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Effect of Health Literacy Education on Chemotherapy-Induced Nausea and Vomiting
Purpose: To improve patient understanding of recommended antiemetics and self-reported nausea following chemotherapy with a simple pill-identifying calendar handout.
Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most severe adverse effects and important concerns in cancer patients. While there are multiple antiemetics available, dosing and timing can be confusing for patients, especially those with poor health literacy. Inadequate health literacy has been associated with poor self-management behaviors, and greater risk for non-compliance with treatment.
Methods: We assessed CINV in 25 patients treated in the Medical Oncology clinic at the University of Arkansas for Medical Sciences by using the existing validated Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). We performed a Plan-Do-Study-Act (PDSA) cycle by implementing dosing calendar handouts with images and names of antiemetics scheduled per National Comprehensive Cancer Network (NCCN) guidelines.
Data Analysis: McNemar’s test was used for paired nominal data. Wilcoxon signed-rank test was utilized to evaluate differences in cohort means before and after intervention.
Results: At baseline, we utilized the MAT to document patient-reported incidence and severity of acute and delayed nausea and vomiting on a 10-point scale during one cycle of chemotherapy. Subsequently, we provided handouts for future cycles of chemotherapy. MAT was completed again following this intervention. Nausea was improved in 63% of patients. Vomiting was improved in 82% of patients. Severity of acute and delayed nausea improved from 4.40 (SD 4.25) to 2.54 (SD 2.28; P=0.008) and from 5.84 (SD 3.13) to 3.13 (SD 3.15, P=0.0016), respectively. Mean duration of nausea and vomiting was decreased from 3.72 days (SD 2.79) to 2.0 days (SD 2.55, P=0.0002). In addition, a single question was utilized to assess patient’s confidence in understanding their antiemetic regimen on a 10-point scale, which improved in 16 of 25 patients from a mean score of 7.84 (SD 1.97) to 9.50 (SD 1.18, P=0.0001).
Implications: Our calendar handout with pill images is an effective method to improve understanding of cancer treatment and decrease CINV in patients. As a result, a future PDSA cycle is planned to incorporate these handouts into our institution’s electronic medical record system.
Purpose: To improve patient understanding of recommended antiemetics and self-reported nausea following chemotherapy with a simple pill-identifying calendar handout.
Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most severe adverse effects and important concerns in cancer patients. While there are multiple antiemetics available, dosing and timing can be confusing for patients, especially those with poor health literacy. Inadequate health literacy has been associated with poor self-management behaviors, and greater risk for non-compliance with treatment.
Methods: We assessed CINV in 25 patients treated in the Medical Oncology clinic at the University of Arkansas for Medical Sciences by using the existing validated Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). We performed a Plan-Do-Study-Act (PDSA) cycle by implementing dosing calendar handouts with images and names of antiemetics scheduled per National Comprehensive Cancer Network (NCCN) guidelines.
Data Analysis: McNemar’s test was used for paired nominal data. Wilcoxon signed-rank test was utilized to evaluate differences in cohort means before and after intervention.
Results: At baseline, we utilized the MAT to document patient-reported incidence and severity of acute and delayed nausea and vomiting on a 10-point scale during one cycle of chemotherapy. Subsequently, we provided handouts for future cycles of chemotherapy. MAT was completed again following this intervention. Nausea was improved in 63% of patients. Vomiting was improved in 82% of patients. Severity of acute and delayed nausea improved from 4.40 (SD 4.25) to 2.54 (SD 2.28; P=0.008) and from 5.84 (SD 3.13) to 3.13 (SD 3.15, P=0.0016), respectively. Mean duration of nausea and vomiting was decreased from 3.72 days (SD 2.79) to 2.0 days (SD 2.55, P=0.0002). In addition, a single question was utilized to assess patient’s confidence in understanding their antiemetic regimen on a 10-point scale, which improved in 16 of 25 patients from a mean score of 7.84 (SD 1.97) to 9.50 (SD 1.18, P=0.0001).
Implications: Our calendar handout with pill images is an effective method to improve understanding of cancer treatment and decrease CINV in patients. As a result, a future PDSA cycle is planned to incorporate these handouts into our institution’s electronic medical record system.
Purpose: To improve patient understanding of recommended antiemetics and self-reported nausea following chemotherapy with a simple pill-identifying calendar handout.
Background: Chemotherapy-induced nausea and vomiting (CINV) is among the most severe adverse effects and important concerns in cancer patients. While there are multiple antiemetics available, dosing and timing can be confusing for patients, especially those with poor health literacy. Inadequate health literacy has been associated with poor self-management behaviors, and greater risk for non-compliance with treatment.
Methods: We assessed CINV in 25 patients treated in the Medical Oncology clinic at the University of Arkansas for Medical Sciences by using the existing validated Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT). We performed a Plan-Do-Study-Act (PDSA) cycle by implementing dosing calendar handouts with images and names of antiemetics scheduled per National Comprehensive Cancer Network (NCCN) guidelines.
Data Analysis: McNemar’s test was used for paired nominal data. Wilcoxon signed-rank test was utilized to evaluate differences in cohort means before and after intervention.
Results: At baseline, we utilized the MAT to document patient-reported incidence and severity of acute and delayed nausea and vomiting on a 10-point scale during one cycle of chemotherapy. Subsequently, we provided handouts for future cycles of chemotherapy. MAT was completed again following this intervention. Nausea was improved in 63% of patients. Vomiting was improved in 82% of patients. Severity of acute and delayed nausea improved from 4.40 (SD 4.25) to 2.54 (SD 2.28; P=0.008) and from 5.84 (SD 3.13) to 3.13 (SD 3.15, P=0.0016), respectively. Mean duration of nausea and vomiting was decreased from 3.72 days (SD 2.79) to 2.0 days (SD 2.55, P=0.0002). In addition, a single question was utilized to assess patient’s confidence in understanding their antiemetic regimen on a 10-point scale, which improved in 16 of 25 patients from a mean score of 7.84 (SD 1.97) to 9.50 (SD 1.18, P=0.0001).
Implications: Our calendar handout with pill images is an effective method to improve understanding of cancer treatment and decrease CINV in patients. As a result, a future PDSA cycle is planned to incorporate these handouts into our institution’s electronic medical record system.
The Incidence of Immune-Related Adverse Events (irAEs) at a VA Emergency Department (ED) in Cancer Patients Receiving Immune Checkpoint Inhibitors (ICPIs)
Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).
Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.
Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.
Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.
Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.
Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).
Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.
Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.
Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.
Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.
Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).
Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.
Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.
Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.
Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.
How Detection and Prevention of Gynecologic Carcinomas at One Major Veteran Affairs Medical Center (VAMC) is Superior to the Private Sector: A Review of Cervical Squamous Intraepithelial Neoplasia, Grade 3 (CIN III) and Invasive Carcinomas from 2008
Purpose: With an increasing emphasis on Veteran Women’s Health, we designed a study to see how our VAMC was doing at detecting invasive carcinomas and lesions that progress to carcinoma of the gynecologic tract.
Background: Cervical Cytology (also called a Pap smear) is reported to only be sensitive in detecting CIN II-III or carcinoma in 44%-72% of patients in the private sector. Is it higher in the VA System with higher standards of Quality Control?
Methods: Histology to cytology correlation statistics (all biopsies, cervical cones, and cervical resections), cervical smear diagnosis data, and righ-risk HPV (HR-HPV) status maintained by the Director of Cytopathology at the Houston VAMC (Quality Assurance Program) were reviewed from 2008 to 2018. Only patients with CIN III (severe dysplasia or carcinoma in situ) or invasive squamous cell carcinoma and adenocarcinoma were used for outcomes. All PAP smears are screened by both Staff Cytotechnologists and Staff Cytopathologists.
Results: From 2008-2018, there were 21,086 cervical smears performed and 184 cases of CIN III or Carcinoma were detected. Of the 6 invasive carcinomas, 2 had no previous pap smear and 4 had their 1st PAP smear show CIN III or Carcinoma. In CIN III, which includes Carcinoma In Situ, the first PAP smear showed 58 High Grade Squamous Intraepithelial Neoplasia, 68 Low Grade Squamous Intraepithelial Neoplasia and 52 Atypical Squamous Cells of Undetermined Significance warranting biopsy. Three patients had no VA Pap smear but presented with abnormal cytology in the private sector.
Implications: Compared to the private sector, the Houston VAMC had a 100% detection rate for CIN III and invasive carcinomas when there was a screening pap smear. None of the patients with CINIII/CIS progressed to an invasive carcinoma because they had been treated for their CIN III/CIS. When a strong QA program is used in Cytopathology, results can exceed the private sector.
Purpose: With an increasing emphasis on Veteran Women’s Health, we designed a study to see how our VAMC was doing at detecting invasive carcinomas and lesions that progress to carcinoma of the gynecologic tract.
Background: Cervical Cytology (also called a Pap smear) is reported to only be sensitive in detecting CIN II-III or carcinoma in 44%-72% of patients in the private sector. Is it higher in the VA System with higher standards of Quality Control?
Methods: Histology to cytology correlation statistics (all biopsies, cervical cones, and cervical resections), cervical smear diagnosis data, and righ-risk HPV (HR-HPV) status maintained by the Director of Cytopathology at the Houston VAMC (Quality Assurance Program) were reviewed from 2008 to 2018. Only patients with CIN III (severe dysplasia or carcinoma in situ) or invasive squamous cell carcinoma and adenocarcinoma were used for outcomes. All PAP smears are screened by both Staff Cytotechnologists and Staff Cytopathologists.
Results: From 2008-2018, there were 21,086 cervical smears performed and 184 cases of CIN III or Carcinoma were detected. Of the 6 invasive carcinomas, 2 had no previous pap smear and 4 had their 1st PAP smear show CIN III or Carcinoma. In CIN III, which includes Carcinoma In Situ, the first PAP smear showed 58 High Grade Squamous Intraepithelial Neoplasia, 68 Low Grade Squamous Intraepithelial Neoplasia and 52 Atypical Squamous Cells of Undetermined Significance warranting biopsy. Three patients had no VA Pap smear but presented with abnormal cytology in the private sector.
Implications: Compared to the private sector, the Houston VAMC had a 100% detection rate for CIN III and invasive carcinomas when there was a screening pap smear. None of the patients with CINIII/CIS progressed to an invasive carcinoma because they had been treated for their CIN III/CIS. When a strong QA program is used in Cytopathology, results can exceed the private sector.
Purpose: With an increasing emphasis on Veteran Women’s Health, we designed a study to see how our VAMC was doing at detecting invasive carcinomas and lesions that progress to carcinoma of the gynecologic tract.
Background: Cervical Cytology (also called a Pap smear) is reported to only be sensitive in detecting CIN II-III or carcinoma in 44%-72% of patients in the private sector. Is it higher in the VA System with higher standards of Quality Control?
Methods: Histology to cytology correlation statistics (all biopsies, cervical cones, and cervical resections), cervical smear diagnosis data, and righ-risk HPV (HR-HPV) status maintained by the Director of Cytopathology at the Houston VAMC (Quality Assurance Program) were reviewed from 2008 to 2018. Only patients with CIN III (severe dysplasia or carcinoma in situ) or invasive squamous cell carcinoma and adenocarcinoma were used for outcomes. All PAP smears are screened by both Staff Cytotechnologists and Staff Cytopathologists.
Results: From 2008-2018, there were 21,086 cervical smears performed and 184 cases of CIN III or Carcinoma were detected. Of the 6 invasive carcinomas, 2 had no previous pap smear and 4 had their 1st PAP smear show CIN III or Carcinoma. In CIN III, which includes Carcinoma In Situ, the first PAP smear showed 58 High Grade Squamous Intraepithelial Neoplasia, 68 Low Grade Squamous Intraepithelial Neoplasia and 52 Atypical Squamous Cells of Undetermined Significance warranting biopsy. Three patients had no VA Pap smear but presented with abnormal cytology in the private sector.
Implications: Compared to the private sector, the Houston VAMC had a 100% detection rate for CIN III and invasive carcinomas when there was a screening pap smear. None of the patients with CINIII/CIS progressed to an invasive carcinoma because they had been treated for their CIN III/CIS. When a strong QA program is used in Cytopathology, results can exceed the private sector.
Unusual Case of Renal Cell Carcinoma Metastasis To Duodenum Presenting as Gastrointestinal Bleeding
Background: Renal Cell carcinoma (RCC) possesses the ability to metastasize to distant places most commonly lungs, lymph nodes, liver, bone, and brain. While RCC can metastasize potentially to any organ, the gastrointestinal tract involvement is exceedingly rare.
