Phase 2 Study of Dose-Dense Doxorubicin and Cyclophosphamide Followed by Eribulin Mesylate With or Without Prophylactic Growth Factor for Adjuvant Treatment of Early-Stage Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer

Cadoo, Karen A.; Kaufman, Peter A.; Seidman, Andrew D.; Chang, Cassandra; Xing, Dongyuan; Traina, Tiffany A.

doi:10.1016/j.clbc.2018.04.001

Cited by 11 publications

(8 citation statements)

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“…In this study, the combination of carboplatin and eribulin produced a pCR rate of 43%, with mostly grade 1 and 2 toxic effects [6]. Cadoo et al conducted a phase II trial of the feasibility (defined as the percentage of patients who completed the regimen) of dose‐dense doxorubicin/cyclophosphamide (AC) followed by eribulin with and without prophylactic filgrastim in patients with stage I–III, HER2‐nonamplified early‐stage breast cancer, and showed that eribulin along with AC combination in neoadjuvant therapy for stage I–III patients was feasible in only 72.9% when pegfilgrastim was used and in only 60% when pegfilgrastim was not used [7]. This is in line with the toxicity that was observed in our study.…”

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confidence: 99%

A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast Cancer

et al. 2020

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confidence: 99%

A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast Cancer

et al. 2020

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“…Possible causes of the difference in the results of pre-operative eribulin treatment for early breast cancer and those of eribulin treatment for metastatic breast cancer include the following factors. First, eribulin has different modes of action: one is a blockade of cell cycle progression by inhibition of microtubule growth, and the other is non-mitotic complex effects on tumor biology, including induction of vascular remodeling, suppression of cancer cell migration and invasion, and reversal of the epithelial-tomesenchymal transition (13)(14)(15)(16)(17)(18)(19). Short-term exposure to eribulin of a bulky mass with stage III would not be enough to improve the tumor microenvironment.…”

Section: Discussionmentioning

confidence: 99%

A Phase II Study of Sequential Treatment With Anthracycline and Taxane Followed By Eribulin in Patients With HER2-Negative, Locally Advanced Breast Cancer (JBCRG-17)

Fukada

Ito

Kondo

et al. 2021

Preprint

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PurposeThe sequence of taxanes (T) followed by anthracyclines (A) as neoadjuvant chemotherapy (NAC) has been the standard of care for almost 20 years for locally advanced breast cancer (LABC). Sequential administration of eribulin (E) following A/T could provide a greater response rate for women with LABC.MethodsIn this single-arm, multicenter, Phase II prospective study, the patients received 4 cycles of the FEC regimen and 4 cycles of taxane. After the A/T-regimen, 4 cycles of E were administered followed by surgical resection. The primary endpoint was the clinical response rate. Eligible patients were women aged 20 years or older, with histologically confirmed invasive breast cancer, clinical Stage IIIA (T2-3 and N2 only), Stage IIIB, and Stage IIIC, HER2-negative.ResultsA preplanned interim analysis aimed to validate the trial assumptions was conducted after treatment of 20 patients and demonstrated that clinical progressive disease (cPD) rates in the E phase were significantly higher (30%) than assumed. Therefore, the Independent Data Monitoring Committee recommended stopping the study. Finally, 53 patients were enrolled, and 26 patients received the A/T/E-regimen. The overall observed clinical response rate (RR) was 73% (19/26); RRs were 77% (20/26) in the AT phase and 23% (6/26) in the E phase. Thirty percent (8/26) of patients had PD in the E phase, 6 of whom had achieved cCR/PR in the AT phase. Reported grade >3 AEs related to E were neutropenia (42%), white blood cell count decrease (27%), febrile neutropenia (7.6%), weight gain (3.8%), and weight loss (3.8%)ConclusionSequential administration of eribulin after the A/T-regimen provided no additional effect for LABC patients. Future research should continue to focus on identifying specific molecular biomarkers that can improve response rates.

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“…Importantly, significant anticancer activity is seen in ER, PgR and HER2 negative metastatic BC cases [10]. So far few studies evaluating E in localized BC either in combination with carboplatin [27], and trastuzumab [28], or as monotherapy [29] after anthracycline-based chemotherapy have been reported. Overall, results showed that E has a favorable peripheral neuropathy toxicity profile, without any clearly improved activity over historical results with standard treatment with paclitaxel [28].…”

Section: Discussionmentioning

confidence: 99%

Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study

et al. 2019

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Background Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy. Methods Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m 2 and paclitaxel 200 mg/m 2 x 4 cycles (AT) followed by E 1.4 mg/m 2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study. Results In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2–5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR. Conclusions Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial – mesenchymal transition, claims for further investigation. Trial registration EU Clinical Trial Register, EudraCT number 2012-004956-12 .

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Phase 2 Study of Dose-Dense Doxorubicin and Cyclophosphamide Followed by Eribulin Mesylate With or Without Prophylactic Growth Factor for Adjuvant Treatment of Early-Stage Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer

Cited by 11 publications

References 25 publications

A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast Cancer

A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast Cancer

A Phase II Study of Sequential Treatment With Anthracycline and Taxane Followed By Eribulin in Patients With HER2-Negative, Locally Advanced Breast Cancer (JBCRG-17)

Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study

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