Secco Giovanni B, Fardelli Roberto, Gianquinto Daniela, Bonfante Pierfrancesco, Baldi Eleonora, Ravera Giambattista, Derchi Lorenzo, Ferraris Romano
DICMI - Sezione di Semeiotica Chirurgica I, University of Genoa School of Medicine, Genoa, Italy.
Eur J Surg Oncol. 2002 Jun;28(4):418-23. doi: 10.1053/ejso.2001.1250.
This paper aims to evaluate the diagnostic efficacy and costs of follow-up tailored according to risk of recurrence compared with minimal surveillance.
A total of 358 patients treated by surgery alone for colorectal cancer were prospectively divided into two groups of 200 and 158 patients considered at high and low risk of recurrence respectively, according to prognostic factors. They were further randomized into two subgroups: group 1, 192 patients undergoing risk-adapted follow-up, intensive and low-intensity; group 2, 145 patients undergoing minimal surveillance. Twenty-one cases dropped out. Median follow-up was 61.5 months and 42 months for cases at high risk (intensive follow-up) and at low risk (low-intensity follow-up) respectively.
At the end of the study, 52.6% of patients undergoing risk-adapted follow-up and 57.2% undergoing minimal follow-up had developed recurrence. In patients at high risk, a significant difference in the incidence of curative re-operations was observed between the subgroups undergoing risk-adapted follow-up and subgroups undergoing minimal surveillance (P<0.05). The actuarial 5 year survival of patients at high and at low risk of recurrence undergoing risk-adapted follow-up is significantly better than that of cases undergoing minimal follow-up. The economic costs for 34 patients in the intensive follow-up group and for the 57 patients in the low-intensity follow-up group who were free from disease after primary surgery was very similar.
Risk-adapted follow-up has significantly improved the targeting of curative re-operations and overall survival of patients independently of risk of recurrence and has allowed a reduction in the costs of following up of disease-free patients.
本文旨在评估根据复发风险进行的针对性随访与最低限度监测相比的诊断效能及成本。
共有358例仅接受手术治疗的结直肠癌患者,根据预后因素前瞻性地分为两组,分别为200例和158例,复发风险被认为高和低。他们又被进一步随机分为两个亚组:第1组,192例患者接受根据风险调整的随访,分为强化随访和低强度随访;第2组,145例患者接受最低限度监测。21例退出研究。高风险(强化随访)和低风险(低强度随访)病例的中位随访时间分别为61.5个月和42个月。
在研究结束时,接受根据风险调整随访的患者中有52.6%出现复发,接受最低限度随访的患者中有57.2%出现复发。在高风险患者中,接受根据风险调整随访的亚组与接受最低限度监测的亚组之间,根治性再次手术的发生率存在显著差异(P<0.05)。接受根据风险调整随访的高复发风险和低复发风险患者的5年精算生存率显著高于接受最低限度随访的病例。初次手术后无病的强化随访组34例患者和低强度随访组57例患者的经济成本非常相似。
根据风险调整的随访显著改善了根治性再次手术的针对性及患者的总生存率,与复发风险无关,并降低了无病患者的随访成本。