The Efficacy and Safety of Preoperative Chemotherapy With Triweekly Abraxane and Cyclophosphamide Followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Therapy for Resectable Breast Cancer: A Multicenter Clinical Trial

Shigematsu, Hideo; Kadoya, Takayuki; Masumoto, Norio; Sasada, Tatsunari; Emi, Akiko; Ohara, Masahiro; Kajitani, Keiko; Okada, Morihito

doi:10.1016/j.clbc.2014.09.010

Cited by 26 publications

(12 citation statements)

References 25 publications

(36 reference statements)

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“…A phase II trial of nab -paclitaxel 260 mg/m 2 q3w and cyclophosphamide 600 mg/m 2 followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) q3w for operable breast cancer resulted in a pCR rate of 37% (95% CI 24–50%) [10]. Hormone receptor–positive/HER2-negative tumors demonstrated the lowest pCR rate (8%), whereas all other molecular subgroups had pCR rates ranging from 56 to 63%.…”

Section: Resultsmentioning

confidence: 99%

nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

Brufsky

2017

Exp Hematol Oncol

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PurposeThe purpose of this systematic review is to discuss recent studies and ongoing trials of nab-paclitaxel in breast cancer and to examine the potential role of nab-paclitaxel as a backbone for immuno-oncology therapies.MethodsPubMed and selected congress proceedings were searched for studies of nab-paclitaxel in breast cancer published between 2013 and 2015. All phase II and III clinical trials, retrospective analyses, and institutional studies were included. Active, ongoing, phase II or III trials on nab-paclitaxel that were listed on ClinicalTrials.gov were also included.ResultsSixty-three studies, including 23 in early-stage and 30 in metastatic breast cancer (some studies not classifiable by setting), were included in this analysis. Trials of neoadjuvant nab-paclitaxel–containing regimens have reported pathological complete response rates ranging from 5.7 to 53%. Median overall survival in metastatic breast cancer studies ranged from 10.8 to 23.5 months, depending on dose and regimen. Adverse event profiles of nab-paclitaxel were generally similar to those reported from previous studies. Several ongoing trials are evaluating nab-paclitaxel in the early-stage and metastatic settings, including in combination with immuno-oncology agents.Conclusions nab-Paclitaxel continues to demonstrate promising efficacy in breast cancer. Recent studies demonstrate high pathological complete response rates in early-stage breast cancer, particularly in triple-negative breast cancer, an area of high unmet need, and encouraging overall survival in metastatic breast cancer across doses and schedules. Ongoing trials will provide further insights into the role of nab-paclitaxel in breast cancer including use as a potential backbone chemotherapy agent for immuno-oncology therapies such as checkpoint inhibitors.

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Section: Resultsmentioning

confidence: 99%

nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

Brufsky

2017

Exp Hematol Oncol

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“…Although Nab-PTX has been widely used for metastatic breast cancer (7,14,15), there are only a few reports on the therapeutic efficacy and safety profile of Nab-PTX monotherapy in an upfront setting (16)(17)(18). Moreover, most studies of neoadjuvant Nab-PTX in breast cancer reported on the every-3-week (q3w) Nab-PTX administration regimen (16,17,(19)(20)(21) (22).…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, most studies of neoadjuvant Nab-PTX in breast cancer reported on the every-3-week (q3w) Nab-PTX administration regimen (16,17,(19)(20)(21) (22). Chemotherapy agents, including taxanes, which are recommended in the metastatic (23) and adjuvant settings (24), are also considered in the neoadjuvant setting.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Efficacy and Safety of Upfront Weekly Nanoparticle Albumin-bound Paclitaxel for HER2-negative Breast Cancer

Matsui

Tatibana

Suzuki

et al. 2017

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“…Third, adoption of concurrent regimens with other agents could be preferred over nab-PTX monotherapy. Some investigations have displayed a favorable pCR rate of 20-50% in HER2-negative patients who received qw nab-PTX in combination with carboplatin and bevacizumab in a neoadjuvant setting (17,23,24). Thus, the majority of neoadjuvant studies with nab-PTX have demonstrated satisfactory efficacy in combination regimes, but have not compared it with solvent-based taxanes (19).…”

Section: Discussionmentioning

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

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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.

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The Efficacy and Safety of Preoperative Chemotherapy With Triweekly Abraxane and Cyclophosphamide Followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Therapy for Resectable Breast Cancer: A Multicenter Clinical Trial

Cited by 26 publications

References 25 publications

nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

nab-Paclitaxel for the treatment of breast cancer: an update across treatment settings

Evaluation of Efficacy and Safety of Upfront Weekly Nanoparticle Albumin-bound Paclitaxel for HER2-negative Breast Cancer

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

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