Comparison of gemcitabine plus nab-paclitaxel and FOLFIRINOX in metastatic pancreatic cancer

doi:10.12998/wjcc.v8.i17.3718

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World Journal of Clinical Cases

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World J Clin Cases. Sep 6, 2020; 8(17): 3718-3729
Published online Sep 6, 2020. doi: 10.12998/wjcc.v8.i17.3718

Table 1 Baseline patients’ characteristics, n (%)

Variable	GA (n = 54)	FOLFIRINOX (n = 47)	P value
Age (yr)	65.7 ± 7.8	64.4 ± 8.4	0.445
Male	39 (72.2)	31 (66.0)	0.501
Body weight (kg)	59.2 ± 9.5	58.5 ± 9.9	0.716
Height (m)	1.65 ± 0.08	1.63 ± 0.07	0.352
Body mass index (kg/m²)	21.9 ± 3.1	22.0 ± 3.5	0.852
Psoas muscle area (cm²)	8.6 ± 2.9	8.3 ± 2.1	0.639
Number of metastasis ≥ 2	48 (88.9)	35 (74.5)	0.060
Liver meta	32 (59.3)	31 (66.0)	0.493
Carcinomatosis peritonei	21 (38.9)	16 (34.0)	0.618
Lung meta	13 (24.1)	8 (17.0)	0.389
Primary tumor site			0.778
Head	25 (46.3)	25 (53.2)
Body	14 (25.9)	8 (17.0)
Tail	15 (27.8)	14 (29.8)
ECOG performance status			0.018^a
0 or 1	48 (88.9)	47 (100)
2	6 (11.1)	0 (0)
Diabetes	22 (40.7)	23 (48.9)	0.414
Hypertension	12 (22.2)	12 (25.5)	0.700
Laboratory findings
White blood cell (/µL)	6465.6 ± 2743.0	9780.0 ± 16931.6	0.159
Platelet (10³/µL)	235.9 ± 122.4	270.1 ±107.7	0.142
Neutrophil/lymphocyte ratio	3.72 ± 2.98	3.0 ± 1.87	0.167
Pletelet/lymphocyte ratio	190.2 ± 120.7	159.5 ± 71.0	0.129
C-related protein (mg/dL)	1.49 ± 2.23	1.29 ± 2.00	0.641
Albumin (g/dL)	3.92 ± 0.46	3.98 ± 0.57	0.552
Total bilirubin (mg/dL)	1.41 ± 3.06	1.42 ± 1.60	0.988
CA 19-9 (U/mL)	12881.3 ± 54407.2	1307.1 ± 2079.1	0.153

^aP < 0.05, mean ± SD. GA: Gemcitabine plus nab-paclitaxel; ECOG: Eastern Cooperative Oncology Group; CA: Carbohydrate antigen.

Table 2 Result of chemotherapy response of each regimen, n (%)

	GA (n = 54)	FOLFIRINOX (n = 47)	P value
Best response			0.216
PR	10 (18.5)	5 (10.6)
SD	35 (64.8)	31 (66.0)
PD	9 (16.7)	11 (23.4)
DCR (PR + SD)	45 (83.3)	36 (76.6)	0.402
Dose reduction	41 (75.9)	32 (68.1)	0.385
Delivery dose (%)	78.9 ± 16.5	87.3 ± 11.6	0.005^b
Total over 80% dose	24 (44.4)	30 (65.2)	0.038^a
Duration of chemotherapy (mo)	2.33 (1.43-3.24)	1.63 (1.19-2.08)	0.005^b
Progression free survival (mo)	6.43 (4.43-8.43)	4.90 (4.44-5.36)	0.058
Overall survival (mo)	10.17 (6.03-14.31)	6.93 (5.32-8.54)	0.008^b
2^nd Chemotherapy	24 (44.4)	19 (40.4)	0.687
TS-1	15 (27.8)	1 (2.1)
Gemcitabine mono	0 (0)	12 (25.5)
GA	0 (0)	5 (10.6)
FOLFIRINOX	3 (5.6)	0 (0)
Onyvide	1 (1.9)	0 (0)
5-FU base	5 (9.3)	1 (2.1)
2^nd chemotherapy PFS (mo)	3.23 (2.55-3.91)	2.70 (1.56-3.84)	0.191

^aP < 0.05,

^bP < 0.01, mean ± SD; median (95%CI). GA: Gemcitabine plus nab-paclitaxel; PR: Partial response; SD: Stable disease; PD: Progression disease; DCR: Disease control rate; TS-1: Tegafur/gimeracil/oteracil; 5-FU: 5-fluorouracil; PFS: Progression-free survival.

Table 3 Result in subgroup analysis (neutrophil/lymphocyte ratio)

	NLR ≥ 3 (n = 43)			NLR < 3 (n = 58)			P value
	GA (n = 24)	FFX (n = 19)	P value	GA (n = 30)	FFX (n = 28)	P value	P value
PFS (mo)	3.83 (3.19-4.47)			7.60 (6.51-8.69)			0.000^b
PFS (mo)	3.40 (2.76-4.04)	4.40 (2.65-6.15)	0.676	8.10 (5.06-11.14)	6.57 (3.38-9.76)	0.008^b
OS (mo)	4.47 (2.80-6.14)			10.87 (9.22-12.52)			0.001^b
OS (mo)	3.87 (2.79-4.95)	5.33 (3.87-6.80)	0.648	12.87 (10.41-15.33)	9.93 (5.91-13.95)	0.002^b

^bP < 0.01, median (95%CI). NLR: Neutrophil/lymphocyte ratio; PFS: Progression free survival; OS: Overall survival; GA: Gemcitabine plus nab-paclitaxel; FFX: FOLFIRINOX.

