Ifosfamide and vinorelbine as first-line chemotherapy for metastatic breast cancer.

Leone, Bernardo Amadeo; Vallejo, Carlos; Romero, A; Pérez, J. Eduardo; Cuevas, M A; Lacava, J.; Sabatini, C; Dominguez, M. E.; Rodríguez, Ricardo; Barbieri, Mario; Ortíz, Eduardo; Salvadori, M.; Acuña, Luis A. Romero; Acuña, Juan; Langhi, M.; Amato, S.; Machiavelli, M

doi:10.1200/jco.1996.14.11.2993

Cited by 20 publications

(6 citation statements)

References 12 publications

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“…Combination of ifosfamide with vinorelbine demonstrated RR of 56% in a group of patients with no or minimally pretreated metastatic breast cancer [11]. The combination of a fixed dose of doxorubicin 20 mg/m 2 /day×3 days with escalating doses of ifosfamide (1.2-2.75 g/m 2 /day for 5 days) with G-CSF support in a phase I study focusing in stage IV chemotherapy-naïve breast cancer has yielded the feasibility of a quite high dose of ifosfamide 12.5 g/m 2 (total) with a RR of 83%, of which 33% were CRs [9].…”

Section: Discussionmentioning

confidence: 99%

“…However, ifosfamide can be administered at significantly higher doses than Cyclophosphamide with considerably much less myelosuppression, thereby permitting for a higher alkylator dose-intensity than cyclophosphamide. There have been several phase I/II studies incorporating ifosfamide with other agents in chemotherapy-naïve or pre-treated patients with advanced breast cancer, such as doxorubicin [9], paclitaxel [10], and vinorelbine [11] and have demonstrated the feasibility of considerably high ifosfamide doses as well as substantial activity of the combinations. A single previous phase I study has evaluated the feasibility of the docetaxel-ifosfamide combination without G-CSF in pretreated patients with a variety of advanced solid tumors.…”

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confidence: 99%

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Docetaxel–ifosfamide combination in patients with HER2-non-overexpressing advanced breast cancer failing prior anthracyclines

Kosmas

Tsavaris²,

Malamos

et al. 2007

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The feasibility of the docetaxel-ifosfamide combination, as well as the definition of maximum tolerated doses (MTD) in a previous phase I study, led us to continue evaluating the regimen in an extended phase II study in patients with HER2-non-overexpressing, anthracycline pre-treated advanced breast cancer. Patients with histologically confirmed metastatic breast cancer failing prior anthracycline-based chemotherapy were treated with docetaxel 100 mg/m2 over 1 h on day 1 followed by ifosfamide 5 g/m2 divided over days 1 and 2 (2.5 g/m2/day over 1 h), and recycled every 21 days with prophylactic granulocyte-colony stimulating factor (G-CSF) administration from day 3-until a neutrophil count >10,000/microl. Between March 1999 and June 2002, 71 patients with a median age of 55 years (range, 28-72) and performance status (World Health Organization; WHO) of 1 (range, 0-2) were treated; all were assessable for toxicity and 70 patients for response. Clinical response rates (RRs), on an intention-to-treat basis were: 41/71 [58%; 95% CI, 46.5-69.5%]; 7 complete remissions (CRs), 34 partial remissions (PRs), 15 stable disease (SD) and 15 progressive disease (PD). The median response duration was 7.5 months (2-28 months), median time-to-progression (TTP) 6 months (0.1-30 months), and median overall survival (OS) 12 months (0.1-36 months). Grade 3/4 toxicities included; neutropenia in 63% of patients-with 52% developing grade 4 neutropenia (>or=7 days) and in 11% of these febrile neutropenia (FN), while no grade 3/4 thrombocytopenia was observed. Other toxicities included; peripheral neuropathy grade 2 only in 7%, grade 1/2 reversible central nervous system (CNS) toxicity in 11%, no renal toxicity, grade 2 myalgias in 7%, grade 3 diarrhea in 4%, skin/nail toxicity in 11%, and grade 1/2 fluid retention in 28% of patients. The present report has demonstrated encouraging activity of the docetaxel-ifosfamide combination in anthracycline-pretreated, HER2-negative advanced breast cancer. Therefore, future randomized phase III studies versus single-agent docetaxel or currently established combinations of the latter with other agents in this setting with established clinical activity, such as capecitabine or gemcitabine, will be warranted.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Docetaxel–ifosfamide combination in patients with HER2-non-overexpressing advanced breast cancer failing prior anthracyclines

Kosmas

Tsavaris²,

Malamos

et al. 2007

Invest New Drugs

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“…Venous irritation can cause all or any of the following: injection site reaction, local reaction or superficial phlebitis accompanied by erythema, pain at the injection site, which may last for a few days, and vein discoloration and tenderness along the vein. The incidence of VNR phlebitis in patients who received the drug as a 20-to 30-min peripheral infusion is high and ranges from 18% to 50% [3,4,5,6,7,8], dropping to 11% if the administration lasts 5-10 min [5].…”

Section: Introductionmentioning

confidence: 99%

Prevention of vinorelbine phlebitis with cimetidine

Vassilomanolakis

Koumakis

Barbounis

et al. 2001

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One hundred eighteen patients with various malignancies received a total of 847 vinorelbine (VNR) infusions, during 25 of which episodes of vinorelbine phlebitis occurred (1 in each of the 25 patients concerned). Venous irritation was graded with reference to the scale devised by Rittenberg et al. To prevent these 25 patients against further venous toxicity, we pretreated them with cimetidine 200 mg i.v. prior to VNR administration in subsequent cycles of chemotherapy. In most (19, or 76%) complete prevention of recurrent phlebitis was observed, while partial prevention was observed in 5 patients (20%). Treatment was unsuccessful in 1 patient. In 127 VNR infusions given after cimetidine prophylaxis only 7 (6%) episodes of phlebitis occurred. These data show that i.v. administration of cimetidine prior to vinorelbine infusion can successfully prevent recurrence of phlebitis in patients who have shown venous irritation upon prior VNR treatment, at a rate of 94%.

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“…Only Leone et al [19]treated 45 first-line patients combining ifosfamide with vinorelbine and reported 58% response rate. In all studies, toxicity was rarely severe and mainly hematological.…”

Section: Combination Therapymentioning

confidence: 99%

Ifosfamide in Advanced/Disseminated Breast Cancer

et al. 2003

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Ifosfamide is an alkylating agent active in various tumor types including breast cancer. The availability of mesna (sodium 2-mercaptoethanesulfonate) has increased its safety, avoiding the main dose-limiting side effect, urotoxicity. Interesting activity as a single agent, with response rates ranging from 7 to 30%, is reported in pretreated patients; more attractive data derived from phase II studies on ifosfamide combined with drugs known to be active in advanced breast cancer show response rates always over 35%. This review has taken in consideration papers published after 1995 and available on PubMed medline: the data indicate a potential usefulness of ifosfamide in the clinical management of advanced breast cancer, even if the exact therapeutic role of the drug in this setting should be derived from randomized studies not yet available.

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Ifosfamide and vinorelbine as first-line chemotherapy for metastatic breast cancer.

Abstract: IFX/VNB is an active combination against MBC with moderate toxicity and deserves further evaluation.

Cited by 20 publications

References 12 publications

Docetaxel–ifosfamide combination in patients with HER2-non-overexpressing advanced breast cancer failing prior anthracyclines

Docetaxel–ifosfamide combination in patients with HER2-non-overexpressing advanced breast cancer failing prior anthracyclines

Prevention of vinorelbine phlebitis with cimetidine

Ifosfamide in Advanced/Disseminated Breast Cancer

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