FDA approves Erbitux for colorectal cancer after standard treatment fails

Based on research that showed Erbitux® (cetuximab) improved survival compared to best supportive care in patients with advanced colorectal cancer who had already had their cancer get worse with standard chemotherapy treatments,  the Food and Drug Administration has approved a change in Erbitux labeling.  The label will now reflect improved survival when Erbitux is used alone  to treat patients after failure of irinotecan and oxaliplatin regimens.

Results from a phase III clinical trial of cetuximab used alone compared to best supportive care for patients who had no other remaining standard treatment options was reported during the 2007 meeting of the American Association for Cancer Research.

In that study. 572 patients were randomly assigned either to receive cetuximab by IV every week or to have best quality supportive care. Supportive care was designed to reduce symptoms but not directly treat tumors.  All patients had previously been treated with chemotherapy regimens that included irinotecan and oxaliplatin, as well as 5FU or capecitabine.

Cetuximab  improved overall survival by 23 percent.  Median survival with cetuximab was 6.1 months compared to 4.6 months with supportive care.

There was also an improvement in the time before the cancer began to progress with cetuximab.  Nineteen patients (6.6 percent) had their tumors shrink partially with cetuximab, but none had a similar response with supportive care.

Serious side effects that were more frequent in the cetuximab group included rash, infection, confusion, pain, and low magnesium levels.  Twelve percent of patients had a severe (grade 3) rash.

Cetuximab targets the epidermal growth factor receptor (EGFR) on cancer cells, blocking a pathway that leads to cell division and cancer growth.

A video webcast of Dr. Derek Jonker’s presentation at AACR 2007 can be found by on the American Association for Cancer Research website.

Posted by Kate Murphy on October 3rd, 2007
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Laparoscopy can reduce futile surgery for colorectal liver mets

During surgery to remove tumors that have spread to the liver from colon or rectal cancer, surgeons sometimes identify further cancer that makes completing the operation impossible.

Avoiding “open and close”  operations saves patients unnecessary risk, pain, and anxiety.

Using laparoscopy to evaluate the liver and interior of the abdomen reduced the rate of liver resections that could not be completed after its used became routine in a United Kingdom hospital.

The laparoscope identified liver tumors that could not be safely removed as well as cancer outside the liver.

Comparing two groups — one in which laparoscopy was not used and a second after laparoscopy became routine before liver resection — surgeons found that the open and close rate was cut in half.  For the no-laparoscopy group, 19 percent of liver surgeries could not be completed.  In the routine laparoscopy group, 8 percent of resections were not finished.

SOURCE:  Kahn et al,  European Journal of Surgical Oncology, Volume 33, Issue 8,  October 2007, Pages 1010-1013.

Posted by Kate Murphy on October 1st, 2007
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In small trial new UFT treatment regimen for advanced colorectal cancer highly effective and less toxic

NEWS FROM ECCO 14 Barcelona 2007

Combining the oral drug Uftoral®® with both Camptosar and Eloxatin® for the initial treatment of advanced colorectal cancer has a high response rate and low side effects.

Uftoral® is an oral drug that combines tegafur and uracil.  It is also known as UFT.  Camptosar® is irinotecan or CPT-11, and Eloxatin® is oxaliplatin.

Over the 28 day SCOUT regimen cycle, people with metastatic colorectal cancer received:

• Oral UFT and oral leucovorin taken at home every day from day 1 through day 21.
• Irinotecan infusion on day 1
• Oxaliplatin infusion on day 15
• A week of rest, days 22-28.

In the Phase I/II trial,  90 percent of patients had some clinical benefit from treatment, including 66 percent whose tumors got smaller.  In addition,

• Median time to progression was 8.5 months.
• Median overall survival was 16.8 months.
• 70 percent of patients were able to go on to second treatment after their cancer progressed.

Side effects were manageable and milder than some other treatments.  There was no hand-foot syndrome of any grade. Hand-foot syndrome with redness, swelling, and cracking  is common and can be severe with other treatments that include 5FU or Xeloda® (capecitabine).

Neuropathy was minimal with only one patient experiencing severe grade 3 problems.  There was little hair loss.

In reporting their results to ECCO,  H.Y. Shiekh and the team from Christie Hospital in Manchester, UK, concluded,

In the first-line treatment of patients with advanced colorectal cancer, UFT plus leucovorin with alternating irinotecan and oxaliplatin gives a high response rate, with minimal alopecia and neurotoxicity and no hand-foot syndrome, thus permitting administration of repeated treatment courses and resection in suitable patients. The SCOUT regimen is an effective and convenient treatment for patients with advanced colorectal cancer.

SOURCE:  ECCO 14 Abstract P#3069:  Sheikh et. al, European Journal of Cancer Supplements, Volume 5 No 4, Page 257.

Another story about the SCOUT study appeared in Medical News Today on September 27, 2007. 

The European Cancer Organisation  (ECCO) Conference was held in Barcelona from September 23-27, 2007.

Posted by Kate Murphy on October 1st, 2007
Posted in: Research & Treatment News | No Comments »