Head & Neck/Thyroid Cancers

CORONADO, CALIF. – Expect significant enhancements to the updated thyroid cancer management guidelines from the American Thyroid Association, due to be released in early 2015.

Last updated in 2009, the goal of the new guidelines is to “be evidence based and helpful,” guidelines task force chair Dr. Bryan R. Haugen said at the annual meeting of the American Thyroid Association. For example, the new guidelines will contain 101 recommendations, up from 80 in the 2009 version; 175 subrecommendations, up from 103; and 998 references, up from 437. “Still, 59 of the existing 80 recommendations are not substantially changed, showing a general stability in our field over the past 5 to 6 years,” he said.

One enhancement is a definition of risk of structural disease recurrence in patients without structurally identifiable disease after initial therapy for thyroid cancer. Low risk is defined as intrathyroidal differentiated thyroid cancer involving up to five metastases less than 0.2 cm in size. Intermediate risk is defined as the presence of aggressive histology, minor extrathyroidal extension, vascular invasion, or more than five involved lymph nodes with metastases 0.2-0.3 cm in size. High risk is defined as the presence of gross extrathyroidal extension, incomplete tumor resection, distant metastases, or lymph node metastases greater than 3 cm in size.

The guidelines also include a table that defines a patient’s response to therapy as a dynamic risk assessment. “This best applies to the low- to intermediate-risk patients, although it definitely applies to high risk as well,” said Dr. Haugen, who heads the division of endocrinology, metabolism, and diabetes at the University of Colorado Health Sciences Center, Denver. “It’s [a] strong recommendation based on low-quality evidence to use this risk-based response to therapy. A lot of this data is generated from patients who’ve had a thyroidectomy and have received radioiodine. So we’re on a bit more shaky ground right now in a patient who’s had a thyroidectomy but no radioiodine, or a patient who’s had a lobectomy.”

Other changes include the concept that it’s not necessary to biopsy every nodule more than 1 cm in size. “We’re going to be guided by the sonographic pattern in who we biopsy and how we monitor them,” Dr. Haugen explained. “A new recommendation adds follow-up guidance for nodules that do not meet FNA [fine-needle aspiration] criteria. We’re also recommending use of the Bethesda Cytology Classification System for cytology.”

Changes in the initial management of thyroid cancer include a recommendation for cross-sectional imaging with contrast for higher-risk disease and the consideration of lobectomy for some patients with tumors 1-4 cm in size. “This is a controversial recommendation,” Dr. Haugen said. “We got some feedback from members asking if you do it, what’s the TSH target? Should we give them synthetic levothyroxine? We are revising the guidelines based on this feedback to help guide clinicians.”

The new guidelines also call for more detailed/standardized pathology reports, with inclusion of lymph node size, extranodal invasion, and the number of invaded vessels. “I’ve talked to a number of pathologists and clinicians who are very happy about this guidance,” he said. “We also need to look at tumor stage, recurrence risk, and response to therapy in our patients, and the use of selective radioiodine. There is some more information on considering lower administered activities, especially in the lower-risk patients.”

For the first time, the guidelines include a section on radioiodine treatment for refractory differentiated thyroid cancer, including tips on directed therapy, clinical trials, systemic therapy, and bone-specific therapy.

Dr. Haugen disclosed that he has received grants and research support from Veracyte and Genzyme.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Expect significant enhancements to the updated thyroid cancer management guidelines from the American Thyroid Association, due to be released in early 2015.

Last updated in 2009, the goal of the new guidelines is to “be evidence based and helpful,” guidelines task force chair Dr. Bryan R. Haugen said at the annual meeting of the American Thyroid Association. For example, the new guidelines will contain 101 recommendations, up from 80 in the 2009 version; 175 subrecommendations, up from 103; and 998 references, up from 437. “Still, 59 of the existing 80 recommendations are not substantially changed, showing a general stability in our field over the past 5 to 6 years,” he said.

One enhancement is a definition of risk of structural disease recurrence in patients without structurally identifiable disease after initial therapy for thyroid cancer. Low risk is defined as intrathyroidal differentiated thyroid cancer involving up to five metastases less than 0.2 cm in size. Intermediate risk is defined as the presence of aggressive histology, minor extrathyroidal extension, vascular invasion, or more than five involved lymph nodes with metastases 0.2-0.3 cm in size. High risk is defined as the presence of gross extrathyroidal extension, incomplete tumor resection, distant metastases, or lymph node metastases greater than 3 cm in size.

The guidelines also include a table that defines a patient’s response to therapy as a dynamic risk assessment. “This best applies to the low- to intermediate-risk patients, although it definitely applies to high risk as well,” said Dr. Haugen, who heads the division of endocrinology, metabolism, and diabetes at the University of Colorado Health Sciences Center, Denver. “It’s [a] strong recommendation based on low-quality evidence to use this risk-based response to therapy. A lot of this data is generated from patients who’ve had a thyroidectomy and have received radioiodine. So we’re on a bit more shaky ground right now in a patient who’s had a thyroidectomy but no radioiodine, or a patient who’s had a lobectomy.”

Other changes include the concept that it’s not necessary to biopsy every nodule more than 1 cm in size. “We’re going to be guided by the sonographic pattern in who we biopsy and how we monitor them,” Dr. Haugen explained. “A new recommendation adds follow-up guidance for nodules that do not meet FNA [fine-needle aspiration] criteria. We’re also recommending use of the Bethesda Cytology Classification System for cytology.”

Changes in the initial management of thyroid cancer include a recommendation for cross-sectional imaging with contrast for higher-risk disease and the consideration of lobectomy for some patients with tumors 1-4 cm in size. “This is a controversial recommendation,” Dr. Haugen said. “We got some feedback from members asking if you do it, what’s the TSH target? Should we give them synthetic levothyroxine? We are revising the guidelines based on this feedback to help guide clinicians.”

The new guidelines also call for more detailed/standardized pathology reports, with inclusion of lymph node size, extranodal invasion, and the number of invaded vessels. “I’ve talked to a number of pathologists and clinicians who are very happy about this guidance,” he said. “We also need to look at tumor stage, recurrence risk, and response to therapy in our patients, and the use of selective radioiodine. There is some more information on considering lower administered activities, especially in the lower-risk patients.”

For the first time, the guidelines include a section on radioiodine treatment for refractory differentiated thyroid cancer, including tips on directed therapy, clinical trials, systemic therapy, and bone-specific therapy.

Dr. Haugen disclosed that he has received grants and research support from Veracyte and Genzyme.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – Expect significant enhancements to the updated thyroid cancer management guidelines from the American Thyroid Association, due to be released in early 2015.

Last updated in 2009, the goal of the new guidelines is to “be evidence based and helpful,” guidelines task force chair Dr. Bryan R. Haugen said at the annual meeting of the American Thyroid Association. For example, the new guidelines will contain 101 recommendations, up from 80 in the 2009 version; 175 subrecommendations, up from 103; and 998 references, up from 437. “Still, 59 of the existing 80 recommendations are not substantially changed, showing a general stability in our field over the past 5 to 6 years,” he said.

One enhancement is a definition of risk of structural disease recurrence in patients without structurally identifiable disease after initial therapy for thyroid cancer. Low risk is defined as intrathyroidal differentiated thyroid cancer involving up to five metastases less than 0.2 cm in size. Intermediate risk is defined as the presence of aggressive histology, minor extrathyroidal extension, vascular invasion, or more than five involved lymph nodes with metastases 0.2-0.3 cm in size. High risk is defined as the presence of gross extrathyroidal extension, incomplete tumor resection, distant metastases, or lymph node metastases greater than 3 cm in size.

The guidelines also include a table that defines a patient’s response to therapy as a dynamic risk assessment. “This best applies to the low- to intermediate-risk patients, although it definitely applies to high risk as well,” said Dr. Haugen, who heads the division of endocrinology, metabolism, and diabetes at the University of Colorado Health Sciences Center, Denver. “It’s [a] strong recommendation based on low-quality evidence to use this risk-based response to therapy. A lot of this data is generated from patients who’ve had a thyroidectomy and have received radioiodine. So we’re on a bit more shaky ground right now in a patient who’s had a thyroidectomy but no radioiodine, or a patient who’s had a lobectomy.”

