Bachaud J M, Albin N, Gay C, Chatelut E, Benchalal M, David J M, Boneu A, Serrano E, Canal P, Daly-Schveitzer N
Département de radiothérapie, centre Claudius-Regaud, Toulouse, France.
Bull Cancer. 1994 Mar;81(3):212-8.
In order to enhance radiation effects in the treatment of unresectable Head and Neck squamous cell carcinoma, we initiated a phase I-II study in February 1991 with concomitant radiation and cisplatin in the treatment of resectable Head and Neck squamous cell carcinoma. The first patient was treated in a palliative intend for a cervical recurrence (cutaneous metastatic lymphangitis) of laryngeal cancer. The seven other patients had a Stage IV M0, previously untreated, oropharyngeal carcinoma. Standard external radiation was carried out up to a total dose of 60 Gy/6 weeks (7 MeV electron beam) for the 1st patient and 72 Gy/8 weeks (Co60 beam) for the 7 other patients. Cisplatin was given during the entire radiation treatment, by continuous infusion, 5 days a week, at doses of 4 mg/m2/d for the 1st patient, 5 mg/m2/d for the two following patients and 6 mg/m2/d for the last five patients. One patient with a poor initial performance status (three in the WHO scale) stopped his treatment on the 6th week due to a grade 3 mucositis with deglutition pneumonia. He died 2 months later with progressive carcinoma. For one other patient, treatment was discontinued for 1 week after 48 Gy, due to a grade 3 mucositis. The other patients completed the planned protocol without any interruption. Mucositis (grade 3 in two cases, grade 2 in four cases), dermitis (grade 3 in two cases, grade 2 in four cases) and neutropenia (grade 2 in two cases) were the most frequent acute toxicity. Of the seven patients treated with a curative intend, six are free of disease at 6 to 28 months after completion of treatment. A pharmacokinetic study showed a total platinum accumulation. The mean value at the end of treatment reached 1157 ng/ml. Only one patient experienced an accumulation of the ultrafilterable platinum (137 ng/ml at the end of treatment).
为提高不可切除的头颈部鳞状细胞癌的放疗效果，我们于1991年2月启动了一项I-II期研究，采用放疗联合顺铂治疗可切除的头颈部鳞状细胞癌。首例患者因喉癌颈部复发（皮肤转移性淋巴管炎）接受姑息性治疗。其他7例患者为IV期M0、未经治疗的口咽癌。首例患者采用标准外照射，总剂量达60 Gy/6周（7 MeV电子束），其他7例患者为72 Gy/8周（钴60射线）。在整个放疗期间持续输注顺铂，每周5天，首例患者剂量为4 mg/m²/d，接下来2例患者为5 mg/m²/d，最后5例患者为6 mg/m²/d。1例初始体能状态较差（WHO评分为3分）的患者因3级黏膜炎伴吞咽性肺炎在第6周停止治疗。2个月后因癌进展死亡。另1例患者在48 Gy后因3级黏膜炎中断治疗1周。其他患者均顺利完成既定方案。黏膜炎（2例为3级，4例为2级）、皮炎（2例为3级，4例为2级）和中性粒细胞减少（2例为2级）是最常见的急性毒性反应。在接受根治性治疗的7例患者中，6例在治疗结束后6至28个月无疾病复发。一项药代动力学研究显示有铂的总蓄积。治疗结束时的平均值达到1157 ng/ml。仅1例患者出现可超滤铂的蓄积（治疗结束时为137 ng/ml）。
