Posted by Michael Sola on June 19th, 2013

A brief in a running series from 2013 ASCO® conference:

Prognostic Tests – to use or not use . . .  or rather  … To treat or not to treat?

New studies for stage II colon cancer patients contemplating chemotherapy .

by: Nancy Roach

One of the toughest decisions for patients with stage II colon cancer is whether or not to receive chemotherapy after surgery.

In a perfect world, there would be a test that could predict whether or not the cancer will reoccur and research to predict which treatment will help each patient at risk. For now, each patient’s decision is based on a wide variety of factors.

Tests to determine if the cancer has spread

Fight Colorectal Cancer hosted a webinar in 2010 with Dr. John Marshall from Lombardi Cancer Center and the late Kate Murphy from Fight Colorectal Cancer. The webinar laid out a decision-making roadmap, including a discussion of OncoType DX®, a test that may help predict risk of recurrence. Another webinar in 2011 featured Dr. Edith Mitchell from Kimmel Cancer Center and discussed research results from two similar tests, Previstage^TM  and Coloprint®.

At this year’s ASCO® meeting, a poster (abstract 3639) presented by Dr. Daniel Sargent from Mayo Clinic provided an update on research around Previstage^TM . GCC is a gene present on the surface of colon cells, but not on the surface of normal lymph node cells. The Previstage^TM  test looks for GCC genes in lymph node cells.

The theory is that if the GCC gene is present in lymph nodes, cells from the colon traveled outside of the colon. This type of cellular activity happens in cancer cells – not normal cells.  Check out this video to learn more (note:  the video was created by DiagnoCure, the company that owns Previstage^TM ).

Testing for GCC genes

Dr. Sargent’s team looked at GCC test results from lymph nodes collected between 1999 and 2008 from 463 patients with stage II colon cancer. The patients were classified as “High Risk” or “Low Risk” based on the ratio of lymph nodes with positive GCC results to lymph nodes with negative results.

Their prediction was that patients classified as “High Risk” would be much more likely to have recurrences.

The first analysis of the data did not provide the insight researchers hoped for:  The GCC results classified 195 patients as “High Risk,” but only 22 of those patients had recurrences.

The team looked back to see if they could understand why their prediction was so far off and found that:

• One research site had collected lymph nodes in a way that meant the Previstage^TM  test wouldn’t work correctly
• A different “risk scale” of High, Medium and Low might be more helpful

When they re-ran the data leaving out the un-analyzable nodes and the High, Medium and Low risk scale, the test results were more meaningful:

Risk Category	# Patients	# Recurrences
High	80	15
Medium	64	5
Low	222	18

 

The results of the second test look more promising; however, they need to be validated with a pre-specified hypothesis.

In addition, 23 patients with Medium or Low Risk tumors also had a recurrence, which means that while GCC may be important, it is not the only factor involved with recurrence.

While Previstage^TM  can’t predict whether chemotherapy will reduce the chance that cancer will come back, it may help patients and their doctors decide whether or not to undergo chemotherapy in combination with other factors.

Patient take-away:

If you are diagnosed with stage II colon cancer, there is no single test that will tell you how likely you are to have a recurrence. You and your doctor need to discuss a variety of risk factors such as:

• Micro-satellite instability status
• Depth of tumor penetration into your colon wall
• How far the tumor has penetrated your colon wall
• Risks of chemotherapy

The National Comprehensive Cancer Network patient guidelines have a thorough overview of risk factors starting on page 47.  A 2^nd opinion at a major cancer center may also be appropriate.

Disclosure: Fight Colorectal Cancer has accepted funding for projects and educational programs from Genomic Health in the form of unrestricted educational grants. Fight Colorectal Cancer has ultimate authority over website content.

 

 

Posted by Michael Sola on June 12th, 2013

Now accepting artwork submissions for their annual Expressions of Hope wall calendar, American Society of Clinical Oncology® (ASCO) invites anyone who has been affected by cancer – patients, family members, friends and caregivers – to share their hope through art and submit their artwork for consideration.

