Product information and disease description Place of product in therapy Disease description Burden of Adenoid cystic carcinoma with solid histology or high-grade transformation

Humanistic burden and health-related quality of life

11 evidence topics · 5 sources

Summary: health-related quality of life

The only ACC-specific HRQoL study identified used the EQ-5D-5L in 161 participants (563 questionnaires, 2019 to 2023) at an experimental medicine center: median EQ-5D value was 0.81 (mean 0.79) and median visual analogue scale score was 70, and a decrease in value from 1 to 0 was associated with an eightfold increase in the risk of death. The mean value of 0.79 is below the age-matched general population mean of 0.86. Utility declined significantly over time, and adding NOTCH1 status, primary site, sex, age, recurrence status, or type of recurrence to the time model did not improve its fit, so no clinical predictor of decline was identified. In a 5-year prospective cohort of 252 participants with salivary gland cancer (all histologies), 41 (16.2%) had a declining quality-of-life trajectory and 79 (31.3%) had delayed recovery; recurrence, worse baseline pain, female sex, and older age were associated with unstable trajectories. The only interventional HRQoL data in recurrent or metastatic ACC come from the lenvatinib phase II trial, in which general quality-of-life scores fell by more than 10 points from baseline to 6 months for role functioning, global health, fatigue, pain, and diarrhea and by more than 10 points to 12 months for those domains plus physical functioning, social functioning, and appetite loss; head and neck scores fell by more than 10 points for sexuality, dry mouth, sticky saliva, coughing, and weight gain; EQ-5D-derived utilities ranged from 0.7 to 0.9 across the 12 months; and health status was below that of the general Italian population at every time point. No HRQoL data were identified separately for solid or high-grade transformation ACC.

EQ-5D-5L utility values and association with mortality in ACC

“Between 2019 and 2023, 161 patients with ACC were identified who had completed at least one EQ-5D-5L questionnaire. A total of 563 EQ5D-5L questionnaires were completed with a median of two responses per patient (range 1 to 20).” (opens the source at this quote in a new tab)
“At the time of analysis, 41 % had died.” (opens the source at this quote in a new tab)
“These subgroups were well represented in this study, with 40 % local recurrence (14 % local recurrence only; 26 % local and metastatic recurrence) and 72 % metastatic recurrence (46 % metastatic recurrence only; 26 % both local and metastatic recurrence) for the 86 % of patients with recurrent disease (139/161).” (opens the source at this quote in a new tab)
“For all 161 patients, median EQV was 0.81 (range −0.22 to 1.0) and mean EQV was 0.79.” (opens the source at this quote in a new tab)
“For patients with ACC, a poorer QoL, as measured by EQ-5D-5L, was associated with a significantly increased risk of death. It remains unclear whether poorer QoL is a surrogate marker of increasing disease burden or whether there is a causal relationship with mortality. NOTCH1 status and pattern of disease recurrence were not associated with a poorer QoL in this cohort.” (opens the source at this quote in a new tab)

Quality-of-life trajectories over 5 years after salivary gland cancer treatment

“Among 252 participants, three QoL trajectories were identified: Stable Good (n = 132, 52.4%), Declining (n = 41, 16.2%), and Delayed Recovery (n = 79, 31.3%). Female sex, older age, worse baseline pain score, and recurrence were significantly associated with an unstable trajectory of QoL.” (opens the source at this quote in a new tab)
“The Declining group experienced deterioration in role, cognitive, and social functioning, along with increased fatigue, pain, and head-and-neck-specific symptoms.” (opens the source at this quote in a new tab)

Long-term quality of life in salivary gland cancer survivors

“Dry mouth is a frequent and disturbing problem in SGC survivors.” (opens the source at this quote in a new tab)

Patient counseling: risk of late recurrence and need for long-term follow-up

“Upon diagnosis, the patient should be counseled regarding the slow-growing and locally aggressive nature of the tumor.” (opens the source at this quote in a new tab)
“The patient should, however, be educated about the possibility of recurrence of the malignancy even as late as more than 5 years after the initial surgery, so periodic medical follow-up should be reinforced.” (opens the source at this quote in a new tab)

Quality-of-life instruments and assessment schedule in the lenvatinib phase II trial

