A Randomized Phase II Study of Paclitaxel and Bevacizumab With and Without Gemcitabine as First-Line Treatment for Metastatic Breast Cancer

Brufsky, Adam; Hoelzer, Karen; Beck, Thaddeus; Whorf, Robert C.; Keaton, Mark; Nadella, P.; Krill-Jackson, Elisa; Kroener, Joan F.; Middleman, Edward L.; Frontiera, Michael; Paul, Devchand; Panella, Timothy J.; Bromund, Jane; Zhao, Luping; Orlando, Mauro; Tai, Fritz; Marciniak, Martin; Obasaju, Coleman K.; Hainsworth, John D.

doi:10.1016/j.clbc.2011.03.019

Cited by 29 publications

(25 citation statements)

References 15 publications

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“…Specifically, higher frequencies of anemia (HR 2.02, 95% CI 1.35-3.02; P ¼ 0.006), neutropenia (HR 2.33, 95% CI 1.37-3.63; P ¼ 0.01) and thrombocytopenia (HR 8.31, 95% CI 5.00-13.82; P50.0001) were observed in the gemcitabine-based arm ( Figure 11). 12 Zielinski 13 Martín 14 Albain 15 Joensuu 17 Chan 16 Brufsky 19 Pallis 20 Nielsen 18 Test for overall effect: Z = 0.71 (P = 0.48) Heterogeneity: Tau 2 = 0.07; Chi 2 = 51. 16 Feher 12 Martín 14 Albain 15 Chan 16 Joensuu 17 Pallis 20 Nielsen 18 Brufsky 19 Test for overall effect: Z = 1.05 (P = 0.29) Heterogeneity: Chi 2 = 6.72, df = 6 (P = 0.035); I 2 = 11% 12 Martín 14 Albain 15 Chan 16 Joensuu 17 Nielsen 18 Brufsky 19 Pallis 20 Test for overall effect: Z = 0.53 (P = 0.60) Heterogeneity: Tau 2 = 0.04; Chi 2 = 18.08, df = 7 (P = 0.01); I 2 = 61% Subgroup: gemcitabine-based doublet versus single agent…”

Section: Toxicitymentioning

confidence: 99%

“…The quality was high in seven phase III studies [12][13][14][15][16][17][18] (Jadad score 3). Two trials were of low quality (Jadad score 2) including one phase II trial 19 and one phase III trial 20 .…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Given that different chemotherapeutics are associated with multiple adverse events, we compared only grade 3 and 4 hematologic toxicity adverse effects between gemcitabine-free and Feher 12 Zielinski 13 Martín 14 Albain 15 Chan 16 Joensuu 17 Nielsen 18 Brufsky 19 Pallis 20 Test for overall effect: Z = 1.83 (P = 0.07) Heterogeneity: Chi 2 = 7.14, df = 8 (P = 0.52); I 2 = 0% Zielinski 13 Feher 12 Martín 14 Albain 15 Joensuu 17 Chan 16 Nielsen 18 Brufsky 19 Pallis 20 Test for overall effect: Z = 0.13 (P = 0.90) Heterogeneity: Tau For personal use only.…”

Section: Toxicitymentioning

confidence: 99%

“…Four trials were excluded [8][9][10][11] , namely, a phase III trial using a three-arm design, two phase III trials without a gemcitabine-free control arm and a phase II trial without sufficient data. A total of nine trials met the inclusion criteria in this metaanalysis [12][13][14][15][16][17][18][19][20] , from which 2651 patients were included in the assessment for overall response and toxicity. Eight of these trials were assessed for overall survival, and seven for time to progression.…”

Section: Study Characteristicsmentioning

confidence: 99%

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Efficacy of gemcitabine-based chemotherapy in metastatic breast cancer: a meta-analysis of randomized controlled trials

Wang

2013

Current Medical Research and Opinion

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Section: Toxicitymentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Toxicitymentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy of gemcitabine-based chemotherapy in metastatic breast cancer: a meta-analysis of randomized controlled trials

Wang

2013

Current Medical Research and Opinion

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“…[18,19] It is extracted from the bark of Yew tree [20] and is used alone or in combination with other chemotherapeutics [21] to treat many types of cancer cells such as breast, [22] ovarian, [23] and lung cancers. [24] Some nanoparticle drug carriers functionalised with Taxol have been investigated for biomedical applications.…”

