Vinorelbine and Paclitaxel as First-Line Chemotherapy in Metastatic Breast Cancer

Acuña, L; Langhi, M.; Pérez, J. Eduardo; Acuña, Jesús Manuel Ramírez; Machiavelli, M; Lacava, J.; Vallejo, Carlos; Romero, A; Fasce, Hebe Margot; Ortíz, Eduardo; Grasso, S.; Amato, S.; Rodríguez, Rafael Riosmena; Barbieri, Mario; Leone, Bernardo Amadeo

doi:10.1200/jco.1999.17.1.74

Cited by 47 publications

(9 citation statements)

References 20 publications

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“…Another phase II clinical trial tested the sequential vinorelbine-paclitaxel schedule, with objective responses in 60% of the patients and a median time to treatment failure of 7 months. Myelosuppression (G4 neutropenia in 71% of the patients and 2 treatment-related deaths) and peripheral neurotoxicity were the dose-limiting toxicities [15]. The results observed in our study compare favorably with those obtained at the M.D.…”

Section: Discussionsupporting

confidence: 80%

First-Line Chemotherapy with Vinorelbine and Paclitaxel as Simultaneous Infusion in Advanced Breast Cancer

Vici¹,

Amodio²,

Lauro³

et al. 2000

Oncology

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Based on preclinical data showing a synergistic activity of simultaneous administration of vinorelbine and paclitaxel, we carried out a phase II trial in previously untreated advanced breast cancer patients. Treatment consisted of vinorelbine 25 mg/m² and paclitaxel 150 mg/m², both drugs given by intravenous infusion over 3 h on day 1, with cycles repeated every 3 weeks. Granulocyte colony-stimulating factor, 300 μg subcutaneously, was given on days 7–12 to the first 10 patients. From October 1995 to January 1997, 43 patients with advanced breast cancer entered the study, and 41 were evaluable for response. We obtained 2 complete responses (5%) and 18 partial responses (44%), for an overall response rate of 49% (95% CI 34–64%). Median time to response, time to progression and survival were 2, 7 and 22 months, respectively. Myelosuppression was the dose-limiting toxicity, with G4 neutropenia in 21% and neutropenic fever in 7% of the patients. Other toxicities were mild. Simultaneous infusion of vinorelbine and paclitaxel is a well-tolerated and active regimen in metastatic breast cancer, with overall results similar to those reported with more toxic regimens; furthermore, it may be a good option in patients with anthracycline contraindications.

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Section: Discussionsupporting

confidence: 80%

First-Line Chemotherapy with Vinorelbine and Paclitaxel as Simultaneous Infusion in Advanced Breast Cancer

Vici¹,

Amodio²,

Lauro³

et al. 2000

Oncology

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“…The schedule variable also interacted with the ratio of docetaxel and vinorelbine, suggesting that the ratio was only important if the clinicians chose to intersperse single drug doses between treatments with the combination of drugs (test 8, Table IV). The results of the tests were similar when additional trials, mainly with paclitaxel substituted for docetaxel, were included in the dataset (57,(59)(60)(61)(62)(63)(64)(65)(66)(67)(68)(69)(70)(71)(72)(73)(74)(75)(76)(77).…”

Section: Analysis Of Chemotherapy Clinical Trialssupporting

confidence: 52%

Pattern analysis of microtubule-polymerizing and -depolymerizing agent combinations as cancer chemotherapies

Uppal

Li²,

Wendt³

et al. 2007

Int J Oncol

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Abstract. Subcellular distribution of mass can be analyzed by a technique that involves culturing cells on interferometers and digitizing their interference contours. Contour sampling resulted in 102 variables per cell, which were predictors of oncogenic transformation. Cell phenotypes can be deconstructed by use of latent factors, which represent the covariance of the real variables. The reversal of the cancertype phenotype by a combination of microtubule-stabilizing and -depolymerizing agents was described previously. The implications of these results have been explored by clinicians who treated patients with the combination of docetaxel and vinorelbine (Navelbine ® ). The current study was performed to determine the effects of different combinations on phenotype and in phases of the cell cycle other than mitosis. Combinations of paclitaxel with either colchicine, podophyllotoxin, nocodazole, or vinblastine caused phenotype reversal. Paclitaxel analogue, 7-deoxytaxol, by itself caused reversal. Factors #4, (filopodia), #5 (displacement and/or deep invaginations in the periphery), #8, and #12 took on values typical of normal cells, whereas the values of #7 (p21-activated kinase), and #13 (rounding up) shifted toward the cancer-type. All combinations altered microtubule arrangement at the cell edge. Delivery schedules and drug ratios used in clinical studies were subjected to analysis. Clinical response rates were better when the combination was not interspersed with a single agent (P=0.004). The results support the idea that efficacy depends upon simultaneous exposure to both agents, and suggest a novel mechanism for combination therapies. These therapies appear to restore in transformed cells some of the features of a contactinhibited cell, and to impede progress through the cell cycle even when provided at nanomolar concentrations.

