Burris H A, Vogel C L, Castro D, Mishra L, Schwarz M, Spencer S, Oakes D D, Korey A, Orenberg E K
Brooke Army Medical Center, Fort Sam Houston, Texas, USA.
Otolaryngol Head Neck Surg. 1998 Apr;118(4):496-503. doi: 10.1177/019459989811800412.
Intratumoral injections of cisplatin/epinephrine-injectable gel were administered weekly for 4 weeks in 45 patients with malignant tumors of various histologic types. Tumors were located on the skin and subcutaneous tissue primarily of the head, neck, and trunk, and on the tongue, oral pharynx, and esophagus. Patients were not candidates for surgery, radiation, or systemic chemotherapy. Each of the treated tumors (n = 82) was evaluated 2, 4, 8, and 12 weeks after the final injection. The initial dose of cisplatin was 1 mg/cm3 tumor volume, with escalation to 6 mg/cm3 allowed, depending on observed toxicities. The mean cumulative dose per patient for the four treatments ranged from 0.56 to 380 mg cisplatin. No dose-limiting cisplatin-related toxicities, such as nephrotoxicity, neurotoxicity, or ototoxicity, were observed. The overall objective tumor response rate was 50% (41 of 82), with 40% (33 of 82) complete responses and a median response duration of 160 days. Complete responses for adenocarcinoma and squamous cell carcinoma were 58% (21 of 36) and 38% (12 of 32), respectively. These results justified further clinical trials to evaluate the role of local chemotherapy with intratumoral cisplatin/epinephrine-injectable gel in the palliative treatment of patients with selected accessible solid tumors.
45例不同组织学类型恶性肿瘤患者接受了瘤内注射顺铂/肾上腺素可注射凝胶治疗，每周注射1次，共4周。肿瘤主要位于头、颈和躯干的皮肤及皮下组织，以及舌、口咽和食管。这些患者不适合手术、放疗或全身化疗。在最后一次注射后2、4、8和12周对每个治疗的肿瘤（n = 82）进行评估。顺铂的初始剂量为1mg/cm³肿瘤体积，根据观察到的毒性反应，允许剂量增至至6mg/cm³。每位患者4次治疗的顺铂平均累积剂量为0.56至380mg。未观察到与顺铂相关的剂量限制性毒性，如肾毒性、神经毒性或耳毒性。总体客观肿瘤反应率为50%（82例中的41例），完全缓解率为40%（82例中的33例），中位反应持续时间为160天。腺癌和鳞状细胞癌的完全缓解率分别为58%（36例中的21例）和38%（32例中的12例）。这些结果证明进一步开展临床试验是合理的，以评估瘤内注射顺铂/肾上腺素可注射凝胶进行局部化疗在选定的可触及实体瘤患者姑息治疗中的作用。
