Clinical study of sunitinib as first line treatment in 40 patients with metastatic renal cell carcinoma / 肿瘤研究与临床

ABSTRACT

Objective To evaluate the efficacy and safety of sunitinib as first line treatment in patients with metastatic renal cell carcinoma (mRCC).Methods A total of 40 patients with mRCC were treated with sunitinib between January 2009 and December 2011,including 27 males and 13 females.The median age was 59 (31-75) years old.All patients received a pathologic diagnosis of renal clear cell carcinomas with radical nephrectomy.All cases were treated with first line therapy.Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks,followed by 2 weeks off in 34 patients,while another 6 patients received 37.5 mg/d continuously until disease progression or unacceptable toxicities occurred.Overall response rate and safety were evaluated.Results The median follow up was 14 months (range 4-36 months).All patients could be evaluated the efficacy.17.5 ％ (7/40) patients achieved partial responses,77.5 ％ (31/40) atients were in stable and 2 (5.0 ％) patients were with disease progression including 1 death.The objective response rate was 17.5 ％ (7/40),and the disease control rate was 95.0 ％ (38/40).The most common side effects included fatigue 12 cases (30.0 ％),alopecia 3 cases (7.5 ％),thrombocytopenia 23 cases (57.5 ％),thyroid dysfunction 26 cases (65.0 ％),neutropenia 20 cases (50.0 ％),hypertension 18 cases (45.0 ％),hand-foot syndrome 17 cases (42.5 ％) and diarrhea 4 cases (10.0 ％).The major grade 3 adverse events included thrombocytopenia 2 cases (5.0 ％) and edema 1 case (2.5 ％).Most adverse events were ameliorated by treatment interruption.Conclusion Sunitinib has definitive efficacy for patients with mRCC with slight side effects.