Frustaci S, Barzan L, Tumolo S, Comoretto R, Quadu G, Galligioni E, Lorenzini M, Crivellari D, Caruso G, Piccinin G
Cancer. 1986 Mar 15;57(6):1118-23. doi: 10.1002/1097-0142(19860315)57:6<1118::aid-cncr2820570610>3.0.co;2-5.
The authors report the final analysis of a prospective phase I-II study in 53 previously untreated patients with squamous cell carcinoma (48 patients) and other histologic classifications (5 patients) of the head and neck region. Treatment consisted of cisplatin 10 mg infused intra-arterially in a 12-hour period, twice a day for 5 to 10 days via an external infusion pump. After a rest period of 5 to 7 days treatment could be restarted, with the same schedule, until a maximal total dose of 400 mg or toxicity. Patients who received at least 200 mg of cisplatin were considered evaluable for response. In 3 patients catheterization was not performed because of technical difficulties, in 9 treatment was stopped before reaching the total dose of 200 mg, (because of catheter-related toxicity in 7 patients, drug toxicity in 1, and both toxicities in 1); therefore, the patients evaluable for response, drug toxicity and catheter toxicity were 41, 43, and 49 respectively. Overall, 8 patients (19.5%) obtained a complete response (CR) and 20 (48.8%) a partial response (PR) with an objective response rate (RR) of 68.3%. Eleven patients obtained a minor response (MR), whereas only 2 (4.8%) developed a progressive disease (PD). The figures, limited only to squamous cell carcinoma of oral cavity and oropharinx (33 patients), are as follows: CR 8 (24.2%), PR 17 (51.5%), MR 7 (21.2%), and PD 1 (3.0%) for an objective RR of 75.7%. No grade IV and only 5 grade III toxicity were observed; whereas the most frequent grade I and II drug-related toxicities were anemia, transient renal impairment, and thrombocytopenia. Catheter-related toxicity accounted for five central nervous system complications (three transient motor weaknesses, one hemiparesis, one embolism) and six local problems (one coagulation of the catheter, one displacement, and four local extravasations). Intra-arterial cisplatin is, in our experience, an effective treatment and further trials employing cisplatin combination chemotherapy are needed in order to establish the exact role of the intra-arterial approach before definitive local treatments.
作者报告了一项针对53例头颈部鳞状细胞癌（48例）及其他组织学类型（5例）的既往未接受过治疗的患者的前瞻性I-II期研究的最终分析结果。治疗方案为通过外置输液泵在12小时内动脉内输注顺铂10mg，每天2次，持续5至10天。经过5至7天的休息期后，可按相同方案重新开始治疗，直至最大总剂量达到400mg或出现毒性反应。接受至少200mg顺铂治疗的患者被视为可评估疗效。3例患者因技术困难未进行导管插入术，9例患者在达到200mg总剂量之前停止治疗（7例因导管相关毒性，1例因药物毒性，1例因两种毒性反应）；因此，可评估疗效、药物毒性和导管毒性的患者分别为41例、43例和49例。总体而言，8例患者（19.5%）获得完全缓解（CR），20例（48.8%）获得部分缓解（PR），客观缓解率（RR）为68.3%。11例患者获得轻微缓解（MR），而仅有2例（4.8%）出现疾病进展（PD）。仅局限于口腔和口咽鳞状细胞癌（33例患者）的数据如下：CR 8例（24.2%），PR 17例（51.5%），MR 7例（21.2%），PD 1例（3.0%），客观RR为75.7%。未观察到IV级毒性反应，仅5例出现III级毒性反应；而最常见的I级和II级药物相关毒性反应为贫血、短暂性肾功能损害和血小板减少。导管相关毒性导致5例中枢神经系统并发症（3例短暂性运动无力、1例偏瘫、1例栓塞）和6例局部问题（1例导管凝血、1例移位和4例局部外渗）。根据我们的经验，动脉内注射顺铂是一种有效的治疗方法，在进行确定性局部治疗之前，需要进一步开展采用顺铂联合化疗的试验，以确定动脉内治疗的确切作用。
