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Persistent HPV16 DNA in oral rinse signaled oropharyngeal cancer’s return
Patients with human papillomavirus–related oropharyngeal carcinoma (HPV-OPC) who had human papillomavirus type 16 (HPV16) detected in oral rinses both at diagnosis and at any time after treatment were more likely to have OPC recurrence, according to a report published online in JAMA Oncology.
Detection of HPV16 DNA was frequent among patients at diagnosis (67 of 124 patients), but rare posttreatment (6 of 124 patients). Persistent HPV16 detection (at and after diagnosis) was associated with greater risk of disease recurrence (hazard ratio, 29.7) and death (HR, 23.5).
Approximately 10%-25% of patients with HPV-OPC experience progression after treatment, and surgical salvage is the most favorable treatment in these cases. However, surgery is not feasible for the significant proportion of HPV-OPC cases that have already spread to distant sites at the time of diagnosis.
“There is a need for clinically relevant biomarkers of disease recurrence to facilitate timely initiation of aggressive diagnostic investigation and subsequent salvage treatment to potentially improve outcomes for the growing population of HPV-OPC survivors,” wrote Dr. Eleni M. Rettig of the department of otolaryngology–head and neck surgery, Johns Hopkins University, Baltimore, and her colleagues (JAMA Oncol. 2015 July 30 [doi:10.1001/jamaoncol.2015.2524]).
“Detection of recurrent local or locoregional disease prior to distant spread is particularly desirable given the favorable response of HPV-OPC to surgical salvage,” the study authors observed.
The multisite, prospective cohort study evaluated 124 patients with HPV-related oropharyngeal carcinoma who had at least one posttreatment oral rinse sample. Most patients with HPV16 DNA detected at diagnosis had none detected after treatment (62 of 67 patients). Contrary to persistent HPV16 DNA detection, HPV16 detected at diagnosis was not significantly associated with disease-free or overall survival.
Based on the six patients who had posttreatment detection of HPV16 DNA in oral rinses, the sensitivity and specificity of predicting recurrence at 9-12 months were 43% and 100%, respectively. Considering only local disease recurrence, the sensitivity and specificity were 100% and 100%, respectively.
The median time from the first posttreatment detection of HPV16 DNA to recurrence was 7.0 months. That “clinically meaningful lead time” is important in evaluating HPV16 DNA detection in oral rinses as “a valuable tool for long-term posttreatment surveillance of HPV-OPC for local recurrence,” the investigators concluded.
Dr. Rettig reported having no disclosures. Several coauthors reported ties to industry sources.
HPV16 DNA was detected in oral rinses in just 54% of patients with HPV-OPC at diagnosis. This low sensitivity in the presence of gross disease calls into question the test’s utility as a biomarker for subclinical disease. The positive predictive value (PPV) of 83%, calculated based on five of six patients who had persistent HPV16 DNA detection and disease recurrence, requires further analysis.
First, the persistence criteria immediately eliminates the 46% of patients who had HPV-OPC but tested negative for HPV16 DNA at diagnosis. Second, the intent of the biomarker is early detection of local or locoregional recurrence, but only two of the patients had local or locoregional recurrence prompting surgical salvage.
Detection of HPV16 DNA had a median lead time of 7 months, but clinical utility of the test requires some assumptions about the natural course of HPV-OPC. First, local or locoregional recurrence must precede the spread of disease to distant sites; second, earlier surgical salvage must prevent systemic reseeding; and finally, the oral rinse test must be robust enough to warrant salvage surgery in the absence of measurable disease.
The operating characteristics of the HPV16 DNA oral rinse test (e.g., low sensitivity and low confidence in PPV) preclude clinical adoption. However, the high negative predictive value of the test may be useful as criteria to scale back surveillance visits and/or costly imaging, particularly during prospective trials.
Dr. Julie E. Bauman is director of the head and neck cancer section in the division of hematology-oncology at the University of Pittsburgh. Dr. Robert L. Ferris is chief, division of head and neck surgery at the University of Pittsburgh. Dr. Bauman and Dr. Ferris reported no conflicts of interest. These comments were taken from their editorial accompanying the study (JAMA Oncol. 2015 July 30 [doi:10.1001/jamaoncol.2015.2606]).
HPV16 DNA was detected in oral rinses in just 54% of patients with HPV-OPC at diagnosis. This low sensitivity in the presence of gross disease calls into question the test’s utility as a biomarker for subclinical disease. The positive predictive value (PPV) of 83%, calculated based on five of six patients who had persistent HPV16 DNA detection and disease recurrence, requires further analysis.
First, the persistence criteria immediately eliminates the 46% of patients who had HPV-OPC but tested negative for HPV16 DNA at diagnosis. Second, the intent of the biomarker is early detection of local or locoregional recurrence, but only two of the patients had local or locoregional recurrence prompting surgical salvage.
Detection of HPV16 DNA had a median lead time of 7 months, but clinical utility of the test requires some assumptions about the natural course of HPV-OPC. First, local or locoregional recurrence must precede the spread of disease to distant sites; second, earlier surgical salvage must prevent systemic reseeding; and finally, the oral rinse test must be robust enough to warrant salvage surgery in the absence of measurable disease.
The operating characteristics of the HPV16 DNA oral rinse test (e.g., low sensitivity and low confidence in PPV) preclude clinical adoption. However, the high negative predictive value of the test may be useful as criteria to scale back surveillance visits and/or costly imaging, particularly during prospective trials.
Dr. Julie E. Bauman is director of the head and neck cancer section in the division of hematology-oncology at the University of Pittsburgh. Dr. Robert L. Ferris is chief, division of head and neck surgery at the University of Pittsburgh. Dr. Bauman and Dr. Ferris reported no conflicts of interest. These comments were taken from their editorial accompanying the study (JAMA Oncol. 2015 July 30 [doi:10.1001/jamaoncol.2015.2606]).
HPV16 DNA was detected in oral rinses in just 54% of patients with HPV-OPC at diagnosis. This low sensitivity in the presence of gross disease calls into question the test’s utility as a biomarker for subclinical disease. The positive predictive value (PPV) of 83%, calculated based on five of six patients who had persistent HPV16 DNA detection and disease recurrence, requires further analysis.
First, the persistence criteria immediately eliminates the 46% of patients who had HPV-OPC but tested negative for HPV16 DNA at diagnosis. Second, the intent of the biomarker is early detection of local or locoregional recurrence, but only two of the patients had local or locoregional recurrence prompting surgical salvage.
Detection of HPV16 DNA had a median lead time of 7 months, but clinical utility of the test requires some assumptions about the natural course of HPV-OPC. First, local or locoregional recurrence must precede the spread of disease to distant sites; second, earlier surgical salvage must prevent systemic reseeding; and finally, the oral rinse test must be robust enough to warrant salvage surgery in the absence of measurable disease.
The operating characteristics of the HPV16 DNA oral rinse test (e.g., low sensitivity and low confidence in PPV) preclude clinical adoption. However, the high negative predictive value of the test may be useful as criteria to scale back surveillance visits and/or costly imaging, particularly during prospective trials.
Dr. Julie E. Bauman is director of the head and neck cancer section in the division of hematology-oncology at the University of Pittsburgh. Dr. Robert L. Ferris is chief, division of head and neck surgery at the University of Pittsburgh. Dr. Bauman and Dr. Ferris reported no conflicts of interest. These comments were taken from their editorial accompanying the study (JAMA Oncol. 2015 July 30 [doi:10.1001/jamaoncol.2015.2606]).
Patients with human papillomavirus–related oropharyngeal carcinoma (HPV-OPC) who had human papillomavirus type 16 (HPV16) detected in oral rinses both at diagnosis and at any time after treatment were more likely to have OPC recurrence, according to a report published online in JAMA Oncology.
Detection of HPV16 DNA was frequent among patients at diagnosis (67 of 124 patients), but rare posttreatment (6 of 124 patients). Persistent HPV16 detection (at and after diagnosis) was associated with greater risk of disease recurrence (hazard ratio, 29.7) and death (HR, 23.5).
Approximately 10%-25% of patients with HPV-OPC experience progression after treatment, and surgical salvage is the most favorable treatment in these cases. However, surgery is not feasible for the significant proportion of HPV-OPC cases that have already spread to distant sites at the time of diagnosis.
“There is a need for clinically relevant biomarkers of disease recurrence to facilitate timely initiation of aggressive diagnostic investigation and subsequent salvage treatment to potentially improve outcomes for the growing population of HPV-OPC survivors,” wrote Dr. Eleni M. Rettig of the department of otolaryngology–head and neck surgery, Johns Hopkins University, Baltimore, and her colleagues (JAMA Oncol. 2015 July 30 [doi:10.1001/jamaoncol.2015.2524]).
“Detection of recurrent local or locoregional disease prior to distant spread is particularly desirable given the favorable response of HPV-OPC to surgical salvage,” the study authors observed.
The multisite, prospective cohort study evaluated 124 patients with HPV-related oropharyngeal carcinoma who had at least one posttreatment oral rinse sample. Most patients with HPV16 DNA detected at diagnosis had none detected after treatment (62 of 67 patients). Contrary to persistent HPV16 DNA detection, HPV16 detected at diagnosis was not significantly associated with disease-free or overall survival.
