Multicenter phase II study of oral capecitabine (Xeloda“) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy

Reichardt, Peter; Minckwitz, Gϋnter von; Thuss‐Patience, Peter; Jonat, W.; Kölbl, H; Jänicke, F.; Kieback, D. G.; Kuhn, Walther; Schindler, A. E.; Mohrmann, Svjetlana; Kaufmann, M.; Lück, Hans-Joachim

doi:10.1093/annonc/mdg346

Cited by 224 publications

(131 citation statements)

References 14 publications

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“…The first trial to assess capecitabine was conducted in 162 patients with paclitaxel-refractory MBC; the ORR in this population was 20%, median time to progression (TTP) 3 months, and OS 12.6 months (Blum et al, 1999). An ORR of 15% was obtained in another clinical study (136 patients), with a median TTP and OS of 3.5 months and 10.1 months was observed respectively; the median interval between the last taxane-containing therapy and start of capecitabine treatment in this study was 4.4 months and 17% of patients discontinued the study drug due to drug-related adverse events, mainly hand-foot syndrome (Reichardt et al, 2003). Most recently, in a study of 126 patients with MBC treated with capecitabine after two or three prior chemotherapies including an anthracycline and a taxane, the ORR was 28.0% and the TTP was 4.9 months (95% CI: 4.0 -6.4 months) with a median OS of 15.2 months (95% CI: 13.5 -19.6 months) (Fumoleau et al, 2004).…”

Section: Discussionsupporting

confidence: 56%

Vinflunine: a new active drug for second-line treatment of advanced breast cancer. Results of a phase II and pharmacokinetic study in patients progressing after first-line anthracycline/taxane-based chemotherapy

Campone

Cortés

Vorobiof³

et al. 2006

Br J Cancer

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To evaluate the single agent activity, pharmacokinetics and tolerability of the novel tubulin targeted agent vinflunine (VFL) (320 mg m À2 q 21 days) as second-line chemotherapy in patients with metastatic breast carcinoma (MBC). All patients had disease progression after anthracycline/taxane (A/T) therapy. They could have received a nonanthracycline adjuvant treatment and subsequently received a first-line A/T combination for advanced/metastatic disease; or relapsed 46 months after completion of adjuvant A/T therapy and were subsequently treated with the alternative agent; or relapsed within 6 months from an adjuvant A/T combination. Objective response was documented in 18 of 60 patients enrolled (RR: 30% (95% confidence interval (CI): 18.9 -43.2%)). Among the responders, seven patients had relapsed during a period of o3 months from taxane-based regimen yielding a RR of 33.3%. The median duration of response was 4.8 months (95% CI: 4.2 -7.2), median progression-free survival was 3.7 months (95% CI: 2.8 -4.2) and median overall survival was 14.3 months (95% CI: 9.2 -19.6). The most frequent adverse event was neutropenia (grade 3 in 28.3% and grade 4 in 36.7% of patients). No febrile neutropenia was observed. Fatigue (grade 3 in 16.7% of patients) and constipation (grade 3 in 11.7% of patients) were also common; these were non-cumulative and manageable permitting achievement of a good relative dose intensity of 93.5%. Vinflunine is an active agent with acceptable tolerance in the management of MBC patients previously treated with (A/T)-based regimens. These encouraging phase II results warrant further investigation of this novel agent in combination with other active agents in this setting or in earlier stages of disease.

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Section: Discussionsupporting

confidence: 56%

Vinflunine: a new active drug for second-line treatment of advanced breast cancer. Results of a phase II and pharmacokinetic study in patients progressing after first-line anthracycline/taxane-based chemotherapy

Campone

Cortés

Vorobiof³

et al. 2006

Br J Cancer

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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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“…Single-agent capecitabine is considered by many to be the reference treatment for patients with taxane-pretreated MBC. In four trials conducted in a total of 500 patients with anthracycline-and taxane-pretreated disease, capecitabine achieved objective response rates ranging from 15 to 28%, overall disease control rates of 57 -63% and median overall survival of approximately 12 months (Blum et al, 1999(Blum et al, , 2001aFumoleau et al, 2004;Reichardt et al, 2003). In addition, capecitabine demonstrated a favourable safety profile, with a particularly low incidence of myelosuppression, severe adverse events and alopecia.…”

mentioning

confidence: 99%

Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer

Batista¹,

Perez-Manga

Constenla

et al. 2004

Br J Cancer

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The addition of oral capecitabine to docetaxel improves response rate, time to progression (TTP) and overall survival in anthracycline-pretreated metastatic breast cancer (MBC). This phase II study evaluates the efficacy and safety of a 21-day cycle of oral capecitabine (1000 mg m À2 twice daily, days 1 -14) plus i.v. paclitaxel (175 mg m À2 , day 1) in anthracycline-pretreated advanced/ MBC. In all, 73 patients were enrolled at 13 Swedish and Spanish centres. The objective response rate was 52% (95% confidence interval (CI): 40 -63%) in the intent-to-treat population, including complete responses in 11%. Disease was stabilised in a further 29%. The median time to disease progression (TTP) was 8.1 months and the median overall survival was 16.5 months. The combination was generally well tolerated with a predictable safety profile. The most common treatment-related nonhaematological adverse events were hand -foot syndrome (42%), alopecia (30%) and diarrhoea (26%). The only treatment-related Grade 3/4 adverse events occurring in 45% of patients were alopecia (22%) and hand -foot syndrome (11%). Grade 3/4 neutropenia and lymphocytopenia were reported in 12 and 14% of patients, respectively. Capecitabine plus paclitaxel is highly active with a favourable safety profile in anthracycline-pretreated MBC.

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Multicenter phase II study of oral capecitabine (Xeloda“) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy

Cited by 224 publications

References 14 publications

Vinflunine: a new active drug for second-line treatment of advanced breast cancer. Results of a phase II and pharmacokinetic study in patients progressing after first-line anthracycline/taxane-based chemotherapy

Vinflunine: a new active drug for second-line treatment of advanced breast cancer. Results of a phase II and pharmacokinetic study in patients progressing after first-line anthracycline/taxane-based chemotherapy

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

Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer

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