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Biomedical subjects

Antonio J Grillo-López

Publications and source records attributed to Antonio J Grillo-López.

At least 19 recordsLinked to original sources
PubMed2005

90Y-ibritumomab tiuxetan: rationale for patient selection in the treatment of indolent non-Hodgkin's lymphoma.

Radioimmunotherapy with 90Y-ibritumomab tiuxetan (Zevalin; Biogen Idec Inc, San Diego, CA, and Schering AG, Berlin, Germany) was approved in the United States in 2002 for patients with relapsed or refractory, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with rituximab-refractory disease, and in Europe in 2003. This agent has yielded good results in the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, for whom limited treatment options are available. Radioimmunotherapy with 90Y-ibritumomab tiuxetan is well tolerated and produces statistically and clinically significant higher overall and complete response rates than rituximab alone. Furthermore, treatment can be safely administered on an outpatient basis, with minimal disruption to patients' daily routines. The 90Y-ibritumomab tiuxetan treatment regimen, appropriate patient selection, and risk assessment are discussed in this article.

Antibodies, Monoclonal↗
PubMed2004

Prolonged clinical and molecular remission in patients with low-grade or follicular non-Hodgkin's lymphoma treated with rituximab plus CHOP chemotherapy: 9-year follow-up.

PURPOSE: Long-term follow-up with updated time to disease progression (TTP) and duration of response (DR) data are presented from a multicenter, phase II trial of rituximab/cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combination therapy in 40 patients with CD20+, B-cell, non-Hodgkin's lymphoma (NHL). Revised response rates based on International Workshop Response Criteria are also provided. PATIENTS AND METHODS: Enrollment began in April 1994 and consisted of patients with histologically confirmed, low-grade, B-cell lymphoma who had received no prior chemotherapy or who had no more than four prior standard therapies. Patients received six cycles of CHOP and six infusions of rituximab. RESULTS: Eight (21%) of the 38 treated patients were classified as International Working Formulation (IWF) A, 16 (42%) were IWF B, 13 (34%) were IWF C, and one (3%) was IWF D. Nine (24%) of 38 patients had received prior chemotherapy. Nine (24%) of 38 were considered poor risk according to the Follicular Lymphoma International Prognostic Index. Overall response rate was 100%; 87% of patients achieved a complete response or unconfirmed complete response. The median TTP and DR were 82.3 months and 83.5 months, respectively. Seven of eight patients who were bcl-2 positive at baseline converted to negative, and three of the seven patients have sustained the molecular remission. CONCLUSION: Although a cure has not been found yet for follicular NHL, the R-CHOP combination provides a lengthy response duration in patients with relapsed or newly diagnosed indolent NHL.

Aged↗
PubMed2003

Radiation dosimetry results from a Phase II trial of ibritumomab tiuxetan (Zevalin) radioimmunotherapy for patients with non-Hodgkin's lymphoma and mild thrombocytopenia.

This was a 30-patient Phase II trial of reduced-dose (90)Y ibritumomab tiuxetan (Zevalin) RIT for patients with low-grade, follicular, or transformed B-cell NHL and mild thrombocytopenia. Patients were given an imaging dose of (111)In-labeled ibritumomab tiuxetan for dosimetry measurements. One week later, patients were administered a therapeutic dose of 0.3 mCi/kg (11 MBq/kg) (90)Y ibritumomab tiuxetan. Both (111)In- and (90)Y-labeled ibritumomab tiuxetan doses were preceded by an infusion of 250 mg/m(2) rituximab (Rituxan, MabThera) an unlabeled chimeric anti-CD20 antibody, to clear peripheral blood B cells and improve biodistribution of the radiolabeled antibody. For all 30 patients, normal organ and red marrow radiation absorbed doses were well below protocol-defined limits of 2000 cGy and 300 cGy, respectively. Median radiation absorbed doses were 48 cGy to red marrow (range: 6.5-95 cGy), 393 cGy to liver (range: 92-1581 cGy), 522 cGy to spleen (range: 165-1711 cGy), 162 cGy to lungs (41-295 cGy), and 14 cGy to kidneys (0.03-65 cGy). Though most correlative analyses were negative, certain analyses demonstrated a statistically significant correlation between the severity or duration of thrombocytopenia and pharmacokinetic or dosimetric parameters. These correlations were not consistent across the total patient population, and therefore, could not be exploited to predict hematologic toxicity.