Based on the six patients who had posttreatment detection of HPV16 DNA in oral rinses, the sensitivity and specificity of predicting recurrence at 9-12 months were 43% and 100%, respectively. Considering only local disease recurrence, the sensitivity and specificity were 100% and 100%, respectively.
The median time from the first posttreatment detection of HPV16 DNA to recurrence was 7.0 months. That “clinically meaningful lead time” is important in evaluating HPV16 DNA detection in oral rinses as “a valuable tool for long-term posttreatment surveillance of HPV-OPC for local recurrence,” the investigators concluded.
Dr. Rettig reported having no disclosures. Several coauthors reported ties to industry sources.
Patients with human papillomavirus–related oropharyngeal carcinoma (HPV-OPC) who had human papillomavirus type 16 (HPV16) detected in oral rinses both at diagnosis and at any time after treatment were more likely to have OPC recurrence, according to a report published online in JAMA Oncology.
Detection of HPV16 DNA was frequent among patients at diagnosis (67 of 124 patients), but rare posttreatment (6 of 124 patients). Persistent HPV16 detection (at and after diagnosis) was associated with greater risk of disease recurrence (hazard ratio, 29.7) and death (HR, 23.5).
Approximately 10%-25% of patients with HPV-OPC experience progression after treatment, and surgical salvage is the most favorable treatment in these cases. However, surgery is not feasible for the significant proportion of HPV-OPC cases that have already spread to distant sites at the time of diagnosis.
“There is a need for clinically relevant biomarkers of disease recurrence to facilitate timely initiation of aggressive diagnostic investigation and subsequent salvage treatment to potentially improve outcomes for the growing population of HPV-OPC survivors,” wrote Dr. Eleni M. Rettig of the department of otolaryngology–head and neck surgery, Johns Hopkins University, Baltimore, and her colleagues (JAMA Oncol. 2015 July 30 [doi:10.1001/jamaoncol.2015.2524]).
“Detection of recurrent local or locoregional disease prior to distant spread is particularly desirable given the favorable response of HPV-OPC to surgical salvage,” the study authors observed.
The multisite, prospective cohort study evaluated 124 patients with HPV-related oropharyngeal carcinoma who had at least one posttreatment oral rinse sample. Most patients with HPV16 DNA detected at diagnosis had none detected after treatment (62 of 67 patients). Contrary to persistent HPV16 DNA detection, HPV16 detected at diagnosis was not significantly associated with disease-free or overall survival.
Based on the six patients who had posttreatment detection of HPV16 DNA in oral rinses, the sensitivity and specificity of predicting recurrence at 9-12 months were 43% and 100%, respectively. Considering only local disease recurrence, the sensitivity and specificity were 100% and 100%, respectively.
The median time from the first posttreatment detection of HPV16 DNA to recurrence was 7.0 months. That “clinically meaningful lead time” is important in evaluating HPV16 DNA detection in oral rinses as “a valuable tool for long-term posttreatment surveillance of HPV-OPC for local recurrence,” the investigators concluded.
Dr. Rettig reported having no disclosures. Several coauthors reported ties to industry sources.
FROM JAMA ONCOLOGY
Key clinical point: Persistent human papillomavirus type 16 (HPV16) DNA detected in posttreatment oral rinses, although infrequent, was associated with HPV-related oropharyngeal carcinoma.
Major finding: Detection of HPV16 DNA in oral rinses both at diagnosis and at any time after treatment was associated with increased risk of recurrence (hazard ratio, 29.7) and death (HR, 23.5).
Data source: The multisite, prospective cohort study evaluated 124 patients with HPV-related oropharyngeal carcinoma who had at least one posttreatment oral rinse sample.
Disclosures: Dr. Rettig reported having no disclosures. Several coauthors reported ties to industry sources.
Similar outcomes for salvage vs. planned surgery after chemoradiotherapy in esophageal cancer
For patients with esophageal cancer, salvage surgery after definitive chemoradiotherapy had similar mortality and morbidity rates, and similar survival outcomes, to the combination of neoadjuvant chemoradiation and planned surgery, according to a study published online in the Journal of Clinical Oncology.
Definitive chemoradiotherapy (dCRT) is an alternative to highly invasive surgical resection, which carries a significant rate of morbidity and mortality; however, recent data indicate that 50% of patients with complete response to dCRT experience tumor recurrence.
“Our study demonstrated a similar survival and recurrence pattern for the SALV [salvage surgery after definitive chemoradiotherapy] and NCRS [neoadjuvant chemoradiation and planned surgery] groups, potentially validating an approach of dCRT with reserved SALV for persistent or recurrent disease. Importantly, there were no differences in oncologic safety of surgery, including extent of nodal dissection, between the SALV and NCRS groups,” wrote Dr. Sheraz Markar, a clinical research fellow from Imperial College, London, and colleagues (Journ. Clin. Onc. 2015 July 20 [doi:10.1200/JCO.2014.59.9092]).
The retrospective study compared 308 patients with esophageal cancer who underwent SALV with 540 patients who received NCRS at European centers from 2000 to 2010. After a median follow up of 54 months, the SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%). The two groups also had similar rates tumor recurrence: overall (46.8% vs. 47.9%), locoregional (18.8% vs. 15.9%), distant (24.3% vs. 28.1%) and mixed (13.0% vs. 13.5%).
The SALV and NCRS groups had similar rates of in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%), but SALV patients had significantly more complications from anastomotic leak (17.2% vs. 10.7%) and surgical site infection (18.5% vs. 12.2%).
Subset analysis of the SALV group showed that patients who received a total radiation dose ≥ 55 Gy (compared with SALV patients who received a lower dose) had significantly increased in-hospital mortality (27.8% vs. 4.3%; P < .001), overall morbidity (75.9% vs. 61%; P = .039), anastomotic leak (27.8% vs. 15%; P = .023), surgical site infection (29.6% vs. 16.1%; P = .02), and pulmonary complications (55.6% vs. 40.2%; P = .038).
“Currently, there is no evidence in terms of locoregional control or survival benefit to support a high total radiation dose (> 50 Gy) in patients receiving dCRT,” according to the researchers, who noted that the findings suggest, “an upper threshold of 50 Gy should be used in these patients to optimize the benefits of dCRT without compromising the safety of SALV, if required.”
Patients who underwent SALV at high-volume centers had significantly lower rates of in-hospital mortality (6.3% vs. 16.2%; P = .009) and overall morbidity (58.8% vs. 80.9%; P = .001) compared with procedures done at low-volume centers.
Compared with recurrent disease, patients with persistent disease after dCRT had poorer long-term prognoses, suggesting a more aggressive tumor biology. Early identification of CRT-resistant tumors to allow early surgical treatment is an important area for future investigation, the investigators said.
For patients with esophageal cancer, salvage surgery after definitive chemoradiotherapy had similar mortality and morbidity rates, and similar survival outcomes, to the combination of neoadjuvant chemoradiation and planned surgery, according to a study published online in the Journal of Clinical Oncology.
Definitive chemoradiotherapy (dCRT) is an alternative to highly invasive surgical resection, which carries a significant rate of morbidity and mortality; however, recent data indicate that 50% of patients with complete response to dCRT experience tumor recurrence.
“Our study demonstrated a similar survival and recurrence pattern for the SALV [salvage surgery after definitive chemoradiotherapy] and NCRS [neoadjuvant chemoradiation and planned surgery] groups, potentially validating an approach of dCRT with reserved SALV for persistent or recurrent disease. Importantly, there were no differences in oncologic safety of surgery, including extent of nodal dissection, between the SALV and NCRS groups,” wrote Dr. Sheraz Markar, a clinical research fellow from Imperial College, London, and colleagues (Journ. Clin. Onc. 2015 July 20 [doi:10.1200/JCO.2014.59.9092]).
The retrospective study compared 308 patients with esophageal cancer who underwent SALV with 540 patients who received NCRS at European centers from 2000 to 2010. After a median follow up of 54 months, the SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%). The two groups also had similar rates tumor recurrence: overall (46.8% vs. 47.9%), locoregional (18.8% vs. 15.9%), distant (24.3% vs. 28.1%) and mixed (13.0% vs. 13.5%).
The SALV and NCRS groups had similar rates of in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%), but SALV patients had significantly more complications from anastomotic leak (17.2% vs. 10.7%) and surgical site infection (18.5% vs. 12.2%).
Subset analysis of the SALV group showed that patients who received a total radiation dose ≥ 55 Gy (compared with SALV patients who received a lower dose) had significantly increased in-hospital mortality (27.8% vs. 4.3%; P < .001), overall morbidity (75.9% vs. 61%; P = .039), anastomotic leak (27.8% vs. 15%; P = .023), surgical site infection (29.6% vs. 16.1%; P = .02), and pulmonary complications (55.6% vs. 40.2%; P = .038).
