Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

Tong, Daniel; Cheng, Carter W.N.; Chan, See Ching; Wong, Lai Ngor; Chow, Louis T. C.

doi:10.1159/000086996

Cited by 12 publications

(4 citation statements)

References 29 publications

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“…Therefore, the focus of the present investigation was the evaluation of QoL in patients with metastatic breast cancer during treatment with capecitabine in a routine setting. Data from this study confirmed former clinical investigations on the efficacy of capecitabine in the treatment of metastatic breast cancer [9,10,11] as well as colorectal cancer [12,13]. These investigations unanimously attested a maintained or improved QoL during capecitabine therapy.…”

Section: Discussionsupporting

confidence: 88%

Quality of Life under Capecitabine (Xeloda®) in Patients with Metastatic Breast Cancer: Data from a German Non-Interventional Surveillance Study

et al. 2014

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Aim: This non-interventional surveillance study (NIS) collected data on the quality of life (QoL) of patients treated with capecitabine as mono- or combination chemotherapy in an outpatient setting. Methods: Capecitabine was administered orally for 14 days of each 21-day cycle. The main parameters of interest were QoL, compliance, patient and physician satisfaction, handling of hand-foot syndrome (HFS), and efficacy. The statistics were descriptive; some differences were compared using confidence intervals (CIs). Results: 735 patients from 161 centers received at least 1 dose of capecitabine. The median duration of observation was 5.5 months overall. The QoL global score was 53% (mean from the entire study population at all times), without any correlation to HFS. The overall response rate (ORR) was 35.1%, and the disease control rate (DCR) 64.4%. The median progression-free survival (PFS) was overall 6.81 months (95% CI 6.32-7.63 months) and it was significantly higher in patients with HFS (8.4 months, 95% CI 7.5-9.2 months, hazard ratio (HR) 0.60; p < 0.0001). The safety and tolerability of capecitabine were considered acceptable. The HFS incidence (all grades) was 27.1%. Conclusions: Capecitabine had a favorable risk-benefit relation in outpatient therapy. The QoL remained stable over the course of the investigation, indicating good compliance. HFS was a strong predictor of longer PFS and had no negative impact on the global QoL.

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Section: Discussionsupporting

confidence: 88%

Quality of Life under Capecitabine (Xeloda®) in Patients with Metastatic Breast Cancer: Data from a German Non-Interventional Surveillance Study

et al. 2014

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“…The clinical interest in oral chemotherapy regimens is evidenced by the recent publication of other studies in this field. One has investigated the combination of idarubicin, 9 cyclophosphamide and capecitabine, and another combined vinorelbine and capaecitabine 10 …”

Section: Discussionmentioning

confidence: 99%

Capecitabine and oral cyclophosphamide: A novel oral treatment combination for advanced cancer

Findlay

Sharples

Riley

et al. 2007

Asia-Pac J Clncl Oncology

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Background: This dose escalation study assessed feasibility of a totally oral chemotherapy regimen using cyclophosphamide and capecitabine. The rationale for this combination was based on the observation that preclinical models of cyclophosphamide up-regulated tumor thymidine phosphorylase and increased the activation of capecitabine. Methods: Eligible patients with advanced cancer were treated with oral cyclophosphamide and capecitabine on a 28-day cycle. If no dose limiting toxicities (DLT) were encountered during the first two treatment cycles, the next patient group was assigned to the next highest dose level until the maximum tolerable dose (MTD) was determined. Results: Twenty-seven patients entered treatment. The majority of non-DLT were grades 1 and 2. DLT experienced in the first 8-week observation period were grade 3 diarrhea (one patient, level III) and grade 3 emesis (two patients, level V). MTD was observed at level 5, 1331 mg/m 2 /day capecitabine days 1-28 with 125 mg/m 2 /day cyclophosphamide days 1-14 of the 28-day cycle. The recommended phase II dose is therefore 1331 mg/m 2 /day capecitabine with 100 mg/m 2 /day cyclophosphamide. The best response evaluation showed four partial responses (breast, colon, ovary and pancreas). Conclusion: Cyclophosphamide and capecitabine can be combined at their full oral single agent dose with promising tolerability and activity.

