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Zoledronate or Denosumab for Lung Cancer with Bone Metastases

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GCVL_LU-CB04_Zoledronate_Denosumab_LC_Bone_Metastases

 

Dr. Benjamin Levy, Mount Sinai Health Systems, compares zoledronic acid and denosumab, two agents used for treatment of bone metastases in lung cancer.

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One of the important points about patients with advanced lung cancer is that 30-40% of patients will develop bone metastases. I think it’s important to recognize this is not bone cancer, this is lung cancer that’s moved to the bone, and in 30-40% of patients at some point who have advanced stage lung cancer, they will develop bone metastases. The question is: how do you manage these patients?

Now of course they’re going to be treated with chemotherapy or targeted therapies or immunotherapies to help control the cancer, but one of the other strategies that’s employed are bone strengthening agents. They come in really two forms, and the goals of giving a bone strengthening agent really are to delay skeletal-related events or fractures, and also strengthen the bones. I would say that they’re the standard of care for any patient with lung cancer who has bone metastases.

So currently there are two approved drugs for lung cancer patients with bone metastases. The first is called zoledronic acid, it’s given every three weeks and it’s a class of drugs called a bisphosphonate. These drugs are also used for osteoporosis. What we know about zoledronic acid or Zometa is that it does delay skeletal-related events or fractures in patients who get these drugs who have bone metastases in lung cancer.

The second class of drugs are called RANK-Ligand inhibitors, and the drug that’s approved for lung cancer is denosumab or Xgeva. This drug is a little different in its administration — it’s given subcutaneously rather than intravenously, and it’s also given every four weeks rather than every three weeks.

I think what we know about both of these drugs is that they do help strengthen the bones and delay skeletal-related events, but there’s a hint that denosumab, that second drug I mentioned, may also have some sort of anti-tumor effect. I’m not sure that this is completely ironed out in the literature, but we do know at least in one study published in 2012 that patients who actually got denosumab as a bone strengthening agent actually lived longer than those patients who got zoledronic acid. Now whether we can make or glean any major messages from this, I’m not sure. Nevertheless, my practice has been that any patient with lung cancer who develops bone metastases needs to be put on one of these two drugs.

These drugs do have side effects — one of the side effects with zoledronic acid is osteonecrosis of the jaw. This has happened in a very, very small percentage of patients so I don’t think that’s enough of a concern for me not to use the drug. Both of these drugs are extremely well tolerated and actually do help with the end points that I mentioned in terms of delaying fracture for those patients with bone metastases, but also potentially improving outcomes specifically with denosumab.


GRACE Video

Video-Assisted Thorascopic Surgery vs. Open Thoracotomy

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GCVL_LU-D07_Video-Assisted_Thorascopic_Surgery_Open_Thoracotomy

 

Dr. David Harpole, Duke University Medical Center, compares traditional open thoracotomy with video-assisted thorascopic surgery, highlighting the advantages of the newer approach.

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Historically, lung cancer has been treated with a large incision between the ribs, and in the early-mid ‘90s we began to investigate uses of the laparoscope, which was used to do gallbladders and so forth, in the chest. So we began using the devices to do more limited resections with this and ultimately we were able to have instrumentation which has allowed us to do more anatomic resections, in other words a lobectomy and segments and so forth, with the video instruments — so-called video thoracoscopy.

Probably at this point two-thirds to three-quarters of my patients undergo a video-assisted approach and in the most recent Society of Thoracic Surgeons Database, which enters all of the information on lung cancer surgery for 500 centers in the U.S., it’s around two-thirds of all of the resections are done this way now. We’ve watched that evolve from centers such as my own where we were islands that did this 12 to 15 years ago, now to the majority of centers have surgeons that are facile with the scope.

The advantage to the patients is obvious. If you don’t have an incision on your side, you have two or three small holes of about three-quarters to half an inch, your recovery time is faster, less drainage from the tubes, home faster. I have people playing golf and tennis in two weeks, certainly everyone is driving in two weeks. What we found in a lot of the investigations we’ve done, not only that, if a patient has a larger tumor that requires adjuvant chemotherapy which is chemotherapy after surgery, sometimes there is a delay in the recovery of the patient because of the large incision, so that it delays their chemotherapy, and we’ve found with the video-assisted approach there is no delay and so patients are able to get their therapies on time and are able to tolerate them better because they haven’t had such a large insult.

Now not all cancers are able to be resected with a video-assisted approach, but I will say that in 2015 the vast majority are. We can do pneumonectomies or take out the whole lung with a scope, we can do surgery after chemotherapy and radiation — I just did one of those last week with a large tumor but we were able to do it with a scope. You can take out two lobes with a scope and you can do chest wall resections with a scope, so that’s much less invasive.

So we’ve really reserved now, the large incisions for really large operations that require you frankly from a safety standpoint to have your hands in there. Our instrumentation is so good with the video-assisted technique that we’re able to do it on lots of people.

