A Conversation about Cyramza with Dr. Charles Fuchs


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"Stomach cancer has not had sufficient attention in terms of drug development, efforts in finding new drugs or really in understanding the fundamental biology until recently," said Charles Fuchs, who leads Dana-Farber Cancer Institute's Gastrointestinal Cancer Center. "I've been pleased to see over the past several years that more attention has been paid to the disease."

That attention resulted in the Food and Drug Administration (FDA) approval of Cyramza (ramucirumab) on April 21 for patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (read the FDA announcement). Historically, gastric cancer treatment has been limited to chemotherapies developed for other cancers, Fuchs says. "That may seem like a subtle point, but most of the drugs used in gastric cancer were actually developed for other cancers and subsequently tested and approved for stomach cancer."

Moreover, Cyramza is the first drug approved for patients whose gastric cancers have progressed on first-line treatment. While oncologists have been treating patients in the second-line treatment setting for years, until now, there has been no standard of care. That unmet need was a catalyst for the priority review the FDA granted last year to help speed along the potential approval (read more).

The approval was based on the phase 3 REGARD study, in which Fuchs was a lead investigator. The study found that patients who received Cyramza had a 1.4 month improvement in median overall survival over patients receiving best supportive care (5.2 months compared with 3.8 months), in addition to better progression-free survival. Side effects included high blood pressure and diarrhea, but overall, side effects were well managed and tolerable, he says.

Fuchs points out that the risk of certain side effects, such as fatigue and nausea, were actually lower in the Cyramza arm than in the placebo arm. "That may seem a bit odd, but patients with stomach cancer who have progressed on first-line therapy have symptoms from the disease," he says. "What's also interesting is that when you look at the results of the REGARD study, which I was involved in, and you compare those results to similarly designed studies where they compared second-line chemotherapy to placebo, the benefit is almost exactly the same (to Cyramza)."

He concludes that the benefit of Cyramza appears to be comparable to standard chemotherapy, but with a better side effect profile. The next step may be combining the drug with chemotherapy, which was the basis for the RAINBOW trial. This trial looked at the combination of Cyramza and paclitaxel. Results showed an even greater survival benefit not previously seen in second-line stomach cancer, Fuchs says.

"It wasn't part of the approval because that study is more recent, but I hope the FDA, upon reviewing that study, will amend the approval to include the use of the drug with paclitaxel," he says. "In my own practice, I anticipate it will be the principal way I use it to treat patients in that setting."

Cyramza is also being examined for other cancers, including non-small cell lung, liver and colorectal cancers. A Cyramza study looking at the drug in patients with breast cancer did not show progression-free survival benefit.

Read more about the approval in gastric and gastroesophageal junction cancers from CURE here.


Adding surgery in metastatic kidney cancer could improve survival


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One of the stories out of the ASCO Genitourinary Cancers Symposium earlier this year was that patients with metastatic kidney cancer may benefit from surgery in addition to biological treatments.

Before targeted therapies, patients with metastatic renal cell carcinoma were treated with surgery and interferon. With the advent of targeted therapy, it's unknown whether surgery is still beneficial. The retrospective study examined patients treated with a targeted agent--most patients were treated with Sutent (sunitinib) or Nexavar (sorafenib). Because the study was not a randomized prospective study, patients chose whether to proceed with surgery, and about 60 percent elected to undergo a nephrectomy (surgical removal of the kidney). You can read the abstract here.

Patients who had surgery lived longer than patients who did not have surgery (20.6 months versus 9.5 months). However, because those who elected to have surgery were in better health, researchers had to adjust the data, which ultimately came out to a 40 percent survival benefit. This effect was apparent in patients who had longer life expectancy and good prognostic factors. Researchers noted that patients who had poor prognostic factors, such as low blood counts, did not appear to benefit from surgery.