Case Presentation: A 76-year-old male veteran presented with complain of hematuria and was diagnosed initially with stage 3 (pT3cN0M0) clear cell RCC of the right kidney. He underwent right radical nephrectomy with caval thrombectomy. He was then followed for surveillance during which, based on his radiological imaging, he was found to have a mesenteric mass inseparable from the transverse colon, multiple pulmonary nodules, and a large hypo density in the liver. He underwent subsequent biopsy of the mesenteric mass, which confirmed metastatic RCC (clear cell).
He was started on sunitinib 50mg based on NCCN guidelines. He did well on sunitinib for a while, but repeat CT chest, abdomen, and pelvis scans showed progression of his disease. He was started on nivolumab as a second line agent as per the NCCN guidelines. While on nivolumab, he presented in early 2019 with an episode of GI bleeding (melena). He underwent repeat radiological imaging as well as an endoscopy, which showed medium size friable soft tissue mass in the 2nd part of duodenum. Biopsy of that mass con rmed RCC eroding into the duodenal mucosa. His case was discussed at the tumor board, and it was recommended that palliative surgery and radiation were not an option for him. A recommendation for palliative and supportive treatment were made. The patient’s condition was discussed with him, and given that he was asymptomatic and at his general baseline health, he opted to continue with the immunotherapy.
Conclusion: RCC metastasis to GI tract is rare. The duodenum is reported to be the least involved segment of the small intestine. The number of cases reports in literature on duodenal metastasis from RCC is estimated to be around 20-25.Treatment of RCC with duodenal metastases depends upon the location and extent of the tumor as well as patient’s fitness for different modalities.
Background: Renal Cell carcinoma (RCC) possesses the ability to metastasize to distant places most commonly lungs, lymph nodes, liver, bone, and brain. While RCC can metastasize potentially to any organ, the gastrointestinal tract involvement is exceedingly rare.
Case Presentation: A 76-year-old male veteran presented with complain of hematuria and was diagnosed initially with stage 3 (pT3cN0M0) clear cell RCC of the right kidney. He underwent right radical nephrectomy with caval thrombectomy. He was then followed for surveillance during which, based on his radiological imaging, he was found to have a mesenteric mass inseparable from the transverse colon, multiple pulmonary nodules, and a large hypo density in the liver. He underwent subsequent biopsy of the mesenteric mass, which confirmed metastatic RCC (clear cell).
He was started on sunitinib 50mg based on NCCN guidelines. He did well on sunitinib for a while, but repeat CT chest, abdomen, and pelvis scans showed progression of his disease. He was started on nivolumab as a second line agent as per the NCCN guidelines. While on nivolumab, he presented in early 2019 with an episode of GI bleeding (melena). He underwent repeat radiological imaging as well as an endoscopy, which showed medium size friable soft tissue mass in the 2nd part of duodenum. Biopsy of that mass con rmed RCC eroding into the duodenal mucosa. His case was discussed at the tumor board, and it was recommended that palliative surgery and radiation were not an option for him. A recommendation for palliative and supportive treatment were made. The patient’s condition was discussed with him, and given that he was asymptomatic and at his general baseline health, he opted to continue with the immunotherapy.
Conclusion: RCC metastasis to GI tract is rare. The duodenum is reported to be the least involved segment of the small intestine. The number of cases reports in literature on duodenal metastasis from RCC is estimated to be around 20-25.Treatment of RCC with duodenal metastases depends upon the location and extent of the tumor as well as patient’s fitness for different modalities.
Background: Renal Cell carcinoma (RCC) possesses the ability to metastasize to distant places most commonly lungs, lymph nodes, liver, bone, and brain. While RCC can metastasize potentially to any organ, the gastrointestinal tract involvement is exceedingly rare.
Case Presentation: A 76-year-old male veteran presented with complain of hematuria and was diagnosed initially with stage 3 (pT3cN0M0) clear cell RCC of the right kidney. He underwent right radical nephrectomy with caval thrombectomy. He was then followed for surveillance during which, based on his radiological imaging, he was found to have a mesenteric mass inseparable from the transverse colon, multiple pulmonary nodules, and a large hypo density in the liver. He underwent subsequent biopsy of the mesenteric mass, which confirmed metastatic RCC (clear cell).
He was started on sunitinib 50mg based on NCCN guidelines. He did well on sunitinib for a while, but repeat CT chest, abdomen, and pelvis scans showed progression of his disease. He was started on nivolumab as a second line agent as per the NCCN guidelines. While on nivolumab, he presented in early 2019 with an episode of GI bleeding (melena). He underwent repeat radiological imaging as well as an endoscopy, which showed medium size friable soft tissue mass in the 2nd part of duodenum. Biopsy of that mass con rmed RCC eroding into the duodenal mucosa. His case was discussed at the tumor board, and it was recommended that palliative surgery and radiation were not an option for him. A recommendation for palliative and supportive treatment were made. The patient’s condition was discussed with him, and given that he was asymptomatic and at his general baseline health, he opted to continue with the immunotherapy.
Conclusion: RCC metastasis to GI tract is rare. The duodenum is reported to be the least involved segment of the small intestine. The number of cases reports in literature on duodenal metastasis from RCC is estimated to be around 20-25.Treatment of RCC with duodenal metastases depends upon the location and extent of the tumor as well as patient’s fitness for different modalities.
Combination Immunotherapy Leading to Severe Hepatotoxicity and Fatal Aplastic Anemia: Case Report and Review of the Literature
Background: Dual immune checkpoint blockade (DICB) is utilized for a variety of malignancies. These therapies have a unique and often unpredictable side effect profile compared to conventional chemotherapy. We describe a lethal case of aplastic anemia (AA) as a result of DICB and a review of the literature regarding this rare entity.
Case Presentation: A 64-year-old male underwent complete resection for right renal cell carcinoma. He developed metastasis 1 year after resection and was started on nivolumab 240 mg and ipilimumab 1mg/kg every 21 days. After 4 cycles, he had an asymptomatic elevation of liver function tests (LFT) with a total bilirubin of 6.4 mg/DL (Ref Range 0.2-1.2 mg/dL). Immunotherapy was discontinued, and he started IV methylprednisolone. His LFTs normalized after 5 weeks of steroid taper and CT demonstrated complete response.
6 months after his final dose of DICB, he developed progressive fatigue and a petechial rash. Labs were signi cant for white blood cell count of 0.9 K/cm2 (absolute neutrophil count of 0.3 k/cm2), hemoglobin of 12 g/dL and platelets of 11 K/cm2. His complete blood count 2 weeks prior was normal. A bone marrow biopsy demonstrated severely hypocellular marrow (10%) with marked decrease in all hematopoietic precursors. He was treated for DICB AA and started on 1mg/kg prednisone, granulocyte colony stimulating factor and erythropoietin.
