Abstract
Purpose: To evaluate the effect of epirubicin on therapeutic response and survival in patients with indolent non-follicular 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 (IFNα-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 IFNα-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 IFNα maintenance treatment did not prolong response duration.
| Original language | English |
|---|---|
| Pages (from-to) | 1459-1465 |
| Number of pages | 7 |
| Journal | Journal of Clinical Oncology |
| Volume | 21 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Apr 15 2003 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Treatment of indolent B-cell nonfollicular lymphomas : Final results of the LL01 randomized trial of the Gruppo Italiano per lo Studio dei Linfomi. / Baldini, Luca; Brugiatelli, Maura; Luminari, Stefano; Lombardo, Marco; Merli, Francesco; Sacchi, Stefano; Gobbi, Paolo; Liberati, Marina; Cavanna, Luigi; Colombi, Mariangela; Stelitano, Caterina; Goldaniga, Maria; Morabito, Fortunato; Federico, Massimo; Silingardi, Vittorio.
In: Journal of Clinical Oncology, Vol. 21, No. 8, 15.04.2003, p. 1459-1465.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Treatment of indolent B-cell nonfollicular lymphomas
T2 - Final results of the LL01 randomized trial of the Gruppo Italiano per lo Studio dei Linfomi
AU - Baldini, Luca
AU - Brugiatelli, Maura
AU - Luminari, Stefano
AU - Lombardo, Marco
AU - Merli, Francesco
AU - Sacchi, Stefano
AU - Gobbi, Paolo
AU - Liberati, Marina
AU - Cavanna, Luigi
AU - Colombi, Mariangela
AU - Stelitano, Caterina
AU - Goldaniga, Maria
AU - Morabito, Fortunato
AU - Federico, Massimo
AU - Silingardi, Vittorio
PY - 2003/4/15
Y1 - 2003/4/15
N2 - Purpose: To evaluate the effect of epirubicin on therapeutic response and survival in patients with indolent non-follicular 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 (IFNα-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 IFNα-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 IFNα maintenance treatment did not prolong response duration.
AB - Purpose: To evaluate the effect of epirubicin on therapeutic response and survival in patients with indolent non-follicular 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 (IFNα-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 IFNα-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 IFNα maintenance treatment did not prolong response duration.
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U2 - 10.1200/JCO.2003.07.133
DO - 10.1200/JCO.2003.07.133
M3 - Article
C2 - 12697867
AN - SCOPUS:0038518616
VL - 21
SP - 1459
EP - 1465
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 8
ER -