Polyp Prevention Trial: Eight year follow-up

After eight years of follow-up the Polyp Prevention Trial continues to show that a low-fat, high-fiber, high fruit and vegetable diet does not protect against the development of pre-cancerous colon polyps (adenomas).

The original Polyp Prevention Trial randomized men and women who had at least one adenomatous colon polyp removed during colonoscopy into intervention and control groups.  At the beginning of the trial, there was little difference in diet between the two. The intervention group reduced their fat intake and increased fiber, fruits, and vegetables.  The control group continued eating as usual. 

Participants in the intervention group received extensive counseling and support to maintain a daily diet that included:

• no more than 20 percent of calories from fat
• 18 grams or more of dietary fiber
• 5 to 8 servings of fruits and vegetables

After four years, there was no difference in new adenomas between the two groups.  Forty-percent of each group had at least one new polyp.  Neither was there any difference in large adenomas or adenomas with high-risk features.

At that time in 2000, the research team concluded that

Adopting a diet that is low in fat and high in fiber, fruits, and vegetables does not influence the risk of recurrence of colorectal adenomas.

However, the researchers were concerned that four years was not sufficient time to see an impact from dietary changes, so they persuaded 1,300 of the original group to continue follow-up  for an additional four years.

While the intervention group did not maintain as low a percentage of fat and decreased fruits and vegetables somewhat, they did not return to their original way of eating/  There was still a significant difference in diet between the two groups.

After an average of almost four more years, participants had another colonoscopy to evaluate pre-cancerous polyps.  Again, there was no difference between risk of polyps, multiple polyps  or advanced polyps between those on the special diet and those who ate as they had from the beginning of the trial.

After eight years of following the two groups, Elaine Lanza and her team at the National Cancer Institute’s Laboratory for Cancer Prevention wrote,

This study failed to show any effect of a low-fat, high-fiber, high-fruit and -vegetable eating pattern on adenoma recurrence even with 8 years of follow-up.

SOURCE:  Lanza et al, Cancer Epidemiology, Biomarkers, and Prevention, Volume 16, Number 9, pages 1745-1752, September 1, 2007/

Posted by Kate Murphy on September 17th, 2007
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PRECEPT: Phase II trial underway to study Vectibix (panitumumab) to Avastin (bevacizumab) in second-line treatment

Amgen has opened a Phase II clinical trial to study the safety and effectiveness of Vectibix (panitumumab) combined with FOLFIRI chemotherapy as second-line treatment for colorectal cancer that has spread to organs beyond the colon or rectum. 

150 patients will be recruited from the United States, and will receive FOLFIRI — Irinotecan, leucovorin, and continuous infusion 5FU – plus Vectibix (panitumumab)

Who is eligible?

• Patients with confirmed colorectal cancer that has spread to organs beyond the colon (metastatic disease); and
• Patients whose tumor has been removed by surgery and who have paraffin-embedded tumor tissue available; and
• Patients with cancer that can be seen by scans, and which cannot be removed by surgery alone; and
• Patients whose overall organ functioning is adequate based on blood tests; and
• Patients who have received first-line treatment of FOLFOX – oxaliplatin, leucovorin and continuous infusion 5FU – plus Avastin (bevacizumab), and who had to discontinue FOLFOX plus Avastin because:
  • Their cancer progressed; or
  • They were unable to tolerate treatment

Who is not eligible?

• Patients who have received radiotherapy within two weeks of starting the trial; or
• Patients who have taken CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John’s Wort) within two weeks of starting the trial; or
• Patients who have had systemic infections and are taking antibiotics within 2 weeks of starting the trial; or
• Patients with a history of:
  • cardiovascular disease; or
  • pneumonitis or pulmonary fibrosis
• Patients who have had a significant thromboembolic event such as pulmonary embolism or deep vein thrombosis within 8 weeks of starting the trial; or
• Patients who have had significant bleeding within 6 weeks of starting the trial; or
• Patients with active or uncontrolled gastroduodenal ulcer(s) within 4 weeks of starting the trial; or
• Patients with a condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion); or
• Patients who have had major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury within 4 weeks of starting the trial; or
  Patients who experienced treatment toxicities which were unable to be controlled; or
• Patients who have had prior treatment that included irinotecan, any anti-EGFr therapy, or vaccine for the treatment of mCRC

The trial will examine:

• If patients with specific genetic mutations in their tumors have different responses to the combination of FOLFIRI plus Vectibix
• Safety

For more information about the trial, call Amgen at 1-866-572-6436

Disclosure: C3 has accepted funding for projects and educational programs from Amgen in the form of unrestricted educational grants. C3 has ultimate authority over website content.

Posted by Nancy Roach on September 15th, 2007
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Education and race affect deaths from all cancers and from colorectal cancer

Lower educational achievement increases the death rate from all cancers and also from colorectal cancer for black men, white men, and white women.  For all cancers and for lung and colorectal cancer, the difference in educational level made more of an impact on mortality than did race.

However, the death rates for all cancers and for colorectal cancer were higher for blacks than whites at each of the educational levels measured.

Epidemiologists from the American Cancer Society examined death certificate information for nearly 138,000 people between the ages of 25 and 64 who died of cancer in 2001. They focused on years of education as a measure of socioeconomic level.  Educational achievement and race is noted on death certificates, along with cancer diagnosis. 

While there were actually 553,800 cancer deaths in 2001, the research team limited their study to people over 25 who most likely had finished their education.  People over 65 were excluded because education does not relate strongly to socioeconomic status in older adults.

