Efficacy and tolerability of oral oxycodone and oxycodone/naloxone combination in opioid-naïve cancer patients: a propensity analysis

Figures & data

Figure 1 Patient flow during the study.

Abbreviation: WHO, World Health Organization.

Table 1 Baseline characteristics of the study population

	Total (n=146)	Oxycodone (n=73)	Oxycodone + naloxone (n=73)	P-value
Age (years)	62.1±13.2	63.3±10.3	62.7±15.3	NS
Male, n (%)	76 (52.1)	35 (47.9)	41 (56.2)	NS
Primary tumor site, n (%)
Pulmonary	28 (19.2)	12 (16.4)	16 (21.9)	NS
Breast	18 (12.3)	11 (15.1)	7 (9.6)	NS
Prostate	12 (8.2)	7 (9.6)	5 (6.8)	NS
Genitourinary	12 (8.2)	4 (5.5)	8 (10.9)	NS
Head and neck	12 (8.2)	6 (8.2)	6 (8.2)	NS
Pancreas	11 (7.5)	5 (6.8)	6 (8.2)	NS
Myeloma	11 (7.5)	6 (8.2)	5 (6.8)	NS
Lymphoma	9 (6.2)	3 (4.1)	6 (8.2)	NS
Gynecologic	8 (5.6)	7 (9.6)	1 (1.7)	NS
Gastrointestinal	7 (4.8)	5 (6.8)	2 (2.7)	NS
Liver	4 (2.8)	2 (2.8)	2 (2.7)	NS
Others	14 (9.6)	5 (6.8)	9 (12.3)	NS
Bone metastasis, n (%)	39 (26.7)	24 (32.9)	15 (20.5)	0.17
Pain intensity, NRS score	7.3±1.5	7.3±1.6	7.3±1.4	NS
Neuropathic pain*, n (%)	113 (77.4)	61 (83.6)	52 (71.2)	0.08
DN4 inventory	4.9±1.4	4.7±1.4	5.0±1.2	NS
Previous WHO primary analgesics, n (%)
None	77 (52.7)	28 (38.3)	49 (67.1)	0.001
NSAIDs	48 (32.8)	32 (43.8)	16 (21.9)	<0.05
Paracetamol	21 (14.3)	13 (17.8)	8 (10.9)	NS
Rescue pain medication, n (%)	20 (13.7)	12 (16.4)	8 (11.0)	NS
Paracetamol**	14 (9.6)	9 (12.3)	5 (6.8)
Opioids***	6 (4.1)	3 (4.1)	3 (4.1)
Adjuvant pain medication
Pregabalin, n (%)	95 (65.1)	47 (64.4)	48 (65.8)	NS
Pregabalin dose (mg/d)	27.2±6.4	27.1±6.8	27.5±6.3	NS
Other drugs, n (%)	15 (10.3)	11 (15.0)	4 (5.4)	NS
CPSI score	33.3±14.4	33.1±16.2	33.2±12.6	NS
SF12 MCS score	27.2±6.4	27.1±6.8	27.5±6.3	NS
SF12 PCS score	30.5±5.2	30.4±4.9	30.6±5.5	NS
BFI score	26.5±26.8	27.1±25.8	25.5±27.8	NS
BFI >29, n (%)	73 (50.0)	38 (52.1)	35 (47.9)	NS
Laxative use, n (%)	41 (28.1)	21 (28.8)	20 (27.4)	NS
Oxycodone starting dose (mg/d)	11.7±4.3	12.0±4.4	11.5±4.3	NS

Notes: Values are mean ± standard deviation or number of patients (%).

* Includes neuropathic and mixed nociceptive–neuropathic pain.

** Paracetamol 1,000 mg.

*** Immediate-release oral morphine 10 mg or transmucosal fentanyl 100 μg.

Abbreviations: BFI, Bowel Function Index; CPSI, Chronic Pain Sleep Inventory; DN4, Douleur Neuropathique 4; NRS, numerical rating scale; NS, not significant; NSAIDs, nonsteroidal anti-inflammatory drugs; SF12 MCS, Mental Component Summary of the Short Form-12 Health Survey Questionnaire; SF12 PCS, Physical Component Summary of the Short Form-12 Health Survey Questionnaire; WHO, World Health Organization.

