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J.C. Li



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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      MO25.06 - Phase I/II trial of recombinant human endostatin in combination with concurrent chemo-radiotherapy in the patients with stage III non-small-cell lung cancer (ID 2325)

      11:05 - 11:10  |  Author(s): J.C. Li

      • Abstract
      • Presentation
      • Slides

      Background
      Endostatin has been proved to be a potent endogenous angiogenic inhibitor. Recombinant human endostatin (Endostar) was reported to be efficient in blocking angiogenesis and suppressing tumor growth. Preclinical studies demonstrated that Endostar could normalize tumor vasculature, alleviate hypoxia and sensitize the function of radiation. This study was conducted to evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with stage IIInon-small-cell lung cancer (NSCLC).

      Methods
      Patients with unresectable stage IIINSCLC were eligible. Patients received Endostar (7.5 mg/m[2]/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m[2]) and cisplatin (65 mg/m[2]) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy. Primary end points included the short-term efficacy and treatment-related toxicity of Endostar combined with CCRT.

      Results
      In all, 50 patients were enrolled onto the study, and 48 were assessable. Median follow-up was 32.1 months. Response rate was 77%. The estimated median progression-free survival (PFS) was 10.2 months and the estimated median overall survival (OS) was 22.6 months. The 1-year and 2-year PFS rates were 48% and 25%, respectively. The 1-year and 2-year OS rates were 81% and 47%, respectively (Figure 1).Nine patients (19%) experienced grade 3 or higher treatment-related nonhematologic adverse events (AEs). Predominant nonhematologic toxicities were grade 3 esophagitis (n = 4; 8%), and grade 3 to 5 pneumonitis (n = 6; 13%). The rates of observed grade 3 and 4 hematologic AEs were 77% (n = 37). The predominant hematologic toxicity was grade 3 to 4 lymphopenia (n = 32; 67%) and neutropenia (n = 23; 48%). Overall, the entire treatment regimen was well tolerated. Figure 1 Figure 1

      Conclusion
      The combination of Endostar with CCRT is feasible and shows promising activity. This regimen should be studied further in patients with locally advanced NSCLC.

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