Adolescent↗
PubMed2003

Rituximab (Rituxan/MabThera): the first decade (1993-2003).

The first antibody approved for the treatment of cancer, rituximab (Rituxan/MabThera), underwent clinical development between 1993 and 1996. It fulfilled predictions dating back to the early 1900s regarding the therapeutic effect of antibodies and sparked a renewed interest in this area of research. Rituximab was approved, in the USA in 1997 and in Europe in 1998, for the treatment of patients with non-Hodgkin's lymphoma. Since then, hundreds of thousands of patients have been treated with rituximab. In 2002, rituximab became the number one anticancer drug worldwide. During its first decade of use (1993-2003), rituximab has had an important impact on treatment strategies for lymphoma and other hematologic malignancies. During the 5 years following approval, its applications expanded beyond non-Hodgkin's lymphoma to a variety of malignant and non-malignant B-cell disorders. Also, as a result of its early clinical trials, initiatives came about that eventually led to the development of the new international response criteria for non-Hodgkin's lymphoma. Rituximab has been characterized as the most important therapeutic development of the decade.

Animals↗
PubMed2002

Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia: a phase II multicenter trial.

Mildly thrombocytopenic patients with relapsed or refractory low-grade non-Hodgkin lymphoma (NHL) have an increased risk of chemotherapy-induced myelosuppression following treatment. The safety and efficacy of radioimmunotherapy with a reduced dose of (90)Y ibritumomab tiuxetan (0.3 mCi/kg [11 MBq/kg]; maximum 32 mCi [1.2 GBq]) was evaluated in 30 patients with mild thrombocytopenia (100-149 x 10(9) platelets/L) who had advanced, relapsed or refractory, low-grade, follicular, or transformed B-cell NHL. The ibritumomab tiuxetan regimen included an infusion of rituximab (250 mg/m(2)) and injection of (111)In ibritumomab tiuxetan (5 mCi [185 MBq]) for dosimetry evaluation, followed 1 week later with rituximab (250 mg/m(2)) and (90)Y ibritumomab tiuxetan (0.3 mCi/kg [11 MBq/kg]). Patients (median age, 61 years; 90% stage III/IV at study entry; 83% follicular lymphoma; and 67% with bone marrow involvement) had a median of 2 prior therapy regimens (range, 1-9). Estimated radiation-absorbed doses were well below the study-defined maximum allowable for all 30 patients. With the use of the International Workshop criteria for NHL response assessment, the overall response rate was 83% (37% complete response, 6.7% complete response unconfirmed, and 40% partial response). Kaplan-Meier estimated median time to progression (TTP) was 9.4 months (range, 1.7-24.6). In responders, Kaplan-Meier estimated median TTP was 12.6 months (range, 4.9-24.6), with 35% of data censored. Toxicity was primarily hematologic, transient, and reversible. The incidence of grade 4 neutropenia, thrombocytopenia, and anemia was 33%, 13%, and 3%, respectively. Reduced-dose ibritumomab tiuxetan is safe and well tolerated and has significant clinical activity in this patient population.

Adult↗
PubMed2002

Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.

