Oxycodone/Acetaminophen: The Tailoring Combination Treatment for Specific Clinical Profile of Opioid Well-Responsive Cancer Pain

Figures & data

Table 1 The General Characteristics of the Population Treated with OxyIR/Par for Background Pain Alone (Group A, n=120) and in Combination with Other Opioid Drugs (Group B, n=59)

		Group A (120)	Group B (59)
Gender^a	Male	68 (56.7%)	31 (52.5%)
	Female	52 (43.3%)	28 (47.5%)
Age (years)^a	Median (IQR)	68 (59, 75)	67 (62, 75)
	Mean (95% CI)	66.7 (64.7–68.8)	66.5 (63.2–69.7)
Karnofsky^b	Median (IQR)	70 (60, 80)	50 (45, 70)^b
	Mean (95% CI)	70.3 (67.2–73.5)	58.3 (53.4–63.2)^b
Setting^b	Oncology	61 (50.8%)	13 (22.0%)^b
	Pain therapy	43 (35.8%)	15 (25.4%)
	Radiotherapy	0 (0.0%)	2 (3.4%)
	Palliative care	16 (13.3%)	29 (49.2%)^b
Place of visit^b	Hospital inpatient	27 (22.5%)	5 (8.5%)^b
	Outpatients	66 (55.0%)	20 (33.9%)^b
	Day hospital	11 (9.2%)	8 (13.6%)
	Hospice	2 (1.7%)	1 (1.7%)
	Home care	14 (11.7%)	25 (42.4%)^b
Primary tumor^a	Lung	36 (30.0%)	11 (18.6%)
	Gastrointestinal^c	23 (19.2%)	7 (11.9%)
	Breast	19 (15.8%)	9 (15.3%)
	Pancreas	6 (5.0%)	4 (6.8%)
	Urological	5 (4.2%)	6 (10.2%)
	Prostate	8 (6.7%)	11 (18.6%)
	Head-neck	10 (8,3%)	2 (3.4%)
	Gynecologic	2 (1.7%)	3 (5.1%)
	Hematological	5 (4.2%)	2 (3.4%)
Disease^a	Locoregional	29 (24.2%)	10 (17.0%)
	Metastatic	96 (80.0%)	53 (89.8%)
Metastases^a	Liver	26 (21.7%)	16 (27.1%)
	Abdominal lymph nodes	13 (10.8%)	8 (13.6%)
	Chest lymph nodes	17 (14.2%)	10 (16.9%)
	Bones	60 (50.0%)	33 (55.9%)
	Peritoneum	7 (5.8%)	1 (1.7%)
	Lungs	21 (17.5%)	14 (23.7%)
	CNS	0 (0.0%)	3 (5.1%)
	Adrenal	2 (1.7%)	2 (3.4%)
	Other	13 (10.8%)	1 (11.9%)

Notes: ^aP>0.05 (group A vs group B). ^bP<0.001 (group A vs group B). ^cGastrointestinal includes: esophagus, stomach, colonic, rectum, anus, liver and biliary cancers.

Table 2 Background Pain and BTcP Characteristics in the Population Treated Only with OxyIR/Par for Background Pain (n=120) and in Combination with Other Opioid Drugs (n=59)

		Group A (n=120)	Group B (n=59)
Background pain	Median (IQR)	3 (3, 4)	3 (2, 4)
Intensity during last week^a	Mean (95% CI)	3.2 (3.0–3.3)	2.9 (2.7–3.2)
Background pain	Median (IQR)	3 (2, 4)	3 (2, 4)
Intensity on day of assessment^a	Mean (95% CI)	3.3 (3.0–3.6)	3.2 (2.6–3.7)
Pain duration (months)	Median (IQR)	1.8 (1.0–2.6)	1.1 (0.6–3.1)
	Mean (95% CI)	2.6 (2.0–3.2)	3.5 (1.6–5.3)
BGP Pain sites^a	Abdominal	31 (25.8%)	10 (16.9%)
	Lower limbs	19 (15.8%)	11 (18.6%)
	Pelvis	10 (8.3%)	12 (20.3%)
	Cervical spine	7 (5.8%)	6 (10.2%)
	Dorsal spine	23 (19.2%)	13 (22.0%)
	Lumbar spine	26 (21.7%)	22 (37.3%)
	Sacral spine	6 (5.0%)	4 (6.8%)
	Chest	29 (24.2%)	8 (13.6%)
Pain type^a	Mixed	68 (56.7%)	34 (57.6%)
	Neuropathic	20 (16.7%)	2 (3.4%)
	Nociceptive	32 (26.6%)	23 (39.0%)
Pain therapy taken from [months]^a	Median (IQR)	0.8 (0.4–1.3)	1.0 (0.3–2.0)
	Mean (95% CI)	1.2 (0.9–1.5)	2.0 (1.0–3.1)
BTP (episodes/day)^a	Median (IQR)	2 (2–3)	2 (2–3)
	Mean (95% CI)	2.5 (2.3–2.8)	2.9 (2.4–3.4)
BTP Intensity (NRS)^b	Median (IQR)	7 (7–8)	8 (7–9)
	Mean (95% CI)	7.5 (7.2–7.7)	7.9 (7.6–8.2)^b
BTP duration (days)^a	Median (IQR)	15 (7–27)	6 (3–11)
	Mean (95% CI)	21.9 (14.6–29.2)	21.0 (3.6–38.6)
Predominant BTP type^a	Not predictable	85 (70.8%)	37 (62.7%)
	Predictable	35 (29.2%)	22 (37.3%)
Spike reaching time^c	≤10 minutes	98 (81.7%)	35 (59.3%)^c
	>10 minutes	22 (18.3%)	24 (40.7%)^c
Type of BTP^a	Mixed	69 (57.5%)	31 (52.5%)
	Neuropathic	19 (15.8%)	2 (3.4%)
	Nociceptive	32 (26.7%)	26 (44.1%)
Trigger event (if predictable)^a	Ingestion of food	7 (5.8%)	3 (5.1%)
	Stool	1 (0.8%)	1 (1.7%)
	Movement	22 (18.3%)	15 (25.4%)
	Procedures	3 (2.5%)	1 (1.7%)
	Cough	2 (1.7%)	3 (5.1%)
BTcP Pain sites^a	Abdominal	28 (23.3%)	9 (15.3%)
	Lower limbs	17 (14.2%)	12 (20.3%)
	Pelvis	10 (8.3%)	12 (20.3%)
	Dorsal spine	20 (16.7%)	10 (16.9%)
	Lumbar spine	29 (24.2%)	17 (28.8%)
	Chest	31 (25.8%)	7 (11.9%)

