The preliminary results of docetaxel-prednisolone combination therapy for the Japanese patients with hormone-refractory prostate cancer

Abstract

Between April 2004 and August 2005, we used docetaxel in combination with prednisolone to treat 14 patients with hormone-refractory prostate cancer (HRPC). Docetaxel was administered at a dose of 70 mg/m2 once every 21 days and oral prednisolone 5 mg was administered twice daily concurrently on days 1-21. The treatment was continued until disease progression or unacceptable adverse events occurred. Prostate specific antigen (PSA) was used as a tumor marker. PSA response was defined as a reduction from baseline of at least 50% that was maintained for 4 weeks. Five patients had measurable soft tissue lesions, which were nodal metastases in 4 and liver metastasis in 1. The median follow-up was 8.4 months. During follow-up, 5 patients died. The median treatment cycle was 7 cycles. Manifestations of hematologic toxicity included 11 patients (78%) with grade 3/4 neutropenia and only I with febrile neutropenia. Two patients with gastric hemorrhage and febrile neutropenia needed hospitalization. During follow-up, 8 patients (57%) achieved a PSA reduction from baseline of at least 50%. Three patients with nodal metastases and 1 patient with liver metastasis had partial response. Combined docetaxel and prednisolone was shown to be effective and feasible in Japanese patients.

【目的】ホルモン抵抗性前立腺癌に対しドセタキセル+プレドニゾロン療法を行い, その有用性を検討した。【対象・方法】対象は2004年4月以降に再燃前立腺癌と診断された14例。観察期間は8.4ヵ月, 7コース(5.5コース)施行した。プレドニゾロン(10mg/日)連日投与を併用しドセタキセル70mg/m2を21日毎に点滴投与を繰り返した。全例, 転移巣を有しており, 測定可能病変は4例がリンパ節, 1例は肝臓であった。原則として外来通院治療とした。【結果】14例中8例(57%)で腫瘍マーカーが50%以上減少した。測定可能病変とでは肝臓の1例とリンパ節の2例がPRとなった。鎮痛剤を使用していた7例中4例が減量・中止可能であった。貧血が2例で改善し, 1例で発熱も改善した。血液有害事象では好中球減少ではgrade3/4が11例であった。PDのため4例, 高度の皮膚粘膜病変のため1例が中止し, ステロイドによる出血性胃潰瘍, 帯状疱疹のため1例ずつが休薬となった。発熱性好中球減少のため1例が入院を要した。【結語】好中球減少症を高頻度に認めるが外来治療が可能であり, また抗腫瘍効果, 疼痛の改善においても有用と思われた。(著者抄録)