Frustaci S, Barzan L, Caruso G, Ghirardo R, Foladore S, Carbone A, Comoretto R, Serafini I, Monfardini S
Division of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.
Head Neck. 1991 Jul-Aug;13(4):291-7. doi: 10.1002/hed.2880130405.
Fifty-two consecutive patients, affected by large T2 (greater than 3 cm), T3, T4, N0, or N1 previously untreated squamous cell carcinoma of the head and neck, entered this phase I-II study. Treatment consisted of a continuous 8-day infusion on the following daily schedule: cisplatin 25 mg and bleomycin 15 mg administered for 4 and 20 hours, respectively. Technical-related toxicities were 1 case each of coagulation and displacement of the catheter and 1 case of reversible monoparesis of the contralateral arm. Drug-related relevant toxicities accounted for 4 cass of grade 3 or 4 leukopenia and 2 cases of peripheral palsy of the 7th and 12th cranial nerve, respectively. Forty-five of 50 evaluable patients obtained an objective response. In particular, 13 patients obtained a complete response, 22 a partial response greater than or equal to 75%, and 10 a partial response greater than or equal to 50%. Furthermore, 5 of 31 patients showed a complete pathologic disappearance of the tumor, whereas in 12 of 31 only a microscopic residue was found.
52例连续患者,患有大型T2(大于3cm)、T3、T4、N0或N1期先前未经治疗的头颈部鳞状细胞癌,进入了这项I-II期研究。治疗包括按照以下每日方案进行连续8天的输注:顺铂25mg和博来霉素15mg,分别输注4小时和20小时。与技术相关的毒性反应为:导管凝血和移位各1例,对侧手臂可逆性单瘫1例。与药物相关的相关毒性反应分别为4例3级或4级白细胞减少症以及2例第7和第12颅神经周围麻痹。50例可评估患者中有45例获得了客观缓解。具体而言,13例患者获得完全缓解,22例获得大于或等于75%的部分缓解,10例获得大于或等于50%的部分缓解。此外,31例患者中有5例肿瘤完全病理消失,而31例中有12例仅发现微小残留。