Other changes include the concept that it’s not necessary to biopsy every nodule more than 1 cm in size. “We’re going to be guided by the sonographic pattern in who we biopsy and how we monitor them,” Dr. Haugen explained. “A new recommendation adds follow-up guidance for nodules that do not meet FNA [fine-needle aspiration] criteria. We’re also recommending use of the Bethesda Cytology Classification System for cytology.”

Changes in the initial management of thyroid cancer include a recommendation for cross-sectional imaging with contrast for higher-risk disease and the consideration of lobectomy for some patients with tumors 1-4 cm in size. “This is a controversial recommendation,” Dr. Haugen said. “We got some feedback from members asking if you do it, what’s the TSH target? Should we give them synthetic levothyroxine? We are revising the guidelines based on this feedback to help guide clinicians.”

The new guidelines also call for more detailed/standardized pathology reports, with inclusion of lymph node size, extranodal invasion, and the number of invaded vessels. “I’ve talked to a number of pathologists and clinicians who are very happy about this guidance,” he said. “We also need to look at tumor stage, recurrence risk, and response to therapy in our patients, and the use of selective radioiodine. There is some more information on considering lower administered activities, especially in the lower-risk patients.”

For the first time, the guidelines include a section on radioiodine treatment for refractory differentiated thyroid cancer, including tips on directed therapy, clinical trials, systemic therapy, and bone-specific therapy.

Dr. Haugen disclosed that he has received grants and research support from Veracyte and Genzyme.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF.– In an analysis of primary treatments for all stages of differentiated thyroid carcinoma, only thyroid hormone suppressive therapy was associated with both improved overall survival and disease-free survival.

Further, when examining the degree of thyroid hormone suppressive therapy (THST), aggressive THST conferred no additional survival benefit when compared with moderate THST, even when limiting the analysis to patients with distant metastatic disease, results from a long-term analysis of registry showed.

Those are key findings from an updated analysis of data from the National Thyroid Cancer Treatment Cooperative Study Group Registry, which were presented by lead study author Dr. Aubrey Carhill during the annual meeting of the American Thyroid Association.

“To date there are no prospective studies evaluating the longitudinal outcomes of initial long-term therapies in differentiated thyroid carcinoma,” said Dr. Carhill of MD Anderson Cancer Center, Houston. “In the absence of prospective trials, there has been significant reliance on retrospective studies with limited numbers of patients and low event rates as well as significant reliance on expert opinion to guide clinical practice.”

For example, current ATA guidelines for TSH suppression suggest that in long-term follow-up of patients with differentiated thyroid cancer, “those with persistent disease should have TSH levels suppressed to undetectable levels and maintained indefinitely,” Dr. Carhill said, while disease-free, higher-risk patients “should be suppressed to low-moderate levels continued between 5 and 10 years and low-risk patients should be maintained in the low-normal range. Similar levels of evidence exist to support the use of radioactive iodine and the degree of surgical extent.”

The challenge for clinicians, she continued, becomes balancing the potential risks of more aggressive therapies, such as aggressive thyroid hormone suppression, and the risks associated with long-term thyrotoxicosis with the potential benefits of treatment. “This is not always clear, especially in patients who are at very low risk for cancer-specific mortality,” she said. “There remains a need for accurate prognostication in order to identify which patients will benefit from different treatment modalities because current staging systems have limited ability to predict response to treatment.”

Formed in 1987, the National Thyroid Treatment Cooperative Study Group is a multi-institutional effort to assess long-term management of outcomes on patients with differentiated thyroid cancer. The purpose of the present study was to provide a more current analysis of the prospectively collected data, which was last analyzed in 2001. All staging is tracked according to the registry’s staging system, which is very similar to that of the American Joint Committee on Cancer’s TNM Staging System. Therapies analyzed included total/near total thyroidectomy (T/NTT) vs. a lesser extent of surgery; radioactive iodine (RAI) vs. no RAI; and increasing degrees of THST over time.

Dr. Carhill presented findings from an analysis of the effects of initial therapies in 4,941 patients treated at 11 centers in North America between 1987 and 2012. The median length of follow-up was 6 years, which translated to 34,631 person-years of documented follow-up time. The researchers used univariate and multivariate analyses to assess overall and disease-free survival. Moderate THST was defined as TSH maintained in subnormal or normal levels, while aggressive THST was defined as that maintained in undetectable or subnormal levels.

Improved overall survival was observed in stage III patients who received RAI (risk ratio, 0.66; P = .04) and in stage IV patients who received T/NTT and RAI (RR, 0.66 and 0.70, respectively; combined P = .049). Moderate but not aggressive THST was associated with significantly improved overall survival in all stages (RR, 0.13 in stage I, 0.09 in stage II, 0.13 in stage III, and 0.33 in stage IV), as well as with improved disease-free survival (RR, 0.52 in stage I, 0.40 in stage II, 0.18 in stage III, and no RR in stage IV).

In stage I patients, RAI conferred worse disease-free survival (RR, 1.79; P = .0005). “However, further propensity analysis demonstrated that there was no difference in disease-free survival when patients were stratified according to their propensity to receive radioactive iodine,” Dr. Carhill said.

To evaluate the optimal duration of THST, the researchers examined the effect of continuing degrees of suppression beyond 1, 3, and 5 years of follow-up. After 1 and 3 years of follow-up, both initial stage and moderate TSH suppression were independently predictive of improved overall survival (RR, 0.31 and 0.29, respectively). However, after 5 years of follow-up, “although initial stage remained independently predictive, there was no further benefit with any subsequent degree of TSH suppression,” Dr. Carhill said.

The study “confirms prior registry findings of a survival benefit in high-risk groups treated with T/NTT and RAI, and there is no disease-free survival benefit in low-risk groups receiving postoperative RAI,” she concluded. “We also report for the first time that in multivariate analysis of primary treatments for DTC [differentiated thyroid cancer], in all stages, only THST was associated with both improved overall survival and disease-free survival. When examining the degree of THST, aggressive THST confers no additional survival advantage as compared with moderate THST, even in patients with distant metastatic disease, which remains particularly relevant given the risks associated with long-term thyrotoxicosis.” She acknowledged certain limitations of the study, including the potential for institutional bias. “However, we feel that this is somewhat offset due to the size of the registry cohort and the number of sites involved” Dr. Carhill said.

The registry has received support from Genzyme and Pfizer. Dr. Carhill reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF.– In an analysis of primary treatments for all stages of differentiated thyroid carcinoma, only thyroid hormone suppressive therapy was associated with both improved overall survival and disease-free survival.

Further, when examining the degree of thyroid hormone suppressive therapy (THST), aggressive THST conferred no additional survival benefit when compared with moderate THST, even when limiting the analysis to patients with distant metastatic disease, results from a long-term analysis of registry showed.

Those are key findings from an updated analysis of data from the National Thyroid Cancer Treatment Cooperative Study Group Registry, which were presented by lead study author Dr. Aubrey Carhill during the annual meeting of the American Thyroid Association.

“To date there are no prospective studies evaluating the longitudinal outcomes of initial long-term therapies in differentiated thyroid carcinoma,” said Dr. Carhill of MD Anderson Cancer Center, Houston. “In the absence of prospective trials, there has been significant reliance on retrospective studies with limited numbers of patients and low event rates as well as significant reliance on expert opinion to guide clinical practice.”

For example, current ATA guidelines for TSH suppression suggest that in long-term follow-up of patients with differentiated thyroid cancer, “those with persistent disease should have TSH levels suppressed to undetectable levels and maintained indefinitely,” Dr. Carhill said, while disease-free, higher-risk patients “should be suppressed to low-moderate levels continued between 5 and 10 years and low-risk patients should be maintained in the low-normal range. Similar levels of evidence exist to support the use of radioactive iodine and the degree of surgical extent.”

The challenge for clinicians, she continued, becomes balancing the potential risks of more aggressive therapies, such as aggressive thyroid hormone suppression, and the risks associated with long-term thyrotoxicosis with the potential benefits of treatment. “This is not always clear, especially in patients who are at very low risk for cancer-specific mortality,” she said. “There remains a need for accurate prognostication in order to identify which patients will benefit from different treatment modalities because current staging systems have limited ability to predict response to treatment.”

