[Survival of patients with aggressive non-hodgkin's lymphoma: no difference between first line treatment in a prospective randomised phase III clinical trial and first line treatment according to routine clinical practice].
OBJECTIVE
To compare survival of patients with disseminated aggressive non-Hodgkin's lymphoma (NHL) who were treated either as part of a clinical trial or in routine clinical practice.


METHODS
Retrospective.


METHODS
The survival was studied of patients with disseminated NHL of an intermediate or high degree of malignancy who were treated in the Meander Medical Centre, Amersfoort, the Netherlands, in the years 1994-2001 with chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP). This took place either in routine clinical practice (RCP) or as part of a clinical trial where patients < or = 60 years of age received intensified CHOP and patients > 60 years received CHOP with growth factors. Treatment data, the response to therapy, survival and prognostic factors according to the International Prognostic Index for aggressive NHL were collected by a review of the patient records.


RESULTS
Fifty-nine patients were eligible for this analysis: 32 men and 27 women with a median age of 63 years (range 30-83). Of these, 35 were treated within a clinical trial and 24 were treated in RCP. The patient characteristics in the two groups were comparable. There was no difference in median survival between the trial and RCP groups, this being 27 months for all patients, 34 months for the younger patients, 20 months for the elderly patients, and 42 months for patients who achieved complete remission following chemotherapy.


CONCLUSIONS
No difference in overall survival was found between patients with disseminated aggressive NHL who underwent treatment according to either RCP or as part of a clinical trial. It demonstrates that both patients in clinical trials and patients treated according to RCP received equally effective therapy. Recent developments in NHL treatments are promising, and therefore participation in clinical trials should be encouraged.
van Agthoven
M
M
Erasmus Medisch Centrum, Institute for Medical Technology Assessment, Postbus 1738, 3000 DR Rotterdam.
Wittebol
S
S
Budel
L M
LM
Uyl-de Groot
C A
CA
Kramer
M H
MH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D003520:Cyclophosphamide / Q000627:therapeutic use*; D004317:Doxorubicin / Q000627:therapeutic use*; D005260:Female; D006133:Growth Substances / Q000627:therapeutic use; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000627:therapeutic use*
D006133:Growth Substances; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone