First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: Results of the MONICA trial

Kaufmann, M.; Maass, Nicolaì; Costa, Serban Dan; Schneeweiß, Andreas; Loibl, Sibylle; Sütterlin, Marc; Schrader, Iris; Gerber, Bernd; Bauer, Wolfgang; Wiest, W.; Tomé, Oliver; Distelrath, Andrea; Hagen, Volker; Kleine-Tebbe, A.; Ruckhaeberle, Eugen; Mehta, Keyur; Minckwitz, Gϋnter von

doi:10.1016/j.ejca.2010.07.009

Cited by 34 publications

(19 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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: 81%

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

2017

Molecular and Clinical Oncology

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 81%

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

2017

Molecular and Clinical Oncology

View full text Add to dashboard Cite

show abstract

“…Capecitabine, an oral fluoropyrimidine, which has rapidly become established as a pivotal agent in the management of MBC, has a favorable tolerability profile, including minimal alopecia and myelosuppression. As a single agent, capecitabine affords substantial clinical benefit, including an OS benefit compared with classical cyclophosphamide/methotrexate/5-fluorouracil (CMF) [14,15]. Its use in combination chemotherapy is underpinned by preclinical tumor xenograft data, which demonstrate at least additive activity with a wide range of chemotherapy agents, including docetaxel, cyclophosphamide, and doxorubicin ( Fig.…”

Section: Neoadjuvant Chemotherapymentioning

confidence: 97%

“…There is also a substantial body of clinical trial data and extended clinical experience supporting the efficacy and safety of capecitabine monotherapy in first-line MBC [14,15,[78][79][80][81][82]. In a randomized, phase III, three-arm trial comparing CMF, administered at the optimum schedule (days 1 and 8, every 28 days) with two dose schedules of capecitabine (classic intermittent and continuous administration) in 323 previously untreated women with MBC, capecitabine achieved a significant survival benefit compared with CMF [15].…”

Section: Chemotherapy For Metastatic Diseasementioning

confidence: 98%

Going Beyond Anthracyclines and Taxanes in Breast Cancer - What's Next?

Verma¹

2013

Current Cancer Therapy Reviews

View full text Add to dashboard Cite

In recent years, a clear trend has been observed for taxanes to be used earlier in the course of breast cancer, with a large proportion of patients previously treated with anthracyclines and/or taxanes in the (neo)adjuvant setting. In addition, tolerability issues associated with taxane use in elderly patients and patients with substantial comorbidity, means that taxane use is frequently compromised in a substantial proportion of patients with metastatic breast cancer (MBC). Retreatment with taxanes yields variable results, and alternative cytotoxic agents with good activity in patients with anthracycline-and taxane-pretreated MBC are required. Large studies and meta-analyses have helped to establish the role of anthracycline-and taxane-based adjuvant therapy for early breast cancer (EBC). Addition of further cytotoxic agents has generally met with little success, thus the focus has moved towards optimization of adjuvant therapy through scheduling and patient selection. This review considers recent and ongoing developments in the chemotherapeutic management of EBC and MBC.

show abstract

“…The dose of sorafenib was based on the preceding phase II study with a mean daily dose per patient of 584 mg [8]. Capecitabine 2000 mg/m 2 is a well-tolerated and highly effective therapy [18]. In summary, dermatologic toxicities - especially hand-foot (skin) syndrome or reactions - are among the main reasons to stop or reduce multikinase targeting agents such as sorafenib, especially when combined with a chemotherapy inducing similar toxicities [19].…”

Section: Discussionmentioning

confidence: 99%

Sorafenib in the Treatment of Early Breast Cancer: Results of the Neoadjuvant Phase II Study - SOFIA*

et al. 2014

View full text Add to dashboard Cite

Background: Sorafenib was tested for neoadjuvant treatment with an anthracycline/taxane-based chemotherapy in the open-label, multicentre, single-arm phase II study, ‘SOFIA'. Patients and Methods: Inclusion criteria were: HER2 negative, cT3, cT4 or cT2 cN+, M0 primary breast cancer. Patients received 4 × epirubicin 90 mg/m² and cyclophosphamide 600 mg/m² (EC) intravenously (i.v.) in 3-weekly cycles followed or preceded by 12 weeks of paclitaxel (Pw) 80 mg/m². In cohort 1, sorafenib started at 800 mg daily with chemotherapy. An initial daily sorafenib dose of 200 mg was escalated, based on individual toxicities, every 3 weeks in cohort 2 (starting with EC) and every 2 weeks in cohort 3 (starting with Pw). The primary objective was to identify the most feasible regimen; secondary objectives were safety, pathological complete response (pCR) at surgery and pharmacokinetics. Results: Of the 36 recruited patients, 7/12 patients completed the study in cohort 1 and 24/24 patients in cohorts 2 and 3. The median cumulative sorafenib dose per patient was 37%, 65% and 46% in cohorts 1, 2 and 3, respectively. The main grade 3-4 toxicities were neutropenia and hand-foot syndrome. The pCR (ypT0/is) rate was 27.7%. No pharmacokinetic interaction was observed between sorafenib and epirubicin. Conclusion: Sorafenib EC-Pw is feasible if the starting dose is 200 mg, escalated every 3 weeks based on the patients' individual toxicities.

show abstract

First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: Results of the MONICA trial

Cited by 34 publications

References 17 publications

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

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

Going Beyond Anthracyclines and Taxanes in Breast Cancer - What's Next?

Sorafenib in the Treatment of Early Breast Cancer: Results of the Neoadjuvant Phase II Study - SOFIA*

Contact Info

Product

Resources

About