The efficacy and safety of endostar combined gemcitabine and cisplatin in the treatment of non-small cell lung cancer: a meta-analysis

WANG, Yixin; WANG, Lei; GUO, Jia; WANG, Ziyu; HUA, Shucheng

doi:10.1590/fst.40720

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Original Article • Food Sci. Technol (Campinas) 42 • 2022 • https://doi.org/10.1590/fst.40720 linkcopy

The efficacy and safety of endostar combined gemcitabine and cisplatin in the treatment of non-small cell lung cancer: a meta-analysis

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To determine the efficacy and safety of Endostar combined with gemcitabine and cisplatin in the treatment of NSCLC, and provide evidence-based reference for clinical drug use. Retrieved from Cochrane Library, PubMed, Embase, ClinicalTrials, CNKI, Wanfang and VIP database, randomized controlled trials (RCT) were collected. Pooled standard mean differences (SMD) and 95% confidence intervals (CI) were analyzed using R software with a random-effects model. Data from a total of 27 RCTs were included, involving 1646 patients were analyzed. Results of meta-analysis showed that response rate and clinical benefit rate of trial group were significantly higher than those of control group. There was no statistical significance in the incidence of leucopenia, thrombocytopenia and gastrointestinal reaction between 2 groups. The results showed that Endostar combined with gemcitabine and cisplatin may generally improve therapeutic efficacy of NSCLC patients, without increasing the incidence of adverse reactions.

Keywords:
endostar; gemcitabine; cisplatin; non-small cell lung cancer; meta-analysis