After no count recovery he was started on antithymocyte globulin and received 7 doses. Despite aggressive supportive care and prophylactic antibiotics, he developed bacteremia and died of septic shock four weeks after admission.
Discussion: On review of the literature, there are only two reported cases of DICB AA. Our particular case has a few unique features. First, hepatotoxicity developed prior to AA. Second, pancytopenia occurred 6 months after his last dose of DICB. There are no other case reports of AA so far out from last infusion.
Conclusion: This case demonstrates the need to promptly recognize rare toxicities of immunotherapies such as AA and identify effective therapies for serious toxicities that are not steroid responsive.
Background: Dual immune checkpoint blockade (DICB) is utilized for a variety of malignancies. These therapies have a unique and often unpredictable side effect profile compared to conventional chemotherapy. We describe a lethal case of aplastic anemia (AA) as a result of DICB and a review of the literature regarding this rare entity.
Case Presentation: A 64-year-old male underwent complete resection for right renal cell carcinoma. He developed metastasis 1 year after resection and was started on nivolumab 240 mg and ipilimumab 1mg/kg every 21 days. After 4 cycles, he had an asymptomatic elevation of liver function tests (LFT) with a total bilirubin of 6.4 mg/DL (Ref Range 0.2-1.2 mg/dL). Immunotherapy was discontinued, and he started IV methylprednisolone. His LFTs normalized after 5 weeks of steroid taper and CT demonstrated complete response.
6 months after his final dose of DICB, he developed progressive fatigue and a petechial rash. Labs were signi cant for white blood cell count of 0.9 K/cm2 (absolute neutrophil count of 0.3 k/cm2), hemoglobin of 12 g/dL and platelets of 11 K/cm2. His complete blood count 2 weeks prior was normal. A bone marrow biopsy demonstrated severely hypocellular marrow (10%) with marked decrease in all hematopoietic precursors. He was treated for DICB AA and started on 1mg/kg prednisone, granulocyte colony stimulating factor and erythropoietin.
After no count recovery he was started on antithymocyte globulin and received 7 doses. Despite aggressive supportive care and prophylactic antibiotics, he developed bacteremia and died of septic shock four weeks after admission.
Discussion: On review of the literature, there are only two reported cases of DICB AA. Our particular case has a few unique features. First, hepatotoxicity developed prior to AA. Second, pancytopenia occurred 6 months after his last dose of DICB. There are no other case reports of AA so far out from last infusion.
Conclusion: This case demonstrates the need to promptly recognize rare toxicities of immunotherapies such as AA and identify effective therapies for serious toxicities that are not steroid responsive.
Background: Dual immune checkpoint blockade (DICB) is utilized for a variety of malignancies. These therapies have a unique and often unpredictable side effect profile compared to conventional chemotherapy. We describe a lethal case of aplastic anemia (AA) as a result of DICB and a review of the literature regarding this rare entity.
Case Presentation: A 64-year-old male underwent complete resection for right renal cell carcinoma. He developed metastasis 1 year after resection and was started on nivolumab 240 mg and ipilimumab 1mg/kg every 21 days. After 4 cycles, he had an asymptomatic elevation of liver function tests (LFT) with a total bilirubin of 6.4 mg/DL (Ref Range 0.2-1.2 mg/dL). Immunotherapy was discontinued, and he started IV methylprednisolone. His LFTs normalized after 5 weeks of steroid taper and CT demonstrated complete response.
6 months after his final dose of DICB, he developed progressive fatigue and a petechial rash. Labs were signi cant for white blood cell count of 0.9 K/cm2 (absolute neutrophil count of 0.3 k/cm2), hemoglobin of 12 g/dL and platelets of 11 K/cm2. His complete blood count 2 weeks prior was normal. A bone marrow biopsy demonstrated severely hypocellular marrow (10%) with marked decrease in all hematopoietic precursors. He was treated for DICB AA and started on 1mg/kg prednisone, granulocyte colony stimulating factor and erythropoietin.
After no count recovery he was started on antithymocyte globulin and received 7 doses. Despite aggressive supportive care and prophylactic antibiotics, he developed bacteremia and died of septic shock four weeks after admission.
Discussion: On review of the literature, there are only two reported cases of DICB AA. Our particular case has a few unique features. First, hepatotoxicity developed prior to AA. Second, pancytopenia occurred 6 months after his last dose of DICB. There are no other case reports of AA so far out from last infusion.
Conclusion: This case demonstrates the need to promptly recognize rare toxicities of immunotherapies such as AA and identify effective therapies for serious toxicities that are not steroid responsive.
Development of VET-ROC, the Veterans Radiation Oncology Consortium to Support and Promote VA Clinical Research
Purpose: To inform stakeholders of a newly formed, VAbased, research oriented collaborative group, the Veterans Radiation Oncology Consortium (VET-ROC).
Background: To strengthen, promote and enhance VA oncology and radiation oncology centered research, VET-ROC was conceived in October 2018 at the San Antonio VA Radiation Oncology Field Based Meeting and formed with the consent of 18 members sites.
Results: An email sent to all 85 known VA radiation oncologists in October 2018 drew 18 positive responses to join a clinical research consortium within VA. Members responded to 2 questionnaires about the state of their program in October 2018 and April 2019. Per their responses, VET-ROC sites consist of approximately 47 FTE Radiation Oncologists and > 26 FTE Physicists. The sites reported a total of 7.1 FTEE Clinical Research Coordinators (CRC’s) in October 2018 and 10.2 FTE CRC’s in April 2019 with most sites sharing CRC’s with other specialties. Five sites reported a lack of any research coordinator in October 2018, and in April 2019, 3 of those 5 sites had received approval from their resource management committees to hire CRCs.
The group had a face to face meeting in FEB 2019 and has held conference calls every 4-6 weeks since then to review opportunities for research, shared best practices, partake in educational webinars, identify barriers to research development, opportunities for research proposals with at least 2 groups of members submitting Merit Review awards to CSR&D that may have been possible as a result of VET-ROC. Feedback on the progress the group has made has been largely positive. Individual responses noted that the group had created opportunities that would not have been possible otherwise. There were suggestions to formalize the structure of the group.
