Abstract
Abstract Introduction: TACT2, a multicentre phase III trial with E-CMF as control (NEAT Poole NEJM 2006), tests 2 hypotheses in a 2x2 factorial design: A) accelerating chemotherapy (CT) offers superior benefits (CALGB9741 Citron JCO 2003); B) the oral 5FU prodrug capecitabine (X) gives similar efficacy but preferential side-effect profile to CMF. Here, focus is on hypothesis A with results for compliance, QL and acute toxicities (physician & patient (pt) reported) during E vs aE. Materials & Methods: Dec 2005-08 4391 pts (4371 women, 20 men) with node +ve or high risk node -ve invasive EBC were recruited. Pts were randomised to receive either E (100mg/m2 x 4) q3wk or q2wk aE (100mg/m2 x 4 plus pegfilgrastim, 6mg d2) followed by classical CMF q4wk x 4 or X (2500mg/m2/day x 14) q3wk x 4. Detailed CTCAE toxicity was to be assessed in subset (38 centres, 2137 pts). Of these, 2127 pts received ≥1 cycle CT. 1279 of these pts completed pt-reported outcomes (EORTC QLQ-C30 and pre-defined pt-reported TACT2 toxicities) with 910 completing baseline on time and having end cycle 4 data. P<0.01 classed as significant. Toxicities/which differ between groups are shown where p-values are trend tests across all grades & % grade 3+ are reported. QL assessed via linear regression models. Results: 33/4391 pts did not start CT. 4259 (97%) completed the initial 4 cycles (E 2143 (96%), aE 2116 (98%) with RDI >85% for E 2058 (93%) and aE 1983 (91%). During cycles 1-4 higher rates of hand-foot syndrome & anaemia were seen with aE vs E (P<0.001). Few were grade 3+ (E 0%, aE 0.9% & E 0%, aE 0.1%) respectively. Lower grade 3+ rates (all P<0.001) were seen with aE vs E for: ANY toxicity (E 27%, aE 18%), leucopenia (E 4%, aE 1%), neutropenia (E 17%, aE 2%) & febrile neutropenia (E 4%, aE 2%). Change from baseline in global QL, role functioning & fatigue was worse with aE vs E (P<0.001); no differences were reported for aE vs E for impact of individual pre-defined TACT2 toxicities on daily activities (Nausea, vomiting, tingling hands and/or feet, diarrhoea, constipation, sore mouth, mouth ulcers). Conclusion: In TACT2, the largest adjuvant trial reporting acute toxicities for standard vs accelerated E in EBC, serious CTCAE toxicity was less common with aE compared with E, however pts report poorer global QL, fatigue & role function which does not appear to be explained by impact on daily activities due to individual side-effects. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-10-06.
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