Bestraling - Radiotherapie plus immuuntherapie met o.a. Zevalin - Bexxar blijkt uitstekende aanpak voor bepaalde vormen van lymfklierkanker, waaronder non-Hodgkin

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11 januari 2012:
Al in 2004 kregen wij onderstaande informatie van Scheering, de toenmalige producent, over Zevalin. Inmiddels is Zevalin een algemeen goedgekeurd middel bij vormen van lymfklierkanker, waaronder non-Hodgkin. Als u Zevalin intypt in pubmed krijgt u een scala aan studieabstracten. teveel om hier allemaal te vermelden. Wat wel interessant is hier te vermelden is een
overzichts artikel van de aanpak met radiotherapie - bestraling in combinatie met vormen van chemo en immuuntherapeutische middelen waaronder ook Zevalin en Bexxar: Radioimmunotherapy of Non-Hodgkin’s Lymphoma: From the ‘Magic Bullets’ to ‘Radioactive Magic Bullets’
In het abstract staat dit, maar klikt u op deze link voor het volledige studierapport. Onderaan staat het schrijven van Scheering over Zevalin uit 2004.

Source: Radioimmunotherapy (RIT) of lymphoma with Zevalin and Bexxar was approved by FDA in 2002 and 2003, respectively, for the treatment of relapsed or refractory CD20+ follicular B-cell non-Hodgkin´s lymphoma. In 2009, Zevalin was also approved for consolidation therapy in patients with follicular non-Hodgkin’s lymphoma that achieve a partial or complete response to first-line chemotherapy. For follicular lymphoma patients, the overall response and progression-free survival rates have significantly improved since the implementation of RIT. The predominant complication of RIT is hematological toxicity that is usually manageable. There are ongoing trials to further define the expanding role of RIT as first line or concomitant therapy in the treatment of lymphoma as well as for certain antibiotic resistant infections and aggressive malignancies. There is also growing interest in the development of newer protocols for increased and more uniform dose delivery resulting in better outcomes and improved patient survival. This review will primarily focus on the role of RIT in treatment of non-Hodgkin’s lymphoma, which is of established clinical utility and FDA approved. The mechanism of RIT, available radionuclides and pharmacokinetics, therapy administration, clinical utility and toxicities, and future directions would be discussed.

Zevalin, een immunologisch middel (vaccin) te gebruiken naast bestralingen
d.d. 21 januari 2004:
Bron: persbericht van Scheering

Zevalin een immunologisch middel te gebruiken naast bestralingen van non-Hodgkin heeft van de Europese commissie toestemming gekregen als officieel geregistreerd medicijn te mogen worden gebruikt. De resultaten uit o.a. een gerandomiseerde fase III studie waren: 143 patiënten met een herhaald recidief van non-Hodgkin werden verdeeld over twee groepen.
Bij de groep patiënten die Zevalin kregen reageerde 80% op dit medicijn tegenover 56 procent bij de groep die alleen Rituxan kreeg toegediend. 30% van de Zevalin groep kreeg een complete remissie en 4 procent een onbevestigde complete remissie tegenover respectievelijk 16% en 4% in de andere groep. Deze resultaten worden aangemerkt als significant.
De remissie bij de patiënten duurde over vier trials gezien bijna twee jaar met een aantal patiënten die tot 6,5 jaar geen recidief vertoonden. Dit lijkt erg goed nieuws, aan de andere kant zit hier ook het addertje onder het gras namelijk met Zevalin wordt wel een remissie bereikt maar vaak geen definitieve genezing. Maar goed dit is o.i. weer een stap voorwaarts.
Lees overigens ook eens het verhaal van mw. Bruins die met alleen dieet en suppletie nu al jaren geen recidief heeft van non-Hodgkin.

CAMBRIDGE, Mass. and SAN DIEGO, Calif., Jan. 22 /PRNewswire-FirstCall/--Biogen Idec (Nasdaq: BIIB) today announced that the European Commission has granted marketing approval for ZEVALIN(R) (Ibritumomab tiuxetan)radioimmunotherapy. ZEVALIN is approved in Europe for the treatment of adult patients with CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL) who are refractory to or have relapsed following RITUXAN(R) (rituximab) therapy. ZEVALIN was approved in February 2002 by the U.S. Food and Drug Administration (FDA). It is marketed and distributed by Biogen Idec in the U.S. Schering AG, Biogen Idec's corporate partner, holds marketing and distribution rights for ZEVALIN outside the U.S. and expects to launch the product in Europe within the next few months.

