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clinically node-negative PTC (cN0) and for most follicular cancers.
(Strong recommendation, Moderate-quality evidence) | 316 |
RECOMMENDATION 37
Therapeutic lateral neck compartmental lymph node dis- section should be performed for patients with biopsy-proven metastatic lateral cervical lymphadenopathy.
(Strong recommendation, Moderate-quality evidence) | 317 |
Regional lymph node metastases are present at the time of diagnosis in a majority of patients with papillary carcinomas and a lesser proportion of patients with follicular carcinomas (290,334,335). Although PTC lymph node metastases are reported by some to have no clinically important effect on outcome in low risk pati... | 318 |
The preceding recommendations should be interpreted in light of available surgical expertise. For patients with small, noninvasive, cN0 tumors, the balance of risk and benefit may favor thyroid lobectomy and close intraoperative inspection of the central compartment, with the plan adjusted to total thyroidectomy with c... | 320 |
[B9] Completion thyroidectomy | 321 |
RECOMMENDATION 38
Completion thyroidectomy should be offered to pa- tients for whom a bilateral thyroidectomy would have been recommended had the diagnosis been available before the initial surgery. Therapeutic central neck lymph node dis- section should be included if the lymph nodes are clinically involved. Thyroid l... | 322 |
Completion thyroidectomy may be necessary when the diagnosis of malignancy is made following lobectomy for an indeterminate or nondiagnostic biopsy. In addition, some patients with malignancy may require completion thyroidectomy to provide complete resection of multicentric disease and to allow for efficient RAI t... | 323 |
[B10] What is the appropriate perioperative approach to voice and parathyroid issues?
[B11] Preoperative care communication | 324 |
RECOMMENDATION 39
Prior to surgery, the surgeon should communicate with the patient regarding surgical risks, including nerve and parathyroid injury, through the informed consent process and communicate with associated physicians, including anesthesia personnel, regarding important findings elicited during the preopera... | 325 |
The preoperative consent process should include explicit discussion of the potential for temporary or permanent nerve injury (and its clinical sequelae, including voice change, swallowing disability, risk of aspiration, and tracheostomy) as well as hypoparathyroidism, bleeding, scarring, disease recurrence, need for ad... | 326 |
[B12] Preoperative voice assessment | 327 |
RECOMMENDATION 40
All patients undergoing thyroid surgery should have preop- erative voice assessment as part of their preoperative physical examination. This should include the patient’s description of vocal changes, as well as the physician’s assessment of voice.
(Strong recommendation, Moderate-quality evidence) | 328 |
RECOMMENDATION 41
Preoperative laryngeal exam should be performed in all patients with
Preoperative voice abnormalities
(Strong recommendation, Moderate-quality evidence)
History of cervical or upper chest surgery, which places the RLN or vagus nerve at risk
(Strong recommendation, Moderate-quality evidence)
Known thyr... | 329 |
Voice alteration is an important complication of thyroid surgery affecting patients’ quality of life (with regard to voice, swallowing, and airway domains), and it can have medico-legal and cost implications (393–401).
Preoperative assessment provides a necessary baseline reference from which to establish perioperative... | 331 |
Table 9. Preoperative Factors Which May
Be Associated with Laryngeal Nerve Dysfunction | 332 |
Factor Symptoms/signs | 333 |
History Voice abnormality, dysphagia, airway symptoms, hemoptysis, pain, rapid progression, prior operation in neck or upper chest
Physical exam Extensive, firm mass fixed to the
larynx or trachea
Imaging Mass extending to/beyond periphery of thyroid lobe posteriorly and/or tracheoesophageal infiltration, or bulky cerv... | 334 |
[B13] Intraoperative voice and parathyroid management | 335 |
RECOMMENDATION 42
Visual identification of the RLN during dissection is required in all cases. Steps should also be taken to preserve the external branch of the superior laryngeal nerve (EBSLN) during dissection of the superior pole of the thyroid gland.
(Strong recommendation, Moderate-quality evidence)
Intraoperative... | 336 |
RECOMMENDATION 43
The parathyroid glands and their blood supply should be preserved during thyroid surgery.
