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Use of Template to Increase Referral of Hematology/Oncology Patients to Palliative Care/Hospice Service When Appropriate
Background: Patients with late stage metastatic cancer unresponsive to front line therapies have a poor prognosis and yet are often admitted to the ICU or other acute care settings without having had referral to palliative care/hospice service for goals-of-care discussion. In order to increase awareness of the need to consider palliative care/hospice services early in the course of patients with poor-prognosis cancer, we developed a template in the progress notes of CPRS. The template required response to two questions: is this patient appropriate for referral to palliative care and/or hospice service; if so, why and if not, why not? Completion of the template was required to continue the note.
Methods: We initiated the template in April 2018 and we evaluated numbers of patients referred to palliative care/hospice services in the 12-month period prior to, and 12-month period after initiating the template. Prior to initiating the template, there were 99 consults to palliative care/hospice and 2375 patients not referred.
Results: For the 12- month period after introduction of the template, there were 138 patients referred for palliative care/hospice and consults to palliative care/ hospice and 2314 patients not referred. The odds risk for referring after the template compared to prior to the template was 1.4 (95% CI: 1.098-1.864, P=0.004). Thus, patients were 1.43 times more likely to be referred to palliative care/hospice services after initiation of the template. Further research to know the reasons for referral and the precise diagnosis of patients who were referred is ongoing.
Conclusion: This study suggests that addition of a template to the CPRS chart can raise awareness of the need for palliative care/hospice consultations when appropriate.
Background: Patients with late stage metastatic cancer unresponsive to front line therapies have a poor prognosis and yet are often admitted to the ICU or other acute care settings without having had referral to palliative care/hospice service for goals-of-care discussion. In order to increase awareness of the need to consider palliative care/hospice services early in the course of patients with poor-prognosis cancer, we developed a template in the progress notes of CPRS. The template required response to two questions: is this patient appropriate for referral to palliative care and/or hospice service; if so, why and if not, why not? Completion of the template was required to continue the note.
Methods: We initiated the template in April 2018 and we evaluated numbers of patients referred to palliative care/hospice services in the 12-month period prior to, and 12-month period after initiating the template. Prior to initiating the template, there were 99 consults to palliative care/hospice and 2375 patients not referred.
Results: For the 12- month period after introduction of the template, there were 138 patients referred for palliative care/hospice and consults to palliative care/ hospice and 2314 patients not referred. The odds risk for referring after the template compared to prior to the template was 1.4 (95% CI: 1.098-1.864, P=0.004). Thus, patients were 1.43 times more likely to be referred to palliative care/hospice services after initiation of the template. Further research to know the reasons for referral and the precise diagnosis of patients who were referred is ongoing.
Conclusion: This study suggests that addition of a template to the CPRS chart can raise awareness of the need for palliative care/hospice consultations when appropriate.
Background: Patients with late stage metastatic cancer unresponsive to front line therapies have a poor prognosis and yet are often admitted to the ICU or other acute care settings without having had referral to palliative care/hospice service for goals-of-care discussion. In order to increase awareness of the need to consider palliative care/hospice services early in the course of patients with poor-prognosis cancer, we developed a template in the progress notes of CPRS. The template required response to two questions: is this patient appropriate for referral to palliative care and/or hospice service; if so, why and if not, why not? Completion of the template was required to continue the note.
Methods: We initiated the template in April 2018 and we evaluated numbers of patients referred to palliative care/hospice services in the 12-month period prior to, and 12-month period after initiating the template. Prior to initiating the template, there were 99 consults to palliative care/hospice and 2375 patients not referred.
Results: For the 12- month period after introduction of the template, there were 138 patients referred for palliative care/hospice and consults to palliative care/ hospice and 2314 patients not referred. The odds risk for referring after the template compared to prior to the template was 1.4 (95% CI: 1.098-1.864, P=0.004). Thus, patients were 1.43 times more likely to be referred to palliative care/hospice services after initiation of the template. Further research to know the reasons for referral and the precise diagnosis of patients who were referred is ongoing.
Conclusion: This study suggests that addition of a template to the CPRS chart can raise awareness of the need for palliative care/hospice consultations when appropriate.
Evaluating the Impact of the Multidisciplinary Gastrointestinal Malignancy Clinic (MGMC) on the Delivery of Care at the Dallas VA Medical Center
Background: Digestive system malignancies constitute 18% of all cancers in the US veteran population (VA Central Cancer Registry 2010 data). Managing these patients involves multiple treatment modalities. The Multidisciplinary Gastrointestinal Malignancy Clinic (MGMC) was established at the Dallas VAMC in 2016. Prior to the MGMC, patients presented to their primary care physicians, who once a malignancy was biopsy confirmed, consulted an oncologic specialist. Patients requiring multidisciplinary oncologic care had three or more appointments (medical, surgical, and radiation oncology) scheduled on separate days. However, since the MGMC was established, various oncologic specialists now evaluate the patients on a single clinic day and a definitive consensus therapy course is planned.
Methods: Patients seen in the MGMC were matched to patient controls (seen 2 years before the MGMC was established) by pathologic diagnosis and stage. The main endpoints were; time between initial oncologic consult and first definitive therapy; time from biopsy to completion of staging and first definitive therapy. The average times for each endpoint for these 2 groups was evaluated statistically using the student T test.
Results: 40 patient cases were selected from the group seen at the MGMC from July 2016 - June 2018 and matched with 40 controls. A statistically significant reduction in the average time between initial oncologic consult to the time of first definitive therapy was found in favor of patients seen in the MGMC (44.3 ±20.5 days vs 60.7 ±41.4 days). The average time from biopsy to first definitive therapy was not statistically significant different between patient groups. Average time from biopsy to completion of staging was significantly reduced in the MGMC group (31.4±33.1 days vs 53.2±40.5 days). Post-MGMC, fewer patients were referred to the CHOICE program and more patients completed treatment.
