2018 ASCO Annual Meeting Research Round Up: Side Effects, Head and Neck Cancer, Breast Cancer, and Melanoma

August 2, 2018
Download MP3 (18.79 MB/24:22)

The ASCO Annual Meeting brings together physicians, researchers, patient advocates, and other health care professionals to discuss the latest in cancer care. The research presented at this meeting frequently leads to treatment advances and new ways to improve the quality of life for people with cancer. In today’s podcast, Cancer.Net Associate Editors share their thoughts on the most exciting and practice-changing news to come out of the 2018 ASCO Annual Meeting.



ASCO: You’re listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology, known as ASCO, the world’s leading professional organization for doctors who care for people with cancer.

The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Cancer research discussed in this podcast is ongoing, so the data described here may change as research progresses.

The ASCO Annual Meeting brings together physicians, researchers, patient advocates, and other health care professionals to discuss the latest in cancer care. The research presented at this meeting frequently leads to treatment advances and new ways to improve the quality of life for people with cancer. In today’s podcast, Cancer.Net Associate Editors share their thoughts on the most exciting and practice-changing news to come out of the 2018 ASCO Annual Meeting.

First, Dr. Charles Loprinzi will discuss several studies that looked at ways to prevent or manage side effects of cancer treatment. Dr. Loprinzi is a medical oncologist and the Regis Professor of Breast Cancer Research at the Mayo Clinic. He is also the Cancer.Net Associate Editor for Psychosocial Oncology.

Dr. Loprinzi: Hello, I'm Dr. Charles Loprinzi, a medical oncologist at Mayo Clinic in Rochester, Minnesota. At this time, I'm going to highlight areas that were addressed at the 2018 ASCO meeting regarding means to help patients prevent and/or treat symptoms caused by cancer and/or cancer therapy, the first 1 being looking at chemotherapy-induced nausea and vomiting, a big problem for many patients.

Olanzapine is a drug that is relatively new to the nausea and vomiting world but has been around for a long time as an antipsychotic medication. Recent reports have suggested—demonstrated that it actually increases the chance that a patient will not have nausea or vomiting associated with chemotherapy. So it's a nice, cheap medication. It's relatively well-tolerated. At ASCO, there was further data supported that this was beneficial for something to keep in mind if patients are having nausea and vomiting related to chemotherapy.

The next 2 items actually we'll talk about chemotherapy-induced peripheral neuropathy. Numbness, tingling, pain, fingers, toes, hands, feet sort of problem associated with many different types of chemotherapy. It can be a major problem for many of these patients that are getting some types of chemotherapy, especially Taxane and Platinum-type chemotherapies. There are data that giving cold therapy might improve this process. If you cool the hands and the feet, kind of like when you put cold caps on the scalp to decrease hair loss, that cooling the hands and the feet may decrease the amount of neuropathy that patients get when they get Paclitaxel chemotherapy.

They were data from the ASCO Meeting that further supported that when you cool them and put some pressure on the hands and feet, therefore, less blood supply when there's a lot of chemotherapy in the system. So more data should become apparent in the future. This is not guaranteed to be helpful. Some caution is in order because there had been rare reports of patients who have gotten some frostbite if the hands get too cold or their feet get too cold during this process.

Another way of trying to influence chemotherapy-induced peripheral neuropathy to try to prevent it is with exercise. At previous meetings, there was a report suggesting that exercise during the months the patients are getting chemotherapy can decrease chemotherapy-associated peripheral neuropathy. At this year's meeting, there was actually information that people who are exercising prior to chemotherapy—people who exercised more compared to patients who weren't exercising—that those who had exercised more had decreased amounts of chemotherapy-induced peripheral neuropathy afterwards. So decreased pain, numbness and tingling problems. My scientific mind tells me that we haven't proven that exercise is beneficial for preventing this problem, but I think it's certainly suggested that's true and I recommend it because it's got a low risk and it's good for people anyway.

