Table 5.
Summary of the endostatin clinical trials for head and neck squamous cell carcinoma.
| Reference, clinical trial number | Intervention | Phase | Completion year, Country | Treatment line | No. of patients | Follow-up | Evaluation criteria | CR | PR | ORR | SD | PD | DCR | OS | PFS | Conclusion |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 67 | N/A | 2016, China | First | Total: n = 23 | Median years | RECIST | N/A | N/A | N/A | N/A | 2-year OS | 2-year PFS | “The present study demonstrates that, compared with IMRT combined with chemotherapy, IMRT combined with endostar has similar efficacy in the treatment of locally advanced NPC, but significantly weaker acute adverse reactions, which improve the life quality of NPC patients.” | |||
| Control group: Radiotherapy with concurrent cisplatin | Control group: n = 13 | Control group: 49 | Control group: 61.5% (n = 8) | Control group: 38.5% (n = 5) | Control group: 69.6% | Control group: 67.3% | ||||||||||
| E10A group: 59 | ||||||||||||||||
| Endostar group: Radiotherapy with endostar | Endostar group: n = 10 | Endostar group: 60.0% (n = 6) p | Endostar group: 40.0% (n = 4) | Endostar group: 100.0% | Endostar group: 100.0% | |||||||||||
| 68 | Endostar with gemcitabine and cisplatin | II | 2014, China | Second | n = 28 | Median 56 years | RECIST | 50.0% (n = 14) | 35.7% (n = 10) | 85.7% (n = 24) | 3.6% (n = 1) | 10.7% (n = 3) | 89.3% | 1-year OS 90.2% | 1-year PFS 69.8% | “Our results of this study suggest that a combination of Endostar with GC chemotherapy can lead to effective tumour regression, control disease progression, and improve prognosis in M NPC. Therefore, a combined Endostar and GC regimen should be considered as a potential treatment for patients with M NPC.” |
| NCT01612286 | Median PFS 19.4 months | |||||||||||||||
| (95% CI 66.42-95.31) | (95% CI 70.65-97.20) | (95% CI 13.6–25.1 months) | ||||||||||||||
| 69 | II | 2010, China | Not stated | Total: n = 135 | Median years | RECIST | Median months | Median months | “In summary, E10A plus chemotherapy is a safe and effective therapeutic approach in patients with advanced head and neck squamous cell carcinoma or nasopharyngeal carcinoma.” | |||||||
| NCT00634595 | Control group: Cisplatin and paclitaxel | Control group: n = 67 | Control group: 51 | Control group: 1.5% (n = 1) | Control group: 28.4% (n = 19) | Control group: 29.9% (n = 20) | Control group: 52.2% (n = 35) | Control group: 19.4% (n = 13) | Control group: 80.6% (n = 54) | Control group: 14.53 months | Control group: 3.60 months | |||||
| E10A group: Cisplatin and paclitaxel with endostatin (E10A) | E10A group: n = 68 | E10A group: 53 | EA10 group: 4.4% (n = 3) | EA10 group: 35.3% (n = 24) | E10A group: 39.7% (n = 27) | E10A group: 55.9% (n = 38) | E10A group: 7.4% (n = 5) | E10A group: 92.6% (n = 63) | E10A group: 19.10 months | E10A group: 7.03 months |
CDR, disease control rate; CI, confidence interval; CR, Complete response rate; HR, hazard ratio; IMRT, intensity-modulated radiation therapy; N/A, not available; NPC, nasopharyngeal carcinoma; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression free survival; PR. Partial response rate; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease; WHO, World Health Organization criteria.