Resumen de Preliminary clinical study of weekly recombinant human endostatin as a hypoxic tumour cell radiosensitiser combined with radiotherapy in the treatment of NSCLC

Xiao-Dong Jiang, Yun Qiao, Peng Dai, Jin Wu, Da-An Song, Shi-Qiu Li, Yue-Wei Fan

• Objective To investigate the clinical effects and adverse effects of weekly recombinant human endostatin (RHES) as a hypoxic tumour cell radiosensitiser combined with radiotherapy in the treatment of non-small-cell lung cancer (NSCLC).

  Methods Fifty hypoxia-positive cases of pathology-diagnosed NSCLC (stage I�III) were randomly divided into a RHES+radiotherapy group (25 cases) and a radiotherapy alone group (25 cases). Intensity-modulated radiotherapy (IMRT) with a total dose of 60 Gy/30F/6W was adopted in the two groups. Target area included primary foci and metastatic lymph nodes. In the RHES+radiotherapy group, RHES (15 mg/day) was intravenously given during the first week. The therapeutic effects and adverse reactions were evaluated after treatment.

  Results In the RHES+radiotherapy and radiotherapy alone groups, the total effective rates (CR+PR) were 80% and 44% (?2=6.87, p=0.009), respectively. The one-year and two-year local control rates were (78.9±8.4)% and (68.1±7.8)% (p=0.027), and (63.6±7.2)% and (43.4±5.7)% (p=0.022), respectively. The median progression-free survival was (21.1±0.97) and (16.5±0.95) months, respectively. The one-year and two-year overall survival rates were (83.3±7.2)% and (76.6±9.3)% (p=0.247), and (46.3±2.4)% and (37.6±9.1)% (p=0.218), respectively.

  Conclusion RHES combined with radiotherapy within the first week has better short-term therapeutic effects and local control rate, and no severe adverse reactions in treatment of NSCLC. However, it failed to significantly improve the one-year and two-year overall survival rates.