A Phase II Trial of Dose-Dense Neoadjuvant Gemcitabine, Epirubicin, and Albumin-Bound Paclitaxel With Pegfilgrastim in the Treatment of Patients With Locally Advanced Breast Cancer

Yardley, Denise A.; Zubkus, John D.; Daniel, Brooke R.; Inhorn, Roger C.; Lane, Cassie M.; Vazquez, Elizabeth R.; Naot, Yuval; Burris, Howard A.; Hainsworth, John D.

doi:10.3816/cbc.2010.n.048

Cited by 19 publications

(15 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This type of complication had been reported with gemcitabine combinations for neoadjuvant treatment in significantly variable rates (10 to 54%), making some authors to advocate for the use of granulocyte stimulating factor during the AG phase, while others do not [9, 13-15, 18, 19] .In our study, the use of weekly paclitaxel seemed not to have potentiated the neutropenic effect, which was more related to the AG combination, as observed in other studies [14,24,25] . Mucositis was much more frequent in our study than reported in other gemcitabine-combination strategies.…”

supporting

confidence: 76%

“…Further evidence showing that the use of sequential gemcitabine and doxorubicin has a highly toxic hematological profile came from an Indian study published soon after we had terminated the accrual of our study. The use of different schedules of gemcitabine and doxorubicin in this study demonstrated that a subgroup of patients that had received gemcitabine on days 1 and 8 and doxorubicin on day 2 presented an unacceptable rate of severe neutropenia and mucosites (80% of the cases) [14] . It is possible that the use of prophylactic granulocyte colony-stimulating factor may reduce the toxicities of AG-T, and this strategy may be worthy of evaluation in further phase III studies, since the efficacy of the combination seems to be equivalent to the therapies presently recommended for neoadjuvancy.…”

mentioning

confidence: 72%

“…For instance, three recent trials obtained 18-23% of complete pathological response. One of these combined gemcitabine, epirubicin, and docetaxel, while the others used gemcitabine with epirubicin and paclitaxel or dose-dense gemcitabine, epirubicin and albumin-bound paclitaxel [14,18,19] . …”

Section: Discussionmentioning

confidence: 99%

“…On the other hand, the toxicity profile is a matter of debate, since mucositis and neutropenia are common and intense. For this reason, some authors advocate for the use of granulocyte stimulating factor, while others do not [13,14,15] . The response rates were similar to the ones previously described in the combination of anthracyclin and taxanes [16,17] .…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

Petrarca

Calleari

Morelle

et al. 2012

JST

View full text Add to dashboard Cite

Background: Neoadjuvant chemotherapy is a therapeutic strategy for patients with locally advanced breast cancer. To evaluate the toxicity and clinical efficacy of the combination of Gemcitabine plus doxorubicin followed by paclitaxel in neoadjuvancy. Methods:A phase II trial, in which 19 patients, ages 37 to 65, with pathologically proven breast cancer, were included. They received four cycles of doxorubicin 50mg/m 2 on day 1 and Gemcitabine 1000 mg/m 2 on days 1 and 8, every 21 days;followed by four cycles of paclitaxel 80 mg/m 2 on days 1, 8, and 15, every 28 days. The follow-up was performed with mammography and clinical examination. Results:The planned regimen was completed in 17 (89.4%) of the 19 patients. Thirty seven percent of the patients presented mucositis grades 3-4 and 15% had diarrhea grades 3-4. Hematologic toxicities grades 3-4 were seen in 31.5% of the cases (6 patients). Complete clinical response was observed in 9 (47%) patients; of whom four showed complete pathological response after surgery. Conclusion:The response rate (clinical and pathological) in this study was similar to the one observed in the usual regimen of neoadjuvancy using doxorubicin, cyclophosphamide, and paclitaxel. However, the toxicity profile of the combination regimen containing gemcitabine was exceedingly high, causing the interruption of the protocol.

show abstract

supporting

confidence: 76%

mentioning

confidence: 72%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

Petrarca

Calleari

Morelle

et al. 2012

JST

View full text Add to dashboard Cite

show abstract

“…Baseline clinical staging using mammography, ultrasonography and breast magnetic resonance imaging (MRI) was determined before enrollment. 18 F-fluorodeoxyglucose (FDG) PET combined with computed tomography (CT) or whole-body CT and bone scintigraphy was used to detect distant metastasis. Needle core biopsy was performed before chemotherapy to diagnose invasive carcinoma.…”

Section: Patient Eligibilitymentioning

confidence: 99%

Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety

Shimada

Ueda

Sendo

et al. 2015

Japanese Journal of Clinical Oncology

View full text Add to dashboard Cite

Objective: Nanoparticle albumin-bound paclitaxel (nab-PTX) is a solvent-free paclitaxel coupled to human albumin without an associated increase in toxicity. The neoadjuvant study of primary breast cancer was planned to evaluate tumor response and safety of triweekly nanoparticle albumin-bound paclitaxel. Methods: Patients with Stage II/III HER2-negative primary breast cancer received four courses of nanoparticle albumin-bound paclitaxel 260 mg/m 2 every 3 weeks (q3w), followed by four courses of epirubicin 90 mg/m 2 plus cyclophosphamide 600 mg/m 2 q3w. Tumor response after nanoparticle albumin-bound paclitaxel was histologically evaluated. In addition, the clinical response, breastconserving rate and safety of this treatment were monitored. Results: Among 53 patients who received nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide neoadjuvant chemotherapy, pathological complete response and near-pathological complete response were confirmed in 3 (5.7%) and 7 (13.2%) patients who had surgery, respectively. The overall objective response rate was 71.7% after completion of chemotherapy. Based on Positron Emission Tomography Response Criteria in Solid Tumors using 18 F-fluorodeoxyglucose, complete metabolic response and partial metabolic response after 2-3 courses of nanoparticle albumin-bound paclitaxel were 15.1 and 52.8%, respectively. The most common significant toxicities of q3w nanoparticle albumin-bound paclitaxel were Grade 3 muscle pain, neuropathy and febrile neutropenia, each in 1 (1.9%) patient. There were no incidences of anaphylaxis or Grade 4/5 adverse events. Conclusion: Neoadjuvant chemotherapy using q3w nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide was feasible in breast cancer patients with acceptable clinical response and drug tolerance, but conferred a low rate of pathological complete response. Monotherapy with q3w nanoparticle albumin-bound paclitaxel could be an appropriate substitute for solvent-based taxane in terms of therapeutic and safety management.

show abstract

Use of rHuG-CSF in New Chemotherapy Strategies

Renwick

2011

Twenty Years of G-CSF

View full text Add to dashboard Cite

A Phase II Trial of Dose-Dense Neoadjuvant Gemcitabine, Epirubicin, and Albumin-Bound Paclitaxel With Pegfilgrastim in the Treatment of Patients With Locally Advanced Breast Cancer

Cited by 19 publications

References 31 publications

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

A phase II trial of neoadjuvant doxorrubicin plus gemcitabine, followed by weekly paclitaxel in lo- cally advanced breast cancer: an analysis of effectiveness and toxicity

Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety

Use of rHuG-CSF in New Chemotherapy Strategies

Contact Info

Product

Resources

About