Table 2.
Prospective randomized controlled studies in ENKTCL.
| Author | Disease stage | Treatment modality | Arm | N | CR rate (%) | PFS (%) | OS (%) |
|---|---|---|---|---|---|---|---|
| Ma et al., 2009 (93) | I/II | CT-RT | CEOP | 38 | 4CC: 21.1; ET: 94.4 | 2y: 65.8 | 2y: 73.3 |
| CEOP + semustine | 37 | 4CC: 27.1; ET: 87.1 | 2y: 62.2 | 2y: 62.2 | |||
| Wei et al., 2020 (69) | I/II | CT-RT-CT | SVILE | 36 | 3CC: 38.9; ET: 83.4 | 3y: 88.3 | 3y: 88.8 |
| P-GemOx | 33 | 3CC: 39.4; ET: 97.0 | 3y: 93.9 | 3y: 97.0 | |||
| Zhang et al., 2021 (77) | I/II | RT alone | RT | 35 | ET: 48.6 | 5y: 56.5 | 5y: 60.4 |
| CT-RT | DDGP | 30 | ET: 73.3 | 5y: 82.9 | 5y: 85.7 | ||
| Chai et al., 2022 (75) | I/II | RT-CT | GDP + chidamide | 37 | ET: 83.8 | 2y: 75.2; 5y: 67.5 | 2y: 89.2; 5y: 89.2 |
| GDP | 37 | ET: 78.4 | 2y: 70.2; 5y: 66.7 | 2y: 83.8; 5y: 81.0 | |||
| Huang et al., 2019 (143) a | I-IV | CT-RT | P-GemOx + thalidomide | 85 | 4CC: 60.0 | 3-y: 61.4 b | 3-y: 63.4 b |
| AspMetDex | 80 | 4CC: 55.0 | |||||
| Wei et al., 2020 (69) | III/IV | CT alone | SVILE | 16 | 3CC: 6.2; ET: 68.8 | 3y: 46.2 | 3y: 68.8 |
| P-GemOx | 18 | 3CC: 11.1; ET: 61.1 | 3y: 65.7 | 3y: 72.2 | |||
| Wang et al., 2022 (130) | III/IV c | CT alone | DDGP | 40 | ET: 67.5 | 3y: 56.5 | 5y: 74.3 |
| SMILE | 40 | ET: 47.5 | 3y: 41.8 | 5y: 51.7 |
CR, complete response; PFS, progression-free survival; OS, overall survival; CT, chemotherapy; RT, radiotherapy; CEOP, cyclophosphamide, vincristine, etoposide, and prednisone; CC, cycles of chemotherapy; ET, end of treatment; SVILE, ifosfamide, PEG-Asp, vindesine, etoposide, and dexamethasone; P-GemOx, PEG-Asp, gemcitabine, and oxaliplatin; DDGP, PEG-Asp, gemcitabine, cisplatin and dexamethasone; GDP, gemcitabine, cisplatin, and dexamethasone; AspMetDex, PEG-Asp, methotrexate, and dexamethasone; SMILE, dexamethasone, methotrexate, ifosfamide, L-asparaginase, and etoposide.
This was a multicenter randomized phase 2 trial. The analysis included 107 patents with newly diagnosed early-stage disease and 58 patients with advanced-stage or R/R disease. The CR rates were from patients with both early-stage and advanced-stage disease;
The survival data were for the whole cohort. Separate data for each arm were not reported;
This study adopted the CA staging system and included Ann Arbor stage II disease. PEG-Asp was used in the DDGP arm, while L-Asp in the SMILE arm.