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[Efficacy and safety of rh-endostatin combined with docetaxel in second-line or intolerant toxicity for first-line treatment in patients with advanced non-small cell lung cancer].
- Source :
-
Zhonghua zhong liu za zhi [Chinese journal of oncology] [Zhonghua Zhong Liu Za Zhi] 2013 Aug; Vol. 35 (8), pp. 618-22. - Publication Year :
- 2013
-
Abstract
- Objective: To analyze the efficacy and safety of combination of rh-endostatin (Endostar) with docetaxel treatment on patients of non-small cell lung cancer (NSCLC) who presented PD or intolerable toxicity in/after first-line chemotherapy.<br />Methods: A randomized, double-blind, placebo-controlled and multi-center clinical trial was conducted. Patients with stage IIIB/IV of NSCLC experienced previous chemotherapy of one-regimen were screened for this trial. A total of 68 cases were included in this study. Single docetaxel and that combined with endostar were conducted in two arms. The response, time to progression (TTP) and adverse effects were observed in both arms.<br />Results: The objective response rate (ORR) and clinical benefit rate (CBR) were 0 and 62.5% in the combined arm, along with 0 and 53.3% in the single docetaxel arm, with a non-significant difference between the two groups (all P > 0.05), respectively. The median TTPs in the combined and single docetaxel arms were 2.63 and 2.07 months, respectively (P = 0.079). The median TTPs of the participants with progressive disease (PD) after first-line chemotherapy were 1.33 and 1.67 months in the combined and single docetaxel arms, respectively (P = 0.946). The median TTPs of the participants with intolerant adverse effects in first-line chemotherapy were 4.70 months and 3.17 months in the combined and single docetaxel arms, respectively (P = 0.070). The median TTPs of the patients with SD after 2 therapeutic cycles in the combined and single docetaxel arms were 6.23 months and 3.27 months, respectively (P = 0.040). The differences between two arms were non-significant in adverse, serious adverse and cardiovascular adverse effects (all P > 0.05).<br />Conclusions: Endostar may prolong TTP in patients with advanced NSCLC benefited from docetaxel treatment without increased toxicities.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Carcinoma, Non-Small-Cell Lung pathology
Disease Progression
Docetaxel
Double-Blind Method
Endostatins administration & dosage
Endostatins adverse effects
Female
Humans
Leukopenia chemically induced
Lung Neoplasms pathology
Male
Middle Aged
Neoplasm Staging
Neutropenia chemically induced
Prospective Studies
Remission Induction
Taxoids administration & dosage
Taxoids adverse effects
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Lung Neoplasms drug therapy
Subjects
Details
- Language :
- Chinese
- ISSN :
- 0253-3766
- Volume :
- 35
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Zhonghua zhong liu za zhi [Chinese journal of oncology]
- Publication Type :
- Academic Journal
- Accession number :
- 24314222