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Clinical

Andre H. Goy, MD; Sandra M. Swain, MD, FACP, FASCO Associate Dean for Research; Carolina Bernabe Ramirez, MD; Jonathan E. Rosenberg, MD; David H. Vesole, MD, PhD, FACP Director, Myeloma Program; Isabel Preeshagul, DO, MBS  
 

Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

The KEYNOTE-689 study evaluating pembrolizumab in this patient population met its primary end point of event-free survival. 

Perioperative Pembrolizumab Betters Survival in Stage III/IV Head and Neck Cancer

Evidence suggests that extranodal extension on radiological imaging is a negative prognostic factor in head and neck cancer, but diagnostic criteria and terminology have been unclear. 

Experts Reach Consensus on Detecting Extranodal Extension in HNC Imaging

Camrelizumab increased the 3-year event-free survival rate vs standard of care from 77.3% to 86.9%, translating to a 44% reduced risk of death or relapse in patients with nasopharyngeal carcinoma.

Camrelizumab Boosts EFS in Nasopharyngeal Carcinomas

Neoadjuvant chemotherapy prior to surgery and postoperative radiation therapy could improve organ preservation in patients with T3 and T4a nasal and paranasal sinus squamous cell carcinoma.

Neoadjuvant Therapy Could Improve Outcomes for Nasal and Paranasal Sinus Cancer

Christina Henson, MD, discussed proposed guidelines for head and neck cancer imaging to improve patient outcomes and consistency across practices.  

Improving Imaging Guidelines for Extranodal Extension in Head and Neck Cancer

Understanding Extranodal Extension in Head and Neck Cancer: New Imaging Guidelines Explained

Extranodal extension is an important prognostic factor in head and neck cancer. Imaging plays a crucial role in detecting extranodal extension. However, current guidelines often rely on clinical findings, which may overlook subtle cases.

 aimed to establish a consensus-based grading system for imaging-detected extranodal extension in head and neck cancer. This system seeks to enhance diagnostic accuracy and standardization. The proposed guidelines recommend specific criteria for identifying imaging-detected extranodal extension, which include:

Indistinct or irregular nodal margin or border

Conglomerate, matted, and coalescent nodes

Additionally, the guidelines stipulate that certain factors should not influence the assessment of imaging-detected extranodal extension. These factors include:

Type or number of involved adjacent structures

, Christina Henson, MD, radiation oncologist at the University of Oklahoma, discusses how these proposed guidelines could change practice for physicians and the effects on patients. 

There's some discussion of potentially incorporating these grading criteria into the next iteration of the [National Comprehensive Cancer Network (NCCN)]. guidelines. So that would be great, because everyone pretty much uses the NCCN guidelines, and that would mean that everyone's using the same scoring system, and that going forward, we'll be able to really evaluate this grading system better, just because everyone will be using it in the same way. That's an important part of being able to validate a new tool, right? If it is being widely used and we can study it better. Also for clinical trials, going forward, it will be helpful to have this framework as well, just for better communication and clarity and standardization of things on clinical trials. 

As far as for how it will affect patients, the the biggest way we think this will affect patients is that with the increased use of transoral robotic surgery [TORS] for [human papillomavirus (HPV)]-related oropharyngeal cancer. We really try to avoid offering TORS to patients who have extranodal extension. But again, right now, we don't really have the tools to call those more subtle varieties of extranodal extension, so a lot of times, those patients will go to surgery, then they're found to have extranodal extension after the fact on pathology, meaning that then they have to get chemo and radiation after surgery, whereas they probably just should have been treated with chemoradiation upfront and avoided surgery. So now they've been treated with 3 different modalities with 3 different sets of toxicities. So that'll be the biggest thing: we'll be more appropriately selecting the right treatment for the right patient based on suspicion for extranodal extension prior to pursuing a surgical route.

Videos

Christina Henson, MD, discusses how new guidelines for head and neck cancer imaging could change dynamics for physicians and patients. 



Convenient Saliva Test Could Predict Head and Neck Cancer Recurrence

A study sought to evaluate the effectiveness of soluble CD44 and total protein (TP) as biomarkers for monitoring head and neck cancer recurrence. Here, patients were monitored using a point-of-care (POC) salivary test and laboratory-based assays for CD44 and TP levels.

