Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer.

Seidman, Andrew D.; Hudis, Clifford A.; Albanell, Juan; Albanel, J.; Tong, William P.; Tepler, Isidore; Currie, Violante E.; Moynahan, Mary Ellen; Theodoulou, Maria; Gollub, M.; Baselga, José; Norton, Larry

doi:10.1200/jco.1998.16.10.3353

Cited by 356 publications

(192 citation statements)

References 17 publications

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“…Seidman et al first explored the use of weekly schedules of paclitaxel alone [17] or combined with trastuzumab [10]. The results of these studies were encouraging in terms of activity and, particularly, regarding the toxicity profile.…”

Section: Discussionmentioning

confidence: 99%

“…In vitro studies suggested an additive activity of trastuzumab when combined with paclitaxel [13,14] and several Phase I-II clinical studies have assessed the antitumoral activity and the tolerability of such a combination [12][13][14][15][16][17]. The combination of weekly paclitaxel with trastuzumab [10,15,16] produces extended cumulative exposure to the drug and ameliorates the toxicities associated with the standard tri-weekly administration [17], with mild, non-cumulative, hematologic toxicity allowing its administration for prolonged periods of time [18].…”

Section: Introductionmentioning

confidence: 99%

“…The combination of weekly paclitaxel with trastuzumab [10,15,16] produces extended cumulative exposure to the drug and ameliorates the toxicities associated with the standard tri-weekly administration [17], with mild, non-cumulative, hematologic toxicity allowing its administration for prolonged periods of time [18].…”

Section: Introductionmentioning

confidence: 99%

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Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Gasparini

Gion²,

Mariani³

et al. 2006

Breast Cancer Res Treat

129

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Background A randomized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2. Patients and methods Among 124 patients randomized, 123 are assessable for toxicity and 118 for response. Patients received weekly paclitaxel single agent (80 mg/m 2 ) or combined with trastuzumab (4 mg/kg loading dose, then weekly 2 mg/kg). HER-2 overexpression was determined by immunohistochemistry (IHC). Patients with 2+/3+ IHC scores were eligible. IHC was compared with HER-2 serum extracellular domain (ECD). Results Patient characteristics were similar in the two arms. Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity. No patient developed cardiac toxicity. The combined treatment was statistically significant superior for overall response rate (ORR) (75% vs. 56.9%; P = 0.037), particularly in the subset of IHC 3+ patients (84.5% vs. 47.5%; P = 0.00050). A statistically significant better median time to progression was seen in the subgroup with IHC 3+ (369 vs. 272 days; P = 0.030) and visceral disease (301 vs. 183 days; P = 0.0080) treated with combination. Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR (P = 0.0035). Conclusion Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Gasparini

Gion²,

Mariani³

et al. 2006

Breast Cancer Res Treat

129

View full text Add to dashboard Cite

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“…Three of them, paclitaxel and carboplatin [3,4], docetaxel and gemcitabine [5,6] and weekly paclitaxel [7][8][9] have demonstrated significant activity and manageable toxicity. Furthermore, the first of these combinations was found to be effective in a phase III trial [10], when compared to the combination of paclitaxel and epirubicin, in terms of overall response rate (ORR), survival and quality of life (QoL).…”

Section: Introductionmentioning

confidence: 99%

A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

Fountzilas

Dafni

Dimopoulos

et al. 2008

Breast Cancer Res Treat

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“…In the present study, paclitaxel was added to this regimen. Since weekly paclitaxel infusion has been reported to be more active than 3-weekly administration (Seidman et al, 1998), paclitaxel was administered on a sustained weekly schedule.…”

Section: Discussionmentioning

confidence: 99%

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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Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer.

Abstract: Weekly paclitaxel therapy is active and well tolerated in patients with metastatic breast cancer. Weekly therapy should be considered as a current clinical option for these patients and should be incorporated into future comparative clinical trials.

Cited by 356 publications

References 17 publications

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer

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

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