Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer

Stockler, Martin R.; Harvey, Vernon; Francis, Prudence A.; Byrne, Michael; Ackland, Stephen P.; Fitzharris, Bernie; Hazel, G. Van; Wilcken, Nicholas; Grimison, Peter; Nowak, Anna K.; Gainford, M. Corona; Fong, Akiko; Paksec, Lisa; Sourjina, T.; Zannino, Diana; Gebski, Val; Simes, R. John; Forbes, John F.; Coates, Alan S.

doi:10.1200/jco.2010.33.9101

Cited by 140 publications

(80 citation statements)

References 26 publications

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“…PFS was similar in women receiving capecitabine or CMF, and OS was longer in the capecitabine group. The results were consistent across all relevant clinical subgroups, although HER2 and ER status were often unknown [19]. In contrast, another study found that standard adjuvant chemotherapy (classical CMF or doxorubicin/cyclophosphamide (AC)) was superior to capecitabine in older patients, and the benefit was pronounced in those with hormone receptor-negative breast cancer [20].…”

Section: Discussionmentioning

confidence: 75%

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

et al. 2018

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Background: Few data are available on the benefit of metronomic cyclophosphamide, capecitabine, and vinorelbine as first-line therapy in patients with metastatic triple-negative breast cancer. Methods: This phase II study assessed the safety and efficacy of metronomic oral chemotherapy with vinorelbine 40 mg orally 3 times a week, cyclophosphamide 50 mg daily, and capecitabine 500 mg 3 times a day (VEX regimen) in untreated metastatic triple-negative breast cancer patients. The biopsy of the metastatic site had to be triple-negative, independent of the hormone receptor expression of the primary tumor. The primary endpoint was time to progression (TTP). Secondary endpoints included assessment of safety and clinical benefit (objective response rate plus stable disease rate at ≥24 weeks). Results: 25 patients were included, and 22 were evaluable for both efficacy and toxicities (median age, 66 years). Median TTP was 6.4 months (95% confidence interval 3.6-12.6). The most common grade 1-2 toxicities were nausea, diarrhea, leuko-/neutropenia, and reversible liver enzyme alteration. Grade 3 events included hand and foot syndrome (9%). Conclusion: The VEX regimen demonstrated activity and was relatively well tolerated when given as first-line therapy in selected metastatic breast cancer patients with triple-negative disease.

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Section: Discussionmentioning

confidence: 75%

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

et al. 2018

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“…The combination protocol of cisplatin/capecitabine was considered non-effective if the response rate was < 20% (because this is inferior to standard single agent capecitabine in historical investigations [34][35][36][37] ) and was considered worthy of further study if the proportion of responses was 40%. With the type I error being 5% and the type II error 20%, 18 patients were to be enrolled during the first step and an additional 15 patients during the second step.…”

Section: Statisticsmentioning

confidence: 99%

A phase II study of capecitabine plus cisplatin in metastatic triple-negative breast cancer patients pretreated with anthracyclines and taxanes

Zhang

et al. 2015

Cancer Biology & Therapy

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Background: Cisplatin is an effective agent for triple-negative breast cancer (TNBC) and synergistic activity between cisplatin and capecitabine has been demonstrated by in vitro and in vivo studies. This study was designed as a prospective clinical trial to evaluate the efficacy and safety of capecitabine plus cisplatin (XP) regimen in metastatic TNBC patients pretreated with anthracyclines and taxanes. Patients and Methods: Thirty-three patients with metastatic TNBC who had anthracyclines and taxanes as prior therapy were treated with capecitabine 2000 mg/m 2 orally on day 1 through 14 plus cisplatin 75mg/m 2 intravenously on day 1 of a 21-day cycle, followed by capecitabine maintenance medications after a maximum of 6 cycles. The primary end point was objective response rate (ORR) and the secondary end points included progression-free survival (PFS), overall survival (OS) and toxicity profiles. Results: A total of 162 cycles was given. ORR was 63.6%. Median PFS was 8.2 (95%CI: 4.8-11.6) months in the entire population and 10.8 (95%CI: 6.5-15.1) months in responding patients. Median OS was 17.8 (95%CI: 14.4-21.2) months in all enrolled patients and 25.8 (95%CI: 14.6-37.0) months in responding patients. Most adverse events were mild and manageable, with neutropenia and nausea/vomiting as the most common toxicities. Grade 3/4 toxicities included leukopenia (10, 30.3%), neutropenia (10, 30.3%), anemia (2, 6.1%), thrombocytopenia (1, 3.0%), nausea/vomiting (3, 9.1%), hand-foot syndrome (HFS; 1, 3.0%), and sensory neuropathy (1, 3.0%). Conclusions: Capecitabine plus cisplatin demonstrated an excellent activity and an acceptable safety profile in metastatic TNBC patients pretreated with anthracyclines and taxanes.

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“…The response rate of metastatic breast cancer to capecitabine monotherapy is ~30% (6,7). Capecitabine clearly improved the survival rate in second-and later-line salvage chemotherapy (6-10), and its efficacy has been also proven in the first-line treatment of metastatic breast cancer (11)(12)(13)(14). Kamal et al observed similar survival between capecitabine monotherapy and single-agent taxane as a first-line therapy for metastatic breast cancer (15).…”

Section: Discussionmentioning

confidence: 80%

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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Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer

Abstract: Capecitabine improved OS by being similarly active, less toxic, and more tolerable than CMF. Capecitabine is a good first-line chemotherapy option for women with advanced breast cancer who are unsuited to more intensive regimens.

Cited by 140 publications

References 26 publications

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

Metronomic Chemotherapy for First-Line Treatment of Metastatic Triple-Negative Breast Cancer: A Phase II Trial

A phase II study of capecitabine plus cisplatin in metastatic triple-negative breast cancer patients pretreated with anthracyclines and taxanes

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

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