Conclusion: Since its formation, VET-ROC has been a very positive experience for its members who consist of a select group of Radiation Oncologists with shared common interests in clinical research. The group will likely continue to move grow and move forward if it can translate its momentum into research support obtained from a diverse source of funding mechanisms.
Purpose: To inform stakeholders of a newly formed, VAbased, research oriented collaborative group, the Veterans Radiation Oncology Consortium (VET-ROC).
Background: To strengthen, promote and enhance VA oncology and radiation oncology centered research, VET-ROC was conceived in October 2018 at the San Antonio VA Radiation Oncology Field Based Meeting and formed with the consent of 18 members sites.
Results: An email sent to all 85 known VA radiation oncologists in October 2018 drew 18 positive responses to join a clinical research consortium within VA. Members responded to 2 questionnaires about the state of their program in October 2018 and April 2019. Per their responses, VET-ROC sites consist of approximately 47 FTE Radiation Oncologists and > 26 FTE Physicists. The sites reported a total of 7.1 FTEE Clinical Research Coordinators (CRC’s) in October 2018 and 10.2 FTE CRC’s in April 2019 with most sites sharing CRC’s with other specialties. Five sites reported a lack of any research coordinator in October 2018, and in April 2019, 3 of those 5 sites had received approval from their resource management committees to hire CRCs.
The group had a face to face meeting in FEB 2019 and has held conference calls every 4-6 weeks since then to review opportunities for research, shared best practices, partake in educational webinars, identify barriers to research development, opportunities for research proposals with at least 2 groups of members submitting Merit Review awards to CSR&D that may have been possible as a result of VET-ROC. Feedback on the progress the group has made has been largely positive. Individual responses noted that the group had created opportunities that would not have been possible otherwise. There were suggestions to formalize the structure of the group.
Conclusion: Since its formation, VET-ROC has been a very positive experience for its members who consist of a select group of Radiation Oncologists with shared common interests in clinical research. The group will likely continue to move grow and move forward if it can translate its momentum into research support obtained from a diverse source of funding mechanisms.
Purpose: To inform stakeholders of a newly formed, VAbased, research oriented collaborative group, the Veterans Radiation Oncology Consortium (VET-ROC).
Background: To strengthen, promote and enhance VA oncology and radiation oncology centered research, VET-ROC was conceived in October 2018 at the San Antonio VA Radiation Oncology Field Based Meeting and formed with the consent of 18 members sites.
Results: An email sent to all 85 known VA radiation oncologists in October 2018 drew 18 positive responses to join a clinical research consortium within VA. Members responded to 2 questionnaires about the state of their program in October 2018 and April 2019. Per their responses, VET-ROC sites consist of approximately 47 FTE Radiation Oncologists and > 26 FTE Physicists. The sites reported a total of 7.1 FTEE Clinical Research Coordinators (CRC’s) in October 2018 and 10.2 FTE CRC’s in April 2019 with most sites sharing CRC’s with other specialties. Five sites reported a lack of any research coordinator in October 2018, and in April 2019, 3 of those 5 sites had received approval from their resource management committees to hire CRCs.
The group had a face to face meeting in FEB 2019 and has held conference calls every 4-6 weeks since then to review opportunities for research, shared best practices, partake in educational webinars, identify barriers to research development, opportunities for research proposals with at least 2 groups of members submitting Merit Review awards to CSR&D that may have been possible as a result of VET-ROC. Feedback on the progress the group has made has been largely positive. Individual responses noted that the group had created opportunities that would not have been possible otherwise. There were suggestions to formalize the structure of the group.
Conclusion: Since its formation, VET-ROC has been a very positive experience for its members who consist of a select group of Radiation Oncologists with shared common interests in clinical research. The group will likely continue to move grow and move forward if it can translate its momentum into research support obtained from a diverse source of funding mechanisms.
Surgical Margins and Other Important Prognostic Factors in Dedifferentiated Liposarcoma Survival
Background: Liposarcoma is the most common malignant soft tissue sarcoma (STS). Surgical resection is the most utilized therapeutic option. In this study, we aim to explore the effects of varying degrees of surgical margins on survival in patients with dedifferentiated liposarcoma (DDLPS).
Methods: The National Cancer Database (NCDB) was used to select patients with DDLPS to determine if surgical margins and other variables were associated with decreased overall survival after accounting for age, gender, race, Charlson-Deyo score, anatomic site, treatment approach, tumor size, tumor grade, and presence of metastases through multivariable analysis.
Results: Of the 1004 selected patients, 64.4% were male, 87.0% were white, and the median age was 63 years. About 95% had no metastases at the time of diagnosis, and 91.5% had high grade liposarcoma. For the status of surgical margins, 50.8% had no residual tumors, 26.1% had microscopic residual tumors, 4.3% had macroscopic residual tumors. In general, the risk of death was higher for older males (25.8% increased risk of mortality) and those with metastases (312.9% increased risk of mortality) as well as patients with high grade liposarcoma (112.4% increased risk of mortality). Patients with macroscopic residual tumors in comparison to those with no residual tumors had a 96.7% increased risk of death (HR 95% CI:1.24 to 3.13; P=0.004).
Conclusion: Older age, presence of metastasis, male patients, retroperitoneal/abdomen primary site, highgrade tumors, and macroscopic or residual tumor present after surgery lead to an increased risk of mortality. These outcomes highlight the importance and benefits of negative or complete surgical margins as prognostic indicators for patients with DDLPS, especially considering that resection is the most commonly utilized therapeutic option. The NCDB contains about 70% of cancer incidents within the US, therefore a future study incorporating the Surveillance, Epidemiology, and End Results (SEER) registry could enhance and possibly add to the results brought forth by this study.
Background: Liposarcoma is the most common malignant soft tissue sarcoma (STS). Surgical resection is the most utilized therapeutic option. In this study, we aim to explore the effects of varying degrees of surgical margins on survival in patients with dedifferentiated liposarcoma (DDLPS).
Methods: The National Cancer Database (NCDB) was used to select patients with DDLPS to determine if surgical margins and other variables were associated with decreased overall survival after accounting for age, gender, race, Charlson-Deyo score, anatomic site, treatment approach, tumor size, tumor grade, and presence of metastases through multivariable analysis.
