The Efficacy and Safety of PD-1 Inhibitors Combined with Nab-Paclitaxel Plus Gemcitabine versus Nab-Paclitaxel Plus Gemcitabine in the First-Line Treatment of Advanced Pancreatic Cancer: A Retrospective Monocentric Study

Figures & data

Table 1 Baseline Characteristics

Characteristics		Number (%)		P
		AG Group	PD-1+AG Group
Gender	Male	16(51.6%)	10(58.8%)	0.632
	Female	15(48.4%)	7(41.2%)
Age	≤60	11(35.48%)	20(64.52%)	0.119
	>60	10(58.82%)	7(41.18%)
ECOG	0–1	26(83.9%)	12(70.6%)	0.476
	2	5(16.1%)	5(29.4%)
Surgery	Yes	16(51.6%)	9(52.9%)	0.161
	No	15(48.4%)	8(47.1%)
Location	Head	17(54.8.7%)	8(47.1%)	0.281
	Body	8(25.8%)	6(35.3%)
	Tail	6(19.4%)	3(17.6%)
Metastatic	Local recurrence	5(16.2%)	2(11.8%)	0.413
	Liver	6(19.4%)	7(41.2%)
	Retroperitoneal lymph node	8(25.8%)	2(11.8%)
	Multiple metastases	12(38.7%)	6(35.3%)
KRAS	Mutant type	24(77.4%)	12(70.6%)	0.862
	Wild type	7(22.6%)	5(29.4%)

Figure 1 Next generation sequencing heat map of 48 patients.

Table 2 KRAS/TP53 Co-Mutation Patients (N = 20)

ID	KRAS Mutation			TP53 Mutation
	Mutation Site	Mutation Subtypes	Mutation Frequency	Mutation Site	Mutation Subtypes	Mutation Frequency
P01	Exon 2	p.G12V	19.48%	Exon 10	Nonsense mutations	27.93%
P02	Exon 2	p.G12D	23.83%	Exon 7	Missense mutation	23.46%
P03	Exon 2	p.G12D	15.91%	Exon 7	Missense mutation	20.87%
P04	Exon 2	p.G12D	17.49%	Exon 5	Missense mutation	5.94%
P05	Exon 2	p.G12V	26.00%	Exon 5	Missense mutation	33.10%
P06	Exon 4	p.K117N	24.10%	Exon 8	Missense mutation	10.50%
P07	Exon 2	p.G12V	5.25%	Exon 4	Frameshift mutation	28.10%
P08	Exon 2	p.G12V	18.50%	Exon 8	Missense mutation	26.90%
P09	Exon 2	p.G12V	39.27%	Exon 2	Missense mutation	21.75%
P10	Exon 2	p.G12D	34.84%	Exon 8	Nonsense mutations	51.33%
P11	Exon 2	p.G12V	5.75%	Exon 9	Frameshift mutation	3.97%
P12	Exon 2	p.G12D	7.63%	Exon 5	Missense mutation	12.23%
P13	Exon 2	p.G12V	4.95%	Exon 7	Missense mutation	4.72%
P14	Exon 2	p.G12C	3.71%	Exon 3	Frameshift mutation	7.64%
P15	Exon 2	p.G12D	14.78%	Exon 6	Missense mutation	8.63%
P16	Exon 2	p.G12V	5.52%	Exon 6	Frameshift mutation	7.28%
P17	Exon 2	p.G12D	7.30%	Exon 6	Nonsense mutations	6.50%
P18	Exon 2	p.G12V	18.90%	Exon 5	Missense mutation	27.20%
P19	Exon 2	p.G12V	17.80%	Exon 5	Frameshift mutation	2.60%
P20	Exon 2	p.G12D	31.50%	Exon 5	Missense mutation	73.20%

Figure 2 Comparison of efficacy between the two groups. (A) Efficacy evaluation results of AG group; (B) Efficacy evaluation results of PD-1+AG group.

Figure 3 (A) Kaplan–Meier PFS curves of patients treated with PD-1 +AG versus AG (P=0.154); (B) Kaplan–Meier OS curves of patients treated with PD-1+AG versus AG (P<0.001).

Figure 4 (A) Forest plot for univariate analysis. (B) Forest plot of multivariate analysis.

Table 3 Comparison of Grade 1–2 Adverse Events

Adverse Events	Number (%)		Total	P
	AG Group (n=31)	PD-1+AG Group (n=17)
Leukopenia	13(41.9%)	7(41.2%)	20(41.7%)	0.959
Neutrophilia	11(35.5%)	5(29.4%)	16(33.3%)	0.670
Anemia	23(74.2%)	13(76.5%)	36(75.0%)	0.862
Thrombocytopenia	7(22.6%)	6(35.3%)	13(27.1%)	0.543
Transaminase elevation	12(38.7%)	5(29.4%)	17(35.4%)	0.519
Rash	12(38.7%)	10(58.8%)	22(45.8%)	0.181
Diarrhea	3(9.7%)	3(17.6%)	6(12.5%)	0.651
Nausea and vomiting	10(32.3%)	5(31.3%)	15(31.3%)	0.839
Fatigue	10(32.3%)	6(35.3%)	16(33.3%)	0.831
Fever	4(12.9%)	5(29.4%)	9(18.8%)	0.310
Hypothyroidism	2(6.5%)	6(35.3%)	8(16.7%)	0.031
Reactive cutaneous capillary hyperplasia	0(0.0%)	5(29.4%)	5(10.4%)	0.004

Table 4 Comparison of Grade 3–4 Adverse Events

Adverse Events	Number (%)		Total	P
	AG Group (n=31)	PD-1+AG Group (n=17)
Leukopenia	12(38.7%)	6(35.3%)	18(37.5%)	0.815
Neutrophilia	2(6.5%)	3(17.6%)	5(10.4%)	0.471
Anemia	4(12.9%)	3(17.6%)	7(14.6%)	0.686
Thrombocytopenia	7(22.6%)	6(35.3%)	13(27.1%)	0.543
Transaminase	8(25.8%)	6(35.3%)	14(29.2%)	0.719
Reactive cutaneous capillary hyperplasia	0(0.0%)	2(11.7%)	2(4.2%)	0.121

Figure 5 (A) Kaplan–Meier PFS curves of patients with KRAS and TP53 co-mutations (P=0.323); (B) Kaplan–Meier OS curves of patients with KRAS and TP53 co-mutations (P=0.004).