“Currently, there is no evidence in terms of locoregional control or survival benefit to support a high total radiation dose (> 50 Gy) in patients receiving dCRT,” according to the researchers, who noted that the findings suggest, “an upper threshold of 50 Gy should be used in these patients to optimize the benefits of dCRT without compromising the safety of SALV, if required.”
Patients who underwent SALV at high-volume centers had significantly lower rates of in-hospital mortality (6.3% vs. 16.2%; P = .009) and overall morbidity (58.8% vs. 80.9%; P = .001) compared with procedures done at low-volume centers.
Compared with recurrent disease, patients with persistent disease after dCRT had poorer long-term prognoses, suggesting a more aggressive tumor biology. Early identification of CRT-resistant tumors to allow early surgical treatment is an important area for future investigation, the investigators said.
For patients with esophageal cancer, salvage surgery after definitive chemoradiotherapy had similar mortality and morbidity rates, and similar survival outcomes, to the combination of neoadjuvant chemoradiation and planned surgery, according to a study published online in the Journal of Clinical Oncology.
Definitive chemoradiotherapy (dCRT) is an alternative to highly invasive surgical resection, which carries a significant rate of morbidity and mortality; however, recent data indicate that 50% of patients with complete response to dCRT experience tumor recurrence.
“Our study demonstrated a similar survival and recurrence pattern for the SALV [salvage surgery after definitive chemoradiotherapy] and NCRS [neoadjuvant chemoradiation and planned surgery] groups, potentially validating an approach of dCRT with reserved SALV for persistent or recurrent disease. Importantly, there were no differences in oncologic safety of surgery, including extent of nodal dissection, between the SALV and NCRS groups,” wrote Dr. Sheraz Markar, a clinical research fellow from Imperial College, London, and colleagues (Journ. Clin. Onc. 2015 July 20 [doi:10.1200/JCO.2014.59.9092]).
The retrospective study compared 308 patients with esophageal cancer who underwent SALV with 540 patients who received NCRS at European centers from 2000 to 2010. After a median follow up of 54 months, the SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%). The two groups also had similar rates tumor recurrence: overall (46.8% vs. 47.9%), locoregional (18.8% vs. 15.9%), distant (24.3% vs. 28.1%) and mixed (13.0% vs. 13.5%).
The SALV and NCRS groups had similar rates of in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%), but SALV patients had significantly more complications from anastomotic leak (17.2% vs. 10.7%) and surgical site infection (18.5% vs. 12.2%).
Subset analysis of the SALV group showed that patients who received a total radiation dose ≥ 55 Gy (compared with SALV patients who received a lower dose) had significantly increased in-hospital mortality (27.8% vs. 4.3%; P < .001), overall morbidity (75.9% vs. 61%; P = .039), anastomotic leak (27.8% vs. 15%; P = .023), surgical site infection (29.6% vs. 16.1%; P = .02), and pulmonary complications (55.6% vs. 40.2%; P = .038).
“Currently, there is no evidence in terms of locoregional control or survival benefit to support a high total radiation dose (> 50 Gy) in patients receiving dCRT,” according to the researchers, who noted that the findings suggest, “an upper threshold of 50 Gy should be used in these patients to optimize the benefits of dCRT without compromising the safety of SALV, if required.”
Patients who underwent SALV at high-volume centers had significantly lower rates of in-hospital mortality (6.3% vs. 16.2%; P = .009) and overall morbidity (58.8% vs. 80.9%; P = .001) compared with procedures done at low-volume centers.
Compared with recurrent disease, patients with persistent disease after dCRT had poorer long-term prognoses, suggesting a more aggressive tumor biology. Early identification of CRT-resistant tumors to allow early surgical treatment is an important area for future investigation, the investigators said.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: As management for esophageal cancer, salvage esophagectomy after definitive chemoradiotherapy (SALV) produced similar outcomes to the combination of neoadjuvant chemoradiation and planned surgery (NCRS).
Major finding: The SALV and NCRS groups had similar rates of 3-year overall survival (43.3% vs. 40.1% ) and disease-free survival (39.2% vs. 32.8%), tumor recurrence (46.8% vs. 47.9%), and in-hospital mortality (8.4% vs. 9.3%) and morbidity (63.6% vs. 58.9%).
Data source: Retrospective analysis of 848 patients (308 SALV, 540 NCRS) who underwent surgical resection for esophageal cancer in French-speaking European centers from 2000 to 2010.
Disclosures: Dr. Markar reported having no disclosures. Two of his coauthors reported ties to industry.
Harnessing new data on immunotherapies
Immunotherapies once again took center stage at the 2015 annual meeting of the American Society for Clinical Oncology in Chicago, though many other groundbreaking clinical advances were also presented. The meeting’s theme, “Illumination and innovation: transforming data into learning,” captured the current focus, by both researchers and practicing oncologists, on the importance of being able to draw on new and enticing data and use it as the basis for improving the care of and outcomes for cancer patients.
CheckMate 067: Two immunotherapies better than one for advanced melanoma
Key clinical point Nivolumab alone or combined with ipilimumab significantly improves progression-free survival (PFS) and objective response rates (ORRs), compared with ipilimumab alone in previously untreated metastatic melanoma. Major finding Median PFS was 11.5 months with nivolumab plus ipilimumab, 6.9 months with nivolumab, and 2.9 months with ipilimumab. Data source Phase 3, double-blind randomized trial in 945 patients with previously untreated metastatic melanoma. Disclosures Bristol-Myers Squibb funded the trial. Dr Wolchok reported financial relationships with several firms including research funding from and consulting or advising for Bristol-Myers Squibb…
Click on the PDF icon at the top of this introduction to read the full article.
Immunotherapies once again took center stage at the 2015 annual meeting of the American Society for Clinical Oncology in Chicago, though many other groundbreaking clinical advances were also presented. The meeting’s theme, “Illumination and innovation: transforming data into learning,” captured the current focus, by both researchers and practicing oncologists, on the importance of being able to draw on new and enticing data and use it as the basis for improving the care of and outcomes for cancer patients.
CheckMate 067: Two immunotherapies better than one for advanced melanoma
Key clinical point Nivolumab alone or combined with ipilimumab significantly improves progression-free survival (PFS) and objective response rates (ORRs), compared with ipilimumab alone in previously untreated metastatic melanoma. Major finding Median PFS was 11.5 months with nivolumab plus ipilimumab, 6.9 months with nivolumab, and 2.9 months with ipilimumab. Data source Phase 3, double-blind randomized trial in 945 patients with previously untreated metastatic melanoma. Disclosures Bristol-Myers Squibb funded the trial. Dr Wolchok reported financial relationships with several firms including research funding from and consulting or advising for Bristol-Myers Squibb…
Click on the PDF icon at the top of this introduction to read the full article.
Immunotherapies once again took center stage at the 2015 annual meeting of the American Society for Clinical Oncology in Chicago, though many other groundbreaking clinical advances were also presented. The meeting’s theme, “Illumination and innovation: transforming data into learning,” captured the current focus, by both researchers and practicing oncologists, on the importance of being able to draw on new and enticing data and use it as the basis for improving the care of and outcomes for cancer patients.
CheckMate 067: Two immunotherapies better than one for advanced melanoma
Key clinical point Nivolumab alone or combined with ipilimumab significantly improves progression-free survival (PFS) and objective response rates (ORRs), compared with ipilimumab alone in previously untreated metastatic melanoma. Major finding Median PFS was 11.5 months with nivolumab plus ipilimumab, 6.9 months with nivolumab, and 2.9 months with ipilimumab. Data source Phase 3, double-blind randomized trial in 945 patients with previously untreated metastatic melanoma. Disclosures Bristol-Myers Squibb funded the trial. Dr Wolchok reported financial relationships with several firms including research funding from and consulting or advising for Bristol-Myers Squibb…
Click on the PDF icon at the top of this introduction to read the full article.
A weekly speech and language therapy service for head and neck radiotherapy patients during treatment: maximizing accessibility and efficiency
Background Our hospital did not provide a weekly speech and language therapy (SLT) service for head and neck cancer patients during radiotherapy treatment. SLT is recommended in the international guidelines, but many centers do not offer this service. In the case of our hospital, SLT was not provided because there were no funds to cover the costs of additional staff.
Objectives To create a new service model within a multidisciplinary setting to comply with the international SLT guidelines and without increasing staff. We aimed to measure the accessibility and efficiency of a new model of service delivery at our center both for patients and for the service.
Methods 79 patients were recruited for the study. We followed 1 group of patients (n = 29; observation group) throughout their treatment for 6 weeks to establish if there was a clinical need to offer SLT at the treatment center. A second group of patients (n = 50; intervention group) received a weekly SLT review at the treatment center throughout their radiotherapy. Data collected at the tertiary cancer center for 6 months included: age, gender, tumor site and size, treatment modality, swallowing outcomes, communication outcomes, patient satisfaction, multidisciplinary team feedback, and time efficiency. The observation group did not participate in the intervention group because the data was collected between 2 different groups of participants. However, all participants were referred to their local SLT service at the end of their treatment if that was clinically indicated, regardless of the group they had been in.