Both CD44 and TP levels were associated with an increased risk of cancer recurrence. CD44 was found to be a particularly promising biomarker. The POC test for CD44 and TP showed potential, but further development is needed.

The study suggests that measuring CD44 and TP levels in saliva could be a valuable tool for monitoring head and neck cancer recurrence and identifying patients at high risk of disease progression.

Here, Elizabeth Franzmann, MD, professor of Otolaryngology and director of head and neck research at the University of Miami Miller School of Medicine, discusses the next steps in this research and the implications of these findings.

I think that moving forward, we will want to look at, first of all, combining the markers. We've looked at them individually, combining them to see what the prediction is. And then, you know, this is the first study in this, in this of this type of work, and so we would want to validate our findings before making official recommendations or seeking regulatory approval.

if these cancers are caught early, they are very treatable. It's a little harder after a recurrence, but still very treatable. If, if someone's been through radiation and chemo from from oropharyngeal cancer. It's tough. It's a it's a tough road, and there's a lot of side effects from that, and it's hard to hear that. Oh, you may have to go through something again, or through more more treatment. But I think the the upside of this is that if we catch it earlier, we can treat it with less invasive and morbid treatments and have a better chance of cure.

Elizabeth Franzmann, MD, discusses findings of a study exploring a novel method of testing recurrence of head and neck cancer. 

Christina Henson, MD, radiation oncologist at The University of Oklahoma, discusses unmet needs among patients with head and neck cancer. Here, she discusses studies investigating how to best customize treatment for these patients, especially regarding deescalating treatment to avoid unnecessary toxicities. 

So far, we haven't found the kind of magic solution or the best way to deescalate on a large scale, but there have been a lot of really promising smaller studies selecting more niche groups of patients either with advanced imaging modalities that aren't necessarily available everywhere but that are able to kind of measure the tumor biology during the course of treatment and use that to determine who's having a good response and who's not having a good response and have the option to stop treatment earlier at lower doses for patients who are responding well. 

So everyone's hopeful that some time in the near future one of or more than one of is these studies will pan out in a widely applicable way that will be very beneficial for our patients.

Christina Henson, MD, discusses unmet needs among patients with head and neck cancer. 

Emerging Trends in Head and Neck Cancer Treatment: Advanced Imaging Modalities and Personalized Therapy

Frontline Petosemtamab/Pembrolizumab Shows Early Efficacy in HNSCC

Cesar Augusto Perez, MD, hematologist and medical oncologist at Florida Cancer Specialists & Research Institute’s Lake Nona Cancer Center & Drug Development Unit, discusses the efficacy data reported in a phase 2 study (NCT03526835) of

petosemtamab (MCLA-158) with pembrolizumab

 (Keytruda) for the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma.

In terms of the efficacy, 67% of the patients developed a response, so there was a response rate of 67%. In total, there were 24 patients that had evaluable disease by RECIST1.1, there was 1 patient with a complete response, and 12 patients with a partial response, and there were also 3 patients with an unconfirmed partial response. There were patients with responses with HPV-negative and HPV-positive disease, and they also were divided among the CPS score. There were 10 patients with CPS between 1-19, and 14 patients with CPS of 20 [or higher]. And there were responses in both subsets. In CPS, 1-19, 60% of patients responded and patients with CPS more than 20, there was a 71% response rate, which is obviously very encouraging.

 In terms of the duration of response, most of the patients were still in response at the data cutoff. I think 1 of the things that I learned from these molecules that is very interesting is that you can see responses pretty early, which is something that we are not used to seeing in checkpoint inhibitors. Usually we have to wait a little bit longer. But for unknown reasons, the activity of this antibody can be seen pretty early on during the treatment course, which is very important for patients who are symptomatic, and that is very important, because some patients have a life-threatening disease in the immediate term, so we try not to lose patients, and the good thing military about this antibody is that we can see activity early on. And as a single-agent, we saw the same thing as in the combination arm.

Cesar Augusto Perez, MD, discusses the efficacy data reported in a phase 2 study of petosemtamab plus pembrolizumab for the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma.

News

Jimmy Caudell, MD, PhD, senior member and vice chair for the Clinical Research Department of Radiation Oncology at Moffitt Cancer Center, discusses the overall incidence of human papillomavirus (HPV)-positive and negative oropharyngeal cancers in the United States.

