First Efficacy Results of Capecitabine with Anthracycline- and Taxane-Based Adjuvant Therapy in High-Risk Early Breast Cancer: A Meta-Analysis

Jiang, Yiwei; Yin, Wen; Zhou, Liheng; Yan, Tingting; Zhou, Qiong; Du, Yueyao; Shen, Zhenzhou; Shao, Zhimin; Lu, Jinsong

doi:10.1371/journal.pone.0032474

Cited by 19 publications

(15 citation statements)

References 22 publications

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“…Another study showed an increased OS but not DFS (O'Shaughnessy et al 2009 ). A recent meta-analysis suggested an increased 5-year DFS and OS with adjuvant capecitabine (Jiang et al 2012 ). In our study, capecitabine significantly improved the 4-year DFS (p = 0.016), but the OS just failed to reach significance (p = 0.056), probably due to the small number of deaths.…”

Section: Discussionmentioning

confidence: 99%

Women with large (≥3 cm) and locally advanced breast cancers (T3, 4, N1, 2, M0) receiving neoadjuvant chemotherapy (NAC: cyclophosphamide, doxorubicin, docetaxel): addition of capecitabine improves 4-year disease-free survival

et al. 2015

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PurposeTo determine whether capecitabine (X), combined with docetaxel (T) following doxorubicin (A) and cyclophosphamide (C), enhanced the pathological complete response (pCR) in the breast and axillary lymph nodes (ALNs) of women with large or locally advanced breast cancers (LLABCs) improving outcome, and the effect on quality of life (QoL).Patients and methods117 women were enrolled, 112 randomised to 2 cycles of AC (60 mg/m2, 600 mg/m2) given 3 weekly. Tumour responses were assessed by magnetic resonance mammography. Responders (n = 77) received 2 further cycles of AC and were randomised to 4 cycles of T (100 mg/m2) (Group A) or T (75 mg/m2) and X (2000 mg/m2/day), day one to 14 of each 3 weekly cycle (Group B). Non-responders (n = 35) were randomised to 6 cycles of T (Group C) or T + X (Group D). QoL questionnaires were completed at each chemotherapy visit. Pathological responses were evaluated using established criteria.ResultsThe groups were comparable in patient and tumour characteristics (79.5% T2, 85.7% ductal, 73.2% ER +ve, 22.3% HER2 +ve, 42% involved ALNs). Overall breast pCR was 27.1%, Groups A + C versus B + D (p = 0.446). ALN +ve pCR was 41.9%, Groups A + C versus B + D (p = 0.231). 4-year disease-free survival (DFS) was significantly improved with X (p = 0.016) but not overall survival (p = 0.056). Triple -ve and HER2 +ve tumours, and persistent ALN disease were risk factors for metastases. X increased severe nail changes (p = 0.0002) and hand-foot syndrome (p = 0.014) without affecting QoL.ConclusionNAC-X did not increase breast and ALN pCR but improved 4-year DFS, without detriment to QoL.

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Section: Discussionmentioning

confidence: 99%

Women with large (≥3 cm) and locally advanced breast cancers (T3, 4, N1, 2, M0) receiving neoadjuvant chemotherapy (NAC: cyclophosphamide, doxorubicin, docetaxel): addition of capecitabine improves 4-year disease-free survival

et al. 2015

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“…type="uri">www.ClinicalTrials.gov]. In the U.S. Oncology Group randomized trial USON01062, where 2611 women were assigned to receive first four cycles of doxorubicin and cyclophosphamide (AC) followed by either four cycles of docetaxel or four cycles of TX, there was no significant difference in the primary endpoint (disease-free survival) between the two arms, but women treated with TX had significantly better overall survival [16]. A joint analysis of the FinXX and the USON01062 trials found addition of capecitabine to a taxane-anthracycline regimen to improve significantly disease-free survival, overall survival and to reduce death from breast cancer [17], whereas a randomized single-center trial that compared weekly paclitaxel with TX as adjuvant or neo-adjuvant treatments of early breast cancer was interrupted early due to absence of benefit associated with TX [18]. …”

