Randomized phase II trial on escalated doses of Rh-endostatin (YH-16) for advanced non-small cell lung cancer.
- Author:
Lin YANG
1
;
Jin-wan WANG
;
Yan SUN
;
Yun-zhong ZHU
;
Xia-qing LIU
;
Wei-lian LI
;
Li-jun DI
;
Pei-wen LI
;
You-liang WANG
;
Shu-ping SONG
;
Chen YAO
;
Li-fen YOU
Author Information
- Publication Type:Journal Article
- MeSH: Adolescent; Adult; Aged; Antineoplastic Agents; administration & dosage; therapeutic use; Carcinoma, Non-Small-Cell Lung; drug therapy; pathology; Disease Progression; Dose-Response Relationship, Drug; Drug Administration Schedule; Endostatins; administration & dosage; therapeutic use; Female; Humans; Lung Neoplasms; drug therapy; pathology; Male; Middle Aged; Neoplasm Staging; Quality of Life; Recombinant Proteins; administration & dosage; therapeutic use; Remission Induction
- From: Chinese Journal of Oncology 2006;28(2):138-141
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo investigate the response rate (RR), time to tumor progression (TTP), quality of life (QOL) and adverse reaction in the treatment of pretreated advanced non-small cell lung cancer (NSCLC) using escalated doses of rh-endostatin (YH-16), and to determine the optimal dose for clinical application.
METHODSIn this phase II randomized, controlled, multicenter trial, the patients were randomly divided into two groups to receive daily 3 hours intravenous infusion of either 7.5 mg x m(-2) or 15 mg/m(2) YH-16 for 28 days.
RESULTSTotally, 68 patients were entered and 60 patients were evaluable. There were no differences in RR (3.0% in both groups, P > 0.05), median TTP (ITT: 60 days versus 71 days, P > 0.05), QOL and incidence rate of adverse reactions (48.6% versus 38.7%, P > 0.05). No significant unexpected adverse events were observed.
CONCLUSIONRh-endostatin may have anti-tumor activity with high clinical benefit rate and is well tolerated in pretreated advanced NSCLC patients. The dose of 7.5 mg x (m(2))(-1) x d(-1) is clinically recommended.
