GRACE :: Lung Cancer


Supportive care

Denise Brock

Not Your Father’s Squamous Lung Cancer – Supportive Care for Patients

 Presented by the
Global Resource for Advancing Cancer Education
in collaboration with 
UNC Lineberger and the Lung Cancer Initiative of North Carolina

On Friday, November 4th, 2016, in collaboration with the UNC Lineberger and the Lung Cancer Initiative of North Carolina, GRACE presented ‘Not Your Father’s Squamous Lung Cancer’, webcast live in Chapel Hill, North Carolina.  Our fourth and final presentation discusses supportive care for patients, including pain management, drug side effects, anorexia and shortness of breath, with Amber Procter, PharmD, and Jason Akulian, MD, MPH.    

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Dr West

Selective Androgen Receptor Modulator GTx-024: A New Effective Treatment for Cancer Cachexia?


Anorexia-cachexia syndrome (ACS), a negative spiral of diminished appetite and weight loss (lean body mass), is a common problem in many kinds of cancer, where it not only leads to patient weakness and diminished function but is also associated with shorter survival.  While it’s possible that the ACS is a late effect that might be an irreversible product of progression of an underlying cancer, it may also be that ACS directly contributes to a patient’s decline by making them unable to tolerate further cancer therapy.

GTx-024, also now known as Ostarine™ or enobosarm, is a selective androgen receptor modulator (SARM), which activates the androgen (male hormone) receptor and leads to the activation of a wide range of genes in the cell, the net result of which being increased muscle mass, increased bone mass, and often an increase in mood, energy level, sense of well being, and libido.  Not surprisingly, these are the exact opposite effects we routinely see in men placed on androgen suppression as a common (and effective) treatment for prostate cancer.  Risks include increased hair growth/virilization in women, prostate stimulation and hyperplasia (excess growth) in men, elevated red blood cell counts (potentially to levels above normal), decrease in HDL cholesterol (the “good cholesterol” associated with exercise and decreased risk of cardiac events), and potentially abnormalities in liver function tests.

The phase I and II studies in patients with cancer-associated weight loss thus far have pretty consistently shown that treatment with daily oral GTx-024 leads to a modest (typically 1-2 kg) increase in lean body mass after 16 weeks, while recipients of placebo had no change or a trend toward slight further weight loss.  The GTx-024 studies also assessed physical function with a stair climb function, assessing both the time required to ascend stairs and “power”.  The pattern is the same as with body mass: there is a modest but statistically significant improvement in stair climb function in recipients of GTx-024, but little or no change in recipients of placebo.  Here are some figures that represent the results in the subset of patients with NSCLC, for instance:

In addition, improvement in function on the stair climb exercise was also associated with an improvement in quality of life on an “anorexia-cachexia scale” (so the questions were specifically related to eating and weight issues, not more global qualify of life).  More importantly, one subset analysis of this work also suggested that a worse survival associated with weight loss could be abrogated with the addition of GTx-024.

  Continue reading

Dr West

The Troubling Symptom of Bronchorrhea in BAC


Warning: this symptom can be a little gross, so the delicate flowers out there should skip this post.

One of the more unusual but quite vexxing symptoms we sometimes see in lung cancer is called bronchorrhea, which is the copious production of watery sputum, specifically at least 100 ml per day. The setting in which it’s most frequently seen is in bronchioloalveolar carcinoma (BAC), and we typically think of it as being a manifestation of the mucinous subtype. In its worst form, patients can drain vast amounts of phegm each day, typically worst in the morning. Patients have told me that they lean their head down off the bed to drain a half a liter or more at a time before starting their day. Though rare, there have been frequently cited cases that have been life-threatening because of severe electrolyte imbalances that develop from losing so much fluid and salt (case report here). Interestingly, there’s a sheep virus that appears clinically remarkably similar to BAC (though there hasn’t been a human form of the virus ever isolated, despite searching), and I’ve seen video footage of researchers demonstrating bronchorrhea by lifting the hind legs of the sheep into the air, putting a beaker under its nose, and letting the watery mucus drain out for several minutes. Sorry, I told you this post has some indelicate moments. I don’t think that video’s on YouTube yet.

Unfortunately, bronchorrhea is a very difficult symptom to treat effectively. Among the things that have been tried and were written up as possibly successful in individual cases have been steroids (abstract here), inhaled indomethicin (a non-steroidal anti-inflammatory drug)(abstract here and here), a drug called octreotide (reference here), radiation therapy to the most “consolidated” area of lung (reference here), and most recently EGFR tyrosine kinase inhibitors like iressa (full text here, another abstract here, and there are several other reports out there).

