[A multicenter, randomized, double-blind, placebo-controlled safety study to
evaluate the clinical effects and quality of life of paclitaxel-carboplatin (PC)
alone or combined with endostar for advanced non-small cell lung cancer (NSCLC)]. [Article in Chinese]
Author(s): Han BH, Xiu QY, Wang HM, Shen J, Gu AQ, Luo Y, Bai CX, Guo SL, Liu WC, Zhuang ZX,
Zhang Y, Zhao YZ, Jiang LY, Shi CL, Jin B, Zhou JY, Jin XQ.
Affiliation(s): Shanghai Chest Hospital, Shanghai,China. email@example.com
Publication date & source: 2011, Zhonghua Zhong Liu Za Zhi. , 33(11):854-9
OBJECTIVE: To analyze the efficacy and quality of life and safety for paclitaxel
and carboplatin (TC) and TC combined with endostar in the treatment of advanced
non-small cell lung cancer (NSCLC).
METHODS: This is a prospective, multicenter, randomized, double-blind,
placebo-controlled clinical study. A total of 126 cases of untreated advanced
NSCLC were enrolled in this study. There were 63 patients in the TC control arm
and TC combined endostar arm, respectively. All enrolled patients were
continuously followed-up for disease progression and death.
RESULTS: The objective response rate (ORR) of TC combined with endostar arm was
39.3%, and that of TC control arm was 23.0%, P = 0.078. The progression-free
survival rates for TC combined with endostar arm and TC control arm were 78.3%
and 58.8%, respectively, in 24 weeks (P = 0.017). The hazard ratio for the risk
of disease progression was 0.35 (95%CI 0.13 to 0.90, P = 0.030). The median time
to progression (TTP) of the TC combined with endostar arm was 7.1 months and TC
arm 6.3 months (P > 0.05). The follow-up results showed that the median survival
time (mOS) of the TC + Endostar arm was 17.6 months; (95%CI 13.4 to 21.7 months),
and the TC + placebo arm 15.8 months (95%CI 9.4 to 22.9 months) (P > 0.05). The
quality of life scores (LCSS patient scale) after treatment of the TC combined
with endostar arm was improved, and that of the TC group was improved after
completion of two cycles and three cycles of treatment. The quality of life
scores compared with baseline after the completion of one cycle treatment was
significantly improved for both the TC combined with endostar arm (P = 0.028
and), and TC arm (P = 0.036). It Indicated that TC combined with endostar
treatment improved the patient's quality of life in the early treatment. The
difference of adverse and serious adverse event rates between the two groups was
not significant (P > 0.05).
CONCLUSIONS: Compared with TC alone treatmrnt, TC combined with endostar
treatment can reduce the risk of disease progression at early time (24 weeks),
increase the ORR, and can be used as first-line treatment for advanced NSCLC. The
TC combined with endostar treatment has good safety and tolerability, improves
the quality of life, and not increases serious adverse effects and toxicity for
patients with advanced NSCLC.