.

“Staging helps clinicians answer two questions,” said Allen Ho, MD, professor of Surgery, director of the Head and Neck Cancer Program at Cedars-Sinai and lead author of the study. “The first: How serious is the cancer? The second: What is the best treatment?”

Previous staging guidelines for HPV-positive throat cancer were so broad that as many as 80% of patients were classified as stage 1, with three different possible treatment strategies. Some stage 1 patients were treated with surgery alone, some with surgery plus radiation therapy, and some with surgery and radiation plus chemotherapy.

“The new staging will better inform clinicians and patients about a patient’s prognosis and will minimize inconsistencies in the treatments patients are offered,” Ho said. “Currently, a patient diagnosed as stage 1 might be offered surgery plus radiation and chemotherapy, while another stage 1 patient may be offered surgery alone. The new guidelines will help ensure each patient receives the most appropriate treatment.”

Investigators divided the huge group of stage 1 patients into three separate groups, Ho said. They created new subdivisions of nodal staging, which consider whether cancer has spread to lymph nodes, and paired a more cohesive treatment recommendation with each.

“Perhaps the biggest change in the new staging system is that it takes into account something called extranodal extension, where the cancer has not only spread to the lymph nodes, but has progressed further to destroy the lymph node capsule and spill into the surrounding tissue. Inclusion of this factor is important, because it often changes both prognosis and the recommended treatment following surgery,” said Zachary Zumsteg, MD, professor of Radiation Oncology and Biomedical Sciences at Cedars-Sinai and senior author of the paper. 

Ho noted that cases of HPV-positive throat cancer, caused by the same virus that causes cervical cancer, have outpaced cervical cancer because women are routinely screened for cervical cancer. They are also more likely than men to receive the HPV vaccine, which can prevent both cancer types.

The new guidelines were developed by an international committee led by Ho that analyzed data on more than 14,000 patients from 984 healthcare facilities. They are set to become the official worldwide staging guidance in the coming year.

“These findings represent compelling evidence for staging modification,” said Robert Figlin, MD, interim director of Cedars-Sinai Cancer and the Steven Spielberg Family Chair in Hematology Oncology. “It is a challenging endeavor, but it improves the information and care that we are able to offer our patients; Cedars-Sinai Cancer is honored to be part of this international effort.”

Ho suggested that patients with newly diagnosed HPV-positive throat cancer ask their care team how these new guidelines have shaped their staging and treatment options.

“Patients should ask their caregivers how these new guidelines impact the clinician’s thinking about the patient’s staging, prognosis and which treatment to offer,” Ho said.

Additional Cedars-Sinai authors include Brian O’Sullivan.

Additional authors include Shao Hui Huang, Michael Luu, Mererid Evans, Robert L. Ferris, James S. Lewis Jr., Raja R. Seethala, Sue S. Yom, Hisham Mehanna, Barton F. Branstetter, Nabil F. Saba, Snehal G. Patel, and William M. Lydiatt.

Cedars-Sinai Health Sciences University is advancing groundbreaking research and educating future leaders in medicine, biomedical sciences and allied health sciences. Learn more about the university.

Active surveillance is an established practice for managing certain low-risk cancers that are unlikely to cause harm. It is an increasingly common and effective way to manage certain early-stage cancers, including those in the prostate, thyroid and kidney. However, adoption of active surveillance in practice has been hit-and-miss for several reasons. Among them, according to multiple studies, is a perceived increased risk of malpractice among physicians, stemming from unease that the window for a cure may unexpectedly close.

In a new study, Cedars-Sinai Cancer investigators explored malpractice trends related to active surveillance as a treatment strategy across cancers. They found that to date, there has been no successful litigation related to active surveillance. Their research was recently published in the peer-reviewed journal Annals of Surgery.

BACKGROUND  

Cancer clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) consider active surveillance an effective strategy for managing low-risk prostate, kidney and thyroid cancers. Active surveillance is also considered standard of care for certain lymphomas and an emerging option for managing stage 0 breast cancer. This less-invasive approach reserves surgery for cases in which the cancer progresses. In doing so, it avoids the adverse side effects of treatment when the benefit of that treatment (surgery, chemotherapy) is unclear.

Because some cases do progress, physicians have indicated a reluctance to use active surveillance for fear of malpractice lawsuits. However, data on malpractice trends across cancers had previously been lacking.

METHODS

Cedars-Sinai Cancer investigators analyzed comprehensive data from Westlaw Edge and LexisNexis Advance databases between 1990 and 2022 and examined federal and civil medical malpractice cases in all 50 states involving active surveillance for lymphoma and thyroid, prostate, kidney and breast cancer.

They found five prostate cancer cases related to active surveillance; no pertinent cases were found regarding active surveillance in any other cancers. In two of the five prostate cancer cases, the court defended the practice of active surveillance, determining that it was in accordance with national standards of “sound clinical judgment” and “accepted medical practices.” The other cases involved alleged physician negligence for not having recommended active surveillance as a treatment option, after the patients had complications from surgery. All cases were ruled in favor for the physicians, who had documented informed consent for active surveillance.

IMPACT

The authors concluded that given the legal precedent detailed in the identified cases—and increasing support across national guidelines—active surveillance is a sound management option in appropriate low-risk cancers and appears to present no increased risk of malpractice litigation.

“Our team previously published research showing that active surveillance is an effective treatment for many low-risk thyroid cancer patients,” said Allen Ho, MD, lead author of the study and co-director of the Thyroid Cancer Program at Cedars-Sinai Cancer. “These latest findings show no increased risk of medical malpractice with active surveillance across multiple cancer types.”  

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” said Timothy Daskivich, MD, co-author of the study and assistant professor of Surgery at Cedars-Sinai. “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study. In fact, in some cases, physicians were sued because they didn’t offer active surveillance.”

The authors added that failure to discuss an NCCN-recommended approach as a treatment option with patients could be considered just as prone to litigation. Their recommendations to strengthen patient communication and guard against malpractice include thoroughly explaining active surveillance to patients, engaging with the institution’s compliance officers or legal counsel to develop standardized consent templates, and integrating patient preferences and personal values when proposing the treatment option. 

AUTHORS 

Other Cedars-Sinai authors include Missael Vasquez, Wendy Sacks, MD, and Zachary Zumsteg, MD.

Follow Cedars-Sinai Academic Medicine on X for more on the latest basic science and clinical research from Cedars-Sinai.