Chemotherapy before and after surgery to remove liver mets reduces the risk of colorectal cancer recurrence.

NEWS FROM ASCO 2007

Chemotherapy given before and after surgery to remove colorectal cancer tumors that have spread to the liver significantly improves three-year progression-free survival.

Results of a randomized phase III clinical trial were discussed at the 2007 ASCO annual meeting in Chicago.  Patients who had cancer that had spread to their liver  considered surgically removable by their doctors either had surgery to remove the liver tumors right away or were assigned to a chemotherapy group.

Patients in the trial had four or fewer liver metastases and had no other cancer outside their livers. 

The chemotherapy group received 6 FOLFOX4 treatments before surgery and 6 treatments afterwards.

After three years there was almost a ten percent absolute improvement in progression-free survival in the group that had chemotherapy — 42.4 percent had not had their cancer return or spread outside the liver versus 33.2 percent for those who had surgery alone.

Bernard Nordlinger M.D. presented the results of the international EPOC trial at the ASCO Plenary session on Monday, June 4th.  In discussing the improved progression-free survival with the use of chemotherapy, he concluded:

This treatment should be proposed as a new standard for these patients and should be delivered by a multidisciplinary team.

Nicholas Petrelli, M.D., a surgical oncologist, disagreed that the approach should be the standard first choice for treating resectable liver metastases.  In a discussion following Nordlinger’s presentation, Petrelli pointed out that chemotherapy can harm normal liver tissue and lead to surgical complications.

He said that doing surgery first is still a good option for people whose liver metastases are resectable.

He called for a clinical trial to compare effectiveness of both pre and post surgical chemotherapy to improve survival.

SOURCE: Nordlinger et. al. Abstract #LBA5 ASCO 2007.

Posted by Kate Murphy on June 25th, 2007
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Senate Appropriations Committee Approves Fiscal Year 2008 Legislation on Labor, Health and Human Services and Education Related Agencies

On Thursday, June 21, 2007, The Senate Appropriations Committee approved the FY08 Legislation on Labor, Health and Human Services, and Education Related Agencies. This bill sets the funding levels for the National Institutes of Health (NHI). The Senate increased funding by $1 billion over the FY07 budget and by $1.2 billion over the President’s request. The bill now makes it way to the Senate Floor.

Though the funding levels are the highest we have seen in years, and MUCH higher than the levels proposed by the House of Representatives and The President, it is not the 6.7% increase we hoped for.

I urge you to contact your Senators and let them know that while we are making great progress in the war against cancer, over 52,000 people will die from colorectal cancer in 2007 alone. We must provide for the resources needed to win this war!

Click here to find your Senators’ contact information

Click here to read the Committee’s Press Release on the FY08 LHHS Legislation

Click here to read the Senate FY08 LHHS Funding Summary

Posted by Joe Arite on June 25th, 2007
Posted in: Policy & Advocacy News | No Comments »

Biological markers predict who will benefit from cetuximab treatment for colorectal cancer

NEWS FROM ASCO 2007

In an effort to predict which patients might benefit the most from treatment with cetuximab (Erbitux), researchers studied three biological markers in both primary and metastatic colorectal cancers. 

They measured EGFR (epidermal growth factor receptor) levels using both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) tests.  They also measured cchanges copy numbers of the HER2 gene with FISH.  In addition, they tested for mutations in the KRAS gene.

• While IHC tests of EGFR showed no difference in response rates, FISH EGFR positive patients had a significantly higher response rate to cetuximab — 29.3 percent had tumor shrinkage compared to 6.8% of those with negative EGFR FISH.
• Positive EGFR by FISH testing almost doubled the median time to when the cancer began progressing again — 6.6 months versus 3.7 months.
• Increased HER2 gene copy number was associated with shorter time to progression and survival.
• KRAS mutation carriers had a significantly lower response rate (6.4 percent versus 26.5 percent).  They also had shorter median time to progression  (3.7 months versus 6.3 months) and shorter survival (8.3 versus 10.8 months).

Giovanna Finocchiaro  M.D. presented the results of the study at ASCO:

This study, the largest biomarker analysis in colorectal cancer patients treated with cetuximab, shows a significant benefit in response and TTP for EGFR FISH positive patients. KRAS mutation analysis identifies a group of patients with the lowest chance to benefit from the therapy. Increased HER2 gene copy number predicts early escape from cetuximab therapy.