(Strong recommendation, Moderate-quality evidence) | 337 |
RLN injury rates are lower when the nerve is routinely visualized in comparison with surgeries in which the nerve is simply avoided (402,416,423). If the EBSLN can be visu- alized and preserved, that is ideal. If the EBSLN cannot be visually identified, steps should be taken to avoid the nerve; this can be done by stay... | 338 |
ary subgroup analyses of high-risk patients (including those | 339 |
with thyroid cancer) suggested statistically significant het- erogeneity (variability) in treatment effect for overall and transient RLN injury, when analyzed per nerve at risk. Several studies show that intraoperative nerve monitoring is more commonly utilized by higher volume surgeons to fa- cilitate nerve management... | 341 |
[B14] Postoperative care | 342 |
RECOMMENDATION 44
Patients should have their voice assessed in the postoper- ative period. Formal laryngeal exam should be performed if the voice is abnormal
(Strong recommendation, Moderate-quality evidence) | 343 |
RECOMMENDATION 45
Important intraoperative findings and details of postoper- ative care should be communicated by the surgeon to the patient and other physicians who are important in the patient’s postoperative care.
(Strong recommendation, Low-quality evidence) | 344 |
Voice assessment should occur after surgery and should be based on the patient’s subjective report and physician’s ob- jective assessment of voice in the office (409). Typically this assessment can be performed at 2 weeks to 2 months after surgery. Early detection of vocal cord motion abnormalities after thyroidectomy ... | 345 |
[B15] What are the basic principles of histopathologic evaluation of thyroidectomy samples? | 346 |
RECOMMENDATION 46
In addition to the basic tumor features required for AJCC/UICC thyroid cancer staging including status of resection margins, pathology reports should contain ad- ditional information helpful for risk assessment, such as the presence of vascular invasion and the number of in- vaded vessels, number of l... | 347 |
Pathologic examination of thyroid samples establishes the diagnosis and provides important information for risk stratification of cancer and postsurgical patient manage- ment. Histopathologically, papillary carcinoma is a well- differentiated malignant tumor of thyroid follicular cells that demonstrates characteristic ... | 348 |
well-differentiated malignant tumor of thyroid follicular cells that shows transcapsular and/or vascular invasion and lacks the diagnostic nuclear features of papillary carcinoma. Oncocytic (Hu¨rthle cell) follicular carcinoma shows the follicular growth pattern but is composed of cells with abundant granular eosin- op... | 350 |
46% in a series of 152 patients diagnosed using the Turin criteria (479).
The prognostic implication of the diffuse sclerosing variant of papillary cancer remains controversial. This variant is characterized by diffuse involvement of the thyroid gland and a higher rate of local and distant metastases at presentation, a... | 352 |
dedifferentiated anaplastic carcinoma. Another term used in the past for this tumor was ‘‘insular carcinoma.’’ Diagnostic criteria for poorly differentiated carcinoma are based on the consensus Turin proposal and include the following three features: (i) solid/trabecular/insular microscopic growth pattern, (ii) lack of... | 354 |
[B16] What is the role of postoperative staging systems and risk stratification in the management of DTC?
[B17] Postoperative staging | 355 |
RECOMMENDATION 47
AJCC/UICC staging is recommended for all patients with DTC, based on its utility in predicting disease mortality, and its requirement for cancer registries.
(Strong recommendation, Moderate-quality evidence) | 356 |
Postoperative staging for thyroid cancer, as for other cancer types, is used (i) to provide prognostic information, which is of value when considering disease surveillance and therapeutic strategies, and (ii) to enable risk-stratified description of pa- tients for communication among health care professionals, tracking... | 357 |
[B18] AJCC/UICC TNM staging
Over the years, multiple staging systems have been de- veloped to predict the risk of mortality in patients with DTC (522). Each of the systems uses some combination of age at diagnosis, size of the primary tumor, specific tumor histol- ogy, and extrathyroidal spread of the tumor (direct ext... | 358 |
Table 10. AJCC 7th Edition/TNM Classification System for Differentiated Thyroid Carcinoma
Definition
RAI, external beam radiation therapy or other systemic therapies). Furthermore, recent studies have questioned the use of the age of 45 years as a cutoff to upstage patients using | 360 |
the AJCC/UICC TNM system (340,531–533). | 361 |
T0 No evidence of primary tumor
T1a Tumor £1 cm, without extrathyroidal extension T1b Tumor >1 cm but £2 cm in greatest dimension,
without extrathyroidal extension
T2 Tumor >2 cm but £4 cm in greatest dimension, without extrathyroidal extension.
T3 Tumor >4 cm in greatest dimension limited to the thyroid
or
Any size tu... | 362 |
Patient age <45 years old at diagnosis | 363 |
Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Seventh Edition (1077) published by Springer Science and Business Media LLC (http://www.springer.com).
Even though the various staging systems designed t... | 364 |
[B19] What initial stratification system should be used to estimate the risk of persistent/recurrent disease? | 365 |
RECOMMENDATION 48
The 2009 ATA Initial Risk Stratification System is recommended for DTC patients treated with thyroidec- tomy, based on its utility in predicting risk of disease re- currence and/or persistence.
