BraveHoods for brave kids


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Several companies have adopted the "one for one" idea after the philanthropic success of TOMS, the shoe company that donates one pair of shoes to a child in need when you buy a pair of their espadrilles.

In honor of Childhood Cancer Awareness Month, we wanted to point out another organization that is doing good. BraveHoods may not be on the same scale as TOMS, but its one-for-one campaign of delivering comfortable clothing to kids with cancer--and their siblings--while also bringing attention to childhood cancer is worth noting.

Allison Yacht started BraveHoods in June 2013 in response to her daughter's cancer diagnosis and treatment. "One of the hardest things for her was going out and about when she was bald. We struggled for some time to try to make her more comfortable and finally found that a hoodie t-shirt worked perfectly," she says. "It is an easy and inconspicuous way for her to feel like she fit in."

Yacht realized that other kids might be having the same issues and created BraveHoods, a clothing line that featured soft clothing with inspirational messages--with hoodies. Yacht said her first goal was to help kids with pediatric cancers be more comfortable. In her experience, she noted children didn't like hat, scarves or wigs, and being bald made them feel "on display." What most kids appreciated were hoodies, which are popular even with kids without hair loss. Her second goal was to create a business model where families dealing with cancer could receive one for free.

When people purchase a BraveHood, Yacht donates one to a kid with cancer. Currently, they have given away almost 700 shirts. "We also donate to siblings because we know that they can get lost in the shuffle sometimes," she says.

Yacht has made a goal to donate 1300 shirts. "We picked this number because there are 13,000 kids diagnosed each year and we want to reach just 10 percent of these kids," she says. Currently, BraveHoods are distributed through families contacting Yacht individually, as well as through Children's Hospital Colorado, Rocky Mountain Children's Health Foundation and Bags of Fun. Soon, BraveHoods will be going to Memorial Sloan-Kettering Cancer Center, St. Jude Children's Research Hospital and the Jimmy Fund. To learn more, you can visit


New class of drug debuts with melanoma treatment approval


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While yesterday's approval of Keytruda (pembrolizumab) is a win for the melanoma community, it also marks the first approval of a new drug class called PD-1 inhibitors, which has shown promise in treating a variety of cancers, including kidney and lung cancers.

After being granted breakthrough status last year and then priority review in May, the Food and Drug Administration gave Keytruda (also known as MK-3457) accelerated approval, which means the agency felt the drug's safety and potential effectiveness filled an unmet need to patients and pushed it through the pipeline much sooner--four months compared with the traditional 10 months of review. The approval marks the sixth new melanoma treatment since 2011.

[Learn more about breakthrough therapy, priority review, fast track status and more here ]

Keytruda, a monoclonal antibody, blocks the PD-1 pathway, which allows cancer cells to evade the immune system. The drug makes it possible for T cells to identify and attack melanoma tumors. Stay tuned to hear more about PD-1 (programmed cell death protein 1) inhibitors, as well as PD-L1 (programmed death-ligand 1) inhibitors, which works against the same cell pathway.

The approval is designated for patients with advanced melanoma or whose cancer cannot be surgically removed and no longer responds to other treatments, including Yervoy (ipilumumab), another type of immunotherapy. The approval was based on two trials that showed tumor shrinkage that lasted from 1 to 8 months and that the drug was safe.

In the phase 1 study, the drug appeared to work in patients with newly diagnosed melanoma as well as in those who had been heavily pretreated. Common side effects included fatigue, cough and nausea; reports of immune-related side effects were rare. When the data was originally presented at the American Society of Clinical Oncology's annual meeting in early June, researchers were very complimentary of the lack of severe side effects seen – only 4 percent of participants in the clinical study discontinued treatment because of side effects, a result many researchers hadn't seen before in a metastatic patient population. (You can read more about melanoma advancements in CURE's ASCO 2014 coverage here.)

Of course, the approval is contingent on further testing. Because it was based on tumor responsiveness in a phase 1 trial, follow-up studies will need to be completed to see if there is an improvement in overall survival or other benefit.

Keytruda is now one of several treatments that boosts the immune system against cancer. Additional studies are testing various combinations of these drugs, hoping that targeting different pathways may boost survival.

"The news of FDA's first approval of an anti-PD-1 drug is extremely exciting and shows just how far the field has come in the last few years," says Debra Black, co-founder of the Melanoma Research Alliance, in a statement released by the organization.

Update: Previous version stated that breakthrough status was granted in February. Pembrolizumab was granted breakthrough status by the FDA in April 2013.


Could cholesterol-lowering drugs work against colorectal cancer?


