The study of sunitinib in the treatment of renal clear cell carcinoma

Abstract

Objective To summarize the safety and efficacy of Sunitinib in the treatment of metastatic renal clear cell carcinoma. Methods Fifteen patients with clear cell metastatic RCC were treated with Sunitinib,with 11 males and 4 females,aged from 26 to 74 years with median age of 55 years.Thirteen cases of 15 were T3 to T4 stage,and 8 cases underwent radical nephrectomy,while 5 other cases underwent renal biopsy with the pathological diagnosis of renal cancer.The other two cases (one man and one woman)with the solitary kidney renal cell carcinoma ( stage T1a) and renal insufficiency,were diagnosed as metastatic renal cell carcinoma by biopsy.Sunitinib monotherapy was administered by the regimen of 6 weeks per cycle with daily oral Sunitinib 4 weeks,followed by 2 weeks off ( from 1 - 10 cycles).Response was evaluated by RECIST.Renal tumor was 9.52 ± 3.3 cm in diameter at baseline,and the assessment of metastases included retroperitoneal lymph nodes (6 cases),mediastinal lymph nodes (3 cases),brain (2 cases),lung (6 cases),bone (2 cases) and liver (2 cases).Karnofsky score,tumor changes,adverse events and the survival of each patient was assessed and recorded. Results The follow-up duration was from 1.5 - 15months,with median follow-up of 6 months,and tumor response was evaluated by RECIST.Seven of 15 patients (46.7％) treated with Sunitinib achieved partial responses (PR),7 patients (46.7％) demonstrated stable disease (SD),and 1 patient (6.7％) developed progressive disease (PD) during the follow-up.Objective Response Rate (ORR) was 46.7％,PR + SD was 93.3％,6 months PFS was 93.3％,and median PFS was 12 months,respectively.Renal tumor was 8.7 ± 4.0 cm in diameter after therapy.Two PR patients with the obvious effectiveness had experienced progressed hypertension,and one cases with hypertension that could be controlled below 140/90 mm Hg ( 1 mm Hg =0.133 kPa) by a single drug before treatment,showed increased blood pressure ( ＞ 160/105 mm Hg) following the second cycles treatment,who were administered increased dosage and combination therapy.The other case without history of hypertension,showed high blood pressure ( ＞ 150/100 mm Hg) in the third cycle,and could be controlled well by antihypertensive drugs.Fortunately,the tumor of these two cases reduced obviously by more than 50％. 1/2 adverse reactions of 12 cases:yellowing of the skin and yellow sweat ( 12 cases,80％ ),fatigue ( 12 cases,80％ ),4 cases of hypothyroidism (26.7％),bilirubin and triglyceride levels elevated in 7case (46.7％); Four cases showed 3/4 degree adverse events with the emergence of gastrointestinal bleeding in one case secondary to platelets reduction (6.7％).Three cases (20％) showed serious fatigue,nausea,vomiting and severe hand-foot skin reaction. Conclusions Sunitinib is recommended for the treatment of metastatic renal clear cell carcinoma with good efficacy and safety. Key words: Carcinoma, renal cell; Sunitinib; Hypertension