Chlorambucil plus rituximab with or without maintenance rituximab as first‐line treatment for elderly chronic lymphocytic leukemia patients. Issue 5 (18th February 2014)

• Record Type: Journal Article
• Authors: Foà, Robin; Del, Ilaria; Cuneo, Antonio; Del, Giovanni; Ciolli, Stefania; Di, 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; Di, 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; De, Maria Stefania; Starza, Irene Della; Piciocchi, Alfonso; Alietti, Alessandra; Runggaldier, Eva Josephine; Gamba, Enrica; Mauro, Francesca Romana; Chiaretti, Sabina; Guarini, Anna;
• Is Part Of: American journal of hematology. Volume 89:Issue 5(2014:May)
• Page Start: 480
• Page End: 486
• Publication Date: 2014-02-18
• Subjects: Hematology -- Periodicals; 616.15
• DOI: 10.1002/ajh.23668
• Languages: English
• ISSNs: 0361-8609

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <p>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<sup>2</sup>/day, days 1–7) and R (day 1 of cycle 3, 375 mg/m<sup>2</sup>; cycles 4–8, 500 mg/m<sup>2</sup>). Responders were randomized to 12 8‐week doses of R (375 mg/m<sup>2</sup>) 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). <italic>TP53</italic> abnormalities, complex karyotype, and low <italic>CD20</italic> gene expression predicted lack of response; <italic>SF3B1</italic> mutation and <italic>BIRC3</italic> disruption low CR rates. <italic>IGHV</italic> 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 <italic>IGHV</italic> cases. CLB‐R represents a promising option for elderly CLL patients. Am. J. Hematol. 89:480–486, 2014. © 2014 Wiley Periodicals, Inc.</p> </abstract>