Fludarabine, cyclophosphamide and rituximab plus granulocyte macrophage colony-stimulating factor as frontline treatment for patients with chronic lymphocytic leukemia

Ferrajoli, Alessandra; Lerner, Susan; O’Brien, Susan; Wierda, William G.; Keating, Michael J.

doi:10.3109/10428194.2013.819574

Cited by 12 publications

(6 citation statements)

References 27 publications

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“…In a randomized trial of FCR versus FC, the FCR arm produced superior 3-year PFS and OS rates of 65% and 85%, respectively (Hallek et al, 2010). FCR plus granulocyte-macrophage colony-stimulating factor produced 75% CR in patients with untreated CLL, with a lower risk of infections compared to the previous study with FCR alone (Strati et al, 2014). For a group of 46 patients with previously untreated non-follicular low-grade lymphomas, 46% of whom had SLL, FCR produced 96% OR and 63% CR/CRu, with 90% of patients progression-free at 40Á9 months (Ferrario et al, 2012).…”

Section: Discussionmentioning

confidence: 74%

Pentostatin, cyclophosphamide and rituximab for previously untreated advanced stage, low‐grade B‐cell lymphomas

et al. 2015

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Summary We conducted a prospective phase II trial of pentostatin, cyclophosphamide and rituximab as initial therapy for patients with previously untreated advanced stage low-grade or indolent B-cell lymphomas (iNHLs). Of 83 evaluable patients, 91·6% attained an overall response and 86·8% a complete or unconfirmed complete response. The 3-year progression-free survival (PFS) and overall survival rates were 73% and 93%, respectively. The 3-year PFS rate was significantly different for different diagnoses (P = 0·01): 83% [95% confidence interval (CI): 0·72, 0·96] for follicular lymphomas, 73% (95% CI: 0·54, 1·0) for marginal zone lymphomas and 61% (95% CI: 0·46, 0·81) for small lymphocytic lymphomas. The most common adverse events were haematological. Of 509 cycles of chemotherapy administered, grade 3 or 4 neutropenia was reported in 68 cycles (13% of cycles administered) and most frequently occurred during cycles 4–6. This is the first report demonstrating the effectiveness of pentostatin, cyclophosphamide and rituximab in patients with previously untreated iNHLs, including those over 60 years of age.

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Section: Discussionmentioning

confidence: 74%

Pentostatin, cyclophosphamide and rituximab for previously untreated advanced stage, low‐grade B‐cell lymphomas

et al. 2015

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“…In a previous trial, the routine addition of GM-CSF to FCR resulted in a numerically higher rate of t-MDS/AML compared to FCR alone (6% vs. 3%, respectively), although this difference did not reach statistical significance. 29 The use of growth factors in the historical FCR cohort was not recorded, and therefore our ability to draw conclusions about the role of growth factors in the development of t-MDS/AML is limited.…”

Section: Discussionmentioning

confidence: 99%

Fludarabine, cyclophosphamide, and multiple‐dose rituximab as frontline therapy for chronic lymphocytic leukemia

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Keating

Wierda

et al. 2015

Cancer

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Background Fludarabine, cyclophosphamide and rituximab (FCR) results in durable responses in patients with previously untreated chronic lymphocytic leukemia (CLL). Previous reports suggest that in patients with relapsed CLL a dose-intensified rituximab regimen increases response rates compared to standard-dose rituximab. It is unknown whether rituximab intensification of the FCR regimen will result in improved response rates and patient outcomes in patients with previously untreated CLL. Methods We conducted a single-arm study to evaluate the safety and efficacy of a modified FCR regimen with multiple-dose rituximab (FCR3) in 65 patients with previously untreated CLL. Results were compared to an historical cohort treated with FCR. Results The overall response rate to FCR3 was 97%, with 75% of patients achieving a complete remission. Minimal residual disease negativity was achieved in 62% of patients by flow cytometry. Median time to progression (TTP) was 81 months, and median overall survival (OS) was not reached, with 58% of patients still alive at a median survivor follow-up of 9.7 years. Grade 3-4 neutropenia, grade 3-4 thrombocytopenia and major infection were observed with 45%, 5% and 1.9% of FCR3 courses, respectively. Therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) developed in 7 patients (11%) (P <0.01 compared to the historical FCR cohort). Conclusions In patients with previously untreated CLL, FCR3 resulted in similar response rates, TTP and OS compared to a historical cohort of patients treated with FCR. FCR3 was associated with an increased incidence of t-MDS/AML.

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“…Details of treatment protocols have been reported previously. [ 20-23 ] Of note, the patients included in frontline CFAR regimen were high risk patients with β2 microglobulin ≥ 4.0 and del17p 6/24 (22%). Following the completion of the therapy, all patients were periodically followed up at MDACC by clinical assessment and relevant investigations.…”

Section: Methodsmentioning

confidence: 99%

Second cancers in patients with chronic lymphocytic leukemia who received frontline fludarabine, cyclophosphamide and rituximab therapy: distribution and clinical outcomes

Benjamini

Jain

Trinh

et al. 2014

Leukemia & Lymphoma

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Patients with Chronic Lymphocytic Leukemia (CLL) are known to have an increased incidence of second cancers, but the contribution of commonly used frontline therapies to the incidence of second cancers is unclear. We report on the characteristics, incidence, outcomes and factors associated with second cancers in 234 patients receiving Fludarabine, Cyclophosphamide, and Rituximab (FCR) based regimens in the frontline setting. The risk of second cancers was 2.38 times higher than the expected risk in the general population. Ninety three patients (40%) had other cancers before and 66 patients (28%) after FCR. The rates of t-AML/MDS (5.1%) and Richter’s transformation (RT) (9%) were high while solid tumors were not increased. Overall survival of patients with second cancers after frontline FCR was shorter (median of 4.5 years) compared to patients with and without prior cancers. Second cancer risk after frontline FCR is mainly due to high rates of t-AML/MDS and RT and as speculated the survival of affected patients is shorter.

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Fludarabine, cyclophosphamide and rituximab plus granulocyte macrophage colony-stimulating factor as frontline treatment for patients with chronic lymphocytic leukemia

Cited by 12 publications

References 27 publications

Pentostatin, cyclophosphamide and rituximab for previously untreated advanced stage, low‐grade B‐cell lymphomas

Pentostatin, cyclophosphamide and rituximab for previously untreated advanced stage, low‐grade B‐cell lymphomas

Fludarabine, cyclophosphamide, and multiple‐dose rituximab as frontline therapy for chronic lymphocytic leukemia

Second cancers in patients with chronic lymphocytic leukemia who received frontline fludarabine, cyclophosphamide and rituximab therapy: distribution and clinical outcomes

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