Contributions
Abstract: PB1884
Type: Publication Only
Background
There are little published „real life“ data about fludarabine, cyclophosphamide, and rituximab (FCR) combination in patients with chronic lymphocytic leukemia (CLL).
Aims
Herein, we present single-center experience based on long-term follow up of 170 CLL pts treated with FCR with focus on side effects and their impact on the outcome.
Methods
In this retrospective study, we analyzed data from 170 pts with CLL treated with FCR, mostly as a first-line treatment pointing at the correlation between side effects frequency, dosage, and treatment outcome.
Results
Median follow-up was 49 months (range, 2-180). Male/female ratio was 2.8:1 and median age before treatment commencement was 61 year, while 72% of pts were younger than 65 years. Unfavourable cytogenetic profile (del17p and/or del11q) carried 25% of patients. Most of the pts (72%) received FCR as a first-line treatment. Thirty-five percent of patients had a dose reduction of FC from the beginning (82%) or during the treatment (18%), most of them (87%) of > 25% of the expected full dose. More than a half dose reductions were due to decreased creatinine clearance, in 18% the reason was neutropenia and/or infections, 13% physician’s decision and 15% for other reasons. A hundred and ten (67%) pts completed their treatment with 6 FCR cycles, but only 72 (42%) pts received 6 cycles of full-dose FCR. Fifty-six percent of pts at least once received granulocyte colony-stimulating factor (GCSF) for neutropenia grade 3 or 4, 45% of pts had at least one episode of prolonged neutropenia, 16% exhibited late-onset neutropenia, while 28% of pts had infection that caused treatment delay and/or interruption, and/or hospitalization.
Neutropenia occurrence was not related to sex, age, comorbidity status, leukocyte count, or cytogenetic profile, but it was significantly more frequent in pts who had already been treated with some chemotherapy regimen (p= 0.035). It occurred significantly more often in pts who did not complete their treatment with 6 cycles (67% vs. 50%; p=0.046).
Treatment delay was observed in almost half of pts (48%), mostly due to severe neutropenia and infections, and in 90% of pts, it happened for the first time after some of the first 4 cycles. Thirty-four percent of pts experienced treatment discontinuation, 60% of them due to cytopenia(s) and/or infections and 22% due to the resistant or progressive disease.
The overall response rate was 70,6%, equally split between complete (CR) and partial response (PR). When observing untreated pts, CR was achieved in 46,6% in contrary to 10,9% of previously treated pts (p<0.001). In our group, cytogenetic profile predicted treatment response only in treatment-naïve pts (p<0.001 vs p=0.376 for previously treated). Pts who received 6 cycles of full-dose FCR experienced significantly better treatment response (p< 0.001). Treatment delay had not been shown to change the outcome when we observed the whole group and pts with favorable cytogenetic, but when the group was further restricted on pts received full-dose 6 FCR cycles, the adverse impact of treatment delay on outcome was statistically significant (p=0.024). Treatment interruption significantly decreased CR rate (12% vs 46%; p<0.001).
Conclusion
In “real-life” setting treatment with FCR protocol is severely compromised with myelosuppression and infective complications which can considerably influence its therapeutic effect. Further studies are warranted to define risk-factors for myelosuppression after FCR.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Chronic Lymphocytic Leukemia, neutropenia, Outcome
Abstract: PB1884
Type: Publication Only
Background
There are little published „real life“ data about fludarabine, cyclophosphamide, and rituximab (FCR) combination in patients with chronic lymphocytic leukemia (CLL).
Aims
Herein, we present single-center experience based on long-term follow up of 170 CLL pts treated with FCR with focus on side effects and their impact on the outcome.
Methods
In this retrospective study, we analyzed data from 170 pts with CLL treated with FCR, mostly as a first-line treatment pointing at the correlation between side effects frequency, dosage, and treatment outcome.
Results
Median follow-up was 49 months (range, 2-180). Male/female ratio was 2.8:1 and median age before treatment commencement was 61 year, while 72% of pts were younger than 65 years. Unfavourable cytogenetic profile (del17p and/or del11q) carried 25% of patients. Most of the pts (72%) received FCR as a first-line treatment. Thirty-five percent of patients had a dose reduction of FC from the beginning (82%) or during the treatment (18%), most of them (87%) of > 25% of the expected full dose. More than a half dose reductions were due to decreased creatinine clearance, in 18% the reason was neutropenia and/or infections, 13% physician’s decision and 15% for other reasons. A hundred and ten (67%) pts completed their treatment with 6 FCR cycles, but only 72 (42%) pts received 6 cycles of full-dose FCR. Fifty-six percent of pts at least once received granulocyte colony-stimulating factor (GCSF) for neutropenia grade 3 or 4, 45% of pts had at least one episode of prolonged neutropenia, 16% exhibited late-onset neutropenia, while 28% of pts had infection that caused treatment delay and/or interruption, and/or hospitalization.
Neutropenia occurrence was not related to sex, age, comorbidity status, leukocyte count, or cytogenetic profile, but it was significantly more frequent in pts who had already been treated with some chemotherapy regimen (p= 0.035). It occurred significantly more often in pts who did not complete their treatment with 6 cycles (67% vs. 50%; p=0.046).
Treatment delay was observed in almost half of pts (48%), mostly due to severe neutropenia and infections, and in 90% of pts, it happened for the first time after some of the first 4 cycles. Thirty-four percent of pts experienced treatment discontinuation, 60% of them due to cytopenia(s) and/or infections and 22% due to the resistant or progressive disease.
The overall response rate was 70,6%, equally split between complete (CR) and partial response (PR). When observing untreated pts, CR was achieved in 46,6% in contrary to 10,9% of previously treated pts (p<0.001). In our group, cytogenetic profile predicted treatment response only in treatment-naïve pts (p<0.001 vs p=0.376 for previously treated). Pts who received 6 cycles of full-dose FCR experienced significantly better treatment response (p< 0.001). Treatment delay had not been shown to change the outcome when we observed the whole group and pts with favorable cytogenetic, but when the group was further restricted on pts received full-dose 6 FCR cycles, the adverse impact of treatment delay on outcome was statistically significant (p=0.024). Treatment interruption significantly decreased CR rate (12% vs 46%; p<0.001).
Conclusion
In “real-life” setting treatment with FCR protocol is severely compromised with myelosuppression and infective complications which can considerably influence its therapeutic effect. Further studies are warranted to define risk-factors for myelosuppression after FCR.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Chronic Lymphocytic Leukemia, neutropenia, Outcome