Multiple effectiveness aspects of tapentadol for moderate–severe cancer-pain treatment: an observational prospective study

Figures & data

Table 1 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Consenting patients aged >18 years	Unable to provide informed consent
Life expectancy >3 months	Drug abuse/alcoholism
Pain intensity: NRS ≥5	Renal (GFR < 30 mL/min/1.73 m^2) or liver impairment*
No severe cognitive impairment	No malignant chronic pain syndromes
Male/female patients	Severe respiratory failure (PaO2<50 mmHg), untreated asthma, OSA
Opioid-naïve or opioid-experienced	Acute pancreatitis or biliary-tract disease
	Paralytic ileus
	IBD
	NYHA >3
	Recent ACS (6 months)
	Recent stroke, head injury (1 year)
	Medication: MAOI
	Nursing mothers
	Lactose intolerance

Notes:

* ALAT >45 U/L; ASAT >35 U/L; ALP >105 U/L; GT >45 U/L (age 18–39 years) or GT>75 U/L (age over 39 years).

Abbreviations: ACS, acute coronary syndrome; GFR, glomerular filtration rate; IBD, inflammatory bowel disease; MAOI, monoamine oxidase inhibitors; NRS, numeric rating scale; NYHA, New York Heart Association; OSA, obstructive sleep apnea.

Table 2 Baseline demographic and clinical data (n=80)

Sex, n (%)
Male	37 (46.2)
Female	43 (53.8)
Age (mean ± SD)	63.3±12.5
Weight*	72.8±11.8
Tumor type, n (%)
Lung	15 (18.8)
Breast	14 (17.5)
Gastrointestinal	23 (28.8)
Urological	10 (12.5)
Head/neck	4 (5)
Gynecological	2 (2.5)
Others#	12 (15)
Stage of disease, n (%)
Initial	9 (11.2)
Under treatment	33 (41.2)
Relapsed/progression	38 (47.6)
Previous analgesic therapy (n/%)
Opioid-naïve	76 (95)
Opioid-experienced	4 (5)
Other analgesic§	20 (25)
ECOG performance status (n/%)
0	1 (1.2)
1	17 (21.2)
2	34 (42.5)
3	23 (28.8)
4	0
5	0
Not available	5 (6.2)
Concomitant anticancer therapy, n (%)
Chemotherapy	30 (37.5)
Radiotherapy	14 (17.5)
Others	2 (2.5)
No therapy	34 (42.5)
Comorbidities, n (%)ç	16 (20)
Previous surgery, n (%)	11 (13.8)
Duration of pain^ (mean ± SD)	4.4±3.2

Note:

* Data not available for seven patients;

# melanoma (2), pancreas (1), bone (2), hematologic (2), not specified (5);

^ expressed in months;

§ NSAIDs 12.5%, acetaminophen 8.8%, others 3.8%;

ç cardiovascular 6.2%, hepatic 1.2%, renal 3.8%, others 8.8%.

Abbreviations: ECOG, Eastern Cooperative Oncology Group; NSAIDs, nonsteroidal anti-inflammatory drugs.

Figure 1 Primary end point.

Figure 2 Regression analysis showed that no covariate tested was significant.

Abbreviations: ECOG, Eastern Cooperative Oncology Group; NRS, numeric rating scale.

Figure 3 Survival analysis: median time to response 65 days.

Figure 4 Pain intensity.

Notes: Pain-intensity reductions were statistically significant compared to T₀ for all evaluations (*P<0.01).
Abbreviation: NRS, numeric rating scale.

Figure 5 Pain-intensity differences.

Note: During the study, pain-intensity difference progressively increased, although never reached significance.

Figure 6 TP-dosage trend.

Note: Mean TP dosage increased in the course of the study. SD: 89.0 (T₀), 81.6 (T₁), 86.0 (T₂), 113.1 (T₃), 137.1 (T₄).
Abbreviation: TP, tapentadol.

Figure 7 NeP analysis.

Notes: The percentage of patients with NeP progressively decreased during the study. At the last evaluation compared to baseline, the difference was significant (*P<0.01).
Abbreviations: DN, Douleur Neuropathique; NeP, neuropathic pain.

Figure 8 Evaluation of quality of life (QOL).

Note: QOL progressively increased from the beginning of the study (P<0.01).