Safety and Efficacy of Two Different Doses of Capecitabine in the Treatment of Advanced Breast Cancer in Older Women

Bajetta, Emilio; Procopio, Giuseppe; Celio, Luigi; Gattinoni, Luca; Torre, S. Della; Mariani, Luigi; Catena, Laura; Ricotta, Riccardo; Longarini, Raffaella; Zilembo, Nicoletta; Buzzoni, Roberto

doi:10.1200/jco.2005.02.167

Cited by 195 publications

(120 citation statements)

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“…There was a steady decrease in the relative dose intensity of capecitabine during treatment caused by treatment delays or dose reductions mostly because of hand -foot syndrome, whereas that of S-1 remained steady (Figure 2). Considering these findings, we suggest that a dose of 1000 mg m À2 two times daily, lower than that recommended, would be appropriate for capecitabine in elderly patients (Bajetta et al, 2005), whereas the recommended dose of 40 mg m À2 two times daily would be acceptable for S-1. These findings suggest that dose escalation of S-1 may be possible in younger patients.…”

Section: Discussionmentioning

confidence: 96%

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

et al. 2008

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This randomised multicentre phase II study was conducted to investigate the activity and safety of two oral fluoropyrimidines, capecitabine or S-1, in elderly patients with advanced gastric cancer (AGC). Elderly (X65 years) chemo-naive patients with AGC were randomly assigned to receive capecitabine 1250 mg m À2 two times daily on days 1 -14 every 3 weeks or S-1 40 -60 mg two times daily according to body surface area on days 1 -28 every 6 weeks. Ninety-six patients were enrolled and 91 patients were randomised to capecitabine (N ¼ 46) or S-1 (N ¼ 45). Overall response rate, the primary end point, was 27.2% (95% CI, 14.1 -40.4, 12 of 44 assessable patients) with capecitabine and 28.9% (95% CI, 15.6 -42.1, 13 of 45) with S-1. Median times to progression and overall survival in the capecitabine arm (4.7 and 9.5 months, respectively) were similar to those in the S-1 arm (4.2 and 8.2 months, respectively). The incidence of grade 3 -4 granulocytopenia was 6.8% with capecitabine and 4.8% with S-1. Grade 3 -4 nonhaematologic toxicities were: asthenia (9.1% with capecitabine vs 7.1% with S-1), anorexia (6.8 vs 9.5%), diarrhoea (2.3 vs 0%), and hand -foot syndrome (6.8 vs 0%). Both capecitabine and S-1 monotherapies were active and tolerable as first-line treatment for elderly patients with AGC.

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Section: Discussionmentioning

confidence: 96%

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

et al. 2008

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“…There were no treatmentrelated deaths, and the most common grade 3 or grade 4 AEs included asthenia, 13% (95% CI, 6%-24%); diarrhea, 10% (95% CI, 4%-20%); vomiting, 6% (95% CI, 2%-16%); and mucositis, 3% (95% CI, 1%-12%), with grade 2 or 3 HFS in 24% (95% CI, 14%-36%) of patients. More recently, Bajetta et al [22] treated 73 patients ≥65 years of age (93% chemotherapy-naïve for metastatic disease) with single-agent capecitabine. The first 30 patients received the standard dose and regimen, but because of two (7%) deaths, both a result of severe dehydration, the investigators decided to reduce the initial capecitabine dose to 1,000 mg/m 2 bid for the next 43 patients (low-dose cohort).…”

Section: Metastatic Disease: First-linementioning

confidence: 99%

“…A phase II RCT by Talbot et al [42] compared the safety profile of single-agent capecitabine with that of singleagent paclitaxel in patients who had failed or were resistant to anthracycline-based therapy and/or who had undergone 19 (14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26) All regimens used twice daily dosing, 2 weeks on/1 week off, unless otherwise noted.…”

Section: Safetymentioning

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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“…Although only limited data are available on the efficacy and safety of capecitabine monotherapy in China, several studies have suggested that it may be a suitable option for elderly patients with AGC [37][38][39][40]. In an RCT [38], 60 elderly stage II-III GC patients who had undergone dissection were randomly assigned to either high-dose capecitabine (2500 mg/m 2 b.i.d.…”

Section: Capecitabine Monotherapymentioning

confidence: 99%

A Review of Capecitabine-Based Adjuvant Therapy for Gastric Cancer in the Chinese Population

Cheng

2017

Future Oncol.

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In China, the treatment of locally advanced gastric cancer (AGC) faces unique challenges. Chinese patients may harbor more unfavorable prognostic factors than western populations and, in comparison with other Asian populations such as Japan and South Korea, a higher proportion of Chinese patients are diagnosed with AGC due to inadequate early diagnosis of the malignancy. This review summarizes the use of combination chemotherapy regimens with capecitabine as adjuvant therapy in the Chinese AGC population. Based on the available domestic data in China, the review concludes that capecitabine-based chemotherapy regimens, especially XELOX, offer good efficacy following radical gastrectomy in patients with AGC, with a low incidence of adverse events, acceptable tolerance, greater patient convenience and a lower overall cost than other regimens.

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Safety and Efficacy of Two Different Doses of Capecitabine in the Treatment of Advanced Breast Cancer in Older Women

Abstract: This study shows that capecitabine is safe and effective in the elderly breast cancer patient. Based on the overall results, the capecitabine dose of 1,000 mg/m(2) twice daily merits consideration as "standard" for older patients who do not have severely impaired renal function.

Cited by 195 publications

References 20 publications

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

A randomised multicentre phase II trial of capecitabine vs S-1 as first-line treatment in elderly patients with metastatic or recurrent unresectable gastric cancer

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

A Review of Capecitabine-Based Adjuvant Therapy for Gastric Cancer in the Chinese Population

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