Table 2.
Investigator | QOL Outcome Studied | Significant Findings |
---|---|---|
Thibault [21] | Mean QOL at 1 week, 6 weeks, 3 months, by component | ~ No clinically or statistically significant decline in QOL at final endpoint (3 months) in either QOL tool ~ Mostly stable QOL item scores (12/15 in QLQ-C15, 21/21 in QLQ-LM21) in measurements over 12 weeks ~ Increased fatigue, decreased global health status at 1 week post treatment on C15 (p = 0.049, p = 0.033); both returned to baseline at 6 weeks and 3 months |
Shun [22] | Mean QOL at 1 week pretreatment, weekly for 6 weeks during | ~ Non-clinically and non-statistically significant increase in QOL scores at 6 weeks ~ Mean symptom severity (measured on Symptom Severity Scale) increased at final endpoint ~ Mean depression (measured on POMS-D Depression subscale) increased at final endpoint ~ Functional status (p = 0.003), depression (p = 0.0001), symptom severity significantly (p = 0.0002), level of albumin (p = 0.001) associated with changes in QOL ~ Radiation dosage not significant factor in QOL during treatment |
Mendez Romero [20] | ~Mean QOL at pretreatment and 1/3/6 month ~Symptom and functional domains |
~ No statistically significant decline in mean QOL over 6 months ~ Fatigue at 1 month showed significant decline when compared baseline (p = 0.004); returned to baseline thereafter; was only functional or symptom-specific domain to show significant decline; though trends showed worsening symptoms across time points ~ Non statistically significant trend towards improvement noted at final endpoint ~ Baseline QOL of patients was lower than general population comparison group (p < 0.001) |
Klein [18] | ~ Mean QOL @ 0 1,3,6,12 months ~ Percent patients where QOL “improved” vs “Stable” vs “Worsened”), (MID = 10 on QLQ C30, vs 14 on FACT-Hep) |
~ Beyond 3 months, no significant worsening vs baseline in both tools ~ Using FACT-Hep/QLQ-C30, 54%/48% reported stable QOL, 27%/39% showed clinically significant worsening, 19%/23% showed significant improvement at 12 months post treatment ~ Significant worsening from baseline in appetite (11.7 points) and fatigue (11.0 points) at 1 month, both return to baseline by 3 months on QLQ-C30 ~ Other variables show no clinically or statistically significant change from baselines ~ Higher baseline QOL predicts improved survival in both FACT-HEP (p = 0.001) and QLQ-C30 (p = 0.012) ~ LM patients experienced statistically significantly, but not clinically significant, better quality of life at 6 months when compared to HCC (p = 0.04); no difference between LM and IHC, or IHC and HCC patients |
Law [19] | Mean QOL @ baseline, post treatment, 3, 6 months ~ MID > 5% change |
~ No statistically or clinically significant change in FACT-Hep score in all time points vs baseline, trend towards poorer QOL at final end point (p = 0.09) |