Section: Introductionmentioning

confidence: 99%

Effect of Modification Protocols on the Effectiveness of Gold Nanoparticles as Drug Delivery Vehicles for Killing of Breast Cancer Cells

et al. 2016

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The current study evaluated the potential of gold nanoparticles (AuNPs) for the delivery of Taxol to breast cancer cells (T47D) using an in vitro cell culture model. For this study, new loading approaches and novel chemical attachments were investigated. Five different gold nanoparticle-based complexes were used to determine their cytotoxicity towards T47D cells using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) viability assay. There was no significant decrease (P . 0.05) in cell viability when T47D cells were treated with AuNPs that did not contain Taxol. However, cells were significantly killed by gold nanoparticles chemically conjugated to Taxol using three different approaches and one novel hybrid AuNP-Taxol nanoparticle, wherein no chemical bonds were involved. These Taxolloaded AuNPs were more effective at inducing cell death in vitro than a solution of free Taxol used to treat cells. This result demonstrated that Taxol could be released from the particles in the cell culture media for subsequent therapeutic action. Additionally, the experiments proved that the Taxol-loaded AuNPs were more toxic in a dose dependent manner than Taxol as a formulation for the treatment of breast cancer cells. The results of this study suggest that gold nanoparticles have potential for the efficient delivery of Taxol to breast cancer cells. This could provide a future solution as an alternative application method to overcome adverse side effects resulting from current high-dose treatment regimes.

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A phase I study of hepatic arterial infusion of nab-paclitaxel in combination with intravenous gemcitabine and bevacizumab for patients with advanced cancers and predominant liver metastases

Tsimberidou

Yang

Wheler

et al. 2013

Cancer Chemother Pharmacol

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PURPOSE We conducted a Phase I clinical trial for patients with advanced cancer and predominant liver disease. EXPERIMENTAL DESIGN Patients were treated with HAI nab-paclitaxel (120-210 mg/m2; day 1); intravenous bevacizumab (10 mg/kg; day 1); and intravenous gemcitabine (600-800 mg/m2; days 1 and 8). A conventional “3 + 3” study design was used. RESULTS Fifty patients with advanced cancer and predominant liver metastases were treated (median age, 58 years; 27 women, 23 men; median number of prior therapies, 3 [range, 0-12]). The most common cancers were breast (n=9) and pancreatic (n=9). Overall, 264 cycles were administered (median/patient, 4; range, 1-17). No dose-limiting toxicities were noted during the escalation phase. On dose level 4, 3 patients were unable to receive gemcitabine on day 8 because of severe thrombocytopenia. Dose level 3 was selected as the maximum tolerated dose (HAI nab-paclitaxel 180 mg/m2 and intravenous gemcitabine 800 mg/m2 and bevacizumab 10 mg/kg); Thirty-two patients were treated in the expansion phase. The most common treatment-related toxicities were thrombocytopenia (n=17), neutropenia (n=10), and fatigue (n=12). Of 46 patients evaluable for response, 9 (20%) had a partial response [1] and 9 (20%) had stable disease for {greater than or equal to} 6 months. The median overall survival duration was 7.0 months (95% CI: 4, 22 months) and the median progression-free survival duration was 4.2 months (95% CI: 2.7, 8.6 months). CONCLUSIONS HAI nab-paclitaxel in combination with gemcitabine and bevacizumab was well tolerated and had antitumor activity in selected patients with advanced cancer and liver metastases.

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A Randomized Phase II Study of Paclitaxel and Bevacizumab With and Without Gemcitabine as First-Line Treatment for Metastatic Breast Cancer

Cited by 29 publications

References 15 publications

Efficacy of gemcitabine-based chemotherapy in metastatic breast cancer: a meta-analysis of randomized controlled trials

Efficacy of gemcitabine-based chemotherapy in metastatic breast cancer: a meta-analysis of randomized controlled trials

Effect of Modification Protocols on the Effectiveness of Gold Nanoparticles as Drug Delivery Vehicles for Killing of Breast Cancer Cells

A phase I study of hepatic arterial infusion of nab-paclitaxel in combination with intravenous gemcitabine and bevacizumab for patients with advanced cancers and predominant liver metastases

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