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dc.contributor.authorMcCarthy, N
dc.contributor.authorBoyle, F
dc.contributor.authorZdenkowski, N
dc.contributor.authorBull, J
dc.contributor.authorLeong, E
dc.contributor.authorSimpson, A
dc.contributor.authorKannourakis, G
dc.contributor.authorFrancis, PA
dc.contributor.authorChirgwin, J
dc.contributor.authorAbdi, E
dc.contributor.authorGebski, V
dc.contributor.authorVeillard, AS
dc.contributor.authorZannino, D
dc.contributor.authorWilcken, N
dc.contributor.authorReaby, L
dc.contributor.authorLindsay, DF
dc.contributor.authorBadger, HD
dc.contributor.authorForbes, JF
dc.date.accessioned2017-05-03T12:46:00Z
dc.date.available2017-05-03T12:46:00Z
dc.date.issued2014
dc.identifier.issn0960-9776
dc.identifier.doi10.1016/j.breast.2013.12.001
dc.identifier.urihttp://hdl.handle.net/10072/65083
dc.description.abstractBackground 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.
dc.description.peerreviewedYes
dc.description.publicationstatusYes
dc.languageEnglish
dc.language.isoeng
dc.publisherChurchill Livingstone
dc.publisher.placeUnited Kingdom
dc.relation.ispartofstudentpublicationN
dc.relation.ispartofpagefrom142
dc.relation.ispartofpageto151
dc.relation.ispartofissue2
dc.relation.ispartofjournalThe Breast
dc.relation.ispartofvolume23
dc.rights.retentionY
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchClinical sciences not elsewhere classified
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode320299
dc.titleNeoadjuvant chemotherapy with sequential anthracycline-docetaxel with gemcitabine for large operable or locally advanced breast cancer: ANZ 0502 (NeoGem)
dc.typeJournal article
dc.type.descriptionC1 - Articles
dc.type.codeC - Journal Articles
gro.hasfulltextNo Full Text
gro.griffith.authorAbdi, Ehtesham


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