Figure and Table | Update on the Treatment of Gastric Cancer

Table 1. Major Phase III Trials of Extended Surgery for Resectable Gastric Cancer.

Trial name	Published year	No. of patients	Eligible patients	Treatment groups	Morbidity (%)	5-year OS (%)	P-value
MRC trial ^{(17), (18)}	1996, 1999	737	cStage I-III	D1 D2	28 46	35 33	0.43
Dutch trial ^{(19), (20)}	1995, 2010	1078	cStage I-III	D1 D2	25 43	45 47	0.53
Taiwanese trial ⁽²¹⁾	2006	335	cStage I-III	D1 D2	7.3 17.1	53.6 59.5	0.041
JCOG9501 ⁽⁷⁾	2008	523	cT3-T4b	D2 alone D2 + PAND	20.9 28.1	69.2 70.3	0.85
JCOG9502 ^{(8), (9)}	2006, 2015	167	cT2-T4b (cardia/subcardia)	TH LTA	34.1 49.4	52.3 37.9	0.92^*
JCOG0110 ⁽¹⁰⁾	2017	505	cT2-T4b (proximal)	Spleen-preservation Splenectomy	16.7 30.3	76.4 75.1	0.025^* (for non-inferiority)
JCOG1001 ⁽¹¹⁾	2018	1204	cT3-T4a	Omentectomy alone Bursectomy	10.6 12.8	76.7 76.9	0.65^*

Table 2. Major Phase III Trials Comparing Laparoscopic Surgery with Open Surgery for Gastric Cancer.

Trial name	Published year	No. of patients	Eligible patients	Treatment groups	Morbidity (%)	P-value	Mortality (%)	P-value
JCOG0912 ⁽³⁰⁾	2017	921	cStage IA/IB	ODG LDG	3.7 3.3	0.72	0 0	-
KLASS-01 ^{(31), (32)}	2015, 2016	1416	cStage IA/IB	ODG LDG	19.9 13.0	0.001	0.3 0.6	0.450
JLSSG0901 ⁽³³⁾	2017	507	cT2-T4a	ODG LDG	4.7 3.1	0.285	0.4 0.4	1.000
KLASS-02 ⁽³⁴⁾	2016	1050	cT2-4a N0-1	ODG LDG	24.3 16.4	0.002	0.6 0.4	0.683
CLASS-01 ⁽³⁵⁾	2018	1056	cT2-T4a	ODG LDG	15.2 12.9	0.285	0.4 0	0.249

Table 3. Major Phase III Trials of Adjuvant Chemotherapy and Chemoradiotherapy for Gastric Cancer.

Trial name	Published year	No. of patients	Eligible patients	Treatment groups	Survival (%)	P-value
ACTS-GC ^{(39), (40)}	2007, 2011	1059	pStage II-III (D2 gastrectomy)	no treatment (surgery alone) S-1	3-year OS: 70.1 3-year OS: 80.1	0.003
SAMIT ⁽⁴¹⁾	2014	1495	cT4a-T4b (D2 gastrectomy)	UFT with or without paclitaxel S-1 with or without paclitaxel	3-year DFS: 53.0 3-year DFS: 58.2	0.0048
CLASSIC ⁽⁴²⁾	2014	1035	pStage II-III (D2 gastrectomy)	no treatment (surgery alone) Capecitabine + oxaliplatin	3-year DFS: 59 3-year DFS: 74	<0.0001
OPAS-1 ⁽⁴³⁾	2017	528	pStage II	S-1 (6 months) S-1 (12 months)	3-year RFS: 88.9 3-year RFS: 95.3	0.93^* (for non-inferiority)
START-2 ⁽⁴⁴⁾	2018	951	pStage III	S-1 S-1 + docetaxel	3-year RFS: 49.6 3-year RFS: 65.9	0.0007
INT-0116 ⁽⁴⁵⁾	2001	556	pStage IB-III (D0/D1 gastrectomy)	no treatment (surgery alone) 5-FU + LV + RT	3-year OS: 41 3-year-OS: 50	0.005
ARTIST ⁽⁴⁶⁾	2015	458	pStage IB-III (D2 gastrectomy)	Capecitabine + cisplatin Capecitabine + cisplatin + CRT (Capecitabine + RT)	3-year DFS: 74.2 3-year DFS: 78.2	0.0862
CRITICS ⁽⁴⁷⁾	2018	788	cStage IB-III (D1+/D2 gastrectomy)	ECX or EOX ECX or EOX + RT	5-year OS: 42 5-year OS: 40	0.90

Table 4. Major Phase III Trials of Neoadjuvant Chemotherapy for Gastric Cancer.