Figure 2 Average pain intensity (score on an 11-point NRS) during treatment with OXY and OXN.

Notes: P-values: within groups over time, <0.001; between groups, 0.90; interaction, 0.91. T0= baseline, T15= day 15, T30= day 30, and T60= day 60.

Abbreviations: NRS, numerical rating scale; OXN, oxycodone/naloxone; OXY, oxycodone.

Figure 3 OXY and OXN mean daily dosages during the study.

Note: T0= baseline, T15= day 15, T30= day 30, and T60= day 60.
Abbreviations: OXN, oxycodone/naloxone; OXY, oxycodone.

Table 2 Summary of quality of life endpoints and comparison between groups

	Oxycodone (n=73)	Oxycodone + naloxone (n=73)	P-value
CPSI score
Baseline	33.1±16.2	33.2±12.6	NS
Day 60	57.1±17.6	60.3±16.5	NS
Difference	24.0±22.4	27.2±15.5	NS
SF12 MCS score
Baseline	27.1±6.8	27.4±6.4	NS
Day 60	37.4±8.3	38.3±5.1	0.01
Difference	10.3±8.9	10.9±7.0	NS
SF12 PCS score
Baseline	30.4±4.9	30.6±5.5	NS
Day 60	33.6±4.5	37.6±5.0	<0.001
Difference	3.2±6.1	7.1±5.7	<0.001

Note: Values are mean ± standard deviation.

Abbreviations: CPSI, Chronic Pain Sleep Inventory; NS, not significant; SF12 MCS, Mental Component Summary of the Short Form-12 Health Survey Questionnaire; SF12 PCS, Physical Component Summary of the Short Form-12 Health Survey Questionnaire.

Table 3 Summary of intestinal function endpoints and comparison between groups

	Oxycodone (n=73)	Oxycodone + naloxone (n=73)	P-value
BFI score
Baseline	27.1±25.8	25.5±27.8	NS
Day 30	40.3±29.3	12.1±16.5
Day 60	41.0±27.5	9.5±13.4
Baseline to day 30 difference	13.2±17.9	−13.4±16.7	<0.001
Baseline to day 60 difference	13.8±19.7	−16.0±19.2	<0.001
Laxative use, % of patients
Baseline	28.8	21.9	NS
Day 30	26.0	17.8
Day 60	24.6	8.2
Baseline to day 30 difference	−2.8	−4.1	NS
Baseline to day 60 difference	−4.2	−13.7	0.08
Laxative use, times per week
Baseline	4.5±1.4	4.3±1.9	NS
Day 30	5.5±1.6	1.8±0.8
Day 60	5.4±1.7	1.2±0.4
Baseline to day 30 difference	0.5±1.4	−2.2±1.7	<0.001
Baseline to day 60 difference	0.7±1.8	−3.5±2.4	<0.001

Note: Values are mean ± standard deviation, or percentage of patients.

Abbreviations: BFI, Bowel Function Index; NS, not significant.

Table 4 Summary of moderate-to-severe adverse drug reactions

	Oxycodone (n=73)	Oxycodone + naloxone (n=73)	P-value
Nausea	9 (12.3)	2 (2.7)	0.06
Vomiting	4 (5.5)	2 (2.7)	NS
Abdominal pain	1 (1.4)	0	NS
Dizziness	1 (1.4)	0	NS
Sleepiness	3 (4.1)	1 (1.4)	NS
Headache	1 (1.4)	0	NS
Asthenia	0	1 (1.4)	NS
Insomnia	1 (1.4)	0	NS
Itch	1 (1.4)	0	NS
Total	21 (28.9)	6 (8.2)	0.002

Note: Values are number of patients (%).

Abbreviation: NS, not significant.