Copyright
©The Author(s) 2018.
World J Gastroenterol. Jan 14, 2018; 24(2): 274-289
Published online Jan 14, 2018. doi: 10.3748/wjg.v24.i2.274
Published online Jan 14, 2018. doi: 10.3748/wjg.v24.i2.274
Table 1 Quality assessment of all the 16 randomized controlled trials found in literature and included in this study
Ref. | Randomization | Allocation concealment | Blind | Withdrawal and dropout | Jadad score | ITT |
Yonemura et al[29], 1993 | Adequate | Inadequate | Adequate | Well reported | 5 | NR |
Shchepotin et al[30], 1995 | Unclear | Unclear | Inadequate | NR | 1 | NR |
Kang et al[31], 1996 | Unclear | Unclear | Inadequate | Well reported | 3 | NR |
Lygidakis et al[32], 1999 | Inadequate | Unclear | Inadequate | Well reported | 2 | NR |
Takiguchi et al[33], 2000 | Unclear | Inadequate | inadequate | Well reported | 2 | NR |
Wang et al[22], 2000 | Unclear | Unclear | Inadequate | Well reported | 3 | NR |
Kobayashi et al[35], 2000 | Adequate | Adequate | Inadequate | Well reported | 5 | NR |
Hartgrink et al[4], 2004 | Adequate | Adequate | Inadequate | Well reported | 5 | NR |
Nio et al[36], 2004 | Inadequate | Inadequate | Inadequate | Well reported | 1 | NR |
Zhao et al[37], 2006 | unclear | Unclear | Inadequate | Well reported | 3 | NR |
Cunningham et al[17], 2006 | Adequate | Adequate | Adequate | Well reported | 7 | YES |
Schuhmacher et al[15], 2010 | Unclear | Unclear | Unclear | Well reported | 4 | YES |
Imano et al[38], 2010 | unclear | unclear | Unclear | Well reported | 4 | NR |
Biffi et al[39], 2010 | Unclear | Unclear | Unclear | Well reported | 4 | YES |
Qu et al[40], 2010 | Adequate | Unclear | Unclear | NR | 4 | NR |
Ychou et al[18], 2011 | Adequate | Well reported | Unclear | Well reported | 6 | YES |
AuthorCountries | Year,Type of publication | N° patientsrandomization | SiteStage | Regimen | Response rate | Resectability rate | Survival rate (HR; p) | Node dissection (D1,D2, others) |
Yonemura et al[29] Japan | 1993 Abstract | 55 Tot 29 NAC + S 26 S | GC IV | PMUE | Adv NAC + S | Adv NAC + S | Adv NAC+S Rates NR | NR |
Shchepotin et al[30] Ukraine | 1995 Abstract | 146 Tot 50 S 49 IVCH + S 47 IACH + S | GC NR | NR | Adv IACH + S | Adv IACH + S | Adv IACH + S P < 0.001 | NR |
Kang et al[31] South Korea | 1996 Abstract | 107 Tot 54 S 53 NAC + S | GC III/IV | PEF | NR | Adv NAC + S | No difference P = 0.114 | NR |
Lygidakis et al[32] Greece | 1999 Paper | 59 Tot 19 S 20 NAC + S + IVCH 20 NAC + S | GC All stages | Mitomycin-C + 5-FU + FA + Farmorubicin | NR | NR | Adv NAC + S + IVCH | NR |
Takiguchi et al[33] Japan | 2000 Abstract | 262 Tot 139 S 123 NAC + S | GC III/IV | 5FU + CDDP | Adv NAC + S | Adv NAC+S | Adv NAC + S P = 0.0996 | NR |
Wang et al[22] China | 2000 Paper | 60 Tot 30 S 30 NAC + S | EGJ NR | 5FU | Adv NAC + S | NR | Adv NAC + S P = 0.17 | NR |