Conclusion: Establishment of the MGMC allowed cancer patients to meet with various oncology specialists in a single setting and for these providers to form an initial treatment plan, resulting in reduced time between initial consult and first definitive treatment. Staging was completed more efficiently. These results suggest that a multidisciplinary oncology clinic enhances delivery of care in patients with gastrointestinal malignancies.
Background: Digestive system malignancies constitute 18% of all cancers in the US veteran population (VA Central Cancer Registry 2010 data). Managing these patients involves multiple treatment modalities. The Multidisciplinary Gastrointestinal Malignancy Clinic (MGMC) was established at the Dallas VAMC in 2016. Prior to the MGMC, patients presented to their primary care physicians, who once a malignancy was biopsy confirmed, consulted an oncologic specialist. Patients requiring multidisciplinary oncologic care had three or more appointments (medical, surgical, and radiation oncology) scheduled on separate days. However, since the MGMC was established, various oncologic specialists now evaluate the patients on a single clinic day and a definitive consensus therapy course is planned.
Methods: Patients seen in the MGMC were matched to patient controls (seen 2 years before the MGMC was established) by pathologic diagnosis and stage. The main endpoints were; time between initial oncologic consult and first definitive therapy; time from biopsy to completion of staging and first definitive therapy. The average times for each endpoint for these 2 groups was evaluated statistically using the student T test.
Results: 40 patient cases were selected from the group seen at the MGMC from July 2016 - June 2018 and matched with 40 controls. A statistically significant reduction in the average time between initial oncologic consult to the time of first definitive therapy was found in favor of patients seen in the MGMC (44.3 ±20.5 days vs 60.7 ±41.4 days). The average time from biopsy to first definitive therapy was not statistically significant different between patient groups. Average time from biopsy to completion of staging was significantly reduced in the MGMC group (31.4±33.1 days vs 53.2±40.5 days). Post-MGMC, fewer patients were referred to the CHOICE program and more patients completed treatment.
Conclusion: Establishment of the MGMC allowed cancer patients to meet with various oncology specialists in a single setting and for these providers to form an initial treatment plan, resulting in reduced time between initial consult and first definitive treatment. Staging was completed more efficiently. These results suggest that a multidisciplinary oncology clinic enhances delivery of care in patients with gastrointestinal malignancies.
Background: Digestive system malignancies constitute 18% of all cancers in the US veteran population (VA Central Cancer Registry 2010 data). Managing these patients involves multiple treatment modalities. The Multidisciplinary Gastrointestinal Malignancy Clinic (MGMC) was established at the Dallas VAMC in 2016. Prior to the MGMC, patients presented to their primary care physicians, who once a malignancy was biopsy confirmed, consulted an oncologic specialist. Patients requiring multidisciplinary oncologic care had three or more appointments (medical, surgical, and radiation oncology) scheduled on separate days. However, since the MGMC was established, various oncologic specialists now evaluate the patients on a single clinic day and a definitive consensus therapy course is planned.
Methods: Patients seen in the MGMC were matched to patient controls (seen 2 years before the MGMC was established) by pathologic diagnosis and stage. The main endpoints were; time between initial oncologic consult and first definitive therapy; time from biopsy to completion of staging and first definitive therapy. The average times for each endpoint for these 2 groups was evaluated statistically using the student T test.
Results: 40 patient cases were selected from the group seen at the MGMC from July 2016 - June 2018 and matched with 40 controls. A statistically significant reduction in the average time between initial oncologic consult to the time of first definitive therapy was found in favor of patients seen in the MGMC (44.3 ±20.5 days vs 60.7 ±41.4 days). The average time from biopsy to first definitive therapy was not statistically significant different between patient groups. Average time from biopsy to completion of staging was significantly reduced in the MGMC group (31.4±33.1 days vs 53.2±40.5 days). Post-MGMC, fewer patients were referred to the CHOICE program and more patients completed treatment.
Conclusion: Establishment of the MGMC allowed cancer patients to meet with various oncology specialists in a single setting and for these providers to form an initial treatment plan, resulting in reduced time between initial consult and first definitive treatment. Staging was completed more efficiently. These results suggest that a multidisciplinary oncology clinic enhances delivery of care in patients with gastrointestinal malignancies.
Characterization of Adverse Reactions to ‘4-week’ Nivolumab Dosing
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Characterization of Adverse Reactions to ‘4-week’ Nivolumab Dosing
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Atypical Presentation and Management of Refractory Multisystem Checkpoint Inhibitor Toxicities
Background: Immunotherapy with checkpoint inhibition represents a significant development in the management of advanced malignancies. Toxicity associated with this therapy, or immune-related adverse events (irAEs), is most frequently seen in the form of colitis, dermatitis, pneumonitis, or hepatitis. Prompt initiation of high-dose corticosteroids in severe cases is essential. Refractory toxicity can be seen and requires a multimodality approach.
Case Report: A 68 year old male with a history of stage IVB squamous cell carcinoma (SCC) and an illdefined left renal mass (4.8 × 4.1 cm2, presumed urothelial carcinoma) was successfully maintained on nivolumab monotherapy for nearly two years. However, after 45 cycles he presented to the emergency department with acute hypoxic respiratory failure. He was admitted and found to have multifocal pulmonary consolidations refractory to empiric antibiotics. Ultimately his symptoms were attributed to nivolumab-induced pneumonitis. He improved on corticosteroids and was discharged with a prednisone taper. One month later he returned with severe lower extremity weakness, an elevated creatinine kinase, grade IV hepatitis, and hematuria. Notwithstanding immediate escalation to intravenous methylprednisolone (2 mg/kg) and a trial of IVIG, his myositis and liver dysfunction worsened. Mycophenolate mofetil was added (1000 mg BID) and successfully reversed his creatinine kinase (from 3633 U/L); however, his hepatitis continued to progress (total bilirubin to 16.4 mg/dL). After further discussion with gastroenterology, tacrolimus was also started (2 mg BID) and caused gradual improvement in his transaminases. Once stabilized, he underwent a left nephrectomy for persistent hematuria; pathology results revealed an unusual focus of metastatic SCC. Unfortunately, he developed post-operative bleeding complications and CMV viremia. He elected to pursue comfort measures and passed 2 weeks later.
