[Clinical study on recombinant human interleukin-2 (Proleukin) in the treatment of metastatic renal cell carcinoma].
OBJECTIVE
To evaluate the efficacy and safety of subcutaneous injection of recombinant human interleukin-2 (Proleukin) in the treatment of metastatic renal cell carcinoma (RCC).


METHODS
Forty-one patients with pathologically confirmed metastatic RCC after radical nephrectomy were enrolled into this study. Two or four consecutive cycles of subcutaneous injection of rhLL-2 were given, with each cycle duration of five weeks consisting of 4 weeks of treatment and one week of rest. The rhLL-2 was injected twice daily subcutaneously at a dose of 9 MIU on D1-D5 during week one, then 9 MIU twice daily on D1-D2 and followed by 9 MIU daily on D3-D5 during week 2-4. Patients were evaluated after the second cycle of treatment. If an objective response or stable disease was observed, the patient would receive another two cycles of treeatment.


RESULTS
Of the 41 patients, the overall objective response rate was 17.1% (95% confidence interval, 5.6% to 28.6%) with a complete response (CR) rate of 0.0% and partial response rate (PR) of 17.1%. However, nineteen patients (46.3%) still had a stable disease (SD), and 15 (36.6%) had progressed disease (PD). The disease control rate was 63.4% and the median time to progression (mTTP) was 6 months. The 1-year survival rate was 71.2% with a median overall survival (mOS) rate of 22.5 months. Among 36 PP population, the overall objective response rate was 19.4% (95% confidence interval, 6.5% to 32.3%) with CR rate of 0.0% and PR rate of 19.4%. Sixteen patients(44.4%) had stable disease, and 13 (36.1%) progressed disease. The disease control rate was 63.9%. The 1-year survival rate was 66.7% with a median time to progression of 6 months. The median overall survival (mOS) had not reached yet. The follow-up data showed that the long term survival of the patient who responsed to the IL-2 therapy can be prolonged. Severe toxicity (> or = grade III) was rarely observed. Grade I or II toxicities such as fatigue (100.0%) and fever (82.9%) were frequently observed but reversible.


CONCLUSIONS
Subcutaneous injection of recombinant human interleukin-2 may prolong the survival of patients with a metastatic renal cell carcinoma. This regimen is tolerable with rare severe toxicities.
Sheng
Xi-Nan
XN
Department of Melenoma and Renal Cell Carcinoma, Beijing Cancer Hospital, Beijing 100036, China.
Li
Jun-Ling
JL
Guo
Jun
J
Zhao
Xiao-Hui
XH
Zhu
Jun
J
Chu
Da-Tong
DT
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D018450:Disease Progression; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008175:Lung Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009392:Nephrectomy; D016016:Proportional Hazards Models; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012074:Remission Induction; D015996:Survival Rate
D000970:Antineoplastic Agents; D007376:Interleukin-2; D011994:Recombinant Proteins; C082598:aldesleukin