Thödtmann F, Theiss F, Kemmerich M, Heinrich B, Laubenbacher C, Quasthoff S, Kau R, Herzog M, Diergarten K, Hanauske A R
III. Medical Department, Klinikum Rechts der Isar, Technical University, Munich, Germany.
Ann Oncol. 1998 Mar;9(3):335-7. doi: 10.1023/a:1008298915121.
Paclitaxel as single agent has shown marked activity in several malignancies. The aim of the present phase II trial was to determine the activity of paclitaxel/cisplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck.
200 mg/m2 paclitaxel was administered over three hours followed by cisplatin (100 mg/m2), repeated every 22 days. Twenty-eight patients were entered and received a total of 99 cycles (median 2, range 1-6). All patients were evaluable for toxicity, and 25 for response.
Hematologic toxicities included leukopenia CTC grade 3 in 13 patients, and grade 4 in five patients, neutropenia grade 3 in nine patients, and grade 4 in eight patients, grade 3 anemia and grade 2 thrombocytopenia in one patient each. Non-hematologic toxicities included hypotension grade 2 (six patients), grade 3 (four patients), and grade 4 (two patients). A decline in renal function was observed in 15 courses and 10 patients, leading to a median delay of 2.5 days. Neurosensory and neuromotor toxicity grade 1 were observed in 13 patients (grade 2: 12 patients; grade 3: one patient), myalgia grade 3 in one patient, asthenia grade 3 in two and grade 4 in one patient. Partial responses were observed in 12 patients for an overall response rate of 48% (95% CI: 28%-68%) with a median response duration of 6.5 months (range 1-10 months). Stable disease was observed in seven patients, of who two also had clinical benefit.
Paclitaxel 200 mg/m2 administered over three hours combined with cisplatin 100 mg/m2 is an active regimen warranting further evaluation.
紫杉醇作为单一药物已在多种恶性肿瘤中显示出显著活性。本II期试验的目的是确定紫杉醇/顺铂对转移性或复发性头颈部鳞状细胞癌患者的活性。
200mg/m²紫杉醇静脉滴注3小时，随后给予顺铂（100mg/m²），每22天重复一次。28例患者入组，共接受99个周期（中位数2个周期，范围1 - 6个周期）。所有患者均可评估毒性，25例可评估疗效。
血液学毒性包括13例患者白细胞减少症为3级，5例为4级；9例患者中性粒细胞减少症为3级，8例为4级；各有1例患者出现3级贫血和2级血小板减少症。非血液学毒性包括2级低血压（6例患者）、3级（4例患者）和4级（2例患者）。15个疗程和10例患者观察到肾功能下降，导致中位延迟2.5天。13例患者观察到1级神经感觉和神经运动毒性（2级：12例患者；3级：1例患者），1例患者出现3级肌痛，2例患者出现3级乏力，1例患者出现4级乏力。12例患者出现部分缓解，总缓解率为48%（95%CI：28% - 68%），中位缓解持续时间为6.5个月（范围1 - 10个月）。7例患者病情稳定，其中2例也有临床获益。
3小时内静脉滴注200mg/m²紫杉醇联合100mg/m²顺铂是一种有效的治疗方案，值得进一步评估。