Conclusion: Checkpoint inhibitor toxicities can demonstrate delayed presentations despite numerous cycles of successful therapy. In cases where aggressive corticosteroid therapy is unsuccessful, additional immunomodulatory agents are required to curb progression of organ-specific damage. Close surveillance for opportunistic infections must be maintained. Additional studies are needed to assess whether earlier discontinuation of checkpoint inhibition is feasible in patients with sustained responses to minimize late irAEs.
Background: Immunotherapy with checkpoint inhibition represents a significant development in the management of advanced malignancies. Toxicity associated with this therapy, or immune-related adverse events (irAEs), is most frequently seen in the form of colitis, dermatitis, pneumonitis, or hepatitis. Prompt initiation of high-dose corticosteroids in severe cases is essential. Refractory toxicity can be seen and requires a multimodality approach.
Case Report: A 68 year old male with a history of stage IVB squamous cell carcinoma (SCC) and an illdefined left renal mass (4.8 × 4.1 cm2, presumed urothelial carcinoma) was successfully maintained on nivolumab monotherapy for nearly two years. However, after 45 cycles he presented to the emergency department with acute hypoxic respiratory failure. He was admitted and found to have multifocal pulmonary consolidations refractory to empiric antibiotics. Ultimately his symptoms were attributed to nivolumab-induced pneumonitis. He improved on corticosteroids and was discharged with a prednisone taper. One month later he returned with severe lower extremity weakness, an elevated creatinine kinase, grade IV hepatitis, and hematuria. Notwithstanding immediate escalation to intravenous methylprednisolone (2 mg/kg) and a trial of IVIG, his myositis and liver dysfunction worsened. Mycophenolate mofetil was added (1000 mg BID) and successfully reversed his creatinine kinase (from 3633 U/L); however, his hepatitis continued to progress (total bilirubin to 16.4 mg/dL). After further discussion with gastroenterology, tacrolimus was also started (2 mg BID) and caused gradual improvement in his transaminases. Once stabilized, he underwent a left nephrectomy for persistent hematuria; pathology results revealed an unusual focus of metastatic SCC. Unfortunately, he developed post-operative bleeding complications and CMV viremia. He elected to pursue comfort measures and passed 2 weeks later.
Conclusion: Checkpoint inhibitor toxicities can demonstrate delayed presentations despite numerous cycles of successful therapy. In cases where aggressive corticosteroid therapy is unsuccessful, additional immunomodulatory agents are required to curb progression of organ-specific damage. Close surveillance for opportunistic infections must be maintained. Additional studies are needed to assess whether earlier discontinuation of checkpoint inhibition is feasible in patients with sustained responses to minimize late irAEs.
Background: Immunotherapy with checkpoint inhibition represents a significant development in the management of advanced malignancies. Toxicity associated with this therapy, or immune-related adverse events (irAEs), is most frequently seen in the form of colitis, dermatitis, pneumonitis, or hepatitis. Prompt initiation of high-dose corticosteroids in severe cases is essential. Refractory toxicity can be seen and requires a multimodality approach.
Case Report: A 68 year old male with a history of stage IVB squamous cell carcinoma (SCC) and an illdefined left renal mass (4.8 × 4.1 cm2, presumed urothelial carcinoma) was successfully maintained on nivolumab monotherapy for nearly two years. However, after 45 cycles he presented to the emergency department with acute hypoxic respiratory failure. He was admitted and found to have multifocal pulmonary consolidations refractory to empiric antibiotics. Ultimately his symptoms were attributed to nivolumab-induced pneumonitis. He improved on corticosteroids and was discharged with a prednisone taper. One month later he returned with severe lower extremity weakness, an elevated creatinine kinase, grade IV hepatitis, and hematuria. Notwithstanding immediate escalation to intravenous methylprednisolone (2 mg/kg) and a trial of IVIG, his myositis and liver dysfunction worsened. Mycophenolate mofetil was added (1000 mg BID) and successfully reversed his creatinine kinase (from 3633 U/L); however, his hepatitis continued to progress (total bilirubin to 16.4 mg/dL). After further discussion with gastroenterology, tacrolimus was also started (2 mg BID) and caused gradual improvement in his transaminases. Once stabilized, he underwent a left nephrectomy for persistent hematuria; pathology results revealed an unusual focus of metastatic SCC. Unfortunately, he developed post-operative bleeding complications and CMV viremia. He elected to pursue comfort measures and passed 2 weeks later.
Conclusion: Checkpoint inhibitor toxicities can demonstrate delayed presentations despite numerous cycles of successful therapy. In cases where aggressive corticosteroid therapy is unsuccessful, additional immunomodulatory agents are required to curb progression of organ-specific damage. Close surveillance for opportunistic infections must be maintained. Additional studies are needed to assess whether earlier discontinuation of checkpoint inhibition is feasible in patients with sustained responses to minimize late irAEs.
A Rural VA Utilizing Telehealth Platform to Address Dietary Issues of Veterans With Cancer
Background: The Salisbury VA Medical Center (SVA) is a rural VA and some of our veterans with cancer are treated at VA Health Care Center (HCCs) in Kernersville or Charlotte. The VA telehealth platform provides a bridge to address dietary issues for veterans that cannot travel to Salisbury. The SVA offers virtual nutrition counseling sessions conveniently scheduled in conjunction with veterans HCC oncology visit and eliminates the need for additional appointments or having to arrange transportation to SVA.
