Flaherty L E, Liu P Y, Mitchell M S, Fletcher W S, Walker M J, Goodwin J W, Stephens R L, Sondak V K
Wayne State University School of Medicine, Detroit, Michigan 48201, USA.
Am J Clin Oncol. 1996 Apr;19(2):108-13. doi: 10.1097/00000421-199604000-00004.
Based on the reports of substantial improvement in the response rate w ith the addition of tamoxifen to a multiagent chemotherapy regimen for metastatic melanoma, Southwest Oncology Group (SWOG)-8921 was initiated. A prior regimen (SWOG-8804) of dacarbazine (DTIC) 750 mg/m(2) i.v. day 1 and cisplatin 100 mg/m(2) day 1 repeated every 3 weeks produced a 13% response rate in patients with metastatic melanoma without brain metastasis. SWOG-8921 using identical chemotherapy and schedule added tamoxifen 10 mg twice daily. There were 55 eligible patients registered, median age 52, with 37 men and 18 women. Fifty (91%) patients had evidence of visceral metastasis at registration. There were 10 responders (2 complete and 8 partial responses) for an 18% response rate (95% CI, 9-31%). The response rate in women was 28% (95% CI, 10-53%; in men, 14% (95% CI, 5-29%). Tamoxifen has produced a small increase in the response rate when added to the present combination and schedule of chemotherapy. Further Phase III trials will be necessary to assess whether there is a statistical advantage to the use of tamoxifen when combined with chemotherapy and whether there are statistical differences between men and women.
基于在转移性黑色素瘤多药化疗方案中添加他莫昔芬后缓解率显著提高的报告，西南肿瘤协作组（SWOG）开展了8921研究。之前的方案（SWOG - 8804）为静脉注射达卡巴嗪（DTIC）750 mg/m²第1天和顺铂100 mg/m²第1天，每3周重复一次，该方案在无脑转移的转移性黑色素瘤患者中产生了13%的缓解率。SWOG - 8921采用相同的化疗方案和疗程，并添加他莫昔芬每日两次，每次10 mg。登记了55例符合条件的患者，中位年龄52岁，其中男性37例，女性18例。50例（91%）患者在登记时有内脏转移证据。有10例缓解者（2例完全缓解和8例部分缓解），缓解率为18%（95%CI，9 - 31%）。女性的缓解率为28%（95%CI，10 - 53%）；男性为14%（95%CI，5 - 29%）。当添加到目前的化疗组合和疗程中时，他莫昔芬使缓解率略有提高。有必要进行进一步的III期试验，以评估他莫昔芬与化疗联合使用是否具有统计学优势，以及男性和女性之间是否存在统计学差异。
