Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in patients with operable breast cancer

Ganem, G.; Tubiana-Hulin, M.; Fumoleau, P.; Combe, M.; Misset, Jean-Louis; Vannetzel, Jean-Michel; Bachelot, Thomas; Ybarlucea, L.-R. De; Lotz, V.; Bendahmane, Belguendouz; Dièras, Véronique

doi:10.1093/annonc/mdg449

Cited by 36 publications

(39 citation statements)

References 23 publications

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“…Swain et al [3] reported that 3-5 cycles were optimal to achieve partial and complete responses, respectively. Ganem et al [25] reported that 6 cycles of doxorubicin and docetaxel were optimal for operable breast cancer with tolerable toxicity. Nonetheless, the overall response rate (85%) and pCR (15%) are similar to other reports in which patients received 3 or 4 cycles of combination PST [8]; however, 12% of patients did not complete the whole 6-cycle regimen.…”

Section: Discussionmentioning

confidence: 99%

Increased Feasibility of Weekly Epirubicin and Paclitaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Carcinoma

Chen¹,

Chang²,

Lin³

et al. 2005

Oncol Res Treat

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Background: Primary systemic therapy (PST) with a combination of epirubicin and paclitaxel achieves high response rates in locally advanced breast cancer (LABC), but considerable toxicity occurs and the patient’s compliance is poor. In this open-label phase II trial toxicitiy of a weekly administration schedule was evaluated. Patients and Methods: On days 1 and 8 of each 3-week cycle, 45 patients with non-inflammatory breast cancer received epirubicin (35 mg/m2, intravenous bolus) followed by paclitaxel (80 mg/m2 in 500 ml of normal saline infused over 3 h) for 3 cycles. Surgery was done 2 weeks after primary chemotherapy, followed by another 6 cycles of adjuvant CEF (cyclophosphamide 500 mg/m2, epirubicin 70 mg/m2, 5-fluorouracil 500 mg/m2) chemotherapy. Results: The median tumor size before and after PST was 6.0 and 2.0 cm, respectively. The clinical response rate was 96%, including 24% complete remission; 5 patients (11%) achieved pathologically complete response (pCR) including 3 patients with carcinoma in situ. Only 5 (11%) patients underwent breast conserving surgery although there were 15 patients suitable. Axillary nodes were negative in 16 (36%) of the 45 patients. Febrile neutropenia was found in 1 patient. There was no severe cardiac toxicity or serious adverse events. Conclusions: PST with weekly epirubicin and paclitaxel was an effective and well-tolerated combination for LABC, although only few patients underwent breast conserving surgery.

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Section: Discussionmentioning

confidence: 99%

Increased Feasibility of Weekly Epirubicin and Paclitaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Carcinoma

Chen¹,

Chang²,

Lin³

et al. 2005

Oncol Res Treat

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“…Four Phase II studies have evaluated docetaxel in combination with doxorubicin [36][37][38][39]. In the earliest study by von Minckwitz et al [38], a dose-dense AT schedule yielded one of the highest clinical tumour response rates reported in the literature.…”

Section: Docetaxel-anthracycline Concomitant Regimensmentioning

confidence: 99%

“…Results of two further studies of primary AT in traditional 3-weekly schedules are available [36,37]. Preliminary results currently published in abstract form by Valero et al [37] show that for 70 patients with stage III-IV breast cancer, a clinical ORR of 90% (CR 4%) and a complete pathological response rate of 10% can be achieved with AT.…”

Section: Docetaxel-anthracycline Concomitant Regimensmentioning

confidence: 99%

Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival

Heys

Sarkar

Hutcheon

2005

Breast Cancer Res Treat

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Primary chemotherapy achieves high clinical response rates and facilitates breast conservation in many patients with large and locally advanced breast cancer. It may also serve to indicate responsiveness to chemotherapeutic agents. A pathological complete response to primary chemotherapy is a primary predictor and surrogate marker of long-term outcome, but occurs in only approximately 15% of patients. Docetaxel is of particular interest in this setting. Primary docetaxel chemotherapy has single-agent activity in both dose-dense and traditional schedules, with acceptable tolerability. Furthermore, concomitant docetaxel-anthracycline schedules have shown promise in Phase II trials, achieving clinical overall response rates (ORRs) of 77-96%, pathological complete responses of up to 24%, and breast conservation in up to 89% of patients. Two Phase III studies have shown that pathological complete response is significantly improved with the addition of docetaxel to anthracycline-based therapy versus the latter alone: the Aberdeen study achieved a rate of 34% versus 16%, respectively (p = 0.04), and the NSABP-B27 study a rate of 26% versus 14%, respectively (p < 0.001). The Aberdeen study has suggested that the addition of docetaxel may yield a survival benefit at 5 years (p = 0.04). The Phase II GEPAR-DUO study hints at a benefit for sequential over concomitant docetaxel-based therapy, with improvements in both clinical response (ORR 87% versus 77%, respectively) and pathological complete response (23% versus 12%, respectively). Non-anthracycline docetaxel-based primary regimens have shown early promise. As we continue to define the optimal regimen, a growing body of evidence supports the use of docetaxel in primary chemotherapeutic regimens for breast cancer.

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“…Neoadjuvant treatment is commonly used to treat advanced tumors. [13][14][15][16][17] Consequently, many patients must undergo major surgery while chemotherapy is active; however, it is well known that chemotherapy impairs wound healing, which increases morbidity and prolongs hospitalization. 3,[18][19][20][21][22][23][24] Adriamycin is a wide-spectrum anthracycline group chemotherapeutic agent, which is frequently used but has many side effects.…”

Section: Discussionmentioning

confidence: 99%

Local Granulocyte-Macrophage Colony-Stimulating Factor Improves Incisional Wound Healing in Adriamycin-Treated Rats

Gülçelik¹,

Dinç²,

Dinç

et al. 2005

Surg Today

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Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in patients with operable breast cancer

Abstract: Docetaxel and doxorubicin is an effective and well-tolerated combination in the neoadjuvant therapy of breast cancer. Future controlled trials are warranted to investigate the best schedules and to correlate response with biological factors.

Cited by 36 publications

References 23 publications

Increased Feasibility of Weekly Epirubicin and Paclitaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Carcinoma

Increased Feasibility of Weekly Epirubicin and Paclitaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Carcinoma

Primary docetaxel chemotherapy in patients with breast cancer: impact on response and survival

Local Granulocyte-Macrophage Colony-Stimulating Factor Improves Incisional Wound Healing in Adriamycin-Treated Rats

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