Results The proportion of patients accessing SLT services during treatment and the time efficiency of the service were both improved with this model of delivery. The service’s compliance with international guidelines was met. More patients continued with oral intake during their treatment at our center with the new service. Improvements were also reported in communication clarity and communication confidence in the same group.
Conclusion Offering head and neck cancer patients SLT at the same time and place as their radiotherapy treatment improves patient outcomes and increases SLT efficiencies. As this was not a treatment study, further clinical trials are required with regards to functional outcomes.
Click on the PDF icon at the top of this introduction to read the full article.
Background Our hospital did not provide a weekly speech and language therapy (SLT) service for head and neck cancer patients during radiotherapy treatment. SLT is recommended in the international guidelines, but many centers do not offer this service. In the case of our hospital, SLT was not provided because there were no funds to cover the costs of additional staff.
Objectives To create a new service model within a multidisciplinary setting to comply with the international SLT guidelines and without increasing staff. We aimed to measure the accessibility and efficiency of a new model of service delivery at our center both for patients and for the service.
Methods 79 patients were recruited for the study. We followed 1 group of patients (n = 29; observation group) throughout their treatment for 6 weeks to establish if there was a clinical need to offer SLT at the treatment center. A second group of patients (n = 50; intervention group) received a weekly SLT review at the treatment center throughout their radiotherapy. Data collected at the tertiary cancer center for 6 months included: age, gender, tumor site and size, treatment modality, swallowing outcomes, communication outcomes, patient satisfaction, multidisciplinary team feedback, and time efficiency. The observation group did not participate in the intervention group because the data was collected between 2 different groups of participants. However, all participants were referred to their local SLT service at the end of their treatment if that was clinically indicated, regardless of the group they had been in.
Results The proportion of patients accessing SLT services during treatment and the time efficiency of the service were both improved with this model of delivery. The service’s compliance with international guidelines was met. More patients continued with oral intake during their treatment at our center with the new service. Improvements were also reported in communication clarity and communication confidence in the same group.
Conclusion Offering head and neck cancer patients SLT at the same time and place as their radiotherapy treatment improves patient outcomes and increases SLT efficiencies. As this was not a treatment study, further clinical trials are required with regards to functional outcomes.
Click on the PDF icon at the top of this introduction to read the full article.
Background Our hospital did not provide a weekly speech and language therapy (SLT) service for head and neck cancer patients during radiotherapy treatment. SLT is recommended in the international guidelines, but many centers do not offer this service. In the case of our hospital, SLT was not provided because there were no funds to cover the costs of additional staff.
Objectives To create a new service model within a multidisciplinary setting to comply with the international SLT guidelines and without increasing staff. We aimed to measure the accessibility and efficiency of a new model of service delivery at our center both for patients and for the service.
Methods 79 patients were recruited for the study. We followed 1 group of patients (n = 29; observation group) throughout their treatment for 6 weeks to establish if there was a clinical need to offer SLT at the treatment center. A second group of patients (n = 50; intervention group) received a weekly SLT review at the treatment center throughout their radiotherapy. Data collected at the tertiary cancer center for 6 months included: age, gender, tumor site and size, treatment modality, swallowing outcomes, communication outcomes, patient satisfaction, multidisciplinary team feedback, and time efficiency. The observation group did not participate in the intervention group because the data was collected between 2 different groups of participants. However, all participants were referred to their local SLT service at the end of their treatment if that was clinically indicated, regardless of the group they had been in.
Results The proportion of patients accessing SLT services during treatment and the time efficiency of the service were both improved with this model of delivery. The service’s compliance with international guidelines was met. More patients continued with oral intake during their treatment at our center with the new service. Improvements were also reported in communication clarity and communication confidence in the same group.
Conclusion Offering head and neck cancer patients SLT at the same time and place as their radiotherapy treatment improves patient outcomes and increases SLT efficiencies. As this was not a treatment study, further clinical trials are required with regards to functional outcomes.
Click on the PDF icon at the top of this introduction to read the full article.
ASCO 2015: from data and learning, to daily practice
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Click on the PDF icon at the top of this introduction to read the full article.
Moderate THST was most effective at treating thyroid cancer
Moderate thyroid hormone suppression therapy (THST) is associated with the best outcomes for patients with all stages of thyroid cancer, according to a prospective analysis of a multi-institutional registry published in the Journal of Clinical Endocrinology & Metabolism.
The researchers examined the outcomes of initial treatment for 4,941 patients with differentiated thyroid cancer (DTC), according to registry data from the National Thyroid Cancer Treatment Cooperative Study Group. The treatments included total/near total thyroidectomy (T/NTT), postoperative radioactive iodine-131 (131I), and THST. The median duration between treatment and follow-up for a patient was 6 years, with follow-up information available for all but 94 (1.9%) of the patients in the cohort.
Overall improvement was noted in stage III patients who received 131I (risk ratio, 0.66; P = .04) and stage IV patients who received both T/NTT and 131I (RR, 0.66; P = .049). In all stages, moderate THST was associated with significantly improved overall survival (RR stages I-IV: 0.13, 0.09, 0.13, and 0.33, respectively) and disease-free survival (DFS) (RR stages I-III: 0.52, 0.40, and 0.18, respectively); no additional survival benefit was achieved with more aggressive THST, even when distant metastatic disease was diagnosed during follow-up.
Lower initial stage and moderate THST were independent predictors of improved overall survival during follow-up years 1-3.
Consistent with previous research, this study also showed that T/NTT followed by 131I is associated with benefit in high-risk, but not low-risk patients.
“We report for the first time, in multivariate analysis of primary treatments for DTC, across all stages, only THST was associated with both improved stage-adjusted OS and DFS,” noted Dr. Aubrey A. Carhill and his colleagues.
“This analysis of the larger, more mature registry database extends and refines earlier observations regarding the impact of initial therapies on patient outcomes and further justifies the need for prospective, long-term, controlled studies,” the researchers noted.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2015-1346).
Moderate thyroid hormone suppression therapy (THST) is associated with the best outcomes for patients with all stages of thyroid cancer, according to a prospective analysis of a multi-institutional registry published in the Journal of Clinical Endocrinology & Metabolism.
The researchers examined the outcomes of initial treatment for 4,941 patients with differentiated thyroid cancer (DTC), according to registry data from the National Thyroid Cancer Treatment Cooperative Study Group. The treatments included total/near total thyroidectomy (T/NTT), postoperative radioactive iodine-131 (131I), and THST. The median duration between treatment and follow-up for a patient was 6 years, with follow-up information available for all but 94 (1.9%) of the patients in the cohort.
Overall improvement was noted in stage III patients who received 131I (risk ratio, 0.66; P = .04) and stage IV patients who received both T/NTT and 131I (RR, 0.66; P = .049). In all stages, moderate THST was associated with significantly improved overall survival (RR stages I-IV: 0.13, 0.09, 0.13, and 0.33, respectively) and disease-free survival (DFS) (RR stages I-III: 0.52, 0.40, and 0.18, respectively); no additional survival benefit was achieved with more aggressive THST, even when distant metastatic disease was diagnosed during follow-up.
Lower initial stage and moderate THST were independent predictors of improved overall survival during follow-up years 1-3.
Consistent with previous research, this study also showed that T/NTT followed by 131I is associated with benefit in high-risk, but not low-risk patients.
“We report for the first time, in multivariate analysis of primary treatments for DTC, across all stages, only THST was associated with both improved stage-adjusted OS and DFS,” noted Dr. Aubrey A. Carhill and his colleagues.
“This analysis of the larger, more mature registry database extends and refines earlier observations regarding the impact of initial therapies on patient outcomes and further justifies the need for prospective, long-term, controlled studies,” the researchers noted.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2015-1346).
Moderate thyroid hormone suppression therapy (THST) is associated with the best outcomes for patients with all stages of thyroid cancer, according to a prospective analysis of a multi-institutional registry published in the Journal of Clinical Endocrinology & Metabolism.
The researchers examined the outcomes of initial treatment for 4,941 patients with differentiated thyroid cancer (DTC), according to registry data from the National Thyroid Cancer Treatment Cooperative Study Group. The treatments included total/near total thyroidectomy (T/NTT), postoperative radioactive iodine-131 (131I), and THST. The median duration between treatment and follow-up for a patient was 6 years, with follow-up information available for all but 94 (1.9%) of the patients in the cohort.
Overall improvement was noted in stage III patients who received 131I (risk ratio, 0.66; P = .04) and stage IV patients who received both T/NTT and 131I (RR, 0.66; P = .049). In all stages, moderate THST was associated with significantly improved overall survival (RR stages I-IV: 0.13, 0.09, 0.13, and 0.33, respectively) and disease-free survival (DFS) (RR stages I-III: 0.52, 0.40, and 0.18, respectively); no additional survival benefit was achieved with more aggressive THST, even when distant metastatic disease was diagnosed during follow-up.
Lower initial stage and moderate THST were independent predictors of improved overall survival during follow-up years 1-3.
Consistent with previous research, this study also showed that T/NTT followed by 131I is associated with benefit in high-risk, but not low-risk patients.
“We report for the first time, in multivariate analysis of primary treatments for DTC, across all stages, only THST was associated with both improved stage-adjusted OS and DFS,” noted Dr. Aubrey A. Carhill and his colleagues.