A variety of mediums will be considered including oil, watercolor, charcoals, acrylics, pencil, pen and ink, and crayon, among others. Please consider letting your family and friends know about this open call for artwork.

Submission is free; information on how to submit can be found on Cancer.Net.

Read about how the artist, Kristy Day, expresses her passion through artwork.

Posted by Mary Miller on June 5th, 2013

For patients getting the common FOLFOX chemotherapy for colorectal cancer, many oncologists add intravenous calcium and magnesium, hoping to decrease the neuropathy (nerve damage) associated with oxaliplatin-based drugs.

But this week, experts at the 2013 ASCO meeting (American Society of Clinical Oncology), announced strong evidence that the calcium/magnesium does no good in either preventing or decreasing neuropathy—and it should no longer be part of routine treatment.

Neuropathy affects cancer treatment

Oxaliplatin-based chemotherapy (e.g. FOLFOX, with Eloxatin®) is one of the most commonly used drugs for people having high-risk stage II, or stages III or IV colorectal cancer. But far too often after patients have had many doses of FOLFOX over months, they have to stop this effective treatment because of increasing neuropathy—burning or numbness especially in hands and feet that becomes chronic, even permanent.

Based on two earlier preliminary studies (and biological reasoning), many oncologists began giving calcium and magnesium intravenously a half-hour before and/or after the chemotherapy, in an effort to prevent the nerve damage.

But in results from the first large, randomized trial announced at this week’s ASCO meeting, researchers found absolutely no effect from the calcium/magnesium.

Trial shows no benefit

A multisite trial randomly assigned 350 colon cancer patients receiving FOLFOX into three groups—one receiving the calcium/magnesium before and after chemo; a second receiving a look-alike placebo; and the third group getting calcium/magnesium before chemo and a placebo afterwards.

The symptoms of nerve damage—measured in multiple ways—were no different in any of the three groups of patients.

Also, there were no differences in the average number of days until symptoms became significant, or in the number of patients who had to stop the chemotherapy.

“This study did not demonstrate any activity of IV CaMg [calcium magnesium]…” said lead author Charles Loprinzi from the Mayo Clinic. He noted that when he has asked medical meeting audiences how many use intravenous Ca/Mg, more than half the clinicians present say they do.

“This practice should now be stopped,” he told Medscape Medical News in an interview.

Practice-changing results; lesson learned

The study was called “practice changing,” by Dr. Richard Wilson from Queen’s University Belfast in Northern Ireland, speaking at a “Highlights of the Day” ASCO session.

The lesson learned, Dr. Wilson said, was that the original 2004 French study was not randomized and too small for definitive proof, but raised doctors’ hopes. Another 2011 study by Mayo Clinic’s Dr. Axel Grothey (a Medical Advisory Board member for Fight Colorectal Cancer) also showed promising early results. But Grothey’s study had to be stopped early before it could get enough participants because of concerns (later disproven) from a different ongoing study. Studies have shown that the calcium/magnesium infusion does not cause harm, and does not interfere with other chemotherapy drugs’ effectiveness.

Patient take-away

If you are currently getting chemotherapy based on oxaliplatin (e.g. FOLFOX, CapeOx), ask if you are also getting a calcium/magnesium intravenous infusion. If you are, take some time to discuss your particular case with your doctor—because another lesson we’ve learned is that every individual situation is different.

This is also an excellent example of why you see recommendations for treatment, tests, and diet change over time. Science—and our understanding of cancer—builds step by step, as evidence and lessons are learned from many tests done over time.

 

For more information: You can ask further questions by email in advance, or live by phone, in the upcoming webinar reviewing ASCO called “What’s New and What’s On the Horizon” on Wed., June 19, at 8-9:30 pm. ET. Click here for more information or to register.