The last one deals with aromatase inhibitor-associated joint aches and pains. Aromatase inhibitor are medications that are given to patients with breast cancer. They decrease the amount of estrogen in postmenopausal women. They can cause joint aches in up to 50% of patients, 15% of whom have them quite significantly. There are new data that demonstrate that omega-3 fatty acids, which are available clinically without a prescription, can be helpful with patients with aromatase inhibitor arthritis if they happen to be obese. In patients who were not obese, it didn't seem to be helpful. Therefore, omega-3 fatty acids, while they're not proven to be beneficial, they seem to be quite safe and are something that could be used in patients who are obese and have this problem.

In summary, Olanzapine can help decrease nausea and vomiting associated with chemotherapy. Cold therapy might be able to decrease paclitaxel neuropathy. Exercise may decrease chemotherapy-associated neuropathy. And omega-3 fatty acids may decrease aromatase inhibitor-associated joint aches and pains in obese patients. Thank you very much.

ASCO: Thank you Dr. Loprinzi.

Next, Dr. Ezra Cohen will discuss several studies that looked at different combinations of therapy to treat head and neck cancer, and 1 study on a new drug that could reduce mucositis, a common side effect of some head and neck cancer treatment. Dr. Cohen is Associate Director of Translational Science and leads the Solid Tumor Therapeutics research program at Moores Cancer Center at UC San Diego Health. He is the Cancer.Net Associate Editor for Head and Neck Cancer.

Dr. Cohen: Hello. My name is Dr. Ezra Cohen from the University of California at San Diego Moores Cancer Center. And I'm going to talk to you today about some of the interesting presentations at the recent Annual Meeting of the American Society of Clinical Oncology. And I'm going to focus on head and neck cancer, and in that, I'll talk to you about 4 separate presentations, 2 of them related to immunotherapy, 1 of them related to the side effects of treatment and diminishing those side effects, and then the last 1 related to a novel combination of therapy that looks to be quite effective in patients with recurrent or metastatic disease. So let's get started.

The first 2 abstracts to discuss were both focused on the idea of adding things to standard immunotherapy to make it more effective. The first one added a drug called lenvatinib. Lenvatinib is a pill that is now approved for different types of cancers, but not head and neck cancer. Interestingly, when added to pembrolizumab, an immunotherapy that's approved in head and neck cancer, what it appeared to do was improve the response rate dramatically. That is, the rate by which tumors shrink in a significant manner. This went from about 15%, which is what we would expect from pembrolizumab alone, to a little over 40% when pembrolizumab was combined with this drug, lenvatinib. Of course, this was a small study and uncontrolled, and needs to be confirmed, but the early results appear to be quite promising.

By the same token, another separate study combined the same drug, pembrolizumab, with another approved drug in head and neck cancer called cetuximab, or Erbitux as the trade name. Here again, what we saw was an apparent augmentation of the response rate to the combination compared with either single drug. For cetuximab, we'd expect a response rate of about 10%. For prembrolizumab, we'd expect a response rate of about 15%. But when the 2 were combined, we saw response rates of about 30%, maybe a little bit higher than that, suggesting that, indeed, the combination appears to work better than either single drug alone. Again, this was an uncontrolled trial and will be confirmed as we go forward into other settings and other studies with this combination.

Perhaps the most impactful abstract that was presented at this year's meeting for patients was for a drug called GC4419. This was a randomized trial looking at the most common side effect of chemotherapy and radiation in the treatment of patients with locally advanced head and neck cancer. What we know is that when we treat patients with locally advanced disease, that is a tumor and involved lymph nodes, we're trying to cure these patients with fairly intensive chemotherapy and radiation.

During that treatment, the great majority of patients, in fact, almost all patients develop what we call mucositis, experienced as pain in the mouth and throat and often ulcerations or sores in the mouth and throat. In fact, the mucositis can be so severe that patients have to stop eating and need a feeding tube to maintain their nutrition. What this study attempted to do was add this drug during radiation and reduce the rates of mucositis significantly. This was a controlled trial, so half the patients received the drug and the other half did not receive the drug, they received placebo. And all patients got the exact same chemotherapy and radiation regimen.

