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. 2004;2004(3):CD003445.
doi: 10.1002/14651858.CD003445.pub2.

Supportive care for patients with gastrointestinal cancer

N Ahmed  1 , S Ahmedzai, V Vora, S Hillam, S Paz
Affiliations

Supportive care for patients with gastrointestinal cancer

N Ahmed et al. Cochrane Database Syst Rev. 2004.

Abstract

Background: Supportive care has traditionally been given to optimise the comfort of patients and their ability to function, as well as to minimise the side-effects of anti-cancer treatments. The scope of modern comprehensive supportive care however is broadening and covers not only specific palliative treatment but non-tumour specific treatment such as social, psychological and spiritual support. In oncology, best supportive care (BSC) has been used as a comparator arm of randomised controlled trials in chemotherapy. However the BSC arm is usually not well defined and its evaluation is therefore difficult because of the heterogeneity of the definitions. A systematic review was undertaken of the evidence from all RCTs of gastrointestinal cancers (includes gastrointestinal/gastric, colorectal/colon cancer but excludes pancreatic cancer trials) which include a BSC/SC arm.

Objectives: 1. To examine the effectiveness/outcomes of best supportive care interventions versus cancer therapies for gastrointestinal cancer trials;2. To determine whether trials containing best supportive care include a definition of this.

Search strategy: Electronic databases, grey literature sources, citation searching and reference checking, handsearches of journals and discussion with experts were used to identify potentially eligible trials from both published and unpublished sources.

Selection criteria: RCTs comparing BSC/SC versus anticancer therapies in patients with gastrointestinal cancers.

Data collection and analysis: Four RCTs were found and reviewed. Because of the heterogeneity of studies, a meta-analysis was not attempted. Data was extracted from the included papers and the quality of each included study was assessed using the Jadad 1996 and Rinck 1997 methods of assessing the quality of RCTs.

Main results: Data from four trials (483 patients) were included. Due to the heterogeneity of studies (in terms of populations studied, the interventions used, the variety of outcomes and assessments used) it was not possible to make direct comparisons between the studies. The primary outcome in all four trials was survival, in spite of patients with advanced/metastatic gastrointestinal cancer having a poor prognosis, and the interventions being primarily palliative.

Reviewers' conclusions: Overall the results show that for most of the trials included in this review, certain forms of chemotherapy plus supportive care improve both survival and quality of life in patients with gastrointestinal cancer (gastric and colorectal cancers) compared to receiving supportive care alone. Trials involving BSC/SC in patients with advanced gastrointestinal cancer require careful evaluation. Oncologists and researchers alike should strive for improvements in trial design and reporting. Future trials should focus on clearer definitions of supportive care. The EORTC definition of supportive care can be used as a guide. BSC/SC trials should use standardised validated outcome measures for symptom control, quality of life, toxicity and other useful palliative measures.

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Conflict of interest statement

None known. The involvement of the Advisory Group should serve to limit any potential conflict of interest during the review process.

Comment in

References

References to studies included in this review

Cascinu 1995 {published data only}
    1. Cascinu S, Ferro Del E, Catalano G. A randomised trial of octreotide vs best supportive care only in advanced gastrointestinal cancer patients refractory to chemotherapy. British Journal of Cancer 1995;71:97‐101. - PMC - PubMed
Cunningham 1998 {published data only}
    1. Cunningham D, Pyrhonen S, James RD, Punt CJA, Hickish TF, Heikkila R, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. The Lancet 1998;352:1413‐8. - PubMed
Glimelius 1997 {published data only}
    1. Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, et al. Randomised comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Annals of Oncology 1997;8:163‐8. - PubMed
Scheithauer 1993 {published data only}
    1. Scheithauer W, Rosen H, Kornek GV, Sebesta C, Depisch D. Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. BMJ 1993;306:752‐5. - PMC - PubMed

References to studies excluded from this review

Barni 1995 {published data only}
    1. Barni S, Lissoni P, Cazzaniga M, Ardizzoia A, Meregalli S, Fossati V. A randomized study of low‐dose subcutaneous interleukin‐2 plus melatonin versus supportive care alone in metastatic colorectal cancer patients progressing under 5‐fluorouracil and folates. Oncology 1995;52(3):243‐5. - PubMed
Beretta 1994 {published data only}
    1. Beretta G, Bollina R, Labianca R, Arnoldi E, Luliri P, Martignoni G. A controlled study of supportive care (SC) versus SC plus 5‐fluorouracil/folinic acid (Ff) for advanced metastatic gastrointestinal carcinomas (AMGC) in the elderly patients (pts). Proceedings of the Annual Meeting of the American Society of Clinical Oncology. 1994; Vol. 13:A669.
Blijham 1998 {published data only}
    1. Blijham G, Mesbah M, Glimelius B. Quality of life evaluation of CPT‐11 compared to best supportive care or infusional 5‐FU in patients with 5‐FU resistant advanced colorectal cancer. Proceedings of the Annual Meeting of the American Society for Clinical Oncology. 1998; Vol. 17:A1592.
Cunningham 1999 {published data only}
    1. Cunningham and Glimelius 1999 On behalf of the V301 Study Group. A phase III study of irinotecan (CPT‐11) versus best supportive care in patients with metastatic colorectal cancer who have failed 5‐fluorouracil therapy. Seminars in Oncology 1999;26((1 Suppl 5)):6‐12. - PubMed
Delfino 1993 {published data only}
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Glimelius 1994 {published data only}
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Petrioli 1995 {published data only}
    1. Petrioli R, Lorenzi M, Aquino A, Marsili S, Frediani B, Palazzuoli V. Treatment of advanced colorectal cancer with high‐dose intensity folinic acid and 5‐fluorouracil plus supportive care. European Journal of Cancer 1995;31A(12):2105‐8. - PubMed
Pyrhonen 1995 {published data only}
    1. Pyrhonen S Kuitunen T, Nyandoto P, Kour M. Randomised comparison of fluorouracil, epidoxorubicin and methotreaxate (FEMTX) plus supportive care with supportive care alone in patients with non‐resectable gastric cancer. British Journal of Cancer 1995;71:587‐91. - PMC - PubMed
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References to other published versions of this review

Ahmed 2004
    1. Ahmed N, Ahmedzai S, Vora V, Hillam S, Paz S. Supportive care for patients with gastrointestinal cancer. Cochrane Database of Systematic Reviews 3, Issue 2004. [DOI: 10.1002/14651858.CD003445.pub2] - DOI - PMC - PubMed
Ahmed 2006
    1. Ahmed N, Ahmedzai S, Vora V, Hillam S, Paz S. Supportive care for patients with gastrointestinal cancer. Cochrane Database of Systematic Reviews 4, Issue 2006. [DOI: 10.1002/14651858.CD003445.pub2] - DOI - PMC - PubMed

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