 

Sources:

• “Phase III randomized, placebo-controlled, double-blind study of intravenous calcium/magnesium…” 2013 ASCO meeting and Journal of Clinical Oncology 31, 2013 (suppl; abstract 3501)
• ‘Stop Using Calcium and Magnesium With Oxaliplatin,” June 3 2013 Medscape News
• Intravenous Calcium and Magnesium…”, Grothey, Feb. 1 2011 Journal of Clinical Oncology

Disclosure: Fight Colorectal Cancer has accepted funding for projects and educational programs from sanofi-aventis in the form of unrestricted educational grants. Fight Colorectal Cancer has ultimate authority over website content. See the Fight Colorectal Cancer Funding Policy and Disclosure.

Posted by Mary Miller on June 3rd, 2013

Even as scientists plumb deep into cells and molecules to understand cancer, there are many immediate and “real-life” questions that researchers and clinicians are discussing at the 2013 annual ASCO meeting (American Society of Clinical Oncology).

One of the biggest puzzles for colorectal cancer is how to best treat the elderly, especially those with stages II or III (non-metastatic) cancer. It’s a huge question: today, 40 percent of colorectal cancer patients are elderly, and by the year 2030, more than 70 percent of non-inherited colorectal cancer will be among those 65 or older.

Currently, 70 years old is the median age at diagnosis, with fully 40 percent of diagnoses made in people over age 75. Yet when oncologists must consider, and explain, the risks versus benefits for treating colorectal cancer—especial stages II or III—in the elderly, there’s not enough research evidence to back informed decisions in that age group.

Lack of evidence, but elderly get chemo less often

Colorectal cancer clinical trials only enroll a minority of over-65s—and with the way current trials are designed, those probably  are the healthiest of seniors, wrote Dr. Richard Goldberg, a member of Fight Colorectal Cancer’s Medical Advisory Board, and his colleague Dr. Christina Wu also from Ohio State University, in a careful review of existing evidence. Their article, “Managing Choices for Older Patient with Colon Cancer,” one of just 133 articles among the hundreds selected for the 2013 ASCO Educational Book.

We do know that elderly patients get chemotherapy significantly less often than younger patients, according population-wide studies of patients in community practices, the authors wrote. One study found that only 58% of older-65s received chemo, compared to 84% of patients under 65.

But “it’s a disservice to classify patients based on their ..age alone,” Drs. Wu and Goldberg wrote. Doctors and patients must consider physiologic differences that can affect tolerance for chemo (e.g. body fat vs. muscle body composition; heart, liver and kidney function). Common medications (e.g. blood-thinners) can interact with chemo. Seniors who have neuropathy (i.e., numbness in feet) from diabetes or spinal stenosis perhaps shouldn’t try Eloxitin® (oxaliplatin) in the FOLFOX chemo regimen.

Life quality–and length

For elderly patients, other facts affecting treatment choices include social support—such as whether a person lives alone, and can drive or get a ride to treatments—and especially the individual’s desires for quality versus length of life.

Another paper presented at 2013 ASCO notes considerations of life-expectancy—how long the patient might expect to live—might challenge some stereotypes among both doctors and patients. In 65-year-old people (a common age for diagnosis), women have an average 18 more years of life, and men have about 14 more years. And an individual’s level of basic fitness makes a huge difference, the authors note: A healthy, fit 75-year-old man has a life expectancy of more than 14 years compared to barely 5 years for a frail 75-year-old man.

In their summary, Drs. Wu and Goldberg concluded:

“Analyses of available data in older patients…show that, as a group, they may not benefit from adjuvant chemotherapy regimens containing [Eloxitin] oxaliplatin, or at least benefit as much as younger patients. Although older patients do appear to benefit from adjuvant FOLFOX in stage III disease…the benefit is less than that observed in younger patients….It is likely that some of the fit elderly will gain value from oxaliplatin-based regimens. In advising patients, clinicians should remember that the incremental benefit from 5FU-based adjuvant therapy overshadows the incremental benefit from adding oxaliplatin to those regimens, while avoiding long-term issues with peripheral neuropathy.”

