Contributions
Abstract: PB1791
Type: Publication Only
Background
In recent years, there have been advances in the treatment of CLL with the approval of several novel oral agents that show improvement in PFS and OS. Additionally, some agents induce a deep response indicated by complete remission (CR) and/or minimal residual disease negativity (MRD-). However, there is limited information on the longer-term clinical benefits of achieving a deep response in a real-world setting.
Aims
This study aimed to characterize PFS and OS for patients who achieved a deep response to first-line therapy for CLL.
Methods
Patient-level data were collected between July and August 2016 from 93 oncologists/hematologists in the United States. Oncologists/hematologists provided patient level clinical data obtained from patient charts among CLL patients who initiated first-line therapy for CLL between January 2010 and December 2014. Selected patients were categorized into 2 cohorts based on their best response: patients who achieved CR and patients who did not achieve CR (non-CR). The non-CR cohort included patients with partial remission (PR), stable disease (SD) and progressive disease (PD). iwCLL 2008 criteria were provided to guide physicians’ assessment of treatment response. The target sample size for each response type was a priori determined based on distribution of response in clinical trials. Data on disease progression and mortality was provided by the treating oncologist/hematologist. PFS and OS were compared using univariate and multivariate Cox proportional analyses between the CR and non-CR cohorts (OS multivariate analyses were not conducted due to the small number of events). An additional analysis was conducted to examine the benefits of achieving MRD- versus not achieving MRD- among patients who achieved CR or PR.
Results
Data was collected on 330 CLL patients, including 179 patients in the CR cohort and 151 patients in the non-CR cohort (120 patients with PR, 25 with SD, and 6 with PD). Most patients were male, in their early sixties, and had an ECOG status of O/1 at the time of initiating first-line therapy. The median observation period was approximately 30 months. There were 43 (24%) patients in the CR cohort and 75 (50%) patients in the non-CR cohort who progressed/died (Table 1). Patients in the non-CR cohort had an > 2-fold higher hazard of progression/death (adjusted hazard ratio [HR]=2.30, p<0.05) and death (unadjusted HR=2.61, p<0.05) compared to patients in the CR cohort. Among patients who achieved CR or PR, 84 patients achieved MRD- and 62 patients did not; 14(17%) patients who achieved MRD- and 27 (44%) patients who did not achieve MRD- progressed/died. Patients who did not achieve MRD- had an over three-fold higher hazard of progression/death compared to patients who achieved MRD- (adjusted HR=3.75, p<0.05). No death events were observed among patients who achieved MRD- while 4 (6%) events were observed among those who did not achieve MRD-.
Conclusion
Findings from this real-world study suggest that achieving CR is associated with improved PFS and OS compared to patients who do not achieve CR. Furthermore, significantly better outcomes were observed in patients who achieved MRD- compared to those who did not achieve MRD- but still achieved CR or PR. This suggests that deep response may be an important clinical parameter to consider in the treatment of CLL.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Survival, Progression, Chronic Lymphocytic Leukemia
Abstract: PB1791
Type: Publication Only
Background
In recent years, there have been advances in the treatment of CLL with the approval of several novel oral agents that show improvement in PFS and OS. Additionally, some agents induce a deep response indicated by complete remission (CR) and/or minimal residual disease negativity (MRD-). However, there is limited information on the longer-term clinical benefits of achieving a deep response in a real-world setting.
Aims
This study aimed to characterize PFS and OS for patients who achieved a deep response to first-line therapy for CLL.
Methods
Patient-level data were collected between July and August 2016 from 93 oncologists/hematologists in the United States. Oncologists/hematologists provided patient level clinical data obtained from patient charts among CLL patients who initiated first-line therapy for CLL between January 2010 and December 2014. Selected patients were categorized into 2 cohorts based on their best response: patients who achieved CR and patients who did not achieve CR (non-CR). The non-CR cohort included patients with partial remission (PR), stable disease (SD) and progressive disease (PD). iwCLL 2008 criteria were provided to guide physicians’ assessment of treatment response. The target sample size for each response type was a priori determined based on distribution of response in clinical trials. Data on disease progression and mortality was provided by the treating oncologist/hematologist. PFS and OS were compared using univariate and multivariate Cox proportional analyses between the CR and non-CR cohorts (OS multivariate analyses were not conducted due to the small number of events). An additional analysis was conducted to examine the benefits of achieving MRD- versus not achieving MRD- among patients who achieved CR or PR.
Results
Data was collected on 330 CLL patients, including 179 patients in the CR cohort and 151 patients in the non-CR cohort (120 patients with PR, 25 with SD, and 6 with PD). Most patients were male, in their early sixties, and had an ECOG status of O/1 at the time of initiating first-line therapy. The median observation period was approximately 30 months. There were 43 (24%) patients in the CR cohort and 75 (50%) patients in the non-CR cohort who progressed/died (Table 1). Patients in the non-CR cohort had an > 2-fold higher hazard of progression/death (adjusted hazard ratio [HR]=2.30, p<0.05) and death (unadjusted HR=2.61, p<0.05) compared to patients in the CR cohort. Among patients who achieved CR or PR, 84 patients achieved MRD- and 62 patients did not; 14(17%) patients who achieved MRD- and 27 (44%) patients who did not achieve MRD- progressed/died. Patients who did not achieve MRD- had an over three-fold higher hazard of progression/death compared to patients who achieved MRD- (adjusted HR=3.75, p<0.05). No death events were observed among patients who achieved MRD- while 4 (6%) events were observed among those who did not achieve MRD-.
Conclusion
Findings from this real-world study suggest that achieving CR is associated with improved PFS and OS compared to patients who do not achieve CR. Furthermore, significantly better outcomes were observed in patients who achieved MRD- compared to those who did not achieve MRD- but still achieved CR or PR. This suggests that deep response may be an important clinical parameter to consider in the treatment of CLL.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Survival, Progression, Chronic Lymphocytic Leukemia