Ongoing Trials Will Help Push Toward Evidence-Based Treatment in Head and Neck Cancer

Benjamin L. Judson, MD

Benjamin L. Judson, MD

As an increasing variety of treatments for patients with head and neck cancer become available, surgical oncologists are also exploring more minimally invasive approaches to lower associated adverse events and, overall, improve patient outcomes.

“If we could incorporate surgery, either endoscopic laser surgery or transoral robotic surgery, in order to minimize or reduce the treatments that might have side effects, that is going to be beneficial,” states Benjamin L. Judson, MD.

In an interview withTargeted Oncology, Judson, an associate professor of surgery at Yale School of Medicine, highlights the importance of a multidisciplinary team and shares insight on some of the advancements related to surgery for patients with head and neck cancer.

TARGETED ONCOLOGY:Can you please discuss the case study you were involved in?

Judson:

We presented a few cases of head and neck cancer. Our panel consisted of a surgeon, a radiation oncologist, and a medical oncologist. Just as we would when we take care of patients, we discussed the patients in a multidisciplinary fashion. We covered some of the issues by discussing them from different perspectives.

TARGETED ONCOLOGY:What are the benefits of having a multidisciplinary team?

Judson:

Head and neck cancer is one of those diseases where the treatments are multidisciplinary. For some patients, the most beneficial treatment might involve surgery, whereas for others it does not. Similarly, some patients are going to benefit from radiation or chemotherapy instead of surgery. Having each of those perspectives present while discussing a case is important in terms of coming up with a treatment that will be beneficial for an individual.

TARGETED ONCOLOGY:How do you determine if a patient should receive surgery over other forms of treatment?

Judson:

In many cases, the evidence makes it straightforward as to what the best treatment option is, whether it be surgery followed by radiation or whether it’s radiation therapy only. There are always specific factors for each patient that might make receiving 1 form of treatment more difficult or riskier than others.

Some patients might not be able to get radiation because of a disease that they have or because of prior treatments, when radiation would normally be the standard of treatment for that patient. Similarly, with chemotherapy, some are unable to receive it because of a medical condition that they have. In terms of surgery, some might not be healthy enough to undergo surgery, which makes it important to discuss the specifics of individual cases.

TARGETED ONCOLOGY:What are some of the most prominent recent advancements that have been made?

Judson:

In head and neck cancers, there are a few major changes that are happening. Even in my short 15 years, there has been this rise of human papillomavirus (HPV)-associated cancers. It’s distinct from the disease that we have taken care of before.

Additionally, there has been surgical advances in terms of different ways to provide minimally invasive surgery for patients. Currently, people are unsure what the best treatments are. There are clinical trials underway and, hopefully, in a few years we will begin to know more about what the best treatment is based on evidence—but we are not there yet.

TARGETED ONCOLOGY:What impact has minimally invasive surgery had on the patient population?

Judson:

In my opinion, the impact of minimally invasive surgery is based on whether you can use it judiciously and balance it with the other treatments that are available. For patients with whom the prognosis is already excellent, we are trying to minimize the treatment and the treatment side effects. If we could incorporate surgery, either endoscopic laser surgery or transoral robotic surgery, in order to minimize or reduce the treatments that might have side effects, that is going to be beneficial. One really needs to be thoughtful about if surgery is going to fit in with the other treatments that are needed.

TARGETED ONCOLOGY:What challenges would you like to see tackled regarding surgery for patients with head and neck cancer?

Judson:

In terms of minimally invasive surgery in head and neck tumors there are 2 areas where there is going to be changes in the years ahead. One change is involving technologically. There are new developments coming down the pipeline that will affect what we can do with surgery and how it’s done. In my opinion, what is more important is starting to get back data from trials that will allow us to make evidence-based decisions and recommendations about how to use this tool.

TARGETED ONCOLOGY:Are there any ongoing trials that you’re particularly excited to see the results of?

Judson:

ECOG-3311 is an open trial that we’re hopefully getting close to seeing data. In that trial patients with HPV-positive disease are going to receive minimally invasive surgery and, if their pathology report is low risk, they go into the observation arm. If the report is high-risk they get the standard treatment, which is chemotherapy and radiation. If they demonstrate an intermediate-risk stage, the patients will be randomized to either standard radiation or lower-dose radiation.

In all of the arms, there are multiple quality-of-life functional outcome measures, which is a great advancement to have. Surgery is frequently used in the treatment of head and neck cancer, it’s important and unique to have a trial like this that involves surgery because there have not been many surgery-based trials in the past.

TARGETED ONCOLOGY:Why do you think surgical based trials have not been as prevalent in this field?

Judson:

One of the rationales behind ECOG-3311 was that patients with HPV-positive disease have a much better prognosis. The trial in many ways is aimed to determine if we could give a less intensive treatment to minimize the side effects while maintaining the same cure rate.

We found that HPV-negative cancers, meaning the critical smoking- and drinking-related cancers, have a much worse prognosis than previously thought. The response rates are quite low. At the same time of the ECOG-3311 trial, there was another ECOG Group trial that was aimed at the HPV-negative cancers.

In that trial, the design was for patients to be randomized to either transoral minimally invasive surgery or chemoradiation therapy. We opened that trial at Yale Cancer Center and I tried to enroll patients, but no one would do it. Patients don’t want to be randomized to surgery versus a non-surgery arm. They have biases as to what they think is the best treatment and they don’t want to give up making that decision.

That does point to difficulty with surgical-based trials. Patients tend not to want to get randomized or give up that decision about whether to have surgery or not.

TARGETED ONCOLOGY:What advice can you give to doctors who are looking to enroll patients in their clinical trials?

Judson:

It’s important to have the trials open and it sounds simple; however, it takes a lot of work to get a trial to the point of accrual. Being at a center where you have multiple people who are opening trials is helpful.

It is important to develop collaboration amongst the team. If you have a patient who you think is a great candidate for a trial run by a member of your team, you can recommend that patient to that trial. Likewise, if they have a patient who they think will fit well with that trial, they will do the same.

TARGETED ONCOLOGY:Is there anything else you would like to add?

Judson: