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Annals of Oncology Advance Access originally published online on January 30, 2006
Annals of Oncology 2006 17(4):676-682; doi:10.1093/annonc/mdl002
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© 2006 European Society for Medical Oncology

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)

P. G. Gobbi1,*, C. Broglia1, F. Valentino1, C. Mammi2, M. Lombardo3, F. Merli4, S. Luminari2, G. Polimeno5, A. Riezzo6, P. Lambelet7, A. Rovati8, G. R. Corazza1 and M. Federico2

1 Medicina Interna, Oncologia e Gastroenterologia, Università di Pavia, IRCCS Policlinico S. Matteo, Pavia; 2 Sez. di Oncologia, Università di Modena e Reggio E., Policlinico di Modena; 3 Dip. di Oncologia, Ospedale S. Spirito, Pescara; 4 Serv. di Ematologia, Arcispedale ‘S. Maria Nuova’, Reggio Emilia; 5 Serv. di Ematologia, Div. di Medicina, Ospedale ‘Miulli’, Acquaviva delle Fonti (BA); 6 Div. di Ematologia, Ospedale ‘S. Nicola Pellegrino’, Trani (BA); 7 Div. di Medicina, Ospedale di Viareggio (PI); 8 Sez. di Ematologia, Medina I, Ospedale Maggiore, Lodi, Italy

* Correspondence to: Prof. P. G. Gobbi, Medicina Interna, Oncologia e Gastroenterologia, Università di Pavia, IRCCS Policlinico S. Matteo, P.le Golgi n° 2, 27100 Pavia, Italy. (Tel: 0039–0382–502954; fax: 0039–0382–526223; E-mail: gobbipg{at}smatteo.pv.it

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.

Key words: chemotherapy, large B-cell lymphoma, dose intensity, dose size, dose density


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