Combining EFGR status determined by FISH analysis and KRAS mutations may predict those patients most likely to benefit from cetuximab and help others avoid its expense and side effects.

SOURCE:  Finocchiaro et. al. Abstract #4021 ASCO 2007

Posted by Kate Murphy on June 24th, 2007
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Adding cetuximab to first-line FOLFIRI improves outcomes for patients with advanced colorectal cancer

NEWS FROM ASCO 2007

When cetuximab (Erbitux®) was added to a combination of irinotecan, leucovorin, and fluorouracil (FOLFIRI), both response rates and progression-free survival improved.

The phase III CRYSTAL trial randomized 1200 patients who had not had previous chemotherapy for metastatic colorectal to receive either

• Standard arm: FOLFIRI regimen of intravenous irinotecan and leucovorin followed by a 46 hour continuous infusion of 5FU every two weeks.
• Experimental arm: Weekly infusion of cetuximab added to the FOLFIRI treatment.

Cetuximab improved progression free survival by 15%, with median time to when cancer got worse of 8.0 months for FOLFIRI alone and 8.9 months for the combination treatment of FOLFIRI plus cetuximab.

At one year 23 percent of patients on FOLFIRI had not had any progression compared to 34 percent of those on the experimental cetuximab arm.

More patients had their tumors shrink while on the experimental arm that included cetuximab (46.9 percent versus 38.7 percent).

Three times as many patients on the cetuximab arm were able to have liver metastases successfully removed. (6 percent vs. 2.5%).  Among patients whose only metastases were in their livers, nearly 10 percent who initially could not have a surgery to remove them were able to have complete resection surgery after treatment with the FOLFIRI plus cetuximab.

Grade 3 or 4 serious side effects included low white cell counts, vomiting, and fatigue that were similar in both arms.  There was slightly more severe diarrhea in the cetuximab arm (10.5 percent versus 15 percent.)  Nearly 20 percent of the cetuximab patients experienced a serious skin rash, and 2.3 percent had a reaction during the infusion.

Skin reactions were strongly related to length of progression-free time, with those having the most severe rash also having the longest progression-free survival.

Eric Van Cutsem reported the CRYSTAL results at ASCO, concluding:

Cetuximab in combination with FOLFIRI significantly increases response rate and significantly prolongs PFS in the first-line treatment of pts with mCRC, reducing the relative risk of progression by approximately 15%. Treatment-related side effects of cetuximab in combination with FOLFIRI were as expected, with diarrhea being moderately and skin reactions significantly more frequent as compared to FOLFIRI alone.

WHAT THIS MEANS FOR PATIENTS

Patients newly diagnosed with metastatic colorectal cancer have another option for treatment.  The FOLFIRI plus cetuximab treatment may be especially helpful to those with with liver-only mets that are initially not able to be removed surgically — shrinking them so they can be treated with surgery and potential cure.

Posted by Kate Murphy on June 23rd, 2007
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LIVE WEBCAST: Minimally invasive surgery for hard-to-remove colon polyps

Surgeons at New York Presbyterian Hospital will demonstrate a new technique for surgical treatment of colon polyps that cannot be removed during normal colonoscopy during a live webcast on June 20, 2007.

• Advances in Colorectal Cancer Therapies
• June 20, 2007
• 8:00 P.M. (Eastern Daylight Time)
• Jeffrey W. Milsom, MD, Richard L. Whelan, MD, Alfred I. Neugut, MD, PhD, Joseph T. Ruggiero, MD
• New York Presbyterian Hospital, New York NY

Polyps (adenomas) found during colonoscopy need to be removed to prevent their developing into colon or rectal cancer.  They also need to be examined more carefully for existing cancer cells.

However, some polyps in difficult-to-reach places or those that are flat against the colon wall cannot be removed during colonoscopy.  Traditionally, open abdominal surgery was necessary to remove and biopsy them.

New York Presbyterian doctors have developed a laproscopic approach to locating and removing these polyps.  Abdominal laproscopy is combined with colonoscopy, and carbon dioxide is used to inflate the colon during the procedure.

The new technique avoids lengthy three to seven day hospital stays for recovery after open surgery.  Most patients will be able to go home in less than a day.

Webcast viewers will be able to email questions during the surgery.  Replays are available online after the live date.

To see the webcast go to the NY Presbyterian Live Webcast site on June 20th at 8:00.

The webcast programming is managed by OR-Live.

Posted by Kate Murphy on June 19th, 2007
Posted in: Research & Treatment News | No Comments »