Notes: ^aP>0.05 (group A vs group B). ^bP=0.04. ^cP<0.002 (group A vs group B).

Abbreviations: BGP, background pain; BTcP, breakthrough cancer pain.

Table 3 Treatment Characteristics in the Population Treated Only with OxyIR/Par for Background Pain (n=120) and in Combination with Other Opioid Drugs (n=59)

		Group A (120)	Group B (59)
Other opioids		0	59 (100%)
Hydromorphone			1 (1.7%)
Morphine slow release			1 (1.7%)
Oxycodone slow release			6 (10.2%)
Codeine+acetaminophen			3 (5.1%)
Oxycodone+naloxone			26 (44.1%)
Tapentadol			2 (3.4%)
Tramadol			2 (3.4%)
Morphine IR			2 (3.4%)
Fentanyl TD			17 (28.8%)
Buprenorphine TD			2 (3.4%)
Non-opioid	No	98 (81.7%)	48 (81.3%)
analgesics drugs^a	Yes	22 (18.3%)	11 (18,7%)
Drugs^c	NSAID	12 (10.0%)	6 (10.2%)
	COXIB	1 (0.8%)	0 (0.0%)
	Paracetamol	10 (8.3%)	5 (8.5%)
OxyIR/Par	No	115 (95.8%)	44 (74.6%)
as needed^a	Yes	5 (4.2%)	15 (25.4%)
OxyIR/Par dose	Median (IQR)	10 (5, 15)	10 (7.5, 20)
(mg)^a	Mean (95% CI)	12.0 (10.5–13.4)	13.1 (11.0–15.1)
N of	1	1 (0.8%)	17 (28.8%)
administration/die^a	2	47 (39.2%)	17 (28.8%)
	3	55 (45.8%)	18 (30.5%)
	4	13 (10.8%)	6 (10.2%)
	5	0 (0.0%)	1 (1.7%)
	6	4 (3.3%)	0 (0.0%)
	Median (IQR)	3 (2, 3)	2 (1, 3)
	Mean (95% CI)	2.8 (2.6–3.0)	2.3 (2.0–2.5)
Mean daily oxycodone dose of	Median (IQR)	30 (20–40)	20 (10–50)
OxyIR/Par^a	Mean (95% CI)	32.7 (28.6–36.8)	31.4 (24.7–38.0)
Mean opioid doses	Median (IQR)	45 (30–60)	119 (75–153)^b
OME (mg)^b	Mean (95% CI)	49.1 (42.9–55.2)	168.7 (115.1–222.3)^b

Notes: ^aP>0.05 (group A vs group B). ^bP<0.001 (group A vs group B). Patients could receive more than one non-opioid treatment.

Table 4 Adverse Reaction Reported by the Population Treated Only with OxyIR/Par for Background Pain (n=120) and in Combination with Other Opioid Drugs (n=59)

	Group A (120)	Group B (59)
No adverse events	28 (96.5%)	26 (100.0%)
Adverse events	1 (3.5%)	0 (0.0%)
Missing	91	33
Headache	0 (0%)	0 (0%)
Mental confusion	0 (0%)	0 (0%)
Nausea	0 (0%)	0 (0%)
Constipation	1 (0.8%)	0 (0%)
Other	0 (0%)	0 (0%)