(Strong recommendation, Moderate-quality evidence)
Additional prognostic variables (such as the extent of ly... | 366 |
Because the AJCC/TNM risk of mortality staging system does not adequately predict the risk of recurrence in DTC (536–539), the 2009 version of the ATA thyroid cancer guidelines proposed a three-tiered clinico-pathologic risk stratification system that classified patients as having low, intermediate, or high risk of rec... | 367 |
FIG. 4. Risk of structural disease recurrence in patients without structurally identifiable disease after initial therapy. The risk of structural disease recurrence associated with selected clinico-pathological features are shown as a continuum of risk with percentages (ranges, approximate values) presented to reflect ... | 369 |
bed, vascular invasion, or aggressive tumor histology. High- risk patients had gross extrathyroidal extension, incomplete tumor resection, distant metastases, or inappropriate post- operative serum Tg values (Table 11).
The 2009 ATA risk stratification system was somewhat different than staging systems proposed by a Eu... | 371 |
defined as a stimulated Tg <1 ng/mL with no other radio- logical or clinical evidence of disease. Prospectively col- lected validation data for the ATA initial risk stratification system are needed.
Three additional studies, in which the ATA risk classifi- cation system was retrospectively evaluated, have also sug- ges... | 372 |
Table 11. ATA 2009 Risk Stratification System with Proposed Modifications
ATA low risk Papillary thyroid cancer (with all of the following):
No local or distant metastases;
All macroscopic tumor has been resected
No tumor invasion of loco-regional tissues or structures
The tumor does not have aggressive histology (e.g... | 373 |
ATA intermediate risk
the first posttreatment whole-body RAI scan
No vascular invasion
Clinical N0 or £5 pathologic N1 micrometastases (<0.2 cm in largest dimension)a Intrathyroidal, encapsulated follicular variant of papillary thyroid cancera
Intrathyroidal, well differentiated follicular thyroid cancer with capsular ... | 377 |
Clinical N1 or >5 pathologic N1 with all involved lymph nodes <3 cm in largest dimensiona Multifocal papillary microcarcinoma with ETE and BRAFV600E mutated (if known)a
ATA high risk Macroscopic invasion of tumor into the perithyroidal soft tissues (gross ETE) Incomplete tumor resection
Distant metastases
Postoperative... | 378 |
isolated thyroglobulinemia, which may be of less clinical significance than structural disease persistence or recurrence. Similar to what was seen with the staging systems designed to predict risk of mortality from thyroid cancer (see section [B18] above), the PVE by the ATA risk of recurrence system was suboptimal, ra... | 379 |
Table 12. American Thyroid Association Risk Stratification System: Clinical Outcomes Following Total Thyroidectomy and Radioiodine Remnant Ablation or Adjuvant Therapy | 380 |
aBecause the ATA intermediate- and high-risk groups were merged into a single ‘‘high-risk’’ group in the series by Castagna et al. (542), risk of persistent/recurrent disease for these subgroups is not presented.
bProportion of patients with a biochemical incomplete response. Definition: suppressed Tg >1 ng/mL, TSH-sti... | 381 |
high) can vary depending on the specific clinical features of individual patients (Fig. 4). In addition, the three-tiered system did not specifically address the risk of recurrence associated with specific DTC histologies, multifocality, ge- notype, extent of vascular invasion, or extent of metastatic lymph node invo... | 383 |
[B21] Potential impact of BRAFV600E and other mutations on risk estimates in PTC
In a pooled univariate analysis of 1849 PTC patients, the presence of a BRAFV600E mutation was associated with in- creased disease-specific mortality, although this was not significantly associated with mortality in a multivariate analysis... | 384 |
recurrence in multivariate analysis. Furthermore, a recent publication demonstrated a small, but statistically signifi- cant improvement in risk stratification if BRAF status was used in conjunction with the 2009 ATA initial risk stratifi- cation system (569). In a meta-analysis of 2167 patients, the presence of a BRAF... | 386 |
[B22] Potential impact of postoperative serum Tg on risk estimates
Several studies have demonstrated the clinical utility of a serum Tg measurement (either TSH stimulated or non- stimulated) obtained a few weeks after total thyroidectomy (postoperative Tg) and before RAI remnant ablation as a tool to aid in initial ris... | 387 |
[B23] Proposed modifications to the 2009 ATA initial risk stratification system
While the 2009 risk stratification system has proven to be a valuable tool for initial risk stratification in PTC, modifica- tions are required to better incorporate our new understanding regarding the risks associated with the extent of ly... | 389 |
[B24] Risk of recurrence as a continuum of risk
While the ATA initial risk stratification system provides a meaningful and valuable tool for predicting risk of recur- rence when used as a three-tiered categorical staging system, additional insights can be gained if one appreciates that the risk of structural disease re... | 390 |
[B25] How should initial risk estimates be modified over time? | 391 |
RECOMMENDATION 49
Initial recurrence risk estimates should be continually modified during follow-up, because the risk of recurrence and disease-specific mortality can change over time as a function of the clinical course of the disease and the re- sponse to therapy.
