Preliminary results of a randomized trial comparing intensive chemotherapy with growth factor(gf) for peripheral blood progenitor(pbpc) cell mobillization to growth factor alone for hematopoietic rescue after high dose chemotherapy(hdc)

How to optimally collect PBPC for use after HOC is unknown. Intensive chemotherapy plus GF for PBPC mobilization may increase PBPC yield and reduce relapse, but may increase toxicity over GF alone. To answer this, 85 patients entered a randomized trial comparing cyclophosphamidefCTX) 1.5gm/m²dx3 VP-16 200mg/m² q12x6 doses and cisplatin 45mg/m²/dx3 (CVP) plus G-CSF 6mcg/kg q12 to G-CSF 6mcg/kg q12 alone for PBPC mobilization. HOC was CTX 2gm/m²/dx3 and BCNU 150m²/dx3 with PBPC. CVP/G-CSF GSF Age (med, range) (29-58), 45d (29-62), 48d p=.01 Dx to BMT (167-3158) 294d (147-2967) 320d Stage II-III/IV 19/23 22/21 Follow up of survivors range (40-702) 331d. Pheresis started when WBC≥2×10⁹/l post CVP+G-CSF and 4d post G-CSF. Minimum PBPC dose 2×10⁶CD34(+)/kg, targeted dose 4×10⁶CD34(+)kg. CVP/G-CSF GSF P value No. Of Pheresis 1(1-5) 3(1-9) p=.0001 Pheresis Failure 0 3 p=.2 Infection w/PBPC 2 1 p=<.0001 Collection HOC Related Death 4 0 p=.2 CD34+/kg 13.39(3.25-121.95) 9.08(1.07=8.40 p=.0001 Day ANC 500 9(7-10) 10(9-11) p=.001 DayPlt 20k 9(7-10) 11(9-38) p=.001 1yr Overall Survival 79%(.07) (SE) 95%(.04) p=.2 1yr Event Free 73%(.08) 51%(.08) p=.3 1yr Actuarial Relapse 13%(.06) 47%(.08) p=.04 In conclusion: CVP+G-CSF improves PBPC collection and engraftment after HDC and reduces relapse risk. CVP+G-CSF increased morbidity during PBPC collection and may increase mortality after HDC.