Dietary counseling for veterans with cancer is an integral part of the SVA cancer care program. This commitment is shown by SVA Medical Centers commitment to a board certified oncology dietician FTE. The oncology dietician staffs the SVA outpatient medical oncology clinic and manages dietary issues that are present at diagnosis or arise during treatment. Annually, the oncology dietician averages a case load of 334 unique veterans and averages 1395 visits with these veterans. Most of these dietary encounters occur at the SVA infusion center while veterans are getting treatment or in the SVA oncology exam room after the veteran visits with their oncologic provider.
Methods: To provide this same dietary service to Kernersville and Charlotte veterans, the dietary oncology telehealth program was established. The program has performed 99 telehealth visits. The telehealth visits accomplish the same objectives as the live clinic appointments.
Common dietary issues that are managed in the clinic involve weight loss in lung cancer veterans, weight gain in prostate cancer veterans, and malabsorption in colorectal cancer veterans. The oncology dietician has competency and resources in managing these nutrition impact symptoms.
Implizations: Ideas for expansion of the Salisbury oncology dietary telehealth program would be to utilize the new Anywhere to Anywhere initiative, to improve access to veterans in the SVA system and to possibly aid other VAs oncology programs that do not have a dedicated oncology dietician.
Background: The Salisbury VA Medical Center (SVA) is a rural VA and some of our veterans with cancer are treated at VA Health Care Center (HCCs) in Kernersville or Charlotte. The VA telehealth platform provides a bridge to address dietary issues for veterans that cannot travel to Salisbury. The SVA offers virtual nutrition counseling sessions conveniently scheduled in conjunction with veterans HCC oncology visit and eliminates the need for additional appointments or having to arrange transportation to SVA.
Dietary counseling for veterans with cancer is an integral part of the SVA cancer care program. This commitment is shown by SVA Medical Centers commitment to a board certified oncology dietician FTE. The oncology dietician staffs the SVA outpatient medical oncology clinic and manages dietary issues that are present at diagnosis or arise during treatment. Annually, the oncology dietician averages a case load of 334 unique veterans and averages 1395 visits with these veterans. Most of these dietary encounters occur at the SVA infusion center while veterans are getting treatment or in the SVA oncology exam room after the veteran visits with their oncologic provider.
Methods: To provide this same dietary service to Kernersville and Charlotte veterans, the dietary oncology telehealth program was established. The program has performed 99 telehealth visits. The telehealth visits accomplish the same objectives as the live clinic appointments.
Common dietary issues that are managed in the clinic involve weight loss in lung cancer veterans, weight gain in prostate cancer veterans, and malabsorption in colorectal cancer veterans. The oncology dietician has competency and resources in managing these nutrition impact symptoms.
Implizations: Ideas for expansion of the Salisbury oncology dietary telehealth program would be to utilize the new Anywhere to Anywhere initiative, to improve access to veterans in the SVA system and to possibly aid other VAs oncology programs that do not have a dedicated oncology dietician.
Background: The Salisbury VA Medical Center (SVA) is a rural VA and some of our veterans with cancer are treated at VA Health Care Center (HCCs) in Kernersville or Charlotte. The VA telehealth platform provides a bridge to address dietary issues for veterans that cannot travel to Salisbury. The SVA offers virtual nutrition counseling sessions conveniently scheduled in conjunction with veterans HCC oncology visit and eliminates the need for additional appointments or having to arrange transportation to SVA.
Dietary counseling for veterans with cancer is an integral part of the SVA cancer care program. This commitment is shown by SVA Medical Centers commitment to a board certified oncology dietician FTE. The oncology dietician staffs the SVA outpatient medical oncology clinic and manages dietary issues that are present at diagnosis or arise during treatment. Annually, the oncology dietician averages a case load of 334 unique veterans and averages 1395 visits with these veterans. Most of these dietary encounters occur at the SVA infusion center while veterans are getting treatment or in the SVA oncology exam room after the veteran visits with their oncologic provider.
Methods: To provide this same dietary service to Kernersville and Charlotte veterans, the dietary oncology telehealth program was established. The program has performed 99 telehealth visits. The telehealth visits accomplish the same objectives as the live clinic appointments.
Common dietary issues that are managed in the clinic involve weight loss in lung cancer veterans, weight gain in prostate cancer veterans, and malabsorption in colorectal cancer veterans. The oncology dietician has competency and resources in managing these nutrition impact symptoms.
Implizations: Ideas for expansion of the Salisbury oncology dietary telehealth program would be to utilize the new Anywhere to Anywhere initiative, to improve access to veterans in the SVA system and to possibly aid other VAs oncology programs that do not have a dedicated oncology dietician.
VHA-Wide Automated Assessment of EGFR Mutation Testing in Advanced Stage, Non-Squamous, Non-Small Cell Lung Cancer (nsNSCLC)
Purpose: To assess feasibility of implementing an automated method to identify patients who should have EGFR testing, and whether they have been tested, as a tool for quality improvement.
Background: Approximately 7% of veterans with metastatic, nsNSCLC have sensitizing mutation of EGFR, which predicts sensitivity to oral EGFR inhibitors. Prior studies have shown under testing for EGFR mutations in this population in VHA.
Methods: An endorsed quality measure (NQF and ASCO) for EGFR testing was utilized. Data to implement the measure were extracted from the cancer registry (ONC RAW), problem and encounter ICD codes, national oncology note template-generated health factors, laboratory test results, National Precision Oncology Program NGS testing, vital status, and pharmacy drug file to populate a SQL database. A dashboard in SharePoint allowed users to retrieve data based on national data access permissions. Descriptive statistics were used.
