Epirubicin and Docetaxel as Neoadjuvant Treatment of Locally Advanced Breast Cancer: A Phase II Study

Lombardi, Davide; Scalone, Simona; Crivellari, Diana; Magri, M. D.; Mura, N. La; Miolo, Gian Maria; Murrone, Antonio; Perin, Tiziana; Coran, Francesco; Candiani, Ezio; Massarut, Samuele; Veronesi, Andrea

doi:10.1177/030089161009600207

Cited by 3 publications

(6 citation statements)

References 22 publications

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“…In a previous series of 45 evaluable patients treated with 4 cycles of neoadjuvant ET at our Institution, 7 (16%) showed no signs of disease and 2 additional patients presented only carcinoma in situ at histological examination of the breast 15. However, some of these patients had persistent nodal disease, leaving only 3 patients with pCR.…”

Section: Discussionmentioning

confidence: 82%

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Epirubicin and docetaxel as neoadjuvant treatment of hormone receptor positive, HER-2 negative breast cancer: findings from two successive phase II studies

Tuzi

Lombardi

Crivellari

et al. 2013

Radiology and Oncology

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BackgroundWe report on the activity of the combination of epirubicin and docetaxel given in neoadjuvant setting for 4 and 8 cycles respectively in 2 successive series of patients with large operable or locally advanced, hormone receptor positive, HER-2 negative breast cancer.Patients and methodsPatients were treated from 2002 to 2006 with epirubicin 90 mg/m2 and docetaxel 75 mg/m2 intravenously, every 3 weeks for 4 cycles before and 4 cycles after surgery (Series I – 13 patients), and from 2006 to 2010 with the same regimen administered for 8 cycles preoperatively (Series II – 37 patients), plus hormonal therapy for 5 years and radiation therapy if indicated. All Series I and 32 Series II patients were able to complete the preoperative chemotherapy.ResultsA complete response was found in 1 patient from Series I and 13 patients from Series II and the partial remission in 10 patients from Series I and 21 patients from Series II. Two Series I and 3 Series II patients did not respond clinically. Response rate (Series I/Series II) was 84/92%. All 50 patients underwent surgery. In Series I patients, 3 pCR occurred in the breast and the axilla was histologically negative in 2 cases. No evidence of disease both in the breast and in the axilla was achieved in 7.6% (1/13) of patients. In Series II patients, 8 pCR occurred in the breast and axilla was histologically negative in 15 patients. No evidence of disease both in the breast and in the axilla occurred in 10.8% (4/37) of patients. G3–G4 toxicity included myelosuppression in 3 patients from Series I and all patients from Series II, and mucositis in 1 patient from Series I and 4 patients from series II. No other G3–4 toxicities or toxic deaths occurred. Five-year progression free survival was 38% and 90% in Series I and Series II patients respectively.ConclusionsThe incidence of pathologic complete remissions was lower in our patient population, compared to reported data. A longer duration of the preoperative treatment might be associated with a longer progression-free survival.

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Section: Discussionmentioning

confidence: 82%

“…Patients were not selected according to the molecular subtype. The results of that study have been reported previously 15. Since 2006, the neoadjuvant treatment was changed and for the subsequent study hormone receptor positive, HER-2 negative patients were selected only.…”

Section: Introductionmentioning

confidence: 80%

Epirubicin and docetaxel as neoadjuvant treatment of hormone receptor positive, HER-2 negative breast cancer: findings from two successive phase II studies

Tuzi

Lombardi

Crivellari

et al. 2013

Radiology and Oncology

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“…In the present study, we produced and characterized for the first time an experimental rat model of painful CIPN evoked by the sequential (EPI+DO)-NAC treatment frequently used against breast cancer (Eckhoff et al 2011;Fabi et al 2004;Hainsworth et al 2006;Kaufmann et al 2003;Lombardi et al 2010;Trudeau et al 2015). By using a 3 weeks NAC treatment schedule (one week EPI at 1mg/kg/2days follow by 2 weeks DO at 2mg/kg/2days), we reproduced in rats neuropathic pain-like behavior with symptoms similar to those observed in human clinical practice (Pereira et al 2016;Starobova et al 2017).…”

Section: Discussionmentioning

confidence: 99%

“…Neoadjuvant chemotherapy (NAC) is a widely used standard treatment for locally advanced breast cancer at inoperable stages (Connolly et al 2013;Lombardi et al 2010;Teshome et al 2014;van de Wiel et al 2017). By inducing a net tumor shrinking, NAC offers attractive benefits as it increases the rate of breast-conserving surgery and improves surgical resection (Connolly et al 2013;Rouzier et al 2004;Teshome et al 2014;Wolmark et al 2001).…”

Section: Introductionmentioning

confidence: 99%

“…DO neurotoxicity induces chronic CIPN in about 31% of patients (Mustafa Ali et al 2017), and this situation usually requires a dose-reduction or early discontinuation of the chemotherapeutic treatment (Eckhoff et al 2015;Hershman et al 2014). In the sequential (EPI+DO)-NAC used for breast cancer treatment (Hainsworth et al 2006;Lombardi et al 2010), DO-evoked toxicity may be worsened by an additional EPI-related neurotoxicity (Bigotte et al 1989) and this may considerably affect for the long-term patients' quality of life since neuroprotective drugs to prevent efficiently painful CIPN are still missing although many attempts have been made with various compounds that are not fully satisfactory but induce themselves several adverse effects (Cruccu et al 2017;Pachman et al 2014).…”