Kobayashi et al[35] Japan | 2000 Paper | 171 Tot 80 S 91 NAC + S | AGC | FUDR | NR | NR | Adv S P = 0.010 | NR |
Hartgrink et al[4] The Netherlands | 2004 Paper | 59 Tot 30 S 29 NAC + S | Proper AGC (not EGC) | FAMTX | 32% CR or PR | EQUAL | Adv S 34% S vs 21% NAC + S P = 0.017 | At least 15 nodes |
Nio et al[36] Japan | 2004 Paper | 295 Tot 193 S 102 NAC + S | GC All stages > 50% stage I | UFT | NR | NR | Overall No Adv. NAC + S P = 0.6878 stage II/III -pN + Adv. NAC + S P = 0.0486 | D2 48% S 56% NAC + S |
Zhao et al[37] China | 2006 Paper | 60 Tot 20 5’-DFUR 20 5FU + CF 20 S | GC All stages | 5’-DFUR Or 5FU+CF | 5’-DFUR and 5FU + CF increase AI and reduce PI | NR | NR | NR |
Cunningham et al[17] United Kingdom | 2006 Paper | 503 Tot 250 S 253 NAC + S | GC, EGJ, LE All stages | Epirubicin Cisplatinum 5-FU | Diameter 5 cm vs 3 cm P < 0.001 T1 + T2 stages > NAC + S P = 0.002 | NR | Adv NAC + S OS/DFS 23% S 36.3%/NAC+S HR 0.75/0.66 P = 0.009/0.001 more evident for EGJ | D2 40% S 42% NAC + S |
Schumacher et al[15] Germany | 2010 Paper | 282/144 Tot 72 S 72 NAC + S | GC, EGJ (Siewert II, III) stages III, IV | Cisplatinum + FF | Adv in S Tumor length, thickness and width and P Stages more | R0 67% S 81.9% NAC + S P = 0.036 LN + 76.5% S 61.4% NAC + S P = 0.018 | No Adv NAC + S 52 ms S 64 ms NAC + S HR = 0.84 P = 0.46 | D2 94% 92.6% S 95.7% NAC + S |
Imano et al[38] Japan | 2010 Paper | 63 Tot 16 S 15 CDDP 16 5-FU 16 5-FU + CDDP | GC NR | 5FU or CDDP or 5F +CDDP | 5-FU + CDDP Increases AI Reduces PI | NR | No differences in 4 arms | D2 in all arms |
Biffi et al[39] Italy | 2010 Paper | 240/70 Tot 35 S 34 NAC + S | EGJ (Siewert II, III), AG | TCF | 65% CR + PR | Adv NAC + S (P value NR) | not evaluated premature interruption for low accrual | D2 in almost all cases |
Qu et al[40] China | 2010 Paper | 78 Tot 39 S 39 NAC + S | AGC | Paclitaxel and FOLFOX4 | Adv NAC + S P = 0.001 | Adv NAC + S P = 0.025 | Adv NAC+S P = 0.006 at 2 yr | NR |
Ychou et al[18] France | 2011 Paper | 224 Tot 111 S 113 NAC + S | LE,EGJ,GC All stages | CDDP + 5FU | Adv NAC + S P = 0.054 | Adv NAC + S P = 0.04 | OS (NAC + S/S) = 38/24 HR = 0.69 P = 0.02 DFS (NAC + S/S) = 34/19 HR= 0.65 P = 0.003 more evident for EGJ | D2 recommended No data on the effect of D2 vs other LN dissection |
Table 3 Characteristics and outcomes of randomized controlled trial describing the type of lymph node dissection and the site of primary tumor in both arms
Ref. | No. patients randomization | Site of primary tumor | Node dissection (D1, D2, others) | Survival rate (HR, p) | HR for site of primary tumor |
Nio et al[36], 2004 | 295 Tot 193 S 102 NAC + S | Stomach | D2 in less than 50% overall 48% S 56% NAC + S | Overall No Adv NAC + S P = 0.6878 stage II/III -pN+ Adv NAC + S P = 0.0486 | NR |
