Department of Gynecology and Obstetrics, Maasstad Hospital, Rotterdam, The Netherlands; Department of Gynecology, Leiden University Medical Center, The Netherlands.
Eur J Cancer. 2010 Mar;46(5):880-4. doi: 10.1016/j.ejca.2009.12.012. Epub 2010 Jan 13.
Early ovarian cancer patients are often incompletely staged during initial surgery.(1-3) This omission can have serious adverse consequences for the prognosis of patients as the completeness of surgical staging has been identified as an independent prognostic parameter for survival.(4,5) The reasons for the problem of inadequate staging of early ovarian cancer are largely unknown. We have analysed the data of a large randomised trial in early ovarian cancer in which detailed information of the surgical staging procedure was monitored.(5)
Data of the EORTC Adjuvant ChemoTherapy In Ovarian Neoplasm (ACTION) Trial were used in which 448 early ovarian cancer patients were randomised between postoperative chemotherapy in one arm and observation following surgery in the other. In this trial strict criteria for surgical staging were advised but optimal, complete staging was performed in only 1/3 of patients. Staging characteristics of the incompletely staged patients were analysed and factors that could explain the failure to perform a complete staging were studied.
Sampling of para-aortic nodes was omitted in 78% of the incompletely staged patients, while 52% of these patients had no pelvic lymph node dissection. Taking blind biopsies from different peritoneal sites was not performed in more than 1/3 of the incompletely staged group. Omission of the staging steps ranged from 3% (infracolic omentectomy) to 55% (biopsy of the right hemi-diaphragm). A significant difference (p=0.04) between the fraction of completely staged patients was found when comparing institutes who entered less than 5 patients (21%) versus those who included more than 20 patients (37%) in the trial.
Even in a randomised trial in which comprehensive surgical staging was strongly advised in the study protocol the majority of patients (66%) were incompletely staged. Factors relating to a lack of surgical skills attributed most to the number of incompletely staged patients, but insufficient knowledge of the tumour behaviour and routes of spread of ovarian cancer also contributed substantially to this problem. Multicentre trials recruiting patients from many institutes with small volume contribution to the study, run the risk of inadequate adherence to the study protocol.
早期卵巢癌患者在初次手术中常常无法进行完整分期。（1-3）这种遗漏会对患者的预后产生严重的不利后果，因为手术分期的完整性已被确定为生存的独立预后参数。（4,5）早期卵巢癌分期不足的原因在很大程度上尚不清楚。我们分析了一项大型早期卵巢癌随机试验的数据，该试验中详细监测了手术分期过程的信息。（5）
使用 EORTC 辅助化疗治疗卵巢肿瘤（ACTION）试验的数据，该试验中 448 名早期卵巢癌患者被随机分为术后化疗组和手术后观察组。在该试验中，建议采用严格的手术分期标准，但只有 1/3 的患者进行了最佳、完整的分期。分析了分期不完整患者的分期特征，并研究了导致无法进行完整分期的因素。
在分期不完整的患者中，78%的患者未行腹主动脉旁淋巴结取样，而其中 52%的患者未行盆腔淋巴结清扫术。在分期不完整组中，超过 1/3的患者未进行从不同腹膜部位进行盲式活检。未进行分期步骤的范围从 3%（结肠下网膜切除术）到 55%（右半膈肌活检）。在比较入组患者少于 5 例（21%）和入组患者超过 20 例（37%）的机构时，发现完全分期患者的比例存在显著差异（p=0.04）。
即使在一项随机试验中，研究方案强烈建议进行全面的手术分期，但仍有大多数（66%）患者分期不完整。与手术技能缺乏相关的因素是导致分期不完整患者数量最多的因素，但对肿瘤行为和卵巢癌播散途径的了解不足也在很大程度上导致了这一问题。招募来自许多机构的患者且每个机构贡献的样本量较少的多中心试验存在研究方案依从性不足的风险。
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