"ZEVALIN radioimmunotherapy represents a major advancement in the treatment of certain non-Hodgkin's lymphomas," said Burt Adelman, Executive Vice President, Development for Biogen Idec. "We are pleased that through this partnership with Schering AG, patients in Europe will soon have access to this innovative therapy." Radioimmunotherapy is a new area of cancer treatment that combines the targeting power of monoclonal antibodies with the cell-damaging ability of localized radiation. ZEVALIN is made by linking monoclonal antibodies to radioactive isotopes. When infused into a patient, these radiation-carrying antibodies circulate in the body until they locate and bind to the surface of specific cells, and then deliver their cytotoxic radiation directly to malignant cells. ZEVALIN binds to malignant and normal B-cells. Normal B-cells generally are replenished by CD20-negative progenitor cells within six-to-nine months following therapy.

About Clinical Studies
Extensive clinical studies of ZEVALIN have confirmed high response rates and durable responses in patients with relapsed, refractory follicular or transformed B-cell NHL:

-- In a Phase 2 study evaluating patients with follicular NHL who did not respond to or responded inadequately to RITUXAN, ZEVALIN produced an overall response rate of 74 percent, with 15 percent of patients achieving a complete remission (disappearance of all evidence of disease), according to International Workshop Response Criteria (IWRC). -- A pivotal Phase 3 randomized, controlled trial was conducted in 143 patients with relapsed or refractory, low-grade or follicular NHL or transformed B-cell NHL. The 73 patients who received the ZEVALIN regimen showed an overall response rate of 80 percent, compared to 56 percent in the 70 patients who received RITUXAN alone. Thirty percent of ZEVALIN patients achieved a complete remission and 4 percent achieved an unconfirmed complete remission to therapy, compared to 16 percent of RITUXAN patients who achieved a complete remission and 4 percent who achieved an unconfirmed complete remission. The improvement in ORR and CR were statistically significant.

-- ZEVALIN has been shown to induce durable remissions in many patients with relapsed or refractory B-cell NHL, as evidenced by long-term follow-up of complete responders from four registrational clinical trials. The median duration of remission for these patients approached two years, with some responses still ongoing at 75 months (6.25 years). -- Thirty-seven percent of the responding patients treated in the registrational trials achieved long-term responses, defined as time to progression of longer than 12 months. Among these long-term responders, the median duration of response was 28.1 months.

-- The registrational trials of ZEVALIN involved more than 30 academic and community cancer centers in the U.S. and included the only randomized clinical trial to date comparing radioimmunotherapy to another standard therapy. A high proportion of the patients in the trials were greater than 60 years old and had received three or more prior therapies. Schering AG, Germany is currently investigating the use of ZEVALIN in the treatment of aggressive NHL (i.e., diffuse large B-cell lymphoma) and as consolidation therapy for follicular NHL in earlier disease stages.

About ZEVALIN
On February 19, 2002, the FDA approved ZEVALIN, a new type of targeted cancer therapy called radioimmunotherapy, making it the first commercially available radioimmunotherapy for the treatment of B-cell non-Hodgkin's lymphoma (NHL). A unique treatment regimen for patients with certain types of B-cell NHL, the ZEVALIN therapeutic regimen combines a monoclonal antibody with a radioisotope. The monoclonal antibody in ZEVALIN recognizes and attaches to a particular cell-surface part of a B-cell called the CD20 antigen. This allows ZEVALIN to specifically target B-cells, destroying the malignant NHL B-cells and also normal B-cells. ZEVALIN, as part of the ZEVALIN therapeutic regimen, is indicated in the U.S. for the treatment of relapsed, or refractory low-grade, follicular or transformed B-cell NHL, including patients with RITUXAN refractory follicular NHL.
Today, ZEVALIN is being investigated in multiple clinical trials at major medical centers in the U.S. and in a variety of treatment strategies, including combinations with front-line and salvage chemotherapy regimens and as part of
autologous and allogeneic stem cell transplantation.

ZEVALIN Safety Profile
In safety data based upon 349 patients, the most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, with grade 4 neutropenia, thrombocytopenia, and anemia occurring in 30 percent, 10 percent and 3 percent of patients treated at the 0.4 mCi/kg dose, respectively. Infusion-related toxicities were typically grade 1 or 2 and were associated with pre-administration of Rituximab (RITUXAN). The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Seven percent of patients were hospitalized with infection or febrile neutropena (3 percent) and fatal cerebral hemorrhage (less than 1 percent) has occurred in a minority of patients in clinical studies. The annualized rate for the development of treatment-related myelodysplasia or acute myelogenous leukemia is less than 1 percent of patients and can occur at 8 to 34 months after treatment.

ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides. Fatal Infusion Reactions: Rare deaths have occurred within 24 hours of Rituximab infusions. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome,
myocardial infarction, ventricular fibrillation, or cardiogenic shock. Prolonged and Severe Cytopenias: Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients.

zevalin, non-hodgkin, b-cell, follicular, lymphoma, radioimmunotherapy, refractory, rituxan, remission, approved