A randomized controlled Phase II trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer.
Background: Previous studies have shown that vinorelbine/capecitabine (NX) and docetaxel/capecitabine (TX) chemotherapy has a certain effect in advanced breast cancer. However, there are few clinical studies directly comparing TX and NX regimen chemotherapy, especially in patients with advanced brea...
| Publicado en: | Journal of Cancer Research & Therapeutics Vol. 16; no. 5; pp. 1069 - 1077 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wolters Kluwer India Pvt Ltd
Oct2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=146218476&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 146218476 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09731482 1BS3 jtl: Journal of Cancer Research & Therapeutics issn: 09731482 maglogo: N pubinfo: dt: Oct2020 vid: 16 iid: 5 pid: 16919 pub: Wolters Kluwer India Pvt Ltd artinfo: ui: 146218476 146218476 NLM33004749 146218476 10.4103/jcrt.JCRT_792_19 NLM33004749 146218476 ppf: 1069 ppct: 8 formats: tig: atl: A randomized controlled Phase II trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with metastatic breast cancer. aug: au: Li, Shufen Meng, Wenjing Zhang, Jibo Xie, Xiaojuan Hao, Chunfang Jia, Yongsheng Tong, Zhongsheng affil: Department of Breast Oncology, Cancer Hospital of Tianjin, Department of Breast Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Breast Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin sug: subj: Antineoplastic Agents, Combined Therapeutic Use Breast Neoplasms Drug Therapy Drug Resistance, Neoplasm Breast Neoplasms Pathology Anthracyclines Administration and Dosage Survival Neoplasm Metastasis Middle Age Treatment Outcomes Human Female Clinical Trials Validation Studies Comparative Studies Evaluation Research Multicenter Studies Randomized Controlled Trials Middle Aged: 45-64 years Female ab: Background: Previous studies have shown that vinorelbine/capecitabine (NX) and docetaxel/capecitabine (TX) chemotherapy has a certain effect in advanced breast cancer. However, there are few clinical studies directly comparing TX and NX regimen chemotherapy, especially in patients with advanced breast cancer previously treated with anthracycline and taxane. The purpose of this Phase II study was to compare survival and side effects between patients with anthracycline- and taxane-resistant advanced breast cancer treated with NX and those treated with TX chemotherapy.Patients and Methods: From February 2012 to March 2014, a total number of 97 patients were randomly assigned to NX (n = 55) or TX (n = 42). Baseline characteristics were relatively well-balanced in the two treatment arms. The clinical trial registration number (clincaltrials.gov) is NCT01635465.Results: After a median follow-up of 46.0 months, there was no significant difference between the NX and TX arms in objective response rate (17.9% vs. 21.1%; P = 0.686) and progression-free survival (6 months vs. 7 months; P = 0.560). The overall survival period of the TX arm was longer than that of the NX arm (32 months vs. 27 months) but without statistical significance. Both regimens were well-tolerated. The main toxicities were neutropenia, leukopenia, and anemia. In the TX arm, hand-foot syndrome occurred more frequently than in the NX arm (P < 0.01), but frequencies of other minor adverse effects were similar between the two arms.Conclusion: NX and TX regimens are both alternative treatments for patients with anthracycline- and taxane-resistant advanced breast cancer, but the safety profile was more favorable and manageable with the NX regimen.Trial Registrations: ClinicalTrials.gov NCT01635465. Registered 09 July 2012. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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