A Phase III trial of fludarabine, cyclophosphamide, and rituximab vs. pentostatin, cyclophosphamide, and rituximab in B-cell chronic lymphocytic leukemia

Reynolds, Craig H.; Bella, Nicholas Di; Lyons, Roger M.; Hyman, William; Richards, Donald A.; Robbins, Gerald J.; Vellek, Mark; Boehm, Kristi A.; Zhan, Feng; Asmar, Lina

doi:10.1007/s10637-011-9737-y

Cited by 54 publications

(33 citation statements)

References 17 publications

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“…1,2 This regimen and comparable treatments have since been explored in different clinical settings in various CLL trials. [3][4][5][6][7] Most participants in these studies were relatively young and not affected by additional health problems. However, many CLL patients in routine practice are elderly and suffer from comorbidities.…”

Section: Introductionmentioning

confidence: 99%

Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials

et al. 2014

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© F e r r a t a S t o r t i F o u n d a t i o nthis on-site documentation, causes of death were grouped into the following categories: therapy-related, CLL-related, CLL-unrelated, or unknown. Both studies were approved by the Institutional Review Board and Ethics Committee of the University of Munich and performed in accordance with the Declaration of Helsinki. Comorbidity assessmentFor both trials, comorbid conditions present at baseline had to be assessed and documented in the patient's case report form by the treating physician. Further quantification of the comorbidity burden by use of specific comorbidity scores was not part of the study protocols. Thus, all comorbid conditions reported within the case report form were captured only in a qualitative manner. Health problems resulting from the CLL itself and CLL as the primary disease were not recorded as comorbidity.To assess the comorbidity burden for each patient individually in the absence of quantitative data derived from scores, the number of comorbidities was calculated as the sum of all conditions abstracted from the patient's case report form according to the rules described above. Since information on the severity of comorbid conditions was mostly unobtainable, a retrospective scoring of comorbidity by use of a validated comorbidity score was not reliably possible (although an attempt was made to calculate the Charlson comorbidity index from the available data). 16 For a general description of the spectrum of comorbidities in the study population, each of the concomitant diseases was assigned to disease categories abstracted from the Cumulative Illness Rating Scale. 17 Statistical analysisThe statistical analysis was performed with SPSS 17 software (SPSS Inc., USA) and based on data collected by Results Baseline characteristicsOf the 581 patients recruited into the CLL4 and CLL5 trials, 555 were eligible for this analysis. Twenty-six patients were excluded because of inaccurate diagnosis (n=5), no need of therapy (n=2), previous therapy (n=3), consent issues (n=6), or other reasons (n=10). The characteristics of the study population are summarized in Table 1. The median time of follow-up for all patients was 58 months. Patients treated within the CLL4 and CLL5 trials were younger and older, respectively (median: 58 versus 70 years). Comorbidity burdenThe patients' comorbidity burden at baseline is presented in Table 2 and Online Supplementary Table S1. Fifty-three percent of the patients had at least one concurrent disease. The number of comorbidities ranged from zero to seven (median: 1) and increased continuously with advanced age (P<0.001). Of 139 patients presenting with more than one comorbidity, most had two or three co-existing diseases, while there were only 24 patients with more than three health problems. Impact of comorbidity on overall prognosisBy univariate analysis, patients with ≥2 comorbidities had a significantly shorter median overall survival than patients with <2 comorbid conditions (71.7 versus 90.2 months, P<0.001). ...

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Section: Introductionmentioning

confidence: 99%

Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials

et al. 2014

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“…Thus, there may be significant differences in outcome in patients treated with FCR within the framework of a clinical study when compared to patients treated in everyday life. In an attempt to reduce associated toxicity, some investigators used modified FCR-based regimens, employing protocols with reduced doses of chemotherapy and increased amounts of rituximab, 12 sequential F→C→R regimen, 13 and even substitution of fludarabine by pentostatin 14 or cladribine. 15,16 The present study aimed to evaluate the efficacy and safety of the FCR regimen for physically fit This study aimed to evaluate the efficacy and safety of the fludarabine-cyclophosphamide-rituximab regimen for young physically fit patients with chronic lymphocytic leukemia in the "real-life" setting.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of front-line therapy with fludarabine-cyclophosphamide-rituximab regimen for chronic lymphocytic leukemia outside clinical trials: the Israeli CLL Study Group experience

et al. 2015

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“…The PCR regimen ( Table 1) has been studied as initial therapy for chronic lymphocytic leukemia (CLL), [1][2][3][4][5][6] small lymphocytic lymphoma, 2 Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma, 7,8 and low-grade B-cell lymphomas. 9 Current guidelines do not list the PCR regimen as one of the regimens for treatment of Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma.…”

Section: Indicationsmentioning

confidence: 99%

Pentostatin, Cyclophosphamide and Rituximab (PCR) Regimen

Solimando¹,

Waddell²

2016

Hosp Pharm

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A Phase III trial of fludarabine, cyclophosphamide, and rituximab vs. pentostatin, cyclophosphamide, and rituximab in B-cell chronic lymphocytic leukemia

Abstract: PCR and FCR have significant activity in CLL and can be given safely in the community setting despite significant toxicity. ORRs were lower than expected; the CR rate was higher (NS) with FCR. This trial did not demonstrate a lower infection rate with PCR.

Cited by 54 publications

References 17 publications

Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials

Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials

Efficacy and safety of front-line therapy with fludarabine-cyclophosphamide-rituximab regimen for chronic lymphocytic leukemia outside clinical trials: the Israeli CLL Study Group experience

Pentostatin, Cyclophosphamide and Rituximab (PCR) Regimen

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