Clinical management of advanced gastric cancer: The role of new molecular drugs

doi:10.3748/wjg.v20.i40.14537

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World Journal of Gastroenterology

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1007-9327

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World J Gastroenterol. Oct 28, 2014; 20(40): 14537-14558
Published online Oct 28, 2014. doi: 10.3748/wjg.v20.i40.14537

Table 1 Phase II/III trials with anti vascular-endothelial growth factor agents for advanced gastric cancer and gastro-esophageal junction cancers

Trial	Phase	Setting	Regimen	Patients (n)	RR	OS (mo)	TTP/PFS (mo)
NCT00084604[49], 2006	II	1^st line	Iri + C + Bev	47	65%	12.3	8.3
NCT00217581[50], 2010	II	1^st line	DOCOX + Bev	38	59%	11.1	6.6¹
	II	1^st line	DOCOX + Bev	38	59%	11.1	6.6¹
AVAGAST[51,54], 2010	III	1^st line	XC + Bev	387	46%	12.1	6.7
	III	1^st line	XC + Placebo	387	37.4%	10.1	5.3
ST03[55], 2012	II/III	Perioperative	ECX-B	200	-	-	-
	II/III	Perioperative	ECX-B	200	-	-	-
REGARD[58], 2012	III	2^nd line	Ram + BSC	235	-	5.2	2.1¹
	III	2^nd line	BSC	117	-	3.8	1.7¹
RAINBOW[60], 2014	III	2^nd line	PTX + Ram	665	28%	9.6	4.4
	III	2^nd line	PTX + placebo	665	28%	9.6	4.4
ECOG 5203[63], 2010	II	1^st line	TXT + C + Sor	44	39%	13.6	5.8
	II	1^st line	TXT + C + Sor	44	39%	13.6	5.8
NCT01262482[64], 2012	II	2^nd line	Sor + O	40	-	6.5	3.0¹
	II	2^nd line	Sor + O	40	-	6.5	3.0¹
NCT00411151[67], 2011	II	2^nd line	Sun	52	3.9%	5.81	1.28¹
	II	2^nd line	Sun	52	3.9%	5.81	1.28¹
NCT00226811[68], 2011	II	2^nd line	Sun	78	2.6%	6.8	2.3
	II	2^nd line	Sun	78	2.6%	6.8	2.3
NCT00970138[73], 2011	II	3^rd line	A: Placebo		-	2.5	1.4¹
			B: Apa (850 mg)		-	4.83	3.67¹
			C: Apa (425 mg bid)	144		4.27	3.2¹
NCT01512745[74], 2012	III	3^rd line	Apa	-	-	-	-
NCT01512745[74], 2012	III	3^rd line	Placebo	-	-	-	-
TEL0805 trial[75], 2011	II	1^st line	XC + Tel	39	6.7%	-	-

¹Progression free survival (PFS). Iri: Irinotecan; Cis: Cisplatin; Bev: Bevacizumab; X: Capecitabine; C: Cisplatin; E: Epirubicin; Ram: Ramucirumab; PTX: Paclitaxel; Sor: Sorafenib; Sun: Sunitinib; Apa: Apatinib; Tel: Telantinib; DOCOX: Docetaxel plus oxaliplatin; O: Oxaliplatin; TXT: Docetaxel; BSC: Best supportive care; RR: Response rate; OS: Overall survival; TTP/PFS: Time to progression/progression free survival.

Table 2 Phase II trials of epidermal growth factor receptor tyrosine kinase inhibitors for advanced gastric cancer and gastro-esophageal junction cancers

Author/trial	Phase	Setting	Regimen	Patients (n)	RR	OS (mo)	TTP (mo)
NCT00237900[86], 2010	II	Neoadjuvant	CF + G + RT	80	-	42% (3-yr)	-
SWOG 0127[89], 2006	II	1^st line	Erlotinib 150 mg/d	44 (GEJ)	9% (GEJ)	6.7 (GEJ)	-
SWOG 0127[89], 2006	II	1^st line	Erlotinib 150 mg/d	26 (stomach)	0% (stomach)	3.5 (stomach)	-

C: Cisplatin; F: 5 fluorouracil; G: Gefitinib; RT: Radiotherapy; RR: Response rate; OS: Overall survival; TTP: Time to progression; GEJ: Gastro-esophageal junction.

