ABSTRACT
Objective To observe prospectively and systematically the effect and safety of rhendostati injection (endostar) combined with FOLFOX as a second line chemotherapy for advanced/metastatic colorectal cancer. Methods 23 patients with histological confirmed advanced/metastatic colorectal cancer after first line chemotherapy failure were observed. The dosage of 15 mg/time of endostar solved in 500ml normal saline was slowly intravenously dropped 4 h from day 1 to day 14. Oxaliplatin 85 mg/m~2 iv 2-3 h dl, d15. CF 200 mg/m~2 iv 2 h followed by 5-Fu 400 mg iv bolus and 5-Fu 600 mg/m~2 iv 22 h dl-2, d15-16 were given, every 4 weeks as one cycle. Efficacy was evaluated after 2 cycles according to RECIST criteria. Results 23 cases had been completed totally 56 cycles. Among 23 cases, 8 cases were PR, 12 cases SD, and 3 cases PD. The objective response rate (RR) was 34.8 % (8/23), and the disease control rate (DCR) was 87.0 % (20/23). The median time to progression was 7 months. The 1-year survival rate were 50.0 %. The 2-year survival rate was 40.0 %. The occurrence rate of G3/4 toxicities was low, including neutropenia(21.7 %), anemia(4.3 %), thrombocytopenia (13.0 %). Those toxicities were mainly related with the chemotherapy agents. Meanwhile transient electrocardiogram changes mild ST-T of changes occurred in 3 cases. 2 cases were mild hypertension and were symptomatically controlled. Conclusion There are better efficacies of endostar combined with FOLFOX chemotherapy for advanced/metastatic colorectal cancer, and it is low toxic and tolerable. It is worth of further clinical observation. More experiences need to be accumulated.
ABSTRACT
Objective To observe the effect and toxicity of oxaliplatin plus 5-Fu and CF (FOLFOX) vs irinteean plus 5-Fu and CF (FOLFIRI) in patients with advanced/metastatic colorectal cancer. Methods 67 patients with histologicaly confirmed advanced/metastatic colorectal cancer were non-randomized to enter the study. Patients for FOLFOX: oxaliplatin 85 mg/m2 iv 2 h d1.CF 200 mg/m2 iv 2 h followed by 5-Fu 250 mg iv bolus and 5-Fu 600 mg/m2 iv 22 h d1,2 were given, every 2 weeks as one cycle. FOLFIRI: irinotecan 150 mg/m2 iv d1. CF, 5-Fu do so. Efficacy was evaluated at 4 cycles. Results For 39 patients to FOLFOX and 37 patients to FOLFRI, the objective response rate (CR+PR) was 41.0 % vs 35.1%. The median time to progression was 5.2 months vs. 5.8 months in the FOLFOX and FOLFIRI arm. The median survival time was 13.2 months vs. 14.0 months in the FOLFOX and FOLFIRI arm respectively. The clinical benefit rate was 71.8 % vs 78.4 % in the FOLFOX and FOLFIRI ann respectively. There was no significantly differences between two arms (P>0.05). The most frequently observed toxicity reaction was hematological toxicity nausea/vomiting and neurn-sensory toxicity in FOLFOX arm, and hematological toxicity and diarrhea in FOLFIRI arm. FOLFIRI arm had a remarkably higher incidence rate of grade 3 diarrhea than FOLFOX arm(P<0.025). Conclusion FOLFOX and FOLFIRI arm provid high effective and well tolerable treatment for advanced/ metastatic colorectal cancer.