#LCSM Chat Topic 3/26: The Landscape of the #LungCancer World After Opdivo–Where We Are, Where We’re Going

Post by #LCSM Moderator Dr. H. Jack West:

Earlier this month, the FDA made quick work of the application that Bristol-Myers-Squibb had just completed for Opdivo (nivolumab) for patients with squamous cell NSCLC that has previously been treated with standard chemotherapy.  This was a very rapid decision, which highlighted the improvement in median overall survival from 6 to 9.2 months. So where are we now? What are the implications of the approval, both in terms of future approvals and the current treatment options for patients? Will Opdivo be the default best treatment in the second line setting, replacing chemo? Will cost be a barrier? What are people’s expectations now that we are entering into a new era of immunotherapy for lung cancer? For the upcoming #LCSM tweetchat on Thursday, March 26, at 8 PM Eastern/5 PM Pacific, let’s discuss the implications and expectations around Opdivo’s approval.  Specifically, we’ll cover the following questions:

  1. Given rapid FDA approval, should we be hopeful that FDA is now expediting approval of pivotal new therapies? Was this fast enough?
  2. What do we expect/understand about Opdivo? Likely helpful for most pts? Are side effects a concern? Do folks expect it to cure pts?
  3. Will people seek Opdivo in other settings, such as 1st line or non-squamous NSCLC? Should coverage be expected?
  4. What will role of immunotherapies be for #LungCancer in 5-10 yrs? Will it replace chemo? Be added to current standards? Cure pts?

There are no easy answers, but it’s exciting to have entered into a new era where the role of immunotherapy is likely to become better defined and will lead to marked improvements for at least some people with lung cancer. I hope you’ll join us on Thursday for the chat!  Please remember to include #LCSM in ALL your tweets so the other chat participants can see them.  You can read a primer on participating in the chat here.

Special #LCSM Chat 3/19 starting ~10 AM PDT: Patient’s Experience of Lung Cancer Surgery via Live Tweets

On March 19th, 2015, starting around 10AM PT, UC Davis will be using #LCSM and #UCDVATS hashtags to live tweet the experience of a patient undergoing minimally invasive surgery for lung cancerDavid Tom Cooke, MD, FACS, (@UCD_ChestHealth) , head of University of California at Davis Thoracic Surgery and #LCSM Co-Founder, explains why:

“Is there a cure for lung cancer?”

I hear this question often.  Many of you know that lung cancer has a five-year survival rate of around 15%.  One reason this rate is so low is because lung cancer patients are rarely diagnosed in early stages of the disease.  The majority of patients are diagnosed at an advanced stage (stage III or IV) when the disease has already spread outside the lung.  Currently, only 25% of lung cancer patients are diagnosed at stage I or II, although we expect more patients will have their disease caught early by lung cancer screening programs.

The standard of care treatment for the physically fit person with stage I and II lung cancer is surgery, or removal of part of the lung.  The five year survival for someone treated with surgery for Stage I lung cancer is around 80%.  That means 80% of those individuals are effectively cured of their lung cancer.

An 80% cure rate is great news, right?  So why do early stage lung cancer patients hesitate to have lung surgery?  Well, most people don’t know much about lung cancer or ways to treat it effectively.  Forums like #LCSM Chat are leading the charge to disseminate evidence-based information.  But the bottom line is:  people are afraid of surgery.   Patients view thoracic surgery (surgery on the contents of the chest, in this case the lungs) as high risk, with potentially serious complications.  Patients frequently ask me, “Are you going to crack my chest open?”   Their fear can be overwhelming.

The fact is, most early stage lung cancer patients can have surgery without cracking their chest open.  Minimally invasive lung surgery has evolved considerably.  For most stage I lung cancer patients, surgery can be performed with small incisions and a high definition camera, just like most gall bladder surgeries have been done over the past ten years.

This type of surgery for lung cancer is called video-assisted thorascopic surgery (or VATS) (scopic meaning camera, thora or thorax meaning chest).  VATS  results in smaller incisions, a shorter stay in the hospital, less need for pain medicine,  and faster return to work and activities of daily living.  Moreover, VATS has the same survival results as traditional open surgery, where we have to make a larger cut and spread the ribs.

