Retrospective Study
Copyright ©The Author(s) 2021.
World J Gastrointest Oncol. Apr 15, 2021; 13(4): 252-264
Published online Apr 15, 2021. doi: 10.4251/wjgo.v13.i4.252
Table 6 Summaries of studies on neoadjuvant chemotherapy without radiotherapy
Study
Design
n
Eligibility
NAC regimen
CRT regimen
AC regimen
Response
Compliance
Recurrence
Survival
Koizumi et al[17]Phase II single-arm30Lower edge under S2, cT3-4FOLFOX (× 6)--pCR 6.7%NAC 93.3%LR 2 pts; DM 5 pts3Y-OS 95.7%
FORTUNE[18]Phase II single-arm106cT3-4, cN1-2, distal edge < 12 cm from AVmFOLFOXIRI (× 4-6)RT 50.4Gy/28Fx’s; mFOLFOX61 or RT 25Gy/5Fx’smFOLFOX6(× 6)pCR 20.4%; pCR 17.4% after NACNAC 100%--
Ishii et al[19]Prospectivesingle-arm26cT3-4 with cN0-2IFL (× 2)--Downstaging 57.0%; pCR 3.8%NAC 100%-5Y-OS 84.0%
FOWARC[20,21]Phase III RCT165cT3-4, N1-2-RT 45Gy/25Fx’s 5-FU5-FU (× 7)pCR 14.0%CRT 88.4%LR 8.0%3Y-OS 91.3%
165-RT 45Gy/25Fx’s mFOLFOX6mFOLFOX (× 7)pCR 27.5%CRT 94.9%LR 7.0%3Y-OS 89.1%
165mFOLFOX6 (× 4-6)-mFOLFOX6(× 6-8)pCR 6.5%NAC 94.5%LR 8.3%3Y-OS 90.7%
Schrag et al[22]Phase II single-arm32Distal edge within 5-12cm from AV, cT3N-, cT3N+mFOLFOX6/bevacizumab (× 6)RT 50.4Gy/28Fx’s 5-FU1FOLFOXpCR 25.0%NAC 93.8%LR 0; DM 12.5%4Y-OS 91.0%
N-SOG 03[23]Phase II single-arm32MR defined disease: Inferior margin below the S2 lower margin, MRF involved or threatened, cT3b-d, cT4, cN2CAPOX/bevacizumab (× 4)--T down staging 54.0% after surgery pCR 25.0%NAC 79.2%; CRT 94.7%--
GEMCAD 0801[24,32]Phase II single-arm46MR defined disease: Distal edge > 5 cm from AV, cT3 (≥ 2 mm from MRF)CAPOX/bevacizumab (× 4)--pCR 19.5%NAC 95.6%LR 2 pts; DM 8 pts; Both 1 pt-