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Akira Miyauchi, M.D., Ph.D. Department of Surgery Kuma Hospital

Symposium: Postoperative Management of Thyroid Cancer. Dynamic Estimation of Prognosis in Patients with Thyroid Cancer after Surgery. Akira Miyauchi, M.D., Ph.D. Department of Surgery Kuma Hospital Center for Excellence in Thyroid Care.

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Akira Miyauchi, M.D., Ph.D. Department of Surgery Kuma Hospital

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  1. Symposium: Postoperative Management of Thyroid Cancer Dynamic Estimation of Prognosis in Patients with Thyroid Cancer after Surgery Akira Miyauchi, M.D., Ph.D. Department of Surgery Kuma Hospital Center for Excellence in Thyroid Care 10th AOTA Congress, Bali, Indonesia, October 22, 2012

  2. Risk Assessment and Risk Stratification 1. To plan the initial treatment: the extent of surgery 2. To tailor postoperative adjunctive therapies: RAI therapy and TSH suppressive therapy 3. To assess the patient’s risk for recurrence and mortality 4. To decide the frequency and intensity of follow-up 5. To enable accurate communication regarding a patient among health care professionals Risk assessment and risk stratification can be done 1. Preoperatively 2. Postoperatively 3. Following treatments 4. During follow-up

  3. Risk Assessment and Risk Stratification 1. To plan the initial treatment: the extent of surgery 2. To tailor postoperative adjunctive therapies: RAI therapy and TSH suppressive therapy 3. To assess the patient’s risk for recurrence and mortality 4. To decide the frequency and intensity of follow-up 5. To enable accurate communication regarding a patient among health care professionals Risk assessment and risk stratification can be done 1. Preoperatively 2. Postoperatively 3. Following major treatments 4. During follow-up

  4. AJCC/UICC TNM Classification System T status N status cTNM Stage M status 45 years Extent of Surgery Tumor size Extrathyroid extension Node metastasis Distant metastasis Age Gender Histological findings: aggressive variants, vascular invasion pTNM Stage Postoperative Management of the Patients: Thyroid Ablation, TSH Suppressive Therapy, Frequency and Intensity of Follow-up

  5. AJCC/UICC TNM Classification System T status N status cTNM Stage M status 45 years Extent of Surgery Tumor size Extrathyroid extension Node metastasis Distant metastasis Age Gender Histological findings: aggressive variants, vascular invasion pTNM Stage Postoperative Management of the Patients: Thyroid Ablation, TSH Suppressive Therapy, Frequency and Intensity of Follow-up

  6. AJCC/UICC TNM Classification System T status N status cTNM Stage M status 45 years Extent of Surgery Tumor size Extrathyroid extension Node metastasis Distant metastasis Age Gender Histological findings: aggressive variants, vascular invasion pTNM Stage Postoperative management of the patients: thyroid ablation, TSH suppressive therapy, frequency and intensity of follow-up

  7. ATA Risk of Recurrence Classification for Differentiated Thyroid Carcinoma Intermediate risk Any of the following is present 1) Microscopic invasion into the perithyroidalsoft tissue 2) Cervical lymph node metastasis or 131I uptake outside the thyroid bed on the RxWBS done after thyroid remnant ablation 3) Tumor with aggressive histology or vascular invasion High risk Any of the following is present 1) Macroscopic tumor invasion 2) Incomplete tumor resection 3) Distant metastases 4) Thyroglobulinemia out of proportion to what is seen on the posttreatment scan Cooper DS, et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid 19: 1167-1214, 2009. Low risk All of the following are present 1) No local or distant metastases 2) All macroscopic tumor has been resected 3) No invasion of locoregional tissues 4) No aggressive histology tall cell, insular, columnar cell carcinoma vascular invasion 5) If 131I is given, no uptake outside the thyroid bed

  8. Ongoing Risk Stratification Response to Initial Therapy Definitions Acceptable response Any of the following is present 1) Suppressed Tg < 1 ng/ml and stimulated Tg> 1ng and < 10 ng/ml 2) Neck US with nonspecific changes or stable subcentimeter lymph nodes 3) Cross-sectional and / or nuclear medicine imaging with nonspecific changes, although not completely normal Incomplete response Any of the following is present 1) Suppressed Tg> 1ng/ml or stimulated Tg> 10 ng/ml 2) Rising Tg values 3) Persistent or newly identifies disease on cross-sectional and / or nuclear medicine imaging Evaluate based on response to initial therapy during the first 2 years Tuttle RM, Leboeuf R. EndocrinolMetabClin North Am. 37:419-35, 2008. Tuttle RM, et al. Thyroid 20:1341-9, 2010. Excellent response All of the following 1) Suppressed and stimulated Tg < 1 ng/ml 2) Neck US without evidence of disease 3) Cross-sectional and / or nuclear medicine imaging negative (if performed)

  9. Re-staging Based on Response to Initial Therapy Definitions Tuttle RM, et al. Thyroid 20:1341-9, 2010.

  10. Delayed Risk Stratification Evaluated 8-12 months after the initial therapy with surgery and ablation High risk (Persistent Disease) Any of the following is present 1) Any evidence of disease on clinical examination, neck US or other imaging studies 2) Detectable basal/stimulated serum Tg Castagna MG, et al.: Delayed risk stratification, to include the response to initial treatment (surgery and radioiodine ablation), has better outcome predictivity in differentiated thyroid cancer patients. Eur J Endocrinol.165:441-6, 2011 Low risk (Clinical Remission) All of the following are present 1) Undetectable basal and stimulated Tg 2) Negative TgAb 3) No evidence of disease on clinical examination, neck US, diagnostic 131I WBS when performed

  11. 8-12 months after initial treatment New Diseased ATA High risk Intermediate/high risk Remission Low risk Low risk Diseased Remission Diseased High risk ETA High risk Remission Low risk Low risk Diseased Changes in risk groups according to delayed risk stratification Castagna MG, et al. Eur J Endocrinol 165: 441-, 2011 Remission

  12. Clinical outcome at the end of follow-up according to ETA, ATA, and DRS *P = 0.005; #P < 0.0001; ##P < 0.0001 Castagna MG, et al.: Delayed risk stratification, to include the response to initial treatment (surgery and radioiodine ablation), has better outcome predictivity in differentiated thyroid cancer patients. Eur J Endocrinol.165:441-6, 2011

  13. Proposal of an Alternative Approach In patients without thyroglobulin antibody (TgAb): Postoperative serum Tg & Thyroglobulin-doubling time (Tg-DT) 2. In patients with TgAb: Change in serum TgAb concentration Dynamic estimation of prognosis in patients with papillary thyroid carcinoma who underwent total thyroidectomy

  14. Papillary and Follicular Thyroid Carcinoma 1. Normal thyroid tissue also produces Tg. Patients who underwent total thyroidectomy 2. Presence of TgAb interferes Tg measurements. Patients without detectable TgAb 3. Serum Tg values vary according to TSH levels. Serum Tg values measured at TSH < 0.1 μIU/ml Derive from thyroid follicular cells Produce thyroglobulin (Tg) Serum Tg could be a tumor marker

  15. Papillary and Follicular Thyroid Carcinoma 1. Normal thyroid tissue also produces Tg. Patients who underwent total thyroidectomy 2. Presence of TgAb interferes Tg measurements. Patients without detectable TgAb 3. Serum Tg values vary according to TSH levels. Serum Tg values measured at TSH < 0.1 μIU/ml Derive from thyroid follicular cells Produce thyroglobulin (Tg) Serum Tg could be a tumor marker

  16. Patients with Papillary Thyroid Carcinoma Patients: 1. Underwent total thyroidectomy between January 1998 and December 2004 2. Negative TgAb test results 3. 4 or more measurements of serum Tg under TSH < 0.1 μIU/ml 426 patients (female: 349, male: 77) Age: 14 to 81 years (mean: 51.5 years) Follow up period: 20 to 143 months (median: 86.7 months)

  17. Representative results of kinetic analyses on serial serum thyroglobulin measurements log (y) = 0.708 x + 1.29 Tg-DT = 0.979 years log (y) = 0.494 x + 0.266 Tg-DT = 1.404 years ✝ Thyroglobulin (ng/ml) Thyroglobulin (ng/ml) Times (years) Times (years) log (y) = 0.138 x + 1.983 Tg-DT = 5.035 years log (y) = -0.032 x + 2.85 Tg-DT = -21.632 years Thyroglobulin (ng/ml) Thyroglobulin (ng/ml) Times (years) Times (years) Miyauchi, A. et al.: Thyroid, 21:707-709, 2011

  18. Distribution of the Patients According to Tg-DT Number of Patients according to Tg-DT calculated using Biochemically Persistent Disease Equivocal Biochemical Rem. Miyauchi, A. et al. Thyroid, 21:707-709, 2011

  19. Survival Survival 1 1 .8 .8 Stage 1 Tg-DT <1 Tg-DT 1-3 Stage 2 .6 .6 Tg-DT >3 Stage 3 Tg-DT negaive value Stage 4 .4 Tg-DT not calcutated .4 Tg not dettectable a b .2 .2 0 0 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14 Time (years) Time (years) Survival 1 .8 Tg-DT <1 Tg-DT 1-3 Tg-DT >3 .6 Tg-DT negaive value Tg-DT not calcutated .4 Tg not dettectable c .2 0 0 2 4 6 8 10 12 14 Time (years) Disease-specific survival TNM Stage Tg-DT (All data) Tg-DT (first 4 data) Miyauchi, A. et al.: Thyroid, 21:707-709, 2011