“This analysis of the larger, more mature registry database extends and refines earlier observations regarding the impact of initial therapies on patient outcomes and further justifies the need for prospective, long-term, controlled studies,” the researchers noted.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2015-1346).
New guidelines focus on pediatric thyroid nodules and cancer
The evaluation and treatment of thyroid nodules in children should differ from evaluation and treatment in adults in that ultrasound characteristics and clinical context should be used rather than size alone to identify nodules that warrant fine-needle aspiration, according to new pediatric-specific guidelines from the American Thyroid Association.
The Management Guidelines for Children with Thyroid Nodules and Differentiated Thyroid Cancer – the first-ever guidelines for the evaluation and management of thyroid nodules and cancer in children – also note that fine-needle aspiration (FNA) in children should be performed under ultrasound guidance, that preoperative FNA of a hyperfunctioning nodule in a child is not warranted as long as the lesion is removed, that a diffusely infiltrative form of papillary thyroid cancer may occur in children and should be considered in a clinically suspicious gland, and that surgery (lobectomy plus isthmusectomy) is favored over repeat FNA for most nodules with indeterminate cytology, Dr. Gary L. Francis of Virginia Commonwealth University and Children’s Hospital of Richmond, Va., and his colleagues from the American Thyroid Association Guidelines Task Force on Pediatric Thyroid Cancer determined based on an extensive literature search.
Together this guidance with respect to thyroid nodules represents just one of 34 recommendations contained in the guidelines, which, according to the authors, represent “the current optimal care for children and adolescents with these conditions.”
The guidelines were published in the July issue of Thyroid (2015;25:716-59).
Previous guidelines were geared toward adults, but thyroid neoplasms in children differ from those in adults with respect to pathophysiology, clinical presentation, and long-term outcomes. Further, therapy that may be appropriate in adults may not be appropriate for children at low risk for death but higher risk of long-term harm from certain treatments, they said.
For example, recent studies with long-term follow-up revealed an increase in all-cause mortality for survivors of childhood differentiated thyroid cancer (DTC), primarily caused by second malignancies in children treated with radiation.
“These observations, coupled with a better understanding of the excellent prognosis associated with pediatric DTC, have now prompted the American Thyroid Association to specifically address treatment of children with benign and malignant thyroid tumors,” they wrote.
While the task force acknowledged a paucity of randomized, double-blind, controlled clinical trials involving children with DTC, they note that “retrospective analysis of therapeutic options has led to a reconsideration of the former concept that all children with DTC should be similarly treated and has provided the opportunity ... to broaden the scope of acceptable therapy in an attempt to provide aggressive therapy when warranted and to limit overtreatment to those children who are unlikely to benefit.”
In addition to addressing the evaluation and management of thyroid nodules, the guidelines also address DTC, including preoperative staging, surgical management, postoperative staging, the role of radioactive iodine therapy, and goals for thyrotropin suppression. Management algorithms are proposed, and separate recommendations for papillary and follicular thyroid cancers are provided.
The authors note that since DTC recurrence has been reported as long as 40 years after initial therapy, children with DTC should be “followed for life, albeit with decreasing intensity for those with no evidence for disease.”
The guidelines are timely, as Surveillance, Epidemiology and End Results (SEER) program data indicate that new cases of thyroid cancer in persons under the age of 20 years represent 1.8% of all thyroid malignancies diagnosed in the United States, and that the incidence appears to be increasing.
Among 15- to 19-year old adolescents, thyroid cancer is the eighth most frequently diagnosed cancer, and it is the second most common cancer among girls, the authors said, noting that adolescents have a 10-fold greater incidence than do younger children, and that there is a female to male preponderance.
The development of pediatric-specific guidelines was critical, according to guidelines coauthor, Dr. Peter Angelos, professor of surgery and surgical ethics and chief of endocrine surgery at the University of Chicago Medicine and Biological Sciences.
“As they say, ‘children are not just small adults,’ ” he said in an interview.
In addition to the guidance provided on which types of nodules should be evaluated in children (since size alone should not be used to dictate who undergoes biopsy), a highlight of the guidelines is a recommendation that children with thyroid cancer be treated by multidisciplinary teams of physician in high-volume centers, he said.
“Thyroid cancer in children is different than in adults in that children have much higher rates of involved lymph nodes, but their overall prognosis is excellent despite the frequency of involved nodes. This confluence of findings pushes surgeons to do more aggressive operations to clear lymph nodes. This is a good thing, but unfortunately, can lead to higher complication rates (things such as permanently low calcium levels in the blood),” he said, adding that “the implications of finding a high-volume thyroid cancer surgeon with experience in thyroid cancer surgery on children are very significant and the guidelines make some recommendations about how many operations are necessary to constitute high volume.”
The push to limit the use of radioactive iodine in children further underscores the need for an experienced surgeon, he said.
“In an effort to avoid exposing children to radiation, surgeons are further pushed to be more aggressive in the operating room. Thus, it becomes even more important to see an experienced surgeon so that complications can be minimized. Even a seemingly ‘mild’ complication can be devastating for a child who will likely have to live with that complication for decades to come since the prognosis for thyroid cancer is so good,” he said.
An important potential benefit of treatment at centers with multidisciplinary interest and expertise is facilitation of additional research, particularly in areas of uncertainty, including the proper use of 131I, the interpretation of thyroglobulin (Tg) and TgAb (antibody) levels, the role of prospective ultrasound monitoring in presymptomatic children at risk for thyroid neoplasia, the use of novel targeted therapies for advanced disease that fails to respond to 131I, and the long-term psychosocial impacts of the disease on children and their families, the guideline authors said.
“These areas require well-designed long-term, multicenter studies that will be difficult to perform because of the rarity of pediatric DTC and the prolonged follow-up required to reach meaningful endpoints. Further research should be facilitated by ensuring that children with DTC are treated when possible at centers with multidisciplinary interest and expertise in this disease,” they concluded.
The guidelines were funded by the American Thyroid Association and ThyCa: Thyroid Cancer Survivors’ Association. Dr. Francis reported serving as an adviser to ThyCa and receiving research support from Grifols, Novo Nordisk, and the Juvenile Diabetes Research Foundation. Other authors reported relationships (consulting, receiving research support, and/or serving as a speaker) with Akrimax, IBSA Institut Biochimique, Pfizer, Novo Nordisk, Eli Lilly, AstraZeneca, Bayer Healthcare, Genzyme, Sobi, Henning, and Merck, and ThyCa.
The evaluation and treatment of thyroid nodules in children should differ from evaluation and treatment in adults in that ultrasound characteristics and clinical context should be used rather than size alone to identify nodules that warrant fine-needle aspiration, according to new pediatric-specific guidelines from the American Thyroid Association.
The Management Guidelines for Children with Thyroid Nodules and Differentiated Thyroid Cancer – the first-ever guidelines for the evaluation and management of thyroid nodules and cancer in children – also note that fine-needle aspiration (FNA) in children should be performed under ultrasound guidance, that preoperative FNA of a hyperfunctioning nodule in a child is not warranted as long as the lesion is removed, that a diffusely infiltrative form of papillary thyroid cancer may occur in children and should be considered in a clinically suspicious gland, and that surgery (lobectomy plus isthmusectomy) is favored over repeat FNA for most nodules with indeterminate cytology, Dr. Gary L. Francis of Virginia Commonwealth University and Children’s Hospital of Richmond, Va., and his colleagues from the American Thyroid Association Guidelines Task Force on Pediatric Thyroid Cancer determined based on an extensive literature search.
Together this guidance with respect to thyroid nodules represents just one of 34 recommendations contained in the guidelines, which, according to the authors, represent “the current optimal care for children and adolescents with these conditions.”
The guidelines were published in the July issue of Thyroid (2015;25:716-59).
Previous guidelines were geared toward adults, but thyroid neoplasms in children differ from those in adults with respect to pathophysiology, clinical presentation, and long-term outcomes. Further, therapy that may be appropriate in adults may not be appropriate for children at low risk for death but higher risk of long-term harm from certain treatments, they said.
For example, recent studies with long-term follow-up revealed an increase in all-cause mortality for survivors of childhood differentiated thyroid cancer (DTC), primarily caused by second malignancies in children treated with radiation.
“These observations, coupled with a better understanding of the excellent prognosis associated with pediatric DTC, have now prompted the American Thyroid Association to specifically address treatment of children with benign and malignant thyroid tumors,” they wrote.
While the task force acknowledged a paucity of randomized, double-blind, controlled clinical trials involving children with DTC, they note that “retrospective analysis of therapeutic options has led to a reconsideration of the former concept that all children with DTC should be similarly treated and has provided the opportunity ... to broaden the scope of acceptable therapy in an attempt to provide aggressive therapy when warranted and to limit overtreatment to those children who are unlikely to benefit.”
In addition to addressing the evaluation and management of thyroid nodules, the guidelines also address DTC, including preoperative staging, surgical management, postoperative staging, the role of radioactive iodine therapy, and goals for thyrotropin suppression. Management algorithms are proposed, and separate recommendations for papillary and follicular thyroid cancers are provided.