Daniel Yick Chin Heng, presenting author of the study, said these results confirm a previous, but much smaller, study. "Cytoreductive nephrectomy may extend overall survival; however, not all patients should have it," he said. "Patients with a longer estimated survival can potentially stand to gain a lot more benefit from cytoreductive nephrectomy." Two phase 3 randomized studies will, hopefully, answer more questions in which patients would benefit from surgery.


Increased screening leads to decrease in colorectal cancer


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A new report reveals that incidence and mortality rates of colorectal cancer have been drastically reduced in the past 10 years. The article, "Colorectal Cancer Statistics, 2014" was published in CA earlier this month and reveals that there has been a steady drop in incidence rates over the past decade, most notably in individuals age 65 and older.

In the late 40s and early 50s, colorectal cancer was the number one cause of cancer death in the United States. Lung cancer would eventually surpass it, but many other factors over the past several decades have helped drive down colorectal cancer rates and deaths, including improvements in diet and lifestyle, increased aspirin use, the widespread adoption of routine colorectal cancer screening and advances in treatment. Experts predict that mortality rates could drop by 50 percent by 2020.

While there is much good news regarding the drop in incidence and mortality, as we dive a little deeper into the data, there is still much that needs focus.

Racial and socioeconomic disparities still persist. Death from colorectal cancer in black men is still 50 percent higher than in whites. What's interesting is that this wasn't always the story: In the 1960s, risk of death from colorectal cancer was actually lower in blacks than whites. Around the 1970s and 80s, incidence of colorectal cancer in black men began increasing while rates in whites began to drop. This can be traced to adoption of routine screening, stage at diagnosis, social and environmental factors and possibly diet.

Colorectal cancer increased in adults younger than 50. Experts believe that changes in diet and lifestyle may be a contributing factor. Focusing on reducing obesity in this group could be key.

Understanding cancer statistics helps researchers track patterns, which in turn can help identify strategies to reduce cancer incidence and deaths. With these new numbers, we learn that while we're making progress, there is certainly reason to celebrate. However, we also discover that we have much work to do, including continuing to build on improving colorectal cancer screening rates, engaging individuals who are at risk, including racial and socioeconomic groups and those who are underinsured and uninsured. We also have to examine why those under 50 appear to be developing colorectal cancer at increasing rates. Do we lower the age of routine screening, focus on diet and lifestyle changes or promote awareness of other risk factors, such as Lynch Syndrome?


Lynch Syndrome Awareness Day: March 22


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On March 22, communities around the world will recognize Lynch Syndrome Awareness Day. While some may scoff at the multitude of "awareness" events throughout the year, this may be one that could have wide-ranging benefits.

We've learned that this hereditary genetic mutation (LS), also known as hereditary nonpolyposis colorectal cancer (HNPCC), may be the cause of a higher percentage of colorectal and other cancers than previously thought. Approximately 3 to 5 percent of all colorectal cancer cases can be traced back to LS. And it's estimated that 600,000 to 800,000 people in the U.S. may have LS, but only 5 percent are ultimately tested and diagnosed with the syndrome.

This year it seems especially fitting to recognize LS Awareness Day as the National Comprehensive Cancer Network, a group of 25 of the world's leading cancer centers, announced a recommendation at their annual meeting that nearly all patients diagnosed with colorectal cancer should be screened for LS. (There is an option to forego testing on patients older than 70 who do not have other risk factors.) The recommendation is included in the latest set of clinical guidelines issues by the NCCN. You can view the guidelines here, but access requires site registration, which is free.

Because people diagnosed with LS have an 83 percent chance of colorectal cancer, it's important that testing be done early so they can take advantage of preventive measures to reduce their risk of cancer, such as increased screening, surgery or chemoprevention drugs. LS can also greatly increase the risk of bladder, pancreatic, gastric, ovarian and other cancers. For patients who have been diagnosed with cancer, a confirmation of LS can help guide treatment, follow-up and surveillance for other cancers.