Formed in 1987, the National Thyroid Treatment Cooperative Study Group is a multi-institutional effort to assess long-term management of outcomes on patients with differentiated thyroid cancer. The purpose of the present study was to provide a more current analysis of the prospectively collected data, which was last analyzed in 2001. All staging is tracked according to the registry’s staging system, which is very similar to that of the American Joint Committee on Cancer’s TNM Staging System. Therapies analyzed included total/near total thyroidectomy (T/NTT) vs. a lesser extent of surgery; radioactive iodine (RAI) vs. no RAI; and increasing degrees of THST over time.

Dr. Carhill presented findings from an analysis of the effects of initial therapies in 4,941 patients treated at 11 centers in North America between 1987 and 2012. The median length of follow-up was 6 years, which translated to 34,631 person-years of documented follow-up time. The researchers used univariate and multivariate analyses to assess overall and disease-free survival. Moderate THST was defined as TSH maintained in subnormal or normal levels, while aggressive THST was defined as that maintained in undetectable or subnormal levels.

Improved overall survival was observed in stage III patients who received RAI (risk ratio, 0.66; P = .04) and in stage IV patients who received T/NTT and RAI (RR, 0.66 and 0.70, respectively; combined P = .049). Moderate but not aggressive THST was associated with significantly improved overall survival in all stages (RR, 0.13 in stage I, 0.09 in stage II, 0.13 in stage III, and 0.33 in stage IV), as well as with improved disease-free survival (RR, 0.52 in stage I, 0.40 in stage II, 0.18 in stage III, and no RR in stage IV).

In stage I patients, RAI conferred worse disease-free survival (RR, 1.79; P = .0005). “However, further propensity analysis demonstrated that there was no difference in disease-free survival when patients were stratified according to their propensity to receive radioactive iodine,” Dr. Carhill said.

To evaluate the optimal duration of THST, the researchers examined the effect of continuing degrees of suppression beyond 1, 3, and 5 years of follow-up. After 1 and 3 years of follow-up, both initial stage and moderate TSH suppression were independently predictive of improved overall survival (RR, 0.31 and 0.29, respectively). However, after 5 years of follow-up, “although initial stage remained independently predictive, there was no further benefit with any subsequent degree of TSH suppression,” Dr. Carhill said.

The study “confirms prior registry findings of a survival benefit in high-risk groups treated with T/NTT and RAI, and there is no disease-free survival benefit in low-risk groups receiving postoperative RAI,” she concluded. “We also report for the first time that in multivariate analysis of primary treatments for DTC [differentiated thyroid cancer], in all stages, only THST was associated with both improved overall survival and disease-free survival. When examining the degree of THST, aggressive THST confers no additional survival advantage as compared with moderate THST, even in patients with distant metastatic disease, which remains particularly relevant given the risks associated with long-term thyrotoxicosis.” She acknowledged certain limitations of the study, including the potential for institutional bias. “However, we feel that this is somewhat offset due to the size of the registry cohort and the number of sites involved” Dr. Carhill said.

The registry has received support from Genzyme and Pfizer. Dr. Carhill reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF.– In an analysis of primary treatments for all stages of differentiated thyroid carcinoma, only thyroid hormone suppressive therapy was associated with both improved overall survival and disease-free survival.

Further, when examining the degree of thyroid hormone suppressive therapy (THST), aggressive THST conferred no additional survival benefit when compared with moderate THST, even when limiting the analysis to patients with distant metastatic disease, results from a long-term analysis of registry showed.

Those are key findings from an updated analysis of data from the National Thyroid Cancer Treatment Cooperative Study Group Registry, which were presented by lead study author Dr. Aubrey Carhill during the annual meeting of the American Thyroid Association.

“To date there are no prospective studies evaluating the longitudinal outcomes of initial long-term therapies in differentiated thyroid carcinoma,” said Dr. Carhill of MD Anderson Cancer Center, Houston. “In the absence of prospective trials, there has been significant reliance on retrospective studies with limited numbers of patients and low event rates as well as significant reliance on expert opinion to guide clinical practice.”

For example, current ATA guidelines for TSH suppression suggest that in long-term follow-up of patients with differentiated thyroid cancer, “those with persistent disease should have TSH levels suppressed to undetectable levels and maintained indefinitely,” Dr. Carhill said, while disease-free, higher-risk patients “should be suppressed to low-moderate levels continued between 5 and 10 years and low-risk patients should be maintained in the low-normal range. Similar levels of evidence exist to support the use of radioactive iodine and the degree of surgical extent.”

The challenge for clinicians, she continued, becomes balancing the potential risks of more aggressive therapies, such as aggressive thyroid hormone suppression, and the risks associated with long-term thyrotoxicosis with the potential benefits of treatment. “This is not always clear, especially in patients who are at very low risk for cancer-specific mortality,” she said. “There remains a need for accurate prognostication in order to identify which patients will benefit from different treatment modalities because current staging systems have limited ability to predict response to treatment.”

Formed in 1987, the National Thyroid Treatment Cooperative Study Group is a multi-institutional effort to assess long-term management of outcomes on patients with differentiated thyroid cancer. The purpose of the present study was to provide a more current analysis of the prospectively collected data, which was last analyzed in 2001. All staging is tracked according to the registry’s staging system, which is very similar to that of the American Joint Committee on Cancer’s TNM Staging System. Therapies analyzed included total/near total thyroidectomy (T/NTT) vs. a lesser extent of surgery; radioactive iodine (RAI) vs. no RAI; and increasing degrees of THST over time.

Dr. Carhill presented findings from an analysis of the effects of initial therapies in 4,941 patients treated at 11 centers in North America between 1987 and 2012. The median length of follow-up was 6 years, which translated to 34,631 person-years of documented follow-up time. The researchers used univariate and multivariate analyses to assess overall and disease-free survival. Moderate THST was defined as TSH maintained in subnormal or normal levels, while aggressive THST was defined as that maintained in undetectable or subnormal levels.

Improved overall survival was observed in stage III patients who received RAI (risk ratio, 0.66; P = .04) and in stage IV patients who received T/NTT and RAI (RR, 0.66 and 0.70, respectively; combined P = .049). Moderate but not aggressive THST was associated with significantly improved overall survival in all stages (RR, 0.13 in stage I, 0.09 in stage II, 0.13 in stage III, and 0.33 in stage IV), as well as with improved disease-free survival (RR, 0.52 in stage I, 0.40 in stage II, 0.18 in stage III, and no RR in stage IV).

In stage I patients, RAI conferred worse disease-free survival (RR, 1.79; P = .0005). “However, further propensity analysis demonstrated that there was no difference in disease-free survival when patients were stratified according to their propensity to receive radioactive iodine,” Dr. Carhill said.

To evaluate the optimal duration of THST, the researchers examined the effect of continuing degrees of suppression beyond 1, 3, and 5 years of follow-up. After 1 and 3 years of follow-up, both initial stage and moderate TSH suppression were independently predictive of improved overall survival (RR, 0.31 and 0.29, respectively). However, after 5 years of follow-up, “although initial stage remained independently predictive, there was no further benefit with any subsequent degree of TSH suppression,” Dr. Carhill said.

The study “confirms prior registry findings of a survival benefit in high-risk groups treated with T/NTT and RAI, and there is no disease-free survival benefit in low-risk groups receiving postoperative RAI,” she concluded. “We also report for the first time that in multivariate analysis of primary treatments for DTC [differentiated thyroid cancer], in all stages, only THST was associated with both improved overall survival and disease-free survival. When examining the degree of THST, aggressive THST confers no additional survival advantage as compared with moderate THST, even in patients with distant metastatic disease, which remains particularly relevant given the risks associated with long-term thyrotoxicosis.” She acknowledged certain limitations of the study, including the potential for institutional bias. “However, we feel that this is somewhat offset due to the size of the registry cohort and the number of sites involved” Dr. Carhill said.

The registry has received support from Genzyme and Pfizer. Dr. Carhill reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – In a large cohort of patients with differentiated thyroid cancer, the use of radioactive iodine was associated with improved disease-specific survival in those with advanced disease but not in those with papillary thyroid microcarcinoma.

“Everything in medicine is a risk-benefit balance,” lead author Dr. Ryan K. Orosco said in an interview in advance of the annual meeting of the American Thyroid Association, where the work was presented. “Any two patients that receive radioactive iodine (RAI) for differentiated thyroid cancer are likely to have different survival benefit from that therapy. This study provides a quantitative comparison of the impact of RAI in various patient subgroups.”