Results: Of the 1004 selected patients, 64.4% were male, 87.0% were white, and the median age was 63 years. About 95% had no metastases at the time of diagnosis, and 91.5% had high grade liposarcoma. For the status of surgical margins, 50.8% had no residual tumors, 26.1% had microscopic residual tumors, 4.3% had macroscopic residual tumors. In general, the risk of death was higher for older males (25.8% increased risk of mortality) and those with metastases (312.9% increased risk of mortality) as well as patients with high grade liposarcoma (112.4% increased risk of mortality). Patients with macroscopic residual tumors in comparison to those with no residual tumors had a 96.7% increased risk of death (HR 95% CI:1.24 to 3.13; P=0.004).
Conclusion: Older age, presence of metastasis, male patients, retroperitoneal/abdomen primary site, highgrade tumors, and macroscopic or residual tumor present after surgery lead to an increased risk of mortality. These outcomes highlight the importance and benefits of negative or complete surgical margins as prognostic indicators for patients with DDLPS, especially considering that resection is the most commonly utilized therapeutic option. The NCDB contains about 70% of cancer incidents within the US, therefore a future study incorporating the Surveillance, Epidemiology, and End Results (SEER) registry could enhance and possibly add to the results brought forth by this study.
Background: Liposarcoma is the most common malignant soft tissue sarcoma (STS). Surgical resection is the most utilized therapeutic option. In this study, we aim to explore the effects of varying degrees of surgical margins on survival in patients with dedifferentiated liposarcoma (DDLPS).
Methods: The National Cancer Database (NCDB) was used to select patients with DDLPS to determine if surgical margins and other variables were associated with decreased overall survival after accounting for age, gender, race, Charlson-Deyo score, anatomic site, treatment approach, tumor size, tumor grade, and presence of metastases through multivariable analysis.
Results: Of the 1004 selected patients, 64.4% were male, 87.0% were white, and the median age was 63 years. About 95% had no metastases at the time of diagnosis, and 91.5% had high grade liposarcoma. For the status of surgical margins, 50.8% had no residual tumors, 26.1% had microscopic residual tumors, 4.3% had macroscopic residual tumors. In general, the risk of death was higher for older males (25.8% increased risk of mortality) and those with metastases (312.9% increased risk of mortality) as well as patients with high grade liposarcoma (112.4% increased risk of mortality). Patients with macroscopic residual tumors in comparison to those with no residual tumors had a 96.7% increased risk of death (HR 95% CI:1.24 to 3.13; P=0.004).
Conclusion: Older age, presence of metastasis, male patients, retroperitoneal/abdomen primary site, highgrade tumors, and macroscopic or residual tumor present after surgery lead to an increased risk of mortality. These outcomes highlight the importance and benefits of negative or complete surgical margins as prognostic indicators for patients with DDLPS, especially considering that resection is the most commonly utilized therapeutic option. The NCDB contains about 70% of cancer incidents within the US, therefore a future study incorporating the Surveillance, Epidemiology, and End Results (SEER) registry could enhance and possibly add to the results brought forth by this study.
How Long Should it Take to Get a Pathology Diagnosis?
Justification: A diagnosis of malignancy is of great relevance to the patient and sets in motion numerous activities. How long is it reasonable to wait for a pathologic diagnosis on a biopsy obtained for suspected cancer?
Methods: To address this question, we analyzed our turn-around-time (TAT) for biopsies and cytologies obtained for initial diagnosis of malignancy and compared it to relevant literature. Another goal was to evaluate the influence of special stains on TAT. We obtained from VISTA TAT on surgical pathology and cytopathology specimens in which an initial diagnosis of malignancy was made (excluding non-melanoma skin cancer, GYN, and urine cytologies) between January 2016 and August 2018. We analyzed the impact of histochemical and immunohistochemical stains performed on TAT.
Results and Discussion: During this period, 2014 new malignancies were diagnosed among 31,407 biopsies (6.41%). Average TAT for all biopsies was 1.48 days; average TAT for biopsies with initial diagnosis of malignancy was 2.2 days. 149 new diagnoses of malignancy were made by cytology, with an average TAT of 1.49 days, compared with 1.63 days TAT for all cytologies. Performance of special stains had no statistical impact on TAT when compared with cases with no special stains.
Remarkably, no guidelines have been promulgated by institutions or accrediting bodies for TAT on specimens obtained for initial diagnosis of malignancy. Likewise, such data is not available in the literature; it is unclear how many institutions monitor this. The College of American Pathologists indicates that 90% of routine biopsies should be nalized within 2 working days; the Association of Directors of Anatomic and Surgical Pathology indicates that at least 80% of routine biopsies should be nalized in 3 days. However, guidelines for specimens obtained for initial diagnosis of malignancy, which frequently require special handling/ancillary testing (deeper sections, histo/immunohistochemistry, molecular studies, consultation) are not available.
Recommendations: Institutions should develop practices that prioritize study of specimens obtained to rule out malignancy and should monitor their TAT. All institutions and accrediting bodies (CAP, Commission on Cancer, etc.) should develop guidelines for TAT for initial diagnosis of malignancy and audit this information.
Justification: A diagnosis of malignancy is of great relevance to the patient and sets in motion numerous activities. How long is it reasonable to wait for a pathologic diagnosis on a biopsy obtained for suspected cancer?
Methods: To address this question, we analyzed our turn-around-time (TAT) for biopsies and cytologies obtained for initial diagnosis of malignancy and compared it to relevant literature. Another goal was to evaluate the influence of special stains on TAT. We obtained from VISTA TAT on surgical pathology and cytopathology specimens in which an initial diagnosis of malignancy was made (excluding non-melanoma skin cancer, GYN, and urine cytologies) between January 2016 and August 2018. We analyzed the impact of histochemical and immunohistochemical stains performed on TAT.
Results and Discussion: During this period, 2014 new malignancies were diagnosed among 31,407 biopsies (6.41%). Average TAT for all biopsies was 1.48 days; average TAT for biopsies with initial diagnosis of malignancy was 2.2 days. 149 new diagnoses of malignancy were made by cytology, with an average TAT of 1.49 days, compared with 1.63 days TAT for all cytologies. Performance of special stains had no statistical impact on TAT when compared with cases with no special stains.
Remarkably, no guidelines have been promulgated by institutions or accrediting bodies for TAT on specimens obtained for initial diagnosis of malignancy. Likewise, such data is not available in the literature; it is unclear how many institutions monitor this. The College of American Pathologists indicates that 90% of routine biopsies should be nalized within 2 working days; the Association of Directors of Anatomic and Surgical Pathology indicates that at least 80% of routine biopsies should be nalized in 3 days. However, guidelines for specimens obtained for initial diagnosis of malignancy, which frequently require special handling/ancillary testing (deeper sections, histo/immunohistochemistry, molecular studies, consultation) are not available.
