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• W2080610076 abstract "We appreciate the comments from Tetsuya Tanimoto and colleagues, and Ian Haines and colleagues. They allow us to clarify a few important points. Tanimoto and colleagues note that second-line therapies might affect overall survival. We agree with this statement. However, as of June, 2009 (closure of database for analysis), only a minority of patients had received second-line therapy. Therefore, the results were too preliminary to allow reliable conclusions. Moreover, a high proportion of patients with a short progression-free survival had a del(17p) mutation, which predicted a short progression-free survival and overall survival in this trial. Therefore, 3 years after randomisation, genomic aberrations seemed to have a stronger effect on outcome than the type of second-line treatment. 70 patients were assessed as having stable disease after three courses (30 in the fludarabine, cyclophosphamide, and rituximab [FCR] group and 40 in the fludarabine and cyclophosphamide [FC] group); most of them continued with study treatment. So far, more patients in the FC group have received second-line therapies than in the FCR group. A systematic assessment of the response to these therapies would be premature and based on a very small subset of patients. We do not agree with Haines and colleagues' comments on the study population. The proportion of Binet A patients is very small at only 5%; 31% of patients were Binet C stage. The role of granulocyte colony-stimulating factor (G-CSF) needs to be further investigated. However, results from prospective phase 3 trials have found that first-line treatment for chronic lymphocytic leukaemia (CLL) with FC or fludarabine alone can be applied without the addition of G-CSF or similar growth factors.1Eichhorst BF Busch R Schweighofer C Wendtner CM Emmerich B Hallek M German CLL Study Group (GCLLSG)Due to low infection rates no routine anti-infective prophylaxis is required in younger patients with chronic lymphocytic leukaemia during fludarabine-based first line therapy.Br J Haematol. 2007; 136: 63-72Crossref PubMed Scopus (25) Google Scholar In this trial, G-CSF was given only in about 2% of courses, again suggesting that FCR or FC could be safely given in first-line therapy of patients with CLL. The German CLL Study Group is making every possible attempt to follow up patients from its trials until death to gain insight into the long-term consequences of all treatment modalities. Therefore, this study was not discontinued. Although the results of the first interim analysis were robust, reliable, and significant, we decided to repeat the analysis with 1 additional year of follow-up and a longer median observation time (37·7 months). These results were reported in the published manuscript. The primary endpoint of this trial was progression-free survival; secondary endpoints were response rates and overall survival. The repeated analysis with a median observation time of 47·4 months has yielded similar results, with FCR causing a longer overall survival. Moreover, progression-free survival is an accepted and recommended endpoint, since progression was clearly defined by the 1996 guidelines and the updated version.2Cheson BD Bennett JM Grever M et al.National Cancer Institute-Sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment.Blood. 1996; 87: 4990-4997PubMed Google Scholar, 3Hallek M Cheson BD Catovsky D et al.Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines.Blood. 2008; 111: 5446-5456Crossref PubMed Scopus (2648) Google Scholar We agree that the study population of this trial is young compared with most CLL patients. As stated in the Article, conclusions of this trial could not be transferred to patients with relevant comorbidity. However, patients older than 65 years tolerated both treatment modalities quite well with no significant differences in toxic effects, since they were selected according to their physical fitness (cumulative illness rating scale and creatinine clearance). MH declares consultancy or board membership from Roche and Mundipharma and payment for educational presentations from Roche. AF and KF declare travel grants from Roche. RB declares that she has no conflicts of interest. Rituximab-containing therapy for chronic lymphocytic leukaemiaM Hallek and colleagues (Oct 2, p 1164)1 compared fludarabine and cyclophosphamide with fludarabine, cyclophosphamide, and rituximab as a first-line therapy for patients with chronic lymphocytic leukaemia. They showed that use of the rituximab-containing regimen improved 3-year progression-free survival from 45% to 65%. It was also associated with improved overall survival from 83% to 87%. Full-Text PDF Rituximab-containing therapy for chronic lymphocytic leukaemiaThe claim by Peter Hillmen (p 1122),1 on the basis of the CLL8 study,2 that the combination of fludarabine, cyclophosphamide, and rituximab (FCR) is now “the gold standard” for patients with chronic lymphocytic leukaemia seems premature. Full-Text PDF" @default.
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• W2080610076 title "Rituximab-containing therapy for chronic lymphocytic leukaemia – Authors' reply" @default.
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• W2080610076 doi "https://doi.org/10.1016/s0140-6736(11)60043-3" @default.
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