First-Line Treatment With Epirubicin and Vinorelbine in Metastatic Breast Cancer

Vici, Patrizia; Colucci, Giuseppe; Gebbia, Vittorio; Amodio, Antonella; Giotta, Francesco; Belli, F.; Conti, Francesca; Gebbia, Nicola; Pezzella, G.; Valerio, Maria Rosaria; Brandi, Mario; Pisconti, Salvatore; Durini, Ernesto; Giannarelli, Diana; Lopez, Massimo

doi:10.1200/jco.2002.06.039

Cited by 32 publications

(21 citation statements)

References 25 publications

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“…We found that the regimen was very active even in patients previously treated with adjuvant or neoadjuvant chemotherapy or having visceral metastases. The toxicity was manageable and compares favorably with that of other regimens (see table 3) [28, 29, 30, 31, 32, 33, 34]. The treatment was administered on an outpatient basis and the majority of patients did not require G-CSF support.…”

Section: Discussionmentioning

confidence: 89%

Front-Line Chemotherapy with Docetaxel and Gemcitabine Administered Every Two Weeks in Patients with Metastatic Breast Cancer: A Multicenter Phase II Study

Mavroudis

Malamos

Polyzos³

et al. 2004

Oncology

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Objective: To evaluate the docetaxel-gemcitabine combination administered every 2 weeks in women with untreated metastatic breast cancer (MBC). Methods: Fifty-two patients with MBC received docetaxel 65 mg/m² as front-line chemotherapy intravenously over 1 h followed by gemcitabine 1,500 mg/m² intravenously over 30 min on days 1 and 14. Cycles were repeated every 28 days without prophylactic growth factor support. Twenty-eight (54%) patients had previously received chemotherapy as adjuvant or neoadjuvant treatment. Thirty-six (69%) patients had visceral disease including 20 (38%) with liver metastases. All patients were evaluated for toxicity and 45 for response. Results: In an intention-to-treat analysis, a complete response occurred in 7 (13%) patients and partial response in 24 (46%) for an overall response rate of 59% (95% CI: 46.3–73.0%). The response rate was 68% for the 28 patients who had previously received adjuvant or neoadjuvant chemotherapy and 67% for the 36 patients with visceral metastases. The median duration of response was 6.1 months and the median time to disease progression 10.9 months. A total of 254 cycles were administered with dose reduction in 26 (10%) cycles and no lethal toxicity. Grade III–IV neutropenia occurred in 17 (33%) patients and thrombocytopenia in 3 (6%). Febrile neutropenia developed in 3 (6%) patients. Nonhematological toxicity was generally mild. Conclusion: The docetaxel-gemcitabine combination is an active and well-tolerated front-line treatment for patients with MBC. This regimen represents a suitable option especially for women relapsing after anthracycline-based adjuvant chemotherapy.

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Section: Discussionmentioning

confidence: 89%

Front-Line Chemotherapy with Docetaxel and Gemcitabine Administered Every Two Weeks in Patients with Metastatic Breast Cancer: A Multicenter Phase II Study

Mavroudis

Malamos

Polyzos³

et al. 2004

Oncology

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“…vinorelbine and epirubicin in the first-line treatment of MBC is rather extensive based on several phase II studies (Chadjaa et al, 1993;Ezzat et al, 1996;Baldini et al, 1998;Tabiadon et al, 1998;Nistico et al 1999;Vici et al, 2002) and a phase III study conducted by the Danish Breast Cancer Group (DBCG) (Ejlertsen et al, 2001).…”

Section: Discussionmentioning

confidence: 99%

“…vinorelbine was generally given at 25 mg m À2 on days 1 and 8 (Chadjaa et al, 1993;Ezzat et al, 1996;Baldini et al, 1998;Tabiadon et al, 1998) or on days 1 and 5 (Vici et al, 2002) of every 3-week cycles. Epirubicin was combined on day 1 of cycles at doses ranging from 60 to 100 mg m À2 .…”

Section: Discussionmentioning

confidence: 99%

“…vinorelbine has enabled its use in combination with other cytotoxic agents active against MBC. It has been safely and effectively combined with epirubicin in several noncomparative studies (Chadjaa et al, 1993;Ezzat et al, 1996;Baldini et al, 1998;Tabiadon et al, 1998;Nistico et al 1999;Vici et al, 2002). Recently, B Ejlertsen reported the results of a randomised phase III study comparing the combination of i.v.…”

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confidence: 99%

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Vinorelbine alternating oral and intravenous plus epirubicin in first-line therapy of metastatic breast cancer: results of a multicentre phase II study

Serin

Verrill²,

Jones

et al. 2005

Br J Cancer

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The combination of intravenous (i.v.) vinorelbine and epirubicin is highly active in the treatment of metastatic breast cancer (MBC). In an effort to improve patient convenience, we investigated a regimen alternating i.v. and oral vinorelbine in combination with epirubicin as first-line chemotherapy of patients with MBC. In all, 49 patients with MBC received, as first-line treatment, a combination regimen consisting of i.v. vinorelbine 25 mg m À2 plus epirubicin 90 mg m À2 given on day 1, and oral vinorelbine 60 mg m À2 on day 8 (or day 15 if neutrophils o1500 mm À3 ) every 3 weeks, in an open-label, multicentre phase II study. Treatment was to be repeated for a maximum of six cycles. The study population had a median age of 55 years, half of the patients had received prior adjuvant chemotherapy and 86% presented a visceral involvement. In all, 25 responses were documented and validated by an independent panel review, yielding response rates of 51% (95% CI: 36 -66) in the 49 enrolled patients and 54.5% (95% CI: 39 -70) in the 44 evaluable patients. Median durations of progression-free survival and survival were 8 and 20 months, respectively. Neutropenia was the main dose-limiting toxicity, but complications were uncommon, four patients having experienced febrile neutropenia and six having developed neutropenic infection. Other frequently reported adverse events included stomatitis, nausea and vomiting, which were rarely severe. No toxic death was reported. Among patients who received six cycles, global score of quality of life remained stable. This regimen alternating oral and i.v. vinorelbine in combination with epirubicin is effective and safe. Oral vinorelbine on day 8 offers greater convenience to the patient, and decreases the need for i.v. injection and reduces time spent in hospital. Therefore, oral vinorelbine is a convenient alternative to the i.v. form in combination regimens commonly used to treat MBC.

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“…The highest activity of this drug has been observed in patients with non-small-cell lung cancer [7,10,18] and advanced breast cancer [1,8,17]. Short-duration and non-cumulative granulocytopenia is the major dose-limiting toxicity and is rated as moderate to severe in 30% to 40% of patients.…”

Section: Introductionmentioning

confidence: 98%

Venous damage prevention by defibrotide in vinorelbine-treated patients

Mare

Maisano²,

Caristi

et al. 2003

Support Care Cancer

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First-Line Treatment With Epirubicin and Vinorelbine in Metastatic Breast Cancer

Cited by 32 publications

References 25 publications

Front-Line Chemotherapy with Docetaxel and Gemcitabine Administered Every Two Weeks in Patients with Metastatic Breast Cancer: A Multicenter Phase II Study

Front-Line Chemotherapy with Docetaxel and Gemcitabine Administered Every Two Weeks in Patients with Metastatic Breast Cancer: A Multicenter Phase II Study

Vinorelbine alternating oral and intravenous plus epirubicin in first-line therapy of metastatic breast cancer: results of a multicentre phase II study

Venous damage prevention by defibrotide in vinorelbine-treated patients

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