Doctors and families sometimes worry that older patients with colorectal cancer will not be able to tolerate chemotherapy or that it won’t benefit them.  Too often they are not included in clinical trials.

However, researchers who studied a subgroup of colorectal cancer patients over 75 who were part of the OPTIMOX 1 trial found this wasn’t true.

OPTIMOX 1 looked at a stop and go method of giving oxaliplatin, a drug that causes numbness, tingling, and pain in the hands and feet.   FOLFOX combines Eloxatin® (oxaliplatin) with continuous infusion 5FU and leucovorin.

One arm (A) of the study gave standard FOLFOX treatment until cancer progressed.  The other (B)gave FOLFOX for 6 cycles, stopped the oxaliplatin for 12 cycles, and then reintroduced oxaliplatin, the stop and go plan.

Thirty-seven patients aged 75 to 80 were part of the trial, 20 in arm A without stop and go and 17 in arm B where oxaliplatin was withheld for part of the treatment.

When the older patients were compared to younger ones:

• Overall response to the treatment was almost exactly the same with 59.4 percent of older patients experiencing some reduction in their tumors compared to 59 percent of younger patients.
• Progression-free survival for both groups was 9 months.
• Median overall survival was very similar — 20.7 months for the older patients, 20.2 months for the younger one.
• Older patients did have more serious side effects (grade 3 or 4 toxicity) — 65 percent compared to 48 percent for patients younger than 75.
• Severe side effects included
  • Low white cell counts in 41 percent of older patients, 24 percent of younger ones.
  • Tingling, numbness and pain (neuropathy) in 22 percent versus 11 percent.

However, the research team pointed out that the side effects were manageable and no older patients died during the treatment.

Arié Figer, MD and the team that analyzed the results for the older group of patients wrote

The efficacy of FOLFOX-based treatment was maintained in patients >75 years with both FOLFOX regimens. The oxaliplatin stop-and-go management strategy performed well in this population.

SOURCE:  Figer et al, Cancer, Volume 110, Issue 12, December 15, 2007.

Cyroablation reduced pain from cancer that had spread to the bones, and pain relief was long lasting.

Patients with bone metastases in a Mayo Clinic study had severe pain that was not relieved with narcotics or other standard treatments.  Treated with cryoablation, 80 percent reported significant reduction in pain, and even 6 months after treatment they were still having less pain.  Their quality of life also improved.

Matthew Callstrom, M.D., Ph.D., a radiologist at Mayo Clinic, presented his findings on cryoablation for pain management at the Radiological Society of North America (RSNA) annual meeting on November 27.

He used CT or ultrasound scans to place a small needle-like probes directly into bone tumors.  Gas was circulated through the probes, and tumors were supercooled and turned to ice.  The procedure shrinks or destroys bone metastases and provides long-term pain relief.

Dr. Callstrom pointed out

Cancer patients are living longer and we need to be able to manage their pain over a long period of time.

Bone metastases can be excruciatingly painful.  Radiation therapy is currently the gold standard treatment for them, but pain relief after radiation may be short-lived.  Cyroablation may provide another option for managing pain and improving quality of life.

Dr. Callstrom has recently received a grant from the National Cancer Institute that will fund a randomized clinical study comparing cyroablation to radiation therapy for bone metastases.

Compared to best supportive care, Erbitux® (cetuximab) improved both progression-free survival and overall survival for patients with advanced colon or rectal cancer where all previous treatments had failed according to a study published in the New England Journal of Medicine this month.

In addition, patients who received Erbitux had a better quality of life with fewer problems with physical functioning.

In the study conducted in Canada and Australia, 570 patients were randomly assigned to receive weekly Erbitux infusions or supportive care alone.  Previously all had been treated with a fluoropyrimidine (5FU or Xeloda®), Eloxatin® (oxaliplatin), and Camptosar® (irinotecan).

Patients had already been heavily treated with chemotherapy.  Two-thirds had three or four previous treatment regimens.  Fifteen percent had more than five.

Results included:

• 23 percent increase in overall survival in the Erbitux group compared to supportive care.
• 32 percent improvement in progression-free survival for Erbitux
• Median overall survival:  6.1 months with Erbitux vs 4.6 months with supportive care alone
• 8 percent of Erbitux patients had partial shrinkage of their cancer compared to none of those on supportive care
• At six months half of patients who were taking Erbitux were alive compared to one third of those on supportive care.
• After one year, 21 percent of the Erbitux arm were alive compared to 16 percent of those on supportive care alone.

While other clinical studies of Erbitux have shown improvements in response rate and progression-free survival, this is the first trial to show a survival advantage.

Based on this research, the FDA has approved the use of Erbitux for patients whose colorectal cancer has progressed on other treatments.

Derek Jonker, MD and his colleagues concluded,

Cetuximab improves overall survival and progression-free survival and preserves quality-of-life measures in patients with colorectal cancer in whom other treatments have failed.

SOURCE:  Jonker et al. New England Journal of Medicine, Volume 357, Number 20, November 15, 2007.

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

Nearly half of men and women over the age of 50 will have a colon or rectal polyp that has the potential of turning into cancer.  Fewer than 1 in 20 will actually progress to cancer.

Particularly worrisome are advanced adenomas, those polyps that are 1 centimeter or larger or have features that indicate  precancerous changes.

There is no difference between men and women in the rate that advanced adenomas move on to cancer, but age makes a significant difference.

According to a German study of over 840,000 screening colonoscopies, an individual with an advanced adenoma at age 55 has 1 chance in 4 that it will become cancer within 10 years.  By age 80, that risk has become 2 chances in 5 or 40 percent.

For women with advanced adenomas, ten year risk of developing cancer is 25.4% at age 55 and 40.8% at age 80.  For men, the risk is very similar: 25.2% at 55 and 39.7% at 80.

SOURCE: Brenner et al. Gut, Volume 36, Number 11, November 2007.

The FDA has expanded the approved uses of the CellSearch® System to monitor metastatic colorectal cancer.  CellSearch finds and counts circulating tumor cells in the bloodstream.

Circulating tumor cells are shed from the cancerous tumor.  They can indicate treatment effectiveness and predict cancer progression and overall survival.  CellSearch is designed to be used together with more traditional imaging to help make decisions about what treatments to continue.

The CellSearch device was originally approved by the FDA in 2004 to monitor metastatic breast cancer