Included trails	Pathological staging	Course, d	Intervention		Sample size		Age mean (SD) (years)		Outcome measures	Jadad评分
Included trails	Pathological staging	Course, d	Control group	Trial group	Control group	Trial group	Control group	Trial group	Outcome measures	Jadad评分
Tan et al. (2013)	IIIb~IV	21	Gemcitabine(G) 1000 mg/m², intravenous injection (ij), qd, d1-8+Cisplatin (C) 25 mg/m², ij, qd, d_1-3	The same chemotherapy as control group+ Endostar (E) 7.5 mg/m² with 0.9% sodium chloride injection (SCI) 500 mL, intravenous injection (ij), qd, d_1-14	38	38	61.7 ± 9.8		①②③④⑤	3
Xie & Huang (2009)	III~ IV	21	G1000 mg/m², d₁ and d₈+ C75 mg/m², ij, qd, d_1-3	The same chemotherapy as control group+E 15 mg with 0.9% SCI 500 mL, d_1-14, ij	26	22	56.5	59	①②③④⑤	2
Chen et al. (2010)	IIIb~IV	21	G 1000 mg/m², ij, d₁ and d₈+C 25 mg/m², ij, d_1-3	The same chemotherapy as control group+E 15 mg with 0.9% SCI 500 mL, d_1-14, ij	25	30	49 ± 3	50 ± 2	①②③④⑤	1
Gu et al. (2010)	IIIb~IV	21	G 1000 mg/m², d₁ and d₈+C 25 mg/m², ij, d_1-3	The same chemotherapy as control group+E 15 mg with 0.9% SCI 500 mL, d_1-14, ij	33	27	53.6		①②③④⑤	1
Guo (2010)	III~ IV	21	G 1000 mg/m², ij, d₁ and d₈+C 30 mg/m², ij, d_1-3	The same chemotherapy as control group+E15 mg, ij, d_1-14	38	38	55 ± 12	53 ± 14	① ②④	2
Wei et al. (2010)	IIIb~IV	21	G1g/m², ij, d₁ and d₈+ C 30 mg/m², ij, d_2-4	The same chemotherapy as control group+E15 mg, qd, d_1-14, ij	16	16	59.8		①②③④⑤	2
Xu (2010)	IIIb~IV	36	G1000 mg/m² +C 30 mg/m²,Tumor target artery perfusion, d₁; G1000 mg/m², ij, d₈+0.9% SCI 500 mL, ij, d_2-12	G 1000 m g/m²+C 30 mg/m²,Tumor target artery perfusion, d₁;G 1000 mg/m², ij, d₈,E 15 mg/d+0.9% SCI 500 mL, ij, d_2-12	20	20	64		①②③④⑤	2
Chen et al. (2011)	III~ IV	21	G1000 mg/m², ij, d₁、d₈+C80 mg/m², ij, d₁	The same chemotherapy as control group+E 15 mg with 0.9% SCI 500 mL, d_1-14, ij	35	33	65	63	①②③④⑤	1
Ruan & Sun (2011)	IIIb~IV	21	G1000 mg/m², d₁ and d₈+C75 mg/m², ij, d_1-3	The same chemotherapy as control group+E 15 mg with 0.9% SCI 500 mL, d_1-14, ij	19	17	58.5		①②③⑤	1
Wang (2011)	IIIb~IV	21	G 1000 mg/m², ij, d₁ and d₈+C 75 mg/m², ij, d₁	The same chemotherapy as control group+E 15 mg with 0.9% SCI500 mL, d_1-14, ij	29	31	55	56	① ②	1
Zheng et al. (2011)	IV	21-28	G 1000 mg/m², ij, d₁ and d₈+Cisplatin 20 mg/m², intravenous injection, d_1-5	The same chemotherapy as control group+Endostar 15 mg/d, d_1-14	18	17	54.5	50.1	①②⑤	1
Chen & Yang (2012)	Not mentioned	14	Gemcitabine 1000 mg/m² wiht 0.9% Sodium chloride injection 100 mL, intravenous injection, d₁ and d₈+Cisplatin 25 mg/m² with 0.9%Sodium chloride injection 500 mL, intravenous injection, d_2-4	The same chemotherapy as control group+Endostar 15 mg, intravenous injection, qd, d_1-14	26	27	56.5 ± 7.3	55.7 ± 8.6	①②③④⑤	1
He (2012)	III~ IV	21	Gemcitabine 1000 mg/m², d₁ and d₈+Cisplatin 30 mg/m², d_2-4	The same chemotherapy as control group+Endostar 7.5 mg/m², d_1-14	32	40	69.8 ± 5.5	70.5 ± 5.3	①②⑤	1
Liu et al. (2012)	IIIb~IV	21	Gemcitabine 1000 mg/m², intravenous injection, d₁ and d₈+Cisplatin 75 mg/m², intravenous injection	The same chemotherapy as control group+Endostar 15 mg, d_1-7	30	30	56	58	①②③④⑤	2
Luan (2012)	III~ IV	21	Gemcitabine 1250 mg/m², intravenous injection, d₁ and d₈+Cisplatin 75 mg/m², intravenous injection, d₁	The same chemotherapy as control group+Endostar 75 mg/m² with 0.9% Sodium chloride injection 500 mL, d_1-14, intravenous injection	27	25	40-67	42-68	① ②	1
Yin et al. (2012)	Not mentioned	21	Gemcitabine 1000 mg/m², intravenous injection, d₁ and d₈+Cisplatin 30 mg/m², intravenous injection, d_2-4	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 500 mL, intravenous injection, qd, d_1-14	90	94	49.3 ± 4.5	48.3 ± 5.2	①②⑤	1
Alimujiang et al. (2013)	IIIb~IV	21	Gemcitabine 1.0 g/m² with 250 mL 0.9% Sodium chloride injection, d₁ and d₁₄, intravenous injection +Cisplatin with 500 mL 0.9% Sodium chloride injection, intravenous injection, d_1-3	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 500 mL, d_1-14, intravenous injection	40	40	59.2 ± 9.5	58.3 ± 9.6	①②③④⑤	2
Zhang (2014)	IIIb~IV	21	Gemcitabine 1000 mg/m², d₁ and d₈+Cisplatin 75 mg/m², dosing in 3 days	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 250 mL, Intravenous pumping, d_1-9	28	31	54	53	①②③④⑤	2
Fu et al. (2015)	IIIb~IV	21	Gemcitabine 1000 mg/m², intravenous injection, d₁ and d₈+Cisplatin 25 mg/m², intravenous injection, d_1-3	The same chemotherapy as control group+Endostar15 mg with 0.9% Sodium chloride injection 500 mL, d_1-14, intravenous injection	28	32	55.81	56.21	①②③④⑤	2
Liu (2015)	III~ IV	21	Gemcitabine 1000 mg/m², intravenous injection, d₁ and d₈+Cisplatin 80 mg/m², intravenous injection, d_1-2	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 500 mL, d_1-14	32	32	无		① ②	2
Li et al. (2016)	IIIb~IV	21	Gemcitabine 1000 mg/m², intravenous injection, d₁ and d₈+Cisplatin 30 mg/m², intravenous injection, d_1-3	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 500 mL, d_1-14, intravenous injection	23	23	52.3 ± 10.6		①②③④⑤	3
Fang (2017)	Not mentioned	21	Gemcitabine 1000 mg/m², intravenous injection, d₁ and d₈+Cisplatin 75 mg/m², intravenous injection,used 3 days continuously	The same chemotherapy as control group+Endostar 7.5 mg/m² with 0.9% Sodium chloride injection 500 mL, qd, d_1-14	23	23	52	60	① ②	2
Jia et al. (2017)	IIIb~IV	21	Gemcitabine 1.0 mg/m² with 0.9% Sodium chloride injection 150 mL, intravenous injection, d₁ and d₈+Cisplatin 25 mg/m² with 0.9% Sodium chloride injection 500 mL, intravenous injection, d_1-3	The same chemotherapy as control group+Endostar 30 mgwith 0.9% Sodium chloride injection 110 mL, d_1-7	20	20	50 ± 2		①②③④⑤	2
Xu & Wu (2017)	Not mentioned	21	Gemcitabine 1.0 g/m² wiht 0.9% Sodium chloride injection 250 mL, intravenous injection, d₁ and d₈+Cisplatin 30 mg/m² with 0.9% Sodium chloride injection 500 mL, intravenous injection, d_1-3	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 500 mL, intravenous injection, d_1-14	35	35	54.1 ± 11.3		①②③⑤	3
Song et al. (2018)	III~ IV	21	Gemcitabine 1250 mg/m², intravenous injection, d₁ and d₈+Cisplatin 25 mg/m², intravenous injection, d_1-3	The same chemotherapy as control group+Endostar 15 mg/m², d_1-7, intravenous injection	30	30	61.7	57.4	①②③④⑤	1
Wang (2018)	IIIb~IV	21	Gemcitabine 1000 mg/m² with 0.9% Sodium chloride injection 100 mL, intravenous injection, d₁ and d₂ applied Cisplatin 75 mg/m² with 0.9% Sodium chloride injection 500 mL, intravenous injection, dosing in 3 days	The same chemotherapy as control group+Endostar 15 mg with 0.9% Sodium chloride injection 250 mL, intravenous pumping, d_1-9	30	34	55.45	55.97	①②③④⑤	1
Zhong & Chen (2018)	Not mentioned	21	Gemcitabine 1000 mg/m² with 0.9% Sodium chloride injection 150 mL, intravenous injection, d₁ and d₈ applied Cisplatin 30 mg/m² with 0.9% Sodium chloride injection 500 mL, intravenous injection, d_1-3	The same chemotherapy as control group+Endostar 7.5 mg/m² with 0.9% Sodium chloride injection 100 mL, d_1-14	25	25	70.34	70.21	①②③④⑤	2