Lynch Syndrome International is keeping a running track of events around the world and the U.S. on its Facebook page to help spread the word. In response, the awareness of LS has brought about a conversation that could have as much impact as the "Katie Couric Effect" had on colorectal cancer screening.

A friend's husband was recently diagnosed with colorectal cancer. Barely 40 and a family history of the disease, my immediate thought was Lynch Syndrome. It's disappointing that LS screening wasn't a priority for all patients with CRC earlier, as he could have been more closely monitored for the disease and preventive actions could have been taken. But screening for LS may still benefit him through treatment and survivorship, as well as his children and other family members.

To help learn more about LS, several studies are underway, including this one from the Ohio Colorectal Cancer Prevention Initiative. All patients diagnosed with colorectal cancer in Ohio will be screened for LS to help provide recommendations for high-risk individuals, as well as genetic counseling.

With a recent report out that routine screening and advances in treatment have significantly reduced colorectal cancer incidence and mortality, it seems that awareness and action for those with LS may be the next frontier.


National Lung Cancer Partnership becomes "free to breathe"


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After more than a decade as the National Lung Cancer Partnership, the organization rebrands itself as "Free to Breathe," taking the name of its popular nationwide events.

The cancer community has seen rebranding of several non-profits over the years, whether it's to stay relevant to its audience or provide a more recognizable face to the public. It hasn't been that long ago that the Susan G. Komen Breast Cancer Foundation became Susan G. Komen for the Cure, taking the name of its long-standing and popular races. It has since become known simply as Susan G. Komen. In 2011, Gilda's Club and the Wellness Community came together as the Cancer Support Community, although you'll see that iconic red door of Gilda's, and her name, has remained in some communities.

I questioned why a lung cancer organization would drop the words "lung cancer" from its name. Did this mean it would focus primarily on fundraising for research as opposed to providing support services for patients? And how would that research funding equate into cures?

Thanks to Tracy Fischer at Free to Breathe for answering my questions.

What was the impetus for the name change from the National Lung Cancer Partnership to Free to Breathe?

Hundreds of thousands of people championing the lung cancer cause have come to know the National Lung Cancer Partnership through our Free to Breathe event series. After extensive research and analysis, we've decided to unite the efforts of our entire organization under the Free to Breathe name. Our research revealed that the name Free to Breathe resonates deeply with people whose lives have been touched by lung cancer. It inspires passion, dedication and hope. It is active, engaging, simple, and more clearly conveys who we are and what we do. Plus, it's easier to remember!

To make it clear that our organization is still 100 percent focused on lung cancer, we decided on the tagline "a Partnership for Lung Cancer Survival." This helps people who know us as "The Partnership" recognize our organization, and ensures our purpose and focus are clear to those just getting to know us.

How will Free to Breathe achieve the goal of doubling lung cancer survivorship by 2022? Is it by funding research or will Free to Breathe have a hand in directing specific research?

While our name has changed, our focus has not. We believe that every lung cancer patient deserves a cure, and we remain passionately committed to our vision of doubling lung cancer survival by 2022.

We will continue funding research in addition to helping people living with the disease understand their treatment options and benefit from innovative therapies, with a focus on molecular tumor testing and clinical trials.

While funding research is a key component of our program of work, it is not our only strategy. For example, in collaboration with several partners, we have developed a program to measure and reduce the time it takes patient to go from diagnosis to appropriate treatment (

Free to Breathe also plays a crucial role in the administration of the Lung Cancer Mutation Consortium, a partnership of 16 cancer centers across the US working together to test patients' tumors for mutations and characteristics that can be targeted with very specific treatments. This knowledge will help doctors better understand which patients may benefit from which therapies, and help increase clinical trial enrollment which ultimately helps new treatments get to market faster. For example, the LCMC played a key role recently in patient recruitment for a study that led to a "Breakthrough Therapy Designation" from the FDA for a new therapy designed to target BRAF-mutated non-small cell lung cancer. This designation makes it easier for the drug to make its way through the FDA's testing and approval processes and get to patients faster.