PURPOSE: Radioimmunotherapy combines biologic and radiolytic mechanisms to target and destroy tumor cells, thus offering a needed therapeutic alternative for refractory non-Hodgkin's lymphoma (NHL) patients. This phase III randomized study compares the novel radioimmunotherapy yttrium-90 ((90)Y) ibritumomab tiuxetan with a control immunotherapy, rituximab, in 143 patients with relapsed or refractory low-grade, follicular, or transformed CD20(+) transformed NHL. PATIENTS AND METHODS: Patients received either a single intravenous (IV) dose of (90)Y ibritumomab tiuxetan 0.4 mCi/kg (n = 73) or rituximab 375 mg/m(2) IV weekly for four doses (n = 70). The radioimmunotherapy group was pretreated with two rituximab doses (250 mg/m(2)) to improve biodistribution and one dose of indium-111 ibritumomab tiuxetan for imaging and dosimetry. The primary end point, overall response rate (ORR), was assessed by an independent, blinded, lymphoma expert panel. RESULTS: ORR was 80% for the (90)Y ibritumomab tiuxetan group versus 56% for the rituximab group (P =.002). Complete response (CR) rates were 30% and 16% in the (90)Y ibritumomab tiuxetan and rituximab groups, respectively (P =.04). An additional 4% achieved an unconfirmed CR in each group. Kaplan-Meier estimated median duration of response was 14.2 months in the (90)Y ibritumomab tiuxetan group versus 12.1 months in the control group (P =.6), and time to progression was 11.2 versus 10.1 months (P =.173) in all patients. Durable responses of > or = 6 months were 64% versus 47% (P =.030). Reversible myelosuppression was the primary toxicity noted with (90)Y ibritumomab tiuxetan. CONCLUSION: Radioimmunotherapy with (90)Y ibritumomab tiuxetan is well tolerated and produces statistically and clinically significant higher ORR and CR compared with rituximab alone.

Adult↗
PubMed2002

Monoclonal antibody therapy for B-cell lymphoma.

Treatment strategies and outcomes for patients with non-Hodgkin's lymphoma (NHL) are undergoing rapid and important evolution. We have recently witnessed the advent of novel targeted therapies, such as gene therapies, active immunotherapies, antisense therapies, new small molecules and biologicals, and monoclonal antibodies (MoAbs). The first MoAb approved for the treatment of cancer, rituximab, was approved in 1997 and has been rapidly incorporated into treatment regimens for NHL. In a randomized trial in combination with CHOP chemotherapy (cyclophosphamide, hydroxydaunomycin, vincristine, and prednisone), rituximab showed superiority to CHOP for patients with diffuse large cell NHL (DLCL).The rituximab + CHOP combination has become the gold standard for frontline therapy for DLCL and has shown significant activity in the management of follicular NHL. In February 2002, the first radioimmunotherapeutic agent for the treatment of cancer, ibritumomab tiuxetan (Zevalin), was approved. Ibritumomab tiuxetan, an yttrium-labeled antibody used in conjunction with rituximab, has significant activity in follicular and transformed NHL. Use of rituximab has proved that antibodies are safe and active even as single agents. The results have helped dispel the negativity and biases resulting from many years of disappointing results in this important area of research. Results with rituximab have opened the doors to continued research and have provided the impetus necessary for renewed enthusiasm and optimism in continuing the search for curative regimens for patients with NHL.

Antibodies, Monoclonal↗
PubMed2002

AntiCD20 mAbs: modifying therapeutic strategies and outcomes in the treatment of lymphoma patients.

The first monoclonal antibody for the treatment of cancer, rituximab, was approved 5 years ago and has had a remarkable impact on the treatment of non-Hodgkin's lymphomas. Additionally, it sparked a renewed interest in antibodies in general that has revitalized this field of research. Multiple antibodies for a variety of malignant and nonmalignant indications are being evaluated. Some are now approved for anticancer indications (rituximab, ibritumomab, trastuzumab, gemtuzumab, alemtuzumab) and others are completing the review process at US (FDA) and European (EMEA) regulatory agencies. The impact of antiCD20 antibodies, particularly rituximab and ibritumomab, is evident in the way treatment strategies and outcomes have changed for the lymphoma patient. Other unconjugated antibodies (including Hu1D10, epratuzumab and alemtuzumab) and conjugated antibodies (including radiolabeled tositumomab) are under evaluation.

Alemtuzumab↗