Well, what we saw was quite remarkable in that not only was the rate of mucositis reduced, but also the duration—and in fact, duration was the primary endpoint of the study—going down from 19 days of severe mucositis to only 9 days. And moreover, even the number of patients who developed severe mucositis decreased dramatically, suggesting that this drug, GC4419, could have a dramatic impact on the most important side effect that patients experience during curative intent therapy. A phase III study is currently being started, and we hope that the phase III trial will show similar results to the phase II study, and that this drug will eventually get approved in patients with head and neck cancer.

Lastly, we saw a novel combination of drugs being used in patients with recurrent and metastatic disease. The first drug was called cetuximab. Again, this is an already-approved agent in head and neck cancer, but it was combined with a drug called palbociclib, which is approved currently in breast cancer but not in head and neck cancer. And what we saw from the abstract was a startling high response rate for this combination in patients who'd already received chemotherapy for their disease and had progressive disease on chemotherapy. The response rate was 39% which, again, would be much higher than expected from cetuximab alone. And this combination is currently being pursued in randomized studies for patients with recurrent or metastatic head and neck cancer. Moreover, the combination appeared to be very well tolerated, with the side effects that we'd expect from either drug alone but no increase in side effects when the combination was tried.

Therefore, in summary, what we saw at this year's ASCO were some early data of different combinations, some of them using chemotherapy, some of them using targeted agents. All of them need to be confirmed in larger trials, but hopefully, the start of new treatment options for patients with head and neck cancer that are going to be quite effective.

And we also saw a remarkable result for the reduction of oral mucositis, a very important side effect that we encounter and patients encounter when being treated for locally advanced head and neck cancer, and the possibility that this could be reduced dramatically with an agent called GC4419. Thanks for tuning in, and that's the summary of head and neck cancer at this year's American Society of Clinical Oncology.

ASCO: Thank you Dr. Cohen.

Next, Dr. Lynn Henry will discuss a study that looked at whether some women with breast cancer would be able to safely avoid chemotherapy and its side effects. Dr. Henry is an Associate Professor and Interim Division Chief of Oncology in the Department of Medicine at the University of Utah and Director of Breast Medical Oncology at the Huntsman Cancer Institute. She is also the Cancer.Net Associate Editor for Breast Bancer.

Dr. Henry: Hello, I'm Dr. Lynn Henry from the Huntsman Cancer Institute in Salt Lake City. I would like to share with you one of the exciting breast cancer advances from the 2018 ASCO Annual Meeting. First, just a reminder that breast cancer is divided into 3 main categories determined by the presence or absence of receptors on the cancer cell. These categories include hormone receptor-positive, HER2-positive, and the so-called triple-negative, when those 3 main receptors are all negative.

The study I'm highlighting called TAILORx focused specifically on women with hormone receptor-positive, HER2-negative breast cancer whose lymph nodes were not involved. The TAILORx trial is important because it asked the question, "Do women whose tumors are intermediate risk get benefit from chemotherapy or can they safely avoid chemotherapy and all of its associated short and long-term toxicities?" In this study, tumors were analyzed using a test called Oncotype DX, which assigns a Recurrence Score that corresponds to the prognosis of that cancer or the likelihood of the cancer recurring. We already know from an earlier report that people whose tumors have scores of 10 or less are at very low risk of having their cancer recur, assuming they take anti-hormone therapy for at least 5 years. The TAILORx study looked at patients whose tumors have intermediate risk, with scores from 11 to 25.

Overall, it appears that there is no additional benefit to giving chemotherapy in addition to anti-hormone therapy compared to anti-hormone therapy alone for women with this type of breast cancer. However, when the researchers looked at the data more closely, it appeared that for those women who were under age 50, they might obtain a benefit from chemotherapy if the Recurrence Scores are over 21 and possibly, also, if they have scores between 16 and 20.