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“…All-oral regimens of capecitabine plus oral vinorelbine also show promise [118][119][120][121][122][132][133][134]. Other combinations attracting interest include capecitabine plus oral idarubicin [135], capecitabine plus oral cyclophosphamide [136], capecitabine/ idarubicin/cyclophosphamide triple combination [124], and capecitabine plus tipifarnib [137]. Studies of metronomic therapy using an all-oral combination of cyclophosphamide and methotrexate suggest that this is an effective and minimally toxic approach [128][129][130].…”

Section: All-oral Combinationsmentioning

confidence: 99%

Effective oral chemotherapy for breast cancer: pillars of strength

2008

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Traditionally, anticancer therapy has been dominated by intravenous drug therapy. However, oral agents provide an attractive approach to chemotherapy and use of oral treatments is increasing. We discuss the benefits and challenges of oral chemotherapy from the perspectives of patients, healthcare providers and healthcare funders. Important issues include patient preference, efficacy, compliance, bioavailability, reimbursement, use in special patient populations, financial and staff time savings and flexibility of dosing. We review data for traditional oral agents (e.g. cyclophosphamide, methotrexate), newer oral chemotherapies (e.g. capecitabine), oral formulations of traditionally intravenous agents (e.g. vinorelbine, idarubicin) and new biologic agents under evaluation in breast cancer (e.g. tyrosine kinase inhibitors). Lastly, we review studies of all-oral combination regimens. The wealth of data available and the increasing use of oral agents in breast cancer suggest that many of the concerns and perceptions about oral therapy, including efficacy and bioavailability, have been overcome, and that oral therapy will play a major role in breast cancer management in the future in both the metastatic and adjuvant settings. Key words: breast cancer, capecitabine, oral chemotherapy, vinorelbine introduction Cancer treatment has traditionally been dominated by intravenous drug therapy [1]. There has, however, been a steady increase in the number of oral anticancer agents available during recent years, offering obvious benefits in terms of convenience and ease of administration, as well as addressing patients' preference for oral therapy [2][3][4][5]. It is estimated that one-quarter of all anticancer agents under development are oral agents [6]. Several agents that are already approved in a range of tumour types (e.g. capecitabine, erlotinib, gefitinib, imatinib, lapatinib, lenalidomide, thalidomide, sunitinib, sorafenib) and many others in development (e.g. vatalanib, satraplatin) are or will be available only as oral formulations. Novel approaches to drug delivery, such as the development of hydrophilic polymer carriers to deliver drugs to the gut [7], are likely to further increase the number of oral drugs available.This review investigates the impact of the expanding range of oral agents on cancer treatment, focusing on issues that have previously prevented the use of oral agents in patients with cancer and the opportunities that oral therapy offers. Oral agents that are already available, or that are under clinical evaluation for the treatment of breast cancer, are profiled to illustrate the potential of oral chemotherapy in this patient group.defining the ideal oral agent the patient's perspective Several surveys have shown that most patients prefer oral to intravenous therapy [3,4,8]. Nevertheless, a minority of patients prefer intravenous therapy because they believe that oral therapy is less effective than intravenous treatment [5,8,9]. In a survey of 59 patients starting oral chemotherapy for advanced breas...

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Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

Cited by 12 publications

References 29 publications

Quality of Life under Capecitabine (Xeloda®) in Patients with Metastatic Breast Cancer: Data from a German Non-Interventional Surveillance Study

Quality of Life under Capecitabine (Xeloda®) in Patients with Metastatic Breast Cancer: Data from a German Non-Interventional Surveillance Study

Capecitabine and oral cyclophosphamide: A novel oral treatment combination for advanced cancer

Effective oral chemotherapy for breast cancer: pillars of strength

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