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A recent study published in the Journal of Clinical Oncology found that statins, drugs used to lower cholesterol levels by blocking a key enzyme, improved survival in patients with non-metastatic colorectal cancer. The class of drugs is one of the most widely used in the country, with nearly half of Americans aged 65 and older taking them. The medications have a pretty good safety profile and are relatively inexpensive, but doctors aren't yet ready to begin prescribing the drug to patients with colorectal cancer.

The study looked at a group of more than 7,500 participants based in England with newly diagnosed stage 1-3 colorectal cancer. Researchers found that statin use, when taken for at least a year after the initial cancer diagnosis, was associated with longer rates of survival.

Earlier studies may explain why statins have an effect on colorectal cancer, including the drug's effect on cell apoptosis ("cell suicide"), inhibiting cell growth and angiogenesis (the process of supplying blood and nutrients to a tumor) and enhancing the immune response--processes that would impact cancer cells. The same cellular process by which statins block cholesterol production also may impact certain processes used in producing cancer cells and their growth. It could be that statins interfere with the cancer's ability to metastasize or possibly enhance the effect of chemotherapy.

Of course, more follow-up and randomized studies will need to happen before statin's effect on cancer can be confirmed and it makes its way into clinical practice. As with any treatment, risks and benefits will need to be weighed for each individual patient before prescribing, but it does look promising.

Thomas Cartwright, a colorectal cancer specialist with Florida Cancer Affiliates and a member of CURE's advisory board, says that while these latest study results are interesting, he doesn't think any physician would prescribe statins to a patient with colon cancer patient based on this single study.

"There are many potential confounding factors and limitations in a study like this," he says. "Statins can have side effects, as well, and a similar study showed statins may increase the risk of diabetes."


Targeted treatment approved for advanced cervical cancer


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The gynecological cancer community is celebrating another milestone in the treatment of cervical cancer. Ahead of schedule, the Food and Drug Administration approved Avastin (bevacizumab) for women with recurrent, persistent or metastatic cervical cancer (read more).

Avastin is the first biological drug to be approved for advanced cervical cancer, a mere four months after it was accepted in the FDA's priority review program. Drugs that show the potential to improve efficacy or safety over currently available treatments can be accepted into the priority review program, which expedites the agency's review from nine months to six months. (You can read more on priority review in "A Primer on How Faster Approval Works.")

This latest approval was based on a study of 452 participants who were randomized to receive two different chemotherapy regimens with or without Avastin. The addition of Avastin improved overall survival from 12.9 months to 16.8 months, regardless of chemotherapy regimen. The full results were published in a recent issue of the New England Journal of Medicine, which you can access here.

Researchers noted in their study results that patients with advanced cervical cancer usually do not have sustained responses to chemotherapy, the standard of care for this disease. Given the aggressive nature of advanced cervical cancer, an improvement of nearly four months is considered meaningful. Some trial participants treated with Avastin, which works by disrupting the blood supply to tumors, experienced hypertension, fatigue and decreased appetite. Rare but severe occurrences of gastrointestinal perforations and fistulas were reported with the treatment.


New screening test approved for colorectal cancer


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This week, the Food and Drug Administration approved a new colorectal cancer screening test called Cologuard, a stool-based test. While there are other stool-based screening tests, Cologuard is the first to use a particular non-invasive method in detecting colorectal cancers and potentially cancerous polyps.

The study results, which led to the approval, were recently published in the New England Journal of Medicine. You can read the full article here.

The trial looked at more than 10,000 individuals who were at average risk of colorectal cancer and between the ages of 50 and 84 years old. The participants used either Cologuard or another type of stool test called a fecal immunochemical test. Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced large polyps, compared with 74 percent and 24 percent, respectively. However, Cologuard did have a higher number of false positives, incorrectly identifying people who were negative for cancer or large polyps called adenomas (87 percent versus 95 percent).

An individual's physician would need to order the test, but the kit is mailed directly to the person's residence. The person collects the sample and mails the kit back to the company using a prepaid mailer. Results are sent to the physician, who then contacts the patient for follow-up.

The test looks for biomarkers in the stool sample that indicate the presence of cancerous cells and blood. As stool moves through the large intestine and rectum, it absorbs cells from large pre-cancerous polyps. By testing the stool using known biomarkers, Cologuard can detect blood cells and polyp cells that contain colorectal cancer-related mutations in its DNA. While the test accurately detects potential cancer, individuals who have a positive result would need to undergo a colonoscopy to confirm the polyp or cancerous mass.

