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©The Author(s) 2022.
World J Gastrointest Oncol. Jan 15, 2022; 14(1): 181-202
Published online Jan 15, 2022. doi: 10.4251/wjgo.v14.i1.181
Published online Jan 15, 2022. doi: 10.4251/wjgo.v14.i1.181
Table 4 Clinical trials comparing chemotherapy regimens
Study name/phase | Size/stage/primary tumor location/histology | Intervention | Primary endpoint |
ECOG E7296/phase II[74] | 38 patients/T2N1-2, T3-4Nany/stomach 45% GEJ 55%/adenocarcinoma 95% SCC 5% | E: neoadjuvant cisplatin, paclitaxel → surgery → 5-FU/LV + 45 Gy radiation | Tolerability: 66% grade 3/4 toxicities during neoadjuvant treatment 7.9% completed per protocol treatment |
CALGB 80803/ Phase II[76] | 241 patients/T1N1-3M0, T2-4NanyM0 (resectable)/esophagus GEJ adenocarcinoma | E1: induction oxaliplatin, 5-FU/LV OR E2: induction carboplatin, paclitaxelAND PET scan → non-responders change chemotherapy arm, responders continue → chemotherapy + 50,4 Gy radiation → surgery (both arms) | pCR: 18% [95%CI (7.5-33.5)] experimental 1; and 20% [95%CI (10, 33.7)] experimental 2 of PET non-responders who switched chemotherapy arm achieved pCR |
E1201/phase II[77] | 81 patients/II-Iva/esophagus GEJ/adenocarcinoma | E1: preoperative cisplatin, irinotecan + 45 Gy radiation → surgery → cisplatin, irinotecan OR E2: preoperative cisplatin, paclitaxel + 45 Gy radiation → surgery → cisplatin, paclitaxel | pCR: 15.4%, exact, unadjusted 90% binomial CI: 6.9%-28.1% experimental 1 and 16.7%, exact, unadjusted 90% binomial CI: 8.1%-29.0% experimental 2 achieved pCR |
RTOG-0114/phase II[78] | 73 patients/IB-IIIB/stomach/adenocarcinoma | Gastrectomy (both arms) AND E1: cisplatin, paclitaxel, 5-FU + 45 Gy radiation OR E2: cisplatin, paclitaxel + 45 Gy radiation | DFS rate: E1 closed early due to toxicity (14.6 m DFS) 52% (95%CI: 36%-68%) experimental 2 2-yr DFS |
NCCTG N0849/phase II[79] | 42 patients/T3-4N0, TanyN+/III-IVA/esophagus/55% GEJ 40% cardia 3.6% adenocarcinoma | E: induction docetaxel, oxaliplatin, capecitabine OR C: no induction AND oxaliplatin, 5-FU + 50.4 Gy radiation → surgery (both arms) | pCR: 33% experimental and 48% control achieved pCR |
CALGB 80101/phase III[80] | 546 patients/IB-IV (M0)/stomach 78% (4% proximal gastric, 41% distal gastric, 15% stomach NOS, 17% multicentric) GEJ 22%/adenocarcinoma | Surgery (both arms) AND E: epirubicin, cisplatin, 5-FU → 5-FU + 45 Gy radiation → chemotherapy OR C: 5-FU/LV → 5-FU + 45 Gy radiation → chemotherapy | OS rate: 44% control vs 44% experimental multivariate HR 0.98 (95%CI: 0.78-1.24, P = 0.69) 5-yr OS |
PRODIGE5/ACCORD17 phase II/III[81] | 259 patients/I-IVA/esophagus/adenocarcinoma 14% SCC 86% | E: oxaliplatin, 5-FU/LV + 50 Gy radiation OR C: cisplatin, 5-FU + 50 Gy radiation | mPFS: 9.7 m experimental vs 9.4 m control HR 0.93 (95%CI: 0.70-1.24, P = 0.64) |
- Citation: Charalampakis N, Tsakatikas S, Schizas D, Kykalos S, Tolia M, Fioretzaki R, Papageorgiou G, Katsaros I, Abdelhakeem AAF, Sewastjanow-Silva M, Rogers JE, Ajani JA. Trimodality treatment in gastric and gastroesophageal junction cancers: Current approach and future perspectives. World J Gastrointest Oncol 2022; 14(1): 181-202
- URL: https://www.wjgnet.com/1948-5204/full/v14/i1/181.htm
- DOI: https://dx.doi.org/10.4251/wjgo.v14.i1.181