According to Caudell, patients with HPV-positive cancers are overall younger in age while the incidence of HPV-positive oropharynx cancer is increasing among older adults.

However, the overall incidence of HPV-positive oropharynx cancers is increasing in the United States as a whole. At the same time, the incidence of HPV-negative cancer is decreasing. Both are likely linked with the impact of smoking and cancer stage of patients.

 Overall, the incidence of oropharyngeal cancer is relatively stable, but within the incidence of HPV-positive oropharyngeal cancer, it is increasing quite rapidly, whereas HPV-negative, at least in the United States, is decreasing. Recent publications released in the last 5-10 years consider HPV-related oropharyngeal cancer to be an epidemic.

Similar to many other smoking-related cancers, HPV-negative cancers of the head and neck have been decreasing because people have been smoking less or not smoking at all. HPV-positive oropharyngeal cancer is increasing in incidence because, at the base of it, it is a sexually transmitted disease.

Jimmy Caudell, MD, PhD, discusses the overall incidence of human papillomavirus-positive and negative oropharyngeal cancers in the United States.


Varying Incidence of HPV-Positive and Negative Oropharyngeal Cancers

Jean Bourhis, MD, a professor of radiation oncology at the University of Paris, discusses results from the phase 2 study of xevinapant plus chemoradiation vs placebo and chemoradiation in patient with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN; NCT02022098).

Results from the 5-year analysis of the study were presented during the European Society of Medical Oncology Congress 2022 by Bourhis. It was shown that the addition of xevinapant to standard-of-care chemoradiation improved the durability of responses in patients with LA SCCHN.

The study was a phase 2 randomized trial comparing placebo versus xevinapant with standard of care in patients with locally advanced from cell carcinoma the head and neck. These patients were really high-risk patients, the most advanced among the locally advanced cases. And we knew already that xevinapant was active and well tolerated in the same study. tThe results that we presented [at ESMO] are long-term follow up results. And especially we have data here on overall survival at 5 years, which we didn't have before.

 What do we see here in this study with long-term follow up the 5-year overall survival is markedly improved with the xevinapant when compared to placebo. And there is nearly a doubling of the overall survival at 5 years. The data [shows that] it's from 28%, with placebo to 53% with xevinapant and we can say that in this selection of patients, again with really high-risk, locally advanced squamous cell cancer of the head and neck. This is something we've never seen in the last 3 decades because the standard of care, cisplatin radiotherapy, has never been improved with the new treatme

Jean Bourhis, MD, discusses results from the phase 2 study of xevinapant plus chemoradiation vs placebo and chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck.

Duration of Response With Xevinapant Plus Standard Chemoradiation in LA SCCHN

Joseph M. Curry, MD, a professor in the department of otolaryngology and vice chairman of research at Thomas Jefferson University, discusses the introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with head and neck cancers.

Anti–PD-1 therapies have shown efficacy in head and neck cancer in clinical trials, leading to the approval of pembrolizumab (Keytruda) based on the KEYNOTE-012 trial (NCT01848834), and nivolumab (Opdivo) based on the CheckMate 141 trial (NCT02105636) for recurrent and metastatic head and neck squamous cell carcinoma. Curry notes that pembrolizumab is now considered first-line therapy for unresectable metastatic disease based on the results of the KEYNOTE-048 trial (NCT02358031).

ICIs also have potential for use in the neoadjuvant setting even for resectable disease. Curry and other investigators are conducting a phase 1 trial (NCT03618654) of durvalumab (Imfinzi) and metformin in head and neck squamous carcinoma. The trial is exploring the efficacy of PD-1 inhibition in the 4-week window prior to surgery, indicating that ICIs play multiple valuable roles in treating head and neck cancer.

 ICIs have been a popular and exciting development because of the efficacy they've shown in head and neck cancer—specifically within head and neck cancer, anti–PD-1 therapy. So, both pembrolizumab and nivolumab have been approved for the treatment of recurrent and metastatic head and neck cancer and squamous cell carcinoma because of the efficacy that they've shown in a number of clinical trials. And in fact, after the initial approval, they've moved up in the algorithm such that pembrolizumab is now included in first line therapy for metastatic and inoperable disease.