Trial name	Published year	No. of patients	Eligible patients	Treatment groups	R0 resection rate (%)	OS (%)	P-value
MAGIC ⁽⁴⁸⁾	2006	503	cStage II-III	Surgery alone ECF (Peri)	66.4 69.3	5-year: 23.0 5-year: 36.3	0.009
FLOT4 ^{(49), (50)}	2016, 2017	716	cStage IB-III	ECF/ECX (Peri) FLOT (Peri)	77 84	3-year: 48 3-year: 57	0.012
JCOG0501 ⁽⁵²⁾	2018	300	Type 3 (≥8cm) or Type 4	CS (Pre) + S-1 (Post) S-1 (Post)	74.2 65.7	3-year: 62.4 3-year: 60.9	0.284^*

Table 5. Major Phase III Trials of Chemotherapy for Unresectable or Recurrent Gastric Cancer.

Trial name	Published year	No. of patients	Line of treatment	Treatment groups	Response rate (%)	MST (months)	P-value
JCOG9912 ⁽⁵⁸⁾	2009	704	1^st	5-FU Irinotecan + cisplatin S-1	9 38 28	10.8 12.3 11.4	0.0552^* (Irinotecan + cisplatin vs. 5-FU) 0.0005^* (for non-inferiority of S-1 vs. 5-FU)
SPIRITS ⁽⁵⁹⁾	2008	298	1^st	S-1 CS	31 54	11.0 13.0	0.04
JCOG1013 ⁽⁶⁰⁾	2018	741	1^st	CS DCS	56.0 59.3	15.3 14.2	0.47^*
G-SOX ⁽⁶¹⁾	2015	642	1^st	CS SOX	52.2 55.7	13.1 14.1	0.0583 (for non-inferiority)
REAL-2 ⁽⁶²⁾	2008	964	1^st	ECF ECX EOF EOX	40.7 46.4 42.4 47.9	9.9 9.9 9.3 11.2	0.02 (ECF vs. EOX)
ToGA ⁽⁶³⁾	2010	584	1^st (HER2-positive)	Capecitabine/5-FU + cisplatin Capecitabine/5-FU + cisplatin + trastuzumab	35 47	11.1 13.8	0.0046
RAINFALL ⁽⁶⁷⁾	2018	645	1^st	Capecitabine/5-FU + cisplatin Capecitabine/5-FU + cisplatin + ramucirumab	36 41	10.74 11.17	0.68
REGARD ⁽⁶⁵⁾	2014	355	2^nd	Placebo Ramucirumab	3 3	3.8 5.2	0.047
RAINBOW ⁽⁶⁶⁾	2014	665	2^nd	Paclitaxel Paclitaxel + ramucirumab	16 28	7.4 9.6	0.017
ABSOLUTE ⁽⁶⁸⁾	2017	741	2^nd	weekly paclitaxel (w-Ptx) weekly nab-paclitaxel (w-Nab) triweekly nab-paclitaxel (t-Nab)	25 24 33	10.9 11.1 10.3	0.0085^* (for non-inferiority of w-Nab vs. w-Ptx) 0.062^* (for non-inferiority of t-Nab vs. w-Ptx)
ATTRACTION-2 ⁽⁶⁹⁾	2017	493	≥3^rd	Placebo Nivolumab	0 11.2	4.14 5.26	< 0.0001
KEYNOTE-061 ⁽⁷¹⁾	2018	395	2^nd	Paclitaxel Pembrolizumab	13.6 15.8	8.3 9.1	0.042^*