Excluded trails	Heterogeneity		95% CI	P
Tan et al. (2013)	P=0.99	I²=0	1.67(1.47, 1.89)	P<0.000 01
Xie & Huang (2009)	P=0.99	I²=0	1.68(1.48, 1.90)	P<0.000 01
Chen et al. (2010)	P=0.99	I²=0	1.66(1.46, 1.88)	P<0.000 01
Gu et al. (2010)	P=1.00	I²=0	1.65(1.45, 1.86)	P<0.000 01
Guo (2010)	P=0.99	I²=0	1.67(1.47, 1.90)	P<0.000 01
Wei et al. (2010)	P=0.99	I²=0	1.67(1.47, 1.89)	P<0.000 01
Xu (2010)	P=1.00	I²=0	1.65(1.46, 1.87)	P<0.000 01
Chen et al. (2011)	P=0.99	I²=0	1.69(1.49, 1.92)	P<0.000 01
Ruan & Sun (2011)	P=0.99	I²=0	1.66(1.47, 1.89)	P<0.000 01
Wang (2011)	P=1.00	I²=0	1.70(1.50, 1.93)	P<0.000 01
Zheng et al. (2011)	P=0.99	I²=0	1.67(1.47, 1.89)	P<0.000 01
Chen & Yang (2012)	P=0.99	I²=0	1.69(1.48, 1.91)	P<0.000 01
He (2012)	P=0.99	I²=0	1.68(1.48, 1.91)	P<0.000 01
Liu et al. (2012)	P=1.00	I²=0	1.70(1.50, 1.93)	P<0.000 01
Luan (2012)	P=0.99	I²=0	1.67(1.48, 1.90)	P<0.000 01
Yin et al. (2012)	P=0.99	I²=0	1.66(1.45, 1.90)	P<0.000 01
Alimujiang et al. (2013)	P=0.99	I²=0	1.69(1.49, 1.92)	P<0.000 01
Zhang (2014)	P=0.99	I²=0	1.68(1.48, 1.91)	P<0.000 01
Fu et al. (2015)	P=0.99	I²=0	1.67(1.47, 1.89)	P<0.000 01
Liu (2015)	P=0.99	I²=0	1.68(1.48, 1.90)	P<0.000 01
Li et al. (2016)	P=0.99	I²=0	1.68(1.48, 1.91)	P<0.000 01
Fang (2017)	P=0.99	I²=0	1.66(1.47, 1.89)	P<0.000 01
Jia et al. (2017)	P=0.99	I²=0	1.68(1.48, 1.90)	P<0.000 01
Xu & Wu (2017)	P=0.99	I²=0	1.68(1.48, 1.91)	P<0.000 01
Song et al. (2018)	P=0.99	I²=0	1.68(1.48, 1.90)	P<0.000 01
Wang (2018)	P=0.99	I²=0	1.67(1.47, 1.89)	P<0.000 01
Zhong & Chen (2018)	P=0.99	I²=0	1.66(1.46, 1.88)	P<0.000 01

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the efficacy of endostar combined gemcitabine and cisplatin in treating NSCLC; 2) clinical benefit rate; 3) incidence of leukopenia; 4) incidence of thrombocytopenia; 5) incidence of gastrointestinal reactions.