Results: The initial algorithm implementation was evaluated by comparison to manual review of patient records from one medical center. The second generation algorithm was then evaluated in the same manner at a second medical center (MC2). Among 117 cases identified during 2018, 68 (58%) were identified as having been tested and 49 (42%) not tested (31 living and 18 deceased patients). 48 of the non-tested samples were reviewed: 28 had not been tested, 14 had data documentation or coding problems (11 correctable by using the national note template), 1 correctable limitation of the national note template, and 5 limitations of the algorithm (all but 1 of which has been corrected). For stage 3 and stage VA-wide, there were 871 and 2832 cases, respectively, with documented testing rates of 26% and 36%, and a facility testing rate range of 0% to 100%.
Implications: The EGFR testing dashboard, in conjunction with appropriate structured documentation, has high accuracy of EGFR testing in patients with metastatic nsNSCLC. Current documented testing rates vary widely with a low system-wide rate, that can be improved through utilization of the dashboard.
Purpose: To assess feasibility of implementing an automated method to identify patients who should have EGFR testing, and whether they have been tested, as a tool for quality improvement.
Background: Approximately 7% of veterans with metastatic, nsNSCLC have sensitizing mutation of EGFR, which predicts sensitivity to oral EGFR inhibitors. Prior studies have shown under testing for EGFR mutations in this population in VHA.
Methods: An endorsed quality measure (NQF and ASCO) for EGFR testing was utilized. Data to implement the measure were extracted from the cancer registry (ONC RAW), problem and encounter ICD codes, national oncology note template-generated health factors, laboratory test results, National Precision Oncology Program NGS testing, vital status, and pharmacy drug file to populate a SQL database. A dashboard in SharePoint allowed users to retrieve data based on national data access permissions. Descriptive statistics were used.
Results: The initial algorithm implementation was evaluated by comparison to manual review of patient records from one medical center. The second generation algorithm was then evaluated in the same manner at a second medical center (MC2). Among 117 cases identified during 2018, 68 (58%) were identified as having been tested and 49 (42%) not tested (31 living and 18 deceased patients). 48 of the non-tested samples were reviewed: 28 had not been tested, 14 had data documentation or coding problems (11 correctable by using the national note template), 1 correctable limitation of the national note template, and 5 limitations of the algorithm (all but 1 of which has been corrected). For stage 3 and stage VA-wide, there were 871 and 2832 cases, respectively, with documented testing rates of 26% and 36%, and a facility testing rate range of 0% to 100%.
Implications: The EGFR testing dashboard, in conjunction with appropriate structured documentation, has high accuracy of EGFR testing in patients with metastatic nsNSCLC. Current documented testing rates vary widely with a low system-wide rate, that can be improved through utilization of the dashboard.
Purpose: To assess feasibility of implementing an automated method to identify patients who should have EGFR testing, and whether they have been tested, as a tool for quality improvement.
Background: Approximately 7% of veterans with metastatic, nsNSCLC have sensitizing mutation of EGFR, which predicts sensitivity to oral EGFR inhibitors. Prior studies have shown under testing for EGFR mutations in this population in VHA.
Methods: An endorsed quality measure (NQF and ASCO) for EGFR testing was utilized. Data to implement the measure were extracted from the cancer registry (ONC RAW), problem and encounter ICD codes, national oncology note template-generated health factors, laboratory test results, National Precision Oncology Program NGS testing, vital status, and pharmacy drug file to populate a SQL database. A dashboard in SharePoint allowed users to retrieve data based on national data access permissions. Descriptive statistics were used.
Results: The initial algorithm implementation was evaluated by comparison to manual review of patient records from one medical center. The second generation algorithm was then evaluated in the same manner at a second medical center (MC2). Among 117 cases identified during 2018, 68 (58%) were identified as having been tested and 49 (42%) not tested (31 living and 18 deceased patients). 48 of the non-tested samples were reviewed: 28 had not been tested, 14 had data documentation or coding problems (11 correctable by using the national note template), 1 correctable limitation of the national note template, and 5 limitations of the algorithm (all but 1 of which has been corrected). For stage 3 and stage VA-wide, there were 871 and 2832 cases, respectively, with documented testing rates of 26% and 36%, and a facility testing rate range of 0% to 100%.
Implications: The EGFR testing dashboard, in conjunction with appropriate structured documentation, has high accuracy of EGFR testing in patients with metastatic nsNSCLC. Current documented testing rates vary widely with a low system-wide rate, that can be improved through utilization of the dashboard.
A Rare Case of Immunotactoid Glomerulopathy and Monoclonal Gammopathy of Renal Significance due to an IgM Kappa Clone at the VA Pittsburgh Healthcare System
Introduction: Monoclonal gammopathy of renal significance (MGRS) is a recently recognized disorder from pathologic M protein causing renal disease and minimal hematologic disease burden. Failure to treat leads to poor outcomes from progression to advanced monoclonal gammopathies and end stage renal disease (ESRD). We present a case of MGRS with immunotactoid glomerulopathy.
Case Report: A 66-year-old female presented in December 2015 with mild granulocytopenia and anemia. Workup revealed serum 0.28 mg/dL IgM kappa monoclonal M-protein and kappa/lambda ratio of 2.23. She underwent surveillance for MGUS. Due to acute kidney injury, peripheral edema and hypertension, nephrology workup was obtained in December 2017. She had nephrotic range proteinuria and hematuria. Urine studies suggested paraproteinemia. Renal biopsy demonstrated immunotactoid glomerulopathy with membranoproliferative glomerulonephritis pattern. Immunofluorescence showed kappa light chain in mesangial and capillary loop, and heavy IgM and moderate C3 staining. Electron microscopy revealed numerous immunotactoid deposits beneath the glomerular basement membrane and mesangium. M-protein burden remained stable. Her bone marrow biopsy was nondiagnostic, however peripheral flow cytometry identified a small CD20+, CD5-, CD10-, CD23-, B-cell population with kappa light chain restriction. Diagnosis was reclassified as MGRS and she was treated with rituximab weekly for four doses. Follow-up demonstrated stability of M-protein and light chains, improvement of AKI and hypertension, but persistent nephrotic range proteinuria. We are planning an additional eight-week course of weekly rituximab. Treatment outcome and further studies are pending.
