Clinical observation on recombinant human endostatin combined with chemotherapy for advanced gastrointestinal cancer

To explore the clinical efficacy and toxic and side effects of recombinant human endostatin (rh- endostatin/endostar) combined with chemotherapy in the treatment of advanced gastric cancer.

A total of 70 patients with advanced gastrointestinal adenocarcioma confirmed by histopathology and/or cytological examination were divided into group A (37 patients) and group B (33 patients). Patients in group A were given intravenous drip of 15 mg endostar added into 500 mL normal saline, once every other day until the cessation of chemotherapy or patients' maximal tolerance to chemotherapy. Patients in group B received chemotherapy alone. Two groups selected the same chemotherapy regimens. FOLFIRI scheme: 90-min intravenous drip of 180 mg/m2 irinotecan, intravenous drip of 200 mg/m2 calcium folinate (CF) and 400 mg/m2 5-fluorouracil (5-Fu) on d1, and continuous intravenous pumping of 2 400 mg/m2 5-Fu for 46 h. FOLFOX4 scheme: intravenous injection of 85 mg/m2 oxaliplatin (L-OHP), 200 mg/m2 calcium folinate (CF) and 400 mg/m2 5-FU on d1 for 2 h, and then continuous intravenous pumping of 2 400 mg/m2 5-Fu for 46 h. XELOX scheme: oral administration of 1 500 mg/m2 xeloda (or tegafur 50~60 mg) in twice during d1~14 and intravenous drip of 135 mg/m2 L-OHP on d1 for 2 h. The modified FOLFOX scheme: intravenous injection of 135 mg/m2 L-OHP on d1 for 2 h, 200 mg/m2 CF and 1.0 g tegafur during d1~5. Whereas, control Group B received chemotherapy regimens which were same as Group A, but no addition of endostar. Before chemotherapy, patients were given intravenous injection of 8 mg ondansetron, intramuscular injection of 10 mg metoclopramide and 20 mg diphenhydramine for prevention of vomiting, protection of liver and stomach as well as symptomatic supportive treatment. One cycle was 21 d, 4~6 cycles in total. The efficacy was evaluated every 2 cycles.

32 patients in Group A could be evaluated, and the response rate (RR) and disease control rate (DCR) were 59.38% and 78.13%, respectively. 31 patients in Groups could be evaluated, and the RR and DCR were 32.26% and 54.84%, respectively. The differences between 2 groups were significant. The toxic effects include myelosuppression, gastrointestinal reaction, fatigue, cardiotoxicity and peripheral neurotoxicity.

Preliminary observations show that endostar (once every other day) combined with chemotherapy is effective in the treatment of advanced gastrointestinal cancer, with low toxic effects, good tolerance, deserving further study.