In an oral presentation at the 10th International Conference on Malignant Lymphoma in Lugano, Switzerland, Paul A. Hamlin, MD, Memorial Sloan-Kettering Cancer Center, presented the results of an investigator-sponsored trial of the investigational treatment consolidation rituximab-CHOP (R-CHOP) with 90Yttrium Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy in high risk elderly patients with previously untreated high-intermediate and high risk diffuse large B-cell lymphoma (DLBCL). Cell Therapeutics Zevalin markets in the United States.
In high-risk elderly patient population with significant comorbidities, sequential R-CHOP followed by radioimmunotherapy resulted in excellent complete response and overall and disease-free survival, concluded Hamlin. This approach is currently the focus of international research phase III.
"Improved disease-free survival in these patients is an important unmet need in the result of poor for patients who relapse of the disease, and who can not tolerate intensive salvage therapy and stem cell transplantation," said Jack W. Singer, MD, chief medical officer officer by CTI. "Survival data from this study are very encouraging compared to historical data and provide the rationale for the registration of a randomized trial aimed Zevalin consolidation in higher risk patients with DLBCL."
Results of the study
Historical studies served as the background of the presentation indicate that approximately 50 percent of elderly patients with high risk diffuse large B-cell lymphoma (DLBCL) relapse after treatment with R-CHOP. Treatment options for patients who are not eligible for autologous stem cell transplantation is limited. In this analysis of 63 patients enrolled in the study, 39 patients were treated with Zevalin. The median age was 75 years (range 62-86), Karnofsky performance status <80 percent to 59 percent of patients with secondary status by 70 percent; prognostic score high-intermediate/high in 53 per cent and 47 per cent of patients, respectively. Moderate or high impact comorbidity is present in 86 percent. It is the intention to treat population, progression-free (PFS) and overall survival (OS) at 59 percent and 65 percent, respectively, at 22 months. In 39 patients who received Zevalin, PFS and OS were 78 percent and 82 percent, respectively, at 26 months.
Responses improved in 11 patients who received Zevalin, with eight patients improved from unconfirmed (CRU) with confirmed complete response (CR) and three patients improved from partial response (PR) to CR / CRU. Side effects reported included the suppression of blood: 26 percent and 36 percent of grade 3 / 4 neutropenia, 15 percent of third degree of anemia, and 36 percent and 31 percent of grade 3 / 4 thrombocytopenia. Six patients had delayed recovery of blood for more than 12 weeks. One patient developed myelodysplasia and two patients died after Zevalin was given, one of the suspected brain haemorrhage, and one of congestive heart failure.
In high-risk elderly patient population with significant comorbidities, sequential R-CHOP followed by radioimmunotherapy resulted in excellent complete response and overall and disease-free survival, concluded Hamlin. This approach is currently the focus of international research phase III.
"Improved disease-free survival in these patients is an important unmet need in the result of poor for patients who relapse of the disease, and who can not tolerate intensive salvage therapy and stem cell transplantation," said Jack W. Singer, MD, chief medical officer officer by CTI. "Survival data from this study are very encouraging compared to historical data and provide the rationale for the registration of a randomized trial aimed Zevalin consolidation in higher risk patients with DLBCL."
Results of the study
Historical studies served as the background of the presentation indicate that approximately 50 percent of elderly patients with high risk diffuse large B-cell lymphoma (DLBCL) relapse after treatment with R-CHOP. Treatment options for patients who are not eligible for autologous stem cell transplantation is limited. In this analysis of 63 patients enrolled in the study, 39 patients were treated with Zevalin. The median age was 75 years (range 62-86), Karnofsky performance status <80 percent to 59 percent of patients with secondary status by 70 percent; prognostic score high-intermediate/high in 53 per cent and 47 per cent of patients, respectively. Moderate or high impact comorbidity is present in 86 percent. It is the intention to treat population, progression-free (PFS) and overall survival (OS) at 59 percent and 65 percent, respectively, at 22 months. In 39 patients who received Zevalin, PFS and OS were 78 percent and 82 percent, respectively, at 26 months.
Responses improved in 11 patients who received Zevalin, with eight patients improved from unconfirmed (CRU) with confirmed complete response (CR) and three patients improved from partial response (PR) to CR / CRU. Side effects reported included the suppression of blood: 26 percent and 36 percent of grade 3 / 4 neutropenia, 15 percent of third degree of anemia, and 36 percent and 31 percent of grade 3 / 4 thrombocytopenia. Six patients had delayed recovery of blood for more than 12 weeks. One patient developed myelodysplasia and two patients died after Zevalin was given, one of the suspected brain haemorrhage, and one of congestive heart failure.
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