To help people understand what patients experience when they undergo VATS for early stage lung cancer, UC Davis will be  performing a lung cancer surgery live on Twitter starting on March 19, 2015 at around 10 AM PDT (don’t worry, we won’t be tweeting while operating — our public relations people will do the tweeting).   Our patient has a keen interest in education and was excited to volunteer and share her story.  She will undergo a right VATS lower lobectomy (removal of the bottom third of the right lung) for early stage lung cancer.

The focus of this live tweeting will not be the surgery itself.  There are plenty of videos on YouTube that show how to do a VATS lobectomy.  Our tweets will focus on our patient and her experience with the preoperative check in process, operation, and postoperative recovery, as well as the clinical care processes that will support her recovery.  Tweets will also follow her tumor through pathology processing and its trip to the UC Davis biobank.  Our tweets will contain the hashtags #LCSM and #UCDVATS.

Our patient’s case highlights some very important facts:

  1. Surgery for lung cancer has evolved.  Now with minimally invasive approaches, small incisions, and state of the art treatment during and after surgery, we are able to “stack the deck” in our patient’s favor to ensure their successful results.
  2. You only need lungs to get lung cancer.  Our patient is a never smoker, and has no appreciable risk factors.
  3. Lung cancer is the number one cancer killer of women, yet only 1% of women when polled identify this fact (source: American Lung Association),
  4. Up to 80% of patients with stage I of lung cancer (early stage) are cured after treatment.

We hope you’ll follow the hashtags #LCSM or #UCDVATS starting around 10 AM PDT on March 19th to share our patient’s experience of lung cancer surgery at UC Davis.

#LCSM Chat Topic 3/12 8PM ET: Giving Back–Ways to Help Other Cancer Patients

image credit: Microsoft

image credit: Microsoft

Cancer patients  and their caregivers come to patient communities (whether online or in real life) for reasons such as seeking support, finding hope, and learning about their disease.  Eventually some become a source of support, hope and information through their activities.

These patients and caregivers sometimes express a desire to reach out to other patients and caregivers, to give back in appreciation for the help they received with their cancer experience.  This may take the form of blogging, participating in fundraisers, volunteering for advocacy projects, or other activities.

But sometimes those who would like to give back are uncertain where to start.
The #LCSM Chat on March 12, 2015, at 8 PM Eastern Time, will discuss motivations for giving back, ways in which patients and caregivers can help others dealing with cancer, and resources available to make this possible. The #LCSM Chat moderator Janet Freeman-Daily (@JFreemanDaily) will post the following topic questions:

T1: What motivated you to reach out and/or give back to cancer patients and/or caregivers?

T2: In what ways might cancer patients or caregivers help others who are dealing with their disease?  How might they reach out?

T3: What resources are available to help give back?  Pls share links if you have them (websites, Inspirational stories, etc.)

Please remember to include #LCSM in ALL your tweets so the other chat participants can see them.  You can read a primer on participating in the chat here.

#LCSM Chat Topic 2/26 at 8PM ET: Changing the Language of Cancer

Cancer is a gift.
Cancer is a battle.
I’m cancer free.
G-d only gives you what you can handle.
Stay positive.
These are words and phrases often associated with a cancer diagnosis. Are they helpful or not?

Obesity is the new smoking.
Limit alcohol consumption.
Exercise more.
Sit less.
There have been countless media reports about cancer prevention. Good advice, right?

Treatable vs. curable.
‘Good’ cancer vs. ‘bad’ cancer.
5-year survival.
Surgical cure.
These are examples of language that may be heard in doctor’s offices. Are health care providers and patients on the same page?

Join moderator Laronica Conway @louisianagirl91 for #LCSM Chat on Thursday, February 26, at 5 PM PT, 7 PM CT, 8 PM ET, as we discuss the language of cancer, what works, and what can be changed for the better.

T1: What do patients want to hear from friends, family and the general public? What doesn’t help?

T2: What do you think of cancer prevention messages? Good advice, or patient blaming?

T3: How can health care providers and patients/caregivers communicate more clearly with each other?

We look forward to seeing you Thursday 2/26 at 8 PM ET.  Please be sure to include #LCSM in your tweets to participate in the chat.  For more about how to participate, see our #LCSM Chat Primer.

#LCSM Chat Topic 2/12 8PM ET: #IWishMyDoc and #IWishMyPatient

Stacey Tinianov (@coffeemommy) wrote an excellent blogpost titled “Context, Understanding and Empathy: #IWishMyDoc & #IWishMyPatient” on the Flip the Clinic website February 1. Below are excerpts from that post that set the stage for our next LCSM Chat on February 12:

If you could openly offer any suggestion to your physician, what would it be and why?

