Case Report
Copyright ©The Author(s) 2021.
World J Clin Cases. Apr 16, 2021; 9(11): 2542-2554
Published online Apr 16, 2021. doi: 10.12998/wjcc.v9.i11.2542
Table 1 Phase II published studies of neoadjuvant/preoperative radiation/chemoradiation following curative gastrectomy in gastric cancer (with or without esophagogastric junction)
Author
Year of published
N (RT + Surgery /RT)
Eligibility
Preoperative treatment arms
Surgery
Response rate
Survival
Adverse outcomes
Roth et al[21]200318/18Stomach, LAGCCF × 2 + RT (3 titers)D26% pCR, 50% ORR2-yr OS 71%, 3-yr OS 59%No TRM; no postoperative death; 17% minimal peritoneal carcinomatosis; 44% grade 3-4 AE
Skoropad et al[22]200367/91Stomach (43% distal), cM045 Gy/25 fractions + metronidazoleD1NA5-yr OS 46%, 10-yr OS 36%, MST 46 moNo TRM; 26% metastasis/inoperable; 6% postoperative death; 4% grade 4 AE
Ajani et al[23] 200429/33Stomach/EGJ (24% distal), cT2-3NxM0 or cT1N1M0 45 Gy/25 fractions + 5-FuD230% pCR, 55% ORR2-yr OS 54%, MST 34 mo3% TRM; 3% postoperative death; 12% metastasis/inoperable; no grade 4 AE
Ajani et al[24]200636/43Stomach/EGJ (23% antrum), cT2-3NxM0 or cT1N1M0 CF × 2 → 45Gy/25 fractions + 5-FuD2 recommended26% pCR. 1-yr OS 72%, MST 23 moNo TRM; no postoperative death; 17% progression; 5% grade 3 AE; 58% site failure
Wydmanski et al[25]200732/40Stomach, LAGC (31% middle/distal)45 Gy/25 fractions + 5-FuD2 recommended18% pCR, 38% ORR1-yr OS 75%, 2-yr OS 63%, MST not reach5% TRM; no postoperative death; 12.5% metastasis/inoperable; no grade 4 AE
Rivera et al[26]20118/13Stomach/EGJ (41% distal), initially unresectable cM0IC × 2 → 45 Gy/25 fractions + ICD1 and beyondNo pCR, 8% PR2-yr OS 27%, MST 10.5 mo (in 17 patients)15% TRM, 12.5% postoperative death; 23% metastasis/inoperable; 46% grade 3-4 neutropenia
Pera et al[27]201231/41Stomach/EGJ/Esophagus (29% stomach), locally advanced (M0)Oxaliplatin/cisplatin/5-FU + 45 Gy/25 fractionsD2 recommended22% pCR, 44% ORR2-yr OS 58%, MST 28 mo2% TRM; 13% postoperative death; 24% progression/inoperable; 14% grade 3-4 neutropenia
Michel et al[28]201431/42Stomach/EGJ (45% lower), cT > 2 or cN > 1 (M0)FOLFIRI × 4 → 50 Gy/25 fractions + 5-FuD2 recommended7% pCR2-yr OS 27%, MST 26 moNo TRM; 17% postoperative death; 6% metastasis; 41% grade 3-4 AE
Trip et al[29]201424/25Stomach, cTNM IB-IV (M0)45 Gy/25 fractions + TCD1+, D216% pCR, 77% ORRMST 15 moNo TRM; 4% postoperative death; 4% progression; no grade 4 AE
Liu et al[30]201833/36Stomach/EGJ, cTNM III (53% lower)SOX × 1 → 45 Gy/25 fractions + S-1 → SOX×1D2 recommended8% pCR, ORR 42%1-yr OS 92%, 2-yr OS 56%, MST 30 moNo TRM, no postoperative death; 3% metastasis; no grade 4 AE
Kim et al[31]201931/39Stomach/EGJ (33% antrum), high-riskTPS × 2 → 45 Gy/25 fractions + CSD210% pCR, 33% ORR3-yr OS 76%, MST not reachNo TRM; no postoperative death; 15% metastasis/inoperable; no grade 4 AE during CRT
Table 2 Phase III published and ongoing studies of neoadjuvant/preoperative radiation/chemoradiation following curative gastrectomy in gastric cancer (with or without esophagogastric junction)
Ref.
Trial (accrual period)
No pts
Eligibility
Treatment/Design
Surgery
Response rate
Survival
Adverse outcomes
Skoropad et al[32](1974-1978)102Stomach/EGJ, cM020 Gy/5 fractions → S vs SD1 and beyondNA5-yr OS 30% vs 39%, NS; 10-yr OS 32% vs 18%, NSComplications 57% vs 49%, NS; postoperative death 9.8% vs 11.8%, NS
Leong et al[33] TOPGEAR (2009-2014)75Stomach/EGJ, cTNM IB-IIICECF×2 → 45 Gy/25 fractions + 5-Fu→ S →ECF × 3 vs ECF × 3 → S →ECF × 3D2, D1+NAIn progressNo/noncurative surgery, 15% vs 10%, NS; Grade 3-4 AE 52% vs 50%, NS; surgical complications 22% vs 22% NS
https://clinicaltrials.gov/ct2/show/study/NCT01815853Neo-CRAG (2013-)620 (estimated)LAGC, cT3N2/N3M0, cT4aN+M0, cT4bNanyM045 Gy/25 fractions → XELOX × 3 → S → XELOX × 3 vs XELOX × 3 → S → XELOX × 3D2In progressIn progressIn progress
Liu et al[34]PREACT (2016-)682 (estimated)Stomach/EGJ, LAGCSOX × 1 → 45 Gy/25 fractions + S-1 → SOX × 1 → S → SOX × 3 vs SOX × 3 → S → SOX × 3D2 recommendedIn progressIn progressIn progress