4 april 2009: Erbitux - Cetuximab naast chemo werkt alleen bij patienten met uitgezaaide darmkanker die het KRAS wild type gen bezitten. In alle andere gevallen (40%) werkt Erbitux absoluut niet. Het werkt dan zelfs klinisch negatief. Zie artikelen hiernaast in linkerkolom.

Het Duitse bedrijf Merck meldt een significant positief effect op overlevingsduur van hun monoklonaal middel Erbitux (cetuximab) in combinatie met irinotecan voor gemetasteerde darmkanker. Opvallend is dat de resultaten uit een studie komen met vooral ook darmkankerpatiënten waar andere chemo's bij hadden gefaald. .

DJ Merck KGaA's Erbitux Effective For Combating Colon Cancer --

Edited Press Release
FRANKFURT (Dow Jones)--Merck KGaA (G.MRK) of Darmstadt, Germany, Sunday said
that data from its European colorectal cancer (BOND) study demonstrate that
Erbitux (cetuximab), when used in combination with irinotecan, represents a
significant advance in the treatment of patients with metastatic colorectal
cancer, slowing progression of the disease by more than four months and
shrinking tumors by 50% or more in 22.9% of patients. Half of all patients saw
their disease stabilize or improve.
Median survival time for the advanced stage patients treated with the
combination therapy was 8.6 months, with approximately a third of the 329
patients in the study alive after one year.
"These are very significant findings, considering how difficult advanced-stage
colorectal cancer is to treat and that patients in the BOND Study had already
failed treatment with the standard course of chemotherapy," said Prof. David
Cunningham, M.D., head of the gastrointestinal and lymphoma units at the Royal
Marsden Hospital in London and Surrey, United Kingdom, and lead investigator for
the BOND study.
Prof. Cunningham presented results of the BOND (Bowel Oncology With Cetuximab
An tibody) study at the annual meeting of the American Society of Clinical
Oncology in Chicago. "These results are likely to change the standard of care
for patients with metastatic colorectal cancer whose disease is becoming worse
despite conventional chemotherapy," said Prof. Cunningham. "Cetuximab gives
doctors a powerful new tool and gives patients who have failed traditional
chemotherapy new hope."
The BOND study was designed to compare cetuximab alone as monotherapy and in
combination with irinotecan in 329 patients with metastatic colorectal cancer
expressing the epidermal growth factor receptor (EGFR) who had ceased to respond
to chemotherapy.
Two thirds of the patients were given cetuximab and irinotecan while one third
received only cetuximab. Data from the BOND study indicate that cetuximab given
alone shows an overall response rate of 11%.
When given in combination with irinotecan, a statistically significant
improvement in efficacy is observed, compared with cetuximab alone, with an
overall response rate of 22,9%. The study demonstrates that a combination of
cetuximab and irinotecan is beneficial even when patients have ceased to respond
to irinotecan.
"We are delighted with the strength of the response and
time-to-disease-progression data on cetuximab," said Merck KGaA CEO Bernhard
Scheuble. "We believe the data promise new hope for patients suffering from
metastatic colorectal cancer and other EGFR-expressing tumors."
Merck KGaA plans to submit an application for approval of cetuximab to the
European Agency for the Evaluation of Medicinal Products (EMEA) and to
authorities in Switzerland this summer. If successful, Merck KGaA could bring
the cancer drug to market in Switzerland as soon as late 2003 and across the
European Union in 2004. Merck licensed the right to market cetuximab outside of
the U.S. and Canada and the co-exclusive right to market cetuximab in Japan from
ImClone Systems Incorporated of New York in 1998.
EGFR, when expressed by tumors, usually results in aggressive disease
progression, poor response to traditional therapy and poor survival. Because
cetuximab blocks the EGFR, thereby inhibiting the abnormal growth of cancer
cells, patients whose colorectal tumors overexpress EGFR will be most likely to
benefit from cetuximab.
Cetuximab is an investigational IgG1 monoclonal antibody that targets the EGFR
and blocks the ability of EGF to initiate receptor activation and signaling to
the tumor. It is believed that this blockade results in an inhibition of tumor
growth by interfering with the effects of EGFR activation including tumor
invasion and metastases, cell repair and angiogenesis.
Cetuximab is given weekly as a slow intravenous infusion over approximately
one hour and is generally well tolerated. As expected, patients who received the
combination of cetuximab and irinotecan experienced severe side effects,
primarily related to irinotecan therapy.
The most frequent Grade 3 or 4 events in patients receiving the combination
were diarrhea (21.2%), weakness (13.7%), low white blood cell count (13.7%) or
vomiting (6.1%). Patients who received only cetuximab experienced fewer side
effects: 13% experienced difficulty breathing, 10.4% weakness and 5.2% abdominal
Approximately half of the patients in the BOND study developed a mild to
moderate skin reaction, or rash, as a side effect of the treatment. The rash
resolved itself spontaneously in most patients and was not considered to be a
serious problem. Severe allergic reactions in BOND have been reported in four
out of 329 patients.
Because cetuximab can shrink tumors and has fewer side effects when used
alone, it may be appropriate as a monotherapy, especially in patients who would
not be able to tolerate further chemotherapy, according to Prof. Cunningham.
Notes to Doctors and Patients: More information about cetuximab in Europe:
Internet: http://www.cetuximab.merck.de 

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