Fight Colorectal Cancer

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.

Diarrhea can be a serious complication when 5FU (fluorouracil) is used to treat colon cancer.  It can lead to dehydration, hospitalization, and the need to reduce or discontinue chemo treatment.

Colon cancer patients in Helsinki were randomly assigned to receive daily supplements of Lactobacillus rhamnosus GG during 5FU chemotherapy.  They were also randomly treated with 5FU either as part of the monthly bolus Mayo Clinic regimen or the twice monthly  infusional deGramont program.

Those who received the probiotic lactobacillus supplements had significantly less severe diarrhea (grades 3 and 4) than those who did not — 22 percent versus 37 percent. 

They had less abdominal discomfort, were hospitalized less often, and needed fewer chemo dose reductions due to bowel problems.

No toxicity due to lactobacillus was detected.

Overall there were significantly more severe side effects of all kinds with the bolus Mayo Clinic regimen than with the infusional deGramont treatment — 89 percent versus 45 percent, including serious diarrhea.

Pia Osterlund and colleagues wrote,

We conclude that Lactobacillus GG supplementation is well tolerated and may reduce the frequency of severe diarrhea and abdominal discomfort related to 5-FU-based chemotherapy.

SOURCE: Osterlund et al, British Journal of Cancer, early online publication, September 25, 2007.

Is being diagnosed with colon cancer under forty a bad sign? Not according to recently published research that found younger patients were no more likely to die of their cancer than older patients.

Surgeons at Memorial Sloan Kettering Cancer Center in New York reviewed a database of more than 1,300 patients with stage I-III colon cancer who had surgery between 1990 and 2001.

Five percent (68 patients) were forty years old or younger when they were diagnosed. They were more likely to have left-sided cancers, but were no more likely than older patients to have symptoms, be diagnosed at an advanced stage, or have worse pathology.

They did have more lymph nodes removed and tested — a median of 18 nodes for younger patients versus 14 for those over age 40.

They were also more likely to have chemotherapy, especially for stage II cancer.  Thirty-nine percent (39%) of the forty and under group with stage II cancers had chemotherapy after surgery compared to 14 percent of older patients.

After five years there was no difference in cancer-specific survival between the younger and older patients — 86 percent vs 87 percent.  However, overall survival (death from any cause) was significantly higher in younger patients where 84% were alive compared to 73% of those diagnosed over the age of 40.

The team concluded,

Younger patients undergoing complete resection of stage I–III colon cancer had disease-specific survival similar to older patients. However, younger patients had more nodes retrieved from their specimens and were more likely to receive adjuvant therapy, especially for node-negative disease. These factors may have contributed to their overall favorable outcome.

SOURCE:  Quah et al, Annals of Surgical Oncology, Volume 14, Number 10, October 2007.

The Food and Drug Administration issued a public health advisory on September 26, 2007 regarding the safe use of Fentora®, an oral medicine used to treat breakthrough cancer pain.

Fentora is a strong  fentanyl-based drug that is dissolved along the gum for increased cancer pain that “breaks through” pain control provided by another long-acting opioid pain drug.

The FDA has received reports of deaths and life-threatening side effects when Fentora was prescribed or used incorrectly.  Issues that have led to problems include:

• patients who did not have cancer pain and should not have been prescribed Fentora
• patients who were not already receiving a round-the-clock opioid drug and were not tolerant to strong narcotic drugs.
• patients who were prescribed the wrong Fentora dose
• patients who took too many Fentora tablets
• doctors who substituted Fentora for other fentanyl drugs such as Actiq® without adjusting the dose to reflect the difference in strength.

In its advisory the FDA emphasizes:

• Fentora should only be used for breakthrough pain in cancer patients who are already opioid-tolerant.  It should not be used to treat other short term pain such as headache, injury, or pain after surgery.
• Fentora should not be used by patients who only take a narcotic pain medicine occasionally.  It is designed to be used together with a regular, round-the-clock opiate drug.
• The dosage strength of Fentora is not equal to strength of other fentanyl drugs.  Fentora dosage should not be substituted directly for other fentanyl medicines including Actiq.
• Doctors need to select the dose of Fentora carefully for each patient.
• Patients and their caregivers need to understand the directions for using Fentora safely and not exceed the dose or number of pills recommended by their doctors.
• Health care professionals, patients, and caregivers need to be aware of the signs of fentanyl overdose and get medical help right away if they occur.