Current guidelines for colorectal cancer, which include fecal occult blood tests, sigmoidoscopy, and colonoscopy, do not include the new screening test. However, that may soon change. The Centers for Medicare and Medicaid Services issued a proposed national coverage determination for the test and is expected to be issuing a coverage ruling before the end of the year. Updated guidelines may follow.

Unlike sigmoidoscopy and colonoscopy, the Cologuard test is not invasive and does not require the prep process that many people find uncomfortable. The new test may ultimately improve the rates of colon cancer screening and hence lower cancer incidence over time. The test's maker has set the price for the test at around $600.

Study authors mentioned in the NEJM article that offering a choice among tests may improve the uptake of screening. "A non-invasive test with a high single-application sensitivity for curable-stage cancer may provide an option for persons who prefer noninvasive testing."

Routine colorectal cancer screening is effective at lowering rates of colorectal cancer and death from the disease. Several groups, including the U.S. Preventive Services Task Force and the American Cancer Society, recommend people of average risk begin screening at age 50. Individuals with a family history of colorectal cancer or a medical history that increases the risk of colorectal cancer should start screening at an earlier age.

Updated 8/15/2014: One of our readers posed the question on when the test would become available. We reached out to the test's maker, Exact Sciences, and received this statement from CEO Kevin Conroy: "Exact Sciences is able to take orders for Cologuard today in the U.S. The company is completing the expected and appropriate packaging and logistical activities that are normal immediately following FDA approval. The company should be able to process orders in the very near future."


Stuart Scott's acceptance of Jimmy V award shows courage, vulnerability


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I'm sure by now you have probably seen or at least heard of Stuart Scott's acceptance speech for the 2014 Jimmy V ESPY Award for Perseverance. Stuart's experience with appendiceal cancer, including qualifying for a clinical trial, was chronicled in a short video that aired before the award presentation.

The video is filled wisdom, humor and inspiration.

"My first thought was 'I'm going to die.' Then about probably 5 seconds later, "I'm going to die and leave Taelor and Sydni. I don't want them to be without a dad. Cancer kills you. People die from cancer."

That was seven years ago. He continued to work at ESPN, travel, exercise, be there for his family... he lived his life. He looked into clinical trials. He underwent treatment. He shared his experience with cancer to the public. He "fought" and promised to "never give up."

Watching it with my family, I noticed some things my family probably may not have: The warrior analogies that many patients and survivors have issues with, the "never giving up," which is from the speech that Jimmy Valvano, who died of cancer in 1993, is so well-known for. Is dying from cancer "giving up" or not fighting hard enough?

Not only was the video moving, but his speech afterward laid those concerns to rest. He was quick to amend what he said in the video.

"Don't give up. Don't ever give up," he quoted Jimmy V's speech again. "I said 'I'm not losing. I'm fighting. I'm not losing.' I have to amend that. When you die that does not mean you lose to cancer. You beat cancer by how you live, why you live and the manner in which you live."

He said he couldn't do the "don't give up" by himself. He mentioned his family, his coworkers and bosses, his medical team, strangers that lift him up, especially when he was too sick to "fight" by himself, which apparently was as recent as last week.

Kudos to Stuart Scott to not only give an inspiring speech about living with cancer, but also showing his vulnerability. Living with cancer is not all about fighting, never giving up, being strong, and hopeful all the time. Scott shared his moments of weakness and doubt, which may have been just as inspiring as him promising to never give up.

You can view the video here.


Lung cancer studies demonstrate incremental progress


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While non-small cell lung cancer (NSCLC) has a reputation as a hard-to-treat cancer, several studies presented at ASCO may help researchers decide on the best treatment for individual patients, as well as uncovering possible new treatments for a type of NSCLC that hasn't benefited from the recent targeted therapy frontier.

On the heels of its Food and Drug Administration approval for gastric cancer, ramucirumab also has promise in NSCLC, as shown by the recently announced results of the REVEL study.

Researchers enrolled 1200 patients with NSCLC that had progressed on platinum-based chemotherapy. Typical second-line therapy for NSCLC includes docetaxel, Alimta (pemetrexed) and the targeted agent, Tarceva (erlotinib), which is reserved for patients with EGFR-mutated lung cancer. Unfortunately, these second-line treatments have limited use and median survival with them is around seven to months months.

In the study, patients who received ramucirumab with standard docetaxel lived a median of 10.5 months compared with patients receiving docetaxel alone (9.1 months). Study researchers noted that while the survival is incremental, this is the first trial that has shown a survival advantage in second-line therapy for NSCLC.