Both black and white men with a high school education or less were almost twice as likely to die of colorectal cancer than those with more than 12 years of education.  However, black men were about 50 percent more likely to die from colon or rectal cancer than white men. 

More education benefited black women by about 30 percent and white women by 75 percent in preventing colorectal cancer death.  But, black women with more than a high school education still had twice the risk of death from colorectal cancer than similarly educated white women.

Click to enlarge

Colorectal cancer mortality rates, by education level, sex, and
race, for persons aged 25 – 64 years in the United States, 2001.

Having had colorectal cancer screening was strongly related to educational achievement for all groups except black men.  (Percentages have been rounded.)

• Screening rates for black men with less than a high school education were 40 percent compared to 36 percent for those with a college education or more.
• White men with less than 12 years of education had a 30 percent screening rate compared to 54 percent for those with 16 years or more.
• Black women’s screening rate was 29 percent for less education compared to 48 percent for college education.
• For white women screening rate was 31 percent compared to 50 percent between lowest and highest educational levels.

Lack of health insurance, smoking, and obesity — all risk factors for colorectal cancer death — were also related to years of education in the entire group of cancer deaths.

Jessica D. Albano and her colleagues from Epidemiology and Surveillance Research at the American Cancer Society wrote,

In conclusion, we have found that cancer death rates vary substantially by race, level of education, and sex in a recent time period in the United States. Our findings provide a baseline against which efforts to reduce cancer disparities can be measured.

SOURCE:  Albano et al, Journal of the National Cancer Institute, Volume 99, Issue 18, September 19, 2007.

An article about the study appears in the Washington Post on September 12, 2007.

Posted by Kate Murphy on September 13th, 2007
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SPIRITT: Phase II trial underway to study Vectibix (panitumumab) in second-line treatment

Amgen has opened a Phase II clinical trial to compare the safety and effectiveness of Vectibix (panitumumab) combined with FOLFIRI chemotherapy with the combination of Avastin (bevacizumab) plus FOLFIRI as second-line treatment for colorectal cancer that has spread to organs beyond the colon or rectum. 

Two hundred patients will be recruited from the United States, and will be randomized to receive either:

• FOLFIRI — Irinotecan, leucovorin, and continuous infusion 5FU – plus Avastin (bevacizumab)
• FOLFIRI plus Vectibix (panitumumab)

Who is eligible?

• Patients with confirmed colorectal cancer that has spread to organs beyond the colon (metastatic disease); and
• Patients whose cancer cannot be removed by surgery alone; and
• Patients whose overall organ functioning is adequate based on blood tests; and
• Patients who have received first-line treatment of at least 4 cycles of FOLFOX – oxaliplatin, leucovorin and continuous infusion 5FU – plus Avastin (bevacizumab), and who had to discontinue FOLFOX plus Avastin because:
  • Their cancer progressed; or
  • They were unable to tolerate treatment

Who is not eligible?

• Patients who experienced treatment toxicities which were unable to be controlled; or
• Patients who have had prior treatment that included irinotecan, any anti-EGFr therapy, or vaccine for the treatment of metastatic colorectal cancer.

The trial will examine:

• Amount of tumor shrinkage
• How long tumors either shrink or do not grow
• Safety

For more information about the trial, call Amgen at 1-866-572-6436

Disclosure: C3 has accepted funding for projects and educational programs from Amgen in the form of unrestricted educational grants. C3 has ultimate authority over website content.

Posted by Nancy Roach on September 12th, 2007
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DC Beads treatment shows promise in treating colorectal cancer liver mets

Tiny beads filled with a chemotherapy drug have reduced  the size of liver tumors and improved quality of life for people with advanced colorectal cancer.  Early results from  clinical trial comparing DC Beads therapy (DEBIRI) to FOLFIRI chemotherapy showed a significant difference in both tumor shrinkage and quality of life.

DC Bead microspheres — or drug-eluting beads — both close off tiny blood vessels feeding cancer tumors and deliver chemotherapy drugs directly to the tumors, killing cancer cells and shrinking tumors.  The beads are injected into an artery in the groin and travel through blood vessels to tumors that have spread to the liver.

Researchers in Italy treated 14 patients with DC Beads containing irinotecan (DEBIRI) and another 18 patients with FOLFIRI chemotherapy.  FOLFIRI is a combination of 5FU, leucovorin, and irinotecan and is injected into a vein. Patients in the trial had advanced colorectal cancer that had worsened with standard chemotherapy.

Response in the DEBIRI group was 80%, compared to only 10% for those who were treated with FOLFIRI.  After eight weeks of treatment, quality of life had improved by 70% for DEBIRI patients, while those on FOLFIRI had a 30% quality of life improvement.

Survival data is preliminary but also favors the DEBIRI arm. 

The cost per patient of the DEBIRI and FOLFIRI treatments was 4,000 euros and 12,000euros respectively.

A previous trial was reported during the 2007 ASCO annual meeting showing a similar response rate.  Side effects included abdominal pain which needed analgesia and fever.  At the time of reporting 22 of 25 patients were still alive with a median survival of 9.5 months.

The process that DC Beads using to treat liver tumors is called Trans-arterial chemoembolism (TACE).

At ASCO, Professor Giammaria Fiorentini said,

DC bead -TACE was feasible and effective in patients with liver metastases from colorectal cancer. Right upper-quadrant pain seems the most significant toxic event and needs analgesic therapy. No survival data are conclusive because the follow up is short. DC bead of IRI 100 mgr-TACE might be an appropriate palliative therapy for these patients.

Posted by Kate Murphy on September 11th, 2007
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