Second-line treatment of metastatic gastric cancer: Current options and future directions

doi:10.3748/wjg.v21.i41.11621

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World Journal of Gastroenterology

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World J Gastroenterol. Nov 7, 2015; 21(41): 11621-11635
Published online Nov 7, 2015. doi: 10.3748/wjg.v21.i41.11621

Table 3 Phase III studies on second-line therapy in metastatic gastric cancer

Ref.	II-line treatment (mg/m²)	Total pts	Performance Status, (ECOG/WHO) (%)	Median ORR (%)	MedianPFS(mo)	MedianOS(mo)	Hazard ratio	Toxicity,grade3-4 (%)
Thuss-Patience et al[62], 2011	Iri 250 cycle 1; 350 subsequent cycles	21/19	0-1/2 - 81/19	0	2.5	4.0	0.48, P = 0.012	D/FN/L/A - 26/16/21/11
Thuss-Patience et al[62], 2011	BSC	19	0-1/2 - 74/26	NR	NR	2.4	0.48, P = 0.012	NR
Kang et al[63], 2012	Dtx 60 d1 q3w;	133	0/1 - 54/46	13.0	NR	5.3	0.657, P = 0.007	Doc: N/A/F/Ano/D/S - 15/30/26/6/3/3
	Iri 150 d1 q2w	133	0/1 - 54/46	13.0	NR	5.3		Iri: N/A/F/Ano/D/S - 18/32/10/5/8/5
	BSC	69	0/1 - 52/48	NR	NR	3.8		N/A/F/D/S - 2/23/27/10/5/2
Hironaka et al[64], 2013	Iri 150 d1/d15 q4w	112	0-1/2 - 96.4/3.6	13.6¹	2.3¹	8.4	1.13, P = 0.38	L/N/A/FN/Ano/Neu/D/AST/Na - 19.1/39.1/30/9.1/17.3/0/4.5/8.2/15.5
Hironaka et al[64], 2013	Ptx 80 d1/d8/d15 q4w	111	0-1/2 - 96.3/3.7	20.9¹	3.6¹	9.5	1.13, P = 0.38	L/N/A/FN/Ano/Neu/D/AST/Na - 20.4/28.7/21.3/2.8/7.4/7.4/0.9/3.7/3.7
Ford et al[65], 2014	Doc 75 d1 q3w	84	0/1/2 - 28/55/17	7.0	29% (at 24 wk)	5.2	0.67, P = 0.01	N/A/FN/I/H/P/Neu - 15/6/7/15/1/11/4
Ford et al[65], 2014	BSC	84	0/1/2 - 28/60/14	NR	NR	3.6	0.67, P = 0.01	N/A/FN/I/H/P/Neu - 0/5/0/3/6/20/4
Higuchi et al[66], 2014	Iri 60 d1 q2w;	64	0/1 - 69/31	22.0¹	3.8	10.7¹	1.00, P = 0.982	N/A/FN/T/D/Ano/F - 13/16/0/0/2/6/3
	Cis 30 d1 q2w	64	0/1 - 69/31	22.0¹	3.8	10.7¹		N/A/FN/T/D/Ano/F - 13/16/0/0/2/6/3
	Iri 150 d1 q4w	66	0/1 - 68/32	16.0¹	2.8	10.1¹		N/A/FN/T/D/Ano/F - 36/18/5/2/6/11/6
Nishikawa et al[67], 2015	Iri 60 d1 q2w;	84	0/1 - 81/19	16.9¹	4.6¹	13.9¹	0.834, P = 0.288	N/A/T/D/Ano/F - 35/16/1/0/6/9
	P 30 d1 q2w	84	0/1 - 81/19	16.9¹	4.6¹	13.9¹		N/A/T/D/Ano/F - 35/16/1/0/6/9
	Iri 150 d1 q4w	84	0/1 - 75/25	15.4¹	4.1¹	12.7¹		N/A/T/D/Ano/F - 28/4/0/3/9/4
Fuchs et al[69], 2014	Ram 8 mg/kg d1 q2w	238	0/1/2 - 28/72/0	3.4¹	2.1	5.2	0.776, P = 0.047	A/F/AbP/Dys/Dyn/Hyt/B/Prot/VTE - 6/6/6/2/2/8/3/< 1/1
	BSC	238	0/1/2 - 28/72/0	3.4¹	2.1	5.2		A/F/AbP/Dys/Dyn/Hyt/B/Prot/VTE - 6/6/6/2/2/8/3/< 1/1
	Placebo	117	0/1/2 - 26/73/0	3.0¹	1.3	3.8		A/F/AbP/Dys/Dyn/Hyt/B/Prot/VTE - 8/10/3/4/6/3/3//< 1
	BSC	117	0/1/2 - 26/73/0	3.0¹	1.3	3.8		A/F/AbP/Dys/Dyn/Hyt/B/Prot/VTE - 8/10/3/4/6/3/3//< 1
Wilke et al[70], 2014	Ram 8 mg/kg d1,15 q4w	330	0/1 - 35/65	27	4.4	9.6	0.807, P = 0.017	N/A/Leu/T/F/Neu/D/H/Hyt/Prot/HepF/VTE - 41/9/18/2/8/4/4/15/1/4/2
	Ptx 80 d1/d8/d15 q4w	330	0/1 - 35/65	27	4.4	9.6	0.807, P = 0.017
	Placebo	335	0/1 - 43/57	16	2.9	7.4		N/A/Leu/T/F/Neu/D/H/Hyt/Prot/HepF/VTE - 19/9/6/2/5/5/1/4/3/0/3/2
	Ptx 80 d1/d8/d15 q4w	335	0/1 - 43/57	16	2.9	7.4
Satoh et al[76], 2014	Lap 1500 mg once daily	132	0/1 - 45/55	27	5.5¹	12.2¹	0.84, P = 0.2	(experienced in > 10% of pts) N/A/Lym/F/Neu/D - 57/11/29/5/< 1/18
	Ptx 80 d1,d8,d15 q4w	132	0/1 - 45/55	27	5.5¹	12.2¹
	Placebo	129	0/1 - 37/63	9	4.4¹	10.5¹		(experienced in > 10% of pts) N/A/Lym/F/Neu/D - 31/6/2/< 1/0/2
	Ptx 80 d1,d8,d15 q4w	129	0/1 - 37/63	9	4.4¹	10.5¹
Dutton et al[77], 2014	Gef 500 mg/d daily	224	0/1/2 - 25/52/22	24 (DC)	1.57	3.73¹	0.90, P = 0.293	D/F/Sk/Rep/I/Hem/Vas/Met - 6/10/20/12/3/7/7/6
Dutton et al[77], 2014	Placebo	225	0/1/2 - 25/55/20	16 (DC)	1.17	3.67¹	0.90, P = 0.293	D/F/Sk/Rep/I/Hem/Vas/Met - 1/5/< 1/12/4/4/5/7