The next question people ask is, “what’s the difference between using the video thoracoscopy and the robot?” The robot has come along over the last five to six years as another potential instrumentation in a minimally invasive fashion you can use for patients. The robot does require several small holes but they’re all holes about 1/4 centimeter each and the robot allows the surgeon at the console to really see things well. The video system that I use magnifies things about 3 times, and I’m at the table with my hands using instruments through small holes. With the robot it magnifies things 6 to 10 times and you have a virtual reality headset that you wear that really shows you things in 3 dimensions. What’s nice about the robot hand, whereas my sticks, I can only do this, the robot has a little wrist on it so it’ll move in all directions inside the chest and some surgeons like that for its mobility.

In my center we have two surgeons that use the robot, there are three of us that use the video-assisted technique. We have the same results and I think the two methods are equivalent and I think that they are allowing us to do more things in smaller areas in patients, because frankly our goal is to remove a cancer and not hurt the patient. “First do no harm” is what we’re all taught and these minimally invasive techniques have allowed us to do that. The other nice thing about it is that we have videos that the patients can watch and see the surgeries, see the incisions and see what’s going to happen to them, and I think they’re more informed when they make the decision of whether or not they would like to have a video-assisted approach for their operation.


GRACE Video

The Surgical Decision: Assessing and Discussing the Patient’s Options

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GCVL_LU-D02a_Surgical_Decision_Assessing_Discussing_Patient_Options

 

Dr. David Harpole, Duke University Medical Center, describes how he assists patients with the surgical decision-making process.

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As a thoracic surgeon, we are the physicians that a lot of patients come to with lung cancer. Unfortunately, the outcomes for lung cancer have not been great, and I would say that there are some physicians that are surgeons where the patients come to them and are wary and don’t want surgery. It’s pretty much the opposite in lung cancer, most patients know that if we’re able to take the tumor out, that’s their best chance for survival.

So the first thing I do when patients come to us is reassure them that we need to adequately assess their strength and so forth for surgery, detail the extent of their disease which often involves not just surgeons but a medical oncologist, a radiation oncologist and an interventional pulmonologist in our practice. We discuss the fact that lung cancer is not treated with any one hammer — I usually say I use two or three different hammers depending on which modality we’re going to take on. Then at the location of their mass, we’ll take pictures from their CT scan and show it to them and discuss what are the surgical options, whether it’s something small that we can do with video-assisted techniques, or is it something that’s going to require quite a bit larger operation, then we discuss those with them.

I have a rule in my practice that I never let a patient decide on their care the very first visit that we have. We always want them and their family to spend time thinking about it, read the materials, then they come back and we decide on the best course of treatment. It’s an awful lot that comes at you when you’ve had the diagnosis of lung cancer and I feel like a judicious, slow approach is the thing that most patients appreciate from their physicians.


GRACE Video

The Basics of a Lung Cancer Workup

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GCVL_LU-B00_Lung_Cancer_Workup_Basics

 

Dr. Gerard Silvestri, Medical University of South Carolina, describes the steps necessary to work up a lung cancer diagnosis, from initial scan to choice of treatment.

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What are the basics of working up a lung cancer? When I see a patient in my clinic, usually they haven’t had anything done yet. They’ve been referred to me with a “spot” or lesion, or a mass on their lungs, and again, the first thing I need to do is take a good history and physical. How long have you had your symptoms, have you had weight loss, do you have bone pain, have you had headaches, what are some of the things going on — what diagnostic workup have you had? Sometimes they’ll already have had a biopsy. My job though is to do these three steps, absolutely simultaneously and sometimes in order — what is it, where is it, what I can do about it — diagnosis, stage and treatment.

The first visit is almost always trying to review the imaging and decide whether you need more imaging, do a good physical exam, do a good smoking history, find out what other health issues the person may have like heart disease, that can give us a challenge in terms of how we’re going to treat the cancer. So that’s the first part.

Sometimes I have to say that some patients are — it’s thought they may have a lung cancer, and in fact it’s something else. It could be a fungal infection or something else going on in the lungs. So usually what happens over sort of the course of the next ten working days is, either some more imaging, or a biopsy, and then perhaps a PET scan to help us with the staging portion of this. So sometimes we get a PET scan that will help us both direct the biopsy, but also help us with the stage. Over the next ten days or so we’ll try to get those tests done.

In addition, we always present our new cases at a multidisciplinary tumor board. What’s that? A multidisciplinary tumor board is where all the different specialties get together to look over the imaging, the biopsy results, the pathologic results, and come up with a better treatment plan. So who’s in the room during the tumor board? A pulmonologist usually, a chest surgeon or a thoracic surgeon, a medical oncologist, a radiation therapist, a pathologist, sometimes you’ll have a dedicated chest radiologist who will help review the films, and then also people from other ancillary services that are extremely helpful like clinical trials staff, like palliative care nursing. So we have all those people in the room at the same time, and they’re either reviewing brand new cases, or difficult and challenging cases that are coming back to the tumor board for consideration.