So how do these findings actually change treatment recommendations? Before these data were available, oncologists were already not recommending chemotherapy for patients with scores of 17 or below. Now, based on these new findings, for post-menopausal women, we are also able to not recommend chemotherapy for patients with scores from 18 to 25. In addition, although it may not be as straightforward for pre-menopausal women, we now at least have data we can use to have a discussion about the pros and cons of chemotherapy.

It is important to remember that these findings are specifically related to patients without lymph node involvement. There is another trial called RxPONDER that is ongoing to address a similar question in those patients with 1 to 3 involved lymph nodes.

In terms of the bottom line, we now have results from this important trial that enable us to avoid overtreating many women who previously would have been recommended chemotherapy. Instead, they can now be reassured that avoiding chemotherapy will not increase their chances of cancer recurrence. However, it is important to remember that all patients on this trial were recommended anti-hormone therapy for at least 5 years. This is a key, very effective component of the treatment plan. If a patient is having difficulty tolerating the anti-hormone therapy medicine, she should talk with her oncology team to see if any changes can be made to improve her quality of life and allow her to keep taking that medicine.

Well, that's it for the quick summary of this important trial from ASCO 2018. Overall, we continue on a fast track in breast cancer with many new and exciting therapies being actively studied. Stay tuned to Cancer.Net for future updates from upcoming breast cancer conferences.

ASCO: Thank you Dr. Henry.

Finally, Dr. Ryan Sullivan will discuss a study that looked at whether it was safe to stop immunotherapy for melanoma after 2 years. Dr. Sullivan is an Attending Physician in the Division of Hematology/Oncology at Massachusetts General Hospital, and the Cancer.Net Associate Editor for melanoma and skin cancer.

Dr. Sullivan: My name is Ryan Sullivan. I'm a medical oncologist at the Massachusetts General Hospital Cancer Center. And I'm the Associate Director of the Melanoma program there. Today, I'm going to talk about some updates that were recently presented at the ASCO Annual Meeting. I think it's important to start by saying this was a meeting that did not have any new major breakthroughs, as we have seen in many recent Annual Meetings in, specifically, regards to new therapies or new contexts for older therapies for patients with melanoma.

However, there was some important information that was presented that helps more the day-to-day management of patients than specifically changing how we potentially treat patients. And hopefully, at future meetings, there will be additional new therapies or trials that are clearly demonstrating superiority of one specific type of therapy over another.

However, I think there are probably 2 to 3 really important pieces of information that came out, that help us to place the current therapies and our strategies in treating patients with metastatic melanoma and even high-risk melanoma with either BFRAF targeted therapies or immune checkpoint inhibitor therapies such as the anti-PD1 antibodies called pembrolizumab and nivolumab.

So the first piece of information, I think, was really important, if not specifically ground-breaking, was a presentation—Dr. Georgina Long from the Melanoma Institute Australia presented findings of the 4-year follow-up of an important clinical trial called KEYNOTE-006, which compared patients receiving ipilimumab versus pembrolizumab. And specifically, the presentation was the 4-year follow-up of the patients who received pembrolizumab. And the data was quite interesting and important in a couple of ways.

First, it was really great to see long-term follow-up with a substantial percentage of patients still remaining progression-free many years after starting therapy. And secondly, it was really important to know that when patients stop therapy, and in this trial, patients were randomized to receive ipilimumab or pembrolizumab. Ipilimumab, at the time, was the standard of care, first line treatment for patients with melanoma. And that served as the control arm for the study, and the pembrolizumab was, at the time, the new kid on the block, comparing how effective this therapy was for that patient population. Patients who were randomized to receive pembrolizumab received up to 2 years of therapy, and following the completion of 2 years of therapy, were allowed to stop therapy. And in fact, that was a planned amount of time: 2 years of treatment. Obviously, if patients' disease progressed, they were taken off study. If patients could not tolerate the treatment, they were taken off active therapy and followed to see how they did in terms of tumor progression or tumor response. But the patients who completed 2 years of therapy were patients who either had limited growth of their disease or regression of their disease or complete or partial, and then completed the 2 years of therapy.