And so, these therapies have really expanded what we think of as options in terms of non-surgical therapies. And in terms of this specific clinical trial, they've also expanded how we approach disease, which is in some cases operable, looking at neoadjuvant strategies for the use of immune checkpoint inhibitors.

Joseph M. Curry, MD, discusses the introduction of immune checkpoint inhibitors for the treatment of patients with head and neck cancers.

Immune Checkpoint Inhibitors Offer New Approaches in Head and Neck Cancer

Christine Dierks, MD, senior physician at the University Hospital Freiburg in Germany, describes the prognosis of the anaplastic thyroid carcinoma and differentiated thyroid cancer populations.

Dierks says that the prognosis is very poor for both patient populations but especially for those with anaplastic thyroid carcinoma. Poor outcomes are seen with patients who have anaplastic thyroid carcinoma even if they have combined therapy, which can include surgery and radiotherapy, followed by chemotherapy. In these patients, the life expectancy is about 4 to 5 months after therapy, according to Dierks.

In terms of survival, there is an exception for patients who had 

-positive disease because imatinib (Gleevec) is available for these patients. Dierks notes that for the other 80% of patients, the prognosis remains poor due to a lack of agents.

Christine Dierks, MD, describes the prognosis of the anaplastic thyroid carcinoma and differentiated thyroid cancer populations.










Outcomes Underscore Need for New Agents to Treat Anaplastic Thyroid Carcinoma

Christopher Nutting, MD, joint head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research and consultant clinical oncologist at The Royal Marsden, discusses the results of a randomized phase 3 trial using dysphagia-optimized intensity modulated radiotherapy (Do-IMRT) versus standard IMRT (S-IMRT) in patients with head and neck cancer.

This study included 112 patients who were randomized 1:1 to receive either S-IMRT or Do-IMRT. The primary end point was the MD Anderson Dysphagia Inventory (MDADI), which was collected 12 months after patients completed treatment. Most of the patients were male, and the most common tumor location was the oropharynx. Among the patients participating, 90% had prior chemotherapy and radiation, which is standard protocol in this setting. A majority of patients were human papilloma virus-positive, which is a group with good long-term prognosis for carrying the burden of the treatment, according to Nutting.

Nutting says the first finding in the study was that the investigators were able to reduce the radiation dose to the muscles in the experimental arm, which is what the investigators were hoping for. The MDADI score at 12 months was about 70 points out of 100 in the group of patients receiving S-IMRT, which is expected in pretrial analyses. The Do-IMRT group had about 78 points for the MDADI score. This was statistically significant, with a 

value of 0.016. A score difference of 5 to 10 points is considered to be a clinically relevant improvement in the MDADI score, he explains.

<< View more resources and information in head and neck cancers

Christopher Nutting, MD, discusses the results of a randomized phase 3 trial using dysphagia-optimized intensity modulated radiotherapy versus standard IMRT in patients with head and neck cancer.

Dysphagia-Optimized IMRT Shows Significance in Head and Neck Cancer

Robert L. Ferris, MD, PhD, director of the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center; Hillman Professor of Oncology; associate vice chancellor for cancer research; professor of otolaryngology, immunology, and radiation oncology; co-director, Tumor Microenvironment Center, discusses the rationale for evaluating STING agonists as treatment for patients with head and neck cancers. ADU-S100/MIW815, in particular, is under evaluation in combination with the checkpoint inhibitor pembrolizumab (Keytruda) in the phase II ADU-CL-20 clinical trial for patients with PD-L1–positive recurrent or metastatic squamous cell carcinoma of the head and neck.

The compound is a proinflammatory agonist that stimulates the STING pathway, says Ferris. Data have shown that the STING pathway is an important inflammatory pathway in a number of epithelial cancers, including head and neck cancer.

Data suggest that intralesional and intratumoral injection with a STING agonist, such as ADU-S100/MIW815 and other compounds that stimulate the STING pathway, can trigger beneficial inflammation and draw immune cells into the tumor microenvironment, says Ferris. This was the rationale for evaluating this agent in combination with an immune checkpoint inhibitor in the phase II study.

Robert L. Ferris, MD, PhD, discusses the rationale for evaluating STING agonists as treatment for patients with head and neck cancers. 

HEAD & NECK CANCERS

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