Aan dit artikel is enkele uren gewerkt. Opzoeken, vertalen, plaatsen enz. Als u ons wilt ondersteunen dan kan dat via een al of niet anonieme donatie. Elk bedrag is welkom hoe klein ook. Klik hier als u ons wilt helpen kanker-actueel online te houden Wij zijn een ANBI organisatie en dus is uw donatie aftrekbaar voor de belasting.

2 januari 2012: in 2003 werden de studieresultaten gepubliceerd van een vorm van immuuntherapie bij eierstokkanker onder de naam ovarex. Echter er is zover ik kan zien niet verder gegaan met deze aanpak. Waarom niet weet ik niet want ik kan geen verdere studies vinden onder de naam ovarex. Wel vond ik een soortgelijke studie met een aanpak zoals met Ovarex onder de naam Oregovomab. Dit lijkt hetzelfde middel, zelfde vorm van aanpak. Echter in die studie werd geen significant verschil gevonden in overall overleving maar wel in ziektevrije tijd door deze aanpak bij gevorderde eierstokkanker. Zie onderaan voor abstract. Het volledige studierapport kunt u gratis inzien als u hier klikt

Bij eierstokkanker wordt wel op veel plaatsen in de wereld onderzocht of en hoe immuuntherapie een rol kan spelen in het behandelen van o.a. eierstokkanker en/of in het voorkomen van een reicidief na een succesvolle behandeling. Er is zoveel te vinden over dit onderwerp, zie ook onderstaande studie. Als u hier klikt kunt een een volledig studie rapport inzien met als titel: Gene Therapy for Cancer Treatment: Past, Present and Future. Het is echt een interessant artikel met vele verwijzingen naar reeds gedane of nog lopende studies. Sommige daarvan zijn wel op onze site te vinden, maar het is echt teveel om dit studierapport te vertalen en/of uit elkaar te halen per kankersoort.

d.d. 3 februari 2003: Ovarex een immuunstimulerend middel - verhoging van T-cellen - voor eierstokkankerpatiënten geeft een significant verschil in overlevingsduur bij 20 patiënten in een fase II trial. Ook op deze pagina staan de resultaten uit eerdere fase III trials met 345 patiënten met dezelfde bemoedigende resultaten. Onderstaande studie is hiervan een afgeleide.

1. Patiënten met gevorderde eierstokkanker hebben een significante langere overlevingsduur en progressievrije periode als er tumorinfiltrerende lymfocyten aanwezig zijn (p<0.001) 
2. Significante langere overleving werd ook gezien onder patiënten met een complete respons op eerdere chemotherapie en waarbij de tumor was geïnfiltreerd met lymfocyten. (p<0.001); de vijfjaarsoverleving was 74% onder de patiënten waarvan de tumoren T-cellen bevatten tegenover 12% bij tumoren zonder T-cellen
3. Onder de patiënten met een complete respons op eerdere chemotherapie de aanwezigheid of afwezigheid van T-cellen (p<0.001) en de uitbreiding van achterblijvend tumorweefsel (p.0.001) correspondeerde met algemene overleving onafhankelijk van tumorgraad, histologisch type, wel of niet gebruik van paclixatel in het chemo regiem en leeftijd.

Een erg mooi resultaat dus. Zie hieronder volledige persbericht dat Altarex, de producent van Ovarex vandaag rondstuurde. 


-- PRESS RELEASE: AltaRex Phase II OvaRex Data Presented --

AltaRex Phase II OvaRex(R) Survival Data Presented at
Society for Gynecological Oncology

