5.34 Efficacy of FC and FCR Regimens in the First-Line Treatment of Patients with Chronic Lymphocytic Leukemia: 9 Years of Follow-up

2011 ◽  
Vol 11 ◽  
pp. S266-S267
Author(s):  
E. Stadnik ◽  
A. Zaritskey
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Five-Year Follow-Up After Ibrutinib Therapy for First-Line Treatment of Chronic Lymphocytic Leukemia

2019 ◽  
Vol 19 ◽  
pp. S274
Author(s):  
Jan Burger ◽  
Alessandra Tedeschi ◽  
Paul M. Barr ◽  
Tadeusz Robak ◽  
Carolyn Owen ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

scholarly journals S107 FIVE-YEAR FOLLOW-UP OF PATIENTS RECEIVING IBRUTINIB FOR FIRST-LINE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

HemaSphere ◽  
2019 ◽  
Vol 3 (S1) ◽  
pp. 5-6
Author(s):  
A. Tedeschi ◽  
J. Burger ◽  
P.M. Barr ◽  
T. Robak ◽  
C. Owen ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

scholarly journals Economic evaluation of obinutuzumab in combination with chlorambucil in first-line treatment of patients with chronic lymphocytic leukemia in Spain

2016 ◽  
Vol Volume 8 ◽  
pp. 475-484 ◽  
Author(s):  
Carlos Rubio-Terrés ◽  
Luis Felipe Casado ◽  
Amparo Burgos ◽  
Eva González-Haba ◽  
Javier Loscertales ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Chronic Lymphocytic Leukemia ◽  
Lymphocytic Leukemia ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

Comparative Safety Analysis of Currently Approved Anti-CD20 Monoclonal Antibodies for First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5587-5587
Author(s):  
Mkaya Mwamburi ◽  
Vasudha Bal ◽  
Teresa Cascella ◽  
Anshul Shah ◽  
Merena Nanavaty ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Safety Profile ◽  
Lymphocytic Leukemia ◽  
Line Treatment ◽  
Phase 2 ◽  
First Line ◽  
Grade 3 ◽  
Anti Cd20 ◽  
Cost Implications ◽  
First Line Treatment

Abstract Introduction: Treatment of CLL has advanced tremendously in the past decade with significant extension of life expectancy in patients diagnosed with the disease. Three anti-CD20 monoclonal antibody (mAB) combinations approved for previously untreated chronic lymphocytic leukemia (CLL) patients are obinutuzumab-chlorambucil (OBI-CHL), ofatumumab-chlorambucil (OFA-CHL), and rituximab-chlorambucil (RTX-CHL), have comparable efficacy but varying safety profiles in pivotal trials. Grade 3-4 adverse events (AEs), including infusion-related reactions (IRRs), neutropenia, thrombocytopenia, anemia, and infections differ by each mAB. Grade 3-4 AEs, defined as requiring hospitalization or life-threatening, result in reductions in patient quality of life (QoL) and bear cost implications. We sought to compare the safety of the IV-administered anti-CD20 mABs in the first-line treatment of CLL and to evaluate the respective QoL and economic implications of these AEs. Methods: A systematic literature review was conducted in PubMed, Embase, and Cochrane library for the time period of 2010-2016 and in conference proceedings of ASH, the American Society of Clinical Oncology (ASCO), and the European Hematology Association (EHA) for 2014-2016. Search was limited to clinical trials conducted on humans and published in English language. The IRRs were compared directly as CHL is administered orally. A Bayesian network meta-analyses (NMA) was conducted with data from phase 3 trials using SAS® (v9.3) to compare grade 3-4 neutropenia, thrombocytopenia, anemia, and infections associated with the three anti-CD20 mABs. A pooled analysis of data from phase 2 trials and cohort studies was conducted using MedCalc® version 16.2.1. Analyses were also conducted to estimate the potential impact of the AEs of respective anti-CD20 mABs on QoL and cost of care based on the NMA results and previously published estimates of utilities associated with CR (0.780), PR (0.790), SD/PD (0.760); disutilities associated with IRR (-0.11), neutropenia (-0.09), thrombocytopenia (-0.05), anemia (-0.09), and infections (-0.20); and costs associated with episodes of IRR ($4,482), neutropenia ($5,406), thrombocytopenia ($12,621), anemia ($8,894), and infections ($7,163) in CLL. Results: Of the 86 studies screened, 10 studies were included. Direct comparison showed that the rate of IRRs in OBI-CHL, OFA-CHL, and RTX-CHL were 21%, 10%, and 4%, respectively. Risks for neutropenia were lower for OFA-CHL compared to OBI-CHL (OR = 0.74; 95% CI: 0.12-4.59) and similar to RTX-CHL (1.08; 0.20-5.82); for thrombocytopenia were lower for OFA-CHL compared to OBI-CHL (0.16; 0.02-1.33) and to RTX-CHL (0.49; 0.06-4.15); for anemia were lower for OFA-CHL compared to OBI-CHL (0.80; 0.21-3.06) and similar to RTX-CHL (1.08; 0.24-4.64); and for infections OFA-CHL, OBI-CHL (1.00; 0.15-6.74) and RTX-CHL (0.86; 0.15-4.43) were similar. The pooled analyses of AEs observed in phase 2 / cohort studies revealed similar trends when assessed. The mean pre-progression QoL utilities associated with OBI-CHL, OFA-CHL, and RTX-CHL weighted by rates of AEs, utilities associated with respective response rates to treatments, and disutilities of the respective AEs were 0.772, 0.761, and 0.748 respectively. The total cost of treating AEs per 1,000 patients on OFA-CHL, OBI-CHL and RTX-CHL were $3.9M, $8.0M and $4.2M, respectively. Conclusion: The safety profile was most desirable for OFA-CHL, followed by RTX-CHL and OBI-CHL. Though RTX-CHL had the lowest rate of grade 3-4 IRR, OFA-CHL had the better grade 3-4 hematologic safety profile compared to OBI-CHL and RTX-CHL. As efficacy of CLL treatments has improved substantially, safety of treatments is increasingly important particularly on the impact of QoL. In addition, in the cost-conscious payer environment, selecting drugs with a better safety profile and lower cost implications is vital. Our findings demonstrate that better safety profile is associated with less impact on QoL and lower costs. We found that for every 1,000 patients covered by a payer, safety alone can save an excess of $4M based on regimen choice. Fewer incidences of AEs also results in better adherence and reduction in treatment interruption or discontinuation. Safety with the QoL and cost implications should be taken into consideration to maximize the overall benefits of the treatment to CLL patients. Disclosures Mwamburi: Novartis Pharmaceuticals: Consultancy. Bal:Novartis Pharmaceuticals: Employment. Cascella:Novartis Oncology: Employment. Shah:Novartis Pharmaceuticals: Consultancy. Nanavaty:Novartis Pharmaceuticals: Consultancy. Gala:Novartis Pharmaceuticals: Consultancy.

Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL)

Blood ◽  
2002 ◽  
Vol 100 (3) ◽  
pp. 768-773 ◽  
Author(s):  
Jeanette Lundin ◽  
Eva Kimby ◽  
Magnus Björkholm ◽  
Per-Anders Broliden ◽  
Fredrik Celsing ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Bone Marrow ◽  
Chronic Lymphocytic Leukemia ◽  
B Cell ◽  
Lymphocytic Leukemia ◽  
Prolonged Treatment ◽  
Line Treatment ◽  
First Line ◽  
Cell Chronic Lymphocytic Leukemia ◽  
First Line Treatment

Abstract This phase II study determined the efficacy and safety of alemtuzumab, a humanized anti-CD52 monoclonal antibody, delivered subcutaneously as first-line therapy, over a prolonged treatment period of 18 weeks in 41 patients with symptomatic B-cell chronic lymphocytic leukemia (B-CLL). Injections were administered subcutaneously 3 times per week, from week 2 to 3 onward. An overall response rate (OR) of 87% (95% CI, 76%-98%; complete remission [CR], 19%; partial remission [PR], 68%) was achieved in 38 evaluable patients (81% of intent-to-treat population). CLL cells were cleared from blood in 95% patients in a median time of 21 days. CR or nodular PR in the bone marrow was achieved in 66% of the patients and most patients achieved this after 18 weeks of treatment. An 87% OR (29% CR) was achieved in the lymph nodes. The median time to treatment failure has not yet been reached (18+ months; range, 8-44+ months). Transient injection site skin reactions were seen in 90% of patients. Rigor, rash, nausea, dyspnea, and hypotension were rare or absent. Transient grade IV neutropenia developed in 21% of the patients. Infections were rare, but 10% patients developed cytomegalovirus (CMV) reactivation. These patients rapidly responded to intravenous ganciclovir. One patient, allergic to cotrimoxazole prophylaxis, developedPneumocystis carinii pneumonia. Alemtuzumab is highly effective as first-line treatment in patients with B-CLL. Prolonged treatment is important for maximal bone marrow response. Subcutaneous administration induced very few “first-dose” flulike symptoms and may reduce health care costs in comparison with the intravenous infusions.

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