Is Free to Breathe a research funding organization or lung cancer support organization? Do you work with other lung cancer organizations to promote awareness, advocacy, education and research funding?

While we don't offer direct patient support, we do offer many patient resources to help patients understand their treatment options and decide which treatment paths are right for them. Our website provides comprehensive information on the disease, diagnosis and various treatment options ( We also offer a clinical trials matching service, as well as advocacy tools to help people recognize symptoms of the disease and raise awareness of its true impact. We empower people to get involved and bring the movement to double survival to their own communities through our nationwide event series and a community fundraising program:

Realizing that collaboration is key to making substantial strides toward doubling survival, we work with other lung cancer organizations in many capacities. For example, this year, we're co-funding our second Impact Award with Uniting Against Lung Cancer. The largest scientific grant offered by both Free to Breathe and UALC, the Impact Award is expected to produce significant improvement for lung cancer patients within the next five years. We are also an active member of LungCAN, a collaborative group of lung cancer advocacy organizations that have come together to raise public awareness about the realities of lung cancer. You can read about other collaborations on our website:

You can read the statements from Free to Breathe's website here. You can also find more lung cancer organizations in CURE's Toolbox, which includes resources for those affected by lung cancer.


Updates in prostate cancer: ASCO GU 2014


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This year marks the 10th anniversary of the oncology meeting devoted to genitourinary cancers, which includes prostate, kidney and bladder. The American Society of Clinical Oncology's Genitourinary Cancers Symposium (, held Jan. 30 to Feb. 1 in San Francisco, presented several studies that may impact clinical practice and future research in prostate cancer. Here are a few notable findings:

Xtandi, Given Before Chemo, Extends Survival in Patients with Advanced Prostate Cancer

Men with advanced prostate cancer are typically given hormone therapy (androgen deprivation) until the disease progresses, whereas the next option is usually chemotherapy. Because prostate cancer is generally a slow-growing disease, delaying time to chemotherapy has been one goal in treatment. Xtandi (enzalutamide), an oral drug that blocks the androgen receptor, was approved in 2012 after it was shown to extend survival for men whose metastatic, castration-resistant prostate cancer had progressed on docetaxel.

The results of the phase 3 PREVAIL study showed that when men were given Xtandi before chemotherapy, the drug delayed disease progression, improved survival, delayed time to chemotherapy and improved quality of life.

The trial randomized more than 1,700 men who had few or no symptoms of their advanced prostate cancer to receive Xtandi or a placebo. Overall, Xtandi delayed the time to chemotherapy by about 17 months. Side effects were minimal and similar in both groups of patients and included fatigue, back pain, constipation and hypertension.

The interim results of the study clearly showed the benefit of Xtandi, which led an independent data monitoring committee to recommend that the trial be stopped early and patients receiving placebo be offered the investigational drug.

"I think it's safe to say that enzalutimde provided a significant clinical benefit to patients with metastatic castration-resistant prostate cancer," said Tomasz Beer, lead author of the study, as he concluded the presentation.

After disease progression, participants in the trial went on to other therapies, including docetaxel, Zytiga (abiraterone), Jevtana (cabazitaxel), Xtandi, and Provenge (sipuleucel-T), many of which were approved in the past few years--a testament to the advances occurring in prostate cancer treatment.

Yervoy in Prostate Cancer

Researchers presented findings from a study of Yervoy (ipilimumab), an immunotherapy that helps the body's own immune system attack the cancer. Approved for melanoma, Yervoy is being tested in several different cancer types, including prostate cancer.

In this latest study, approximately 800 men with metastatic hormone-refractory prostate cancer who had already received chemotherapy were randomized to receive a placebo or immunotherapy. The study did not show an overall survival benefit, which was its primary objective. However, progression-free survival, a secondary endpoint, did show improvement with the drug. The presenting investigator noted that patients who had metastases in lung, liver or other organs did not fare well on the drug. Those who had metastasis limited to the bone fared much better, including an improvement in survival.

