[Phase II clinical trial of homemade human rh-endostatin in the treatment of patients with stage IIIB-IV non-small cell lung cancer].

BACKGROUND: To evaluate the efficacy and safety of homemade human rh-endostatin (YH-16) combined with NP regimen (vinorelbine+cisplatin) for stage IIIB-IV non small cell lung cancer (NSCLC), and to compare with NP regimen alone.
METHODS: Eighteen NSCLC patients were divided into two groups. Group A ( n =9) received YH-16 combined with NP plan. Group B ( n =9) received NP regimen. They were treated with 2 or 3 cycles of chemotherapy. The overall response, time to progression (TTP), quality of life (QOL) and safety were observed.
RESULTS: The overall response was 22.2% in group A, and 0% in group B ( P > 0.05). The clinical benefit rate was 100% in group A, and 44.4% in group B ( P < 0.05). There was no significant relationship between response and clinical pathological characteristics of patients ( P > 0.05). The TTP was 178.8±70.8 days in group A and 85.4±48.2 days in group B ( P < 0.05). The main toxicities of the two groups were hematological toxicities, nausea and vomiting. No significant difference in incidence of toxicity was observed between the two groups ( P > 0.05).
CONCLUSIONS: The rh-endostatin combined with NP regimen for NSCLC tends to show a better chemotherapeutic effect and less toxicity than NP regimen alone. It is worthy of extensive clinical trial.

RCT Entities:   Population Interventions Outcomes