Discussion: MGRS is a rare monoclonal gammopathy that was formerly subclassified under MGUS. Patients were undertreated due to under-recognition of the disorder and its renal sequalae. Treatment with regimens targeting a plasma cell or B-cell clone can reduce the clone and improve renal outcomes. Our patient experienced a partial response to clone directed therapy with rituximab. Further treatment is pending.
Conclusion: Clinicians should be aware of MGRS. Collaboration with nephrology is key for proper diagnosis and prognosis. Consider treating more aggressively than MGUS to improve renal and hematologic outcomes. Prospective interventional studies are needed.
Introduction: Monoclonal gammopathy of renal significance (MGRS) is a recently recognized disorder from pathologic M protein causing renal disease and minimal hematologic disease burden. Failure to treat leads to poor outcomes from progression to advanced monoclonal gammopathies and end stage renal disease (ESRD). We present a case of MGRS with immunotactoid glomerulopathy.
Case Report: A 66-year-old female presented in December 2015 with mild granulocytopenia and anemia. Workup revealed serum 0.28 mg/dL IgM kappa monoclonal M-protein and kappa/lambda ratio of 2.23. She underwent surveillance for MGUS. Due to acute kidney injury, peripheral edema and hypertension, nephrology workup was obtained in December 2017. She had nephrotic range proteinuria and hematuria. Urine studies suggested paraproteinemia. Renal biopsy demonstrated immunotactoid glomerulopathy with membranoproliferative glomerulonephritis pattern. Immunofluorescence showed kappa light chain in mesangial and capillary loop, and heavy IgM and moderate C3 staining. Electron microscopy revealed numerous immunotactoid deposits beneath the glomerular basement membrane and mesangium. M-protein burden remained stable. Her bone marrow biopsy was nondiagnostic, however peripheral flow cytometry identified a small CD20+, CD5-, CD10-, CD23-, B-cell population with kappa light chain restriction. Diagnosis was reclassified as MGRS and she was treated with rituximab weekly for four doses. Follow-up demonstrated stability of M-protein and light chains, improvement of AKI and hypertension, but persistent nephrotic range proteinuria. We are planning an additional eight-week course of weekly rituximab. Treatment outcome and further studies are pending.
Discussion: MGRS is a rare monoclonal gammopathy that was formerly subclassified under MGUS. Patients were undertreated due to under-recognition of the disorder and its renal sequalae. Treatment with regimens targeting a plasma cell or B-cell clone can reduce the clone and improve renal outcomes. Our patient experienced a partial response to clone directed therapy with rituximab. Further treatment is pending.
Conclusion: Clinicians should be aware of MGRS. Collaboration with nephrology is key for proper diagnosis and prognosis. Consider treating more aggressively than MGUS to improve renal and hematologic outcomes. Prospective interventional studies are needed.
Introduction: Monoclonal gammopathy of renal significance (MGRS) is a recently recognized disorder from pathologic M protein causing renal disease and minimal hematologic disease burden. Failure to treat leads to poor outcomes from progression to advanced monoclonal gammopathies and end stage renal disease (ESRD). We present a case of MGRS with immunotactoid glomerulopathy.
Case Report: A 66-year-old female presented in December 2015 with mild granulocytopenia and anemia. Workup revealed serum 0.28 mg/dL IgM kappa monoclonal M-protein and kappa/lambda ratio of 2.23. She underwent surveillance for MGUS. Due to acute kidney injury, peripheral edema and hypertension, nephrology workup was obtained in December 2017. She had nephrotic range proteinuria and hematuria. Urine studies suggested paraproteinemia. Renal biopsy demonstrated immunotactoid glomerulopathy with membranoproliferative glomerulonephritis pattern. Immunofluorescence showed kappa light chain in mesangial and capillary loop, and heavy IgM and moderate C3 staining. Electron microscopy revealed numerous immunotactoid deposits beneath the glomerular basement membrane and mesangium. M-protein burden remained stable. Her bone marrow biopsy was nondiagnostic, however peripheral flow cytometry identified a small CD20+, CD5-, CD10-, CD23-, B-cell population with kappa light chain restriction. Diagnosis was reclassified as MGRS and she was treated with rituximab weekly for four doses. Follow-up demonstrated stability of M-protein and light chains, improvement of AKI and hypertension, but persistent nephrotic range proteinuria. We are planning an additional eight-week course of weekly rituximab. Treatment outcome and further studies are pending.
Discussion: MGRS is a rare monoclonal gammopathy that was formerly subclassified under MGUS. Patients were undertreated due to under-recognition of the disorder and its renal sequalae. Treatment with regimens targeting a plasma cell or B-cell clone can reduce the clone and improve renal outcomes. Our patient experienced a partial response to clone directed therapy with rituximab. Further treatment is pending.
Conclusion: Clinicians should be aware of MGRS. Collaboration with nephrology is key for proper diagnosis and prognosis. Consider treating more aggressively than MGUS to improve renal and hematologic outcomes. Prospective interventional studies are needed.