The authors note that since DTC recurrence has been reported as long as 40 years after initial therapy, children with DTC should be “followed for life, albeit with decreasing intensity for those with no evidence for disease.”
The guidelines are timely, as Surveillance, Epidemiology and End Results (SEER) program data indicate that new cases of thyroid cancer in persons under the age of 20 years represent 1.8% of all thyroid malignancies diagnosed in the United States, and that the incidence appears to be increasing.
Among 15- to 19-year old adolescents, thyroid cancer is the eighth most frequently diagnosed cancer, and it is the second most common cancer among girls, the authors said, noting that adolescents have a 10-fold greater incidence than do younger children, and that there is a female to male preponderance.
The development of pediatric-specific guidelines was critical, according to guidelines coauthor, Dr. Peter Angelos, professor of surgery and surgical ethics and chief of endocrine surgery at the University of Chicago Medicine and Biological Sciences.
“As they say, ‘children are not just small adults,’ ” he said in an interview.
In addition to the guidance provided on which types of nodules should be evaluated in children (since size alone should not be used to dictate who undergoes biopsy), a highlight of the guidelines is a recommendation that children with thyroid cancer be treated by multidisciplinary teams of physician in high-volume centers, he said.
“Thyroid cancer in children is different than in adults in that children have much higher rates of involved lymph nodes, but their overall prognosis is excellent despite the frequency of involved nodes. This confluence of findings pushes surgeons to do more aggressive operations to clear lymph nodes. This is a good thing, but unfortunately, can lead to higher complication rates (things such as permanently low calcium levels in the blood),” he said, adding that “the implications of finding a high-volume thyroid cancer surgeon with experience in thyroid cancer surgery on children are very significant and the guidelines make some recommendations about how many operations are necessary to constitute high volume.”
The push to limit the use of radioactive iodine in children further underscores the need for an experienced surgeon, he said.
“In an effort to avoid exposing children to radiation, surgeons are further pushed to be more aggressive in the operating room. Thus, it becomes even more important to see an experienced surgeon so that complications can be minimized. Even a seemingly ‘mild’ complication can be devastating for a child who will likely have to live with that complication for decades to come since the prognosis for thyroid cancer is so good,” he said.
An important potential benefit of treatment at centers with multidisciplinary interest and expertise is facilitation of additional research, particularly in areas of uncertainty, including the proper use of 131I, the interpretation of thyroglobulin (Tg) and TgAb (antibody) levels, the role of prospective ultrasound monitoring in presymptomatic children at risk for thyroid neoplasia, the use of novel targeted therapies for advanced disease that fails to respond to 131I, and the long-term psychosocial impacts of the disease on children and their families, the guideline authors said.
“These areas require well-designed long-term, multicenter studies that will be difficult to perform because of the rarity of pediatric DTC and the prolonged follow-up required to reach meaningful endpoints. Further research should be facilitated by ensuring that children with DTC are treated when possible at centers with multidisciplinary interest and expertise in this disease,” they concluded.
The guidelines were funded by the American Thyroid Association and ThyCa: Thyroid Cancer Survivors’ Association. Dr. Francis reported serving as an adviser to ThyCa and receiving research support from Grifols, Novo Nordisk, and the Juvenile Diabetes Research Foundation. Other authors reported relationships (consulting, receiving research support, and/or serving as a speaker) with Akrimax, IBSA Institut Biochimique, Pfizer, Novo Nordisk, Eli Lilly, AstraZeneca, Bayer Healthcare, Genzyme, Sobi, Henning, and Merck, and ThyCa.
The evaluation and treatment of thyroid nodules in children should differ from evaluation and treatment in adults in that ultrasound characteristics and clinical context should be used rather than size alone to identify nodules that warrant fine-needle aspiration, according to new pediatric-specific guidelines from the American Thyroid Association.
The Management Guidelines for Children with Thyroid Nodules and Differentiated Thyroid Cancer – the first-ever guidelines for the evaluation and management of thyroid nodules and cancer in children – also note that fine-needle aspiration (FNA) in children should be performed under ultrasound guidance, that preoperative FNA of a hyperfunctioning nodule in a child is not warranted as long as the lesion is removed, that a diffusely infiltrative form of papillary thyroid cancer may occur in children and should be considered in a clinically suspicious gland, and that surgery (lobectomy plus isthmusectomy) is favored over repeat FNA for most nodules with indeterminate cytology, Dr. Gary L. Francis of Virginia Commonwealth University and Children’s Hospital of Richmond, Va., and his colleagues from the American Thyroid Association Guidelines Task Force on Pediatric Thyroid Cancer determined based on an extensive literature search.
Together this guidance with respect to thyroid nodules represents just one of 34 recommendations contained in the guidelines, which, according to the authors, represent “the current optimal care for children and adolescents with these conditions.”
The guidelines were published in the July issue of Thyroid (2015;25:716-59).
Previous guidelines were geared toward adults, but thyroid neoplasms in children differ from those in adults with respect to pathophysiology, clinical presentation, and long-term outcomes. Further, therapy that may be appropriate in adults may not be appropriate for children at low risk for death but higher risk of long-term harm from certain treatments, they said.
For example, recent studies with long-term follow-up revealed an increase in all-cause mortality for survivors of childhood differentiated thyroid cancer (DTC), primarily caused by second malignancies in children treated with radiation.
“These observations, coupled with a better understanding of the excellent prognosis associated with pediatric DTC, have now prompted the American Thyroid Association to specifically address treatment of children with benign and malignant thyroid tumors,” they wrote.
While the task force acknowledged a paucity of randomized, double-blind, controlled clinical trials involving children with DTC, they note that “retrospective analysis of therapeutic options has led to a reconsideration of the former concept that all children with DTC should be similarly treated and has provided the opportunity ... to broaden the scope of acceptable therapy in an attempt to provide aggressive therapy when warranted and to limit overtreatment to those children who are unlikely to benefit.”
In addition to addressing the evaluation and management of thyroid nodules, the guidelines also address DTC, including preoperative staging, surgical management, postoperative staging, the role of radioactive iodine therapy, and goals for thyrotropin suppression. Management algorithms are proposed, and separate recommendations for papillary and follicular thyroid cancers are provided.
The authors note that since DTC recurrence has been reported as long as 40 years after initial therapy, children with DTC should be “followed for life, albeit with decreasing intensity for those with no evidence for disease.”
The guidelines are timely, as Surveillance, Epidemiology and End Results (SEER) program data indicate that new cases of thyroid cancer in persons under the age of 20 years represent 1.8% of all thyroid malignancies diagnosed in the United States, and that the incidence appears to be increasing.
Among 15- to 19-year old adolescents, thyroid cancer is the eighth most frequently diagnosed cancer, and it is the second most common cancer among girls, the authors said, noting that adolescents have a 10-fold greater incidence than do younger children, and that there is a female to male preponderance.
The development of pediatric-specific guidelines was critical, according to guidelines coauthor, Dr. Peter Angelos, professor of surgery and surgical ethics and chief of endocrine surgery at the University of Chicago Medicine and Biological Sciences.
“As they say, ‘children are not just small adults,’ ” he said in an interview.
In addition to the guidance provided on which types of nodules should be evaluated in children (since size alone should not be used to dictate who undergoes biopsy), a highlight of the guidelines is a recommendation that children with thyroid cancer be treated by multidisciplinary teams of physician in high-volume centers, he said.
“Thyroid cancer in children is different than in adults in that children have much higher rates of involved lymph nodes, but their overall prognosis is excellent despite the frequency of involved nodes. This confluence of findings pushes surgeons to do more aggressive operations to clear lymph nodes. This is a good thing, but unfortunately, can lead to higher complication rates (things such as permanently low calcium levels in the blood),” he said, adding that “the implications of finding a high-volume thyroid cancer surgeon with experience in thyroid cancer surgery on children are very significant and the guidelines make some recommendations about how many operations are necessary to constitute high volume.”
The push to limit the use of radioactive iodine in children further underscores the need for an experienced surgeon, he said.
“In an effort to avoid exposing children to radiation, surgeons are further pushed to be more aggressive in the operating room. Thus, it becomes even more important to see an experienced surgeon so that complications can be minimized. Even a seemingly ‘mild’ complication can be devastating for a child who will likely have to live with that complication for decades to come since the prognosis for thyroid cancer is so good,” he said.
An important potential benefit of treatment at centers with multidisciplinary interest and expertise is facilitation of additional research, particularly in areas of uncertainty, including the proper use of 131I, the interpretation of thyroglobulin (Tg) and TgAb (antibody) levels, the role of prospective ultrasound monitoring in presymptomatic children at risk for thyroid neoplasia, the use of novel targeted therapies for advanced disease that fails to respond to 131I, and the long-term psychosocial impacts of the disease on children and their families, the guideline authors said.
“These areas require well-designed long-term, multicenter studies that will be difficult to perform because of the rarity of pediatric DTC and the prolonged follow-up required to reach meaningful endpoints. Further research should be facilitated by ensuring that children with DTC are treated when possible at centers with multidisciplinary interest and expertise in this disease,” they concluded.