(Strong recommendation, Low-quality evidence) | 392 |
While initial staging systems provide important insights into an individual patient’s risk of recurrence and disease- specific mortality, they provide static, single-point estimates of risk based only on data available at the time of initial therapy. None of the currently available initial staging sys- tems are capable... | 393 |
[B26] Proposed terminology to classify response to ther- apy and clinical implications
All clinical, biochemical, imaging (structural and func- tional), and cytopathologic findings obtained during follow- up should be used to redefine the clinical status of the patient and to assess their individual response to therapy... | 395 |
[B27] Excellent response: no clinical, biochemical, or structural evidence of disease after initial therapy (remission, NED)
These patients have no clinical, biochemical, or structural evidence of disease identified on risk-appropriate follow-up studies (Table 13). If a total thyroidectomy and RAI abla- tion were done,... | 396 |
Table 13. Clinical Implications of Response to Therapy Reclassification in Patients with Differentiated Thyroid Cancer Treated with Total Thyroidectomy and Radioiodine Remnant Ablation
Category Definitionsa Clinical outcomes Management implications | 397 |
Excellent response | 398 |
Biochemical incomplete response | 400 |
Structural incomplete response | 404 |
Indeterminate response
Negative imaging
and either
Suppressed Tg <0.2 ng/mLb
or
TSH-stimulated Tg <1 ng/mLb
Negative imaging
and
Suppressed Tg ‡1 ng/mLb
or
Stimulated Tg ‡10 ng/mLb
or
Rising anti-Tg antibody levels | 407 |
Structural or functional evidence of disease With any Tg level
With or without anti-Tg antibodies | 409 |
Nonspecific findings on imaging studies
Faint uptake in thyroid bed on RAI scanning
Nonstimulated Tg detectable, but <1 ng/mL
Stimulated Tg detectable, but <10 ng/mL
or
Anti-Tg antibodies stable or declining in the absence of structural or functional disease
1%–4% recurrencec
<1% disease specific deathc | 411 |
At least 30% spontaneously evolve to NEDd
20% achieve NED after additional therapya
20% develop structural diseasea
<1% disease specific deatha | 412 |
50%–85% continue to have persistent disease despite additional therapye
Disease specific death rates as high as 11% with loco-regional metastases and 50% with structural distant metastasesa | 414 |
15%–20% will have structural disease identified during follow-upa
In the remainder, the nonspecific changes are either stable,
or resolvea
<1% disease specific deatha
An excellent response to therapy should lead to an early decrease in the intensity and frequency of follow up and the degree of TSH suppression
If asso... | 415 |
NED denotes a patient as having no evidence of disease at final follow-up.
aReferences (538,539).
bIn the absence of anti-Tg antibodies.
cReferences (538,539,542,586–593,595–601,1078).
dReferences (598,599,617–621).
eReferences (328,607,626,627,898). | 417 |
While most studies have assessed response to therapy using TSH-stimulated Tg values obtained 6–18 months after initial therapy (538,539,542,586,588–590,593–595,597–600), at least
15 other studies have evaluated the response to surgical therapy using a stimulated Tg obtained at the time of RAI remnant ablation (605). Pa... | 418 |
FIG. 5. Clinical decision- making and management recommendations in ATA low-risk DTC patients that have undergone total thy- roidectomy. R, recommen- dation in text. | 425 |
FIG. 6. Clinical decision- making and management recommendations in ATA low risk DTC patients that have undergone less than total thyroidectomy (lobectomy or lobectomy with isthmu- sectomy). R, recommenda- tion in text. | 438 |
FIG. 7. Clinical decision-making and management recommendations in ATA intermediate risk DTC pa- tients that have undergone total thyroidectomy. R, recommendation in text. | 452 |
patients at very low risk for recurrence, Tg cut points need to be defined for patients whose primary treatment consisted of thy- roid lobectomy or total thyroidectomy without RAI ablation.