Cunningham et al[17], 2006 | 503 Tot 250 S 253 NAC + S | Stomach 73.9% EGJ 11.5% LE 14.6% | D2 in less than 50% 40% S 42% NAC + S | Adv NAC + S OS/DFS 5 yr-SR 23%/NR S 36.3%/NR NAC + S HR = 0.75/0.66 P = 0.009/0.001 | HR LE 0.7 EGJ: 0.5 Stomach: 0.8 |
Schumacher et al[15], 2010 | 282/144 Tot 72 S 72 NAC + S | Stomach 47.2% EGJ 52.8% (Siewert II, III) | Proper D2 in 94% overall 92.6% S 95.7% NAC+S | No adv NAC + S 52 ms S 64 ms NAC + S HR = 0.84 P = 0.46 | NR |
Imano et al[38], 2010 | 63 Tot 16 S 15 CDDP 16 5-FU 16 5-FU + CDDP | Stomach | Proper D2 in all patients of both arms | No differences for all arms | NR |
Biffi et al[39], 2010 | 240/70 Tot 35 S 34 NAC + S | Stomach 59% EGJ 41% (Siewert II, III) | Proper D2 in almost all cases | not evaluated premature interruption for low accrual | NR |
Ychou et al[18], 2011 | 224 Tot 111 S 113 NAC + S | LE 11%, EGJ 64%, Stomach 25% | D2 recommended No data on LND performed | OS (NAC + S/S) 38/24 HR = 0.69 P = 0.02 DFS (NAC + S/S) 34/19 HR = 0.65 P = 0.003 | HR LE 1.14 EGJ 0.57 Stomach 0.92 |
Table 4 Survival results after surgery alone in reference centers
Study, country | Period | Setup | No. of patients | Node dissection | 5-yr OS rates |
Cunningham et al[17] United Kingdom | 1994-2002 | MC RCT | 503 | D2 in 40% S/42% NAC | NAC + S 36.3% Surgery alone 23% |
Ychou et al[18] France | 1995-2003 | MC RCT | 224 | No data on type of LND | NAC + S 38% Surgery alone 24% |
Maruyama et al[48] Japan | 1991-2009 | MC Retr | 11261 | D2 | AJCC Stage II 73.1% AJCC stage III 44.5% |
Wu et al[53] Taiwan | 1993-1999 | MC RCT | 110/111 | D1 vs D3 | D1 53.6%/ D3 59.5% |
Kim et al[49] South Korea | 2009-2011 | MC Retr | 1561 | D2 | AJCC Stage II 86.5% AJCC Stage III 63.7% |
Siewert et al[50] Germany | 1986-1989 | MC Prosp | 1096 | D2 | 46.60% |
Sue-Ling et al[51] United Kingdom | 1970-1989 | SI Prosp | 207 | D2 | 55% |
Viste et al[54] Norway | 1980-1990 | SI Retr | 105 | D2 | 47% |
Robertson et al[55] Hong Kong | 1987-1991 | SI RCT | 25/30 | D1 vs D2 | D1 45%/D2 35% |
Dent et al[56] South Africa | 1982-1985 | SS RCT | 22/21 | D1 vs D2 | D1 69%/D2 67% |
Bonenkamp et al[57] The Netherlands | 1989-1993 | MC RCT | 380/331 | D1 vs D2 | D1/D2: 45%/47% D2, pT2: 44% D2, pT3: 22% D2, LN-/LN+: 69%/30% |
Degiuli et al[13] Italy | 1998-2006 | MC RCT | 133/134 | D1 vs D2 | D1 /D2: 66.5%/64.2% D2 pT2-T4: 59% D2 pT2-pT4 N+: 51% |
- Citation: Reddavid R, Sofia S, Chiaro P, Colli F, Trapani R, Esposito L, Solej M, Degiuli M. Neoadjuvant chemotherapy for gastric cancer. Is it a must or a fake? World J Gastroenterol 2018; 24(2): 274-289
- URL: https://www.wjgnet.com/1007-9327/full/v24/i2/274.htm
- DOI: https://dx.doi.org/10.3748/wjg.v24.i2.274