- Title
- Neoadjuvant chemotherapy with sequential anthracycline-docetaxel with gemcitabine for large operable or locally advanced breast cancer: ANZ 0502 (NeoGem)
- Creator
- McCarthy, N.; Boyle, F.; Gebski, V.; Veillard, A. S.; Zannino, D.; Wilcken, N.; Reaby, L.; Lindsay, D. F.; Badger, H. D.; Forbes, J. F.; Zdenkowski, N.; Bull, J.; Leong, E.; Simpson, A.; Kannourakis, G.; Francis, P. A.; Chirgwin, J.; Abdi, E.
- Relation
- NHMRC.455513 http://purl.org/au-research/grants/nhmrc/1072461
- Relation
- The Breast Vol. 23, p. 142-151
- Publisher Link
- http://dx.doi.org/10.1016/j.breast.2013.12.001
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2014
- Description
- Background: Neoadjuvant chemotherapy has a sound rationale for use in women with large operable breast cancer, and achievement of pathological complete response (pCR) is prognostic. Epirubicin and cyclophosphamide followed by docetaxel is a standard chemotherapy regimen for early breast cancer. In metastatic breast cancer the combination of gemcitabine and a taxane has shown promising results. This phase II study investigated the efficacy and safety of incorporating gemcitabine into neoadjuvant therapy. Methods: Female patients with operable breast cancer that was clinically T2 (≥3 cm) or T3-4, N0-1, M0 were enrolled to receive 24 weeks of neoadjuvant chemotherapy using epirubicin and cyclophosphamide followed by docetaxel and gemcitabine, plus trastuzumab if HER2-positive. The primary endpoint was the pathological complete response (pCR) rate in the breast in separate HER2-negative and HER2-positive cohorts. Secondary endpoints included pCR in both the breast and axillary lymph nodes, clinical and radiological response rates, disease free survival and safety. Results: 81 patients were enrolled: 63 HER2-negative and 18 HER2-positive. 67 (84%) completed all cycles of chemotherapy, and 78 (96%) proceeded to surgery. pCR was achieved by 12 (20%) patients with HER2-negative, and 9 (53%) with HER2-positive disease. At the first interim analysis, addition of prophylactic G-CSF was recommended due to excess neutropenia. The HER2-negative cohort was closed to accrual because it did not meet the pre-specified target for pCR, and the HER2-positive cohort was closed due to slow accrual. At a median follow-up of 24 months, 12 of 81 (15%) patients had experienced a relapse of their breast cancer. Conclusion: Neoadjuvant gemcitabine, when added to docetaxel, after epirubicin and cyclophosphamide, did not reach the pre-specified expectations for pCR rate in HER2-negative tumours. Excess neutropenia was observed, requiring growth factor support. Addition of gemcitabine to docetaxel in this schedule cannot be recommended.
- Subject
- locally advanced breast cancer; neoadjuvant chemotherapy; gemcitabine; phase 2; pathologic complete response
- Identifier
- http://hdl.handle.net/1959.13/1057869
- Identifier
- uon:16286
- Identifier
- ISSN:0960-9776
- Language
- eng
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