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

Vici, Patrizia; Amodio, Antonella; Lauro, Luigi Di; Conti, Francesca; Gionfra, T; Belli, F.; Lopez, Massimo

doi:10.1159/000012071

Cited by 15 publications

(7 citation statements)

References 9 publications

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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%

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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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Section: Discussioncontrasting

confidence: 51%

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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 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: 84%

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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“…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 Trialsmentioning

confidence: 75%

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

Cited by 15 publications

References 9 publications

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

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

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

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

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