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“…Since the prophylactic use of G-CSF was not permitted, leucopenia caused frequent reduction/omission, mainly of paclitaxel and/or vinorelbine. The frequency of bone marrow depression observed here did not differ from that reported in other phase II studies testing the association of paclitaxel and vinorelbine (Martin et al, 1998;Tortoriello et al, 1998;Culine et al, 1999;Ellis et al, 1999;Romero Acuna et al, 1999;Vici et al, 2000;Ibrahim et al, 2001;Ballestrero et al, 2003). This suggests that 5-FU may have influenced this side effect only marginally.…”

Section: Discussioncontrasting

confidence: 51%

“…The combination of paclitaxel and vinorelbine has been evaluated in a number of phase I and II trials. As a whole, the results have been encouraging, with an overall response rate between 47.4 and 67.0% (Martin et al, 1998;Tortoriello et al, 1998;Culine et al, 1999;Ellis et al, 1999;Romero Acuna et al, 1999;Vici et al, 2000;Ibrahim et al, 2001;Ballestrero et al, 2003).…”

mentioning

confidence: 88%

Paclitaxel, vinorelbine and 5-fluorouracil in breast cancer patients pretreated with adjuvant anthracyclines

Berruti¹,

Bitossi²,

Gorzegno³

et al. 2005

Br J Cancer

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We investigated the activity and toxicity of a combination of vinorelbine (VNB), paclitaxel (PTX) and 5-fluorouracil (5-FU) continuous infusion administered as first-line chemotherapy in metastatic breast cancer patients pretreated with adjuvant anthracyclines. A total of 61 patients received a regimen consisting of VNB 25 mg m À2 on days 1 and 15, PTX 60 mg m À2 on days 1, 8 and 15 and continuous infusion of 5-FU at 200 mg m À2 every day. Cycles were repeated every 28 days. Disease response was evaluated by both RECIST and World Health Organization (WHO) criteria. Objective responses were recorded in 39 of 61 patients (64.0%) assessed by WHO and in 36 of 50 patients (72.0%) assessable by RECIST criteria. Complete remission occurred in 15 (24.6%) and 14 patients (28.0%), respectively. The median time to progression and overall survival of entire population was 10.6 and 27.3 months, respectively, and median duration of complete response was 14.8 months. The dose-limiting toxicity was myelosuppression (leucopenia grade 3/4 in 52.5% of patients). Grade 3/4 nonhaematologic toxicities included mucositis/diarrhoea in 13.1%, skin in 3.3% and cardiac in 1.6% of patients. Grade 2/3 neurotoxicity was observed in five patients (7.2%). The VNB, PTX and 5-FU continuous infusion combination regimen was active and manageable. Complete responses were frequent and durable.

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Vinorelbine and Paclitaxel as First-Line Chemotherapy in Metastatic Breast Cancer

Abstract: The combination of VNB-PTX showed significant activity as first-line chemotherapy for patients with MBC. Myelosuppression was the dose-limiting side effect, whereas neurotoxicity was mild to moderate.

Cited by 47 publications

References 20 publications

First-Line Chemotherapy with Vinorelbine and Paclitaxel as Simultaneous Infusion in Advanced Breast Cancer

First-Line Chemotherapy with Vinorelbine and Paclitaxel as Simultaneous Infusion in Advanced Breast Cancer

Pattern analysis of microtubule-polymerizing and -depolymerizing agent combinations as cancer chemotherapies

Paclitaxel, vinorelbine and 5-fluorouracil in breast cancer patients pretreated with adjuvant anthracyclines

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