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| |  Paclitaxel-Carboplatin Plus Endostatin Shows Promise for Patients With Advanced NSCLC: Presented at ASCO By Brian Hoyle CHICAGO -- June 9, 2010 -- Non-small-cell lung cancer (NSCLC) that has not been treated before responds favourably to treatment with paclitaxel-carboplatin administered in combination with a novel and more stable version of endostatin, with significant improvements in progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR), compared with treatment with paclitaxel/carboplatin alone. The research was presented by Baohui Han, MD, Shanghai Chest Hospital, Shanghai, China, at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 7. Endostatin is a naturally occurring fragment from type XVII collagen that is antiangiogenic by virtue of its inhibition of blood vessel growth and consequent starving of tumours. A new recombinant version of endostatin manufactured by the bacterium Escherichia coli has been engineered for increased stability. In a previous phase 3 trial in China involving 493 patients with stage IIIB and IV NSCLC patients, the new version of endostatin displayed clinically meaningful improvements in response rate and median time to progression (TTP), and CBR when used in combination with chemotherapy, with synergistic activity and a favourable toxic profile evident in patients with advanced cancer. To investigate the effect of the new version of endostatin more conclusively, the present study recruited 126 chemotherapy-naïve patients with NSCLC stage IIIB/IV aged 18 to 75 years from 10 hospitals in 7 cities throughout China from July 2007 to August 2008. All patients had stable disease or above after receiving their first-ever cycle of paclitaxel/carboplatin. Eligible patients were randomised to receive treatment with paclitaxel/carboplatin plus endostatin or paclitaxel/carboplatin plus. Both groups received 3 cycles of chemotherapy. The primary endpoint was TTP. Secondary endpoints were ORR, PFS, CBR, and safety. In the patients receiving paclitaxel/carboplatin alone, the ORR was 23.0%, while for those receiving paclitaxel/carboplatin plus endostatin, the ORR was significantly increased to 39.3% (P = .078). The CBR in the paclitaxel/carboplatin and paclitaxel/carboplatin plus endostatin groups was 67.2% and 90.2%, respectively (P = .004), and the median TTP was 6.3 months and 7.1 months, respectively. The 24-week hazard ratio (HR) was 0.416 (95% confidence interval, 0.209-0.827, P = .012). PFS in the paclitaxel/carboplatin and paclitaxel/carboplatin plus endostatin groups were 75% and 90%, respectively, at 16 weeks (P = .033), and 59% and 78% at 24 weeks (P = .017). Adverse events and serious adverse events occurred with similar frequency in both groups. The authors concluded that chemotherapy combined with the new version of endostatin might play a role in the improvement of response rate and the survival of patients with advanced NSCLC. However, longer-term survival of patients needs to be tracked to more conclusively establish this conclusion. While recognising the possible importance of the results, poster discussant Silvia Novello MD, Italian Università degli Studi di Torino, Torino, Italy, cautioned that the all-Chinese subject population and the use of a version of endostatin that is not readily available outside of China imposes possible ethnicity limitations on the findings. Funding for this study was provided by Boehringer Mannheim. [Presentation title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Effects of Paclitaxel-Carboplatin (TC) Alone or With Endostatin for Advanced Non-Small Cell Lung Cancer (NSCLC). Abstract 7527]
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