Clinical outcomes of second-line chemotherapy in patients with advanced pancreatic adenocarcinoma: a real-world study

Yuxiao Liu; Xiaofan Guo; Peijun Xu; Yuning Song; Jing Huang; Xingyun Chen; Wenbo Zhu; Jihui Hao; Song Gao

doi:10.20892/j.issn.2095-3941.2024.0036

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Figure 1
Flow chart.
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Figure 2
Kaplan–Meier curves for OS and PFS. (A) OS of 5-fluorouracil combined regimen group vs. single 5-fluorouracil group for second-line therapy. (B) OS of Gem-based combined regimen group vs. single Gem group for second-line therapy. (C) PFS of 5-fluorouracil combined regimen group vs. single 5-fluorouracil group for second-line therapy. (D) PFS of Gem-based combined regimen group vs. single Gem group for second-line therapy.
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Figure 3
Kaplan–Meier curves for OS and PFS. (A) OS of combined regimen group vs. single 5-fluorouracil/single Gem group for second-line therapy. (B) PFS of combined regimen group vs. single 5-fluorouracil/single Gem group for second-line therapy.
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Figure 4
Kaplan–Meier curves for OS. (A) OS of 5-fluorouracil-based regimen vs. Gem-based regimen group for first-line therapy. (B) OS of receiving second-line chemotherapy group vs. supportive care only group.
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Figure 5
Forest plot of PFS (A) and OS (B).

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Table 1

Patients’ characteristics

Clinicopathologic variables	Total (%)	5-FU-based for first-line therapy (%)	Gem-based for first-line therapy (%)	P
n	1,054	437	617
Age (years)
≤ 63	574 (54.5)	215 (49.2)	359 (58.2)	0.005*
> 63	480 (45.5)	222 (50.8)	258 (41.8)
Gender
Female	472 (44.8)	205 (46.9)	267 (43.3)	0.268
Male	582 (55.2)	232 (53.1)	350 (56.7)
ECOG performance status
0–2	818 (77.6)	349 (79.9)	469 (76.0)	0.161
≥ 3	236 (22.4)	88 (20.1)	148 (24.0)
CA19-9 (U/mL)
≤ 200	460 (43.6)	179 (41.0)	281 (45.5)	0.157
> 200	594 (56.4)	258 (59.0)	336 (54.5)
Primary tumor size (cm)
≤ 4	527 (50.0)	210 (48.1)	317 (51.4)	0.317
> 4	527 (50.0)	227 (51.9)	300 (48.6)
Metastatic lesion size [mean (SD), cm]
	3.06 (1.30)	2.99 (1.33)	3.11 (1.27)	0.145
Location
Pancreas other than the pancreatic head	357 (33.9)	141 (32.3)	216 (35.0)	0.389
Pancreatic head	697 (66.1)	296 (67.7)	401 (65.0)
Distant metastasis
Absent	97 (9.2)	40 (9.2)	57 (9.2)	> 0.999
Present	957 (90.8)	397 (90.8)	560 (90.8)
Liver metastasis
Absent	374 (35.5)	173 (39.6)	201 (32.6)	0.023*
Present	680 (64.5)	264 (60.4)	416 (67.4)
Lung metastasis
Absent	740 (70.2)	303 (69.3)	437 (70.8)	0.651
Present	314 (29.8)	134 (30.7)	180 (29.2)
Bone metastasis
Absent	933 (88.5)	385 (88.1)	548 (88.8)	0.794
Present	121 (11.5)	52 (11.9)	69 (11.2)
Peritoneal metastasis
Absent	804 (76.3)	336 (76.9)	468 (75.9)	0.752
Present	250 (23.7)	101 (23.1)	149 (24.1)
Lymph node metastasis
Absent	635 (60.2)	272 (62.2)	363 (58.8)	0.294
Present	419 (39.8)	165 (37.8)	254 (41.2)
Optimal effect
PD	293 (27.8)	116 (26.5)	177 (28.7)	0.745
PR	105 (10.0)	44 (10.1)	61 (9.9)
SD	656 (62.2)	277 (63.4)	379 (61.4)

ECOG, Eastern Cooperative Oncology Group performance status before second-line therapy; PD, progressive disease; PR, partial response; SD, stable disease. ^*P < 0.05 was considered statistically significant.

