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©The Author(s) 2024.
World J Gastrointest Oncol. Apr 15, 2024; 16(4): 1613-1625
Published online Apr 15, 2024. doi: 10.4251/wjgo.v16.i4.1613
Published online Apr 15, 2024. doi: 10.4251/wjgo.v16.i4.1613
Table 1 Baseline characteristics of clinical trials included in the meta-analysis
| Ref. | Treatment stage | Sample size | Male/female | Median age (IQR) | Trial Abbr. | Register No. | Tumor type | Intervention arm | Control arm | CPS subgroup | Reported outcomes |
| Janjigian et al[12] | Phase 3 | 1581 (789/792) | 1100/481 | 62 (54-69) vs 61 (53-68) | CheckMate 649 | NCT02872116 | G/GEJ/oesophageal adenocarcinoma | Nivolumab + XELOX (capecitabine and oxaliplatin) or FOLFOX (leucovorin, fluorouracil, and oxaliplatin) | XELOX (capecitabine and oxaliplatin) or FOLFOX (leucovorin, fluorouracil, and oxaliplatin) | ≥ 5, ≥ 1 | OS, PFS, ORR |
| Kang et al[11] | Phase 3 | 724 (362/362) | 523/201 | 63.5 vs 65 | ATTRACTION-4 | NCT02746796 | G/GEJ | Nivolumab plus oxaliplatin and capecitabine/s-1 | Placebo plus oxaliplatin and capecitabine/s-1 | NA | OS, PFS |
| Doki et al[18] | Phase 3 | 645 (321/324) | 528/117 | 64 (40-90) vs 64 (26-81) | CheckMate 648 | NCT03143153 | Advanced esophageal squamous-cell carcinoma | Nivolumab + chemotherapy (fluorouracil + cisplatin) | Chemotherapy | NA | OS, PFS, ORR |
| Shitara et al[10] | Phase 3 | 763 (257/250) | 257/250 | 62 (22-83) vs 62.5 (23-87) | KEYNOTE-062 | NCT02494583 | G/GEJ | Pembrolizumab + cisplatin + fluorouracil or capecitabine | Cisplatin + fluorouracil or capecitabine | ≥ 1, ≥ 10 | OS, PFS, ORR |
| Sun et al[16] | Phase 3 | 749 (373/376) | 625/124 | 64 (28-94) vs 62 (27-89) | KEYNOTE-590 | NCT03189719 | Advanced oesophageal cancer | Pembrolizuma + chemotherapy (5-fluorouracil plus cisplatin) | Placebo + chemotherapy (5-fluorouracil plus cisplatin) | CPS < 10, CPS ≥ 10 | OS, PFS, ORR |
| Xu et al[15] | Phase 3 | 650 (327/323) | NA | NA | ORIENT-16 | NCT03745170 | Advanced G/GEJ adenocarcinoma | Sintilimab combined with chemotherapy (CapeOX: oxaliplatin + capecitabine) | Placebo and chemotherapy (CapeOX: oxaliplatin + capecitabine) | CPS ≥ 5 | OS, PFS, ORR |
| Lu et al[14] | Phase 3 | 659 (327/332) | 567/92 | 63 (57-67) vs 63 (56-67) | ORIENT-15 | NCT03748134 | Oesophageal squamous cell carcinoma | Sintilimab combined with chemotherapy (cisplatin + paclitaxel or cisplatin + 5-fluorouracil) | Placebo and chemotherapy (cisplatin + paclitaxel or cisplatin + 5-fluorouracil) | CPS < 10, CPS ≥ 10, CPS < 5, CPS ≥ 5, CPS < 1, CPS ≥ 1 | OS, PFS, ORR |
| Luo et al[13] | Phase 3 | 596 (298/298) | 523/73 | 62 (56-66) vs 62 (56-67) | ESCORT | NCT03691090 | Esophageal squamous cell carcinoma | Camrelizumab combined with paclitaxel and cisplatin | Placebo and paclitaxel and cisplatin | TPS | OS, PFS, ORR |
| Xu et al[17] | Phase 3 | 649 (326/323) | 563/86 | 64 (59-68) vs 65 (58-70) | RATIONALE-306 | NCT03783442 | Esophageal squamous-cell carcinoma | Tislelizumab + chemotherapy [a platinum agent (cisplatin or oxaliplatin) + a fluoropyrimidine (fluorouracil or capecitabine) or paclitaxel] | Chemotherapy [a platinum agent (cisplatin or oxaliplatin) + a fluoropyrimidine (fluorouracil or capecitabine) or paclitaxel] | TAP | OS, PFS, ORR |
- Citation: Zhang XM, Yang T, Xu YY, Li BZ, Shen W, Hu WQ, Yan CW, Zong L. Effectiveness and tolerability of programmed cell death protein-1 inhibitor + chemotherapy compared to chemotherapy for upper gastrointestinal tract cancers. World J Gastrointest Oncol 2024; 16(4): 1613-1625
- URL: https://www.wjgnet.com/1948-5204/full/v16/i4/1613.htm
- DOI: https://dx.doi.org/10.4251/wjgo.v16.i4.1613