A Cochrane review [Abstract] 1 included 5 studies with a total of 1093 subjects. Four trials were in previously untreated patients and one trial in relapsed patients. A statistically significant increased PFS (progression free survival) was found in previously untreated FL (follifular lymphoma)patients in the HDT + ASCT (high-dose therapy + autologous stem cell transplantation) arm (HR = 0.42; 95% CI 0.33 to 0.54; P < 0.00001). However, this effect was not transferred into a statistically significant OS (overalla survival) advantage (HR = 0.97; 95% 0.76 to 1.24; P = 0.81). The subgroup of trials adding rituximab to both intervention arms (one trial) confirmed these results and the trial had to be stopped early after an interim analysis due to a statistically significant PFS advantage in the HDT + ASCT arm (PFS: HR = 0.36; 95% CI 0.23 to 0.55; OS: HR = 0.88; 95% CI 0.40 to 1.92).
In the four trials in previously untreated patients there were no statistically significant differences between HDT + ASCT and the control-arm in terms of TRM (treatment-related mortality) (RR = 1.28; 95% CI 0.25 to 6.61; P = 0.77), secondary acute myeloid leukaemia/myelodysplastic syndromes (RR = 2.87; 95% CI 0.7 to 11.75; P = 0.14) or solid cancers (RR = 1.20; 95% CI 0.25 to 5.77; P = 0.82). Adverse events were rarely reported and were observed more frequently in patients undergoing HDT + ASCT (mostly infections and haematological toxicity).For patients with relapsed FL, there is some evidence (one trial, N = 70) that HDT + ASCT is advantageous in terms of PFS and OS (PFS: HR = 0.30; 95% CI 0.15 to 0.61; OS: HR = 0.40; 95% CI 0.18 to 0.89). For this trial, no results were reported for TRM, adverse events or secondary cancers.
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