Section: Discussionmentioning

confidence: 99%

Outcome of patients with HER2-positive breast cancer treated with or without adjuvant trastuzumab in the Finland Capecitabine Trial (FinXX)

et al. 2013

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Background.Little information is available about survival outcomes of patients with HER2-positive early breast cancer treated with adjuvant capecitabine-containing chemotherapy with or without trastuzumab.Patients and methods.One thousand and five hundred patients with early breast cancer were entered to the Finland Capecitabine trial (FinXX) between January 2004 and May 2007, and were randomly assigned to receive either three cycles of adjuvant TX (docetaxel, capecitabine) followed by three cycles of CEX (cyclophosphamide, epirubicin, capecitabine; TX-CEX) or three cycles of docetaxel followed by three cycles of CEF (cyclophosphamide, epirubicin, fluorouracil; T-CEF). The primary endpoint was recurrence-free survival (RFS). The study protocol was amended in May 2005 while study accrual was ongoing to allow adjuvant trastuzumab for patients with HER2-positive cancer. Of the 284 patients with HER2-positive cancer accrued to FinXX, 176 (62.0%) received trastuzumab after amending the study protocol, 131 for 12 months and 45 for nine weeks. The median follow-up time was 6.7 years.Results.Patients with HER2-positive cancer who received trastuzumab had better RFS than those who did not (five-year RFS 89.2% vs. 75.9%; HR 0.41, 95% CI 0.23–0.72; p = 0.001). Patients treated with trastuzumab for 12 months or nine weeks had similar RFS. There was no significant interaction between trastuzumab administration and the type of chemotherapy. Four (2.3%) patients treated with trastuzumab had heart failure or left ventricular dysfunction, three of these received capecitabine.Conclusion.Adjuvant trastuzumab improves RFS of patients treated with TX-CEX or T-CEF. Few patients had cardiac failure.

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“…However, there is little evidence to support its effectiveness. A meta-analysis by Jiang et al demonstrated that disease-free survival significantly improved following addition of capecitabine to an anthracycline-taxane-based adjuvant chemotherapy in patients with high-risk early breast cancer (19). The final results of the FinXX trial indicated that the addition of capecitabine significantly improved breast cancer-specific survival, although not the recurrence-free survival, in early breast cancer (20).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the clinical benefits of adjuvant capecitabine monotherapy in elderly women with breast cancer: A retrospective study

2017

Molecular and Clinical Oncology

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Abstract.Capecitabine is orally administered and may be safely and conveniently used in patients with cancer. The antitumor activity of capecitabine in breast cancer was mostly demonstrated in the salvage therapy setting, whereas the effect of adjuvant capecitabine monotherapy in breast cancer remains unclear. The aim of the present study was to evaluate adjuvant capecitabine monotherapy in elderly women with breast cancer. A total of 251 patients were enrolled and survival was compared between elderly breast cancer patients who received adjuvant capecitabine monotherapy and those who received no chemotherapy. Cancer-specific and disease-free survival curves were compared using log-rank tests and survival curves were calculated using the Kaplan-Meier method. Multivariate analyses were conducted using Cox's proportional hazard regression model. There was no significant difference between the clinicopathological characteristics, including age, tumor size, lymph node status, histological grade and hormone status, between patients in the two groups. The breast cancer-specific survival rate was 89.3% in the capecitabine monotherapy group vs. 81.3% in the no chemotherapy group; the difference was not statistically significant (P= 0.128). The disease-free survival rate was 81.7% in the capecitabine monotherapy group vs. 65.3% in the no chemotherapy group. Kaplan-Meier analysis indicated a longer disease-free survival in the capecitabine monotherapy group (P= 0.015). On Cox regression analysis, capecitabine monotherapy was found to be associated with the disease-free survival rate (P= 0.014, hazard ratio= 0.500) but not with the cancer-specific survival rate (P= 0.181). The adverse events of capecitabine monotherapy were recorded and there was no chemotherapy interruption due to severe adverse reactions. Therefore, adjuvant capecitabine monotherapy in elderly women with breast cancer is a safe and effective option, as well as a viable alternative for elderly breast cancer patients who refuse standard adjuvant therapy.

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First Efficacy Results of Capecitabine with Anthracycline- and Taxane-Based Adjuvant Therapy in High-Risk Early Breast Cancer: A Meta-Analysis

Cited by 19 publications

References 22 publications

Women with large (≥3 cm) and locally advanced breast cancers (T3, 4, N1, 2, M0) receiving neoadjuvant chemotherapy (NAC: cyclophosphamide, doxorubicin, docetaxel): addition of capecitabine improves 4-year disease-free survival

Women with large (≥3 cm) and locally advanced breast cancers (T3, 4, N1, 2, M0) receiving neoadjuvant chemotherapy (NAC: cyclophosphamide, doxorubicin, docetaxel): addition of capecitabine improves 4-year disease-free survival

Outcome of patients with HER2-positive breast cancer treated with or without adjuvant trastuzumab in the Finland Capecitabine Trial (FinXX)

Evaluation of the clinical benefits of adjuvant capecitabine monotherapy in elderly women with breast cancer: A retrospective study

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