tAnGo Trial Collaborators (Including: Wardley, A. M., Hiller, Louise, Howard, H. C., Dunn, Janet A., Bowman, A., Coleman, R. E., Fernando, I. N., Ritchie, D. M., Earl, H. M. and Poole, Christopher). (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. ISSN 0007-0920

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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
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
Date:	August 2008
Volume:	Vol.99
Number:	No.4
Number of Pages:	7
Page Range:	pp. 597-603
Identification Number:	10.1038/sj.bjc.6604538
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
URI:	http://wrap.warwick.ac.uk/id/eprint/29550

Data sourced from Thomson Reuters' Web of Knowledge

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