So that kind of happens in that first ten days and for us, we know how anxious patients can get during that time period that they just want to get something started, but I would urge anyone listening to this to consider is, if you don’t get it right, if you don’t give the person the correct stage and the correct treatment options, you won’t get the best care. Yes, speed is important, but you’ve got to get it right — what is it, the diagnosis, where is it, the appropriate stage, and then what are your treatment options, which really differ depending on stage. For stage I it’s usually surgery, for stage II, surgery followed by chemotherapy, for stage III, chemotherapy and radiation, and for stage IV, chemotherapy alone or some of the targeted agents. So if you don’t get that right, you’re going to get the wrong treatment, so be patient with that and if your doctors need to biopsy in a different area, as long as they’re explaining it appropriately to you, you should try to stay with that program.

So that’s the general workup of a patient. I will say, every patient gives a little bit of a nuance and so sometimes a patient seemingly needs something that’s a bit unusual in terms of a biopsy or the location of a biopsy or how to best go about getting that biopsy, and I can also say that sometimes the tumor board is split. Sometimes there’s no right answer about whether we should do it via a needle biopsy through the chest wall, or a bronchoscopy, and sometimes talking that through with a patient, they can help us – you can help us as patients make a decision about which way we would go next. That’s the general workup of a lung cancer.


GRACE Video

Immunotherapy for First Line Therapy of Advanced NSCLC

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GCVL_LU-FE09_Immunotherapy_First_Line_Therapy_Advanced_NSCLC

 

Dr. Eddie Garon considers the data on immunotherapies for first line treatment of advanced NSCLC and whether we are likely to use these agents instead of or in combination with standard chemotherapy soon.

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So, initially, development of the PD-1 and PD-L1 inhibitors were in patients who were previously treated, as that is a very difficult clinical scenario. Now, we do know, in the front line setting, that there is data that would indicate that many patients do quite well with chemotherapy, certainly not all, and the toxicities are certainly there, but chemotherapy can be quite effective in patients with non-small cell lung cancer. So, the question when you have a drug that is as effective, or a class of drugs that are as effective, as the PD-1 and PD-L1 inhibitors in previously treated non-small cell lung cancer, is: can those results be moved forward — can patients receive this as their initial therapy, rather than traditional chemotherapy approaches?

This is a place where, in my estimation, evaluation of the biomarker is going to be particularly important. So, there is data that would indicate patients who have higher degrees of staining for PD-L1 are more likely to respond to these immune checkpoint inhibitors. Of course, there is other biomarker work that is underway as well, some of which has been published, and some of which continues to go on, that may also be very helpful in identifying the appropriate set of patients. But, when one is looking at front line checkpoint inhibitors, one has to realize that, if you can identify a group of patients that are unlikely to have a response to a checkpoint inhibitor, that group of patients, probably, would be better off receiving standard chemotherapy in the front line setting, which we know can be quite effective, and, therefore, most of the studies that are looking at front line therapy are selecting patients who have, for instance, high level expression of PD-L1, and that has been, certainly, a major focus — people have taken different approaches. There are some studies that are specifically identifying patients, and only randomizing patients who have a high degree of staining to chemotherapy or a checkpoint inhibitor in the front line setting. Others are enrolling patients more broadly, but limiting their analysis to the patients who have a high degree of staining.

What I will say is, as somebody who has, for instance, studies in the front line setting that would give everyone a checkpoint inhibitor, as well as studies in the front line settings that would give only selected patients a checkpoint inhibitor, I have been very reluctant, at this point, with the data we have available, to enroll patients on a front line checkpoint inhibitor without knowing their PD-L1 status, because my concern is that, although you can say, well, those patients could always get chemotherapy later, we know that some patients with non-small cell lung cancer don’t get to their second treatment, and, in fact, that is not an uncommon scenario. We know, as well, that it does take some time for these checkpoint inhibitors to be effective in many of the patients in whom they are effective.

So, I have some concerns — for instance, if a patient has low level staining, although we don’t have all of the data yet, my suspicion is that, for instance, a patient with absent PD-L1 staining would probably be better off getting standard chemotherapy in the front line setting, and I think that it’s an important thing for patients to know, and of course the clinical data will sort of lead us there, but it is not clear that this is the absolute best therapy for everyone at every time. I think that there is a group of patients for whom that is likely to be the case — the group of patients in the KeyNote 001 study, which was looking at Keytruda, where they had not previously been treated — the survival in that group was so impressive, in fact, that we couldn’t even report on the bottom limit of the 95% confidence interval for survival, because patients just were staying on, they weren’t dying, of the people who had high level staining. That being said, the people who had absent staining — they didn’t do as well, and that’s a group of people, where my suspicion is, would do better with chemotherapy. We will see when the clinical data comes out.


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