Recommendations: Institutions should develop practices that prioritize study of specimens obtained to rule out malignancy and should monitor their TAT. All institutions and accrediting bodies (CAP, Commission on Cancer, etc.) should develop guidelines for TAT for initial diagnosis of malignancy and audit this information.
Justification: A diagnosis of malignancy is of great relevance to the patient and sets in motion numerous activities. How long is it reasonable to wait for a pathologic diagnosis on a biopsy obtained for suspected cancer?
Methods: To address this question, we analyzed our turn-around-time (TAT) for biopsies and cytologies obtained for initial diagnosis of malignancy and compared it to relevant literature. Another goal was to evaluate the influence of special stains on TAT. We obtained from VISTA TAT on surgical pathology and cytopathology specimens in which an initial diagnosis of malignancy was made (excluding non-melanoma skin cancer, GYN, and urine cytologies) between January 2016 and August 2018. We analyzed the impact of histochemical and immunohistochemical stains performed on TAT.
Results and Discussion: During this period, 2014 new malignancies were diagnosed among 31,407 biopsies (6.41%). Average TAT for all biopsies was 1.48 days; average TAT for biopsies with initial diagnosis of malignancy was 2.2 days. 149 new diagnoses of malignancy were made by cytology, with an average TAT of 1.49 days, compared with 1.63 days TAT for all cytologies. Performance of special stains had no statistical impact on TAT when compared with cases with no special stains.
Remarkably, no guidelines have been promulgated by institutions or accrediting bodies for TAT on specimens obtained for initial diagnosis of malignancy. Likewise, such data is not available in the literature; it is unclear how many institutions monitor this. The College of American Pathologists indicates that 90% of routine biopsies should be nalized within 2 working days; the Association of Directors of Anatomic and Surgical Pathology indicates that at least 80% of routine biopsies should be nalized in 3 days. However, guidelines for specimens obtained for initial diagnosis of malignancy, which frequently require special handling/ancillary testing (deeper sections, histo/immunohistochemistry, molecular studies, consultation) are not available.
Recommendations: Institutions should develop practices that prioritize study of specimens obtained to rule out malignancy and should monitor their TAT. All institutions and accrediting bodies (CAP, Commission on Cancer, etc.) should develop guidelines for TAT for initial diagnosis of malignancy and audit this information.
Nivolumab-Induced Hypothyoidism With Consequent Hypothyroid Related Myopathy
Purpose: Nivolumab is a fully human IgG4 programmed death 1 immune checkpoint inhibitor (ICI) antibody that has anti-tumor activity by selectively blocking the interaction of the programmed death 1 receptor with its two known programmed death ligands PD-L1 and PD-L2. In doing so, this immune checkpoint inhibitor removes the negative signal stifling T cell activation and proliferation within the tumor microenvironment and demonstrates favorable antitumor activity.
Case Report: We report an interesting case of immune checkpoint inhibitor-induced primary hypothyroidism with associated hypothyroid myopathy in a young patient with surgically resected stage IIIB melanoma receiving adjuvant nivolumab. He presented 12 weeks into therapy with severe myalgias, arthralgias, and intermittent disequilibrium of unclear etiology. Laboratory evaluation demonstrated a significant elevation in thyroid stimulating hormone and creatine kinase with an undetectable free T4 with standard laboratory measurement. With thyroid hormone replacement therapy alone, he had rapid improvement in his musculoskeletal symptoms and laboratory parameters over a threeweek period.
Discussion: This case emphasizes the serious nature of endocrine immune-related adverse events in patients receiving immune checkpoint inhibitors. Additionally, it highlights that unlike most other immunerelated adverse events, endocrine immune-related adverse events can generally be managed with adequate hormone replacement alone with swift improvements in symptoms. This allows patients to continue immune checkpoint inhibitors safely without immunosuppression which may dampen the anti-tumor activity of these agents.
Conclusion: This case highlights the importance of early recognition and the appropriate management of endocrine immune-related adverse events to maximize patient safety and good outcomes.
Purpose: Nivolumab is a fully human IgG4 programmed death 1 immune checkpoint inhibitor (ICI) antibody that has anti-tumor activity by selectively blocking the interaction of the programmed death 1 receptor with its two known programmed death ligands PD-L1 and PD-L2. In doing so, this immune checkpoint inhibitor removes the negative signal stifling T cell activation and proliferation within the tumor microenvironment and demonstrates favorable antitumor activity.
Case Report: We report an interesting case of immune checkpoint inhibitor-induced primary hypothyroidism with associated hypothyroid myopathy in a young patient with surgically resected stage IIIB melanoma receiving adjuvant nivolumab. He presented 12 weeks into therapy with severe myalgias, arthralgias, and intermittent disequilibrium of unclear etiology. Laboratory evaluation demonstrated a significant elevation in thyroid stimulating hormone and creatine kinase with an undetectable free T4 with standard laboratory measurement. With thyroid hormone replacement therapy alone, he had rapid improvement in his musculoskeletal symptoms and laboratory parameters over a threeweek period.
Discussion: This case emphasizes the serious nature of endocrine immune-related adverse events in patients receiving immune checkpoint inhibitors. Additionally, it highlights that unlike most other immunerelated adverse events, endocrine immune-related adverse events can generally be managed with adequate hormone replacement alone with swift improvements in symptoms. This allows patients to continue immune checkpoint inhibitors safely without immunosuppression which may dampen the anti-tumor activity of these agents.
Conclusion: This case highlights the importance of early recognition and the appropriate management of endocrine immune-related adverse events to maximize patient safety and good outcomes.
Purpose: Nivolumab is a fully human IgG4 programmed death 1 immune checkpoint inhibitor (ICI) antibody that has anti-tumor activity by selectively blocking the interaction of the programmed death 1 receptor with its two known programmed death ligands PD-L1 and PD-L2. In doing so, this immune checkpoint inhibitor removes the negative signal stifling T cell activation and proliferation within the tumor microenvironment and demonstrates favorable antitumor activity.
Case Report: We report an interesting case of immune checkpoint inhibitor-induced primary hypothyroidism with associated hypothyroid myopathy in a young patient with surgically resected stage IIIB melanoma receiving adjuvant nivolumab. He presented 12 weeks into therapy with severe myalgias, arthralgias, and intermittent disequilibrium of unclear etiology. Laboratory evaluation demonstrated a significant elevation in thyroid stimulating hormone and creatine kinase with an undetectable free T4 with standard laboratory measurement. With thyroid hormone replacement therapy alone, he had rapid improvement in his musculoskeletal symptoms and laboratory parameters over a threeweek period.
