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GRACE Video

The Role of Targeted Therapy Post-Resection

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GCVL_LU-D21_Targeted_Therapy_Post-Resection

 

Dr. Heather Wakelee, Stanford University Medical Center, evaluates the lack of evidence for the use of targeted therapies after surgery, and describes ongoing trials attempting to resolve that issue.

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Since the mid-2000s we’ve known that many patients who have non-small cell lung cancer, particularly the adenocarcinoma type, have particular gene mutations that we can identify and when we find them, treat with specific new drugs. We know this data from patients with metastatic lung cancer — the first to be discovered was EGFR or epidermal growth factor receptor, then ALK or anaplastic lymphoma kinase. Now there’s a very long list of gene mutations that we can identify when we look in patients with advanced stage lung cancer, and when we find them, offer specific targeted therapy that can have a very high likelihood of shrinking the tumor. This has really changed the way we think about and treat advanced stage lung cancer. However we haven’t figured out how to best use those treatments for patients who have earlier stages of lung cancer.

So in the setting of an early stage lung cancer that’s been removed with surgery, patients are theoretically cured at that point. Chemotherapy has been proven to lower the chance of the cancer coming back, but when you find one of these mutations in the tumor, the temptation is to give one of these targeted drugs. That strategy has been looked at in multiple clinical trials and we still don’t have a straightforward answer.

The largest trial to look at this so far was called the RADIANT trial and in that trial, after getting chemotherapy if that was the right thing for them, patients either received the EGFR drug called erlotinib, or a placebo. Now most of those patients in that trial actually did not have a specific mutation in EGFR because the study was designed before we knew about how important those mutations were. In the subset of patients who did have the EGFR mutation, those getting erlotinib seemed to have more time before the cancer came back, but if you looked at their overall survival, it wasn’t any different than the patients who had been on the placebo arm. The theory is that those who were on the placebo arm who had the cancer come back, when it came back they were then able to get erlotinib or a similar drug and have the same benefit. So it’s not clear that starting the erlotinib right at the time of surgery actually helps people live longer, though it might slow down the time to recurrence.

That’s obviously not a complete answer so there are more studies happening now trying to get a better sense of what we should do in that setting. There are a couple of trials in China, actually several trials in China, a study in Japan, and now a big study in the United States, all with the same general idea that a patient who has a tumor resected or removed by surgery, who is shown to have an EGFR mutation in that tumor, is randomized to either get an EGFR drug or to get placebo. Some of the studies have chemotherapy before or after, some compare it to chemotherapy, so there are some differences, but the general idea is whether or not giving the EGFR targeted drug will actually help people be cured or live longer versus waiting, and then for those who do have recurrence, giving it at that time. So those are really important trials that are ongoing and we’ll hope to know the answers in the next few years.

For the patients with the ALK translocation in the United States, the big trial called ALCHEMIST is open not just to EGFR but also to ALK patients. What that trial is about is asking that any patient who has a surgery at a site that’s participating in ALCHEMIST have part of their tissue from the tumor sent in to a central laboratory to be tested for EGFR or ALK. Those patients who have EGFR are then randomized to either get the EGFR drug erlotinib, or to get a placebo pill, and those who have ALK to get the ALK drug crizotinib versus a placebo pill. Over time people will be followed to see — does this change when the cancer comes back, and does it ultimately change overall survival for the patients where the cancer does come back?

So this is a really critical trial and it’s going to help us know what the best way is to use these targeted drugs for patients in this setting. Until we have those trial results back, I do not recommend that patients get the EGFR or ALK targeted drugs after surgery because we just don’t know if that’s going to help them live longer.


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

What Is the Significance of Mediastinal Node Sterilization After Neoadjuvant Therapy?

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GCVL_LU-D11_Significance_Mediastinal_Node_Sterilization_After_Neoadjuvant_Therapy

 

Dr. David Harpole, Duke University Medical Center, defines the concept of mediastinal node sterilization and its use after neoadjuvant therapy.

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When we have patients who have a mediastinoscopy that’s positive, in other words we’ve found mediastinal lymph nodes that are involved with cancer, the decision comes down to what’s the best approach. Usually, when patients have what we call locally advanced lung cancer, which is lung cancer that has significantly involved those lymph nodes, that’s reserved for a concurrent chemotherapy plus radiation approach, and surgery is usually not indicated. But we do have patients whose lymph nodes were slightly involved, either with microscopic deposits or only a couple of lymph node areas that were involved, and in those patients we will give them upfront chemotherapy or chemotherapy plus radiation therapy at a moderate dose, and then reassess them after they’ve had their therapy. If their tumor has responded to the therapy, in other words on the PET scan and CT it’s smaller and the lymph nodes are less active, then we may consider a resection in those people.