If you could kindly suggest something that could improve your patient’s time in the clinic or overall health, what would you tell them?

Although whole health and wellness is the goal for both physicians and patients, we occasionally seem disconnected from—or even at odds with—each other. A health care provider’s best intentions can be crushed by time constraints. A patient’s desire to be well can get lost in the mix of misunderstanding.

In an effort to help provide context, improve understanding, generate empathy, and drive a change in behaviors between physician and patient, let’s make these wishes visible. In the month of February, with the hashtags #IWishMyDoc and #IWishMyPatient, we can start a respectful conversation, aimed at bridging the gap between patient and physician, with health, wellness, and shared understanding at the center.

The #LCSM Chat on February 12, 2015, at 8 PM Eastern Time, will support Stacey’s effort by fostering a respectful conversation that aims for shared understanding.  In a change of format for this chat, we will not have formal topics T1, T2, etc.  Instead, your moderator Janet Freeman-Daily (@JFreemanDaily) will post prompts to encourage you to share your wishes using the hashtags below in your tweets in addition to the #LCSM hashtag:

  • #IWishMyDoc
  • #IWishMyPatient
  • #IWishMyNurse
  • #IWishMyHospital
  • #IWishMyInsurer

We’ll introduce ourselves during the first five minutes, then you can tweet any of these hashtags at any time during the one-hour chat.  Please remember to include #LCSM in ALL your tweets so the other chat participants can see them.  You can read a primer on participating in the chat here.

Sample tweets to get you thinking (remember, be respectful – no blaming!):

  • #IWishMyDoc would offer to call me in evening after my scan with results so I won’t worry over a weekend  #LCSM
  • #IWishMyPatient would tell me when they don’t understand a term I’m using so I can clarify it during the visit. #LCSM
  • #IWishMyNurse would send me a follow-up email a few days after an office visit to see if I have questions.  #LCSM
  • #IWishMyHospital would make scan report available online via patient portal after patient and doc discuss it. #LCSM

Stacey will be collating responses collected via Twitter throughout February, and will share the results.  We look forward to seeing you in the chat!

#LCSM Chat Topic 1/29 8PM ET: How Do Patients Decide Where to Seek Cancer Treatment?

Cancer is both a terrible, terrifying disease and big business.  With costs of care rising and delivery of medicine changing, independent private practice groups are increasingly uncommon and sole practitioners are rare.   Cancer care is now becoming consolidated as a system of larger institutions and networks, whether academic or private. And they build business with marketing and a keen eye on competition.

These institutions are targeting market niches with major campaigns. Smaller, local centers may focus on the opportunity to get cancer care close to home. Other centers feature cutting edge care and clinical trials. Still others highlight integrative care and holistic, emotional support.

So … how does a patient choose where to go for treatment?  Are the treatment methods effective?  How do the facility’s results compare to outcomes elsewhere?  How can you determine if the care is as good as the facility claims?

Our upcoming #LCSM tweet chat on Thursday, January 29 at 8PM ET/5PM PT will address what impacts cancer patient decisions about where to receive care. Obviously, different people select all kinds of cancer centers because they prioritize different things. So we’ll turn to questions around marketing cancer care and how important and effective it is. Specifically, moderator Dr. H Jack West will help us explore the following questions during the hour:

T1: What factors are most important in deciding where to seek cancer care? Referring doc? Friends? Marketing? Web ratings?

T2: Do you believe marketing claims about cancer care? What impressed? Disappointed?

T3: Many marketing campaigns are case testimonials. Are personal stories still more effective than stats?

T4: Does access to newest drugs, technology and clinical trials motivate patients to drive >1 hr or get on a plane?

T5: Do most patients make the best choice for their care? Are some misled by bad referrals or inaccurate advertising?

To join, just search for hashtag #LCSM during the hour of the chat and add “#LCSM” to your tweets to add comments (or go to tchat.io and sign in). Hope to see you there!


Do Billboards Influence Cancer Decisions?

Is Cancer Hospital Advertising Misleading Patients?
(access requires free registration on Medscape)

#LCSM Chat Topic 1/15 at 8PM ET: “Should the FDA Regulate Which Cancer Tests You Can Have?”