Radiation Therapy Treatment Breaks and Weight Changes in Head and Neck Cancer Patients in a Veterans Affairs Radiation Oncology Clinic
Background: Unplanned radiation treatment breaks are shown to be related to increased risk of local recurrence, lower survival rates and reduced tumor control rates. Weight loss, along with other side effects, can be a major factor in radiation treatment breaks. This quality improvement project aimed to review weight changes and treatment breaks via retrospective chart review to better understand how to improve the combined nutritional and radiation oncology care of head and neck cancer (HNC) patients.
Methods: Utilizing the Lean Six Sigma Project Management approach to ensure critical components were assessed, this quality improvement project reviewed HNC cases via retrospective chart review that started and/or completed definitive radiation treatment from January 1, 2014 - December 31, 2018. Weights were assessed during the timeframe of treatment and limited to weights obtained within the same unit. Treatment breaks were confirmed via Electronic Medical Records (EMR) systems and defined as one or more missed or cancelled treatments, excluding those missed for nonclinical reasons. Charts were reviewed for documented dysphagia, mucositis, and skin reactions. Information on nutrition visits were assessed.
Results: The incidence of patients who experienced treatment breaks was 47.8%. Patients averaged 5.5 missed treatments. More than half of the patients who experienced treatment breaks had Stage IV disease and 62.5% experienced clinically significant weight loss within their treatment time frame. Approximately 15% of patients were seen within a designated oncology nutrition clinic. Side effects, such as mucositis, dysphagia, and skin reactions, were documented to have contributed to weight changes and treatment breaks.
Conclusion: This project highlighted the multifactorial nature associated with radiotherapy treatment of HNC patients. Based on prior experience with integration of nutrition and radiation oncology services and understanding expected treatment side effects, we recommend that nutrition services are integrated as part of the initial radiation consultation process to proactively approach the known weight loss and nutritionally relevant side effects. It is imperative to integrate medical informatics infrastructure to modernize the process of documenting treatment side effects and outcomes. Continued in-depth review of this data will facilitate us in creating a comprehensive multidisciplinary treatment approach for HNC patients undergoing radiation therapy.
Background: Unplanned radiation treatment breaks are shown to be related to increased risk of local recurrence, lower survival rates and reduced tumor control rates. Weight loss, along with other side effects, can be a major factor in radiation treatment breaks. This quality improvement project aimed to review weight changes and treatment breaks via retrospective chart review to better understand how to improve the combined nutritional and radiation oncology care of head and neck cancer (HNC) patients.
Methods: Utilizing the Lean Six Sigma Project Management approach to ensure critical components were assessed, this quality improvement project reviewed HNC cases via retrospective chart review that started and/or completed definitive radiation treatment from January 1, 2014 - December 31, 2018. Weights were assessed during the timeframe of treatment and limited to weights obtained within the same unit. Treatment breaks were confirmed via Electronic Medical Records (EMR) systems and defined as one or more missed or cancelled treatments, excluding those missed for nonclinical reasons. Charts were reviewed for documented dysphagia, mucositis, and skin reactions. Information on nutrition visits were assessed.
Results: The incidence of patients who experienced treatment breaks was 47.8%. Patients averaged 5.5 missed treatments. More than half of the patients who experienced treatment breaks had Stage IV disease and 62.5% experienced clinically significant weight loss within their treatment time frame. Approximately 15% of patients were seen within a designated oncology nutrition clinic. Side effects, such as mucositis, dysphagia, and skin reactions, were documented to have contributed to weight changes and treatment breaks.
Conclusion: This project highlighted the multifactorial nature associated with radiotherapy treatment of HNC patients. Based on prior experience with integration of nutrition and radiation oncology services and understanding expected treatment side effects, we recommend that nutrition services are integrated as part of the initial radiation consultation process to proactively approach the known weight loss and nutritionally relevant side effects. It is imperative to integrate medical informatics infrastructure to modernize the process of documenting treatment side effects and outcomes. Continued in-depth review of this data will facilitate us in creating a comprehensive multidisciplinary treatment approach for HNC patients undergoing radiation therapy.
Background: Unplanned radiation treatment breaks are shown to be related to increased risk of local recurrence, lower survival rates and reduced tumor control rates. Weight loss, along with other side effects, can be a major factor in radiation treatment breaks. This quality improvement project aimed to review weight changes and treatment breaks via retrospective chart review to better understand how to improve the combined nutritional and radiation oncology care of head and neck cancer (HNC) patients.
Methods: Utilizing the Lean Six Sigma Project Management approach to ensure critical components were assessed, this quality improvement project reviewed HNC cases via retrospective chart review that started and/or completed definitive radiation treatment from January 1, 2014 - December 31, 2018. Weights were assessed during the timeframe of treatment and limited to weights obtained within the same unit. Treatment breaks were confirmed via Electronic Medical Records (EMR) systems and defined as one or more missed or cancelled treatments, excluding those missed for nonclinical reasons. Charts were reviewed for documented dysphagia, mucositis, and skin reactions. Information on nutrition visits were assessed.
Results: The incidence of patients who experienced treatment breaks was 47.8%. Patients averaged 5.5 missed treatments. More than half of the patients who experienced treatment breaks had Stage IV disease and 62.5% experienced clinically significant weight loss within their treatment time frame. Approximately 15% of patients were seen within a designated oncology nutrition clinic. Side effects, such as mucositis, dysphagia, and skin reactions, were documented to have contributed to weight changes and treatment breaks.
Conclusion: This project highlighted the multifactorial nature associated with radiotherapy treatment of HNC patients. Based on prior experience with integration of nutrition and radiation oncology services and understanding expected treatment side effects, we recommend that nutrition services are integrated as part of the initial radiation consultation process to proactively approach the known weight loss and nutritionally relevant side effects. It is imperative to integrate medical informatics infrastructure to modernize the process of documenting treatment side effects and outcomes. Continued in-depth review of this data will facilitate us in creating a comprehensive multidisciplinary treatment approach for HNC patients undergoing radiation therapy.
