The CUP trial: a randomized study analyzing the efficacy of high dose therapy and purging in low-grade non-Hodgkin's lymphoma (NHL).
BACKGROUND
The CUP trial was initiated to analyze the value of high-dose therapy and stem-cell transplantation and purging in patients with relapsed chemosensitive follicular NHL.


METHODS
After three cycles of chemotherapy responsive patients were randomized to either three more cycles of the same chemotherapy (C), high-dose therapy followed by autologous unpurged (U) or purged (P) stem-cell transplantation. Purging was performed using a cocktail of monoclonals. Pretransplant conditioning consisted of cyclophosphamide (60 mg/kg x 2) and total body irradiation.


RESULTS
Of the 140 patients registered from 26 centers in Europe, 89 fulfilled the criteria for randomization (C: 24, U: 33 and P: 32). Reasons for failure to randomize were: no response (28), persistent marrow infiltration (4), patient refusal (7), other (7), no data (5). With the current follow up (median 26 months from randomization) 16 (66%) in C are known to have progressed or relapsed, in contrast to 13 (39%) of U and 12 (37%) of the P patients (P-value 0.002). Overall survival is premature with the current available data.


CONCLUSIONS
Patients in U and P arms had higher progression/relapse-free survival rate. There are some suggestions of some improvement in overall survival rate.
Schouten
H C
HC
University Hospitals Maastricht, The Netherlands. hsch@sint.azm.nl
Kvaloy
S
S
Sydes
M
M
Qian
W
W
Fayers
P M
PM
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016465:Bone Marrow Purging; D003131:Combined Modality Therapy; D016001:Confidence Intervals; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D016019:Survival Analysis; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D006113:United Kingdom