Section: Introductionmentioning

confidence: 99%

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Behavioral, Electrophysiological, and Histological Characterization of a New Rat Model for Neoadjuvant Chemotherapy–Induced Neuropathic Pain: Therapeutic Potential of Duloxetine and Allopregnanolone Concomitant Treatment

et al. 2020

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Neoadjuvant chemotherapy is beneficial against breast cancer but its toxicity causes painful chemotherapy-induced neuropathy which decreases seriously patients' quality of life.Development of effective therapy is crucial because current treatments are unsatisfactory.While animal models have previously been produced to test therapeutics against chemotherapy-induced neuropathy, neuropathic pain evoked by the frequently used neoadjuvant-chemotherapy involving sequentially epirubicin and docetaxel has never been modeled. Duloxetine, a serotonin/noradrenalin-reuptake inhibitor is recommended against chemotherapy-induced neuropathy but duloxetine exhibits controversial and adverse effects requiring its discontinuation. Here, we firstly produced and characterized a rat model for epirubicin-docetaxel induced painful neuropathy by using behavioral methods including the von Frey filament and the acetone tests that were combined with electrophysiological assessment of peripheral nerve functions and immunohistological analyzes. Using this model, we investigated the possibility to improve duloxetine efficacy and safety by combining its low doses (2mg/kg/2days) with the potent neuroprotector allopregnanolone (4mg/kg/2days). This concomitant therapy was more effective than separate duloxetine or allopregnanolone treatment to prevent epirubicin-docetaxel induced cold allodynia, mechanical allodynia/hyperalgesia, peripheral nerve functional/electrophysiological and histological alterations. Interestingly, duloxetine-allopregnanolone concomitant treatment (but not duloxetine) also prevented epirubicin-docetaxel induced Schwann cell dedifferentiation and related macrophage (CD11b/c-positive cells) infiltration in sciatic nerves. Altogether, our results suggest that duloxetine and allopregnanolone concomitant treatment may represent a promising therapeutic option to counteract efficiently painful neuropathy or epirubicindocetaxel evoked peripheral nerve tissue damages and dysfunctions.

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The influence factors of clinical efficacy and prognosis of breast cancer patients treated with neoadjuvant chemotherapy

Tang

Zhang

2023

Preprint

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Objective To investigate predictive indicators of clinical efficacy and prognosis of breast cancer patients treated with neoadjuvant chemotherapy. Methods 290 female patients with breast cancer who treated with neoadjuvant chemotherapy were enrolled in this study. The collected data including tumor position, tumor size, cTNM staging, LNR, pathological molecular types(including ER, PR, Her-2, Ki-67 and so on), neoadjuvant chemotherapy regimens, pathological complete response rate, postoperative treatment and survival time. Results Neoadjuvant chemotherapy curative effect was related to pausimenia, T staging, N staging, ER/PR and Ki-67(P < 0.05), N staging (OR = 0.041, 95% CI = 0.012 ~ 0.134) and Ki-67 (OR = 9.340, 95% CI = 1.770 ~ 49.286) were independent risk factors of pCR. Recurrence of metastases was related to T staging, LNR, Ki-67, ET regimen, postoperative chemotherapy and postoperation radiotherapy(P < 0.05), T staging (OR = 1.731, 95%CI = 1.244 ~ 2.408), LNR (OR = 2.726, 95%CI = 1.430 ~ 5.197) and Ki-67 (OR = 3.107, 95%CI = 1.395 ~ 6.920) were independent risk factors of recurrence of metastases. Patients with low Ki-67 expression, low LNR, T1 staging and T2 staging and N0/N1/N2 staging had a better prognosis. Conclusion Clinical efficacy and prognosis of breast cancer patients treated with neoadjuvant chemotherapy were related to cTNM staging, LNR, ER/PR and Ki-67.

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Epirubicin and Docetaxel as Neoadjuvant Treatment of Locally Advanced Breast Cancer: A Phase II Study

Abstract: The neoadjuvant treatment was active and well tolerated, but the incidence of pathologic complete remissions was relatively low.

Cited by 3 publications

References 22 publications

Epirubicin and docetaxel as neoadjuvant treatment of hormone receptor positive, HER-2 negative breast cancer: findings from two successive phase II studies

Epirubicin and docetaxel as neoadjuvant treatment of hormone receptor positive, HER-2 negative breast cancer: findings from two successive phase II studies

Behavioral, Electrophysiological, and Histological Characterization of a New Rat Model for Neoadjuvant Chemotherapy–Induced Neuropathic Pain: Therapeutic Potential of Duloxetine and Allopregnanolone Concomitant Treatment

The influence factors of clinical efficacy and prognosis of breast cancer patients treated with neoadjuvant chemotherapy

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