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BY ELIZABETH WHITTINGTON | MAY 2, 2012
Bayer, the maker of an experimental drug for colorectal cancer and GIST, has opened an expanded access program for colorectal cancer patients who have progressed on other therapies.
Patients are encouraged to talk to their doctor about whether they are eligible for the program.
Details can be found at: Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy: CONSIGN
Regorafenib is a targeted agent that has shown slight progression-free survival benefit in patients who have progressed on several lines of therapy. Results from the CORRECT trial, which was first presented at the ASCO Gastrointestinal Symposium earlier this year, showed that the drug improved survival by a median of 1.4 months, from 5 months with placebo to 6.4 months--a 29 percent increase in overall survival. The drug controlled the disease in nearly half of patients, delaying or reducing tumor growth in 44.8 percent of patients as opposed to 15.3 percent in the placebo arm.
The phase 3B expanded access program was designed to provide patients with metastatic colorectal cancer the drug if they have no other therapy options. The program will be until the drug is approved, which is not guaranteed. Researchers will be collecting safety data during the study. Common side effects reported included hand-foot rash, fatigue and diarrhea.
Patients will take the oral drug once a day in four-week cycles (daily for three weeks, then one week off before starting therapy again.)
More information on expanded access and other programs to access investigational therapies can be found in "Ethics of Access." You can also find more information on the FDA.gov website.
Bayer has opened 55 sites around the world, including at least 10 sites in the U.S. For more information on access to regorafenib, email Bayer at clinical-trials-contact@bayerhealthcare.com.
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BY ELIZABETH WHITTINGTON | JANUARY 30, 2012
I'm finalizing one of our stories from the ASCO Gastrointestinal Cancers Symposium this week - that of regorafenib, a multi-targeted drug that showed a slight median survival advantage in metastatic colorectal cancer patients who had progressed on three or more lines of therapy. Regorafenib targets several different cancer growth pathways, which makes it unique and could explain why it works against tumors that have progressed on so many other therapies.
And while the phase 1 data wasn't a slam dunk, it was decided that it would skip phase 2 and move directly to phase 3 -- a move one physician called "gutsy." But it worked and will most likely be approved -- much sooner than if the drug had traveled the traditional route.
Another study, which followed the regorafenib presentation, was that of brivanib, another experimental targeted agent for metastatic colorectal cancer. This drug also showed positive results in phase 1 and was moved directly to phase 3. However, unlike regorafenib, the study turned out to be negative. It delayed cancer growth, but survival did not significantly improve.
Both were considered promising drugs and had solid study designs, but one worked and one didn't.
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BY ELIZABETH WHITTINGTON | NOVEMBER 28, 2011
For years, aspirin has been touted as a way to prevent colorectal cancer, but medical groups have stopped short of recommending it because of potential side effects. However, a study published in The Lancet in October shows that at least one group could benefit from taking a couple of aspirin on a daily basis.
The CAPP2 (Colorectal Adenoma/carcinoma Prevention Programme) study followed 861 individuals with Lynch syndrome, a genetic condition that increases one's lifetime risk of colorectal cancer by about 70 percent, as well as endometrial and other cancers.
Individuals in the trial were randomized to receive 600-mg of aspirin or a placebo daily. After two years researchers saw no difference, but after continued follow-up, a delayed benefit did appear in the aspirin group. After 4.6 years, 4 percent of patients in the aspirin group developed colorectal cancer compared with 7 percent in the placebo group. The risk of other Lynch syndrome-associated cancers was also lower in the aspirin group – by around half. The study is designed for a 10-year follow-up, so expect to hear more on this study.
Because this was the first randomized study to look at the chemopreventive effects of aspirin in this high-risk group, further studies will need to be conducted to confirm the effect and to determine the optimum dose and length of treatment. CAPP3 will compare lower doses of aspirin to the 600 mg/day dose used in CAPP2.
For individuals at average risk, the benefits of daily aspirin may not outweigh the risks, which can include gastrointestinal bleeding. However, it may be worth talking to your doctor, especially if the disease runs in your family or you're already taking aspirin to lower your risk of heart attack. Recommendations for those at average risk include colorectal cancer screening from age 50 to 75.
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BY ELIZABETH WHITTINGTON | NOVEMBER 16, 2011
Another cancer-related smart phone application launched in late October – this one specifically for colon cancer and breast cancer patients.
The free app was created by Genomic Health, which markets Oncotype DX, tests that provide genetic information to physicians to help determine treatment options for breast cancer and colorectal cancer patients. Two non-profit organizations, Breastcancer.org and Fight Colorectal Cancer, partnered with Genomic Health to provide information for the app.
Newly diagnosed patients would need to download the app and choose to follow the breast cancer or colorectal cancer tool. It begins by informing the patient what information they will need to fully utilize the app, including their pathology report or simple information about their diagnosis (such as if their colorectal tumor tested positive for the KRAS mutation). Patients would then need to fill out a brief questionnaire to receive a summary of treatment options and information.
The tool offers good information and offers to save the report, which includes questions to ask your doctor and an option to email the report to yourself to print off and take to your next oncology appointment.
The other features of the tool include Questions to Ask – including suggested questions and an option to record your own. You can input your questions and answers by text or voice recorder, which I thought was incredibly helpful. I can see this being useful for caregivers who may want to know exactly what the doctor said during an appointment if they weren't able to make it or for keeping track of questions before meeting with your medical team and then recording the answers immediately.
The Journal feature offers users a way to track appointments, take notes (by text or voice recorder) and even take and save photos. A glossary is also included, as well as a list of resources, including the web version of the tool.
You can download the Cancer Coach app on iTunes or Android Market. And if you'd rather not take your coaching from a cell phone, the app is based on the online tools found at My Breast Cancer Coach and My Colon Cancer Coach.
Do you use the Cancer Coach? What do you think of the app or online tool?
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