Omura G A, Blessing J A, Major F, Lifshitz S, Ehrlich C E, Mangan C, Beecham J, Park R, Silverberg S
J Clin Oncol. 1985 Sep;3(9):1240-5. doi: 10.1200/JCO.1985.3.9.1240.
After hysterectomy, 156 evaluable patients with stage I (limited to the corpus) or stage II (limited to the corpus and cervix) uterine sarcomas were randomly assigned to adjuvant chemotherapy with Adriamycin (Adria Laboratories, Columbus, Ohio) for six months or to no further treatment. Pelvic irradiation (external or intracavitary) was optional before randomization. Of 75 patients receiving Adriamycin, 31 have suffered recurrences compared with 43 of 81 receiving no adjuvant chemotherapy. This difference is not statistically significant. Moreover, there is no difference in progression-free interval or survival. The optional radiotherapy did not influence the outcome although there was a suggestion that vaginal recurrence was decreased by pelvic radiotherapy. The recurrence rates in specific cell types (leiomyosarcoma, homologous mixed mesodermal sarcoma, or heterologous mixed mesodermal sarcoma) were not significantly different although the pattern of recurrence differed, with pulmonary metastases being more common in leiomyosarcoma and extrapulmonary recurrence being more common in mixed mesodermal sarcoma. The outcome with respect to chemotherapy was not altered even after adjusting for maldistribution of cases. Thus, we could not show a benefit for this dose schedule of Adriamycin as adjuvant treatment for uterine sarcomas.
子宫切除术后，156例可评估的I期（局限于宫体）或II期（局限于宫体和宫颈）子宫肉瘤患者被随机分为两组，一组接受阿霉素（阿德里亚实验室，俄亥俄州哥伦布市）辅助化疗6个月，另一组不再接受进一步治疗。随机分组前盆腔放疗（体外或腔内）为可选治疗。接受阿霉素治疗的75例患者中有31例复发，而未接受辅助化疗的81例患者中有43例复发。这种差异无统计学意义。此外，无进展生存期或生存率也无差异。尽管有迹象表明盆腔放疗可降低阴道复发率，但可选的放疗并未影响治疗结果。特定细胞类型（平滑肌肉瘤、同源性混合中胚层肉瘤或异源性混合中胚层肉瘤）的复发率无显著差异，尽管复发模式不同，平滑肌肉瘤肺转移更常见，混合中胚层肉瘤肺外复发更常见。即使在调整病例分布不均后，化疗的结果也未改变。因此，我们未能证明该剂量方案的阿霉素作为子宫肉瘤辅助治疗有获益。
