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上皮性卵巢癌患者完成初始治疗后的随访策略评估。

Evaluation of follow-up strategies for women with epithelial ovarian cancer following completion of primary treatment.

机构信息

Gynaecological Oncology, Royal London Hospital, Barts Health NHS Trust, London, UK.

Medical Oncology, Barking, Havering and Redbridge University Hospital NHS Trust, London, UK.

出版信息

Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD006119. doi: 10.1002/14651858.CD006119.pub4.

Abstract

BACKGROUND

This is an update of a previous Cochrane Review, last updated in 2014. Ovarian cancer is the eighth most common cancer and seventh most common cause of death due to cancer in women worldwide. Traditionally, most women who have been treated for cancer undergo long-term follow-up in secondary care. However, it has been suggested that the use of routine review may not be effective in improving survival, or health-related quality of life (HRQOL), or relieving anxiety. In addition, traditional follow-up may not be cost-effective.

OBJECTIVES

To compare the potential effects of different strategies of follow-up in women with epithelial ovarian cancer, following completion of primary treatment.

SEARCH METHODS

For this update, we searched the Cochrane Gynaecological Cancer Group Trials Register, CENTRAL 2022, Issue 11, MEDLINE, and Embase from August 2013 to November 2022. We also searched review articles and contacted experts in the field.

SELECTION CRITERIA

All randomised controlled trials (RCTs) that evaluated follow-up strategies for women with epithelial ovarian cancer following completion of primary treatment.

DATA COLLECTION AND ANALYSIS

We followed standard Cochrane methodology. Two review authors independently selected potentially relevant trials, extracted data, and assessed risk of bias. They compared results, and resolved disagreements by discussion. We assessed the certainty of evidence, using the GRADE approach, for the outcomes of interest: overall survival (OS), health-related quality of life (HRQOL), psychological effects, and cost analysis.

MAIN RESULTS

For this update, we included one new RCT, including 112 women with ovarian, fallopian tube, or peritoneal cancer, who had completed primary treatment by surgery, with or without chemotherapy. This study reported the effect of individualised, i.e. individually tailored, nurse-led follow-up versus conventional medical follow-up on HRQOL, psychological outcomes, and cost-analysis. Individualised follow-up improved HRQOL in one of the two scales, with a decrease in mean difference (MD) in the QLQ-C30 discomfort scale following 12 months of individualised treatment compared to 12 months of conventional treatment (MD -5.76 points, 95% confidence interval (CI) -10.92 to -0.60; 1 study, 112 participants; low-certainty evidence; minimal important difference 4 to 10 points). There may be little or no difference in the other HRQOL scale (QLQ-Ov28, MD -0.97 points, 95% CI -2.57 to 0.63; 1 study, 112 participants: low-certainty evidence); psychological outcome, measured with the hospital anxiety and depression scale (HADS; MD 0.10 point, 95% CI -0.81 to 1.02; 1 study, 112 participants: low-certainty evidence), or cost analysis (MD -GBP 695.00, 95% CI -1467.23 to 77.23; 1 study, 112 participants: moderate-certainty evidence). Our previous review included one RCT, with 529 women in a confirmed remission, with normal CA125 concentration and no radiological evidence of disease, after surgery and first-line chemotherapy for ovarian cancer. This study evaluated immediate treatment of ovarian cancer relapse following a rise of serum CA125 levels versus delaying treatment until symptoms developed for OS, and HRQOL. There was little or no difference in OS between the immediate and delayed arms after a median follow-up of 56.9 months (unadjusted hazard ratio (HR) 0.98, 95% CI 0.80 to 1.20; 1 study, 529 participants; moderate-certainty evidence). Time from randomisation to first deterioration in global health score or death was shorter in the immediate treatment group than in the delayed treatment group (HR 0.71, 95% CI 0.58 to 0.88).

AUTHORS' CONCLUSIONS: Limited evidence from one trial suggests that routine surveillance with CA125 in asymptomatic women and treatment at CA125-defined relapse does not seem to offer survival advantage when compared to treatment at symptomatic relapse. However, this study pre-dates the use of PARPi maintenance treatment and the increased use of secondary cytoreductive surgery, so the results may be limited in their applicability to current practice. Limited evidence from one trial suggests that individualised nurse-led follow-up may improve HRQOL in women with ovarian cancer following completion of primary treatment. Large RCTs are needed to compare different types of follow-up, looking at survival, HRQOL, psychological effects, and cost as outcomes.

