Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program

Pierga, Jean‐Yves; Fumoleau, P.; Brewer, Y.; Zelek, Laurent; Martin, Daniel S.; Turpin, F; Goudier, M.-J.; Gil-Delgado, M.; Baticle, J. L.; Namer, M.; Chollet, Philippe; Sutherland, W.H.; Barats, Jean-Claude

doi:10.1007/s10549-004-1282-3

Cited by 26 publications

(16 citation statements)

References 22 publications

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“…This safety profile is consistent with that observed in previous studies of capecitabine monotherapy [3,4,5,7,8,9,10,11, 14] or in other named-patient or compassionate-use programs in patients with MBC [16, 17]. In phase II and III trials, the most frequently reported clinical adverse events were hand-foot syndrome (18–71%), diarrhea (28–58%) and nausea (34–55%) [3,4,5, 7, 9].…”

Section: Discussionsupporting

confidence: 91%

“…In phase II and III trials, the most frequently reported clinical adverse events were hand-foot syndrome (18–71%), diarrhea (28–58%) and nausea (34–55%) [3,4,5, 7, 9]. As in the present study, slightly lower incidences of these events were reported in named-patient or compassionate-use studies (36 and 54, 33 and 36 and 24 and 31%, respectively) [16, 17]. It is plausible that in the latter studies, minor toxicities were less likely to be documented than in trials with rigorous formal protocols.…”

Section: Discussionsupporting

confidence: 64%

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An Open-Label, Multicenter Study of Outpatient Capecitabine Monotherapy in 631 Patients with Pretreated Advanced Breast Cancer

Venturini¹,

Paridaens²,

Rossner³

et al. 2007

Oncology

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Background: Phase II/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1–24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, CI, 5.6–7.6) and median overall survival (n = 569) was 10.0 months (95% CI, 8.5–15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 64%

An Open-Label, Multicenter Study of Outpatient Capecitabine Monotherapy in 631 Patients with Pretreated Advanced Breast Cancer

Venturini¹,

Paridaens²,

Rossner³

et al. 2007

Oncology

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“…In a recent retrospective analysis of 197 patients previously treated with an anthracycline, taxane, and/or vinorelbine (French compassionate-use program) [27], multivariate analyses showed that a favorable response to capecitabine therapy was associated with longer survival (relative risk [RR], 5.2; 95% CI, 2.0-13.6; p = .001). Another retrospective study that included 113 anthracycline-and taxane-refractory patients [52] reported that those treated with single-agent capecitabine had a significantly longer MOS time than those treated with single-agent vinorelbine (6.2 vs. 3.4 months; p < .0001).…”

Section: Efficacymentioning

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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“…Its efficacy has been proven through many clinical trials [10,11,12,13,14]. Both capecitabine and S-1 are classified as 5-FU anti-neoplastic agents, but it is known that their profiles of adverse effects are different.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of S-1 in Patients with Metastatic Breast Cancer: Retrospective Review in a Single Institution

Hara¹,

Kiyoto²,

Takahashi³

et al. 2010

Oncology

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Background: It is extremely difficult to bring about a complete cure of metastatic breast cancer: the purpose of treatment is to prolong the patient’s survival while maintaining their quality of life (QOL). The current retrospective study was conducted to find whether S-1, an orally administered 5-FU agent, can produce a therapeutic result in patients with recurrent metastatic breast cancer while maintaining their QOL. Methods: Among the patients who were diagnosed at our institution to have recurrent metastatic breast cancer between November 2001 and December 2008, those who were treated with S-1 were selected and their records retrospectively reviewed. Results: The analysis was conducted on 33 patients. The median number of regimens that these patients underwent was 2 (range 0–6). The overall response rate (ORR), clinical benefit rate (CBR), median time to treatment failure and overall survival were 30%, 42%, 152 days and 338 days, respectively. Among the 11 patients who were treated with S-1 in the first or the second line, ORR and CBR were 45.5 and 63.6%, respectively. Toxicity more than grade 3, leucopenia, neutropenia diarrhea, mucositis, and hand-foot syndrome were found in only 3%. Conclusion: S-1 is well-tolerated by patients, promising a therapy while maintaining their QOL. When applied in the early stage of a disease in particular, the agent promises a very effective anti-tumor effect.

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Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program

Abstract: Capecitabine is active in heavily pretreated MBC patients and has a favorable toxicity profile with the added advantage of being an oral drug administered in an outpatient setting.

Cited by 26 publications

References 22 publications

An Open-Label, Multicenter Study of Outpatient Capecitabine Monotherapy in 631 Patients with Pretreated Advanced Breast Cancer

An Open-Label, Multicenter Study of Outpatient Capecitabine Monotherapy in 631 Patients with Pretreated Advanced Breast Cancer

Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer

Efficacy and Safety of S-1 in Patients with Metastatic Breast Cancer: Retrospective Review in a Single Institution

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