The very best scenario is for patients that we do that, but then we go in and operate, that they’ve actually had their tumor completely sterilized by the therapy. I tell my patients that we use the lung mass as a measure of their response to the chemotherapy in their body, and the reason is that people don’t die from lung cancer in their chest after we operate on them, they die of lung cancer that’s out in their body and if there’s microscopic cancer out in their body, I’m not helping them by taking the lung mass out. I usually say the horses are out of the barn, and it really doesn’t care what I do to the barn, the horses are gone. If the tumor in the chest has been sterilized, there’s a very good chance that denotes that all of the tumor in their body is sterilized.

So when we resect patients who’ve had upfront treatment, if their tumor is completely dead or almost all dead from the therapy, that denotes very good outcome for the patients and they’re the ones that we have that are long-term survivors, and we do have patients that are long-term survivors after they’ve had chemotherapy plus or minus radiation and surgery.


GRACE Video

What Is a Sleeve Resection?

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GCVL_LU-D04_Sleeve_Resection_Defined

 

Dr. David Harpole, Duke University Medical Center, describes the sleeve resection and how it can help selected patients with large tumors retain lung function.

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The next question that I’m often asked is: when a patient has a central tumor, a tumor that’s down the central airway to the lung at the base of the lung, historically that would require one to take the entire lung out or do a pneumonectomy. What we’ve realized is that when you do that, you may take that area with the mass out, but you’re also taking out a significant amount of normal lung and causing a good bit of morbidity to that patient. So we have found that if the tumor is only locally invasive to the central airway, you can cut that airway above and below where the mass is and sew the other parts of the lung back together and actually save the remainder of the lung and I probably do 20 or more of these a year, I’m one of the busier surgeons in the country that does sleeve resections, and they’re really, really useful.

Generally when the patient has a tumor that has grown out of one of their airways, that part of the lung is not functioning. If that’s all that we take out, then we actually leave them all of their functional lung, and the sleeve resections have been very helpful in patients who might otherwise be considered marginal for surgery. If you’re not taking anything out that’s functioning, you can actually take them though the operation very safely.

It does require them to participate in their care more than some of the other surgical procedures, and what I mean by that is that I tell all my patients after the sleeve, on the area where I’ve sewn the two pipes or the airways back together, secretions like to stick there, and so after surgery they have to get up, move around, cough, and deep breathe so that they can keep those areas open. Otherwise, their post-operative care is pretty much the same as any other patient, and their recuperation is very similar as well. I have found this to be quite useful in helping patients remove large tumors that are central then, but you can salvage a lot of the other airway.  I generally draw pictures to display this so they can see exactly what part of the lung we’re taking out and what part that we’re sewing back together.


GRACE Video

How Do Thoracic Surgeons Assess Fitness for Surgery?

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GCVL_LU-B04_Thoracic_Surgeons_Assess_Fitness_Surgery

 

Dr. David Harpole, Duke University Medical Center, details the methods thoracic surgeons use to assess a patient’s fitness for surgery.

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One of the questions that we’re often asked is, “how do thoracic surgeons assess patients’ fitness for surgery?” Interestingly, the old technique that surgeons had before we had pulmonary function studies and so forth was just to get them and walk them up two or three flights of stairs and I still do that occasionally. If a patient’s able to walk up two or three flights of stairs they’re usually fit for a thoracic operation.

However all of our patients now will undergo pulmonary function testing to measure their lung capacity — a test called the diffusion capacity, which tests how well the lung exchanges gases. In other words, when you inhale air how well does your lung take up the oxygen from the air sacs into the blood vessels, and then how well does it release the carbon dioxide from the blood vessels back to the air sacs so you can exhale it out. That test is often the one that’s most predictive of patient’s outcome. Then if a patient has a history of any cardiac disease I will often discuss that with their cardiologist and if necessary, obtain some sort of stress testing and it’s not unusual for us, many of our patients are smokers and many of them have concomitant heart and vascular disease. I would probably say 5% of the time, my patients will have a positive stress test and end up being evaluated by cardiology for interventions before surgery sometimes.

Then we look at the stage of the cancer and if it’s an early stage cancer, we may not obtain any other tests besides routine blood chemistries and so forth. If it’s a more central cancer then we might consider getting head scans and things. I reassure my patients and tell them the likelihood of the cancer having spread to the brain is very unlikely, but we still do it to be safe. Then once that’s been obtained, we’ve gotten a PET scan to assess whether or not the tumor has spread outside the chest. Then we can sit down and discuss what type of operation will be undertaken. For a simple resection or lobectomy that’s usually it; if it’s something that requires more then we may require other testings to measure the impact of the surgery on the patient. If one is taking the entire lung out, that’s certainly a larger operation than taking part of a lung out and so I’ll discuss that with a patient and the possible changes in their lifestyle that may occur with a pneumonectomy, which is the term for removing the whole lung, if that’s required, so that they can fully understand and be fully informed about what they may undergo in the near future.


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