Corticosteroids for the resolution of malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer

 

Abstract

Background

This is an update of the review published in Issue 3, 1999. Gastrointestinal and ovarian cancers are common cancers. The incidence of associated malignant bowel obstruction in patients with advanced cancers of these types is not known, and the best management of these patients is controversial. Inappropriate management may result in uncontrolled (faeculant) vomiting, pain and distress. Management of the symptoms can include palliative surgery, nasogastric tube suction together with intravenous fluids, or pharmacological means, such as corticosteroids. There is uncertainty regarding both the efficacy and possible harmful effects of corticosteroids, and also the most effective type, dose/dosing regime, route and period of administration.

Objectives

To locate, appraise and summarise evidence from scientific studies on intestinal obstruction due to advanced gynaecological and gastrointestinal cancer, in order to assess efficacy of corticosteroids.

Search methods

A comprehensive list of all studies was provided by an extensive search of the electronic databases, relevant journals, reference lists, the grey literature, contact with investigators and other search strategies outlined in the methods. Date of last search conducted in February 2006.

Selection criteria

As the review concentrates on the 'best evidence' available of the role of corticosteroids in malignant bowel obstruction due to advanced gynaecological and gastrointestinal cancer the inclusion criteria were kept fairly broad so as to include all studies relevant to the question.

Data collection and analysis

Data extraction forms were used to collect data from the studies included in the review. The data was checked by a secondary searcher to reduce error.

A qualitative analysis was performed of the dichotomous data of resolution of obstruction and death at one month, obtained from the randomised controlled trials of corticosteroids versus placebo. Both fixed and random effect models were used. Number-needed-to-treat-to-benefit (NNT) was derived from the odds ratio. Kaplan-Meier survival curves from individual patient data were also analysed. Studies of lower methodological quality were assessed in a qualitative manner.

Main results

No new included or excluded trials were found for this update beyond the three unpublished, randomised, placebo, double blind controlled trials and seven published (prospective and retrospective) trials which were previously considered eligible.

Using only the randomised trials (89 patients), there is a trend, which is not statistically significant, for the resolution of bowel obstruction using corticosteroids. There is no statistically significant difference in mortality at one month, nor in the Kaplan-Meier curves, which describe the survival of patients on corticosteroids or placebo. Number needed to treat is six (three, infinity) i.e. six patients need to be treated with corticosteroids to resolve one episode of bowel obstruction. The results are robust to fixed and random effects models and to 'best' and 'worst case' scenarios on the missing data from patients. The morbidity associated with corticosteroids appears to be very low, though the quality of the data limits this conclusion. No other outcomes were available from the published data or from the authors.

Authors' conclusions

There is a trend for evidence that corticosteroids of dose range six to 16 mg dexamethasone given intravenously may bring about the resolution of bowel obstruction. Equally, the incidence of side effects in all the included studies is extremely low. Corticosteroids do not seem to affect the length of survival of these patients. Since the last version of this review, no new studies have been conducted. No new studies have been identified for this update and the conclusions are not altered.

 

Plain language summary

Corticosteroids for the resolution of malignant bowel obstruction in advanced gynaecological and gastrointestinal cancer

Corticosteroids may reduce bowel obstruction for people with advanced gastrointestinal or ovarian cancer. Malignant bowel obstruction is fairly common in people with gastrointestinal (gut) cancer or ovarian cancer. It can lead to pain, vomiting, nausea, or complete constipation. Corticosteroids may lower inflammation and so help to reduce the obstruction especially if surgery is not considered to be suitable. The review found that corticosteroids may reduce bowel obstruction for people with these cancers, with a low rate of adverse effects. The treatment does not appear to affect survival rates compared to the placebo.

 

摘要

背景

以皮質類固醇緩解侵犯性婦癌及胃腸道癌造成的惡性腸阻塞的效果

胃腸道癌和卵巢癌是常見的癌症。這類癌症併發惡性腸阻塞的發生率尚不清楚，針對這些病人最好處理方式仍是有爭議的。不適當的處置可能會導致無法控制的嘔吐，疼痛和無助。症狀處理方式包括緩解性手術，鼻胃管抽吸連同靜脈注射液補充，或藥物治療(如皮質類固醇)。皮質類固醇之療效和可能產生的副作用皆不確定，此外最有效的種類，劑量/藥物配方，途徑和時間也尚未確定。沒有新的研究有確定的結論。

目標

從科學研究中去尋找和侵犯性婦癌及胃腸道癌相關之腸阻塞，批判和綜整證據，以評估皮質類固醇之療效。

搜尋策略

廣泛的搜索至2006年2月為止的電子數據庫，相關期刊，參考清單，灰色文獻，聯繫研究者和利用其他在方法中概述的搜索策略。

選擇標準

本文獻回顧聚焦於針對以皮質類固醇治療因晚期婦科癌和胃腸道癌引起之惡性腸阻塞之“最好的證據”來探討,納入標準相當廣泛，以便包括所有的研究

資料收集與分析

我們利用表格登錄所須資料，並有第二搜尋者檢查數據，以減少錯誤。由隨機對照試驗中比較皮質類固醇與安慰劑定性分析採用二分法，以一個月內解決阻塞和死亡區分，使用固定和隨機效應模組。使用勝算比(Odds ratio)來評估有多少需要治療(Number needed to treat ;NNT)。也以生存曲線(Kaplan  Meier)進行了分析。對於方法學不佳的研究採定性的方式評估。

主要結論

本文獻回顧涵蓋2006年2月之前的研究，僅包含3個尚未發表公佈的隨機安慰劑雙盲對照試驗和7已發表的適合試驗(包括前瞻性與回朔性)。在隨機試驗中(89個案例)，有一趨勢指出使用皮質類固醇可以解決腸阻塞，但未達統計學意義。其一個月之死亡率，Kaplan  Meier曲線皆未達統計學意義。NNT是6，即每用皮質類固醇治療六名病人，可以解決一例腸阻塞。此結果經固定和隨機效應模型以及′最好′和′最壞的情況′的情景分析數據亦可證實。皮質類固醇之併發症非常低，儘管數據的品質並不太好，但目前尚未有更好的資料以供佐證。

作者結論

目前證據顯示，皮質類固醇的劑量範圍6至16 mg靜脈注射可能解決腸阻塞。可能發生之副作用，在所有研究中顯示都非常低。皮質類固醇似乎並不影響這些病人的存活期。自前次的文獻回顧發表迄今並無新的研究在進行中。

翻譯人

本摘要由三軍總醫院吳宜穎翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

皮質類固醇可減少侵犯性胃腸道癌或卵巢癌患者之腸阻塞。惡性腸阻塞在腸道癌或卵巢癌相當普遍。它可以導致疼痛，噁心，嘔吐，或便秘。皮質類固醇可降低發炎反應，有助於減少阻塞，尤其是當手術是不合適的。本文獻回顧發現，皮質激素可以減輕這類癌症病人之腸阻塞症狀，和對照組相比，其存活率並無改變。