- Email: [email protected]
Refractory Chronic Lymphocytic Leukemia
Abstracts and bulky disease as compared with 58% (low) del11q, while this negative impact of high FISH % of del11q on OS and TTFT was abrogated in presence of co-existent del13q (seen in majority of pts with del11q). In multivariate analysis, high FISH % del11q was a significant factor predicting for shorter OS and TTFT in sole del11q (p<0.05). To test the existing FISH hierarchical model, we then compared these del11q subsets with a separate cohort of (n¼677) untreated pts with sole del13q, there was no difference in OS but del11q subsets had a significantly shorter TTFT. Overall, 149 (71%) pts subsequently received therapy. FCR based therapies were given in (109; 74 %) pts. Subsets with high FISH% of del11q (>64%) had significantly shorter PFS when compared to sole del13q (High FISH %) while this difference was not seen when pts with low FISH% were compared. Conclusions: Our findings suggest that the universally acceptable high risk status for del11q FISH category may be restricted to those pts with sole del11q and high FISH%. We conclude that all the CLL pts with positive FISH for dell11q may not have poor outcomes. We therefore propose that FISH% and presence of co-existent del13q should be accounted for while prognosticating pts with del11q in the current clinical practice.
305 Healthcare Resource Utilization (HRU) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
Chris Kozma,1 Terra Slaton,1 Scott McKenzie,2 Lorie Ellis2 1
CK Consulting; 2Janssen Scientific Affairs LLC
Purpose: There is a paucity of data regarding healthcare resource utilization (HRU) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). This observational study investigated patient demographics, CLL treatment patterns, and HRU during the six months following treatment initiation for relapsed/refractory CLL. Methods: This observational analysis was conducted using commercially available U.S. administrative claims data. Inclusion criteria were age 18 years, relapsed (chemotherapy claims following a 90 day treatment gap after initial therapy) or refractory (claims for additional agents to initial therapy) CLL, and six months eligibility following the first relapsed/refractory chemotherapy date. Exclusion criteria included patients with claims for pregnancy or non-CLL chemotherapies. CLL chemotherapies of interest included alemtuzumab, bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin, etoposide, fludarabine, lenalidomide, ofatumumab, oxaliplatin, pentostatin, rituximab, vincristine, or combinations. Demographics, CLL chemotherapy treatment patterns and HRU data were summarized using descriptive statistics. HRU patterns based on initial claims from 2005-2012 were analyzed for the six months following relapsed/refractory CLL therapy. Results: This analysis identified 486 patients with a mean age of 70 (SD 11) years and 62% male. Initial therapy varied; however, 72% of relapsed/refractory CLL therapies consisted of one of the following regimens: rituximab monotherapy, chlorambucil monotherapy, cyclophosphamide-fludarabine-rituximab, and fludarabine-rituximab.
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Clinical Lymphoma, Myeloma & Leukemia September 2014
Chemotherapy claims were observed during a mean of 2.3 (SD 1.5) months in the six months of follow-up. The HRU analysis identified 17% with claims for white blood cell colony stimulating factors, 12% with claims for red blood cell growth factors, 5% with claims for red blood cell transfusion, and 1% with claims for stem cell transplantation. The mean number of hospitalizations (including patients with no hospitalizations as zeros) was 0.2 (SD 0.5)/patient incurring a mean of 1.3 (SD 4.0) hospital days. In the 85 patients hospitalized, the mean hospital length of stay was 7.7 (SD 6.5) days. Conclusion: This observational study of 486 CLL patients with relapsed/refractory CLL reported significant HRU in the six months following initiation of therapy for relapsed or refractory disease. These results provide an indicator of CLL disease burden and allow stakeholders to estimate HRU in the six months following therapy initiation for relapsed/refractory disease.
