Clinical outcome and prognostic survival factors in patients with advanced renal cell carcinoma treated with very low-dose interleukin-2, interferon-alpha, and tegafur-uracil: a single-institution experience.
BACKGROUND
The objective of the current study was to determine the efficacy and safety of very low-dose interleukin-2 (IL-2), interferon (IFN)-alpha, and tegafur-uracil for patients with unresectable renal cell carcinoma (RCC), metastatic RCC, or both. Clinical prognostic factors were also investigated.


METHODS
Fifty consecutive patients underwent a 3-week treatment cycle of IL-2 (0.7 x 10(6) Japanese reference units [JRU])/person on days 1-3 weekly), IFN-alpha (3 x 10(6) international units/person, on days 1-5 weekly), and tegafururacil (300 mg/person daily).


RESULTS
The median follow-up after treatment initiation was 11.3 months. A median of three (range, 1-20) treatment cycles was administered. Of 47 eligible patients, 4 had a treatment response (3 complete responses and 1 partial response; objective response rate, 8.5%). The median progression-free and overall survivals were 8.3 months (95% confidence interval [CI], 5.5-10.9 months) and 38.8 months (95% CI, 27.8-49.7 months), respectively. Only 8 patients had grade III/IV toxicities. Two parameters, i.e., the absence of a previous nephrectomy and a low hemoglobin level, were identified as independent factors predictive of poor survival. Patients with low or intermediate risk (presence of none or one of the two prognostic factors) had a durable median survival exceeding 30 months. High-risk patients with both risk factors had rapid disease progression despite treatment.


CONCLUSIONS
While the effectiveness of this immunochemotherapy resulted in a limited antitumor response, low-and intermediate-risk patients with metastatic RCC seemed likely to have a survival benefit. Patient selection is essential to enhance treatment efficiency and avoid useless treatment for high-risk patients.
Department of Urology, Jichi Medical University, Shimotsuke-shi, Tochigi, Japan. minoruk@jichi.ac.jp
Minoru
M
Kobayashi
Hitoshi
H
Ikeda
Akinori
A
Nukui
Kazumi
K
Suzuki
Yasuhiro
Y
Sugaya
Masayuki
M
Yuzawa
Tatsuo
T
Morita
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007167:Immunotherapy; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects
D016898:Interferon-alpha; D007376:Interleukin-2; D005641:Tegafur; D014498:Uracil