WALTHAM, Mass., Feb. 3 /PRNewswire-FirstCall/ -- AltaRex Corp. (TSE: AXO, OTC:
ALXFF.PK) announced today that Dr. Alan Gordon of U.S. Oncology and Texas
Oncology PA of Dallas, Texas presented updated survival data from a 20 patient
OvaRex(R) (oregovamab) phase II trial conducted by AltaRex yesterday at the
opening oral plenary session of the Society for Gynecological Oncology (SGO).
The results demonstrated that in this study there was a correlation between
OvaRex(R)-induced T cell responses and prolonged survival in platinum-sensitive
patients with recurrent epithelial ovarian cancer.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The objectives of the study were to evaluate immune responses and clinical
outcomes from concurrent OvaRex(R) and chemotherapy treatment. The conclusions
were that OvaRex(R) MAb induced multifaceted antigen-specific immune responses
even when combined with chemotherapy and that patients with a T cell response
survived significantly longer than those without a T cell response. Induction of
T cells by OvaRex(R), which occurred in 61% of the patients, was associated with
a significant survival advantage, with median survival for T cell responders not
reached (64% still alive at 140 weeks) versus 51.9 weeks for T cell
non-responders (p=0.002; hazard ratio 0.157 [0.009-0.347]).
The Company believes that the high frequency of beneficial OvaRex(R)- induced
immune responses seen in the study in conjunction with chemotherapy strongly
supports additional evaluation and has initiated discussions with the European
Organization for the Research and Treatment of Cancer (EORTC) in that regard.
Further, in a recent publication in the New England Journal of Medicine by Zhang
et al., the authors report on their immunohistochemical analysis of tumor
infiltrating lymphocytes in 186 frozen tumor specimens obtained from primary
debulking surgery of FIGO III and IV ovarian cancer patients. The paper,
entitled "Intratumoral T cells, Recurrence and Survival in Epithelial Ovarian
Cancer", makes several observations relevant to OvaRex(R) immune induction and
the survival benefit reported at SGO:
-- Patients with advanced ovarian cancer have significantly longer overall
and progression-free survival if there are tumor-infiltrating
lymphocytes present (p<0.001).
-- Significantly longer survival was also observed among the patients in
which a complete response to primary therapy (optimal debulking and
adjuvant chemotherapy) occurred and the tumor was infiltrated by
lymphocytes (p<0.001); the five-year overall survival rate was 74% among
these patients whose tumors contained T-cells and 12% among those with
no T cells.
-- Among patients with a complete response to primary therapy, the presence
or absence of T cells (p<0.001) and the extent of residual tumor
(p<0.001) correlated with overall survival but tumor grade, histologic
type, inclusion or non-inclusion of paclitaxel in the chemotherapeutic
regimen, and age did not.

The finding from the Zhang paper regarding optimal debulking is addressed by
Unither Pharmaceuticals, the Company's licensee for North America, Japan and
other territories, in their pivotal double-blind placebo-controlled U.S. phase
III trials where the target population is advanced ovarian cancer patients whose
primary therapy resulted in optimal debulking, chemo-responsive disease, and
CA125 in the normal range. This population was identified from the previously
reported AltaRex phase IIb trial in 345 patients.
With regard to Europe, AltaRex continues a dialogue with the EORTC regarding
the conduct of a phase II trial in patients with recurrent disease who were
previously optimally debulked and had chemo-sensitive disease (>6 month
progression free survival). This study is intended to further elucidate Dr.
Gordon's observations regarding the synergistic effect of immunotherapy and
chemotherapy on T cell induction and resulting survival benefit.
AltaRex Corp. is focused on the research, development and commercialization of
foreign antibodies that modulate the immune system for the treatment of certain
cancers and other diseases where there exists an unmet medical need. Additional
information about AltaRex Corp. can be found on the Company website at
www.altarex.com.

