#LCSM

December 19 #LCSM Chat: “Lung Cancer Screening – The Good, The Bad and the Indolent”

The next #LCSM Chat will occur on December 19 at 5 PM Pacific Time (8 PM ET), and will be moderated by Janet Freeman-Daily.  The theme will be “Lung Cancer Screening – The Good, The Bad and the Indolent.”

Discussion topics for #LCSM Chat:

T1: For patients who don’t fit “older heavy smoker” profile, should doctor order low-dose CT screening if patient requests it? #LCSM

T2: Some lung nodules are not cancer. When are you comfortable just watching a lung nodule instead of treating it? #LCSM

T3: A new blood test detects w/ 90% accuracy if lung nodule IS NOT cancer (but can’t tell for sure if it IS). Is this useful when combined with low-dose CT screening? #LCSM

Background

The National Lung Screening Trial found 15% to 20% fewer lung cancer deaths among participants who were screened for lung cancer by low-dose helical CT scans compared to those screened by chest x-ray. Participants included 53,454 current or former heavy smokers ages 55 to 74 between 2002 and 2004.

From this statistic, it would seem obvious that lung cancer screening for older patients who are or were heavy smokers would be a slam dunk. However, the screening does raise some concerns.  For instance, some studies show 20% to 60% of screening CT scans of current and former smokers show abnormalities, most of which are not lung cancer. Lung biopsies and surgery do carry risk, yet the uncertainty over having lung nodules might cause considerable anxiety for the patient. How do we determine whether or not to biopsy such abnormalities?

A biopsy of a nodule found by screening could determine if the nodule is cancerous. However, according to the NCI, studies indicate some small lung cancer tumors are indolent – that is, they so slow growing that they never become life threatening. This situation, called overdiagnosis, might cause some patients to be subjected to challenging and potentially damaging lung cancer treatment when they have no symptoms and an extremely low risk of death from lung cancer. Are the risks associated with biopsies and cancer treatment ALWAYS less than the risk of lung cancer death?

Another issue: this new CT screening is recommended only for patient who fit a specific profile (generally, current or former heavy smokers ages 55 to 79).Never smokers and some smokers and former smokers don’t fit this profile, but might have other risk factors for lung cancer. If a patient who doesn’t fit the recommended profile requests a low-dose helical CT scan, and agrees to pay for it, should their doctor agree to order the scan?

A new blood test announced in October (by Bioinformatics for Integrated Diagnostics and the Institute for Systems Biology) can determine if a detected lung nodule is NOT cancerous with 90% accuracy. However, it can’t reliably detect whether a nodule IS lung cancer. Used in combination with CT screening, this blood test might help determine whether a lung nodule warrants a biopsy. Do doctors and patients feel comfortable using a blood test that can say if the patient does NOT have lung cancer, but can’t say if the patient DOES have it?

For those who wish to do more reading

The National Lung Screening Trial: Results are in

Overdiagnosis in Low-Dose Computed Tomography Screening for Lung Cancer

Harmless lung cancer? Many tumors not lethal

Can Lung Cancer be Clinically Insignificant? The Case for “Overdiagnosis” and “Overtreatment” of Lung Cancer

Blood Test Distinguishes Early Lung Cancer From Benign Nodules

A blood-based proteomic classifier for the molecular characterization of pulmonary nodules.

Blood Test to Define Probability of Lung Nodule Being Cancer? Could Help, but Potential to Backfire

National Lung Screening Trial: Questions and Answers

December 5 #LCSM Chat Topic – Is the System of Clinical Trials Fair For Patients?

By Dr. H. Jack West

IS THE SYSTEM OF CLINICAL TRIALS FAIR FOR PATIENTS? DO YOU BELIEVE IN IT? 

I just watched the movie “Dallas Buyers Club”, about the challenges of getting new drugs for HIV/AIDS just as the first effective treatments were being identified in early clinical trials. It portrays the DEA, FDA, and medical establishment as essentially obstructing the process of patients getting access to life-sustaining treatments, and it led me to wonder whether patients and caregivers feel that the system of novel agents being tested in clinical trials is fair or whether the medical establishment today seems to be protecting people from themselves in unwanted ways.  The movie takes its title from a legal workaround that facilitated people buying non-FDA approved drugs from outside sources outside of clinical trials, learning on the fly in a way that seems far more nimble than the sclerotic, formal trial system being practiced by the doctors.