This echoes other studies that show that immunotherapy may best be used in patients who do not have a heavy disease burden. One expert who commented on the study did suggest that may not be the whole story – it might be the different cellular environments (bone versus soft tissue metastases) that may be the deciding factor and not specifically the level of cancer metastases.

Because the study did not specifically start out by stratifying patients based on the extent of their disease, it will take another study to confirm this effect. An ongoing trial is testing the drug in patients who have not yet received chemotherapy and who do not have metastases in soft organs, such as the liver or the lungs. We'll see results of that study in 2015.


Wider biomarker testing warranted in colorectal cancer


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When KRAS mutations were found to thwart a response to EGFR-targeted therapies, such as Erbitux (cetuximab) and Vectibix (panitumumab), it was a practice-changing discovery in colorectal cancer. (You can read more about colorectal cancer treatment and the use of personalized medicine in CURE here.) Research presented at an oncology meeting held earlier this month on additional mutations may result in yet another change in the way we treat colorectal cancer.

About 40 to 50 percent of colorectal cancers harbor mutations in a particular part of the KRAS gene called exon 2. (An exon is a genetic piece of information that codes for a protein. If the protein isn't coded correctly, it could turn on cancer growth.)

Researchers have learned that patients with colorectal cancer that contain a KRAS exon 2 mutation are not helped by EGFR-targeted therapies. The plus side is physicians can now test for this biomarker to identify these patients, shielding them from the toxicities and cost of a treatment that wouldn't work, and instead focus on other therapies, such as anti-angiogenic drugs.

Recent studies lend more evidence that it is not a single mutation that affects a tumor's response to Vectibix, but an even wider range of mutations.

A phase 3 study presented at the American Society of Clinical Oncology's Gastrointestinal Symposium analyzed the response of metastatic colorectal cancers to second-line chemotherapy with or without the EGFR-targeting drug Vectibix. Tumors were analyzed for KRAS mutations in exons 1-4 and NRAS exons 1-4, collectively known as RAS mutations.

Although the majority of mutations were in KRAS exon 2, an additional 18 percent of tumors were found to harbor one of these other mutations. (You can view the abstract here.) Patients with these additional mutations, much like those patients with a KRAS exon 2 mutation, did not benefit from the addition of Vectibix.

In essence, a patient's tumor could test negative for the mutation in KRAS exon 2 and be prescribed Vectibix. However, if the tumor contains one of these other mutations, the treatment would still fail to work. While this study confirmed what researchers have seen in other studies in newly diagnosed advanced colorectal cancer, this was the first large study that showed a similar effect in second-line therapy.

"Based on all the data that we generated, it's clear that today we need RAS testing instead of KRAS exon 2 testing before embarking on an anti-EGFR treatment in patients with metastatic colorectal cancer," said lead researcher Marc Peeters, of Antwerp University Hospital in Belgium, as he concluded his presentation to other gastrointestinal oncologists at the meeting.

Experts expect that expanded RAS testing will soon become the standard of care in treating patients with metastatic colorectal cancer.


More bad news for smoking


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It's been 50 years since the initial release of the Surgeon General's Report on Smoking and Health. This report provided a scientific basis for us to work toward reducing the public health impact of tobacco use. Since then, 30 additional Surgeon General reports on tobacco have been released.

Today's report, "The Health Consequences of Smoking--50 Years of Progress: A Report of the Surgeon General, 2014," adds new evidence that smoking is bad for us, including that it increases the risk of liver cancer, colorectal cancer, diabetes and rheumatoid arthritis. Secondhand smoke increases the risk of stroke. The report notes that while the evidence is suggestive, it's insufficient to conclude breast cancer risk increases with smoking and exposure to secondhand smoke. However, smoking increases the risk of cancer death. And in cancer survivors, it increases the risk of dying from other diseases.

