PERIPHERAL-BLOOD STEM-CELL TRANSPLANTATION AS FRONT-LINE THERAPY IN PATIENTS AGED 61 TO 65 YEARS - A PILOT-STUDY

The aim of the present trial was to investigate the feasibility of hig h-dose therapy followed by autologous peripheral blood stem cell trans plantation (PBSCT) as a component of front-line treatment in patients with disseminated intermediate- and high-grade non-Hodgkin's lymphoma (NHL) aged 61-65 years. From October 1993 to June 1996, 14 consecutive patients entered this single-center prospective pilot trial. Patients were five males and nine females, median age 63 (range 61-65), The fi rst-line treatment consisted of three courses of CHOP therapy. Patient s achieving either a partial response (PR) or a complete response (CR) after initial therapy were eligible for PBSCT, while those with refra ctory or progressive disease were not autografted but included in the feasibility study in an intent-to-treat analysis. Of the 14 patients, 11 achieved either a CR (one) or a PR (10) after three courses of CHOP while the three patients with no response were not autografted and su bsequently died of progressive disease. PBSC collection was feasible i n responding patients after G-CSF priming (10 mu g/kg/day for 6 days). Conditioning therapy was the BEAM protocol. All patients engrafted af ter PBSCT, The median time to granulocyte (>0.5 x 10(9)/l) and platele t recovery (> 25 x 10(9)/l) was 12 (range 9-18) and 13 days (range 7-2 2), respectively. No toxic deaths VOD or IP were observed, Four of the 11 responding patients relapsed 2, 7, 9 and 12 months after PBSCT, re spectively, and all died from progressive disease. Overall, 7/14 patie nts are alive and free from disease, 16-43 months after initial diagno sis (median 28), The actuarial overall survival is 45.7% , and the act uarial event-free survival is 50% at 3.5 years. This study shows the f easibility of high-dose therapy and PBSCT in patients with intermediat e- or high-grade disseminated NHL aged 61-65 years. Such patients shou ld not be excluded from trials evaluating the role of ASCT as part of initial treatment for disseminated and histologically aggressive NHL.