Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer

Fumoleau, P.; Largillier, R.; Clippe, Christine; Dièras, Véronique; Orfeuvre, Hubert; Lesimple, Thierry; Culine, Stéphane; Audhuy, B.; Serin, D.; Curé, Hervé; Vuillemin, E.; Morère, J. F.; Montestruc, François; Mouri, Z.; Namer, M.

doi:10.1016/j.ejca.2003.11.007

Cited by 282 publications

(181 citation statements)

References 27 publications

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“…In a small study, Jakob et al [43] reported that half of the 12 patients treated with the standard oral capecitabine regimen had improved QoL scores, as measured by the European Organization for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ). A more recent study by Fumoleau et al [30], who used the same regimen and questionnaire on 119 anthracycline-and taxane-resistant patients, reported significant improvements in mean Global Health Status from baseline (10 points) after 6 and 12 treatment cycles.…”

Section: Quality Of Lifementioning

confidence: 99%

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

Ershler

2006

The Oncologist

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After completing this course, the reader will be able to:1. Describe the pharmacology of capecitabine.2. Discuss the use of capecitabine as a single agent and in refractory disease. AbstractOptimal management for metastatic breast cancer frequently involves cytotoxic chemotherapy. Over the years, several complex multidrug regimens have been developed that were based upon a rationale of synergistic antitumor activity and nonoverlapping toxicities. However, recently the clinical value of these complex regimens has been called into question as several drugs used alone (monotherapy) or in sequence (serial single agent) have been shown to be both efficacious and better tolerated. Capecitabine (an orally administered fluoropyrimidine carbamate) is one such agent that has been proven to be effective when used alone for metastatic breast cancer, metastatic colorectal cancer, and adjuvant colon cancer. In this review, published (or reported in abstract form) data examining various aspects of clinical response and tolerability with single-agent capecitabine for (primarily) first-and second-line metastatic breast cancer are examined. For the most part, response rates are comparable with those of the more complex regimens. Dose reductions from the labeled dose of 1,250 mg/m 2 twice daily are relatively common. Toxicities (following dose reductions if needed) are generally manageable, even by more frail patients. Elderly patients are more likely to have impaired renal function or be receiving warfarin treatment, and special attention to these factors is warranted. Nonetheless, the drug administered alone is a reasonable choice when singleagent chemotherapy is entertained as a treatment option for metastatic breast cancer, including in the first-line setting. The Oncologist 2006;11:325-335

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Section: Quality Of Lifementioning

confidence: 99%

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

Ershler

2006

The Oncologist

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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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“…2 It is approved by the US Food and Drug Administration (FDA) as monotherapy at a dose of 2500 mg/m 2 (divided twice daily) for 14 days using a 21-day treatment cycle for anthracycline-resistant and taxane-resistant MBC and in combination with docetaxel for anthracycline-pretreated disease. [3][4][5][6][7][8] Several trials also have demonstrated efficacy for capecitabine combined with chemotherapy (ixabepilone) and newer targeted agents, such as bevacizumab, trastuzumab, and lapatinib. [9][10][11][12] At the standard single-agent dose (1250 mg/m 2 twice daily) and schedule, typical capecitabine-related adverse events include hand-foot syndrome, diarrhea, nausea, vomiting, and stomatitis, which often result in dose reductions and truncated treatment cycles.…”

mentioning

confidence: 99%

Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer

Gajria

Feigin

Tan

et al. 2011

Cancer

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BACKGROUND: Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine schedule 7 days of treatment followed by 7 days of rest (7-7) will improve efficacy and minimize toxicity. Bevacizumab has demonstrated the ability to improve outcomes when it is added to chemotherapy, including capecitabine, in the first-line and second-line settings. METHODS: Patients with measurable MBC received oral capecitabine (2000 mg twice daily; 7-7), and intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was the response rate. Secondary endpoints included toxicity, the clinical benefit rate, and progression-free survival (PFS). RESULTS: Forty-one patients were treated. After a median of 7 cycles (range, 1-32 cycles), partial responses were observed in 20% of patients, and stable disease for !6 months was noted in 35% patients. The median PFS was 8 months. The most common treatment-related toxicities were hand-foot syndrome (49% grade 2, 20% grade 3/4) hypertension (12% grade 2, 10% grade 3/4), and fatigue (12% grade 2, 2% grade 3/4). Diarrhea (5% grade 2, 0% grade 3/4), nausea (0% grade 2-4), and vomiting (0% grade 2-4) were rare. CONCLUSIONS: Capecitabine administered for 7 days followed by a 7-day rest in combination with bevacizumab had modest efficacy and an acceptable toxicity profile in patients with MBC. Gastrointestinal toxicity with this schedule was minimal. Cancer 2011;117:4125-

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Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer

Cited by 282 publications

References 27 publications

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

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

Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer

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