Randomized Phase II Study of Gemcitabine Monotherapy vs. Gemcitabine with an EPA-Enriched Oral Supplement in Advanced Pancreatic Cancer

Figures & data

Table 1. Patient characteristics.

	EPA (N = 43)	GEM (N = 23)
	N (%)		P-value^a
Age
Median [range]	68 [48–83]	69 [42–84]	0.962
Gender
Male	22 (51.2%)	17 (73.9%)	0.114
Female	21 (48.8%)	6 (26.1%)
PS
0	23 (53.5%)	13 (56.5%)	1.000
1	18 (41.9%)	9 (39.1%)
2	2 (4.7%)	1 (4.3%)
Body weight
Median [range]	53.0 [28.8–73.8]	55.2 [43.3–72.8]	0.282
CA19-9
Median [range]	816.0 [8.0–558100.0]	579.0 [58.2–2961100.0]	0.341
Stage
III	9 (20.9%)	5 (21.7%)	1.000
IV, recurrence	34 (79.1%)	18 (78.3%)
Pancreatic resection
No	40 (93.0%)	22 (95.7%)	1.000
Yes	3 (7.0%)	1 (4.3%)
Location
Head	23 (53.5%)	12 (52.2%)	1.000
Body to tail	20 (46.5%)	11 (47.8%)
CRP
Median [range]	0.65 [0.04–7.18]	0.57 [0.03–2.82]	0.165
Albumin
Median [range]	3.8 [3.0–4.5]	3.8 [3.5–4.9]	0.165

ECOG PS: Eastern Cooperative Oncology Group performance status.

a P-values were calculated with Fisher’s exact test (F) or t-test (t).

Figure 1. A: Progression-free survival. B: Overall survival.

Figure 2. Subgroup analysis for men (OS).

Figure 3. A: Subgroup analysis for body to tail (OS). B: Subgroup analysis for body to head (OS).

Figure 4. A: Subgroup analysis for lower CRP (OS). B: Subgroup analysis for higher CRP (OS).

Table 2. Response rate.

	EPA (N = 43)		Gemcitabine (N = 23)
	N	%	N	%	P-value^a
Complete response	0	(0.0)	0	(0.0)
Partial response	2	(4.7)	2	(8.7)
Stable disease	27	(62.8)	13	(56.5)
Progressive disease	12	(27.9)	6	(26.1)
Not evaluable	2	(4.7)	2	(8.7)
Response rate	2	(4.7)	2	(8.7)	0.606
95% CI		[0.6,15.8]		[1.1,28.0]
Disease control rate	29	(67.4)	15	(65.2)	1.000
95% CI		[51.5,80.9]		[42.7,83.6]

CI: confidence interval.

a P-values were calculated with Fisher’s exact test.

Table 3. Adverse events.

	EPA (N = 43)		Gemcitabine (N = 23)		P-value^a (Any grade)
	Any grade	Grade 3–4	Any grade	Grade 3–4
Anemia	41 (95.3%)	6 (14.0%)	23 (100.0%)	2 (8.7%)	0.703
Neutropenia	28 (65.1%)	13 (30.2%)	17 (73.9%)	5 (21.7%)	0.583
Thrombocytopenia	36 (83.7%)	4 (9.3%)	20 (87.0%)	2 (8.7%)	1.000
Leukopenia	30 (69.8%)	9 (20.9%)	18 (78.3%)	3 (13.0%)	0.568
Hyponatremia	25 (58.1%)	4 (9.3%)	11 (47.8%)	1 (4.3%)	0.449
Decreased appetite	31 (72.1%)	3 (7.0%)	17 (73.9%)	0	1.000
Nausea	23 (53.5%)	5 (11.6%)	7 (30.4%)	0	0.119
Diarrhea	13 (30.2%)	0	4 (17.4%)	0	0.377
Fatigue	32 (74.4%)	0	16 (69.6%)	0	0.774
Weight loss	15 (34.9%)	0	7 (30.4%)	0	0.789
Infection	11 (25.6%)	3 (7.0%)	5 (21.7%)	3 (13.0%)	1.000
CRP elevation	5 (11.6%)	0	9 (39.1%)	0	0.013

a P-values were calculated with Fisher’s exact test for the difference in the incidence of adverse events of any grade.