This news release contains forward-looking statements that involve risks and
uncertainties, which may cause actual results to differ materially from the
statements made. For this purpose, any statements that are contained herein
that are not statements of historical fact may be deemed to be forward- looking
statements. Without limiting the foregoing, the words "believes,"
"anticipates," "plans," "intends," "expects" and similar expressions are
intended to identify forward-looking statements. Such risks and uncertainties
include, but are not limited to our need for capital; the risk that the Company
can not raise funds on a timely basis on satisfactory terms or at all; the need
to obtain and maintain corporate alliances, such as the alliance with United
Therapeutics or the proposed alliance with the EORTC, and the risk that the
Company cannot establish corporate alliances on a timely basis, on satisfactory
terms, or at all; changing market conditions; uncertainties regarding the timely
and successful completion of clinical trials and patient enrollment rates,
uncertainty of pre-clinical, retrospective, early and interim clinical trial
results, such as the trial results referred to in this release, which may not be
indicative of results that will be obtained in ongoing or future clinical
trials; whether the Company and/or its collaborators will file for regulatory
approval on a timely basis; uncertainties as to when, if at all, the FDA and
other similar regulatory agencies will accept or approve regulatory filings for
the Company's products; the need to establish and scale-up manufacturing
processes, uncertainty as to the timely development and market acceptance of the
Company's products; the risk that the claims allowed under any issued patent
owned or licensed by the Company will not be sufficiently broad to protect the
Company's technology, that any patents issued to the Company will not be
sustained if challenged in court proceedings or otherwise or that third parties
will be able to develop products or processes that do not infringe valid patents
owned or licensed by the Company, and other risks detailed from time-to-time in
the Company's filings with the United States Securities and Exchange Commission
and Canadian securities authorities. The Company does not assume any obligation
to update any forward-looking statement.

SOURCE AltaRex Corp.

CONTACT: Robert Newman, Vice President, Business Operations of AltRex,
+1-781-672-0138, investor@altarex.com 

 

Although oregovomab has demonstrated bioactivity, the strategy of monoimmunotherapy is not effective as maintenance therapy after front-line treatment of a favorable subset of patients with advanced ovarian cancer.

Source: Journal of Cl;inical Oncology:

Oregovomab Maintenance Monoimmunotherapy Does Not Improve Outcomes in Advanced Ovarian Cancer

  1. Jonathan Berek,
  2. Peyton Taylor,
  3. William McGuire,
  4. L. Mary Smith,
  5. Birgit Schultes and
  6. Christopher F. Nicodemus

+ Author Affiliations

  1. From the Stanford University School of Medicine, Stanford Cancer Center, Stanford, CA; University of Virginia, Charlottesville, VA; Franklin Square Hospital, Baltimore, MD; United Therapeutics Corp, Research Triangle Park, NC; and Advanced Immune Therapeutics, Wellesley Hills, MA
  1. Corresponding author: Jonathan S. Berek, MD, Division of Gynecologic Oncology, Stanford University School of Medicine, 300 Pasteur Dr, HH333, Stanford, CA 94305; e-mail: jberek@stanford.edu

Abstract

Purpose This phase III study tested the hypothesis that the CA-125–specific murine monoclonal antibody, oregovomab, administered as a monoimmunotherapy after front-line therapy in a selected ovarian cancer population would prolong time to relapse (TTR) and, ultimately, survival.

Patients and Methods Patients with stage III to IV ovarian cancer with preoperatively elevated CA-125 and objectively defined characteristics were randomly assigned 4 to 12 weeks after front-line carboplatin and paclitaxel chemotherapy to maintenance monoimmunotherapy in a fully blinded protocol. Two mg of oregovomab or placebo was infused over 20 minutes at weeks 0, 4, and 8 and then 12 weeks until recurrence or up to year 5. Patients were evaluated with serial imaging and clinical evaluation for evidence of recurrence at quarterly visits. TTR was the primary end point.

Results Three hundred seventy-three patients were accrued at more than 60 centers; 251 patients were assigned to oregovomab and 120 patients were assigned to placebo. The treatment arms were well balanced. There were no differences in the clinical outcomes between treatment groups. Median TTR measured from randomization after completion of chemotherapy for the integrated study was 10.3 months (95% CI, 9.7 to 13.0 months) for oregovomab and 12.9 months (95% CI, 10.1 to 17.4 months) for placebo (P = .29, log-rank test). The treatment was well tolerated. Grade 3 to 4 toxicity was reported in 24.6% of patients in the placebo group and 20.1% of patients in the oregovomab group, respectively.

Conclusion Although oregovomab has demonstrated bioactivity, the strategy of monoimmunotherapy is not effective as maintenance therapy after front-line treatment of a favorable subset of patients with advanced ovarian cancer. Future studies of this or other tumor-antigen specific immunization strategies should seek ways to further augment induced immunity.


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