Division of Oncology and Hematology, National Cancer Center Hospital East, Chiba, Japan.
Am J Clin Oncol. 2010 Feb;33(1):32-5. doi: 10.1097/COC.0b013e31819ccc55.
Evaluation of the safety and efficacy of docetaxel and cisplatin in the treatment of unknown primary cancer.
Inclusion criteria included histologic evidence of carcinoma originating in an unknown primary organ, no prior chemotherapy, age range 20 to 75 years, WHO PS < or =3, measurable or evaluable lesions, and adequate organ function. Docetaxel (60 mg/m2) followed by cisplatin (80 mg/m2) was administered intravenously every 3 weeks. Patients were assessed for tumor response after 2 cycles of chemotherapy, and 4 additional cycles were administered unless disease progression was demonstrated.
Between September 1997 and September 2002, 45 patients were enrolled. The median age was 56.5 years (28-73 years), and their performance status (PS) were 0 (11 patients), 1 (26 patients), and 2 (6 patients), respectively, (2 patients were removed from the trial after initial enrollment). A total of 26 patients (60%) presented with lymphadenopathy, 14 patients (33%) with visceral disease, and 3 (7%) with bone and soft-tissue metastases. The overall response rate was 65.1% (4 complete response, 24 partial response, 8 NC, 7 progressive diseases: 95% confidence interval, 48.0-78.4). The median time to progression was 5.0 months. The median survival time was 11.8 months. No treatment-related deaths were observed. Commonly observed side effects included neutropenia (grade 3-4, 16 patients), nausea (grade 3, 13 patients), and nephrotoxicity (grade 2, 5 patients).
These results indicate that the combination of docetaxel and cisplatin is a safe and effective regimen for patients with unknown primary cancer.
评估多西紫杉醇和顺铂治疗不明原发癌的安全性和疗效。
纳入标准包括组织学证据表明癌起源于未知的原发器官，无先前化疗，年龄 20 至 75 岁，WHO PS <或=3，可测量或可评估的病变，以及足够的器官功能。多西紫杉醇（60mg/m2）随后静脉注射顺铂（80mg/m2），每 3 周一次。在化疗 2 个周期后评估患者的肿瘤反应，并且除非疾病进展，否则给予 4 个额外周期。
1997 年 9 月至 2002 年 9 月期间，共纳入 45 例患者。中位年龄为 56.5 岁（28-73 岁），其表现状态（PS）分别为 0（11 例）、1（26 例）和 2（6 例）（2 例患者在初始入组后被排除在试验之外）。共有 26 例（60%）患者出现淋巴结病，14 例（33%）患者出现内脏疾病，3 例（7%）患者出现骨和软组织转移。总缓解率为 65.1%（4 例完全缓解，24 例部分缓解，8 例 NC，7 例进展性疾病：95%置信区间，48.0-78.4）。中位无进展生存期为 5.0 个月。中位总生存期为 11.8 个月。未观察到与治疗相关的死亡。常见的不良反应包括中性粒细胞减少（3-4 级，16 例）、恶心（3 级，13 例）和肾毒性（2 级，5 例）。
这些结果表明，多西紫杉醇和顺铂联合治疗不明原发癌患者是一种安全有效的方案。