In summary, once a patient achieves an excellent response to therapy, the initial risk of recurrence estimate should be modified a... | 461 |
[B28] Biochemical incomplete response: abnormal Tg values in the absence of localizable disease
These patients have persistently abnormal suppressed and/ or stimulated Tg values or rising anti-Tg antibodies without | 462 |
structural evidence of disease that can be detected using risk- appropriate structural and functional imaging (Table 13). Please see section [C6] for discussion of Tg measurements. Previous studies have used nonstimulated Tg values of >1 ng/mL or TSH-stimulated Tg values of >10 ng/mL to define a bio- chemical incomplet... | 463 |
FIG. 8. Clinical decision- making and management recommendations in ATA high risk DTC patients that have undergone total thy- roidectomy and have no gross residual disease re- maining in the neck. R, rec- ommendation in text. | 470 |
Anti-Tg antibody levels measured over time in the same assay can provide clinically useful information (608). Rising anti-Tg antibody titers (or new appearance of anti-Tg anti- bodies) are associated with an increased risk of disease re- currence (609–614). Conversely, patients rendered free of disease with initial the... | 477 |
[B29] Structural incomplete response: persistent or newly identified loco-regional or distant metastases
These patients have structural or functional (RAI scan,
18FDG-PET) evidence of loco-regional or distant metastases | 478 |
(538,539,607). This category includes both patients with biopsy-proven disease and also patients in whom structural or functional disease is identified, which is highly likely to be metastatic disease based on the clinical scenario (Table 13). A structural incomplete response to initial therapy is seen in 2%–6% of ATA ... | 480 |
[B30] Indeterminate response: biochemical or structural findings that cannot be classified as either benign or malig- nant (acceptable response)
Patients with an indeterminate response have biochemical, structural, or functional findings that cannot be confidently classified as either excellent response or persistent d... | 481 |
[B31] Using risk stratification to guide disease surveillance and therapeutic management decisions
Risk stratification is the cornerstone of individualized thyroid cancer management. Initial risk estimates are useful to guide the wide variety of clinical management decisions that need to be made around the time of init... | 482 |
intensity of therapy and follow-up studies to real-time risk estimates that evolve over time for individual patients. | 484 |
[B32] Should postoperative disease status
be considered in decision-making for RAI therapy for patients with DTC? | 485 |
RECOMMENDATION 50
Postoperative disease status (i.e., the presence or ab- sence of persistent disease) should be considered in de- ciding whether additional treatment (e.g., RAI, surgery, or other treatment) may be needed.
(Strong recommendation, Low-quality evidence)
Postoperative serum Tg (on thyroid hormone therapy ... | 486 |
Postoperative disease status is a relevant consideration in postoperative treatment decision-making after initial con- sideration of clinic-pathologic stage. Evaluation of postop- erative disease status may be performed by a number of means including serum Tg, neck ultrasonography, and iodine radioisotope scanning. The... | 487 |
[B33] Utility of postoperative serum Tg in clinical decision- making
Serum Tg measurements (with anti-Tg antibodies), with or without neck US, are frequently performed as part of the early postoperative evaluation. Please see section [C6] for dis- cussion of Tg measurements. The predictive value of the postoperative Tg... | 488 |
Tg is undetectable in three different Tg assays than if it is undetectable only in a single assay (30%) (649). Con- versely, the likelihood of identifying either loco-regional or distant metastases on the posttherapy scan increases as either the suppressed or stimulated Tg values rise above 5–10 ng/mL (631,646,647,65... | 490 |
[B34] Potential role of postoperative US in conjunction with postoperative serum Tg in clinical decision-making
In a prospective study of 218 DTC patients, Lee et al. (659) reported that a stimulated Tg <2 ng/mL after thyroid hormone
withdrawal (with goal TSH of >30 mIU/L), at the time of administration of 100–200 mCi ... | 491 |
[B35] Role of postoperative radioisotope diagnostic scan- ning in clinical decision-making
Iodine radioisotope diagnostic testing may include 131I or 123I diagnostic imaging with or without SPECT-CT, and/or RAI uptake measurements. Postoperative RAI planar imaging (123I or 131I, with or without SPECT-CT) has been repor... | 492 |
benefit outcome. Questions regarding the potentially negative impact of such scans with 131I on RAI therapeutic efficacy for successful remnant ablation (‘‘stunning’’) may be mitigated or avoided by the use of either low-activity 131I (1–3 mCi) or alternative isotopes such as 123I. | 494 |
[B36] What is the role of RAI (including remnant ablation, adjuvant therapy, or therapy
for persistent disease) after thyroidectomy in the primary management of DTC? | 495 |
RECOMMENDATION 51 (details in Table 14)
RAI remnant ablation is not routinely recommended after thyroidectomy for ATA low-risk DTC patients. Consideration of specific features of the individual patient that could modulate recurrence risk, disease follow-up implications, and patient preferences are relevant to RAI decis... | 496 |
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