Intervention Review

Pre-operative radiotherapy and curative surgery for the management of localized rectal carcinoma

  1. Rebecca KS Wong1,*,
  2. Ved Tandan2,
  3. Shiroma De Silva3,
  4. Alvaro Figueredo4

Editorial Group: Cochrane Colorectal Cancer Group

Published Online: 18 APR 2007

Assessed as up-to-date: 28 DEC 2006

DOI: 10.1002/14651858.CD002102.pub2

How to Cite

Wong RKS, Tandan V, De Silva S, Figueredo A. Pre-operative radiotherapy and curative surgery for the management of localized rectal carcinoma. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD002102. DOI: 10.1002/14651858.CD002102.pub2.

Author Information

  1. 1

    Princess Margaret Hospital, Department of Radiation Oncology, Toronto, Ontario, Canada

  2. 2

    St. Joseph's Hospital, Department of Surgery, Hamilton, ON, Canada

  3. 3

    Princess Margaret Hospital, University Health Network, Department of Radiation Oncology, Toronto, Ontario, Canada

  4. 4

    Dept. of Clin. Epid. and Stat.,, Hamilton Regional Cancer Centre, McMaster Univ., Hamilton, Ontario, Canada

*Rebecca KS Wong, Department of Radiation Oncology, Princess Margaret Hospital, 5th Floor, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada. rebecca.wong@rmp.uhn.on.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 APR 2007

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Preoperative radiotherapy (PRT) has become part of standard practice offered to improve treatment outcomes in patients with rectal cancer.

Objectives

To determine if PRT improves outcome for patients with localized resectable rectal cancer and how it compared with other adjuvant or neoadjuvant strategies.

Search methods

A computerized search was performed December 2006 on MEDLINE (from 1966 to December 2006) and the Cochrane Central Register of Controlled Trials (CENTRAL), conference proceedings, using MeSH and textwords where appropriate to identify randomized trials in PRT and rectal cancer. In addition, MetaRegister of Clinical Trials was searched for ongoing trials.

Selection criteria

Randomized trials with a PRT arm versus surgery alone, or other neoadjuvant or adjuvant (NA/A) strategies, targeted patients with localized rectal cancer planned for radical surgery were included.

Data collection and analysis

Trials were selected, data extracted and quality assessed by 2 authors. Quality was assessed using a 14 point checklist. Summary statistics included Hazard ratios and variances (for the outcomes: overall (OA) mortality, cause specific (CS) mortality, any recurrence and local recurrences (LR)) and Odds Ratio (OR) for other outcomes. Potential sources of heterogeneity hypothesized a priori included study quality, biological effective dose (BED), radiotherapy RT technique, and total mesorectal excision (TME) surgery.

Main results

Nineteen trials compared PRT versus surgery alone. Overall (OA) mortality was marginally improved HR 0.93 [95% CI -0.87-1](absolute difference is 2% if the expected survival rate is 60%). Local recurrence (LR) was improved but the magnitude of benefit was heterogeneous across trials. Sensitivity analyses suggested greater benefits in patients treated with BED>30Gy10 and multiple field RT techniques. There was significantly more pelvic or perineal wound infection, late rectal and sexual dysfunction.

Nine trials compared PRT vs. other NA/A. Available evidence did not support an OA mortality or sphincter preserving benefit with the use of combined chemoradiotherapy (CRT) or selective postoperative RT. CRT provides incremental benefit for local control compared with PRT, which was independent of the timing of the CT. There was no significant difference in outcome for different intervals between RT and surgery (2 vs. 8 wk). Dose escalation with endocavitary boost showed significant effect on sphincter preservation.

Authors' conclusions

Optimal PRT improves LR, OA mortality, but no increase in sphincter sparing procedure. CRT further increases local control. If the objective is to increase the incidence of sphincter sparing surgery, endocavitary boost showed the most promise. Strategies with the potential to improve outcomes, especially OAS and spincter sparing while reducing acute and late toxicities (rectal and sexual function) are needed to guide future strategy designs.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Pre-operative radiotherapy and curative surgery for the management of localized rectal carcinoma

Optimal preoperative radiotherapi for localized rectal cancer provide a modest improvement in overall survival, definite improvement in local recurrences, modest increase in the proportion of patients undergoing curative surgery, but is also accompanied by an increase in acute and late rectal and sexual function compared with surgery alone. A combination chemoradiotherapy provides further improvement in local recurrence.
Surgery (i.e. mesorectal excision) is the mainstay of therapy for resectable rectal cancers. This review examines the value of preoperative radiotherapy, and include nineteen randomized trials comparing preoperative radiotherapy with surgery alone.
Preoperative radiotherapy is effective in improving local control. It provides only a marginal benefit in cure rate, and does not improve the likelihood of avoiding a permanent colostomy. It is associated with an increase risk of wound infections following surgery, and long term effect on rectal and sexual function.
Nine trials compared preoperative radiotherapy with other strategies. The addition of chemotherapy to radiotherapy provides even better local control but did not increase the likelihood of cure or the ability to avoiding a permanent colostomy.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

