Details

Autor(en) / Beteiligte

• Hwang, Thomas J.
• Gyawali, Bishal

Titel

Association between progression‐free survival and patients’ quality of life in cancer clinical trials

Ist Teil von

• International journal of cancer, 2019-04, Vol.144 (7), p.1746-1751

Ort / Verlag

Hoboken, USA: John Wiley & Sons, Inc

Erscheinungsjahr

2019

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Quality of life outcomes provide essential information for patients and physicians in oncology care. However, the validity of progression‐free survival (PFS) as a surrogate for quality of life, and the inclusion and reporting of quality of life endpoints in clinical trials, is unclear. We performed a retrospective study of phase III clinical trials of drugs for advanced or metastatic solid tumors published between 2010 and 2015. Correlation coefficient (r) and area under the ROC curve (AUC) for association between PFS and positive quality of life were evaluated. Of the 352 Phase 3 trials included, 190 (54%) included a quality of life endpoint, of which 23% did not report pre‐specified quality of life outcomes; a total of 125,962 patients were enrolled in studies lacking, or not reporting, quality of life outcomes. Among the 147 trials that reported quality of life outcomes, 99 (67%) reported no effect, 38 (26%) reported a positive effect and 10 (7%) reported a negative effect of treatment on patients’ global quality of life. The association between PFS and improvement in global quality of life was weak (r = 0.34; AUC = 0.72), as was the association between PFS and improvement in any domain of quality of life. In conclusion, PFS benefit was not strongly correlated with improvements in patients’ quality of life, and, despite the palliative intent of treatments in the advanced/metastatic setting, the availability of quality of life data from clinical trials of cancer drugs was poor. What's new? To be a success, a cancer therapy must do more than keep the patient alive, but how is that tested? These authors evaluated how quality of life was studied in Phase 3 clinical trials for cancer drugs. Progression‐free survival is often substituted for overall survival when judging treatments, but can it also stand in for quality of life? The authors looked at 353 Phase 3 trials, and only about half included a quality of life endpoint. They found that PFS only weakly correlated with quality of life, and they urge greater inclusion of quality of life outcomes in future trials.