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Table 2

Baseline characteristics of different second-line therapy subgroups

Clinicopathologic variables	Total	Gem-based regimen for second-line treatment subgroup		P	Total	5-FU-based regimen for second-line treatment subgroup		P
Clinicopathologic variables	Total	Combined regimen (%)	Single Gem (%)	P	Total	Combined regimen (%)	Single 5-FU (%)	P
n	344	280	64		453	348	105
Age (years)
≤ 63	173 (50.3)	147 (52.5)	26 (40.6)	0.115	266 (58.7)	199 (57.2)	67 (63.8)	0.273
> 63	171 (49.7)	133 (47.5)	38 (59.4)		187 (41.3)	149 (42.8)	38 (36.2)
Gender
Female	148 (43.0)	123 (43.9)	25 (39.1)	0.569	208 (45.9)	162 (46.6)	46 (43.8)	0.702
Male	196 (57.0)	157 (56.1)	39 (60.9)		245 (54.1)	186 (53.4)	59 (56.2)
CA19-9 (U/mL)
≤ 200	146 (42.4)	115 (41.1)	31 (48.4)	0.350	218 (48.1)	171 (49.1)	47 (44.8)	0.500
> 200	198 (57.6)	165 (58.9)	33 (51.6)		235 (51.9)	177 (50.9)	58 (55.2)
Primary tumor size (cm)
≤ 4	182 (52.9)	152 (54.3)	30 (46.9)	0.351	239 (52.8)	178 (51.1)	61 (58.1)	0.255
> 4	162 (47.1)	128 (45.7)	34 (53.1)		214 (47.2)	170 (48.9)	44 (41.9)
Metastatic lesion size (cm)
≤ 4	194 (56.4)	157 (56.1)	37 (57.8)	0.909	237 (52.3)	184 (52.9)	53 (50.5)	0.749
> 4	150 (43.6)	123 (43.9)	27 (42.2)		216 (47.7)	164 (47.1)	52 (49.5)
Metastatic lesion size [mean (SD), cm]
	2.94 (1.34)	2.93 (1.31)	2.98 (1.46)	0.780	3.04 (1.25)	3.04 (1.24)	3.01 (1.27)	0.806
Location
Pancreas other than the pancreatic head	116 (33.7)	92 (32.9)	24 (37.5)	0.574	159 (35.1)	122 (35.1)	37 (35.2)	> 0.999
Pancreatic head	228 (66.3)	188 (67.1)	40 (62.5)		294 (64.9)	226 (64.9)	68 (64.8)
Distant metastasis
Absent	38 (11.0)	33 (11.8)	5 (7.8)	0.488	49 (10.8)	41 (11.8)	8 (7.6)	0.306
Present	306 (89.0)	247 (88.2)	59 (92.2)		404 (89.2)	307 (88.2)	97 (92.4)
Liver metastasis
Absent	148 (43.0)	123 (43.9)	25 (39.1)	0.569	164 (36.2)	126 (36.2)	38 (36.2)	> 0.999
Present	196 (57.0)	157 (56.1)	39 (60.9)		289 (63.8)	222 (63.8)	67 (63.8)
Lung metastasis
Absent	240 (69.8)	196 (70.0)	44 (68.8)	0.964	338 (74.6)	265 (76.1)	73 (69.5)	0.172
Present	104 (30.2)	84 (30.0)	20 (31.2)		115 (25.4)	83 (23.9)	32 (30.5)
Bone metastasis
Absent	288 (83.7)	242 (86.4)	56 (87.5)	0.133	411 (90.7)	312 (89.7)	99 (94.3)	0.214
Present	56 (16.3)	38 (13.6)	8 (12.5)		42 (9.3)	36 (10.3)	6 (5.7)
Peritoneal metastasis
Absent	265 (77.0)	221 (78.9)	44 (68.8)	0.114	345 (76.2)	263 (75.6)	82 (78.1)	0.689
Present	79 (23.0)	59 (21.1)	20 (31.2)		108 (23.8)	85 (24.4)	23 (21.9)
Lymph node metastasis
Absent	215 (62.5)	171 (61.1)	44 (68.8)	0.208	268 (59.2)	205 (58.9)	63 (60.0)	0.931
Present	129 (37.5)	109 (38.9)	20 (31.2)		185 (40.8)	143 (41.1)	42 (40.0)

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Table 3

Univariate and multivariate Cox regression analyses for OS in the entire cohort

Clinicopathologic variables	Univariate analysis		Multivariate analysis
Clinicopathologic variables	HR (95% CI for HR)	P	HR (95% CI for HR)	P
Age
> 63 years/≤ 63 years	1.089 (0.953–1.270)	0.128	-	-
Gender
Female/male	0.942 (0.834–1.090)	0.454	-	-
Location
Pancreatic head/pancreas other than the pancreatic head	1.014 (0.902–1.186)	0.605	-	-
Chemotherapy first-line
Gem-based/5-FU-based	1.244 (1.090–1.419)	< 0.001	1.428 (1.261–1.621)	< 0.001
Chemotherapy second-line
Receiving chemotherapy/supportive care only	0.766 (0.677–0.867)	< 0.001	0.232 (0.149–0.361)	< 0.001
ECOG performance status
≥ 3/0–2	5.348 (4.566–6.289)	< 0.001	1.222 (0.780–1.912)	0.381
Distant metastasis
Yes/no	1.675 (1.357–2.068)	< 0.001	1.533 (1.240–1.895)	< 0.001
Primary tumor size
> 4 cm/≤ 4 cm	0.930 (0.824–1.050)	0.241	-	-
Metastatic lesion size
> 4 cm/≤ 4 cm	0.926 (0.820–1.045)	0.211	-	-
Liver metastasis
Yes/no	1.358 (1.196–1.542)	< 0.001	1.235 (1.085–1.406)	0.001
Lung metastasis
Yes/no	1.032 (0.904–1.178)	0.645	-	-
Bone metastasis
Yes/no	1.170 (0.967–1.415)	0.106	-	-
Peritoneal metastasis
Yes/no	1.139 (0.988–1.314)	0.072	-	-
Lymph node metastasis
Yes/no	1.133 (1.001–1.283)	0.048	1.107 (0.977–1.254)	0.112
CA19-9
> 200 U/mL/≤ 200 U/mL	1.360 (1.205–1.565)	< 0.001	1.304 (1.151–1.477)	< 0.001