Signs of fentanyl overdose include trouble breathing, shallow breathing, unusual tiredness, sleepiness,inability to think, talk, or walk normally,or  feeling dizzy or confused.

Cephalon, the manufacturer of Fentora, issued a letter to doctors and health professionals early in September emphasizing  how to use Fentora safely. They stressed careful selection of patients and dose, patient and caregiver education, and not substituting Fentora for other fentanyl medications without adjusting the dose.

In their letter to health professionals Cephalon describes what opioid tolerance means:

FENTORA is indicated only for the management of breakthrough pain (BTP) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphinelday, at least 25 rncg transdermal fentanylhour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

 They stress that patients

• Should not take more than two tablets for any one episode of breakthrough pain.
• Should wait at least four hours between episodes of breakthrough pain before taking another Fentora tablet.
• Should only have one strength of tablet available to avoid dose confusion.
• Should keep the tablets out of the reach of children.

WHAT THIS MEANS FOR PATIENTS

Fentora is a strong narcotic drug that can lead to serious, life-threatening problems if not used correctly.

Don’t use Fentora for pain other than cancer pain that already requires you to take another opiate-based drug such as oral morphine, fentanyl patches, oxycodone, or hydromorphone.  You should have been taking one of those drugs for at least a week before starting Fentora.

Fentora is for breakthrough pain or pain that gets worse despite being on a regular, round-the-clock dose of another opioid pain medicine.

Before you begin using Fentora, be sure that your doctor has given you the Medication Guide.  Read it and follow the directions carefully.  If you are caring for someone with cancer, read the Guide and follow it.  Ask your doctor if you don’t understand anything in it.

If you feel breakthrough pain, take only one Fentora tablet in the strength your doctor has prescribed.  If pain does not improve within 30 minutes, take a second tablet — but do not exceed this number.

Wait at least four hours before taking additional Fentora.

If you have  more than 4 episodes of breakthrough pain a day, talk to your doctor about managing your pain medicines differently.

Don’t share Fentora with anyone else, even if they seem to have the same pain you do.

Fentora comes in pills of different doses.  If your doctor changes the dose, discard old pill so you won’t be confused.

Watch for signs of overdose including difficulty breathing, shallow breathing, trouble talking, walking, or thinking normally, excessive sleepiness, or dizziness.  Call your doctor right away or get emergency help.  An overdose can be life-threatening within a short time.

KEEP FENTORA OUT OF THE REACH OF CHILREN.  If a child gets an accidental dose, get emergency help immediately.

from left: Joe Arite (C3: Colorectal Cancer Coalition), Fran Campion (Colon Cancer Alliance), Andrew Porter (Men’s Health Network), Dr. Ralph T. Guild, M.D. (American College of Gastroenterologists), Rep. Dan Boren (D-OK), and Peter Blanchard (Constituent and Colorectal Cancer Survivor) and son

C3: Colorectal Cancer Coalition was proud to help introduce The Colorectal Cancer Screening and Detection Act of 2007 (HR 3060) on Tuesday. A press conference was held on Capitol Hill.

HR 3060 will provide the same protections to non-Medicare beneficiaries that are already provided to Medicare beneficiaries.

Congressman Boren lost his mother to colon cancer nine years ago, and personally understands the need for early detection of the disease.

“Cancer unfortunately has affected millions of lives across the United States,” Boren said. “Coverage is required for many other equally important preventative cancer screenings across the nation. With early detection leading to a 90 percent survival rate, a simple and proven procedure could save the lives of so many (of our) loved ones,” Boren said.

Studies have shown that doctors many times do not refer their patients for tests if those tests are not covered by insurance.

“Americans deserve these life saving medical benefits and should be able to count on these protections,” Boren said.

Currently, 22 states, including Texas and the District of Columbia, require coverage. Oklahoma does not currently require coverage of these cancer screenings.

Congressman Ralph Hall (R-TX) has joined Congressman Boren in his fight.

Joe Arite, Policy and Grassroots Manager for C3