BY ELIZABETH WHITTINGTON | JUNE 4, 2014
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.RELATED POSTS
BY ELIZABETH WHITTINGTON | MAY 20, 2014
The Lung Cancer Action Summit: Tools for Change is currently accepting applications for its annual advocacy meeting, which will take place in mid-September in Pittsburgh. The deadline for applications is July 1. Travel grants are available.
In its seventh year, the Summit offers participants information on educating their community about lung cancer, fundraising, creating a local awareness and advocacy campaign and more. The Summit will also include a guided tour of the University of Pittsburgh Medical Center's lung cancer research labs. The program is limited to 75 participants to keep it interactive and personal.
Geared toward patients, survivors and advocates, registrants do not need experience in advocacy, just a desire to bring lung cancer awareness and action to their local communities.
You can view the 2014 agenda here.
You can learn more about the summit and register at freetobreathe.org/get-involved/action-summit.RELATED POSTS
BY ELIZABETH WHITTINGTON | FEBRUARY 20, 2014
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 (freetobreathe.org/research-grants/other-scientific-programs/access-tlc).
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 (freetobreathe.org/lung-cancer-info/understanding-a-diagnosis). 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: freetobreathe.org/get-involved
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: freetobreathe.org/about-us/who-we-are/collaborations.RELATED POSTS
BY ELIZABETH WHITTINGTON | JANUARY 17, 2014
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.RELATED POSTS
BY ELIZABETH WHITTINGTON | NOVEMBER 26, 2013
Xalkori (crizotinib), a lung cancer drug that was approved in 2011 under the Food and Drug Administration's accelerated approval, has passed the last hurdle to regular approval. On Nov. 20, the FDA gave the ruling after a phase 3 clinical study confirmed that the drug works in patients who have metastatic cancer with a particular genetic mutation called ALK and who had progressed on platinum-based chemotherapy. Specifically, Xalkori works in lung cancers that are driven by a mutation in the anaplastic lymphoma kinase (ALK) gene, which occurs in about 5 percent of non-small cell lung cancers.
Accelerated approval is a conditional approval the FDA grants for drugs that show a significant improvement before a trial is completed. It can be based on survival, delayed disease progression or another endpoint that was pre-determined before the trial began. Efficacy of the drug must be verified in a later study, either a phase 3 or 4 trial before it can be given a regular approval.
Previous results, which led to the accelerated approval, were based on two single-arm studies, meaning all patients in the study received the investigational drug rather than being randomly assigned to receive the investigational drug or a standard of care. These studies showed Xalkori improved objective response rates, meaning the tumors shrunk with Xalkori in 50 percent and 61 percent of the time in the two studies, respectively.
This new approval is based on results that showed the drug delayed disease progression for 7.7 months compared to chemotherapy, which only kept the cancer from growing for 3 months. Side effects included vomiting, diarrhea, constipation, fatigue and vision impairments.
Many accelerated approvals later receive regular approval. A paper examining accelerated approvals and post-marketing studies found that from Dec. 11, 1992 to July 1, 2010, the FDA granted 35 oncology products accelerated approval, which accounted for 47 new indications. Clinical benefit was later confirmed in subsequent studies for 26 of the 47 new indications. The average time between accelerated approval and regular approval was more than four years, but ranged anywhere from less than a year to more than 12 years. During that time, three indications were revoked or had a restricted distribution due to follow-up studies.
To better understand this newest approval for Xalkori, we asked the FDA a few questions:
1. What is the significance of the regular approval for Xalkori?
• Xalkori received a broad indication for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) in 2011 because this magnitude of high response rates had not been observed with standard approved treatments for lung cancer. Because of this, we didn't want to require patients to progress on chemotherapy before enabling access to a drug that appeared to provide a significant benefit over the standard of care. Xalkori's accelerated approval in 2011 was based on response rates in single-arm trials, and its regular approval is based on a post-marketing trial that provides confirmation of the clinical benefit based on a randomized study against chemotherapy.
2. What does it mean to patients?
• Xalkori's regular approval highlights an evolving paradigm of very rapid drug development, where we are able to get drugs to the patients who need them most at an accelerated pace. Practically speaking for NSCLC patients, Xalkori's regular approval gives access to a therapy that demonstrates superior progression-free survival by about five months and a reduction in the relative risk of progression by about 50 percent. The post-marketing trial provided supporting evidence of higher response rates – 65 percent of tumors shrunk versus 20 percent in those receiving chemotherapy. The randomized trial also provided additional safety data, which helped the FDA determine that its risk-benefit was acceptable.