The US Food and Drug Administration (FDA) announced its intention to regulate laboratory developed tests.  Under the FDA’s proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) — which treats LDTs as medical devices and healthcare providers as manufacturers — laboratories would have to submit applications for expensive premarket review for thousands of LDTs if they wish to continue offering them to patients.  This could limit access to life-saving genomic testing for patients who have cancer and other conditions treatable with targeted drugs.

This Thursday, January 15, 2015, at 8 PM Eastern, the subject for #LCSM Chat will be “Should the FDA regulate which cancer tests you can have?”  We invite patients, caregivers, doctors, researchers, professional societies, advocates, and regulators in all cancer communities to participate in this discussion.  Your moderator will be Janet Freeman-Daily.

Our discussion topics:

  • T1: What info about an LDT would give you confidence that it accurately identifies cancer or treatable mutations?
  • T2: Does FDA approval ensure accuracy and usefulness of LDTs? What other info/oversight could do this?
  • T3: Would FDA regulation of LDTs interfere with the practice of medicine?
  • T4: Should only FDA-approved LDTs be used to guide treatment of cancer patients?  Why or why not?

Background information about subject is below.

We look forward to seeing you Thursday 1/15 at 8 PM.  Please be sure to include #LCSM in your tweets to participate in the chat.  For more about how to participate, see our #LCSM Chat Primer.



Laboratory developed tests (LDTs) are developed, validated, performed and interpreted by trained professionals in hospital, academic, and commercial laboratories.  Examples of important LDTs for lung cancer patients include blood tests (blood count, liver function, cancer biomarkers), identification of biopsied cell types (e.g., adenocarcinoma, small cell lung cancer), molecular tests (EGFR, ALK, ROS1), and genomic panels (which can test for over 200 cancer-causing gene mutations and rearrangements from one set of tissue samples).  While some tests are automated, the results of these tests often depend on the judgment and skills of medical professionals such as MD pathologists or PhD scientists.  Cancer-related LDTs are often developed at the request of (and in consultation with) oncologists to allow physicians to tailor treatments for their patients.

LDTs that are performed in your hospital’s lab or commercial labs (like Foundation Medicine) typically are not regulated by the FDA.  However, labs are regulated and certified by the Centers for Medicare and Medicaid Services through Clinical Laboratory Improvement Amendments (CLIA), state health agencies, and organizations such as the College of American Pathologists.  They also participate in programs such as proficiency testing to ensure accuracy.

Unlike LDTs, tests that are boxed and shipped to other labs and professionals contain all of the components and information necessary to perform the test outside of the laboratory in which it was designed and manufactured.  Because they are manufactured by a company and not developed and validated by health professionals as part of a medical service, test kits are regulated by the FDA. The BRAF test manufactured by Roche is an example of an FDA-regulated kit.

Under the proposed framework for regulation of LDTs, the FDA would regulate LDTs just as they would medical devices such as stents, blood glucose monitors or hip replacements.  Regulations would vary depending on risk categories, with tests that determine patient treatments considered as “high risk.”  If this proposal were finalized, in many cases laboratories would have to pull their LDTs from their list of patient services or submit them for review by the FDA.

At first glance, FDA regulation of LDTs might seem like a good idea.  The number of commercially available LDTs to detect mutations in cancer tissue has exploded from a handful in 2011 to dozens today.  Some people argue we need regulations to protect vulnerable patients, citing as one example the Ovasure LDT for early detection of ovarian cancer, which the FDA forced off the market in 2008.  The test aimed to detect specific proteins in the blood that, when analyzed via a mathematical algorithm, could determine whether the patient had ovarian cancer.  However, the LDT was marketed before its accuracy was validated in a large group of patients.  As a result, Ovasure false positives caused some women to have their ovaries removed when they did not actually have ovarian cancer.  We need to prevent such things from happening, right?

Yes, we want LDTs to be as accurate and clinically useful as possible.  But FDA regulation will not change the fact that ALL tests, whether an LDT or test kit, occasionally have false readings.  Early in my cancer journey, a blood test said my blood glucose was 30-something (normal range is 70-120).  The doctor called me late at night, concerned that I was seriously ill (if not dead).  I was fine.  The test result was incorrect.

