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Randomized controlled study of natural interferon α as adjuvant treatment for stage II or III renal cell carcinoma

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Abstract

Background

The prophylactic effect of postoperative interferon on recurrence and distant metastasis in stage II or III renal cell carcinoma is unclear. In most studies, interferon has been administered for 6 months or less. Therefore, we performed a clinical study of the efficacy of 1-year postoperative administration of natural interferon α, which is generally used in Japan.

Methods

The subjects were patients diagnosed with stage II or III renal cell carcinoma who underwent radical nephrectomy. The subjects were randomly allocated to receive an intramuscular injection of natural interferon α (3 million to 6 million units) 3 times a week for 1 year or to receive follow-up observation until recurrence or metastasis occurred. Chest and abdominal CT were performed once yearly for all patients. The primary endpoint was progression-free survival.

Results

From September 2001 to August 2006, a total of 107 patients were registered, but 7 subsequently withdrew from the study. Therefore, 100 patients were included in the analysis. The primary endpoint of progression-free survival did not differ significantly between the groups that received natural interferon α or follow-up observation (p = 0.456, log-rank test). However, peak hazards of progression in the interferon group were delayed for about 6–10 months compared with the observation group.

Conclusion

Progression-free survival showed no improvement after administration of natural interferon α to patients with stage II or III renal cell carcinoma for 1 year after radical nephrectomy. The peak hazards of progression might be delayed by about 6 months by interferon administration.

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Acknowledgments

Subjects were enrolled in the institutions listed below. We sincerely appreciate the cooperation of urologists in these institutions. Oji General Hospital, Iwate Medical University, Kuji Prefectural Hospital, Akita University, Tohoku University Hospital, University of Tsukuba, The Prefecture West General Hospital, The Jikei University, The Jikei University Aoto Hospital, The Jikei University Daisan Hospital, The University of Tokyo, Tokyo Teishin Hospital, Tokyo Metropolitan Police Hospital, Kitasato University, Kitasato Institute, Tokyo Women’s Medical University, Kanazawa University, University of Yamanashi, Hamamatsu University School of Medicine, Seirei Hamamatsu General Hospital, Shinsiro Municipal Hospital, Osaka Medical Center for Cancer and Cardiovascular Diseases, Kobe University, Hyogo Cancer Center, Nara Medical University, Wakayama Medical University, Rinku General Medical Center, Tottori University, Shimane University Faculty of Medicine, Okayama University, Mitoyo General Hospital, Onomichi Municipal Hospital, Yamaguchi University, Ube Industries, LTD. Central Hospital, Kokura Memorial Hospital, The University of Tokushima, Yashima General Hospital, Takamatsu Hospital, Kyushu University, National Kyushu Medical Center, Harasanshin Hospital, Kitakyushu Municipal Medical Center, Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Kitakyushu Municipal Wakamatsu Hospital, Saga Prefectural Hospital Koseikan, Kurume University, Nagasaki University, The Japanese Red Cross Nagasaki Genbaku Hospital, St. Francis Hospital, National Hospital Organization Nagasaki Medical Center, Kumamoto University, National Hospital Organization Kumamoto Medical Center, Oita University Faculty of Medicine Graduate School of Medicine.

Conflict of interest

All authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Pharmacoepidemiology, Kyoto University, Kyoto, Japan

    Shiro Hinotsu

  2. Department of Urology and Andrology, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan

    Koji Kawai

  3. Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan

    Seiichiro Ozono

  4. Department of Urology, Okayama Medical Center, Okayama, Japan

    Tomoyasu Tsushima

  5. Department of Urology, Saga Prefectural Hospital Koseikan, Saga, Japan

    Noriaki Tokuda

  6. Department of Urology, Nagasaki Municipal Hospital, Nagasaki, Japan

    Koichiro Nomata

  7. Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

    Seiji Naito

  8. Department of Strategic Investigation on Comprehensive Cancer Network, Research Center for Advanced Science and Technology, The University of Tokyo, 4-6-1 Komaba, Meguro-ku, Tokyo, 153-0041, Japan

    Hideyuki Akaza

Authors
  1. Shiro Hinotsu
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  2. Koji Kawai
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  3. Seiichiro Ozono
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  4. Tomoyasu Tsushima
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  5. Noriaki Tokuda
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  6. Koichiro Nomata
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  7. Seiji Naito
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  8. Hideyuki Akaza
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Corresponding author

Correspondence to Hideyuki Akaza.

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Hinotsu, S., Kawai, K., Ozono, S. et al. Randomized controlled study of natural interferon α as adjuvant treatment for stage II or III renal cell carcinoma. Int J Clin Oncol 18, 68–74 (2013). https://doi.org/10.1007/s10147-011-0345-9

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  • DOI: https://doi.org/10.1007/s10147-011-0345-9

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