Measures that have been put into place since that first report have more than halved smoking rates. The public's view on smoking has changed drastically. Strategies to reduce tobacco use have included smokefree laws, taxes on tobacco, smoking cessation aids and support and public awareness campaigns. Those measures continue to become more powerful and prevalent.

The report also notes the success of smoking cessation strategies, including nicotine replacement therapy, such as gums, patches, and even electronic cigarettes, which contain nicotine, but not tobacco. During the past few years, electronic cigarette use among current cigarette smokers increased from 9.8 percent to 21.2 percent. While it may be used by smokers in places that don't allow tobacco smoking, I think it's safe to say some current smokers are using the tool as a cessation device. But is it working? Opponents consider it a "gate-way drug" to tobacco use and another marketing tactic by tobacco companies to get people hooked on nictotine, but its use in cessation should be explored. Studies to examine health implications are also needed.

The report also contains a consumer booklet, "Let's Make the Next Generation Tobacco-Free," which aims to helps parents talk to their children about tobacco use.

You can read the full report here.


Top 10 CURE blogs of 2013


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Looking back on 2013, we've compiled CURE's Top 10 blogs of the year. We based the ranking on the number of views for each posting, and noticed that triple-negative breast cancer was a top read this year, along with fear of recurrence and metastatic cancer. There also appears to be a few popular posts from past years that continue to make the list.

What do you think? Did the one that impacted you the most last year make the list?

1. Fear of recurrence like no other fear

It's not hard to imagine why this one topped our list. The fear of cancer returning is a common emotion in survivors after treatment ends. Kathy LaTour describes her own experience with recurrence fears after her diagnosis 27 years ago, and how she overcame it.

2. Finally, good news about triple-negative breast cancer patients!

This post was originally published in 2009, when news of PARP inhibitors as a potential treatment for TNBC excited everyone who had knowledge of the disease. While the original research didn't pan out, there is new "good news" in the field. You can read the latest in our Fall 2013 article "Divide and Conquer."

3. A recap of triple-negative breast cancer research from San Antonio

Continuing on with the TNBC coverage, many of our readers were interested in Patricia Prijatel's account of TNBC research from the 2012 San Antonio Breast Cancer Symposium. Patricia, a survivor of TNBC and a patient advocate, provided a great update that spanned various treatments and the biology of the disease. I wouldn't be surprised if our guest blogger from the 2013 Symposium, Michelle Esser, makes the list next year. Michelle wrote an update from this past year's meeting.

4. When the unexplainable happens

Oncologist Richard Frank shares his experience in treating a family friend, a patient with metastatic liver cancer.

5. Do you need a baseline mammogram?

While this post was originally published in 2012, we're understanding more and more that screening, treatment and follow-up is not a "one-size-fits-all." As for guidelines, and whether many physicians follow them, we'll be covering that topic later this year.

6. The dreaded conversation: Telling friends your parent has cancer

Maya Silver was 15 when her mother was diagnosed with breast cancer. Writing about her own experience and other teens facing a parent's diagnosis, she offers helpful advice on how to share the information with friends and receive the support teens need during this time.

7. Would you date a cancer survivor?

Would you? A lot of survivors have weighed in since the post was originally published in 2009.

8. Six tools you need to reinvent yourself beyond cancer

"When cancer happens to us it's common to feel completely out of control. We go from our "normal" lives to something we reluctantly call the "new normal." The problem is that it doesn't feel normal at all because we are changed suddenly and forever." Debbie Woodbury shares her tips on how to take control over the new normal.

9. Young and living with metastatic breast cancer

This year, Kathy LaTour introduced us to Carrie Corey, a young wife and mother living with metastatic breast cancer. Carrie has become a regular guest blogger with CURE, sharing her experiences including a first beach trip with young son, Henry. You can read her first guest post at "Young, a new mother and metastatic."

10. CURE's "beat cancer" playlist

What song describes your cancer experience the best or helped you with treatment? Our readers gave their best "fighting cancer" songs, and we compiled them for you.


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