 In truth, the movie doesn’t make physicians clearly evil, as they debate the merits of placebo-controlled trials in order to determine whether treatments are safe and effective.  AZT is shown as having potential efficacy but also leading to severe, dangerous side effects in early testing as a single agent at a higher dose than used in later combinations, though I think the overall sense from the movie is that the people pursuing treatments based on collective experience (pre-social media sharing, mind you) were outpacing the pace of progress in the clinical trials system, with its ties to “big pharma” corporations that are suggested as pulling the strings of the puppets in the FDA. 

As someone who runs clinical trials and considers them the building blocks of everything that has come to be defined as our best treatments for cancer, I needed to step back to ask whether people see the clinical trial system as obstructionist. We have the same debates today about trial design and how to provide access to promising drugs, especially in patients with a poor prognosis and few or no compelling standard treatment options.  We want to offer good treatments but not unwittingly harm patients by giving treatments that may be toxic but not formally evaluating outcomes and recognizing the problems as early as possible.

The movie also includes patients on placebo-controlled trials, banding today, pooling their medications and splitting them to provide the best chance that everyone gets some medication, short-circuiting the trials process and ability to determine whether the group receiving study drug did better or worse than those on the placebo.  Of course, placebos remain a dreaded and maligned element of the clinical trials system, even though they sometimes help identify when patients are better off NOT receiving the study drug.

 So I ask you the following questions:

1) Do you believe in the clinical trials system? Do you believe that, in the big picture, it serves its goal of identifying drugs that are safe and beneficial? 

2) Is it too restrictive, either in terms of which patients are permitted to enroll, where trials are available, or both?

3) Do you have clear suggestions of how the system should be changed, bearing in mind that our goals need to be to protect patients from insufficiently tested and potentially harmful treatments as well as to deliver new beneficial ones?

4) If treatments are potentially available “off-protocol”, such as a drug for kidney cancer being written for in a group of patients with lung cancer, do patients and caregivers recognize an incentive to conduct the study to clarify the value of the treatment, or would you favor getting the drug by any means necessary and circumventing the trials system?

5) Do you see ways in which social media, efforts like PatientsLikeMe.com and other self-aggregating patient groups might accelerate research by working along with physician scientists and the pharma/biotech industry trying to test novel agents?

We’re going to cover these topics at an upcoming hour-long “#LCSM tweet chat” on Thursday, December 5 at 8 PM Eastern, 5 PM Pacific. I hope you’ll be inclined to join us, or post your comments here

I would say that these issues are clearly very timely, but the movie I just saw reminds me that many of these central questions explore the same themes that the medical/patient communities have been struggling with for decades.  

 

 

Tweets for #LCAM2013 Week 4 — How to Help Lung Cancer Patients

For Lung Cancer Awareness Month (#LCAM2013), the #LCSM team compiled a list of tweet-sized lung cancer facts – one tweet for each day in November. We ask all #LCSM participants and lung cancer advocates to tweet the fact of the day at noon Eastern time (9 AM Pacific) to help with trending.  You can come here to copy the tweet of the day, or  if you prefer, you can retweet the fact after @LCSMChat tweets each day at 11:55 AM Eastern Time.

Our tweets for the final week of Lung Cancer Awareness Month (#LCAM2013) focus on HELP:  what you can do to help lung cancer patients, whether through providing direct assistance, funding research, advocating, or supporting lung cancer organizations.  For Week 1 tweets, click here.  For Week 2 tweets, click here. For Week 3 tweets, click here. Facts for all weeks of #LCAM2013 are collected here.

HOW TO HELP LUNG CANCER PATIENTS

November 25 tweet:
HELP: Distribute information about low-dose CT screening for #lungcancer. http://www.lung.org/lung-disease/lung-cancer/lung-cancer-screening-guidelines/lung-cancer-one-pager.pdf #LCSM #LCAM2013

November 26 tweet:
HELP: Support #lungcancer patients as a volunteer at your local cancer center. #LCSM #LCAM2013

November 27 tweet:
HELP a #lungcancer patient during/after treatment with transportation, childcare, housework, meals, or fundraising. #LCSM #LCAM2013

November 28 tweet:
HELP: Support #lungcancer charities that fund research or assist LC patients. http://lungcan.org/our-members/ #LCSM #LCAM2013

November 29 tweet:
HELP: Support an LC advocacy org or ask your government reps to fully fund #lungcancer research. http://lungcan.org/advocacy/ #LCSM #LCAM2013

November 30 tweet:
HELP: Join an #LCSM chat on Twitter to discuss #lungcancer topics. https://lcsmchat.wordpress.com/lcsm-chat/ #LCAM2013

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