In one of the largest studies of its kind, Dr. Orosco of the division of head and neck surgery at the University of California, San Diego, and his associates identified 85,740 patients with differentiated thyroid carcinoma from the Surveillance, Epidemiology, and End Results database from 1973 through 2009. They used multivariate analyses to explore the association between RAI and cancer-specific survival in 149 population subgroups, controlling for age, decade of diagnosis, race, gender, tumor type, nodal involvement, metastasis stage, and RAI therapy.

More than three-quarters of the patients (78%) were female, 68% were white, their mean age at diagnosis was 46 years, and the median follow-up time was 85 months. The researchers found that nearly half of patients (43%) received RAI. By American Joint Committee on Cancer stage, RAI was used in 55% of stage I patients, 41% of stage II patients, 94% of stage III patients, and 85% of stage IV patients. In addition, 42% of patients with T1a disease and 88% of those with T4 disease received RAI.

Use of RAI was positively associated with survival in the overall cohort (hazard ratio 1.3; P = .002), while statistically significant HRs for RAI were observed in 49 population subgroups. In patients with metastatic disease, use of RAI was associated with a decreased risk for disease-specific mortality (HR range of 2.28-3.82). Protective effects of RAI were also observed in patients with regional metastases (HR 1.4-1.9), those with T3-positive tumors (HR 1.36-1.39), those with T4 tumors (HR 1.85), and in those with stage IV disease (HR 1.47-1.73).

Dr. Orosco and his associates observed a negative effect of RAI in patients with macropapillary carcinoma. Specifically, those with T1a disease had an increased likelihood of thyroid cancer–specific mortality (HR .13; P less than .001), while similar associations were seen in multiple subgroups of patients with T1a disease (HR 0.04-0.25). No statistically significant effects of RAI were observed in patients with T1b or T2 tumors.

“RAI appears to offer the best survival impact in patients with advanced differentiated thyroid carcinoma,” Dr. Orosco said. “Its use in early-stage patients should be carefully considered.”

In their abstract, the researchers noted that the findings “might help clinicians personalize RAI therapy to specific differentiated thyroid cancer populations – offering treatment in patients most likely to benefit, and sparing others unnecessary costs and potential side effects.”

Dr. Orosco acknowledged certain limitations of the study, including the fact that the SEER database does not contain details about each patient’s surgery, the dose of RAI used, other comorbidities, or data on cancer recurrence. “This study does not attempt to explore the reasons behind the apparent survival disadvantage seen in patients with T1a disease,” he said. “We don’t know exactly why early-stage patients have an increased risk of disease-specific mortality when RAI is used. Additional work is needed to explore this further.”

Dr. Orosco reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – In a large cohort of patients with differentiated thyroid cancer, the use of radioactive iodine was associated with improved disease-specific survival in those with advanced disease but not in those with papillary thyroid microcarcinoma.

“Everything in medicine is a risk-benefit balance,” lead author Dr. Ryan K. Orosco said in an interview in advance of the annual meeting of the American Thyroid Association, where the work was presented. “Any two patients that receive radioactive iodine (RAI) for differentiated thyroid cancer are likely to have different survival benefit from that therapy. This study provides a quantitative comparison of the impact of RAI in various patient subgroups.”

In one of the largest studies of its kind, Dr. Orosco of the division of head and neck surgery at the University of California, San Diego, and his associates identified 85,740 patients with differentiated thyroid carcinoma from the Surveillance, Epidemiology, and End Results database from 1973 through 2009. They used multivariate analyses to explore the association between RAI and cancer-specific survival in 149 population subgroups, controlling for age, decade of diagnosis, race, gender, tumor type, nodal involvement, metastasis stage, and RAI therapy.

More than three-quarters of the patients (78%) were female, 68% were white, their mean age at diagnosis was 46 years, and the median follow-up time was 85 months. The researchers found that nearly half of patients (43%) received RAI. By American Joint Committee on Cancer stage, RAI was used in 55% of stage I patients, 41% of stage II patients, 94% of stage III patients, and 85% of stage IV patients. In addition, 42% of patients with T1a disease and 88% of those with T4 disease received RAI.

Use of RAI was positively associated with survival in the overall cohort (hazard ratio 1.3; P = .002), while statistically significant HRs for RAI were observed in 49 population subgroups. In patients with metastatic disease, use of RAI was associated with a decreased risk for disease-specific mortality (HR range of 2.28-3.82). Protective effects of RAI were also observed in patients with regional metastases (HR 1.4-1.9), those with T3-positive tumors (HR 1.36-1.39), those with T4 tumors (HR 1.85), and in those with stage IV disease (HR 1.47-1.73).

Dr. Orosco and his associates observed a negative effect of RAI in patients with macropapillary carcinoma. Specifically, those with T1a disease had an increased likelihood of thyroid cancer–specific mortality (HR .13; P less than .001), while similar associations were seen in multiple subgroups of patients with T1a disease (HR 0.04-0.25). No statistically significant effects of RAI were observed in patients with T1b or T2 tumors.

“RAI appears to offer the best survival impact in patients with advanced differentiated thyroid carcinoma,” Dr. Orosco said. “Its use in early-stage patients should be carefully considered.”

In their abstract, the researchers noted that the findings “might help clinicians personalize RAI therapy to specific differentiated thyroid cancer populations – offering treatment in patients most likely to benefit, and sparing others unnecessary costs and potential side effects.”

Dr. Orosco acknowledged certain limitations of the study, including the fact that the SEER database does not contain details about each patient’s surgery, the dose of RAI used, other comorbidities, or data on cancer recurrence. “This study does not attempt to explore the reasons behind the apparent survival disadvantage seen in patients with T1a disease,” he said. “We don’t know exactly why early-stage patients have an increased risk of disease-specific mortality when RAI is used. Additional work is needed to explore this further.”

Dr. Orosco reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

CORONADO, CALIF. – In a large cohort of patients with differentiated thyroid cancer, the use of radioactive iodine was associated with improved disease-specific survival in those with advanced disease but not in those with papillary thyroid microcarcinoma.

“Everything in medicine is a risk-benefit balance,” lead author Dr. Ryan K. Orosco said in an interview in advance of the annual meeting of the American Thyroid Association, where the work was presented. “Any two patients that receive radioactive iodine (RAI) for differentiated thyroid cancer are likely to have different survival benefit from that therapy. This study provides a quantitative comparison of the impact of RAI in various patient subgroups.”

In one of the largest studies of its kind, Dr. Orosco of the division of head and neck surgery at the University of California, San Diego, and his associates identified 85,740 patients with differentiated thyroid carcinoma from the Surveillance, Epidemiology, and End Results database from 1973 through 2009. They used multivariate analyses to explore the association between RAI and cancer-specific survival in 149 population subgroups, controlling for age, decade of diagnosis, race, gender, tumor type, nodal involvement, metastasis stage, and RAI therapy.

More than three-quarters of the patients (78%) were female, 68% were white, their mean age at diagnosis was 46 years, and the median follow-up time was 85 months. The researchers found that nearly half of patients (43%) received RAI. By American Joint Committee on Cancer stage, RAI was used in 55% of stage I patients, 41% of stage II patients, 94% of stage III patients, and 85% of stage IV patients. In addition, 42% of patients with T1a disease and 88% of those with T4 disease received RAI.

Use of RAI was positively associated with survival in the overall cohort (hazard ratio 1.3; P = .002), while statistically significant HRs for RAI were observed in 49 population subgroups. In patients with metastatic disease, use of RAI was associated with a decreased risk for disease-specific mortality (HR range of 2.28-3.82). Protective effects of RAI were also observed in patients with regional metastases (HR 1.4-1.9), those with T3-positive tumors (HR 1.36-1.39), those with T4 tumors (HR 1.85), and in those with stage IV disease (HR 1.47-1.73).

Dr. Orosco and his associates observed a negative effect of RAI in patients with macropapillary carcinoma. Specifically, those with T1a disease had an increased likelihood of thyroid cancer–specific mortality (HR .13; P less than .001), while similar associations were seen in multiple subgroups of patients with T1a disease (HR 0.04-0.25). No statistically significant effects of RAI were observed in patients with T1b or T2 tumors.

“RAI appears to offer the best survival impact in patients with advanced differentiated thyroid carcinoma,” Dr. Orosco said. “Its use in early-stage patients should be carefully considered.”