No surprising toxicities arose, but severe cases of neutropenia, fatigue, pneumonia and hypertension were reported during the study. Ramucirumab is an angiogenesis inhibitor, much like Avastin (bevacizumab), which is also approved for lung cancer, but as a first-line therapy. This class of drugs, which target VEGF (vascular endothelial growth factor), blocks blood vessel growth to the tumor and can carry a risk of bleeding issues.

Jyoti Patel, a lung cancer specialist at the Robert H. Lurie Comprehensive Cancer Center in Chicago, says that while the median survival was only a month and a half, patient response to the treatment was over a wide range. "There are certainly patients that benefit more when you look at the wide bell-shape curve."

Unfortunately, strategies to identify patients that would respond to VEGFR-targeted agents, such as ramucirumab have been unsuccessful. "We don't have a biomarker. It's been looked at for bevacizumab, and there are certainly efforts underway to find biomarkers, but it's not a single aberration."

In one of the largest study ever conducted in squamous cell lung cancer, necitumumab, an investigational agent that targets the EGFR mutation in certain lung cancers, did improve survival, albeit modestly.

The drug was tested in 1,092 patients with stage 4 squamous cell NSCLC. Patients who received necitumumab with standard chemotherapy had longer median survival (11.5 months compared with 9.9 months with standard chemotherapy). Progression-free survival was also slightly better with the agent. Because there are few options for this type of NSCLC, the company is expected to file necitumumab for approval by the end of the year.

"Squamous cell lung cancer, although it accounts for less than half of patients with NSCLC, we have not made significant inroads," Patel says. "Every time we see a patient with this type of lung cancer, they are so hungry for options." And while the survival advantage was not what she had hoped, she says it's something. "There are gains, but they are small."

In early-stage lung cancer, a study examined Tarceva (erlotinib) in patients with non-metastatic NSCLC after surgery. While the treatment is approved for metastatic disease, experts wondered if the drug would help prolong disease-free survival and stave off recurrence. While results show that the use of Tarceva in this setting did not extend disease-free survival, further studies in EGFR mutation-positive patients are ongoing, which may reveal benefit in this group of individuals. Another study also examined the combination of Avastin and Tarceva in metastatic NSCLC. While this study had positive results, experts questioned if the Japanese-based trial would translate into the same benefit to Western patients.


ASCO: Huge survival gains when upfront chemotherapy is used in metastatic prostate cancer


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One of the largest jumps in overall survival in advanced prostate cancer was described at this year's annual meeting of the American Society of Clinical Oncology.

Hormone therapy is a standard treatment for men with advanced prostate cancer, but eventually resistance develops and the cancer progresses. Chemotherapy is a common second-line therapy. The question was posed that if chemotherapy was given earlier, during hormone therapy, would it improve survival.

Researchers found that adding docetaxel to hormone therapy improves survival by 10 months in patients with newly diagnosed, hormone-sensitive metastatic prostate cancer. (You can see the full abstract results here.) The trial studied 790 men, with about two-thirds having extensive metastases. Overall survival improved from 44 months to 57.6 months; men with extensive metastases saw an improvement from 32.2 months to 49.2 months--a 17-month improvement. Other than disease extent, the benefit was seen across many subgroups, including race, age and prior therapy for early-stage disease.

Michael Morris, of Memorial Sloan Kettering Cancer Center, provided commentary after the presentation and noted that no other large study in recent times in this patient group has seen such a large jump in survival, even with the new agents recently approved for prostate cancer. "If you look at every other drug trial that prolongs survival none even come close in terms of survival prolongation to 17 months. Our best therapies in castration-resistant disease are less than a third of that for the high-volume patients in ECOG3805 (study)," he said, adding that the combination uses a generic, older chemotherapy at a fraction of the cost of newer therapies.

Overall survival in men with less extensive metastases is not yet known, but researchers are continuing to follow the group to determine if there is a benefit of the combination.

Morris also commented that there should be a better definition of "extensive disease," to help guide the medical community on who would benefit from this regimen. Currently, extensive disease is defined as four or more distant lesions. However, men with small lesions who are asymptomatic may not do as well on the combination as a man who has three large distant lesions.

The addition of chemotherapy resulted in one treatment-related death out of 397 patients, in addition to reports of allergic reaction, low white blood cell counts and fever, which could result in increased infection risk, and neuropathy.

"The benefit in patients with a high volume of metastases is clear and justifies the treatment burden," said lead author and Dana Farber Cancer Institute oncologist, Christopher Sweeney, at the conclusion of the results presentation. "Longer follow up is required for patients with low volume metastatic disease."


National Patient Advocate Foundation creates movement to push cancer innovation


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This morning, the National Patient Advocate Foundation formally released its plan to increase cancer innovation in a goal to get cancer breakthrough therapies to patients sooner.