The guidelines were funded by the American Thyroid Association and ThyCa: Thyroid Cancer Survivors’ Association. Dr. Francis reported serving as an adviser to ThyCa and receiving research support from Grifols, Novo Nordisk, and the Juvenile Diabetes Research Foundation. Other authors reported relationships (consulting, receiving research support, and/or serving as a speaker) with Akrimax, IBSA Institut Biochimique, Pfizer, Novo Nordisk, Eli Lilly, AstraZeneca, Bayer Healthcare, Genzyme, Sobi, Henning, and Merck, and ThyCa.
FROM THYROID
Gene-testing predictive value can depend on institutional cancer prevalence
Molecular profiling may be useful to thyroid surgeons in a variety of scenarios, but results should be interpreted with proper knowledge of cancer prevalence at the clinician’s institution, report Dr. Robert L. Ferris and coauthors of the University of Pittsburgh Cancer Institute.
A large, prospective single-center study examined seven-gene mutational panel performance, and found that for the AUS/FLUS cytologic category, mutation identification had a positive predictive value of 88% for histologic cancers, with a false-positive rate of 12%, the authors said.
Results from two analyses of the gene expression classifier (GEC) test emphasized the importance of cancer prevalence at the institution in interpretation of negative predictive value (NPV) and positive predictive value (PPV). In the first study, though the overall calculated sensitivity for GEC was 94%, the high malignancy rate at the institution resulted in a lower estimated NPV of 90%. The second study found an estimated sensitivity and specificity to be 83% and 10%, respectively, and decreases in estimated NPV (94%) and PPV (16%), Dr. Ferris and his colleagues reported.
“Given the well established and frequently dramatic variations in cancer prevalence in thyroid cytology specimens, clinicians are urged to be aware of the prevalence of disease by cytologic category in their tested patients and carefully consider how local disease prevalence may change PPV and NPV of molecular diagnostic tests when applied to their unique clinical practice,” the authors said in the report.
Additionally, “the use of molecular profiling in cytologic indeterminate categories should be interpreted judiciously and with discretion by the clinician, who must be aware of institutional cytopathologic performance results, as well as the individual clinical and sonographic factors for each patient,” they concluded.
Read the full article in Thyroid (doi/pdf/10.1089/thy.2014.0502).
Molecular profiling may be useful to thyroid surgeons in a variety of scenarios, but results should be interpreted with proper knowledge of cancer prevalence at the clinician’s institution, report Dr. Robert L. Ferris and coauthors of the University of Pittsburgh Cancer Institute.
A large, prospective single-center study examined seven-gene mutational panel performance, and found that for the AUS/FLUS cytologic category, mutation identification had a positive predictive value of 88% for histologic cancers, with a false-positive rate of 12%, the authors said.
Results from two analyses of the gene expression classifier (GEC) test emphasized the importance of cancer prevalence at the institution in interpretation of negative predictive value (NPV) and positive predictive value (PPV). In the first study, though the overall calculated sensitivity for GEC was 94%, the high malignancy rate at the institution resulted in a lower estimated NPV of 90%. The second study found an estimated sensitivity and specificity to be 83% and 10%, respectively, and decreases in estimated NPV (94%) and PPV (16%), Dr. Ferris and his colleagues reported.
“Given the well established and frequently dramatic variations in cancer prevalence in thyroid cytology specimens, clinicians are urged to be aware of the prevalence of disease by cytologic category in their tested patients and carefully consider how local disease prevalence may change PPV and NPV of molecular diagnostic tests when applied to their unique clinical practice,” the authors said in the report.
Additionally, “the use of molecular profiling in cytologic indeterminate categories should be interpreted judiciously and with discretion by the clinician, who must be aware of institutional cytopathologic performance results, as well as the individual clinical and sonographic factors for each patient,” they concluded.
Read the full article in Thyroid (doi/pdf/10.1089/thy.2014.0502).
Molecular profiling may be useful to thyroid surgeons in a variety of scenarios, but results should be interpreted with proper knowledge of cancer prevalence at the clinician’s institution, report Dr. Robert L. Ferris and coauthors of the University of Pittsburgh Cancer Institute.
A large, prospective single-center study examined seven-gene mutational panel performance, and found that for the AUS/FLUS cytologic category, mutation identification had a positive predictive value of 88% for histologic cancers, with a false-positive rate of 12%, the authors said.
Results from two analyses of the gene expression classifier (GEC) test emphasized the importance of cancer prevalence at the institution in interpretation of negative predictive value (NPV) and positive predictive value (PPV). In the first study, though the overall calculated sensitivity for GEC was 94%, the high malignancy rate at the institution resulted in a lower estimated NPV of 90%. The second study found an estimated sensitivity and specificity to be 83% and 10%, respectively, and decreases in estimated NPV (94%) and PPV (16%), Dr. Ferris and his colleagues reported.
“Given the well established and frequently dramatic variations in cancer prevalence in thyroid cytology specimens, clinicians are urged to be aware of the prevalence of disease by cytologic category in their tested patients and carefully consider how local disease prevalence may change PPV and NPV of molecular diagnostic tests when applied to their unique clinical practice,” the authors said in the report.
Additionally, “the use of molecular profiling in cytologic indeterminate categories should be interpreted judiciously and with discretion by the clinician, who must be aware of institutional cytopathologic performance results, as well as the individual clinical and sonographic factors for each patient,” they concluded.
Read the full article in Thyroid (doi/pdf/10.1089/thy.2014.0502).
RAI given to thyroid CA patients does not increase their breast malignancy occurrence, recurrence
Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.
The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.
The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.
“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).
This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.
Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.
The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.
The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.
“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).
This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.
Radioactive iodine (RAI) therapy in thyroid cancer patients does not cause such patients to get breast cancer, suggests a retrospective study of female patients from Seoul National University Hospital in South Korea.
The study enrolled 6,150 patients with thyroid cancer between 1973 and 2009, who were followed until December 2012. Of the sample, 3.691 (59%) received RAI therapy, and 99 were diagnosed with primary breast cancers during the follow-up period.
The study showed that RAI therapy did not significantly increase the incidence of breast cancer subsequent to diagnosis of thyroid cancer among patients, when a 2-year latency period was accounted for. An additional finding was that the numbers of breast cancer diagnoses made during the follow-up period for those study participants who received high doses of RAI therapy (greater than or equal to 120 mCi) and those patients who did not receive any RAI therapy were not significantly different from each other.
“The results from our study based on a large cohort of thyroid cancer patients clearly demonstrated that RAI treatment in these patients did not increase the risk of development nor worsen the recurrence of breast cancer,” Dr. Hwa Young Ahn of the department of internal medicine at Seoul National University, South Korea, and Hye Sook Min, and associates.
Read the full study in the Journal of Clinical Endocrinology & Metabolism (doi:10.1210/JC.2014-2896).
This study was supported by research grants from the Korean Foundation for Cancer Research, Seoul National University Bundang Hospital Research Grants, and the Education and Research Encouragement Fund of Seoul National University Hospital. The investigators reported having no financial conflicts of interest.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Thyroid cancer gene screening questioned for indeterminate nodules
In patients with indeterminate thyroid nodules, routine gene expression classifier testing may not meet standard definitions of cost efficacy relative to conventional care at many treatment centers, according to a decision-tree analysis performed with data from a tertiary treatment center.
In this analysis, gene expression classifier (GEC) testing was associated with a small gain in health benefits, measured in quality adjusted life-years (QALY), but at a much higher cost than conventional care, according to Dr. James X. Wu of the University of California, Los Angeles. The data were presented at the annual meeting of the American Association of Endocrine Surgeons (AAES).
Management of thyroid nodules indeterminate for malignancy after fine needle aspiration, which occurs in up to 30% of patients, is a challenge, according to Dr. Wu. Cancer rates in these patients can be as high as 30%, and often benign and malignant indeterminate nodules are indistinguishable. Conventionally, surgical resection is recommended to avoid missing a cancer diagnosis. However, uniform thyroid lobectomy means that 70% or more of lesions excised will be benign.
GEC testing is a relatively new molecular test that helps guide therapy in these individuals. The high negative predictive value of this test allows the test to reliably predict when patients have benign disease, giving them the option of being observed rather than undergoing surgery, explained Dr. Wu. In this study, the goal was to determine whether GEC testing has the potential to be cost effective, defined as a ratio of added cost to QALYs gained of less than $100,000/QALY relative to conventional treatment.
The decision-tree model was constructed on 2 years of GEC testing performance data prospectively collected at UCLA. In this model, the assumption was made that patients would be observed if the GEC test was negative but would undergo thyroid resection if the gene expression classifier test was suspicious.
Applying the UCLA dataset to the model, the expected cost for conventional management in the reference scenario was $11,119 to produce 22.15 QALYs, according to Dr. Wu. Routine GEC testing produced an additional 0.01 QALY but cost $1,197 more. This translated into an incremental cost-effectiveness ratio of $119,700/QALY, which exceeded the common $100,000/QALY threshold for cost efficacy.