The ideal situation is to treat the underlying cancer effectively, rather than just the symptom. In that sense, the EGFR inhibitors are pretty unique in being the best treatment if a particular person’s BAC happens to respond. Based on the fairly large phase II studies that have been done with iressa and tarceva in BAC, the response rate with this class of drugs is in the 15-25% range (see prior post for review). So for the patients who respond to an EGFR agent, it’s a potentially dramatically helpful treatment for a long time. For the majority of patients who don’t respond to one of these agents, the others are things that can be tried, but most of what’s been reported is a single case of a treatment that worked, not a trend of multiple cases. In truth, it’s probably never going to possible to run a study and enroll 20 patients to get a particular treatment, because bronchorrhea is an uncommon symptom of an uncommon disease. But these are a few things that people may try, and I’d be very interested if there are people out there who have had success with any of these approaches. Another one I’d be inclined to try, although I’ve never seen mention of it being done before, is inhaled lasix, the effective diuretic, which is an approach I’ve heard of hospice folks using to treat secretions.

In the meantime, bronchorrhea is often unpleasant, sometimes scary, and potentially life-threatening complication that nobody sees enough to become an expert at managing.

Dr West

Information and a Resource for Managing EGFR-Based Rash


There’s a really helpful resource for patients, developed by several leading experts in EGFR-based therapy and specifically the very common skin toxicity associated with EGFR inhibitors like iressa, tarceva, erbitux, and some others. I’ve already described some early ideas about rash management (prior post) and a more recent medical education program video on the same subject (prior post here). This is a summary article (here) published in the free oncology journal The Oncologist, but I think that more important than the brief review article are the summary poster and brochure for patients. Rather than recapitulate the content myself, I’ll just reproduce them for you to view here (click on any of these images to enlarge).

Here’s the poster (also available as a pdf here):

Oncologist EGFR Rash poster

Continue reading

Dr West

An Example of Successful Patient-Reported Outcomes (PROs): Tarceva’s Effect on Lung Cancer Symptoms


One of the successful examples of incorporating patient-reported outcome (PRO) measures into an important clinical trial was in the NCI-Canada study BR.21 (abstract here). This study assigned patients to either tarceva or placebo in a 2:1 randomization to the active drug:

BR.21 Schema

(Click on image to enlarge)

This study showed a 9% response rate and an improvement in median overall survival of two months with tarceva, which led to it’s US FDA approval and subsequent widespread use. While the fact that there were responses (although only 8%) and a survival benefit is very important, and probably the most important factor to many patients and oncologists, it’s important to ask whether this comes at the cost of significant side effects. Do patients need to trade quality of life for improved survival? A separate report on the BR.21 trial described PROs on this trial (abstract here).

In BR.21, patients were required to complete questionnaires that asked about a wide range of symptoms commonly seen in lung cancer, as well as global quality of life (QoL) and ability to function normally. Several questions focused on measured of cough, pain, and shortness of breath. The questionnaire was completed before starting treatment, every four weeks during treatment, four weeks after the end of treatment, and (for patients who came off of the study for reasons other than progression, such as side effects) every 12 weeks after ending the study, until progression. Completion rates were about 93% at the start, dipping down to the 80% range as the trial continued. Such a decline in returned responses is typical for QoL patient response assessments.

The symptom-based portion of the study assessment focused on pain, shortness of breath (SOB, also known as dyspnea), and cough. Importantly, the key measure was the time before progression of these symptoms rather than whether there was improvement in these symptoms. Why time to symptomatic worsening rathe than improvement in symptoms? Because you can’t have improvement if you don’t have the symptom, but everyone is a candidate for worsening of symptoms.

The results clearly demonstrated that the survival improvement with tarceva was also accompanied by a relative improvement in cancer symptoms. Specifically, while patients tended to have eventual worsening of symptoms at some point (as indicated by the downward slope of the curves below), recipients of tarceva had an average of a 1-2 month delay in their development of worsening of cough (4.9 vs. 3.7 months), SOB (2.9 vs. 4.7 months), and pain (2.8 vs. 1.9 months).

BR.21 Symptoms change

These differences were all statistically significant, and I would argue also clinically significant, even if we wish the results were better still. Continue reading

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