Quality of Life of Older Patients With Early-Stage Breast Cancer Receiving Adjuvant Chemotherapy: A Companion Study to Cancer and Leukemia Group B 49907

Abstract

Purpose A phase III trial (Cancer and Leukemia Group B CALGB-49907) was conducted to test whether older patients with early-stage breast cancer would have equivalent relapse-free and overall survival with capecitabine compared with standard chemotherapy. The quality of life (QoL) substudy tested whether capecitabine treatment would be associated with a better QoL than standard chemotherapy. Patients and Methods QoL was assessed in 350 patients randomly assigned to either standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil [CMF] or doxorubicin and cyclophosphamide [AC]; n = 182) or capecitabine (n = 168). Patients were interviewed by telephone before treatment (baseline), midtreatment, within 1 month post-treatment, and at 12, 18, and 24 months postbaseline by using questionnaires from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), a breast systemic adverse effects scale (EORTC BR23), and the Hospital Anxiety and Depression Scale (HADS). Results Compared with patients who were treated with standard chemotherapy, patients who were treated with capecitabine had significantly better QoL, role function, and social function, fewer systemic adverse effects, less psychological distress, and less fatigue during and at the completion of treatment (P ≤ .005). Capecitabine treatment was associated with less nausea, vomiting, and constipation and with better appetite than standard treatment (P ≤ .004), but worse hand-foot syndrome and diarrhea (P < .005). These differences all resolved by 12 months. Conclusion Standard chemotherapy was superior to capecitabine in improving relapse-free and overall survival for older women with early-stage breast cancer. Although capecitabine was associated with better QoL during treatment, QoL was similar for both groups at 1 year. The brief period of poorer QoL with standard treatment is a modest price to pay for a chance at improved survival.

Tumor biology in older breast cancer patients – What is the impact on survival stratified for guideline adherence? A retrospective multi-centre cohort study of 5378 patients

“…In the oBCP, side effects have led to a number of publications on treatment efficacy [19,21,24,40], consenting [23], quality of life [18,25], increasing the rate of therapy completion [17] and preoperative chemotherapy [41]. Our study follows up on these findings.…”

Adjuvant chemotherapy in elderly patients with primary breast cancer: are women ≥65 undertreated?

“…In particular, hormone receptor-positive, node-negative women appeared to derive the greatest benefit from chemotherapy. Of note, while quality of life was decreased during treatment with the more aggressive regimen due to its higher toxicity, quality of life 1 year after treatment was the same in both arms of the study (Kornblith et al 2011). …”

Comorbidity, Chemotherapy Toxicity, and Outcomes Among Older Women Receiving Adjuvant Chemotherapy for Breast Cancer on a Clinical Trial: CALGB 49907 and CALGB 361004 (Alliance)

“…A companion study (CALGB-70103) examined quality of life outcomes and captured selfreported comorbidity data before therapy. 4,5 We hypothesized that women with a greater number of comorbid conditions would experience more treatment toxicity during adjuvant chemotherapy, a shorter time to relapse (TTR), and reduced overall survival (OS). We also postulated that the impact of comorbid conditions on daily function, rather than the actual number of conditions, would better predict treatment toxicity, and that specific comorbid conditions would be differentially associated with clinical outcomes.…”