Hainsworth John D, Spigel David R, Litchy Sharlene, Greco F Anthony
Sarah Cannon Research Institute, Nashville, TN 37203, USA.
J Clin Oncol. 2006 Aug 1;24(22):3548-54. doi: 10.1200/JCO.2005.05.0575.
To evaluate the efficacy of chemotherapy with paclitaxel, carboplatin, and etoposide in advanced adult poorly differentiated neuroendocrine carcinomas.
Patients eligible for this multicenter, phase II trial had metastatic poorly differentiated neuroendocrine carcinoma and had received no previous treatment. Patients with a variety of known primary sites (excepting small-cell lung cancer) and patients with unknown primary site were eligible. Patients received four courses of chemotherapy with paclitaxel, carboplatin, and etoposide, administered at 3-week intervals. After completing four courses of treatment, patients with objective response or stable disease received three courses (24 weeks) of weekly paclitaxel.
Seventy-eight patients were treated; 62% had unknown primary site. Forty-one patients (53%) had major responses (complete response rate, 15%), and five patients remain disease free from 18 to 66 months after therapy. Response rates were similar regardless of histology (small-cell v poorly differentiated carcinoma) or primary site. The median, 2-year, and 3-year survivals for the entire group were 14.5 months, 33%, and 24%, respectively. Myelosuppression was the major toxicity, as has been reported previously with this regimen.
This prospective phase II trial provides additional evidence that this family of relatively uncommon carcinomas is initially chemosensitive, with a high overall response rate to combination chemotherapy and a minority of complete responses. The three-drug regimen evaluated in this trial is moderately toxic, and has no obvious efficacy advantages when compared with standard platinum/etoposide regimens. Treatment for advanced poorly differentiated neuroendocrine carcinoma should parallel treatments used for small-cell lung cancer.
评估紫杉醇、卡铂和依托泊苷联合化疗方案治疗晚期成人低分化神经内分泌癌的疗效。
符合这项多中心II期试验的患者患有转移性低分化神经内分泌癌,且此前未接受过治疗。各种已知原发部位(小细胞肺癌除外)及原发部位不明的患者均符合条件。患者接受四个疗程的紫杉醇、卡铂和依托泊苷联合化疗,每3周给药一次。完成四个疗程的治疗后,出现客观缓解或疾病稳定的患者接受三个疗程(24周)的每周一次紫杉醇治疗。
共治疗78例患者;62%的患者原发部位不明。41例患者(53%)有主要缓解(完全缓解率为15%),5例患者在治疗后18至66个月无疾病进展。无论组织学类型(小细胞癌与低分化癌)或原发部位如何,缓解率相似。整个组的中位生存期、2年生存率和3年生存率分别为14.5个月、33%和24%。骨髓抑制是主要毒性反应,此前已有关于该方案的报道。
这项前瞻性II期试验提供了更多证据,表明这类相对罕见的癌症最初对化疗敏感,联合化疗的总体缓解率较高,完全缓解的患者占少数。本试验评估的三药方案毒性中等,与标准铂类/依托泊苷方案相比无明显疗效优势。晚期低分化神经内分泌癌的治疗应与小细胞肺癌的治疗方法相似。