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tAnGo : a randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin/cyclophosphamide-based, adjuvant chemotherapy for early breast cancer : a prospective pulmonary, cardiac and hepatic function evaluation
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Wardley, A. M., Hiller, Louise, Howard, H. C., Dunn, Janet A., Bowman, A., Coleman, R. E., Fernando, I. N., Ritchie, D. M., Earl, Helena M. and Poole, Christopher J. (2008) tAnGo : a randomised phase III trial of gemcitabine in paclitaxel-containing, epirubicin/cyclophosphamide-based, adjuvant chemotherapy for early breast cancer : a prospective pulmonary, cardiac and hepatic function evaluation. British Journal of Cancer, Vol.99 (No.4). pp. 597-603. doi:10.1038/sj.bjc.6604538
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Official URL: http://dx.doi.org/10.1038/sj.bjc.6604538
Abstract
tAnGo is a large randomised trial assessing the addition of gemcitabine(G) to paclitaxel(T), following epirubicin(E) and cyclophosphamide(C) in women with invasive higher risk early breast cancer. To assess the safety and tolerability of adding G, a detailed safety substudy was undertaken. A total of 135 patients had cardiac, pulmonary and hepatic function assessed at (i) randomisation, (ii) mid-chemotherapy, (iii) immediately post-chemotherapy and (iv) 6 months post-chemotherapy. Skin toxicity was assessed during radiotherapy. No differences were detected in FEV1 or FVC levels between treatment arms or time points. Diffusion capacity (TLCO) reduced during treatment (P < 0.0001), with a significantly lower drop in EC-GT patients (P=0.02). Most of the reduction occurred during EC and recovered by 6-months post treatment. There was no difference in cardiac function between treatment arms. Only 11 patients had echocardiography/MUGA results change from normal to abnormal during treatment, with only five having LVEF < 50%. Transient transaminitis occurred in both treatment arms with significantly more in EC-GT patients post-chemotherapy (AST P=0.03, ALT P=0.003), although the majority was low grade. There was no correlation between transaminitis and other toxicities. Both treatment regimens reported temporary reductions in pulmonary functions and transient transaminitis levels. Despite these being greater with EC-GT, both regimens appear well tolerated.
| Item Type: | Journal Article | ||||
|---|---|---|---|---|---|
| Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | ||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Breast -- Cancer -- Treatment -- Research, Cancer -- Adjuvant treatment | ||||
| Journal or Publication Title: | British Journal of Cancer | ||||
| Publisher: | Nature Publishing Group | ||||
| ISSN: | 0007-0920 | ||||
| Official Date: | August 2008 | ||||
| Dates: |
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| Volume: | Vol.99 | ||||
| Number: | No.4 | ||||
| Number of Pages: | 7 | ||||
| Page Range: | pp. 597-603 | ||||
| DOI: | 10.1038/sj.bjc.6604538 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access |
Data sourced from Thomson Reuters' Web of Knowledge
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