Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study

Schneeweiß, Andreas; Huober, Jens; Sinn, Hans‐Peter; Fournier, D. von; Rudlowski, Christian; Beldermann, F.; Krauss, Katja; Solomayer, Erich; Hamerla, R.; Wallwiener, D.; Bastert, G.

doi:10.1016/j.ejca.2004.08.004

Cited by 21 publications

(13 citation statements)

References 14 publications

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“…Gemcitabine has demonstrated singleagent activity in breast cancer (Heinemann, 2003), and is indicated as first-line therapy in combination with paclitaxel for patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy (Albain et al, 2004). In the neoadjuvant setting, gemcitabine has been combined with anthracyclines and/or taxanes in several phase II studies of locally advanced breast cancer, with clinical response rates and pCR rates ranging from 71 -95% and 3 -26%, respectively (Gomez et al, 2001;Silva et al, 2002;Schneeweiss et al, 2004).…”

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confidence: 99%

A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling

Julka

Chacko

Nag³

et al. 2008

Br J Cancer

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This study examined the pathological complete response (pCR) rate and safety of sequential gemcitabine-based combinations in breast cancer. We also examined gene expression profiles from tumour biopsies to identify biomarkers predictive of response. Indian women with large or locally advanced breast cancer received 4 cycles of gemcitabine 1200 mg m À2 plus doxorubicin 60 mg m À2(Gem þ Dox), then 4 cycles of gemcitabine 1000 mg m À2 plus cisplatin 70 mg m À2 (Gem þ Cis), and surgery. Three alternate dosing sequences were used during cycle 1 to examine dynamic changes in molecular profiles. Of 65 women treated, 13 (24.5% of 53 patients with surgery) had a pCR and 22 (33.8%) had a complete clinical response. Patients administered Gem d1, 8 and Dox d2 in cycle 1 (20 of 65) reported more toxicities, with G3/4 neutropenic infection/febrile neutropenia (7 of 20) as the most common cycle-1 event. Four drug-related deaths occurred. In 46 of 65 patients, 10-fold cross validated supervised analyses identified gene expression patterns that predicted with X73% accuracy (1) clinical complete response after eight cycles, (2) overall clinical complete response, and (3) pCR. This regimen shows strong activity. Patients receiving Gem d1, 8 and Dox d2 experienced unacceptable toxicity, whereas patients on other sequences had manageable safety profiles. Gene expression patterns may predict benefit from gemcitabine-containing neoadjuvant therapy.

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confidence: 99%

A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling

Julka

Chacko

Nag³

et al. 2008

Br J Cancer

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“…The high activity of this triplet regimen has been confirmed by Hamm et al (2003) in locally advanced breast cancer, and by Schneeweiss et al (2004) in operable breast cancer. In this last trial, paclitaxel was substituted with docetaxel (75 mg m À2 ), the dose of gemcitabine was reduced to 800 mg m À2 on days 1 and 8, epirubicin was administered at 90 mg m À2 and filgrastim support was required.…”

Section: Discussionmentioning

confidence: 73%

Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: a phase II study

Conte

Donati²,

Gennari³

et al. 2005

Br J Cancer

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This trial was conducted to assess the activity and tolerability of the gemcitabine, epirubicin, taxol triplet combination in patients with operable breast cancer. After core biopsy, 43 women with stage II -IIIA breast cancer were treated with gemcitabine 1000 mg m À2 over 30 min on days 1 and 4, epirubicin 90 mg m À2 as an intravenous bolus on day 1, and taxol 175 mg m À2 as a 3-h infusion on day 1, every 21 days for four cycles. The primary end point was the percentage of pathological complete responses (pCR) in the breast; secondary end points were tolerability, clinical response rates, overall and progression-free survival, tumour biomarkers before and after primary chemotherapy (PCT). All patients were included in safety and survival analyses; 41 eligible patients were evaluated for response. The overall clinical response rate was 87.8% (95% CI 77.8 -97.8), with 26.8% complete responses (95% CI 13.3 -40.3). A pCR in the breast was observed in six patients (14.6%; 95% CI 3.8 -25.4); 15 patients (36.6%; 95% CI 21.9 -51.3) had negative axillary lymph nodes. Grade 4 neutropenia was observed in 67.4% of the patients; febrile neutropenia occurred in 1.9% of cycles (granulocyte colony-stimulating factor was used in 3.2% of the cycles to shorten the duration of neutropenia). A statistically significant difference between Mib-1 at baseline (X20% in 71.4% of the patients) and at definitive surgery (28.6%, Po0.05) was observed. The gemcitabine, epirubicin, taxol regimen is active and well tolerated as PCT for operable breast cancer. This combination allows the administration of full doses of active agents with a low incidence of febrile neutropenia.

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“…The pCR rate reported from these non-randomized trials ranges from 5 to 26%; however, the definition of pCR was not uniform across these studies [20][21][22][23][24][25][26][27][28].…”

Section: Anthracycline-taxane Combinationsmentioning

confidence: 99%

Neoadjuvant chemotherapy for “Triple Negative” breast cancer: a review of current practice and future outlook

Nahleh

2009

Med Oncol

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Patients with breast cancer who achieve a complete pathologic response (pCR) after preoperative (neoadjuvant) chemotherapy have an improved prognosis compared to those with residual disease; pCR being a good surrogate of long-term survival and cure from breast cancer. Despite their relative chemosensitivity, less than 25% of all patients with HER2/neu negative (0-2+), and hormone receptors (HR) negative tumors, so-called "Triple Negative" breast cancer (TNBC) treated with standard preoperative chemotherapy achieve pCR. Among patients with residual disease (no pCR) following neoadjuvant chemotherapy, patients with TNBC have the worst prognosis and overall survival. These patients lack the benefit of subsequent targeted therapy. Many studies have addressed improving the efficacy of neoadjuvant chemotherapy by including different cytotoxic agents, biologic modifiers, regimens, and schedules. Up to now, apart from trastuzumab for HRE2/neu+ tumors, none of the targeted agents can be considered a standard therapeutic option for primary systemic treatment. We hereby review the current literature on neoadjuvant chemotherapy for breast cancer, emphasizing treatment of TNBC. We also discuss potentially new therapeutic strategies that target this high risk group.

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Gemcitabine, epirubicin and docetaxel as primary systemic therapy in patients with early breast cancer: results of a multicentre phase I/II study

Cited by 21 publications

References 14 publications

A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling

A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling

Primary chemotherapy with gemcitabine, epirubicin and taxol (GET) in operable breast cancer: a phase II study

Neoadjuvant chemotherapy for “Triple Negative” breast cancer: a review of current practice and future outlook

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