PMID- 9765760
OWN - NLM
STAT- MEDLINE
DCOM- 19981022
LR  - 20131121
IS  - 1206-548X (Print)
IS  - 1206-548X (Linking)
VI  - 1
IP  - 5
DP  - 1997 Dec
TI  - Adjuvant therapy for stage II colon cancer after complete resection. Provincial 
      Gastrointestinal Disease Site Group.
PG  - 379-92
AB  - GUIDELINE QUESTION: Should patients with resected stage II colon cancer receive 
      adjuvant therapy? OBJECTIVE: To make recommendations regarding the use of 
      adjuvant therapy in the treatment of resected stage II colon cancer. OUTCOMES: 
      Overall survival is the primary outcome of interest. Secondary outcomes are 
      disease-free survival and adverse effects of the treatment regimens. PERSPECTIVE 
      (VALUES): Evidence was selected and reviewed by 2 members of the Provincial 
      Gastrointestinal Disease Site Group (GI DSG) of the Cancer Care Ontario Practice 
      Guidelines Initiative. The recommendations resulting from this review have been 
      approved by the GI DSG, which comprise medical and radiation oncologists, 
      surgeons and epidemiologists. Community representatives did not participate in 
      the development of this practice guideline but will do so in future guidelines 
      development. QUALITY OF EVIDENCE: There are 25 published randomized controlled 
      trials (RCTs) and 1 meta-analysis. The GI DSG pooled data from 11 of the 25 RCTs 
      that provided adequate data. BENEFITS: The 25 RCTs are grouped according to the 
      type of therapy and whether the control patients received no treatment 
      (observation) or other adjuvant therapy after resection. Because the trials 
      usually included patients with stage II and III cancer, the complete trial 
      results and those for a subset of patients with stage II disease were analysed. 
      Although the overall trial results showed a survival benefit for adjuvant 
      treatments, the benefit was not significant for stage II patients. A 
      meta-analysis of 11 trials comparing adjuvant treatment with observation in 
      patients with stage II cancer indicated no significant reduction in the odds 
      ratio (OR) for death (OR 0.83; 95% confidence interval [CI] 0.62 to 1.10). The OR 
      for death among patients receiving chemotherapy by portal vein infusion (PVI) was 
      0.62 (95% CI 0.35 to 1.11). HARMS: The toxic effects of 5-fluorouracil (5-FU) 
      with either levamisole or leucovorin, or both, were mild to moderate and 
      consisted mostly of stomatitis, diarrhea and myelosuppression; 5% of patients 
      required hospital admission. 5-FU plus levamisole was associated with transient 
      neurotoxic effects in 18% of patients. Toxic effects associated with PVI were 
      mild, rare and mostly consisted of leukopenia and diarrhea; 1% of patients 
      experienced bowel perforation. PRACTICE GUIDELINE: Adjuvant therapy is not 
      recommended at this time for the routine management of patients with resected 
      stage II colon cancer. Patients with stage II disease and high-risk factors 
      (bowel obstruction, tumour adhesion, invasion, perforation or aneuploidy) have a 
      poorer prognosis, similar to that of patients with stage III colon cancer. For 
      individual management, these patients should be made aware of their prognosis; 
      treatment can be considered after the uncertainty of the value of adjuvant 
      therapy has been explained to the patient. The enrolment of patients with 
      high-risk stage II disease in clinical trials is encouraged. Trials comparing 
      adjuvant therapy with observation are needed and are ethically acceptable in 
      stage II colon cancer.
FAU - Figueredo, A
AU  - Figueredo A
AD  - Hamilton Regional Cancer Centre, Ont.
FAU - Germond, C
AU  - Germond C
FAU - Maroun, J
AU  - Maroun J
FAU - Browman, G
AU  - Browman G
FAU - Walker-Dilks, C
AU  - Walker-Dilks C
FAU - Wong, S
AU  - Wong S
LA  - eng
PT  - Guideline
PT  - Journal Article
PT  - Practice Guideline
PL  - Canada
TA  - Cancer Prev Control
JT  - Cancer prevention & control : CPC = Prevention & controle en cancerologie : PCC
JID - 9709994
RN  - 2880D3468G (Levamisole)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Chemotherapy, Adjuvant
MH  - Colonic Neoplasms/*therapy
MH  - Combined Modality Therapy
MH  - Fluorouracil/therapeutic use
MH  - Humans
MH  - Immunotherapy
MH  - Levamisole/therapeutic use
MH  - Randomized Controlled Trials as Topic
EDAT- 1998/10/10 00:00
MHDA- 1998/10/10 00:01
CRDT- 1998/10/10 00:00
PHST- 1998/10/10 00:00 [pubmed]
PHST- 1998/10/10 00:01 [medline]
PHST- 1998/10/10 00:00 [entrez]
PST - ppublish
SO  - Cancer Prev Control. 1997 Dec;1(5):379-92.