摘要

背景

这是对之前 Cochrane 综述的更新,上次更新时间为 2014 年。卵巢癌是全世界第八大常见癌症,也是第七大常见癌症死亡原因。传统上,大多数接受癌症治疗的女性在二级保健机构中接受长期随访。然而,有人提出,常规复查可能无法有效提高生存率或健康相关生活质量(HRQOL),也无法缓解焦虑。此外,传统的随访可能不具有成本效益。

目的

比较在完成初级治疗后对上皮性卵巢癌女性采用不同随访策略的潜在效果。

检索方法

为本次更新,我们检索了 Cochrane 妇科癌症组试验注册库、CENTRAL 2022 年第 11 期、MEDLINE 和 Embase,检索时间为 2013 年 8 月至 2022 年 11 月。我们还检索了综述文章,并联系了该领域的专家。

入选标准

所有评估上皮性卵巢癌女性完成初级治疗后随访策略的随机对照试验(RCT)。

数据收集和分析

我们遵循标准的 Cochrane 方法。两位综述作者独立筛选潜在相关试验,提取数据,并评估偏倚风险。他们比较了结果,并通过讨论解决了分歧。我们使用 GRADE 方法评估了感兴趣结局的证据确定性,包括总生存期(OS)、健康相关生活质量(HRQOL)、心理影响和成本分析。

主要结果

本次更新纳入了一项新的 RCT,纳入了 112 名患有卵巢癌、输卵管癌或腹膜癌的女性,这些患者已通过手术联合或不联合化疗完成初级治疗。这项研究报告了个体化(即个性化)护士主导的随访与常规医疗随访对 HRQOL、心理结局和成本分析的影响。与常规治疗相比,个体化随访在 12 个月时改善了 HRQOL,在 QLQ-C30 不适量表上的平均差异为-5.76 分(95%置信区间(CI)-10.92 至-0.60;1 项研究,112 名参与者;低确定性证据;最小重要差异为 4 至 10 分)。在另一个 HRQOL 量表(QLQ-Ov28)上可能差异较小或无差异(MD-0.97 分,95%CI-2.57 至 0.63;1 项研究,112 名参与者;低确定性证据);心理结局,用医院焦虑和抑郁量表(HADS)测量(MD 0.10 分,95%CI-0.81 至 1.02;1 项研究,112 名参与者;低确定性证据),或成本分析(MD-695.00 英镑,95%CI-1467.23 至 77.23;1 项研究,112 名参与者;中等确定性证据)。我们之前的综述纳入了一项 RCT,该研究纳入了 529 名经手术和一线化疗治疗后确认缓解、CA125 浓度正常且无影像学疾病证据的卵巢癌患者。该研究评估了在卵巢癌复发时,血清 CA125 水平升高后立即治疗与出现症状后再治疗对 OS 和 HRQOL 的影响。在中位随访 56.9 个月后,立即治疗组和延迟治疗组的 OS 差异较小或无差异(未调整的危险比(HR)0.98,95%CI 0.80 至 1.20;1 项研究,529 名参与者;中等确定性证据)。从随机分组到全球健康评分首次恶化或死亡的时间在立即治疗组比延迟治疗组更短(HR 0.71,95%CI 0.58 至 0.88)。

作者结论

一项试验的有限证据表明,在无症状女性中使用 CA125 进行常规监测,并在 CA125 定义的复发时进行治疗,与在症状性复发时进行治疗相比,似乎并不能提供生存优势。然而,这项研究早于 PARPi 维持治疗的使用和继发性细胞减灭术的增加,因此结果可能在当前实践中的适用性有限。一项试验的有限证据表明,个体化护士主导的随访可能会改善上皮性卵巢癌女性在完成初级治疗后的 HRQOL。需要开展大型 RCT 来比较不同类型的随访,观察生存、HRQOL、心理影响和成本作为结局。

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