¹The P value non-significant. BSC: Best Supportive Care; Dtx: Docetaxel; Gef: Gefitinib; Iri: Irinotecan; Lap: Lapatinib; P: Cisplatin; Ptx: Paclitaxel; Ram: Ramucirumab; DC: Disease control; ECOG: Eastern Co-operative Oncology Group; NR: Not reported; ORR: Objective Response Rate; OS: Overall-survival; PFS: Progression-free survival; Pts: Patients; WHO: World Health Organization; A: Anemia; AbP: Abdominal Pain; Ano: Anorexia; B: Bilirubin; D: Diarrhea; Dys: Dysphagia; Dyn: Dyspnea; E: Emesis; FN: Febrile neutropenia; H: Hemorrhage; Hem: Hematologic toxicity; HepF: Hepatic failure; Hyt: Hypertension; I: Infection; L: Leucocytopenia; Ly: Lymphopenia; M: Mucositis; Met: Toxicity associated with metabolism and nutrition; N: Neutropenia; Neu: Sensory neuropathy; Nau: Nausea; N-E: Nausea and vomiting; P: Pain; Prot: Proteinuria; Resp: Respiratory toxicity; Sk: Skin toxicity; T: Thrombocytopenia; Vas: Vascular toxicity; VTE: Venous thromboembolic events.

Citation: Kanagavel D, Fedyanin M, Tryakin A, Tjulandin S. Second-line treatment of metastatic gastric cancer: Current options and future directions. World J Gastroenterol 2015; 21(41): 11621-11635
URL: https://www.wjgnet.com/1007-9327/full/v21/i41/11621.htm
DOI: https://dx.doi.org/10.3748/wjg.v21.i41.11621