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Chlorambucil plus rituximab with or without maintenance rituximab as first‐line treatment for elderly chronic lymphocytic leukemia patients
Author(s) -
Foà Robin,
Giudice Ilaria,
Cuneo Antonio,
Poeta Giovanni,
Ciolli Stefania,
Raimondo Francesco,
Lauria Francesco,
Cencini Emanuele,
Rigolin Gian Matteo,
Cortelezzi Agostino,
Nobile Francesco,
Callea Vincenzo,
Brugiatelli Maura,
Massaia Massimo,
Molica Stefano,
Trentin Livio,
Rizzi Rita,
Specchia Giorgina,
Serio Francesca,
Orsucci Lorella,
Ambrosetti Achille,
Montillo Marco,
Zinzani Pier Luigi,
Ferrara Felicetto,
Morabito Fortunato,
Mura Maria Angela,
Soriani Silvia,
Peragine Nadia,
Tavolaro Simona,
Bonina Silvia,
Marinelli Marilisa,
Propris Maria Stefania,
Starza Irene Della,
Piciocchi Alfonso,
Alietti Alessandra,
Runggaldier Eva Josephine,
Gamba Enrica,
Mauro Francesca Romana,
Chiaretti Sabina,
Guarini Anna
Publication year - 2014
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.23668
Subject(s) - ighv@ , chlorambucil , rituximab , chronic lymphocytic leukemia , medicine , fludarabine , gastroenterology , alemtuzumab , cd20 , oncology , leukemia , surgery , chemotherapy , cyclophosphamide , lymphoma , transplantation
In a phase II trial, we evaluated chlorambucil and rituximab (CLB‐R) as first‐line induction treatment with or without R as maintenance for elderly chronic lymphocytic leukemia (CLL) patients. Treatment consisted of eight 28‐day cycles of CLB (8 mg/m 2 /day, days 1–7) and R (day 1 of cycle 3, 375 mg/m 2 ; cycles 4–8, 500 mg/m 2 ). Responders were randomized to 12 8‐week doses of R (375 mg/m 2 ) or observation. As per intention‐to‐treat analysis, 82.4% (95% CI, 74.25–90.46%) of 85 patients achieved an overall response (OR), 16.5% a complete response (CR), 2.4% a CR with incomplete bone marrow recovery. The OR was similar across Binet stages (A 86.4%, B 81.6%, and C 78.6%) and age categories (60–64 years, 92.3%; 65–69, 85.2%; 70–74, 75.0%; ≥75, 81.0%). CLB‐R was well tolerated. After a median follow‐up of 34.2 months, the median progression‐free survival (PFS) was 34.7 months (95% CI, 33.1–39.5). TP53 abnormalities, complex karyotype, and low CD20 gene expression predicted lack of response; SF3B1 mutation and BIRC3 disruption low CR rates. IGHV mutations significantly predicted PFS. R maintenance tended towards a better PFS than observation and was safe and most beneficial for patients in partial response and for unmutated IGHV cases. CLB‐R represents a promising option for elderly CLL patients. Am. J. Hematol. 89:480–486, 2014. © 2014 Wiley Periodicals, Inc.