The main determinants of cost effectiveness were the cost of the gene expression classifier test, the rate of malignancy in patients with indeterminate thyroid nodules, and cost of thyroid lobectomy.
More favorable costs for gene expression testing could be generated by plausible alterations of key clinical factors. This included lowering the cost of the GEC test itself or raising the cost of thyroid lobectomy. For example, the GEC testing became cost effective with the parameters used if the test was less than $2,460 or the cost of thyroid lobectomy exceeded $12,160.
In addition, malignancy rates influenced the relative cost efficacy of gene expression classifier testing. Centers with lower rates of cancer get more value from routine GEC testing than do centers with high rates of cancer, because more patients avoid surgery with testing. At UCLA, the malignancy rate was 24%, and could pay as much as $2,460 per test to remain cost-effective. Institutions with a malignancy rate less than 24% would have a higher cost threshold.
Indeed, even though routine gene expression classifier testing was not found to be cost effective using the assumptions of this study and data from UCLA, on probabilistic sensitivity analysis, it was found to be cost effective in 53.2% of simulations. Dr. Wu suggested the same analyses should be performed at centers using their own data to accurately assess cost effectiveness. Given the wide variation in important variables, particularly the malignancy rate in indeterminate nodules, the results from one institution cannot reliably predict the cost effectiveness at a separate treatment facility.
“Our conclusion is that every center needs to audit themselves to find out whether it’s truly cost effective and not blindly trust that it’s 100% cost effective across the board.” Dr. Wu reported. He noted that gene expression classifier testing, which has been used for 2 years at UCLA, is likely to be continued to be used but with a focus on making the test more cost effective by finding ways to use it more selectively.
In patients with indeterminate thyroid nodules, routine gene expression classifier testing may not meet standard definitions of cost efficacy relative to conventional care at many treatment centers, according to a decision-tree analysis performed with data from a tertiary treatment center.
In this analysis, gene expression classifier (GEC) testing was associated with a small gain in health benefits, measured in quality adjusted life-years (QALY), but at a much higher cost than conventional care, according to Dr. James X. Wu of the University of California, Los Angeles. The data were presented at the annual meeting of the American Association of Endocrine Surgeons (AAES).
Management of thyroid nodules indeterminate for malignancy after fine needle aspiration, which occurs in up to 30% of patients, is a challenge, according to Dr. Wu. Cancer rates in these patients can be as high as 30%, and often benign and malignant indeterminate nodules are indistinguishable. Conventionally, surgical resection is recommended to avoid missing a cancer diagnosis. However, uniform thyroid lobectomy means that 70% or more of lesions excised will be benign.
GEC testing is a relatively new molecular test that helps guide therapy in these individuals. The high negative predictive value of this test allows the test to reliably predict when patients have benign disease, giving them the option of being observed rather than undergoing surgery, explained Dr. Wu. In this study, the goal was to determine whether GEC testing has the potential to be cost effective, defined as a ratio of added cost to QALYs gained of less than $100,000/QALY relative to conventional treatment.
The decision-tree model was constructed on 2 years of GEC testing performance data prospectively collected at UCLA. In this model, the assumption was made that patients would be observed if the GEC test was negative but would undergo thyroid resection if the gene expression classifier test was suspicious.
Applying the UCLA dataset to the model, the expected cost for conventional management in the reference scenario was $11,119 to produce 22.15 QALYs, according to Dr. Wu. Routine GEC testing produced an additional 0.01 QALY but cost $1,197 more. This translated into an incremental cost-effectiveness ratio of $119,700/QALY, which exceeded the common $100,000/QALY threshold for cost efficacy.
The main determinants of cost effectiveness were the cost of the gene expression classifier test, the rate of malignancy in patients with indeterminate thyroid nodules, and cost of thyroid lobectomy.
More favorable costs for gene expression testing could be generated by plausible alterations of key clinical factors. This included lowering the cost of the GEC test itself or raising the cost of thyroid lobectomy. For example, the GEC testing became cost effective with the parameters used if the test was less than $2,460 or the cost of thyroid lobectomy exceeded $12,160.
In addition, malignancy rates influenced the relative cost efficacy of gene expression classifier testing. Centers with lower rates of cancer get more value from routine GEC testing than do centers with high rates of cancer, because more patients avoid surgery with testing. At UCLA, the malignancy rate was 24%, and could pay as much as $2,460 per test to remain cost-effective. Institutions with a malignancy rate less than 24% would have a higher cost threshold.
Indeed, even though routine gene expression classifier testing was not found to be cost effective using the assumptions of this study and data from UCLA, on probabilistic sensitivity analysis, it was found to be cost effective in 53.2% of simulations. Dr. Wu suggested the same analyses should be performed at centers using their own data to accurately assess cost effectiveness. Given the wide variation in important variables, particularly the malignancy rate in indeterminate nodules, the results from one institution cannot reliably predict the cost effectiveness at a separate treatment facility.
“Our conclusion is that every center needs to audit themselves to find out whether it’s truly cost effective and not blindly trust that it’s 100% cost effective across the board.” Dr. Wu reported. He noted that gene expression classifier testing, which has been used for 2 years at UCLA, is likely to be continued to be used but with a focus on making the test more cost effective by finding ways to use it more selectively.
In patients with indeterminate thyroid nodules, routine gene expression classifier testing may not meet standard definitions of cost efficacy relative to conventional care at many treatment centers, according to a decision-tree analysis performed with data from a tertiary treatment center.
In this analysis, gene expression classifier (GEC) testing was associated with a small gain in health benefits, measured in quality adjusted life-years (QALY), but at a much higher cost than conventional care, according to Dr. James X. Wu of the University of California, Los Angeles. The data were presented at the annual meeting of the American Association of Endocrine Surgeons (AAES).
Management of thyroid nodules indeterminate for malignancy after fine needle aspiration, which occurs in up to 30% of patients, is a challenge, according to Dr. Wu. Cancer rates in these patients can be as high as 30%, and often benign and malignant indeterminate nodules are indistinguishable. Conventionally, surgical resection is recommended to avoid missing a cancer diagnosis. However, uniform thyroid lobectomy means that 70% or more of lesions excised will be benign.
GEC testing is a relatively new molecular test that helps guide therapy in these individuals. The high negative predictive value of this test allows the test to reliably predict when patients have benign disease, giving them the option of being observed rather than undergoing surgery, explained Dr. Wu. In this study, the goal was to determine whether GEC testing has the potential to be cost effective, defined as a ratio of added cost to QALYs gained of less than $100,000/QALY relative to conventional treatment.
The decision-tree model was constructed on 2 years of GEC testing performance data prospectively collected at UCLA. In this model, the assumption was made that patients would be observed if the GEC test was negative but would undergo thyroid resection if the gene expression classifier test was suspicious.
Applying the UCLA dataset to the model, the expected cost for conventional management in the reference scenario was $11,119 to produce 22.15 QALYs, according to Dr. Wu. Routine GEC testing produced an additional 0.01 QALY but cost $1,197 more. This translated into an incremental cost-effectiveness ratio of $119,700/QALY, which exceeded the common $100,000/QALY threshold for cost efficacy.
The main determinants of cost effectiveness were the cost of the gene expression classifier test, the rate of malignancy in patients with indeterminate thyroid nodules, and cost of thyroid lobectomy.
More favorable costs for gene expression testing could be generated by plausible alterations of key clinical factors. This included lowering the cost of the GEC test itself or raising the cost of thyroid lobectomy. For example, the GEC testing became cost effective with the parameters used if the test was less than $2,460 or the cost of thyroid lobectomy exceeded $12,160.
In addition, malignancy rates influenced the relative cost efficacy of gene expression classifier testing. Centers with lower rates of cancer get more value from routine GEC testing than do centers with high rates of cancer, because more patients avoid surgery with testing. At UCLA, the malignancy rate was 24%, and could pay as much as $2,460 per test to remain cost-effective. Institutions with a malignancy rate less than 24% would have a higher cost threshold.
Indeed, even though routine gene expression classifier testing was not found to be cost effective using the assumptions of this study and data from UCLA, on probabilistic sensitivity analysis, it was found to be cost effective in 53.2% of simulations. Dr. Wu suggested the same analyses should be performed at centers using their own data to accurately assess cost effectiveness. Given the wide variation in important variables, particularly the malignancy rate in indeterminate nodules, the results from one institution cannot reliably predict the cost effectiveness at a separate treatment facility.
“Our conclusion is that every center needs to audit themselves to find out whether it’s truly cost effective and not blindly trust that it’s 100% cost effective across the board.” Dr. Wu reported. He noted that gene expression classifier testing, which has been used for 2 years at UCLA, is likely to be continued to be used but with a focus on making the test more cost effective by finding ways to use it more selectively.
FROM THE AAES ANNUAL MEETING
Key clinical point: The gene expression classifier testing for malignancy in indeterminate thyroid nodules is not always cost effective.
Major finding: In this analysis, gene expression classifier testing raised costs by $1,197 per patient with only 0.01 additional year of life predicted.
Data source: Decision-tree analysis based on retrospective data evaluation.
Disclosures: Dr. Wu reports no relevant financial conflicts.
