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Treatment of Indolent B-Cell Nonfollicular Lymphomas: Final Results of the LL01 Randomized Trial of the Gruppo Italiano per lo Studio dei Linfomi

Luca Baldini, Maura Brugiatelli, Stefano Luminari, Marco Lombardo, Francesco Merli, Stefano Sacchi, Paolo Gobbi, Marina Liberati, Luigi Cavanna, Mariangela Colombi, Caterina Stelitano, Maria Goldaniga, Fortunato Morabito, Massimo Federico, Vittorio Silingardi

From the Unità Operativa Ematologia 1, Dipartimento di Ematologia, Ospedale Maggiore, IRCCS, Milano; Divisione di Ematologia, Azienda Ospedaliera "Papardo," Messina; Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Modena; Dipartimento di Ematologia ed Oncologia, Presidio Ospedaliero, Pescara; Servizio di Ematologia, Arcispedale S. Maria Nuova, Reggio Emilia; Medicina Interna e Oncologia Medica, Università di Pavia, Policlinico S. Matteo, IRCCS, Pavia; Dipartimento di Ematologia, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria; Istituto di Medicina Interna e Scienza Oncologiche, Policlinico Monteluce, Perugia; and Sezione di Ematologia, Divisione di Medicina I, Ospedale Civile, Piacenza, Italy.

Address reprint requests to Luca Baldini, MD, Unità Operativa Ematologia 1, Centro "G. Marcora," Ospedale Maggiore, IRCCS, Via F. Sforza 35, 20121 Milano, Italy; email: lubaldini{at}policlinico.mi.it.

Purpose: To evaluate the effect of epirubicin on therapeutic response and survival in patients with indolent nonfollicular B-cell lymphomas (INFL) treated with pulsed high-dose chlorambucil.

Patients and Methods: A total of 170 untreated patients with advanced/active INFL were randomly assigned to receive either eight cycles of high-dose chlorambucil (15 mg/m²/d) plus prednisone (100 mg/d) for 5 days (HD-CHL-P; arm A) or eight cycles of HD-CHL-P plus epirubicin 60 mg/m² intravenous on day 1 (arm B). The responding patients were randomly assigned to either maintenance therapy with interferon alfa (IFN-2a; 3 MU, three times weekly) for 12 months or observation.

Results: There were 160 assessable patients (82 males, 78 females; median age, 63 years; range, 33 to 77 years); 77 patients were assigned to arm A, and 83 were assigned to arm B. Induction therapy led to 47 complete responses (CRs; 29.4%) and 68 partial responses (PRs; 42.5%), with no significant difference between the two arms (60 CR + PR in arm A [77.9%] and 55 CR + PR in arm B [66.3%]; P = .07). After a median follow-up of 38 months (range, 2 to 103 months), there was no between-group difference in overall survival (OS; P = .45), failure-free survival (P = .07), or progression-free survival (PFS; P = .5). Eighty-eight patients were randomly assigned to either IFN-2a (n = 43) or observation (n = 45), without any difference in 3-year PFS (44% and 42%, respectively). Univariate analysis showed that OS was influenced by age, anemia, serum lactate dehydrogenase levels, and International Prognostic Index distribution; multivariate analysis identified age and anemia as having influence on OS.

Conclusion: HD-CHL-P treatment outcome in INFL patients was good (50% 3-year PFS, minimal toxicity, and low costs); epirubicin did not add any advantage. One-year IFN maintenance treatment did not prolong response duration.

Supported by a grant (Ricerca Corrente) from the Italian Ministry of Health to Ospedale Maggiore Istituto Ricovero Cura Carattere Scientifico, Milan, Italy, and a grant from Associazione Angela Serra, Modena, Italy.

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