In their abstract, the researchers noted that the findings “might help clinicians personalize RAI therapy to specific differentiated thyroid cancer populations – offering treatment in patients most likely to benefit, and sparing others unnecessary costs and potential side effects.”

Dr. Orosco acknowledged certain limitations of the study, including the fact that the SEER database does not contain details about each patient’s surgery, the dose of RAI used, other comorbidities, or data on cancer recurrence. “This study does not attempt to explore the reasons behind the apparent survival disadvantage seen in patients with T1a disease,” he said. “We don’t know exactly why early-stage patients have an increased risk of disease-specific mortality when RAI is used. Additional work is needed to explore this further.”

Dr. Orosco reported having no financial disclosures.

[email protected]

On Twitter @dougbrunk

Mark Klein, MD, and his team of fellow researchers came to the 2014 AVAHO Meeting to present their poster presentation, Incorporation of Palliative Care with Chemotherapy and Radiation in Patients Treated for Head and Neck Cancer.

To hear Dr. Klein discuss his research, watch the video below.

Mark Klein, MD, and his team of fellow researchers came to the 2014 AVAHO Meeting to present their poster presentation, Incorporation of Palliative Care with Chemotherapy and Radiation in Patients Treated for Head and Neck Cancer.

To hear Dr. Klein discuss his research, watch the video below.

Mark Klein, MD, and his team of fellow researchers came to the 2014 AVAHO Meeting to present their poster presentation, Incorporation of Palliative Care with Chemotherapy and Radiation in Patients Treated for Head and Neck Cancer.

To hear Dr. Klein discuss his research, watch the video below.

Purpose: About 400,000 new cases of Head and Neck Cancer (HNC) are diagnosed and reported each year. HNC patients require frequent follow-up care and additional interventions due to the potential for disease recurrence and second primaries. A robust and automated HNC identification and surveillance program can aid in case identification and can track appointments and required care, using the guidelines of the National Comprehensive Cancer Network (NCCN). An automated tool would provide for optimal treatment interventions while preventing any patients from being inadvertently lost to follow-up, enhancing veteran centered care.

Methods: The ear, nose, and throat (ENT) Cancer Tracking System (CTS) queries the VA Corporate Data Warehouse each night to identify all patients recently diagnosed with a HNC. All patients residing in the Albuquerque, New Mexico, and Big Spring, Texas, catchment areas are included in the capture pool. Cases are identified by examining outpatient visits and inpatient discharge diagnosis International Classification of Diseases (ICD) codes, surgical pathology Systematized Nomenclature of Medicine—Clinical Terms (SNOMED codes), and VistA problem list diagnoses. Patients identified as having cancer are presented, using an interactive report hosted on a secure SharePoint site. Newly identified patients are automatically assigned to “active” management status, minimizing the risk of missing a new patient. The coordinator can toggle a patient’s status between “inactive” and “active” at any time, but can never delete a patient from the CTS. Inactive patients with a new cancer diagnosis are automatically toggled to active status. The CTS report tracks and presents a number of pertinent medical indicators, including patient identifiers and residence location, most recent diagnosis date, days since last diagnosis, diagnosis ICD code, date captured on the CTS, most recent ear, nose, and throat (ENT) visit, most recent ENT appointment, days since last visit, date of last thyroid-stimulating hormone (TSH) test, and date of last PET scan. Cancellations, no-shows, and patients overdue for TSH testing are highlighted.

Results: Baseline data obtained in 2012 prior to the activation of the CTS revealed that about 31.1% of diagnosed HNC patients in the ENT clinic experienced delays in care or were lost to follow-up care through cancellations, no shows, and nonrescheduled appointments. A dedicated cancer care coordinator (CCC) was assigned to the ENT clinic to record, monitor, and track HNC patients manually using an Excel spreadsheet. Although cancer surveillance reports proved that launching a cancer surveillance program prevented patients with cancer from being lost to follow-up care, the manual tracking system was time consuming and labor intensive. The automated CTS has optimized cancer surveillance by providing the CCC with immediate identification of new HNC diagnoses, appointment tracking, alerts for HNC patients that have not been scheduled, alerts of overdue required lab tests, tracking of completed PET CT imaging, and improved timeliness in obtaining quality improvement data; all were accomplished without the CCC manually tracking anything.

Conclusions: During the first 4 months of operation (February to May 2014), 14 new HNC patients were identified automatically—patients that manual tracking might have missed or incurred delays in care. The CTS has proved to be a vital tool to the CCC and will continue to assist in the identification of new HNC patients, provide access to patient information on follow-up care, and improve access to recommended diagnostic procedures from NCCN guidelines. Other benefits of an electronic tracking system are optimized time, improved workflows, and improvements to patient safety by providing timely access to care and treatment.

Purpose: About 400,000 new cases of Head and Neck Cancer (HNC) are diagnosed and reported each year. HNC patients require frequent follow-up care and additional interventions due to the potential for disease recurrence and second primaries. A robust and automated HNC identification and surveillance program can aid in case identification and can track appointments and required care, using the guidelines of the National Comprehensive Cancer Network (NCCN). An automated tool would provide for optimal treatment interventions while preventing any patients from being inadvertently lost to follow-up, enhancing veteran centered care.

Methods: The ear, nose, and throat (ENT) Cancer Tracking System (CTS) queries the VA Corporate Data Warehouse each night to identify all patients recently diagnosed with a HNC. All patients residing in the Albuquerque, New Mexico, and Big Spring, Texas, catchment areas are included in the capture pool. Cases are identified by examining outpatient visits and inpatient discharge diagnosis International Classification of Diseases (ICD) codes, surgical pathology Systematized Nomenclature of Medicine—Clinical Terms (SNOMED codes), and VistA problem list diagnoses. Patients identified as having cancer are presented, using an interactive report hosted on a secure SharePoint site. Newly identified patients are automatically assigned to “active” management status, minimizing the risk of missing a new patient. The coordinator can toggle a patient’s status between “inactive” and “active” at any time, but can never delete a patient from the CTS. Inactive patients with a new cancer diagnosis are automatically toggled to active status. The CTS report tracks and presents a number of pertinent medical indicators, including patient identifiers and residence location, most recent diagnosis date, days since last diagnosis, diagnosis ICD code, date captured on the CTS, most recent ear, nose, and throat (ENT) visit, most recent ENT appointment, days since last visit, date of last thyroid-stimulating hormone (TSH) test, and date of last PET scan. Cancellations, no-shows, and patients overdue for TSH testing are highlighted.

Results: Baseline data obtained in 2012 prior to the activation of the CTS revealed that about 31.1% of diagnosed HNC patients in the ENT clinic experienced delays in care or were lost to follow-up care through cancellations, no shows, and nonrescheduled appointments. A dedicated cancer care coordinator (CCC) was assigned to the ENT clinic to record, monitor, and track HNC patients manually using an Excel spreadsheet. Although cancer surveillance reports proved that launching a cancer surveillance program prevented patients with cancer from being lost to follow-up care, the manual tracking system was time consuming and labor intensive. The automated CTS has optimized cancer surveillance by providing the CCC with immediate identification of new HNC diagnoses, appointment tracking, alerts for HNC patients that have not been scheduled, alerts of overdue required lab tests, tracking of completed PET CT imaging, and improved timeliness in obtaining quality improvement data; all were accomplished without the CCC manually tracking anything.

Conclusions: During the first 4 months of operation (February to May 2014), 14 new HNC patients were identified automatically—patients that manual tracking might have missed or incurred delays in care. The CTS has proved to be a vital tool to the CCC and will continue to assist in the identification of new HNC patients, provide access to patient information on follow-up care, and improve access to recommended diagnostic procedures from NCCN guidelines. Other benefits of an electronic tracking system are optimized time, improved workflows, and improvements to patient safety by providing timely access to care and treatment.

Purpose: About 400,000 new cases of Head and Neck Cancer (HNC) are diagnosed and reported each year. HNC patients require frequent follow-up care and additional interventions due to the potential for disease recurrence and second primaries. A robust and automated HNC identification and surveillance program can aid in case identification and can track appointments and required care, using the guidelines of the National Comprehensive Cancer Network (NCCN). An automated tool would provide for optimal treatment interventions while preventing any patients from being inadvertently lost to follow-up, enhancing veteran centered care.

