 mg/m2 was significantly better tolerated with fewer neurotoxicity-related ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/wos/WOS:000560788200001; volume:22; issue:1; firstpage:83; journal:BREAST CANCER RESEARCH; http://hdl.handle.net/11390/1189175Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85089170533 |
| DOI: | 10.1186/s13058-020-01319-1 |
| الإتاحة: | https://doi.org/10.1186/s13058-020-01319-1Test http://hdl.handle.net/11390/1189175Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.BB50EB9 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13058-020-01319-1 |
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