John Theurer Cancer Center to showcase treatment advancements for cancer at ASCO 2010

The John Theurer Cancer Center at Hackensack University Medical Center announced today important research findings that will be presented at the American Society of Clinical Oncology (ASCO) annual meeting taking place June 4 - 8, 2010 in Chicago. Research highlights include a comparison of first-line treatments for an aggressive form of lymphoma, the efficacy and safety of a new genetically engineered cancer therapy, and the value of a commonly used tool for staging lymphoma. These findings are only three of 16 studies that will be discussed by researchers from the John Theurer Cancer Center.

"We are excited to present significant research findings, particularly in the area of hematological malignancies, as part of our continued commitment to advance cancer research," said Andrew L. Pecora, M.D., F.A.C.P., C.P.E., Chairman and Executive Administrative Director, John Theurer Cancer Center. "The studies we will present at ASCO represent just a small sample of the work that we do to improve outcomes not just for our patients, but for the cancer community as a whole."

Research to be presented at ASCO by researchers at the John Theurer Cancer Center will showcase treatment advancements for cancers of the blood, including lymphoma and multiple myeloma. Poster presentation highlights in these areas include:

Rituximab, fludarabine, mitoxantrone, and dexamethasone (R-FND) combination may help patients with relapsed indolent B-cell lymphoma. (Abstract number 8078; poster session, June 5, 8:00 a.m. - 12:00 p.m.)

Andre Goy, M.D., Deputy Director and Chief, Lymphoma at the John Theurer Cancer Center collaborated with researchers at other major cancer centers to examine the value of adding rituximab to FND (fludarabine, mitoxantrone, and dexamethasone) combination therapy for relapsed indolent B-cell lymphoma. While rituximab is often used as a treatment option for patients with this condition, optimal therapy remains controversial. In phase I-II studies by this research group, they observed a complete remission rate of 48% using FND for this cancer. Adding rituximab to the treatment regimen, they achieved a five-year overall survival rate of 84% and a nine-year rate of 53%.

The researchers concluded that rituximab-FND combination therapy is a very active and well tolerated regimen for relapsed indolent B-cell lymphoma. Patients who received this therapy were also able to receive stem cell transplants, and had favorable outcomes.

Optimal front-line therapies for mantle cell lymphoma. (Abstract number 8067; poster session, June 5, 8:00 a.m. - 12:00 p.m.)

Tatyana Feldman, M.D., Attending, Lymphoma, the John Theurer Cancer Center and colleagues conducted a retrospective analysis of cases at the John Theurer Cancer Center in order to compare the survival of newly diagnosed mantle cell lymphoma patients who were given three distinct first-line treatment regimens. The study was conducted because there is no consensus on the best treatment for this subset of patients, and because data from randomized studies are not available. Recent analyses however, strongly support the use of high-dose treatments for these patients. The researchers' analyzed data to compare the overall survival of patients treated with rituximab plus a combination of doxorubicin, cyclophosphamide, vincristine, and dexamethasone (R-HCVAD); high-dose chemotherapy followed by autologous stem cell transplantation; and standard-dose chemotherapy with rituximab. Patients treated with either R-HCVAD or stem-cell transplantation had better survival rates than the patients treated with standard-dose chemotherapy and rituximab.

The researchers concluded that both R-HCVAD and high-dose chemotherapy combined with autologous stem cell transplantation provide a platform for treatment strategies that integrate novel therapies, or as part of a maintenance strategy.

Is the Mantle Cell Lymphoma International Prognostic Index (MIPI) adequate to stage this cancer? (Abstract number 8092; poster session, June 5, 8:00 a.m. - 12:00 p.m.)

In this study, Anthony Mato, M.D., Attending, Lymphoma, the John Theurer Cancer Center and his colleagues looked at the usefulness of a tool known as the Mantle Cell Lymphoma International Prognostic Index (MIPI) for guiding treatment strategies for mantle cell lymphoma, a difficult-to-treat non-Hodgkin lymphoma. The index is used to classify patients into "low," "intermediate" and "high" risk groups in order to stage the cancer and determine the best treatment strategy. Although MIPI has been validated in other studies, conflicting results on using MIPI to guide an aggressive therapy known as "HCVAD" led the researchers to investigate further. They conducted a single-center, retrospective cohort study to identify predictors of survival in patients treated with first-line rituximab-plus-HCVAD (R-HCVAD), alternating with rituximab-methotrexate-AraC (R-MTX-AraC), another combination therapy.

Although the study is still ongoing, the researchers found that MIPI did not identify the three distinct staging categories with respect to patients' overall survival or progression-free survival, the primary endpoints for this study. Dr. Mato and colleagues are collaborating with another center to verify their results. Future work will focus on identifying molecular markers for failure in mantle cell lymphoma patients treated with dose-intensive regimens.

Vorinostat proves safe and tolerable for treating various cancers. (Abstract number e13600; publication-only abstract)

David S. Siegel, M.D., Ph.D., Co-Chief, Multiple Myeloma at the John Theurer Cancer Center and colleagues will present their analyses of safety and tolerability data from Phase I and II studies of vorinostat. Vorinostat is a medication that is FDA approved to treat skin problems related to cutaneous T-cell lymphoma when other treatments have not been effective. It is a histone deacetylase (HDAC) inhibitor, the first in a class of drugs that regulate enzymes involved in cell signaling. Vorinostat is also being investigated as a treatment option for a range of other solid and hematologic malignancies.

The researchers looked at safety and tolerability data from patients in phase I and II Merck-sponsored clinical trials who received vorinostat as a single (monotherapy) or combination therapy for a variety of cancers. Data from these unblinded trials showed that vorinostat has an acceptable safety and tolerability profile when given as monotherapy, or more commonly in a combination regimen, for patients with refractory metastatic cancer.

Denileukin diftitox shows promise for newly diagnosed T-cell lymphoma patients (the CONCEPT trial). (Abstract number 8045; poster session, June 4, 5:00 - 6:00 p.m.)

As part of the multicenter CONCEPT trial, Dr. Goy tested the efficacy and safety of denileukin diftitox, a genetically engineered fusion protein that targets cancers that express the interleukin-2 receptor. The drug was tested head-to-head against the standard "CHOP" (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy regimen in a Phase II study in which the patients receiving the new drug were also treated with CHOP. The study group consisted of patients newly diagnosed with aggressive T-cell lymphomas. Researchers found the combination therapy effective, with a 68% overall response rate and 57% complete response rate. As a result, they are starting a multicenter comparison study.

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