Introduction
Patients and methods
Study design
Data collection
Medication adherence
Erlotinib AUC
Questionnaires
Patients’ medical file
Statistics
Results
Baseline characteristics
T0 |
T1 |
T2 |
T3 |
T4 | |
---|---|---|---|---|---|
Patients on treatment | 62 | 49 | 29 | 17 | 15 |
Adherence MEMS | 55 | 45 | 27 | 16 | 14 |
Blood sample | x | 42 | 28 | x | 13 |
Questionnaire | 62 | 47 | 27 | 17 | 14 |
MEMS + blood sample | x | 39 | 26 | x | 12 |
MEMS + questionnaire | 55 | 44 | 25 | 16 | 13 |
Blood sample + questionnaire | x | 41 | 26 | x | 12 |
MEMS + blood sample + questionnaire | x | 39 | 24 | x | 11 |
n
a
| % | |
---|---|---|
Age median (years) | 62 | 63.5 |
Range | 46–80 | |
Male | 62 | 53.2 |
Low education | 60 | 40.0 |
Living alone | 62 | 14.5 |
Paid work | 58 | 17.2 |
Smoking | 62 | 19.4 |
Co-morbidity | 61 | 65.6 |
Co-medication | 62 | 82.3 |
Number of drugs | 51 | |
Mean ± SD | 5.0 ± 2.8 | |
Range | 1–13 | |
Initial erlotinib dose 150 mg | 60 | 98.3 |
Duration of use (days) | 62 | |
Mean ± SD | 58.3 ± 39.4 | |
Range | 2–120b
|
Medication adherence
n
| Mean ± SD | Median | Range | |
---|---|---|---|---|
Duration of use (days) | 55 | 60.2 ± 38.8 | 52.0 | 6.0–120.0 |
PDC | 55 | 96.8 ± 4.0 | 98.0 | 85.0–100.0 |
PDC (period 0–28 days) | 55 | 97.5 ± 5.0 | 100.0 | 71.4–100.0 |
PDC (period 29–56 days) | 39 | 96.5 ± 6.4 | 100.0 | 71.4–100.0 |
PDC (period 57–max 120 days) | 25 | 95.2 ± 6.7 | 100.0 | 75.0–100.0 |
PDMO | 34 | 5.6 ± 4.8 | 4.1 | 1.0–21.2 |
% | ||
---|---|---|
100 % PDC | 55 | 43.6 |
≥95 % PDC | 55 | 65.5 |
≥90 % PDC | 55 | 92.7 |
Quality of life and patients’ beliefs and attitude
Symptoms
n
| % any | % severea
| % increaseb
| |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
T0 |
T1 |
T2 |
T3 |
T4 |
T0 |
T1 |
T2 |
T3 |
T4 |
T1 |
T2 |
T3 |
T4 | |
62 | 49 | 29 | 17 | 15 | 62 | 49 | 29 | 17 | 15 | 49 | 29 | 17 | 15 | |
Fatigue | 88.5 | 90.9 | 82.6 | 88.2 | 84.6 | 26.2 | 31.8 | 17.4 | 17.6 | 23.1 | 21.7 | 52.2 | 58.8 | 53.8 |
Rash | 14.8 | 81.8 | 87.0 | 82.4 | 84.6 | 3.3 | 38.6 | 30.4 | 29.4 | 38.5 | 81.8 | 81.8 | 81.3 | 91.7 |
Anorexia | 54.8 | 70.5 | 60.9 | 52.9 | 61.5 | 8.1 | 20.5 | 21.7 | 23.5 | 15.4 | 39.1 | 39.1 | 35.3 | 23.1 |
Diarrhoea | 19.4 | 65.9 | 65.2 | 52.9 | 76.9 | 1.6 | 11.4 | 13.0 | 17.6 | 15.4 | 56.5 | 52.2 | 52.9 | 69.2 |
Ocular symptoms | 26.2 | 59.1 | 39.1 | 35.3 | 69.2 | 0 | 4.5 | 4.3 | 0 | 0 | 36.4 | 22.7 | 18.8 | 41.7 |
Nausea/vomiting | 23.0 | 51.2 | 30.4 | 23.5 | 23.1 | 6.6 | 14.6 | 4.3 | 5.9 | 0 | 33.3 | 28.6 | 12.5 | 8.3 |