Outcomes After Stereotactic Ablative Radiotherapy (SABR) of Early Stage Non-Small Cell Lung Cancers Without Biopsy Proven Disease
Purpose: SABR has become the standard of care for inoperable early stage non-small cell lung cancer. Many patients are unable to safely receive a biopsy given poor pulmonary function with underlying emphysema and thus are empirically treated with radiotherapy. This study was performed to evaluate the efficacy and safety of definitive SABR in this population.
Methods: 69 patients were analyzed with a median follow up of 18 months. Patient, tumor, radiation doses, pulmonary function tests (including subgroups with FEV1 < 1.0 L, FEV1 < 1.5 L, FEV1 < 30%, and FEV1 < 35%) and toxicity (acute ≤ 90 days and late > 90 days) were analyzed to find associations between overall survival (OS) on Kaplan-Meier log-rank testing and differences in the patient populations with Chi- Square and Mann-Whitney U tests.
Results: The median age was 71. Sixty two tumors were peripheral (88.6%). There were 4 local recurrences (5.7%), 10 regional (different lobe and nodal) failures (14.29%), 15 distant metastases (21.4%) and a median survival of 17 months. There were differences in OS based on operability status (P=0.031), acute toxicity (P=0.000), and acute grade 2 toxicity (P=0.003). Significant factors for differences in distribution among patients with and without acute toxicity were O2 dependence (P=0.047), long term toxicity (P=0.000), and long term grade 2 toxicity (P=0.000). In the acute grade 2 toxicity analysis, O2 dependence (P=0.003), central vs peripheral location (P=0.000), new O2 requirement (P=0.022), long term toxicity (P=0.004), and long term grade 2 toxicity P=0.010) were significant. There were no significant differences based on pulmonary function testing (FEV1, FVC, or DLCO) or the analyzed PFT subgroups.
Conclusion: Operability and acute toxicity are associated with differences in OS in those patients undergoing empiric SABR. O2 dependence prior to treatment and not PFT parameters were associated with acute toxicities.
Purpose: SABR has become the standard of care for inoperable early stage non-small cell lung cancer. Many patients are unable to safely receive a biopsy given poor pulmonary function with underlying emphysema and thus are empirically treated with radiotherapy. This study was performed to evaluate the efficacy and safety of definitive SABR in this population.
Methods: 69 patients were analyzed with a median follow up of 18 months. Patient, tumor, radiation doses, pulmonary function tests (including subgroups with FEV1 < 1.0 L, FEV1 < 1.5 L, FEV1 < 30%, and FEV1 < 35%) and toxicity (acute ≤ 90 days and late > 90 days) were analyzed to find associations between overall survival (OS) on Kaplan-Meier log-rank testing and differences in the patient populations with Chi- Square and Mann-Whitney U tests.
Results: The median age was 71. Sixty two tumors were peripheral (88.6%). There were 4 local recurrences (5.7%), 10 regional (different lobe and nodal) failures (14.29%), 15 distant metastases (21.4%) and a median survival of 17 months. There were differences in OS based on operability status (P=0.031), acute toxicity (P=0.000), and acute grade 2 toxicity (P=0.003). Significant factors for differences in distribution among patients with and without acute toxicity were O2 dependence (P=0.047), long term toxicity (P=0.000), and long term grade 2 toxicity (P=0.000). In the acute grade 2 toxicity analysis, O2 dependence (P=0.003), central vs peripheral location (P=0.000), new O2 requirement (P=0.022), long term toxicity (P=0.004), and long term grade 2 toxicity P=0.010) were significant. There were no significant differences based on pulmonary function testing (FEV1, FVC, or DLCO) or the analyzed PFT subgroups.
Conclusion: Operability and acute toxicity are associated with differences in OS in those patients undergoing empiric SABR. O2 dependence prior to treatment and not PFT parameters were associated with acute toxicities.
Purpose: SABR has become the standard of care for inoperable early stage non-small cell lung cancer. Many patients are unable to safely receive a biopsy given poor pulmonary function with underlying emphysema and thus are empirically treated with radiotherapy. This study was performed to evaluate the efficacy and safety of definitive SABR in this population.
Methods: 69 patients were analyzed with a median follow up of 18 months. Patient, tumor, radiation doses, pulmonary function tests (including subgroups with FEV1 < 1.0 L, FEV1 < 1.5 L, FEV1 < 30%, and FEV1 < 35%) and toxicity (acute ≤ 90 days and late > 90 days) were analyzed to find associations between overall survival (OS) on Kaplan-Meier log-rank testing and differences in the patient populations with Chi- Square and Mann-Whitney U tests.
Results: The median age was 71. Sixty two tumors were peripheral (88.6%). There were 4 local recurrences (5.7%), 10 regional (different lobe and nodal) failures (14.29%), 15 distant metastases (21.4%) and a median survival of 17 months. There were differences in OS based on operability status (P=0.031), acute toxicity (P=0.000), and acute grade 2 toxicity (P=0.003). Significant factors for differences in distribution among patients with and without acute toxicity were O2 dependence (P=0.047), long term toxicity (P=0.000), and long term grade 2 toxicity (P=0.000). In the acute grade 2 toxicity analysis, O2 dependence (P=0.003), central vs peripheral location (P=0.000), new O2 requirement (P=0.022), long term toxicity (P=0.004), and long term grade 2 toxicity P=0.010) were significant. There were no significant differences based on pulmonary function testing (FEV1, FVC, or DLCO) or the analyzed PFT subgroups.
Conclusion: Operability and acute toxicity are associated with differences in OS in those patients undergoing empiric SABR. O2 dependence prior to treatment and not PFT parameters were associated with acute toxicities.