You can read more about the regular approval at fda.gov.
You can also read more about accelerated approval and other routes to FDA approval in CURE's article "A Primer on How Faster Approval Works."
We'll be featuring advancements in lung cancer in an upcoming issue of CURE, so stay tuned for more updates.RELATED POSTS
BY ELIZABETH WHITTINGTON | JULY 30, 2013
We had an inkling it was coming, but that doesn't minimize the fact that this is big news.
The U.S. Preventive Services Task Force (USPSTF) is recommending high-risk individuals be screened for lung cancer. Yes, the same panel of experts that recommended we take a step back from screening mammography and the prostate-specific antigen (PSA) test because the harms may outweigh the benefit for some individuals.
That's why this is big news. With the USPSTF's recommendation (currently in a draft version), it's ultimately saying that screening for lung cancer in this population will save lives--about 20,000 a year. And there have been studies to attest to this fact, namely The National Lung Screening Trial. (You can read more about the trial in "Good News to Catch a Bad Disease" from CURE, 2010.)
The last update the USPSTF made regarding lung cancer screening was in 2004, when it concluded that there was insufficient evidence to recommend for or against screening. Nearly 10 years later, the panel's recommendation is backed by a large, randomized clinical trial.
The USPSTF is recommending low-dose computed tomography (CT) scans annually for adults aged 55 to 79 years old who have no signs or symptoms of lung cancer but are at high risk because of their current or former smoking history. High risk is defined as a history of heavy smoking and either a current smoker or someone who quit within the past 15 years. The Task Force defines "heavy smoking" as essentially smoking a pack of cigarettes every day for 30 years (or two packs for 15 years, and so on). You can read about the meaning of the USPSTF's recommendation here.
The upside: Based on previous studies, 14 to 20 percent of lung cancer deaths could be averted (about one life saved for every 320 people screened). The downside: The increased number of false-positives (where the CT scan shows cancer when there is none) and radiation exposure (although minimal) from the imaging scan. This is why individuals who do not fall into the high-risk category should not be screened--because the risks (radiation, overtreatment, anxiety) may outweigh the benefits. The USPSTF has shared the full draft of its recommendations for public review. You can find it here. Public comments will be gathered until Aug. 26.
Several medical organizations have already developed guidelines recommending lung cancer screening, including the American Society of Clinical Oncology and the American Thoracic Society. The American Cancer Society issued new guidelines earlier this year that also called for high-risk individuals (aged 55 to 74 years) to be screened for lung cancer with low-dose CT scans annually.
With an official recommendation from the USPSTF, it is assumed that Medicare and private insurance companies will begin to cover these routine screenings for high-risk individuals, as noted in the Affordable Care Act.
And if you're worried about the cost of screening these individuals, consider this: A report from Health Affairs in 2012 noted that the cost of screening will be much less than the healthcare costs associated with treating advanced lung cancer. The cost per life-year saved would be less than $20,000, which is actually more cost-efficient than mammography.
Plus there is also a suggestion that undergoing lung cancer screening may help smoking cessation rates. You can't beat that.
Update: Talking with lung oncologist and CURE advisory board member, Dr. Mohammad Jahanzeb, he has high hopes for the recommendation's effect.
"[It] will no doubt result in saving thousands of lives (by my estimate, about 15,000 lives per year in the United States alone)," he wrote in an email. "It will perhaps save a lot of patients from expensive, yet non-curative treatments for advanced stage lung cancer."
Updated July 31, 2013RELATED POSTS
BY ELIZABETH WHITTINGTON | JULY 1, 2013
After having a close family member diagnosed with lung cancer, I feel that no one deserves cancer – especially one that carries the stigma of lung cancer. Which is why I was surprised that, after taking The Lung Cancer Project test, it showed I still had a negative bias against lung cancer, more so than another cancer type. Even with new treatments and potentially better screening, I had seen firsthand how dreadful the disease could be.
The Lung Cancer Project tests people's subconscious perceptions or hidden biases of breast and lung cancers. It also poses the question of whether these perceptions and biases influence treatment decisions.
The Lung Cancer Project is a research study that examines the "social psychology" of lung cancer through an Implicit Association test. The test gives the user rapid-fire tasks of associating images and words with either lung cancer or breast cancer. If you subconsciously relate a certain image or word, such as "hopeless," to lung cancer, you will probably complete the task faster than when the word is associated with breast cancer. The test takes about 10 minutes to complete, and gives you your results at the end.