Table 3 Phase II/III trials of anti-epidermal growth factor receptor agents for advanced gastric cancer and gastro-esophageal junction cancer

Trial	Phase	Setting	Regimen	Patients (n)	RR	OS (mo)	TTP (mo)
FOLCETUX[187], 2007	II	1^st line	FOLFIRI + Cet	38	44.1%	16.0	8.0
NCT00477711[188], 2008	II	1^st line	CX + Cet	54	48.1%	-	5.23
DOCETUX[95], 2009	II	1^st line	C + TXT + Cet	72	41.2%	9.0	5.0
AIO[93], 2010	II	1^st line	FUFOX + Cet	52	65.0%	9.5	7.6
NCT01123811[94], 2011	II	1^st line	FOLFIRI + Cet	49	46.0%	16.5	90.0
NCT00398398[189], 2011	II	1^st line	XELOX + Cet	44	52.3%	11.8	6.5
NCT00517829[96], 2013	II	1^st line	DOCOX	75	26.5%	8.5	-
NCT00517829[96], 2013	II	1^st line	DOCOX + Cet	75	38.0%	9.4	-
EXPAND[97], 2013	III	1^st line	CX + Cet	455	29.0%	9.4	4.4
			CX	449	30.0%	10.7	5.6
REAL-III[103], 2013	II-III	1^st line	EOX + P	278	42.0%	8.8	6.0
			EOX	275	46.0%	11.3	7.4
NCT00113581[107], 2008	I	1^st line	ECX + M	21	65.0%	-	5.2
MATRIX[190], 2010	II	1^st line	ECX + M	35	58.0%	12.2	7.1
MATRIX[190], 2010	II	1^st line	ECX	35	31.0%	9.4	4.8
NCT01813253[111], 2011	II	2^nd line	Iri	82	18.4%	7.5%	85 d
NCT01813253[111], 2011	II	2^nd line	Iri + N	82	10.3%	9.7%	73 d

Cet: Cetuximab; C: Cisplatin; TXT: Docetaxel; X: Capecitabine; E: Epirubicin; O: Oxaliplatin; P: Panituimumab; E: Epirubicin; Iri: Irinotecan; M: Matuzumab; N: Nimotuzumab; FOLFIRI: 5 fluorouracil plus folinic acid plus irinotecan; FUFOX: 5 fluorouracil plus oxaliplatin; DOCOX: Docetaxel plus oxaliplatin; XELOX: Capecitabine plus oxaliplatin; RR: Response rate; OS: Overall survival; TTP: Time to progression.

Table 4 Clinical trials with anti-human epidermal growth factor receptor 2 agents for advanced gastric cancer and gastro-esophageal junction cancer

Trial	Phase	Setting	Regimen	Patients (n)	OS (mo)	TTP/PFS (mo)
ToGa Trial[122], 2010	III	1^st line	CF/X + T	594	13.8	6.7
			CF/X		11.1	5.5
NCT00680901[129], 2013	III	1^st line	OX + Lap	487	12.2	6.0
			OX		10.5	5.4
NCT00486954[130], 2010	III	2^nd line	PTX + Lap	430	11.0	5.6
			PTX		8.9	4.2

C: Cisplatin; F: 5-fluorouracil; X: Capecitabine; T: Trastuzumab; O: Oxaliplatin; Lap: Lapatinib; PTX: Paclitaxel; OS: Overall survival; TTP/PFS: Time to progression/progression free survival.

Table 5 Clinical trials with everolimus in previously treated patients with advance gastric cancer and gastro-esophageal junction cancer

Trial	Phase	Setting	Regimen	Patients (n)	OS (mo)	PFS (mo)
NCT00985192[137], 2010	II	Advanced	Eve	53	10.1	2.7
NCT00879333[138], 2013	III	Advanced	Eve + BSC	656	5.4	1.7
NCT00879333[138], 2013	III	Advanced	BSC	656	4.3	1.4
NCT01248403[139], Ongoing	III	Advanced	Eve + PTX	480	-	-
NCT01248403[139], Ongoing	III	Advanced	PTX	480	-	-

Eve: Everolimus; PTX: Paclitaxel; OS: Overall survival; PFS: Progression free survival.

Citation: Vita FD, Martino ND, Fabozzi A, Laterza MM, Ventriglia J, Savastano B, Petrillo A, Gambardella V, Sforza V, Marano L, Auricchio A, Galizia G, Ciardiello F, Orditura M. Clinical management of advanced gastric cancer: The role of new molecular drugs. World J Gastroenterol 2014; 20(40): 14537-14558
URL: https://www.wjgnet.com/1007-9327/full/v20/i40/14537.htm
DOI: https://dx.doi.org/10.3748/wjg.v20.i40.14537