CHICAGO—Understanding quality of life (QoL) and the detrimental impact of disease progression is critical for long-term care and survival of patients with soft-tissue sarcoma (STS), according to a new study presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 3–7 in Chicago.
STS is a rare group of heterogeneous mesenchymal cancers, with an annual incidence of 2 to 3 diagnoses for every 100,000 persons. Median survival time in patients with metastatic STS is usually less than 12 months, with only a small subgroup of these patients achieving long-term survival.
Studies indicate that STS and its treatment negatively impact patient health-related QoL. “As a patient’s disease progresses, symptoms become more severe. This could be treatment-specific,” said lead author Stacie Hudgens, managing partner of Clinical Outcomes in Tucson, Arizona, in an interview.
Hudgens led the study, abstract 11015, which compared eribulin, a microtubule-dynamics inhibitor, to dacarbazine (DTIC), an alkylating agent, and was designed to better understand treatment-related differences in QoL among STS patients who experienced disease progression. Health-related QoL was determined using the European Organisation for Research and Treatment of Cancer QLQ-C30; any change greater than 10 points was considered meaningful.
Differences in health-related QoL between treatment arms and histology type were compared using a multi-factor analysis of variance.
A total of 452 patients were randomized into this phase III clinical trial. The evaluation included 400 patients with progressive disease: 209 patients in the eribulin arm and 191 patients in the DTIC arm. Compared to baseline QoL scores, patients on DTIC had significantly lower global health status scores (56.1) compared with those on eribulin (62.1).
Physical function, nausea, vomiting, and appetite loss were significantly worse in the DTIC arm of the trial. “Patients had a greater than 10-point change in mean on DTIC and overall scores in role functioning—the ability to do every-day activities—at progression. DTIC patients also had a greater than 10-point increase in fatigue and appetite loss,” Hudgens said.
Similar results were observed in the histology subpopulations with adipocytic and leiomyosarcoma, she noted.
“Overall, results indicate significant difference in health-related QoL between DTIC and eribulin, with notably higher increases in symptom severity in fatigue, nausea, vomiting, and appetite loss,” said Hudgens. “These results suggest that health-related QoL is a relevant consideration when selecting therapies among patients with advanced STS.”
Significant differences between treatment arms were also observed in functional scales. Patients in the eribulin arm reported significantly higher levels of global health status and physical functioning.
“Clearly, we want to make patients live longer and do better,” said ASCO discussant Paolo G. Casali, MD, professor of medicine at the University of Milan in Italy. “QoL assessment may provide more data to inform patients at the time of clinical decision.”