Effectiveness of the Combination of Rituximab and Standard Chemotherapeutic Regimens in Previously Untreated Patients with Chronic Lymphocytic Leukaemia in Real-Life

Results from a Noninterventional Study (CILI Study)

Róbert Szász, Elvira Altai, Katalin Pál, Péter Dombi, János Iványi, János Jakucs, Natália Jóni, A. Illés, Ilona Tárkányi, László Szerafin, Zsolt Nagy, Péter Farkas, Ágnes Nagy, Klára Piukovics, György Ujj, Tamás Schneider

Research output: Contribution to journalArticle

Abstract

Chronic lymphocytic leukemia (CLL) is one of the most common haematological malignancies exhibiting remarkable heterogeneity in clinical course. Rituximab added to standard chemotherapy has been proven to increase response rate and eventually survival among previously untreated CLL patients. CILI was an open-label, non-randomized, single arm, multicentric, observational study aimed to collect real-life effectiveness data for rituximab used according to the current label in combination with standard chemotherapy in previously untreated CLL patients. Overall response rates (ORR) in the entire study population as well as in various subgroups were estimated. Adverse events were recorded during the entire course of the study. A total number of 150 patients were enrolled by 15 Hungarian study sites. Out of these, 82 patients received 6 cycles of rituximab containing treatment. Overall response rates of 88.24% (CI95%: 81.6–93.12%) and 94.59% (CI95%: 86.73–98.51%) were recorded in the intent-to-treat (ITT) and per-protocol (PP) populations, respectively. In both study populations, somewhat higher ORR was observed in patients aged ≥65 years. Subgroups defined according to either chromosomal aberrations (presence of 11q and 17p deletions) showed apparently high ORRs, though these rates were most probably biased by low patient numbers. 144 adverse events were reported during the study, of which 15 AEs were considered to be related to the administration of rituximab. Analyses of the efficacy variables have revealed comparable results to those previously reported by controlled clinical trials.

Original languageEnglish
JournalPathology and Oncology Research
DOIs
Publication statusAccepted/In press - Jan 1 2018

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B-Cell Chronic Lymphocytic Leukemia
Population
Drug Therapy
Controlled Clinical Trials
Hematologic Neoplasms
Chromosome Aberrations
Observational Studies
Rituximab
Survival Rate

Keywords

  • Chronic lymphocytic leukemia
  • Overall response rate
  • Rituximab

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Oncology
  • Cancer Research

Cite this

Effectiveness of the Combination of Rituximab and Standard Chemotherapeutic Regimens in Previously Untreated Patients with Chronic Lymphocytic Leukaemia in Real-Life : Results from a Noninterventional Study (CILI Study). / Szász, Róbert; Altai, Elvira; Pál, Katalin; Dombi, Péter; Iványi, János; Jakucs, János; Jóni, Natália; Illés, A.; Tárkányi, Ilona; Szerafin, László; Nagy, Zsolt; Farkas, Péter; Nagy, Ágnes; Piukovics, Klára; Ujj, György; Schneider, Tamás.

In: Pathology and Oncology Research, 01.01.2018.

Research output: Contribution to journalArticle

Szász, Róbert ; Altai, Elvira ; Pál, Katalin ; Dombi, Péter ; Iványi, János ; Jakucs, János ; Jóni, Natália ; Illés, A. ; Tárkányi, Ilona ; Szerafin, László ; Nagy, Zsolt ; Farkas, Péter ; Nagy, Ágnes ; Piukovics, Klára ; Ujj, György ; Schneider, Tamás. / Effectiveness of the Combination of Rituximab and Standard Chemotherapeutic Regimens in Previously Untreated Patients with Chronic Lymphocytic Leukaemia in Real-Life : Results from a Noninterventional Study (CILI Study). In: Pathology and Oncology Research. 2018.
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abstract = "Chronic lymphocytic leukemia (CLL) is one of the most common haematological malignancies exhibiting remarkable heterogeneity in clinical course. Rituximab added to standard chemotherapy has been proven to increase response rate and eventually survival among previously untreated CLL patients. CILI was an open-label, non-randomized, single arm, multicentric, observational study aimed to collect real-life effectiveness data for rituximab used according to the current label in combination with standard chemotherapy in previously untreated CLL patients. Overall response rates (ORR) in the entire study population as well as in various subgroups were estimated. Adverse events were recorded during the entire course of the study. A total number of 150 patients were enrolled by 15 Hungarian study sites. Out of these, 82 patients received 6 cycles of rituximab containing treatment. Overall response rates of 88.24{\%} (CI95{\%}: 81.6–93.12{\%}) and 94.59{\%} (CI95{\%}: 86.73–98.51{\%}) were recorded in the intent-to-treat (ITT) and per-protocol (PP) populations, respectively. In both study populations, somewhat higher ORR was observed in patients aged ≥65 years. Subgroups defined according to either chromosomal aberrations (presence of 11q and 17p deletions) showed apparently high ORRs, though these rates were most probably biased by low patient numbers. 144 adverse events were reported during the study, of which 15 AEs were considered to be related to the administration of rituximab. Analyses of the efficacy variables have revealed comparable results to those previously reported by controlled clinical trials.",
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AU - Szász, Róbert

AU - Altai, Elvira

AU - Pál, Katalin

AU - Dombi, Péter

AU - Iványi, János

AU - Jakucs, János

AU - Jóni, Natália

AU - Illés, A.

AU - Tárkányi, Ilona

AU - Szerafin, László

AU - Nagy, Zsolt

AU - Farkas, Péter

AU - Nagy, Ágnes

AU - Piukovics, Klára

AU - Ujj, György

AU - Schneider, Tamás

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N2 - Chronic lymphocytic leukemia (CLL) is one of the most common haematological malignancies exhibiting remarkable heterogeneity in clinical course. Rituximab added to standard chemotherapy has been proven to increase response rate and eventually survival among previously untreated CLL patients. CILI was an open-label, non-randomized, single arm, multicentric, observational study aimed to collect real-life effectiveness data for rituximab used according to the current label in combination with standard chemotherapy in previously untreated CLL patients. Overall response rates (ORR) in the entire study population as well as in various subgroups were estimated. Adverse events were recorded during the entire course of the study. A total number of 150 patients were enrolled by 15 Hungarian study sites. Out of these, 82 patients received 6 cycles of rituximab containing treatment. Overall response rates of 88.24% (CI95%: 81.6–93.12%) and 94.59% (CI95%: 86.73–98.51%) were recorded in the intent-to-treat (ITT) and per-protocol (PP) populations, respectively. In both study populations, somewhat higher ORR was observed in patients aged ≥65 years. Subgroups defined according to either chromosomal aberrations (presence of 11q and 17p deletions) showed apparently high ORRs, though these rates were most probably biased by low patient numbers. 144 adverse events were reported during the study, of which 15 AEs were considered to be related to the administration of rituximab. Analyses of the efficacy variables have revealed comparable results to those previously reported by controlled clinical trials.

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