306 Hodgkin Transformation of Chronic Lymphocytic Leukemia (CLL): Mayo Clinic Experience Sameer A. Parikh, Kari G. Rabe, Wei Ding, Timothy G. Call, Clive S. Zent, Jose F. Leis, Neil E. Kay, Susan L. Slager, Tait D. Shanafelt Mayo Clinic, Rochester, MN
Background and Methods: Although its prevalence is not well defined, transformation to Hodgkin lymphoma (HL) is a rare but well recognized complication in patients with CLL. We used the Mayo Clinic CLL database to describe outcomes of CLL patients seen at our institution who developed HL. Results: Among 3124 CLL patients seen at Mayo Clinic from January 1995 to July 2011, 26 developed HL. In a nested cohort of 1644 patients in this database who were seen within 12 months of CLL diagnosis, the prevalence of HL was 0.05%/year (10 year risk¼0.5%). The median duration between CLL diagnosis and development of HL was 6.2 years (range, 0-24.5 years). The median age at diagnosis of HL was 68 years (range, 45-88 years) and 21 (81%) were male. Of the 26 patients with HL, 16 (61%) had received therapy for their CLL prior to developing HL. Sixteen patients (61%) received HL therapy with doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD), seven (27%) received other chemotherapy, and treatment was unknown in 3 (12%) patients. No patient underwent stem cell transplantation as therapy for HL. After a median follow-up of 8.7 years from CLL diagnosis date, 16 (61%) patients have died. The median OS from date of HL diagnosis was 3.9 years (95% CI, 1.0 e 5.0 years). The International prognostic score (IPS) for HL predicted median survival as follows: score of 2 (18% of the patients), median survival not reached; score of 3 (23% of the patients), 6.2 years; score of 4 (36% of the patients), 2.4 years; and score 5 (23% of the patients), 0.3 years (p-value¼0.005, Figure 1). The median survival of HL patients who had previously received CLL therapy was significantly worse compared to those who were untreated for CLL (2.8 years vs. 7.6 years, p-value¼0.02). Conclusion: The 10 year incidence of Hodgkin transformation among patients with newly diagnosed CLL
305 Healthcare Resource Utilization (HRU) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
Chris Kozma,1 Terra Slaton,1 Scott McKenzie,2 Lorie Ellis2 1
CK Consulting; 2Janssen Scientific Affairs LLC
Purpose: There is a paucity of data regarding healthcare resource utilization (HRU) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). This observational study investigated patient demographics, CLL treatment patterns, and HRU during the six months following treatment initiation for relapsed/refractory CLL. Methods: This observational analysis was conducted using commercially available U.S. administrative claims data. Inclusion criteria were age 18 years, relapsed (chemotherapy claims following a 90 day treatment gap after initial therapy) or refractory (claims for additional agents to initial therapy) CLL, and six months eligibility following the first relapsed/refractory chemotherapy date. Exclusion criteria included patients with claims for pregnancy or non-CLL chemotherapies. CLL chemotherapies of interest included alemtuzumab, bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin, etoposide, fludarabine, lenalidomide, ofatumumab, oxaliplatin, pentostatin, rituximab, vincristine, or combinations. Demographics, CLL chemotherapy treatment patterns and HRU data were summarized using descriptive statistics. HRU patterns based on initial claims from 2005-2012 were analyzed for the six months following relapsed/refractory CLL therapy. Results: This analysis identified 486 patients with a mean age of 70 (SD 11) years and 62% male. Initial therapy varied; however, 72% of relapsed/refractory CLL therapies consisted of one of the following regimens: rituximab monotherapy, chlorambucil monotherapy, cyclophosphamide-fludarabine-rituximab, and fludarabine-rituximab.
S132
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Clinical Lymphoma, Myeloma & Leukemia September 2014
Chemotherapy claims were observed during a mean of 2.3 (SD 1.5) months in the six months of follow-up. The HRU analysis identified 17% with claims for white blood cell colony stimulating factors, 12% with claims for red blood cell growth factors, 5% with claims for red blood cell transfusion, and 1% with claims for stem cell transplantation. The mean number of hospitalizations (including patients with no hospitalizations as zeros) was 0.2 (SD 0.5)/patient incurring a mean of 1.3 (SD 4.0) hospital days. In the 85 patients hospitalized, the mean hospital length of stay was 7.7 (SD 6.5) days. Conclusion: This observational study of 486 CLL patients with relapsed/refractory CLL reported significant HRU in the six months following initiation of therapy for relapsed or refractory disease. These results provide an indicator of CLL disease burden and allow stakeholders to estimate HRU in the six months following therapy initiation for relapsed/refractory disease.
306 Hodgkin Transformation of Chronic Lymphocytic Leukemia (CLL): Mayo Clinic Experience Sameer A. Parikh, Kari G. Rabe, Wei Ding, Timothy G. Call, Clive S. Zent, Jose F. Leis, Neil E. Kay, Susan L. Slager, Tait D. Shanafelt Mayo Clinic, Rochester, MN
Background and Methods: Although its prevalence is not well defined, transformation to Hodgkin lymphoma (HL) is a rare but well recognized complication in patients with CLL. We used the Mayo Clinic CLL database to describe outcomes of CLL patients seen at our institution who developed HL. Results: Among 3124 CLL patients seen at Mayo Clinic from January 1995 to July 2011, 26 developed HL. In a nested cohort of 1644 patients in this database who were seen within 12 months of CLL diagnosis, the prevalence of HL was 0.05%/year (10 year risk¼0.5%). The median duration between CLL diagnosis and development of HL was 6.2 years (range, 0-24.5 years). The median age at diagnosis of HL was 68 years (range, 45-88 years) and 21 (81%) were male. Of the 26 patients with HL, 16 (61%) had received therapy for their CLL prior to developing HL. Sixteen patients (61%) received HL therapy with doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD), seven (27%) received other chemotherapy, and treatment was unknown in 3 (12%) patients. No patient underwent stem cell transplantation as therapy for HL. After a median follow-up of 8.7 years from CLL diagnosis date, 16 (61%) patients have died. The median OS from date of HL diagnosis was 3.9 years (95% CI, 1.0 e 5.0 years). The International prognostic score (IPS) for HL predicted median survival as follows: score of 2 (18% of the patients), median survival not reached; score of 3 (23% of the patients), 6.2 years; score of 4 (36% of the patients), 2.4 years; and score 5 (23% of the patients), 0.3 years (p-value¼0.005, Figure 1). The median survival of HL patients who had previously received CLL therapy was significantly worse compared to those who were untreated for CLL (2.8 years vs. 7.6 years, p-value¼0.02). Conclusion: The 10 year incidence of Hodgkin transformation among patients with newly diagnosed CLL