 Dr. Goldberg told Fight Colorectal Cancer, “It is particularly important for older patients to maintain very close communication with their medical team with regard to goals and priorities, as well as treatment-related side effects so that prompt and effective management of side effects can be instituted to avert modest effects from transforming into potentially serious and treatment-limiting issues. Enrollment in clinical trials is needed to help us understand management issues in older patients better. ”

Patient take-away

If you are a senior, or have a parent diagnosed with colorectal cancer, know that especially for stage II and some stage III cancers, you should take time with your oncologist to balance risks and benefits, based on your personal level of fitness irrespective of age, plus other conditions, medicines, and especially personal goals.

Sources:

• “Managing Choices for Older Patient with Colon Cancer: Adjuvant Therapy,” ASCO 2013 Educational Book ;
• ‘Approach to the Older Patient with Stage II/III Colorectal Cancer: Who Should Get Curative-Intent Therapy?” by Drs. Ramsdale, Sanoff, Muss in ASCO 2013 Educational Book
• “Future of Cancer Incidence in the U.S.,” Dec. 2008 Journal of Clinical Oncology

 Disclosure: Fight Colorectal Cancer has accepted funding for projects and educational programs from sanofi-aventis in the form of unrestricted educational grants. Fight Colorectal Cancer has ultimate authority over website content. See the Fight Colorectal Cancer Funding Policy and Disclosure.

 

Posted by Michael Sola on June 2nd, 2013

As you may already have read, team members of Fight Colorectal Cancer which includes Staff, Board, Grassroots Action Committee (GAC) along with our Medical Advisory Board (MAB) have been in full swing at the Chicago 2013 Gastrointestinal Cancers Symposium. The American Society of Clinical Oncology® has been on top of their game with the distribution of material which we can barely keep up with! You can find a treasure chest of details here.

This is by far the world’s largest organization of cancer specialists in one place at any time during the year. They are gathered to listen to scientific researchers present their latest findings, clinical specialists (oncologists, surgeons, radiologists, nurses) discuss how the new science can be applied to their patients and share what is happening and what is left to do in their respective fields of expertise.

Attending for the first time Program Coordinator Emily White had an opportunity to see TED speaker and Internet Social Media Theorist Clay Shirky. FightCRC Board member Sally Church had blogged about Clay a few years back at a similar conference, his eloquent and thoughtful style hasn’t changed and left our team brimming with ideas.

In addition to hob knobbing with celebrity and industry leader types our team also ran into GAC & Call-on Congress advocates proving that “Building Bridges to Conquer Cancer” takes an army. 30,000 is a good start!

 
 
 
 
 
FightCRC MAB Adjunct Speaking Materials: Colorectal Cancer Topics

Our MAB Speakers

• Managing Choices for Older Patients with Colon Cancer:
  Adjuvant Therapy Christina Wu, MD, and Richard M. Goldberg, MD
• Hispanic race and outcome of metastatic (MET) colorectal cancer (CRC): Biology or health care (HC) setting? : Heinz-Joseph Lenz, MD, FACP
• Validation of DPYD variants DPYD*2A, I560S, and D949V as predictors of 5-fluorouracil (5-FU)-related toxicity in stage III colon cancer (CC) patients from adjuvant trial NCCTG N0147 : Daniel J. Sargent, PhD

Colorectal Cancer: What’s New and What’s on the Horizon

Wednesday, June 19, 2013
8-9:30pm ET / 7-8:30pm CT / 6-7:30pm MT/ 5-6:30pm PT

For a recap of the American Society of Clinical Oncology® conference join the Colon Cancer Alliance / Fight Colorectal Cancer webinar presented by Dr. John Marshall, where we will highlight the key colorectal cancer findings from the 2013 meeting and what these advances mean for you.