Department of Gynecology, Leiden University Medical Center, Leiden, the Netherlands.
J Natl Cancer Inst. 2010 Jul 7;102(13):982-7. doi: 10.1093/jnci/djq149. Epub 2010 May 5.
A long-term follow-up analysis of the randomized clinical trial Adjuvant Chemotherapy in Ovarian Neoplasm (ACTION) from the European Organization for Research and Treatment of Cancer was undertaken to determine whether the original results with a median follow-up of 5.5 years could be verified after longer follow-up with more events. In the ACTION trial, 448 patients with early ovarian cancer were randomly assigned, after surgery, to adjuvant chemotherapy or to observation (no further treatment). The original analysis found that adjuvant chemotherapy improved recurrence-free survival but not overall survival and found in a subgroup analysis that completeness of surgical staging was an independent prognostic factor, with better recurrence-free and overall survival among those with complete (optimal) surgical staging. After a median follow-up of 10.1 years, we analyzed the more mature data from the ACTION trial and found support for most of the main conclusions of the original analysis, except that overall survival after optimal surgical staging was improved, even among patients who received adjuvant chemotherapy (hazard ratio of death = 1.89, 95% confidence interval = 0.99 to 3.60; overall two-sided log-rank test P = .05). More cancer-specific deaths were observed among nonoptimally staged patients (40 [27%] of the 147 deaths in the observation arm and 11 [14%] of the 76 deaths in the adjuvant chemotherapy arm) than among optimally staged patients (seven [9%] of the 75 deaths in the observation arm and 11 [14%] of the 76 deaths in the adjuvant chemotherapy arm) (two-sided chi(2) test for heterogeneity, P = .06). Thus, completeness of surgical staging in patients with early ovarian cancer was found to be statistically significantly associated with better outcomes, and the benefit from adjuvant chemotherapy appeared to be restricted to patients with nonoptimal surgical staging.
对欧洲癌症研究与治疗组织（EORTC）的辅助化疗卵巢癌随机临床试验（ACTION）进行了长期随访分析，以确定在更长的随访时间和更多事件后，最初的中位随访时间为 5.5 年的结果是否可以得到验证。在 ACTION 试验中，448 例早期卵巢癌患者在手术后被随机分配接受辅助化疗或观察（不进行进一步治疗）。原始分析发现辅助化疗改善了无复发生存率，但未改善总生存率，并且在亚组分析中发现手术分期的完整性是一个独立的预后因素，具有完整（最佳）手术分期的患者具有更好的无复发生存率和总生存率。在中位随访时间为 10.1 年后，我们分析了 ACTION 试验中更为成熟的数据，发现除了最佳手术分期后的总生存率得到改善外，原始分析的大多数主要结论都得到了支持，即使在接受辅助化疗的患者中也是如此（死亡风险比=1.89，95%置信区间=0.99 至 3.60；总双侧对数秩检验 P=0.05）。在非最佳分期患者中观察到更多的癌症特异性死亡（观察组的 147 例死亡中有 40 例[27%]，辅助化疗组的 76 例死亡中有 11 例[14%]），而非最佳分期患者中观察到更多的癌症特异性死亡（观察组的 75 例死亡中有 7 例[9%]，辅助化疗组的 76 例死亡中有 11 例[14%]）（两组之间的异质性检验，P=0.06）。因此，早期卵巢癌患者手术分期的完整性与更好的结果存在统计学显著关联，辅助化疗的益处似乎仅限于非最佳手术分期的患者。
