Challenges of Active Surveillance Protocols for Low-Risk Papillary Thyroid Microcarcinoma in the United States

Dear Editor:

Active surveillance (AS) is increasingly being viewed as a viable alternative to immediate surgical intervention for properly selected patients with low-risk papillary thyroid microcarcinomas (LRPTMC). Rather than rushing to immediate surgical resection, patients are closely monitored with serial ultrasounds, thyroglobulin measurements, and other imaging studies, reserving surgical intervention for patients demonstrating evidence of structural disease progression or those electing to proceed with surgery in the absence of structural disease progression. Two studies based in Japan have shown that AS is an oncologically safe management strategy for carefully selected patients with LRPTMC (1,2). Moreover, Oda et al. found AS to be safer than immediate surgery in terms of the incidence of unfavorable events, such as postsurgical hematoma, voice dysfunction, and hypoparathyroidism (3). Eight percent of patients choosing AS underwent later surgery and at that time had a comparable risk of unfavorable events as the patients who underwent immediate surgery. However, over the entire AS cohort, the incidence of these events was statistically lower, as the overwhelming majority of the AS cohort did not undergo surgery.

Brito et al. identified three domains for assessing patients' appropriateness for AS: tumor/neck ultrasound characteristics, patient characteristics, and medical team characteristics. These domains were used to designate patients as ideal, appropriate, or inappropriate candidates for AS (4).

While the oncologic results from the Japanese studies are encouraging, there are additional factors that could impact the implementation of AS protocols in the United States (5). Both Japanese studies had very high follow-up rates generally not seen in the United States (Ito et al. reported 0% lost to follow-up over 74 months average; Sugitani et al. reported 3% lost to follow up over 11 years average) (1,2). In the United States, where patients are more likely to move and experience changes in health insurance coverage, a mechanism for consistent transfer of medical information between clinicians is needed to maintain lifelong follow-up. Quality-of-life issues may arise in patients undergoing AS, and patients may experience anxiety from living with cancer. Educating patients and clinicians is critical to ensure that patients are selected appropriately and understand their role.

In order for AS protocols to be implemented successfully in the United States, it will be important to:

• provide continuity of care as patients move or change physicians/hospitals;

• store ultrasound data in a detailed and uniform format to identify and report changes readily;

• educate clinicians and patients about entry/exclusion criteria and follow-up;

• evaluate patient quality of life during AS; and

• conduct research on outcomes for patients undergoing AS.

We have developed an online tool, the Thyroid Cancer Care Collaborative (TCCC), which we believe will address each of these critical implementation steps. The TCCC (www.thyroidccc.org) stores patient clinical information that is available to any clinician the patient designates, allowing this information to be transferred to a new clinician. The TCCC collects sonographic information to facilitate tracking of LRPTMCs over time. The Active Surveillance Decision Module provides a point-of-care reference for clinicians to verify that appropriate patients are being selected. The patient portal of the TCCC gives patients access to their health records and to educational material covering thyroid cancer management, including AS. We are working on additional modules to address patient quality of life while undergoing AS. The TCCC can also help track the implementation of AS protocols in the United States.

In summary, the TCCC provides an accessible online solution that addresses the critical issues of successful implementation of AS management approach into routine clinical practice.