TY - JOUR
T1 - The role of dose size in a chemotherapy regimen (ProMECE-CytaBOM) for the first-line treatment of large B-cell lymphomas
T2 - A randomized trial by the Gruppo Italiano Studio Linfomi (GISL)
AU - Gobbi, P. G.
AU - Broglia, C.
AU - Valentino, F.
AU - Mammi, C.
AU - Lombardo, M.
AU - Merli, F.
AU - Luminari, S.
AU - Polimeno, G.
AU - Riezzo, A.
AU - Lambelet, P.
AU - Rovati, A.
AU - Corazza, G. R.
AU - Federico, M.
PY - 2006/4
Y1 - 2006/4
N2 - Background: It is still unclear the actual contribute of dose intensity (DI), dose size (DS) and dose density (DD) in the conventional chemotherapy of large, B-cell non-Hodgkin lymphomas. Methods: A prospective, randomized trial compared the cyclic schedule of ProMECE-CytaBOM chemotherapy (cyc-PC, 6 cycles) with a modified version of it, which administered the same drugs sequentially (seq-PC), with the same planned cumulative DI and an 83% DD, within the same time frame (113 days), but with three times higher DS of all the drugs except vincristine. Results: Fifty-six patients received cyc-PC and 52 seq-PC. The actual mean cumulative DI was 0.79 ± 0.15 with cyc-PC, 0.78 ± 0.17 with seq-PC. Response was complete in 59% and 52%, partial in 20% and 21%, null in 5% and 6%, respectively. There were four toxic deaths (two per arm). Relapses occurred in 36% and 37%, respectively. Toxicity was similar in both arms. Overall, failure-free, progression-free and disease-free survival (median follow-up: 54 months) were statistically indifferent. Conclusions: The very similar DI actually delivered in both arm seems to be the main common determinant of the indifferent results recorded. Increasing DS - at least within the limits clinically attainable without stem cell rescue - does not improve results.
AB - Background: It is still unclear the actual contribute of dose intensity (DI), dose size (DS) and dose density (DD) in the conventional chemotherapy of large, B-cell non-Hodgkin lymphomas. Methods: A prospective, randomized trial compared the cyclic schedule of ProMECE-CytaBOM chemotherapy (cyc-PC, 6 cycles) with a modified version of it, which administered the same drugs sequentially (seq-PC), with the same planned cumulative DI and an 83% DD, within the same time frame (113 days), but with three times higher DS of all the drugs except vincristine. Results: Fifty-six patients received cyc-PC and 52 seq-PC. The actual mean cumulative DI was 0.79 ± 0.15 with cyc-PC, 0.78 ± 0.17 with seq-PC. Response was complete in 59% and 52%, partial in 20% and 21%, null in 5% and 6%, respectively. There were four toxic deaths (two per arm). Relapses occurred in 36% and 37%, respectively. Toxicity was similar in both arms. Overall, failure-free, progression-free and disease-free survival (median follow-up: 54 months) were statistically indifferent. Conclusions: The very similar DI actually delivered in both arm seems to be the main common determinant of the indifferent results recorded. Increasing DS - at least within the limits clinically attainable without stem cell rescue - does not improve results.
KW - Chemotherapy
KW - Dose density
KW - Dose intensity
KW - Dose size
KW - Large B-cell lymphoma
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U2 - 10.1093/annonc/mdl002
DO - 10.1093/annonc/mdl002
M3 - Article
C2 - 16446317
AN - SCOPUS:33645299288
VL - 17
SP - 676
EP - 682
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 4
ER -