Methods: The ear, nose, and throat (ENT) Cancer Tracking System (CTS) queries the VA Corporate Data Warehouse each night to identify all patients recently diagnosed with a HNC. All patients residing in the Albuquerque, New Mexico, and Big Spring, Texas, catchment areas are included in the capture pool. Cases are identified by examining outpatient visits and inpatient discharge diagnosis International Classification of Diseases (ICD) codes, surgical pathology Systematized Nomenclature of Medicine—Clinical Terms (SNOMED codes), and VistA problem list diagnoses. Patients identified as having cancer are presented, using an interactive report hosted on a secure SharePoint site. Newly identified patients are automatically assigned to “active” management status, minimizing the risk of missing a new patient. The coordinator can toggle a patient’s status between “inactive” and “active” at any time, but can never delete a patient from the CTS. Inactive patients with a new cancer diagnosis are automatically toggled to active status. The CTS report tracks and presents a number of pertinent medical indicators, including patient identifiers and residence location, most recent diagnosis date, days since last diagnosis, diagnosis ICD code, date captured on the CTS, most recent ear, nose, and throat (ENT) visit, most recent ENT appointment, days since last visit, date of last thyroid-stimulating hormone (TSH) test, and date of last PET scan. Cancellations, no-shows, and patients overdue for TSH testing are highlighted.

Results: Baseline data obtained in 2012 prior to the activation of the CTS revealed that about 31.1% of diagnosed HNC patients in the ENT clinic experienced delays in care or were lost to follow-up care through cancellations, no shows, and nonrescheduled appointments. A dedicated cancer care coordinator (CCC) was assigned to the ENT clinic to record, monitor, and track HNC patients manually using an Excel spreadsheet. Although cancer surveillance reports proved that launching a cancer surveillance program prevented patients with cancer from being lost to follow-up care, the manual tracking system was time consuming and labor intensive. The automated CTS has optimized cancer surveillance by providing the CCC with immediate identification of new HNC diagnoses, appointment tracking, alerts for HNC patients that have not been scheduled, alerts of overdue required lab tests, tracking of completed PET CT imaging, and improved timeliness in obtaining quality improvement data; all were accomplished without the CCC manually tracking anything.

Conclusions: During the first 4 months of operation (February to May 2014), 14 new HNC patients were identified automatically—patients that manual tracking might have missed or incurred delays in care. The CTS has proved to be a vital tool to the CCC and will continue to assist in the identification of new HNC patients, provide access to patient information on follow-up care, and improve access to recommended diagnostic procedures from NCCN guidelines. Other benefits of an electronic tracking system are optimized time, improved workflows, and improvements to patient safety by providing timely access to care and treatment.

Purpose: To evaluate the effects of feeding tube placement on patient weight and length of treatment breaks during definitive radiotherapy with at least 50 Gy to the bilateral necks of patients with head and neck (H&N) cancer.

Methods: Thirty-five H&N cancer patients underwent definitive radiotherapy at the Radiation Oncology Department at Michael E. DeBakey VA Medical Center from July 23, 2012 to April 25, 2013.  Twenty-three patients received doses of ≥ 50 Gy to bilateral necks, and constituted the study group. The remaining 12 patients did not receive ≥ 50 Gy and were excluded from the study. Among the 23 patients, 11 underwent feeding tube placement (group 1). Group 2 consisted of 12 patients without feeding tubes. All patients with feeding tube placement had concurrent chemotherapy. Some patients in group 2 received radiation treatment only.

Results: Twenty-two patients had weight loss, 1 patient gained 6.9 lb during the course of treatment. The median weight loss for group 1 was 17.8 lb (ranging from 4.4 to 34.4 lb), compared with 18.6 lb in patients in group 2. Those in group 2 who only received radiation therapy had the least median weight loss (5.4 lb). The average treatment break was 3.3 days for patients in group 1, 3.7 days for those in group 2 with concurrent chemo-radiotherapy (chemoRT), and 3.2 days for group 2 subjects receiving radiation therapy only.

Conclusions: In H&N cancer patients, feeding tube placement did not minimize weight loss and did not reduce average treatment breaks in those given concurrent chemoRT. An interesting additional finding of the study was that chemotherapy seems to have greater impact on a patient’s ability to tolerate radiation therapy. Our findings in this small, retrospective study, though suggestive, are insufficient to draw any definitive conclusions about the effectiveness of prophylactic feeding tube placement in the target patient population. Published studies on this subject are contradictory. Treatment decisions should be based on physician expertise and individualized to clinical needs of patients.

Purpose: To evaluate the effects of feeding tube placement on patient weight and length of treatment breaks during definitive radiotherapy with at least 50 Gy to the bilateral necks of patients with head and neck (H&N) cancer.

Methods: Thirty-five H&N cancer patients underwent definitive radiotherapy at the Radiation Oncology Department at Michael E. DeBakey VA Medical Center from July 23, 2012 to April 25, 2013.  Twenty-three patients received doses of ≥ 50 Gy to bilateral necks, and constituted the study group. The remaining 12 patients did not receive ≥ 50 Gy and were excluded from the study. Among the 23 patients, 11 underwent feeding tube placement (group 1). Group 2 consisted of 12 patients without feeding tubes. All patients with feeding tube placement had concurrent chemotherapy. Some patients in group 2 received radiation treatment only.

Results: Twenty-two patients had weight loss, 1 patient gained 6.9 lb during the course of treatment. The median weight loss for group 1 was 17.8 lb (ranging from 4.4 to 34.4 lb), compared with 18.6 lb in patients in group 2. Those in group 2 who only received radiation therapy had the least median weight loss (5.4 lb). The average treatment break was 3.3 days for patients in group 1, 3.7 days for those in group 2 with concurrent chemo-radiotherapy (chemoRT), and 3.2 days for group 2 subjects receiving radiation therapy only.

Conclusions: In H&N cancer patients, feeding tube placement did not minimize weight loss and did not reduce average treatment breaks in those given concurrent chemoRT. An interesting additional finding of the study was that chemotherapy seems to have greater impact on a patient’s ability to tolerate radiation therapy. Our findings in this small, retrospective study, though suggestive, are insufficient to draw any definitive conclusions about the effectiveness of prophylactic feeding tube placement in the target patient population. Published studies on this subject are contradictory. Treatment decisions should be based on physician expertise and individualized to clinical needs of patients.

Purpose: To evaluate the effects of feeding tube placement on patient weight and length of treatment breaks during definitive radiotherapy with at least 50 Gy to the bilateral necks of patients with head and neck (H&N) cancer.

Methods: Thirty-five H&N cancer patients underwent definitive radiotherapy at the Radiation Oncology Department at Michael E. DeBakey VA Medical Center from July 23, 2012 to April 25, 2013.  Twenty-three patients received doses of ≥ 50 Gy to bilateral necks, and constituted the study group. The remaining 12 patients did not receive ≥ 50 Gy and were excluded from the study. Among the 23 patients, 11 underwent feeding tube placement (group 1). Group 2 consisted of 12 patients without feeding tubes. All patients with feeding tube placement had concurrent chemotherapy. Some patients in group 2 received radiation treatment only.

Results: Twenty-two patients had weight loss, 1 patient gained 6.9 lb during the course of treatment. The median weight loss for group 1 was 17.8 lb (ranging from 4.4 to 34.4 lb), compared with 18.6 lb in patients in group 2. Those in group 2 who only received radiation therapy had the least median weight loss (5.4 lb). The average treatment break was 3.3 days for patients in group 1, 3.7 days for those in group 2 with concurrent chemo-radiotherapy (chemoRT), and 3.2 days for group 2 subjects receiving radiation therapy only.

Conclusions: In H&N cancer patients, feeding tube placement did not minimize weight loss and did not reduce average treatment breaks in those given concurrent chemoRT. An interesting additional finding of the study was that chemotherapy seems to have greater impact on a patient’s ability to tolerate radiation therapy. Our findings in this small, retrospective study, though suggestive, are insufficient to draw any definitive conclusions about the effectiveness of prophylactic feeding tube placement in the target patient population. Published studies on this subject are contradictory. Treatment decisions should be based on physician expertise and individualized to clinical needs of patients.

Purpose: High-dose cisplatin is standard in head and neck cancers. Recently, weekly low-dose platinum alone or with cetuximab has been used. All patients received 70 Gy standard fraction intensity-modulated radiation therapy. We are comparing the former used at the VAMC with the latter regimens used in the department of Oncology at the University of Mississippi. We will present the toxicity, response, patterns of failure, and survival by the use of the different types of chemotherapy.

