Capecitabine Impact on QOL Significant in Patients With Metastatic Breast Cancer

September 1, 2004

The 30 reports in this special supplement to Oncology News International represent highlights of ongoing major clinical trials and new research presented at ASCO 2004 regarding state-of-the-art chemotherapeutic management of gastrointestinal and other cancers. Important developments in capecitabine as adjuvant therapy, novel targeted agents, and new combinations are discussed.

JAU SAO PAULO, Brazil-"Capecitabine (Xeloda) confers extensivequality of life [QOL] benefitswith significant and substantial im-provement of almost all functional andsymptomatic measures in patients withmetastatic breast cancer [MBC]," reportedJose G. M. Segalla, MD, a medicaloncologist at Fundaco AmaralCarvalho, Jau Sao Paulo, Brazil (abstract8130). In a multicenter study,he and colleagues from other hospitalsand cancer centers in Brazil monitoredQOL in more than 600 MBCpatients treated with oral capecitabine."Capecitabine has proven efficacyand favorable safety as monotherapyin MBC and improves survival whenadded to docetaxel [Taxotere] in firstlinetherapy," Dr. Segalla said. "However,clinical outcomes need to be balancedwith patient QOL. Patientpreference for oral therapy is well documented.QOL data add to understandingthe potential benefits ofcapecitabine."For the study, 611 patients withMBC were treated with oral capecitabine(1,250 mg/m2 twice daily ondays 1-14 every 3 weeks). All patientshad previous treatment with anthracyclines,and some had prior treatmentwith taxanes.QOL was evaluated at baseline,before cycle 1 of capecitabine, at weeks7 and 13, and at treatment end usingtwo EORTC (European Organisationfor Research and Treatment of Cancer)questionnaires, QLQ-C30 (v3.0)and QLQ-BR23. The proportion ofpatients with improvement, stabilization,or worsening of QOL scoreswas determined from week 7.Improvement was defined as a 10-point or greater improvement in functionalscores or symptom scores onone or more visits. Worsening QOLwas defined as a 10-point or greaterdecrease in functional scores or a10-point increase in symptom scoresat one or more visits.Majority ImprovedDr. Segalla said 81% of patientscompleted the QOL questionnairesat week 7, compared with 58% atweek 13 and 44% at the end of treatment.Almost all QOL domains improvedwith capecitabine treatment,the investigators found (see Table 1).On most scales, more than 70% ofpatients had stable or improved QOLscores. At least 40% of patients reportedimprovements from week 7onwards in pain, fatigue, emotionalfunctioning, arm symptoms (lymphe-dema), global health status, role functioning,and future perspective. QOLimprovements were greatest in patientswho had the worst ECOG (EasternCoopertative Oncology Group) per-formance status (≥ 3) at baseline."When cure is no longer feasible inthe treatment of MBC, maintenanceof QOL is important. The optimal palliativetreatment should provide highefficacy with as little toxicity as possible,and it should improve QOL," Dr.Segalla said. "The efficacy, safety, andconvenience benefits of capecitabineallow patients with MBC to maintaina normal lifestyle, and they have adirect impact on QOL. The QOL benefitsof capecitabine are particularlyimportant when choosing appropriatetherapy for patients with incurableMBC."