Discussion: This case emphasizes the serious nature of endocrine immune-related adverse events in patients receiving immune checkpoint inhibitors. Additionally, it highlights that unlike most other immunerelated adverse events, endocrine immune-related adverse events can generally be managed with adequate hormone replacement alone with swift improvements in symptoms. This allows patients to continue immune checkpoint inhibitors safely without immunosuppression which may dampen the anti-tumor activity of these agents.
Conclusion: This case highlights the importance of early recognition and the appropriate management of endocrine immune-related adverse events to maximize patient safety and good outcomes.
The month of new beginnings is here
This month’s Letter from the Editor is guest authored by Dr. Megan A. Adams, GI & Hepatology News Associate Editor
September is a month of new beginnings, as summer transitions to fall, kids go back to school, and we return to more consistent work routines, refreshed and reinvigorated after some well-deserved time off with family and friends. Among our cover stories this month is a study showing a novel application of deep learning to inform clinical care of patients with pancreatic cysts. We also feature several high-impact studies from AGA’s journals, including a large randomized controlled trial by Dr. Paul Moayyedi and colleagues, demonstrating that PPI therapy may be unnecessary in the majority of patients on oral anticoagulants, despite current guideline recommendations. This study has the potential to substantially change clinical practice, particularly in the context of the current discussion regarding PPI benefits and harms, and our transition to value-based care.
We also highlight a proof-of-concept study demonstrating a potential role for probiotics (specifically Bifidobacteria) in reducing the risk of NSAID-related gastrointestinal bleeding, and another study showing a possible role for clopidogrel in chemoprevention of colorectal cancer. Both articles are accompanied by expert commentaries highlighting their potential effect on clinical practice.
Our September issue also emphasizes the importance of professional advocacy by chronicling the participation of four AGA leaders (Dr. Carr, Dr. Kaufman, Dr. Ketwaroo, and Dr. Mathews) in the 2019 Alliance of Specialty Medicine Fly In, a multisociety effort to lobby legislators on key issues such as reducing prior authorization burdens and minimizing the strict constraints of step-therapy protocols. We also are pleased to acknowledge the future leaders of gastroenterology by recognizing the 17 exceptional fellows who demonstrated their passion for advancing GI clinical care by presenting their institutional quality improvement projects at a special session at DDW® 2019. We hope you find these stories to be thought provoking, inspiring, and directly relevant to your clinical practice – thank you for reading!
Megan A. Adams, MD, JD, MSc
Associate Editor
This month’s Letter from the Editor is guest authored by Dr. Megan A. Adams, GI & Hepatology News Associate Editor
September is a month of new beginnings, as summer transitions to fall, kids go back to school, and we return to more consistent work routines, refreshed and reinvigorated after some well-deserved time off with family and friends. Among our cover stories this month is a study showing a novel application of deep learning to inform clinical care of patients with pancreatic cysts. We also feature several high-impact studies from AGA’s journals, including a large randomized controlled trial by Dr. Paul Moayyedi and colleagues, demonstrating that PPI therapy may be unnecessary in the majority of patients on oral anticoagulants, despite current guideline recommendations. This study has the potential to substantially change clinical practice, particularly in the context of the current discussion regarding PPI benefits and harms, and our transition to value-based care.
We also highlight a proof-of-concept study demonstrating a potential role for probiotics (specifically Bifidobacteria) in reducing the risk of NSAID-related gastrointestinal bleeding, and another study showing a possible role for clopidogrel in chemoprevention of colorectal cancer. Both articles are accompanied by expert commentaries highlighting their potential effect on clinical practice.
Our September issue also emphasizes the importance of professional advocacy by chronicling the participation of four AGA leaders (Dr. Carr, Dr. Kaufman, Dr. Ketwaroo, and Dr. Mathews) in the 2019 Alliance of Specialty Medicine Fly In, a multisociety effort to lobby legislators on key issues such as reducing prior authorization burdens and minimizing the strict constraints of step-therapy protocols. We also are pleased to acknowledge the future leaders of gastroenterology by recognizing the 17 exceptional fellows who demonstrated their passion for advancing GI clinical care by presenting their institutional quality improvement projects at a special session at DDW® 2019. We hope you find these stories to be thought provoking, inspiring, and directly relevant to your clinical practice – thank you for reading!
Megan A. Adams, MD, JD, MSc
Associate Editor
This month’s Letter from the Editor is guest authored by Dr. Megan A. Adams, GI & Hepatology News Associate Editor
September is a month of new beginnings, as summer transitions to fall, kids go back to school, and we return to more consistent work routines, refreshed and reinvigorated after some well-deserved time off with family and friends. Among our cover stories this month is a study showing a novel application of deep learning to inform clinical care of patients with pancreatic cysts. We also feature several high-impact studies from AGA’s journals, including a large randomized controlled trial by Dr. Paul Moayyedi and colleagues, demonstrating that PPI therapy may be unnecessary in the majority of patients on oral anticoagulants, despite current guideline recommendations. This study has the potential to substantially change clinical practice, particularly in the context of the current discussion regarding PPI benefits and harms, and our transition to value-based care.
We also highlight a proof-of-concept study demonstrating a potential role for probiotics (specifically Bifidobacteria) in reducing the risk of NSAID-related gastrointestinal bleeding, and another study showing a possible role for clopidogrel in chemoprevention of colorectal cancer. Both articles are accompanied by expert commentaries highlighting their potential effect on clinical practice.
Our September issue also emphasizes the importance of professional advocacy by chronicling the participation of four AGA leaders (Dr. Carr, Dr. Kaufman, Dr. Ketwaroo, and Dr. Mathews) in the 2019 Alliance of Specialty Medicine Fly In, a multisociety effort to lobby legislators on key issues such as reducing prior authorization burdens and minimizing the strict constraints of step-therapy protocols. We also are pleased to acknowledge the future leaders of gastroenterology by recognizing the 17 exceptional fellows who demonstrated their passion for advancing GI clinical care by presenting their institutional quality improvement projects at a special session at DDW® 2019. We hope you find these stories to be thought provoking, inspiring, and directly relevant to your clinical practice – thank you for reading!
Megan A. Adams, MD, JD, MSc
Associate Editor