Purpose: High-dose cisplatin is standard in head and neck cancers. Recently, weekly low-dose platinum alone or with cetuximab has been used. All patients received 70 Gy standard fraction intensity-modulated radiation therapy. We are comparing the former used at the VAMC with the latter regimens used in the department of Oncology at the University of Mississippi. We will present the toxicity, response, patterns of failure, and survival by the use of the different types of chemotherapy.

Purpose: High-dose cisplatin is standard in head and neck cancers. Recently, weekly low-dose platinum alone or with cetuximab has been used. All patients received 70 Gy standard fraction intensity-modulated radiation therapy. We are comparing the former used at the VAMC with the latter regimens used in the department of Oncology at the University of Mississippi. We will present the toxicity, response, patterns of failure, and survival by the use of the different types of chemotherapy.

Purpose: Concurrent cisplatin and radiation is currently the preferred therapy for stage 3 and 4 head and neck cancer. However, patient tolerability is poor. Concurrent cetuximab and radiation, on the other hand, is well tolerated. However, head-to-head comparative studies with cisplatin are lacking. The purpose of this study was to compare the efficacy, tolerability, and total health care costs of cisplatin- and cetuximab-based regimens among veteran patients with head and neck cancer.

Methods and Materials: We conducted a retrospective study of patients with stage 3 and 4 head and neck cancer at the VA Pittsburgh Healthcare System from 2009-2013. Patients were included if they had biopsy-proven disease treated with cisplatin or cetuximab (both with concurrent radiation). Patients receiving adjuvant chemoradiation, those with non-squamous cell carcinoma, or carcinoma of the nasopharynx were excluded. Baseline characteristics were compared by chi-square or Fisher’s exact tests for categorical variables and by Mann-Whitney for continuous variables. The primary outcome was average chemotherapy dose intensity. Secondary outcomes included progression-free survival (PFS) and overall survival (OS) , which were compared by Kaplan-Meier and the log-rank test. Results: Fifty-two patients were included; 30 received cisplatin and 22 cetuximab. Patients who received cetuximab were older (median age, 66 vs 63; P = .04) and more likely to have diabetes (36% vs 7%; P = .01) and a CrCl 2 (9 vs 7; P = .33) were comparable between both groups. Patients were followed for a median of 29 months (range 0.4-64). Average chemotherapy dose intensity was lower for cisplatin (88% vs 96%; P = .03). Progression-free survival was longer among cisplatin patients (median 21 months, range 0-57) compared with that of cetuximab (median 17 months, range 1-52; P = 0.03) and did not vary among patients who did or did not receive 100% chemotherapy dose-intensity cisplatin (median 18 vs 27 months; P = .16). There was no difference in OS (31 vs 18 months, P = .19). Neutropenia (47% vs 0%; P ≤ .0001), dehydration (33% vs 0%; P = .003), nausea/vomiting (30% vs 0%; P = .07), and hypotension (23% vs 0%; P = .02) were higher among cisplatin patients. Rash was more common with cetuximab (64% vs 7%; P ≤ .0001). The average health care costs were $3,495 and $27,148 for cisplatin and cetuximab, respectively.

Conclusions: Among veterans with stage 3 or 4 head and neck cancer, treatment with cisplatin-based chemotherapy is associated with PFS compared with cetuximab-based regimens despite cisplatin patients receiving only 88% of chemotherapy. Patients who received cetuximab experienced fewer adverse effects. However, total health care costs were significantly higher. Our data suggest that cisplatin should remain the front-line therapy for stage 3 and 4 head and neck cancer. Cetuximab is best reserved for patients who are intolerant of or have a contraindication to cisplatin.

Purpose: Concurrent cisplatin and radiation is currently the preferred therapy for stage 3 and 4 head and neck cancer. However, patient tolerability is poor. Concurrent cetuximab and radiation, on the other hand, is well tolerated. However, head-to-head comparative studies with cisplatin are lacking. The purpose of this study was to compare the efficacy, tolerability, and total health care costs of cisplatin- and cetuximab-based regimens among veteran patients with head and neck cancer.

Methods and Materials: We conducted a retrospective study of patients with stage 3 and 4 head and neck cancer at the VA Pittsburgh Healthcare System from 2009-2013. Patients were included if they had biopsy-proven disease treated with cisplatin or cetuximab (both with concurrent radiation). Patients receiving adjuvant chemoradiation, those with non-squamous cell carcinoma, or carcinoma of the nasopharynx were excluded. Baseline characteristics were compared by chi-square or Fisher’s exact tests for categorical variables and by Mann-Whitney for continuous variables. The primary outcome was average chemotherapy dose intensity. Secondary outcomes included progression-free survival (PFS) and overall survival (OS) , which were compared by Kaplan-Meier and the log-rank test. Results: Fifty-two patients were included; 30 received cisplatin and 22 cetuximab. Patients who received cetuximab were older (median age, 66 vs 63; P = .04) and more likely to have diabetes (36% vs 7%; P = .01) and a CrCl 2 (9 vs 7; P = .33) were comparable between both groups. Patients were followed for a median of 29 months (range 0.4-64). Average chemotherapy dose intensity was lower for cisplatin (88% vs 96%; P = .03). Progression-free survival was longer among cisplatin patients (median 21 months, range 0-57) compared with that of cetuximab (median 17 months, range 1-52; P = 0.03) and did not vary among patients who did or did not receive 100% chemotherapy dose-intensity cisplatin (median 18 vs 27 months; P = .16). There was no difference in OS (31 vs 18 months, P = .19). Neutropenia (47% vs 0%; P ≤ .0001), dehydration (33% vs 0%; P = .003), nausea/vomiting (30% vs 0%; P = .07), and hypotension (23% vs 0%; P = .02) were higher among cisplatin patients. Rash was more common with cetuximab (64% vs 7%; P ≤ .0001). The average health care costs were $3,495 and $27,148 for cisplatin and cetuximab, respectively.

Conclusions: Among veterans with stage 3 or 4 head and neck cancer, treatment with cisplatin-based chemotherapy is associated with PFS compared with cetuximab-based regimens despite cisplatin patients receiving only 88% of chemotherapy. Patients who received cetuximab experienced fewer adverse effects. However, total health care costs were significantly higher. Our data suggest that cisplatin should remain the front-line therapy for stage 3 and 4 head and neck cancer. Cetuximab is best reserved for patients who are intolerant of or have a contraindication to cisplatin.

Purpose: Concurrent cisplatin and radiation is currently the preferred therapy for stage 3 and 4 head and neck cancer. However, patient tolerability is poor. Concurrent cetuximab and radiation, on the other hand, is well tolerated. However, head-to-head comparative studies with cisplatin are lacking. The purpose of this study was to compare the efficacy, tolerability, and total health care costs of cisplatin- and cetuximab-based regimens among veteran patients with head and neck cancer.

Methods and Materials: We conducted a retrospective study of patients with stage 3 and 4 head and neck cancer at the VA Pittsburgh Healthcare System from 2009-2013. Patients were included if they had biopsy-proven disease treated with cisplatin or cetuximab (both with concurrent radiation). Patients receiving adjuvant chemoradiation, those with non-squamous cell carcinoma, or carcinoma of the nasopharynx were excluded. Baseline characteristics were compared by chi-square or Fisher’s exact tests for categorical variables and by Mann-Whitney for continuous variables. The primary outcome was average chemotherapy dose intensity. Secondary outcomes included progression-free survival (PFS) and overall survival (OS) , which were compared by Kaplan-Meier and the log-rank test. Results: Fifty-two patients were included; 30 received cisplatin and 22 cetuximab. Patients who received cetuximab were older (median age, 66 vs 63; P = .04) and more likely to have diabetes (36% vs 7%; P = .01) and a CrCl 2 (9 vs 7; P = .33) were comparable between both groups. Patients were followed for a median of 29 months (range 0.4-64). Average chemotherapy dose intensity was lower for cisplatin (88% vs 96%; P = .03). Progression-free survival was longer among cisplatin patients (median 21 months, range 0-57) compared with that of cetuximab (median 17 months, range 1-52; P = 0.03) and did not vary among patients who did or did not receive 100% chemotherapy dose-intensity cisplatin (median 18 vs 27 months; P = .16). There was no difference in OS (31 vs 18 months, P = .19). Neutropenia (47% vs 0%; P ≤ .0001), dehydration (33% vs 0%; P = .003), nausea/vomiting (30% vs 0%; P = .07), and hypotension (23% vs 0%; P = .02) were higher among cisplatin patients. Rash was more common with cetuximab (64% vs 7%; P ≤ .0001). The average health care costs were $3,495 and $27,148 for cisplatin and cetuximab, respectively.

