The aim of this multicentre prospective study was to establish the role of a third generation regimen (VACOP-B) plus/minus radiotherapy (RT) as front-line therapy in patients (pts) with aggressive stage I-II non-Hodgkin's lymphoma(NHL). Between October 1991 and November 1999,70 pts, aged 15 to 60 years, with diffuse mixed and large cell-type (Working Formulation criteria) non bulky NHL, 28 in Stage 1 (40%) and 42 in Stage II (60%), were enrolled. Stage I pts received VACOP-B for 6 weeks followed by involved field (IF) RT. Stage 11 pts received VACOP-B for 12 weeks plus IF RT on residual masses. 67 pts (96%) presented objective response (CR, 65 pts=93%; PR, 2 pts=3%). No difference in terms of response rate was observed between stage I and II pts. One patient in stage 1 and 2 pts in stage II were primary resistant. Extra-haematological toxicity was very mild. Two pts in stage I and 8 pts in stage II relapsed. With a median follow-up observation time of 38 months, the 7-year overall survival (OS) probability is 89.7% (+-4.7%), with a PFS of 77.6% (+-5.9%) and a DPS of 81.8% (+-5.9%). Univariate analysis showed a trend in favour of Stage 1 in terms of OS (P=0.08). This prospective study suggests that a third generation regimen combined with RT, is effective in patients with stage I-II aggressive NHL. According to previous observations achieved with first generation regimens, 6 courses of VACOP-B plus RT seem to be the therapy of choice in Stage I patients. Moreover, 12 cycles of VACOP-B plus/minus RT seem to be effective in the majority of Stage IT pts. In conclusion, VACOP-B as front-line therapy, with or without RT, was an effective and feasible therapy in these pts, with very low treatment related toxicity. However, this observation must be confirmed with a phase III study.
|Issue number||11 PART II|
|Publication status||Published - 2000|
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