A Cochrane review [Abstract] 1 included 5 trials (4 observational and 1 retrospective, n= 167). Chemotherapy was given uniformly in all studies. However, 4 different chemoradiation schedules were applied; fractionation techniques, fields and target definitions varied. Skin toxicity was observed in nearly all patients. Wound breakdown, infection, lymphedema, lymphorrhea and lymphoceles were also common. Operability was achieved in 63 to 92% of cases in the four studies using 5-Fluorouracil and cis-platium or 5-Fluorouracil and mitomycin C. In contrast, only 20% of the patients who received Bleomycin were operable after chemoradiation. However, complications of treatment are considerable and information on the effects of quality of life is not available. Furthermore, treatment results of the respective studies diverge considerably. After a follow up of 5 to 125 months, 26 to 63% of participants were alive and well, a total of 27 to 85% of participants died.
Comment: The quality of evidence is downgraded by study quality (variable or poor quality), by inconsistency (heterogeneity in interventions and outcomes), and by indirectness (differences in studied patients).
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