So there were 3 categories of patients: the patients who had stable disease, patients who had partial responses, and patients with complete responses. And complete response is 100% of the tumor went away. Partial response is significant percentage of the tumor regressed. And stable disease is could've been a little bit of growth or a little bit of tumor shrinkage. What was important was that at the time of follow-up in this study, patients who received 2 years of therapy and came off of therapy by and large remained in response over the course of the observation.

Specifically, I think the numbers were 20% of patients completed the 2 years. And of those, 85% had not progressed at the time of this presentation. And more importantly, patients who had responses, it was closer to 90% of patients who didn't progress. So to summarize, there's now really robust and maturing follow-up from this study that supports the discontinuation of anti-PD1 antibody therapy, in this case, pembrolizumab, after a set period of time.

Now what are the implications of this? Well, we are asked all the time by our patients who are having great responses to treatment, "How long do I need to remain on therapy?" And ultimately, the goal of us as oncologists and I think the desire from patients with cancer is to receive a course of therapy and ideally tolerate it. And if the patient has a remarkable benefit from the therapy, then the therapy could be discontinued and the patient can remain off of therapy, living their life and not being tied to the oncology office for regular treatment. And this is really the most robust data to date that supports the discontinuation of pembrolizumab. And since pembrolizumab is very much like nivolumab, which is the other anti-PD1 antibody, I think it supports that, for a finite period of time, patients can receive treatment and if they're having a great response to treatment after two years, there's data to support discontinuation of therapy at that point.

Every year, I'm excited to see updates on this trial and other trials to really solidify and fortify my decision to discontinue patients after they've had a great response to therapy and are tolerating. But the question always is, "How much treatment do they really need?" And I think, at this point, we can say, "2 years is probably an appropriate time to stop." And it would be important to note that there may be opportunities to stop earlier if patients have complete regression, and there's some data, not presented at this conference but at other conferences in the past, to support that.

In any event, the other question we receive very often with regard to this concept of discontinuing therapy is, "Okay. What if I stop therapy and the disease comes back? Then what do I do?" And this trial that Dr. Long presented addressed that, as well. There were only 8 patients who had progression of disease after stopping therapy who were retreated with pembrolizumab. In that setting, 2 patients had complete responses, 5 patients had stabilization of their disease, and 1 patient had primary progression of the disease. And so, the majority of patients who were retreated had clinical benefit, which again, makes us feel better about discontinuing therapy, knowing that if we do stop therapy at a certain time point, in this case 2 years, that reintroduction of that therapy is likely to be helpful again.

Well, I think in the interest of time, I will conclude there. But say that, again, this was not an Annual Meeting at ASCO in the Melanoma Program that was associated with dramatic new therapy data that will change the standard of care. But like this example of the KEYNOTE-006 long-term follow-up presentation, there was significant amount of data that was presented that helps oncologists specialize in caring for patients with melanoma, better inform our patients about treatment decisions regarding therapy, and helping make decisions in the interest of our patients with more robust and informed information. With that, I'd like to thank you for your attention.

ASCO: Thank you Dr. Sullivan.

To learn more about all of the science presented at the 2018 ASCO Annual Meeting, visit www.cancer.net/ascoannualmeeting. If you have questions about whether new research may affect your care, be sure to talk with your doctor. And if this podcast was useful, please take a minute to subscribe, rate, and review the show on Apple Podcasts or Google Play.

Cancer.Net is supported by ASCO’s Conquer Cancer Foundation, which funds breakthrough research for every type of cancer, helping patients everywhere. To help fund Cancer.Net and programs like it, donate at conquer.org/support.