Table 4 Prognosis according to response of neutrophil/lymphocyte ratio

Before chemotherapy > post chemotherapy	Post chemotherapy NLR < 3n = 62		Post chemotherapy NLR ≥ 3n = 39		P value
Before chemotherapy > post chemotherapy	Low > Low,n = 47	High > Low,n = 15	Low > High,n = 11	High > High,n = 28	P value
PFS, median mo (95%CI)	7.20 (6.07-8.33)		3.47 (2.81-4.13)		0.000^b
PFS, median mo (95%CI)	7.60 (6.42-8.79)	5.63 (3.14-8.12)	5.77 (2.29-9.26)	3.33 (3.16-3.50)	0.000^b
OS, median mo (95%CI)	10.87 (9.16-12.58)		4.47 (3.37-5.57)		0.002^b
OS, median mo (95%CI)	11.4 (9.93-12.87)	8.00 (2.45-13.55)	7.63 (3.10-12.16)	7.40 (4.49-10.31)	0.001^b
GA regimen	24 (51.1)	8 (53.3)	6 (54.5)	16 (57.1)	0.112
DCR	43 (91.5)	14 (93.3)	8 (72.7)	16 (57.1)	0.000^b

^bP < 0.01, median (95%CI). Low, LNR < 3; high, NLR ≥ 3; Post chemotherapy, evaluation at 1^st tumor response of chemotherapy, LNR: Neutrophil/lymphocyte ratio; PFS: Progression free survival; OS: Overall survival; GA: Gemcitabine plus nab-paclitaxel; DCR: Disease control rate.

Table 5 Result in subgroup analysis (Eastern Cooperative Oncology Group)

	ECOG = 0 (n = 52)			ECOG = 1 (n = 43)			ECOG = 2 (n = 6)			P value
	GA (n = 25)	FFX (n = 27)	P value	GA (n = 23)	FFX (n = 20)	P value	GA (n = 6)	FFX (n = 0)	P value	P value
PFS (mo)	6.60 (4.28-8.92)			3.90 (2.46-5.34)			3.27 (0.00-8.12)			0.003^b
PFS (mo)	8.93 (4.64-13.22)	5.43 (4.58-6.28)	0.002^b	3.87 (2.03-5.71)	4.40 (1.84-6.96)	0.511	3.27 (0.00-8.12)	NA	NA
OS (mo)	10.77 (6.26-15.28)			6.27 (4.26-8.28)			4.47 (0.00-14.00)			0.000^b
OS (mo)	16.10 (10.50-21.70)	6.97 (3.53-10.41)	0.000^b	6.10 (3.31-8.89)	6.27 (2.76-9.78)	0.674	4.47 (0.00-14.00)	NA	NA

^bP < 0.01, mean ± SD. NA: Not-availiable; ECOG: Eastern Cooperative Oncology Group; PFS: Progression free survival; OS: Overall survival; GA: Gemcitabine plus nab-paclitaxel; FFX: FOLFIRINOX.

Table 6 Adverse events of each regimen

Adverse events	GA (n = 54), n (%)	FOLFIRINOX (n = 47), n (%)	P value
Admission	18 (33.3)	18 (38.3)	0.608
Thromboembolism	3 (5.6)	9 (19.1)	0.035^a
Neuropathy (Grade 1,2/3,4)	28 (51.9) (11/17)	11 (23.4) (10/1)	0.000^b
Neutropenia (Grade 1,2/3,4)	38 (70.4) (12/26)	35 (74.5) (10/25)	0.496
Thrombocytopenia (Grade 1,2/3,4)	22 (40.7) (13/9)	17 (36.2) (6/11)	0.893
Nausea (Grade 1,2/3,4)	11 (20.4) (9/2)	22 (46.8) (18/4)	0.008^b
Fatigue (Grade 1,2/3,4)	31 (57.4) (19/12)	26 (55.3) (17/9)	0.740
Diarrhea (Grade 1,2/3,4)	10 (18.5) (7/3)	12 (25.5) (7/5)	0.322
Colitis/pneumonia	11 (20.4) (4/7)	13 (27.7) (7/6)	0.616

^aP < 0.05,

^bP < 0.01. GA: Gemcitabine plus nab-paclitaxel.

Citation: Han SY, Kim DU, Seol YM, Kim S, Lee NK, Hong SB, Seo HI. Comparison of gemcitabine plus nab-paclitaxel and FOLFIRINOX in metastatic pancreatic cancer. World J Clin Cases 2020; 8(17): 3718-3729
URL: https://www.wjgnet.com/2307-8960/full/v8/i17/3718.htm
DOI: https://dx.doi.org/10.12998/wjcc.v8.i17.3718