Stomatitis | 3.3 | 22.0 | 14.3 | 29.4 | 38.5 | 0 | 7.3 | 4.8 | 5.9 | 7.7 | 16.7 | 11.1 | 31.3 | 41.7 |
Infection | 1.7 | 11.6 | 8.7 | 17.6 | 41.7 | 0 | 2.3 | 0 | 5.9 | 8.3 | 0.0 | 4.5 | 18.8 | 36.4 |
Cough | 70.0 | 76.7 | 77.3 | 64.7 | 53.8 | 5.0 | 9.3 | 9.1 | 0 | 23.1 | 20.0 | 35.0 | 12.5 | 33.3 |
Dyspnoea | 71.0 | 65.9 | 60.9 | 64.7 | 66.7 | 9.7 | 18.2 | 8.7 | 17.6 | 25.0 | 26.1 | 39.1 | 41.2 | 41.7 |
Sleep problems | 47.5 | 45.5 | 39.1 | 53.3 | 46.2 | 13.1 | 28.6 | 4.3 | 13.3 | 15.4 | 13.6 | 13.6 | 26.7 | 23.1 |
Emotional symptoms | 74.1 | 67.4 | 56.5 | 70.6 | 69.2 | 13.6 | 13.6 | 4.3 | 5.9 | 15.4 | 33.3 | 28.6 | 40.0 | 36.4 |
Stomach ache | 23.0 | 37.2 | 43.5 | 47.1 | 30.8 | 4.9 | 2.3 | 0 | 0 | 0 | 19.0 | 38.1 | 37.5 | 25.0 |
Headache | 31.3 | 20.5 | 21.7 | 11.8 | 30.8 | 3.3 | 0 | 0 | 0 | 0 | 4.5 | 9.1 | 6.3 | 16.7 |
Pain when breathing | 13.1 | 14.0 | 17.4 | 25.0 | 15.4 | 0 | 0 | 0 | 0 | 7.7 | 0.0 | 13.6 | 13.3 | 8.3 |
(n = 29) |
T0 |
T1 |
T2 | |||
---|---|---|---|---|---|---|
% any | % severe | % any | % severe | % any | % severe | |
Fatigue | 82.6 | 25.0 | 87.0 | 20.7 | 82.6 | 17.4 |
Rash | 9.1 | 0 | 86.4 | 24.7 | 86.4 | 30.4 |
Anorexia | 56.5 | 3.4 | 73.9 | 13.8 | 60.9 | 21.7 |
Diarrhoea | 17.4 | 0 | 69.6 | 10.3 | 65.2 | 13.0 |
Ocular symptoms | 22.7 | 0 | 54.5 | 3.4 | 36.4 | 4.3 |
Nausea/vomiting | 19.0 | 7.1 | 38.1 | 10.7 | 28.6 | 4.3 |
Stomatitis | 0.0 | 0 | 16.7 | 3.7 | 11.1 | 4.8 |
Infection | 0.0 | 0 | 0.0 | 0 | 4.5 | 0 |
Cough | 70.0 | 7.4 | 75.0 | 7.1 | 75.0 | 9.1 |
Dyspnoea | 65.2 | 6.9 | 52.2 | 10.3 | 60.9 | 8.7 |
Sleep problems | 50.0 | 10.7 | 40.9 | 10.3 | 40.9 | 4.3 |
Emotional symptoms | 76.2 | 7.7 | 57.1 | 10.3 | 57.1 | 4.3 |
Stomach ache | 4.8 | 0 | 23.8 | 3.6 | 42.9 | 0 |
Headache | 31.8 | 0 | 22.7 | 3.4 | 18.2 | 0 |
Pain when breathing | 18.2 | 0 | 4.5 | 0 | 13.6 | 0 |
T1 | PRO | Clinical triala
|
p value | ||
---|---|---|---|---|---|
n
| % |
n
| % | ||
Fatigue | 44 | 90.9 | 485 | 79 | 0.075 |
Rash | 44 | 81.8 | 485 | 76 | 0.461 |
Anorexia | 44 | 70.5 | 485 | 69 | 0.057 |
Diarrhoea | 44 | 65.9 | 485 | 55 | 0.205 |
Ocular symptoms | 44 | 59.1 | 485 | 28 | <0.001* |
Nausea/vomiting | 41 | 51.2 | 485 | 40 | 0.186 |
Stomatitis | 41 | 22.0 | 485 | 19 | 0.679 |
Infection | 43 | 11.6 | 485 | 34 | <0.001* |
Adherence and use in daily practice
N = 41 | OR | 95 % CI |
p value |
---|---|---|---|
Male | 1.20 | 0.30–4.80 | 0.797 |
Age | 1.10 | 1.00–1.21 | 0.041* |
Low education | 3.00 | 0.69–13.12 | 0.144 |
Living alone | 0.50 | 0.05–4.83 | 0.549 |
No paid work | 2.86 | 0.31–26.74 | 0.356 |
No smoking | 1.54 | 0.15–15.49 | 0.715 |
