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.

The role of dose size in a chemotherapy regimen (ProMECE-CytaBOM) for the first-line treatment of large B-cell lymphomas: a randomized trial by the Gruppo Italiano Studio Linfomi (GISL) / Gobbi, Pg; Broglia, C; Valentino, F; Mammi, C; Lombardo, M; Merli, F; Luminari, Stefano; Polimeno, G; Riezzo, A; Lambelet, P; Rovati, A; Corazza, Gr; Federico, Massimo. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - STAMPA. - 17:(2006), pp. 676-682. [10.1093/annonc/mdl002]

The role of dose size in a chemotherapy regimen (ProMECE-CytaBOM) for the first-line treatment of large B-cell lymphomas: a randomized trial by the Gruppo Italiano Studio Linfomi (GISL)

LUMINARI, Stefano;FEDERICO, Massimo
2006

Abstract

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.
2006
17
676
682
The role of dose size in a chemotherapy regimen (ProMECE-CytaBOM) for the first-line treatment of large B-cell lymphomas: a randomized trial by the Gruppo Italiano Studio Linfomi (GISL) / Gobbi, Pg; Broglia, C; Valentino, F; Mammi, C; Lombardo, M; Merli, F; Luminari, Stefano; Polimeno, G; Riezzo, A; Lambelet, P; Rovati, A; Corazza, Gr; Federico, Massimo. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - STAMPA. - 17:(2006), pp. 676-682. [10.1093/annonc/mdl002]
Gobbi, Pg; Broglia, C; Valentino, F; Mammi, C; Lombardo, M; Merli, F; Luminari, Stefano; Polimeno, G; Riezzo, A; Lambelet, P; Rovati, A; Corazza, Gr; Federico, Massimo
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/2862
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