The rapid tasks in the survey make it easier for any slight hesitation to be picked up, which will then be calculated into the final score at the end. Of the 1778 responses, researchers found that on average, participants responded faster when lung cancer and a negative word were associated than with breast cancer.
Joan Schiller, a lung cancer specialist at University of Texas Southwestern Medical Center in Dallas, explained the purpose behind the study: "The idea was to quantify and improve upon what we've felt in the past ... that lung cancer patients suffer from guilt, stigma and shame. There hasn't been a way to quantify it or prove that it's been an issue," she says. "This project has led to a benchmark to measure it."
With the results of the study, which were published at the annual meeting of the American Society of Clinical Oncology in early June (Poster #8017), Schiller and others hope to be able to measure progress in the coming years about people's perception of lung cancer. She also hopes that it will be the first step in learning why a majority of individuals diagnosed with advanced lung cancer never receive treatment. Is it due to the perception that treatment is futile? Or that they deserved the disease? Guilt?
The project is the result of a partnership with Genentech, a pharmaceutical company that manufacturers a lung cancer treatment, Project Implicit and various non-profit lung cancer organizations, including the Lung Cancer Alliance and the National Lung Cancer Partnership.
Schiller has been instrumental in promoting lung cancer awareness and research in her role of lung cancer researcher, but also as president and founder of the National Lung Cancer Partnership. "When I went into the field, there weren't a lot of people going into lung cancer for exactly the same reason – it wasn't popular because of the lack of treatments, research and funding."
Take the test and ponder your results. The full results can be viewed in the following infographic.RELATED POSTS
BY ELIZABETH WHITTINGTON | APRIL 24, 2013
A great opportunity to raise awareness and advocacy for lung cancer is in our own backyard - at least for the CURE staff. I hope the distance doesn't hold you back because if you're interested in lung cancer advocacy, Dallas is the place to be Sept. 19-22.
The Annual Lung Cancer Advocacy Summit, which is in its sixth year, will feature three days of training led by grassroots advocacy experts from the National Lung Cancer Partnership. The event is limited to only 75 people, and there is an application process. (Hope you practiced your essay-writing skills during the Healer Award essay contest, because you'll need to write one for the Summit application.)
The agenda is pretty packed. Training sessions include organizing fundraising initiatives, educating your community, reducing the stigma of disease (this is a biggie for me) and contributing to the scientific research process. That last one is equally important because advocates drive awareness, which drives funds, which drives research. This can equal big gains in the lung cancer community.
Participates will also have the chance to receive a tour of UT Southwestern's lung cancer research laboratories. You can view the entire agenda here.
The deadline for applications is June 4 (download the application here). There are scholarships available for transportation, but most meals and a shared hotel room is included for all participants.
Would you be interested in attending?RELATED POSTS
BY ELIZABETH WHITTINGTON | NOVEMBER 12, 2012
As attention moves to lung cancer this month, I wanted to share the infographic below. It highlights current research into lung cancer and shows, among other points, that lung cancer is no longer one disease.
A few years ago, I was attending the annual meeting of ASCO (the professional oncology organization), which showcases studies that will change clinical practice and future research. Scientists were discussing the gains a new treatment had made in that it targets about 10 percent of non-small cell lung cancers. While some people questioned the importance of a treatment that only works in a small group of patients, the researchers were quick to note that 10 percent of patients diagnosed with lung cancer in a year is still more people affected than all those diagnosed with Hodgkin lymphoma in a year (actually, it's more than double). It's the number one cancer killer and a stigma of blame has hindered awareness and research funding. Add to that the absolute complexity of the disease, and it makes for a tough cancer to crack.
Fortunately, research is beginning to make small gains in this hard-to-treat cancer. Advocacy organizations are increasing awareness and funding. Lung cancer survivors are raising their voices to help remove the stigma of the disease.
We have a long way to go, but I'm confident we're on the right track.
You can view a larger version here.RELATED POSTS
BY ELIZABETH WHITTINGTON | FEBRUARY 7, 2012
As the nation prepared for Super Bowl Sunday, many were introduced to the story of Keasha Draft, the newlywed wife of retired NFL linebacker Chris Draft.
A beautiful love story, except that Keasha was diagnosed with lung cancer last year. She was 37 years old. Five weeks after their wedding, she passed away on Dec. 27. The ESPN video is below.
"She courageously faced lung cancer, showing us all with every breath that we all need to hold onto life and love with both hands for as long as we can." --The Chris Draft Family FoundationRELATED POSTS