Tapentadol prolonged release for severe chronic cancer-related pain: effectiveness, tolerability, and influence on quality of life of the patients

Figures & data

Table 1 Baseline demographic and clinical data of the patient population (n=123)

Sexa
Male	63 (51.2%)
Female	59 (48.0%)
Age (years)b	63.9±13.2
Body mass index (kg/m^2)b	24.3±4.6
Type of cancer (ICD-10)
C00–C97 Malignant neoplasms	114 (92.7%)
C50 Breast	33 (26.8%)
C60–C63 Male genital organs	24 (19.5%)
C30–C39 Respiratory and intrathoracic organs	18 (14.6%)
C15–C26 Digestive organs	10 (8.1%)
C81–C96 Lymphoid, hematopoietic, and related tissue, stated or presumed to be primary	10 (8.1%)
C64–C68 Urinary tract	6 (4.9%)
Not specified	13 (10.6%)
D37–D48 Neoplasms of uncertain or unknown behavior	2 (1.6%)
No data	7 (5.7%)
Duration of paina
<1 year	29 (23.6%)
≥1<5 years	65 (52.9%)
≥5 years	28 (22.8%)

Notes:

a Data not available for one patient;

b data expressed as mean ± standard deviation.

Abbreviation: ICD, International Classification of Diseases.

Figure 1 Reduction of pain intensity under tapentadol prolonged release during the 3-month observation period.

Notes: *P<0.001 (descriptive, paired t-test). Data are mean ± standard deviation. Baseline visit n=122, end of observation n=112 (lowest), n=110 (average), and n=109 (highest) pain intensity. NRS-11 scale: from 0= no pain to 10= worst imaginable pain.
Abbreviation: NRS-11, 11-point numerical rating scale.

Table 2 Responder analysis. Patients experiencing treatment success regarding pain reduction (parameter average pain intensity, n=123)

Response criteria	Number of patients (%)
Pain-intensity score of ≤3 (NRS-11)	64 (52)
Pain-free state (score of 0, NRS-11)	3 (2.4)
Attainment of individual treatment target	51 (41.5)
Pain reduction of ≥2 points (NRS-11) compared to baseline	78 (63.4)
Pain reduction >30% compared to baseline	72 (58.5)
Pain reduction >50% compared to baseline	41 (33.3)
Pain reduction >70% compared to baseline	15 (12.2)

Abbreviation: NRS-11, 11-point numerical rating scale.

Table 3 Changes in quality of life and mental state during the 3-month observation (LOCF data, n=123)

	Baseline	End of observation
Anxiety and depression (HADS)
Anxiety (sum score)	11.1±4.8 (10.0–12.3)	7.6±5.0 (6.5–8.9)
Proportion of moderately to severely affected patients	48.1%	31.2%
Depression (sum score)	13.0±4.9 (11.9–14.2)	8.8±5.6 (7.5–10.1)
Proportion of moderately to severely affected patients	66.2%	37.7%
Habitual well-being (MFHW)	1.1±0.8 (0.9–1.3)	1.7±1.4 (1.4–2.0)
Proportion of patients with a score <2.5	76.6%	63.6%
Quality of life
QLIP sum score	11.6±7.3 (9.9–13.3)	15.7±9.1 (13.6–17.8)
Proportion of severely affected patients	75.3%	61%
mPDI-7 (overall quality of life)	7.0±2.3 (6.5–7.6)	4.2±3.4 (3.5–5.0)
SF-12
Physical component score	27.7±6.2 (26.1–29.3)	36.1±10.9 (33.5–38.8)
Mental component score	33.2±9.9 (30.9–35.4)	40.8±12.2 (38.1–43.6)

Notes: Data are mean ± standard deviation (95% confidence interval) or number of patients (%). SF-12 German population norms are 49.6 for the average physical sum score and 52.3 for the average mental sum score. HADS: sum score 1–7= normal, 8–10= mildly affected, 11–21= moderately to severely affected. MFHW: 0= worst possible state to 5= best possible state; <2.5= abnormal. mPDI: from 0= no impairment to 10= total impairment. QLIP: sum score from 0= most affected to 40= not affected; ≤20= severely affected.

Abbreviations: LOCF, last observation carried forward; HADS, Hospital Anxiety and Depression Scale; MFHW, Marburger Fragebogen zum habituellen Wohlbefinden [Marburg questionnaire on habitual health findings]; mPDI, modified Pain Disability Index; QLIP, Quality of Life Impairment by Pain inventory; SF, short form.

Figure 2 Changes in pain-related impairments in daily life under tapentadol prolonged release (LOCF data, n=123).

Notes: Data are mean ± standard deviation. Rating scale from 0= no impairment to 10= total impairment. mPDI-1, related to home and family; mPDI-2, recreational activities; mPDI-3, social activities; mPDI-4, occupational activities including housework or volunteering; mPDI-5, self-care; mPDI-6, sleep; mPDI-7, overall quality of life.
Abbreviations: LOCF, last observation carried forward; mPDI, modified Pain Disability Index.

Figure 3 Change in the general condition of the patients since treatment initiation with tapentadol prolonged release. Ratings were available for 112 patients (physician rating) and for 109 patients (patient rating).