The FDA held a workshop on the proposed regulations on January 8-9, 2015 (see agenda day 1 and day 2 videos).  During the two days of presentations, several issues were raised :

  • PACE of scientific discovery: Our knowledge of cancer-causing genes, how they affect the body, and ways of detecting them is evolving rapidly. FDA regulations move slowly; approvals usually takes years.
  • VARIETY of labs producing LDTs: Some large for-profit labs that offer genomic tests might be able to afford the cost of additional personnel and fees to comply with proposed FDA regulations. Smaller labs such as those associated with hospitals might not be able to absorb the additional costs and might be forced to close.
  • SCOPE of tests: Determining which LDTs to perform, validating results, and applying the results to treatment is the practice of medicine, which the FDA is prohibited from regulating. Also, the FDA seeks to regulate LDTs as medical devices, but laboratory professionals claim LDTs are not medical devices because they involve medical judgment.

Our understanding of existing oncogenes (ALK, EGFR, BRAF, etc.) and their associated targeted therapies continues to evolve even after the FDA approves companion tests to detect targetable mutations.  It’s not unusual for an LDT to be developed that detects a new variation of an oncogene not detected by the FDA-approved test.  Must cancer patients wait years until the FDA approves the new LDT before they can receive an effective targeted therapy?  Most stage IV cancer patients can’t afford to wait that long.

Here’s an example of how pace, variety, and scope can make a difference for patients.  In a presentation to the FDA on January 8, University of Colorado pathologist Dara Aisner, MD, PhD, shared the following:

“This Kaplan-Meier Curve demonstrates survival benefit for patients with metastatic melanoma treated with vemurafinib [vs dacarbazine] when they have an ‘atypical’ mutation – V600K.  Of note, 34% of the V600K mutation positive patients in this cohort were classified as NEGATIVE by an FDA approved assay and were only detected using a non-FDA approved assay. … This is an example of the clinical validity that evolves rapidly with time.  Determining clinical validity is the physician’s job.”

 Survival Analysis of patients with BRAF V600K mutation

As you can see from this example, restricting the targeted therapy vemurafinib only to patients identified by the FDA-approved test would have prevented many patients from receiving effective treatment.  The current FDA approval process takes years, is resource intensive, and could potentially interfere with the practice of medicine.  Dr. Aisner has stated that if the FDA’s proposed regulations are enacted, her lab at the University of Colorado might have to close or at least stop providing many of its tests.

Another example: the current FDA-approved test for detecting ALK rearrangements in lung cancer is only approved for testing biopsied tumor tissue.  If a patient doesn’t have sufficient biopsied tissue for testing, sometimes other sources of cells (such as fluid collected from a pleural effusion or a lymph node) can provide enough cells for ALK testing.  Many labs have independently validated the test on such specimens.  However, under the proposed FDA regulations, testing these alternative specimens would no longer be allowed unless a lab submits the test to the FDA and obtains its approval.  As a result, some lung cancer patients would have more limited options for testing, and might require additional, potentially dangerous biopsies in order to obtain tumor tissue.

Note that the proposed regulations include an exemption for LDTs for unmet needs that would allow the use of non-FDA reviewed LDTs when no approved LDT is available for the condition.  For instance, ROS1 NSCLC (my diagnosis) does not have an approved LDT, so patients could be tested with an unapproved LDT.

This proposed regulation has the potential to prevent targeted therapy treatment for thousands of patients with cancers and other diseases.  We hope you’ll join us for #LCSM Chat on Thursday January 15 at 8 PM.

Comment period for the proposed FDA Framework for Regulation of Laboratory Developed Tests (LDTs) closes on February 2, 2015. Please let the FDA know what you think by submitting your comments ASAP to http://www.regulations.gov (be sure to include the docket number FDA-2011-D-0360). You can also submit comments electronically here .


Overview Articles:

Opinions Divided on Proposed FDA LDT Regulations (Genetic Engineering and Biotechnology News)

To regulate or not: FDA hears arguments on medical tests (New England Center for Investigative Reporting)


Supporting the FDA’s Proposed Framework:

Advamed (medical device manufacturer’s trade association)

American Association of Cancer Research

American Cancer Society Cancer Action Network, American Heart Association, and Ovarian Cancer National Alliance

American Society of Clinical Oncology

Journal of American Medical Association (yes)


Opposing the FDA’s Proposed Framework:

American Clinical Laboratory Association

ARUP Laboratories

Association for Molecular Pathology (white paper)

Joint Letter to FDA (signed by 51 organizations, societies, and laboratory directors)

Journal of American Medical Association (no)