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Clinical Trial
. 2008 Aug 19;99(4):597-603.
doi: 10.1038/sj.bjc.6604538. Epub 2008 Jul 29.

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

A M Wardley  1 , L Hiller, H C Howard, J A Dunn, A Bowman, R E Coleman, I N Fernando, D M Ritchie, H M Earl, C J Poole; tAnGo Trial Collaborators
Collaborators, Affiliations
Clinical Trial

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

A M Wardley et al. Br J Cancer. .

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 FEV(1) or FVC levels between treatment arms or time points. Diffusion capacity (TL(CO)) 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.

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Figures

Figure 1
Figure 1
FEV1 results over the four time points.
Figure 2
Figure 2
Pulmonary function levels over time (GREY dashed=EC-T patients, BLACK solid=EC-GT patients). (A) FVC levels. (B) FVC levels as percent of patient baseline level. (C) Average FVC levels over time for each treatment arm, predicted by random effects model. (D) TLCO levels. (E) TLCO levels as percent of patient baseline level. (F) Average TLCO levels over time for each treatment arm, predicted by random effects model.
Figure 3
Figure 3
Pulmonary, Cardiac, Chest and Hepatic tests over four time points. Weekly RT toxicity. (A) ECHO/MUGA. (B) ECG. (C) Chest X-ray. (D) AST. (E) ALT. (F) Radiotherapy acute skin toxicity.
See this image and copyright information in PMC

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