Conclusions: Among veterans with stage 3 or 4 head and neck cancer, treatment with cisplatin-based chemotherapy is associated with PFS compared with cetuximab-based regimens despite cisplatin patients receiving only 88% of chemotherapy. Patients who received cetuximab experienced fewer adverse effects. However, total health care costs were significantly higher. Our data suggest that cisplatin should remain the front-line therapy for stage 3 and 4 head and neck cancer. Cetuximab is best reserved for patients who are intolerant of or have a contraindication to cisplatin.

Purpose: Recent studies have suggested that incorporation of palliative care concomitantly with therapy for metastatic cancer may be beneficial. The American Society of Clinical Oncology has published a provisional clinical opinion recommending incorporation of palliative care alongside chemotherapy in patients with metastatic cancer or a high symptom burden from cancer. In this project, we evaluate the feasibility of incorporation of palliative care in patients with head and neck (H&N) cancer treated with concurrent chemotherapy and radiation.

Methods: The primary goal of this quality improvement project is to assess the feasibility of participation in a palliative care program for patients with H&N cancer undergoing treatment. Patients are recommended for palliative care consultation if they have squamous cell carcinoma of the head and neck and are treated with concurrent chemotherapy and radiation (definitive or adjuvant therapy). Patients are offered palliative care consultation in their first week of treatment. They are approached in person to discuss goals and potential benefits of concomitant palliative care and chemotherapy/radiation. All patients are provided with informational material to review. If interested in palliative care, the participant is asked to fill out 5 non-mandatory questionnaires. These include the FACT-H&N, FACIT-Sp-12, PHQ-9, EAT-10, and HADS. Patients are seen by the palliative care service at 6, 12, 26, and 52 weeks after starting chemotherapy/radiation, and patients are asked to fill out the questionnaires at those time points as well. In addition, data on several potential quality elements (weight, use of enteral nutrition, laboratory values, site of disease, p16ink4a status, etc) are collected for comparison with a retrospective cohort.

Results: Retrospective data from the charts of 51 patients have been abstracted and analyzed for comparison with the prospective quality improvement cohort. The median age was 63 (range 48 to 87). Forty-four patients were either stage IVa or IVb. The location of primary tumors included the oropharynx (59%), oral cavity (11.8%), hypopharynx (9.8%), larynx (9.8%), and the nasopharnyx (7.8%). Forty-four of the 51 patients had a percutaneous endoscopic gastrostomy tube (for potential enteral nutrition) placed either prophylactically (before or within the first week of treatment, 19 patients) or reactively (after the first week of treatment, 25 patients). In the prospective cohort, 14 patients have thus far been offered palliative care consultation. Six patients agreed to palliative care consultation and 8 declined. The median age was 62, and all patients were male. Data collection and analysis are ongoing.

Conclusions: The results of this project may be able to guide incorporation of routine palliative care with the treatment of patients with (H&N) cancer. Barriers to enrolling in palliative care concomitantly with chemotherapy and radiation should be considered to aid incorporation of early palliative care for patients with H&N cancer.

Purpose: Recent studies have suggested that incorporation of palliative care concomitantly with therapy for metastatic cancer may be beneficial. The American Society of Clinical Oncology has published a provisional clinical opinion recommending incorporation of palliative care alongside chemotherapy in patients with metastatic cancer or a high symptom burden from cancer. In this project, we evaluate the feasibility of incorporation of palliative care in patients with head and neck (H&N) cancer treated with concurrent chemotherapy and radiation.

Methods: The primary goal of this quality improvement project is to assess the feasibility of participation in a palliative care program for patients with H&N cancer undergoing treatment. Patients are recommended for palliative care consultation if they have squamous cell carcinoma of the head and neck and are treated with concurrent chemotherapy and radiation (definitive or adjuvant therapy). Patients are offered palliative care consultation in their first week of treatment. They are approached in person to discuss goals and potential benefits of concomitant palliative care and chemotherapy/radiation. All patients are provided with informational material to review. If interested in palliative care, the participant is asked to fill out 5 non-mandatory questionnaires. These include the FACT-H&N, FACIT-Sp-12, PHQ-9, EAT-10, and HADS. Patients are seen by the palliative care service at 6, 12, 26, and 52 weeks after starting chemotherapy/radiation, and patients are asked to fill out the questionnaires at those time points as well. In addition, data on several potential quality elements (weight, use of enteral nutrition, laboratory values, site of disease, p16ink4a status, etc) are collected for comparison with a retrospective cohort.

Results: Retrospective data from the charts of 51 patients have been abstracted and analyzed for comparison with the prospective quality improvement cohort. The median age was 63 (range 48 to 87). Forty-four patients were either stage IVa or IVb. The location of primary tumors included the oropharynx (59%), oral cavity (11.8%), hypopharynx (9.8%), larynx (9.8%), and the nasopharnyx (7.8%). Forty-four of the 51 patients had a percutaneous endoscopic gastrostomy tube (for potential enteral nutrition) placed either prophylactically (before or within the first week of treatment, 19 patients) or reactively (after the first week of treatment, 25 patients). In the prospective cohort, 14 patients have thus far been offered palliative care consultation. Six patients agreed to palliative care consultation and 8 declined. The median age was 62, and all patients were male. Data collection and analysis are ongoing.

Conclusions: The results of this project may be able to guide incorporation of routine palliative care with the treatment of patients with (H&N) cancer. Barriers to enrolling in palliative care concomitantly with chemotherapy and radiation should be considered to aid incorporation of early palliative care for patients with H&N cancer.

Purpose: Recent studies have suggested that incorporation of palliative care concomitantly with therapy for metastatic cancer may be beneficial. The American Society of Clinical Oncology has published a provisional clinical opinion recommending incorporation of palliative care alongside chemotherapy in patients with metastatic cancer or a high symptom burden from cancer. In this project, we evaluate the feasibility of incorporation of palliative care in patients with head and neck (H&N) cancer treated with concurrent chemotherapy and radiation.

Methods: The primary goal of this quality improvement project is to assess the feasibility of participation in a palliative care program for patients with H&N cancer undergoing treatment. Patients are recommended for palliative care consultation if they have squamous cell carcinoma of the head and neck and are treated with concurrent chemotherapy and radiation (definitive or adjuvant therapy). Patients are offered palliative care consultation in their first week of treatment. They are approached in person to discuss goals and potential benefits of concomitant palliative care and chemotherapy/radiation. All patients are provided with informational material to review. If interested in palliative care, the participant is asked to fill out 5 non-mandatory questionnaires. These include the FACT-H&N, FACIT-Sp-12, PHQ-9, EAT-10, and HADS. Patients are seen by the palliative care service at 6, 12, 26, and 52 weeks after starting chemotherapy/radiation, and patients are asked to fill out the questionnaires at those time points as well. In addition, data on several potential quality elements (weight, use of enteral nutrition, laboratory values, site of disease, p16ink4a status, etc) are collected for comparison with a retrospective cohort.

Results: Retrospective data from the charts of 51 patients have been abstracted and analyzed for comparison with the prospective quality improvement cohort. The median age was 63 (range 48 to 87). Forty-four patients were either stage IVa or IVb. The location of primary tumors included the oropharynx (59%), oral cavity (11.8%), hypopharynx (9.8%), larynx (9.8%), and the nasopharnyx (7.8%). Forty-four of the 51 patients had a percutaneous endoscopic gastrostomy tube (for potential enteral nutrition) placed either prophylactically (before or within the first week of treatment, 19 patients) or reactively (after the first week of treatment, 25 patients). In the prospective cohort, 14 patients have thus far been offered palliative care consultation. Six patients agreed to palliative care consultation and 8 declined. The median age was 62, and all patients were male. Data collection and analysis are ongoing.

Conclusions: The results of this project may be able to guide incorporation of routine palliative care with the treatment of patients with (H&N) cancer. Barriers to enrolling in palliative care concomitantly with chemotherapy and radiation should be considered to aid incorporation of early palliative care for patients with H&N cancer.