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10.1245/ASO.2006.08.035
Annals of Surgical Oncology 13:1078-1084 (2006)
© 2006 Society of Surgical Oncology
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Original Article

Pilot Study of Oncolytic Viral Therapy Using Mutant Herpes Simplex Virus (HF10) Against Recurrent Metastatic Breast Cancer

Hideto Kimata, MD, PhD1, Tsuneo Imai, MD, PhD1, Toyone Kikumori, MD, PhD1, Osamu Teshigahara, MD, PhD1, Tetsuro Nagasaka, MD, PhD2, Fumi Goshima, MD, PhD3, Yukihiro Nishiyama, MD, PhD3 and Akimasa Nakao, MD, PhD1

1 Department of Surgery II, Graduate School of Medicine, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
2 Department of Histopathology, Graduate School of Medicine, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
3 Department of Virology, Graduate School of Medicine, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan

Correspondence: Address correspondence and reprint requests to: Akimasa Nakao, MD, PhD; E-mail: nakaoaki{at}med.nagoya-u.ac.jp.

Background: An oncolytic herpes simplex virus type 1 mutant (HF10) has been isolated and evaluated for antitumor efficacy in a syngeneic immunocompetent mouse model, where it was effective against cancer and conferred resistance to rechallenge with tumor cells in all surviving mice. Several studies have shown that HF10 is effective and safe for use against localized or peritoneally disseminated nonneuronal malignant tumors in animals.

Methods: A pilot study using HF10 was initiated in six patients with cutaneous or subcutaneous metastases from breast cancer. For each patient, .5 mL of HF10 suspension containing various viral doses was injected into one nodule; .5 mL of sterile saline was injected into another. All patients were monitored for local and systemic adverse effects. Nodules were excised 14 days after injection for histopathologic studies.

Results: All patients tolerated the intratumoral injection of HF10. No adverse effects occurred, and histopathological evaluation revealed 30% to 100% cancer cell death.

Conclusions: This pilot study found HF10 to be safe and effective against metastatic breast cancer.

Key Words: Oncolytic viral therapy • Herpes virus therapy • Breast cancer • Clinical study • Cancer • UL56






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