title: Successful outcomes using combination therapy of interleukin-2 and interferon-alpha for renal cell carcinoma patients with lung metastasis.
abstract: OBJECTIVE
  In our previous study, a combination therapy of interleukin-2 and interferon-alpha was found to be more effective than monotherapy, especially for lung metastasis. In order to determine the genetic markers of those who positively responded, a multi-institutional open study was conducted on the patients with lung metastasis. In this paper, the clinical response to our combination therapy is reported.
  
  
  METHODS
  Untreated patients with lung metastasis were enrolled in this study. Patients received interleukin-2 (0.7 x 10(6) U/day) and interferon-alpha (6 x 10(6) IU/day): interleukin-2, 5 days a week and interferon-alpha, 3 days a week for the first 8 weeks, and then both interleukin-2 and interferon-alpha, 2 or 3 days a week for 16 additional weeks.
  
  
  RESULTS
  Forty-two patients were able to be evaluated for response. The overall positive response rate was 35.7% (15 of 42) including 2 patients with complete response. Progression-free patients were observed more frequently in patients with lung metastasis only (80.6%) than those with lung plus other organ metastasis (54.5%). Tumor shrinkage was observed in 81.0% (34 of 42) of patients. Progression-free survival rate at 200 days was 63.6%. Toxicities observed were primarily flu-like symptoms due to the cytokines and were typical of those observed with each single agent.
  
  
  CONCLUSIONS
  Combination therapy of interleukin-2 and interferon-alpha was confirmed to be effective for renal cell carcinoma patients with lung metastasis. Identification of genetic markers is now ongoing with the tissue samples from this trial.
authors.affiliation: Department of Urology and Andrology, Graduate School of Comprehensive Human Science, University of Tsukuba, Tsukuba, Ibaragi, Japan. akazah@md.tsukuba.ac.jp
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Koji
authors.initials: K
authors.lastname: Kawai
authors.forename: Taiji
authors.initials: T
authors.lastname: Tsukamoto
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Fujioka
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.forename: Tadaichi
authors.initials: T
authors.lastname: Kitamura
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Ozono
authors.forename: Tsuneharu
authors.initials: T
authors.lastname: Miki
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Zembutsu
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Nakamura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D016898:Interferon-alpha; D007376:Interleukin-2