Quality of Life of Early Stage Breast Cancer Patients 65 Years Old or Older Randomized to Standard Chemotherapy or Capecitabine: A Cancer and Leukemia Group B Study (CALGB 49907).
Authors: Kornblith A. , Archer L. , Lan L. , Kimmick G. , Partridge A. , Casey R. , Bennett S. , Hudis C. , Winer E. , Cohen H. , Muss H. 
Published: December 2010

Abstract
Background: CALGB conducted a randomized Phase III trial (49907) to test whether older cancer patients receiving capecitabine would have a similar clinical outcome as those receiving standard chemotherapy, but less toxicity. This represented an important quality of life (QoL) paradigm in which treatment recommendations might be based on QoL findings if there was less toxicity for capecitabine with similar clinical outcomes as those achieved with standard chemotherapy. Materials and Methods: A preplanned QoL assessment was preformed in 350 patients randomized to either standard chemotherapy (CMF or AC) (n= 182) or capecitabine (n=168). All patients were interviewed by telephone using standardized questionnaires conducted at baseline, mid-treatment, at 1 month post-treatment, and at 12, 18 and 24 months. Data were analyzed using pattern mixture models and analysis of covariance with repeated measures, in which the sample was divided into groups based on the period of time they had completed assessments. Results: Patients in the capecitabine arm reported a better overall QoL (EORTC p&lt; 0.0001), less fatigue (EORTC p&lt; 0.0001), less nausea and vomiting (EORTC, p&lt; 0.0001), less constipation (EORTC, p&lt; 0.0001), less systemic side effects (EORTC, p&lt; 0.0001), better appetite (EORTC, p&lt; 0.0001), better body image (EORTC, p&lt; 0.0001), less psychological distress (Hospital Anxiety and Depression scale, p&lt; 0.0001), better role (EORTC, p&lt; 0.0001) and social functioning (EORTC, p&lt; 0.0001) than did those in the standard chemotherapy arm at either mid-treatment and/or the end of treatment for those assessed through 24 months. Capecitabine patients reported worse diarrhea (EORTC, p&lt; 0.0001) at mid-treatment, and worse hand–foot symptoms (p&lt; 0.0001) at mid and end of treatment than did those receiving standard chemotherapy. There were no significant differences in most of these measures by 12 months. Discussion: With clinical results showing a significantly improved relapse-free and overall survival for patients who received standard chemotherapy vs. capecitabine (Muss et al., NEJM 2009; 360: 2118), the QoL results will not guide treatment recommendations. However, the QoL results largely confirmed that patients treated with capecitabine experience significantly better QoL vs. those treated with standard chemotherapy due to less toxicity during and at the end of treatment for the sizable group of patients who had completed interviews through 24 months (n=245). These results indicate that despite the worse clinical outcome of patients who receive capecitabine treatment, the majority of capecitabine patients did not experience a worsening QoL from 12 months through 24 months compared to patients receiving standard chemotherapy. Further, these findings are relevant in selecting treatments in the metastatic setting where QoL endpoints often drive decision-making and the goal is to achieve a reasonable level of efficacy while minimizing toxicity.
Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 5035.