NPAF, a national non-profit that helps patients receive access to quality cancer care, created the Project Innovation movement to enhance access to clinical trials, policy changes, research collaborations, data sharing and funding options.

Nancy Davenport-Ennis, a two-time breast cancer survivor and founder of the NPAF, said they are working with researchers, advocates, doctors and legislators to find solutions to overcome the obstacles slowing down cancer innovation, including a drop in federally funded research and private investment in biotechnology and inefficiencies researchers and companies encounter when pushing treatment breakthroughs to the clinic. The group released its paper "Securing the Future of Innovation in Cancer Treatment" outlining how it will work to overcome these obstacles and more.

Launched at the 50th anniversary of the annual meeting of the American Society of Clinical Oncology, the program coincides with ASCO's theme this year of "Science and Society." In addition to improving scientific funding and research, scientists and activists are appealing to the public at large to get behind better cancer care--research, treatment, screening, access to healthcare, survivorship and overall quality of life.

"I thought what a wonderful instance of serendipity," she says. "All stake holders will come together with issues that ASCO is talking about, and those same stakeholders know the importance of innovation. Without innovation, we don't find cancer cures."

The NPAF is partnering on the program with legislators, researchers, other non-profits and oncology organizations, including The Oncology Nursing Society, The Association of Community Cancer Centers, The Colon Cancer Alliance, Cancer Support Community and Friends of Cancer Research. The group is also calling on patients, survivors, advocates and caregivers to share their own personal stories of how cancer innovation has impacted their lives.

"We are on a cusp of major transition," she says. "We feel that Project Innovation can energize the American people ... With the launch of the program, it's an open invitation for anyone in America to join us."


50 Years of progress in cancer ... and more to come at ASCO's annual meeting


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Starting today, more than 30,000 professionals in the oncology field are gathering in Chicago for the largest cancer research meeting in the world. Organizers predict it to be a record attendance this year, which also mark the organization's 50th anniversary of the annual meeting.

With five days of abstracts, presentations and meetings, it can be a little overwhelming.

Clifford Hudis, ASCO president and chief of the breast cancer medicine service at Memorial Sloan Kettering Cancer Center, led off the opening press conference today by mentioning the progress we've made in the past 50 years – that 2 out of 3 people now live at least five years after receiving a cancer diagnosis, the death rate has dropped, and people have a much better quality of life during and after cancer. It's real progress, he says, but there are many more challenges left to overcome.

I'm always amazed at how much information is disseminated in only five days, in the forms of poster abstracts, presentations, press conferences, exhibits and off-site meetings. This is also a chance for oncologists and researchers to collaborate and talk amongst themselves about clinical trials they're working on, what they are doing to help individual patients and treatment strategies. Meetings can start as early as 6:30 in the morning or end in the late hours of the day.

We at CURE will do our best over the next several days to bring you highlights and commentary from the meeting, as well as interviews with experts and a look into what cancer research has on the horizon for patients, survivors, caregivers and advocates.

While the meeting officially begins Friday afternoon, the Plenary Session on Sunday will reveal results of the top abstracts chosen by the ASCO committee. Those studies, which highlight research in breast, colorectal and prostate cancer, will hopefully hold good news and be helpful in patients who are currently being treated for those types of cancer.

Based on the released abstract titles, the studies may answer the following questions: Does a common aromatase inhibitor work better than tamoxifen in young women with hormone-positive, early-stage breast cancer?

In newly metastatic, hormone-sensitive prostate cancer, does adding chemotherapy to hormone therapy improve overall survival for patients?

Does adding either Avastin (bevacizumab), a targeted therapy that blocks blood vessel growth to tumors, or Xeloda (cetuximab) to standard chemotherapy improve survival in patients with newly diagnosed metastatic colorectal cancer?

In patients with HER-positive breast cancer, which treatment regimen works best: Tykerb (lapatinib) alone, Herceptin (trastuzumab) alone, Herceptin followed by Tykerb or a combination of the two? Because they both target HER2, but in different ways, many have wondered if using both will improve outcome. This will be the first results from the phase 3 trial, which is why there is so much interest in the outcome.

Results of these studies will be available Sunday morning through the abstract links listed above.

In addition to these studies, we will also keep an eye out for advances in other cancers, survivorship and quality of life issues, as well as other aspects of cancer care. We will be blogging from ASCO, and CURE will include coverage in our upcoming Summer issue in mid-June and in CURExtra, our online newsletter (sign up here).

You can also follow along on Twitter using the hashtag #ASCO14.


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