No Co-morbidity | 2.80 | 0.68–11.59 | 0.155 |
Number of co-medication | 0.96 | 0.75–1.22 | 0.717 |
N = 40 | OR | 95 % CI |
p value |
---|---|---|---|
SF-12 | |||
Physical component | 1.00 | 0.99–1.01 | 0.959 |
Mental component | 1.02 | 1.00–1.04 | 0.079 |
BMQ | |||
General overuse | 0.97 | 0.92–1.02 | 0.279 |
General harm | 0.97 | 0.92–1.03 | 0.306 |
Specific necessity | 1.01 | 0.97–1.04 | 0.774 |
Specific concerns | 0.99 | 0.97–1.02 | 0.593 |
Necessity-concerns differential | 1.00 | 0.99–1.02 | 0.564 |
Brief IPQ | |||
Consequences | 1.01 | 0.97–1.04 | 0.691 |
Time line | 1.01 | 0.96–1.07 | 0.588 |
Personal control | 0.97 | 0.94–1.00 | 0.085 |
Treatment control | 1.03 | 0.96–1.11 | 0.374 |
Identity | 1.02 | 0.97–1.06 | 0.417 |
Concern | 0.97 | 0.94–1.01 | 0.124 |
Understanding | 0.98 | 0.95–1.02 | 0.313 |
Emotional response | 0.99 | 0.96–1.02 | 0.449 |
MARS < 25 | 4.83 | 1.06–21.99 | 0.042* |
No reminder method | 2.79 | 0.52–14.82 | 0.229 |
Patient-reported symptom (any severity) | |||
Rash | 2.52 | 0.44–14.21 | 0.295 |
Anorexia | 0.36 | 0.11–1.20 | 0.097 |
Diarrhoea | 8.16 | 0.43–154.09 | 0.161 |
Ocular symptoms | 3.13 | 1.11–8.82 | 0.031* |
Nausea/vomiting | 0.62 | 0.13–3.02 | 0.554 |
Stomatitis | 6.59 | 1.77–24.60 | 0.005* |
Infection | 1.18 | 0.12–12.02 | 0.891 |
Cough | 0.32 | 0.08–1.25 | 0.102 |
Dyspnoea | 5.69 | 0.83–38.87 | 0.076 |
Sleep problems | 0.59 | 0.15–2.32 | 0.454 |
Stomach ache | 1.69 | 0.44–6.50 | 0.445 |
Headache | 0.95 | 0.18–4.99 | 0.956 |
Pain when breathing | 0.49 | 0.08–3.04 | 0.443 |
AUC
(n = 41) | No symptom AUC (µg*h/mL) | Symptom AUC (µg*h/mL) |
p value | ||
---|---|---|---|---|---|
Symptom |
n
| Mean ± SD |
n
| Mean ± SD | |
Fatigue | 4 | 26.2 ± 3.0 | 34 | 39.3 ± 2.8 | 0.074 |
Rash | 7 | 27.8 ± 4.7 | 31 | 40.2 ± 2.8 | 0.030* |
Anorexia | 11 | 32.4 ± 4.8 | 27 | 40.2 ± 3.0 | 0.082 |
Diarrhoea | 14 | 35.5 ± 4.4 | 24 | 39.4 ± 3.2 | 0.520 |
Ocular symptoms | 18 | 39.6 ± 4.6 | 20 | 36.4 ± 2.6 | 0.919 |
Nausea/vomiting | 16 | 33.6 ± 2.7 | 19 | 42.3 ± 4.4 | 0.286 |
Stomatitis | 28 | 36.8 ± 2.6 | 8 | 43.3 ± 8.4 | 0.614 |
Infection | 33 | 38.3 ± 2.9 | 4 | 34.8 ± 6.0 | 0.944 |
Cough | 7 | 35.2 ± 3.6 | 30 | 39.3 ± 3.1 | 0.747 |
Dyspnoea | 13 | 32.7 ± 3.4 | 25 | 40.7 ± 3.4 | 0.188 |
Sleep problems | 20 | 35.6 ± 2.9 | 18 | 40.6 ± 4.4 | 0.534 |
Emotional symptoms | 11 | 34.3 ± 4.6 | 26 | 39.7 ± 3.2 | 0.256 |
Stomach ache | 23 | 38.6 ± 3.9 | 15 | 36.9 ± 2.9 | 0.768 |
Headache | 31 | 37.4 ± 3.0 | 7 | 40.3 ± 5.0 | 0.354 |
Pain when breathing | 31 | 38.8 ± 3.1 | 6 | 36.9 ± 2.5 | 0.888 |