Follow-up Evaluation of the Suitability, Efficacy and Safety of New Antineoplastic Drugs

OBJECTIVE To follow up and evaluate the suitability, effectiveness and safety of new antineoplastic drugs, so as to accumulate experience for improving drug supply, ensuring patient access and continuity of drug use, and promoting clinical rational drug use. METHODS Established the examination standards of pre-use indication of new antineoplastic drugs with reference to the instructions for the use of drugs. With reference to the Guiding Principles for Clinical Application of New Antineoplastic Drugs and Drug Instructions, a follow-up evaluation standard was established. The follow-up methodology was used to evaluate the suitability, effectiveness and safety of patients who had passed the review since the implementation of the pre-use review system of new antineoplastic drugs. RESULTS A total of 41 patients with new antineoplastic drugs were approved in 2018, and the results of suitability evaluation showed that 3 cases did not meet the indication of drug use and 2 cases did not meet the method of administration. The results of effectiveness evaluation showed that the objective response rate was 53.7%(22/41), and the disease control rate was 80.5%(33/41). As of May 2020, 24 patients had a progression-free survival period of more than 12 months, accounting for 58.5%(24/41), and 14 patients died, accounting for 34.1%(14/41). The results of safety evaluation showed that 7 cases did not test urine routine with bevacizumab and 4 cases did not check cardiac ultrasound with trastuzumab. Adverse reactions that may be caused by new antineoplastic drugs include:cardiac adverse reactions in 4 cases with trastuzumab, skin and subcutaneous tissue adverse reactions in 2 cases with sorafenib or oxetinib, and bleeding adverse reactions in 1 case with bevacizumab. The incidence of adverse reactions was 17.1%(7/41). CONCLUSION The implementation of the pre-use review system of new antineoplastic drugs can ensure the accessibility and continuity of drug use for patients. Clinical pharmacists should actively implement drug reorganization, pharmaceutical care and drug use education of new antineoplastic drugs to improve the suitability, effectiveness and safety of drug use for patients.