手術前進行放射線治療和治癒性外科手術對於治療局限型大腸癌的影響

手術前進行放射線治療(Preoperative radiotherapy,PRT)已經變成改善大腸癌患者治療成果的標準實務中的一個方法了

目標

本研究的主要目的在於瞭解是否PRT可以改善患有局部性可切除值腸癌的患者其治療成果,並且想要比較這樣的方法和其他輔助性或新輔助性治療策略的差異

搜尋策略

在2006年12月時,針對MEDLINE(由1966年至2006年12月)和Cochrane Central Register of Controlled Trials(CENTRAL)、研討會論文進行電子化的搜索,搜索時使用標題檢索和關鍵字來確認有關PRT和直腸癌的隨機性試驗,此外,藉由檢索MetaRegister of Clinical Trials資料庫來取的正在進行中的試驗資料

選擇標準

凡是針對PRT和僅接受手術治療、其他新輔助性治療、輔助性治療(NA/A)進行隨機性比較的試驗,且目標患者係預定接受放射線手術來治療局部性直腸癌便可納入本研究中

資料收集與分析

由2位作者針對納入研究的試驗進行挑選、並進行資料萃取和品質分析等工作,利用14個評分級距的確認清單來評估品質,總結性的統計包括風險比率和變異性(對於治療效果來說,包括了整體死亡率(OA)、特殊原因死亡率(CS)、任何部位復發或局部性復發(LR))和勝算比(OR)來評估其他治療成果,異質性的潛在原因假設包括研究品質、生物有效劑量(BED)、放射線治療(RT)技術和全直腸繫膜切除(total mesorectal excision)手術

主要結論

有19個試驗是比較PRT和單獨手術治療的效果,整體死亡率有些微的改善(HR值為0.93[95%的信心區間介於 −0.87至0.1之間],當預估存活率為60%時,絕對差異為2%),局部復發率也會獲得改善但是在不同試驗間的重要治療效益卻是存在異質性,靈敏度分析結果顯示患者接受BED大於30Gy10,且多種範圍的RT治療時會產生較大的效益,但是確有較明顯的骨盆及會陰感染、和晚期直腸和性功能障礙,九個試驗係針對PRT和其他NA/A治療法進行比較,可用的證據並無法支持接受混合性化學放射性治療或是選擇性手術後RT治療可以對整體死亡率或是對於括約肌的保護有所幫助,與PRT相較,CRT可對於局部性的控制較有貢獻,與CT的時間相互獨立,在接受RT和手術治療的組別中,對於不同區間的試驗成果並沒有出現顯著差異(2和8週),增加內部照射劑量顯示對於括約肌具有保護作用

作者結論

適當的PRT治療可以改善局部復發率LR、整體死亡率,但是對於括約肌保存手術卻沒有增加的現象,CRT更可以達到局部控制的效果,如果受試者增加進行括約肌保存手術、提升內部照射量會具有較佳的效果,具有可以改善治療成果的策略,特別是OAS和擴約肌保存對於降低急性和晚期毒性(直腸和性功能)的影響都需要備考量以作為設計治療策略的指標

翻譯人

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

總結

對於局部性大腸癌進行適度的手術前放射線治療對於整體存活率來說具有適度的改善效果,對於局部復發也有明確的改善,適度的增加經過治癒性手術患者的人數,但是相對於只有進行手術的組別來說卻也會伴隨著急性和晚期直腸和性功能降低的高風險。混合性的進行化學放射線治療可以對於局部復發率提供更好的改善效果,手術(直腸繫膜切除術)是用來治療大腸直腸癌的主要方法,本研究檢視了進行手術前放射性治療的價值,並且納入19個隨機性試驗將手術前進行放射性治療與單純進行手術的效果相比較,手術前進行放射性治療可以針對局部進行有效控制,但其對治癒率來說僅提供些微的好處,並且無法提供避免形成永久性結腸造口的可能與手術後傷口感染風險的增加有關,長期來說,還會影響直腸和性功能,有9個試驗將手術前進行放射線治療與其他治療策略進行比較,將化學治療法併用於放射線治療法時可提供較佳的局部控制,但是無法增加治癒的可能性或是避免形成永久性結腸造口的可能性