  20. Diseae-specific survival in relation to clinical, pathological and biological variables in patients with Tg-DT. Ex: extra-thyroidal extension, Ex 0: no extension, Ex 1: minimal extension, Ex 2: massive extension. For each variable, the item on the left side showed worse outcome than that on the right. On univariate analysis, data from all patients were used, while data from only patients in Groups 1 to 4 were used for multivariate analysis, since Tg-DT was not calculated in Groups 5 and 6. Miyauchi, A. et al.: Thyroid, 21:707-709, 2011

  21. Distant metastases TNM Stage Tg-DT (All data) 0 0 a b Tg-DT <1 .2 .2 Tg-DT 1-3 Stage 1 Tg-DT >3 Distant metastases Distant metastases .4 .4 Tg-DT negaive value Stage 2 Tg-DT not calcutated # Stage 3 Tg not dettectable Tg not dettectable * * Stage 4 .6 .6 # # * * .8 .8 1 1 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14 Time (years) Time (years) Tg-DT (first 4 data) 0 c .2 Tg-DT <1 Tg-DT 1-3 Tg-DT >3 .4 Distant metastases Tg-DT negaive value Tg-DT not calcutated # .6 .8 1 0 2 4 6 8 10 12 14 Time (years) Miyauchi, A. et al.: Thyroid, 21:707-709, 2011

  22. Loco-regional recurrence TNM Stage Tg-DT (All data) 0 0 a b Recurrence Recurrence Tg-DT <1 .2 .2 Stage 1 Tg-DT 1-3 Stage 2 Tg-DT >3 .4 Stage 3 .4 Tg-DT negaive value Tg-DT not calcutated Stage 4 Tg not dettectable .6 .6 .8 .8 1 1 0 2 4 6 8 10 12 14 0 2 4 6 8 10 12 14 Time (years) Time (years) Tg-DT (first 4 data) 0 c .2 Recurrence Tg-DT <1 Tg-DT 1-3 Tg-DT >3 .4 Tg-DT negaive value Tg-DT not calcutated Tg not dettectable .6 .8 1 0 2 4 6 8 10 12 14 Time (years) Miyauchi, A. et al.: Thyroid, 21:707-709, 2011

  23. TgAb Positive Patients with Papillary Thyroid Carcinoma Problem: Serum Tg measurements are unreliable. Patients who had decrease in serum TgAb concentrations following thyroid ablation had better prognosis than patients who did not, or patients who had increase in serum TgAb concentrations. Kim WG, et a.: J ClinEndocrinolMetab 93: 4683-9, 2008

  24. TgAb Positive Patients with Papillary Thyroid Carcinoma We reviewed the medical records of 225 TgAb positive patients with papillary thyroid carcinoma who underwent total thyroidectomy between April 2002 and March 2007 in Kuma Hospital and who had periodical measurements of TgAb. Most of them did not receive thyroid ablation. We evaluated the relationship between changes in serum TgAb concentrations within 2 years and prognosis.

  25. Changes in TgAb Concentration within 2 years

  26. Outcome in Relation to Changes in TgAb Concentrations

  27. Disease Free Survivals According to Change in TgAbConcentration Loco-regional recurrence free survival Decreased Decreased Distant metastasis free survival Not decreased Not decreased Years after surgery Years after surgery

  28. Analysis on prognostic factors for distant metastases Univariate analysis Multivariate analysis

  29. Analysis on prognostic factors for loco-regional recurrence Univariate analysis Multivariate analysis

  30. 10874XXX 67 y-o woman with PTC Surgery TgAb PTC 1.7 cm Total thyroidectomy with CND Pathological Dx: PTC, pT3, pN0, MIB1 LI 2+ (5-10%)

  31. Dynamic Estimation of Prognosis for Patients with Papillary Thyroid Carcinoma Preoperatively: cTNMStage Extent of Surgery After Total Thyroidectomy: Patients without TgAb Patients with TgAb Change in serum TgAb Tg & Tg-DT Dynamic evaluation Postoperative managements: thyroid ablation, TSH suppressive therapy, frequency and intensity of follow-up.

  32. Dynamic Estimation of Prognosis for Patients with Papillary Thyroid Carcinoma Preoperatively: cTNMStage Extent of Surgery After Total Thyroidectomy: Patients without TgAb Patients with TgAb Change in serum TgAb Tg & Tg-DT Dynamic evaluation Postoperative managements: thyroid ablation, TSH suppressive therapy, frequency and intensity of follow-up.

  33. Thank you for your attention. From Kobe to the world.

  34. 59 y-o woman with papillary carcinoma Total thyroidectomy with left MND in May 2006. Pathology: papillary thyroid carcinoma with columnar cell, solid, trabecular, and insular component

  35. 59 y-o woman with PTC Electronic medical record system in Kuma Hospital Surgery 131I 13 mCi 131I 100 mCi Thyroglobulin TSH

  36. 59 y-o woman with PTC Electronic medical record system in Kuma Hospital Surgery 131I 13 mCi 131I 100 mCi Thyroglobulin TSH

  37. Doubling Time Calculator 59 y-o woman with PTC Tg-DT (years) Date Tg

  38. 59 y-o woman with PTC

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