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194 Chapter 4: Lymphoma<br />

sequential chemotherapy) with peripheral <strong>blood</strong> progenitor cell (PBPC) support<br />

has been associated with improved therapeutic outcome <strong>and</strong> was demonstrated to<br />

be a feasible procedure. 12<br />

' 13<br />

The Italian Non-Hodgkin's Lymphoma Study Group (NHLCSG) began a<br />

multicenter study in 1991. The aim of the study was to compare, in a prospective<br />

<strong>and</strong> r<strong>and</strong>omized trial, VACOP-B chemotherapy plus DHAP as salvage regimen vs.<br />

the same induction protocol plus autoBMT in patients with poor-prognosis<br />

intermediate- <strong>and</strong> high-grade NHL.<br />

PATIENTS AND METHODS<br />

This prospective, r<strong>and</strong>omized phase III study, with 16 participating centers from<br />

the NHLCSG, began in October 1991 <strong>and</strong> closed in June 1995. Eligibility criteria<br />

have been previously described. 14<br />

Patients were 15-60 years old with newly<br />

diagnosed intermediate- or high-grade non-Hodgkin's lymphoma according to the<br />

Working Formulation, in stage II (bulky), III, <strong>and</strong> IV. The pretreatment characteristics<br />

of patients are reported in Table 1. Three patients were ineligible (one was<br />

pretreated <strong>and</strong> two were in stage II with bulky disease 2 9 15 12 19<br />

Histology<br />

Diffuse mixed 5 8 6 9<br />

Diffuse large-cell 32 52 35 56<br />

Large-cell immunoblastic 12 20 13 21<br />

Other<br />

Anaplastic/Ki-1 7 12 5 8<br />

Unclassifiable 5 8 4 6<br />

Table 1 continued on next page

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