“The head and neck–specific EORTC QLQ-H&N35 module contains 35 items that can be condensed into 7 multi-item and 11 single-item scales. Both questionnaires result in scales that score from 0 to 100. For the function scales, a score of 100 indicates perfect QOL, whereas for the symptom scales it would indicate a heavy burden. A difference of 10 points is considered to approximately indicate minimal important clinical differences.” (opens the source at this quote in a new tab)
“Health status was measured using the EuroQol (European Quality of Life) Five Dimension Five Level Scale (EQ-5D-5L).” (opens the source at this quote in a new tab)
“We defined the following QOL domains a priori to be of primary interest for this study: Physical Functioning, Global Quality of Life, Fatigue, Swallowing, and Dry Mouth.” (opens the source at this quote in a new tab)
“These scores were calculated for baseline (t1), 3 months (t3), 6 months (t6), 9 months (t9), and 12 months (t12).” (opens the source at this quote in a new tab)

Quality-of-life change over 12 months of lenvatinib treatment in recurrent or metastatic ACC

“Changes in general QOL between baseline and t6 were >10 points for Role Functioning, Global Health, Fatigue, Pain, and Diarrhea. Changes between baseline and t12 were >10 points for Physical Functioning, Role Functioning, Social Functioning, Global Health, Fatigue, Pain, and Appetite Loss (Fig. 1).” (opens the source at this quote in a new tab)
“Head and neck–specific QOL deteriorated between t1 and t6 by >10 points in the domains of Sexuality, Dry Mouth, Sticky Saliva, Coughing, and Weight Gain (Fig. 2).” (opens the source at this quote in a new tab)
“Mean self-rated health was 67.3 at t1, 62.3 at t3, 62.3 at t6, 66.4 at t9, and 63.3 at t12. The utilities derived from the health profiles ranged from 0.7 (at t3) to 0.9 (at t9) (see Supporting Table 5). Compared with the general Italian population, the health status was found to be decreased at all time points (see Supporting Fig. 3).” (opens the source at this quote in a new tab)

EQ-5D value score by decile in 161 participants with ACC

Decile	EQ-5D value
Mean	“0.79”
1st	“0.57”
2nd	“0.68”
3rd	“0.75”
4th	“0.78”
5th (median)	“0.81”
6th	“0.86”
7th	“0.88”
8th	“0.92”
9th	“0.94”

EQ-5D-5L scale interpretation, visual analogue scale, and comparison with the age-matched general population

“An EQV of 1 equates to perfect QoL, whilst an EQV of 0 is a state considered comparable to death.” (opens the source at this quote in a new tab)
“Median VAS was 70 (IQR 30 80).” (opens the source at this quote in a new tab)
“The mean EQV of 0.79 for patients with ACC is lower than the age-matched general population mean of 0.86” (opens the source at this quote in a new tab)

Decline in quality of life over time and absence of clinical predictors

“This is the first study to characterise the baseline QoL in the ACC population outside of an interventional clinical trial. We have demonstrated that QoL does significantly decrease over time in patients with ACC, but have identified no other significant risk factors for deteriorating QoL.” (opens the source at this quote in a new tab)
“Clinical variables including NOTCH1 status, location of primary site, sex, age, recurrence status and type of recurrence were evaluated by incorporating them into variant models, tested against the time model as a base (Table S1). No variant model with an additional clinical variable significantly improved the fit of the base model, suggesting the other variables do not have a significant impact on QoL (Table S1).” (opens the source at this quote in a new tab)
“No significant differences in QoL were observed between different patterns of recurrence; local recurrence was not demonstrated to have a significantly different QoL to metastatic recurrence, or both types of recurrence together. Furthermore, origin of primary site (major salivary glands or other sites) did not show a significant difference in QoL.” (opens the source at this quote in a new tab)

EQ-5D-5L values reported in an interventional study of lenvatinib in ACC

“Mean EQV at baseline was reported at 0.8, comparable with our findings, whilst they also found that QoL decreased over the study period of 12 months to a mean EQV of 0.7.” (opens the source at this quote in a new tab)
“However, the results of this study must be interpreted with caution as Locati et al only reported EQV to a single decimal place.” (opens the source at this quote in a new tab)