Article

Background

Biliary tract cancers (BTC) represent an important rare cancer type in Veterans. The heterogeneity of BTC has revealed distinct molecular subtypes, however a majority of patients remain without precision-based targeted therapeutics. Epigenomic remodeling has been considered as a shared mechanism of therapeutic resistance. Cyclin dependant kinase 7 (CDK7) is an emerging therapeutic target that functions by phosphorylation of RNA polymerase II and cell cycle progression. Here, we investigate CDK7 inhibition using small molecule inhibition (SY-5609) across a panel of BTC organoid models.

Methods

PCOs were expanded from patient-derived tissues and shared models provided from the NCI. Organoid response was tracked from growth using Z-stacked high content imaging (Cytation5) to track individual organoid growth and established viability markers of Caspase-3/7 (C3/7) and ToPro3, for induced apoptosis and necrosis for phenotypic screening. Treatment groups included media control, positive control (cycloheximide) 200uM continuous, gemcitabine (gem) 10uM 24h, cisplatin (cis) 5uM 48h, combination gem+cis, and SY-5609 10nM 144h. Glass’s delta was used to standardize effect size relative to media control.

Results

Patient-derived cancer organoids were generated across four unique models including pathogenic (A-B) IDH1 p.R132G, (C) FGFR2-HPGDS fusion and (D) non-targetable molecular profile (CCNE1 amplified, BRCA1 splice variant). In the non-targeted model, CDK7 inhibition achieved growth arrest +2.0% (SY-5607) v. +43.0% (media control) with effect size >1.1. This response was similar to standard of care gem+cis with growth of +1.5% and augmented using the combination of gem+SY-5609 -3.1% with effect size of >1.3. When treated with CDK7 inhibition, persistent growth was seen across models of IDH1 mutant and FGFR2-HPGDS2 fusion cancers. High content imaging revealed subclonal populations with failed induction of apoptosis and necrosis at 144h, suggestive of the critical need to address intrinsic resistant populations to both SOC chemotherapy and novel targeted strategies.

Conclusions

Across a diversity of BTC cancer models, CDK7 inhibition was found to achieve growth arrest in a CCNE1 amplified cancer model. High content imaging of organoids can identify subclonal resistant populations as a critical unmet need in future therapeutic development. Ongoing work is adapting these techniques to multiple small molecule inhibitors that target transcription including EZH1/2 and CDK9.

Background

Biliary tract cancers (BTC) represent an important rare cancer type in Veterans. The heterogeneity of BTC has revealed distinct molecular subtypes, however a majority of patients remain without precision-based targeted therapeutics. Epigenomic remodeling has been considered as a shared mechanism of therapeutic resistance. Cyclin dependant kinase 7 (CDK7) is an emerging therapeutic target that functions by phosphorylation of RNA polymerase II and cell cycle progression. Here, we investigate CDK7 inhibition using small molecule inhibition (SY-5609) across a panel of BTC organoid models.

Methods

PCOs were expanded from patient-derived tissues and shared models provided from the NCI. Organoid response was tracked from growth using Z-stacked high content imaging (Cytation5) to track individual organoid growth and established viability markers of Caspase-3/7 (C3/7) and ToPro3, for induced apoptosis and necrosis for phenotypic screening. Treatment groups included media control, positive control (cycloheximide) 200uM continuous, gemcitabine (gem) 10uM 24h, cisplatin (cis) 5uM 48h, combination gem+cis, and SY-5609 10nM 144h. Glass’s delta was used to standardize effect size relative to media control.

Results

Patient-derived cancer organoids were generated across four unique models including pathogenic (A-B) IDH1 p.R132G, (C) FGFR2-HPGDS fusion and (D) non-targetable molecular profile (CCNE1 amplified, BRCA1 splice variant). In the non-targeted model, CDK7 inhibition achieved growth arrest +2.0% (SY-5607) v. +43.0% (media control) with effect size >1.1. This response was similar to standard of care gem+cis with growth of +1.5% and augmented using the combination of gem+SY-5609 -3.1% with effect size of >1.3. When treated with CDK7 inhibition, persistent growth was seen across models of IDH1 mutant and FGFR2-HPGDS2 fusion cancers. High content imaging revealed subclonal populations with failed induction of apoptosis and necrosis at 144h, suggestive of the critical need to address intrinsic resistant populations to both SOC chemotherapy and novel targeted strategies.

Conclusions

Across a diversity of BTC cancer models, CDK7 inhibition was found to achieve growth arrest in a CCNE1 amplified cancer model. High content imaging of organoids can identify subclonal resistant populations as a critical unmet need in future therapeutic development. Ongoing work is adapting these techniques to multiple small molecule inhibitors that target transcription including EZH1/2 and CDK9.

Background

Biliary tract cancers (BTC) represent an important rare cancer type in Veterans. The heterogeneity of BTC has revealed distinct molecular subtypes, however a majority of patients remain without precision-based targeted therapeutics. Epigenomic remodeling has been considered as a shared mechanism of therapeutic resistance. Cyclin dependant kinase 7 (CDK7) is an emerging therapeutic target that functions by phosphorylation of RNA polymerase II and cell cycle progression. Here, we investigate CDK7 inhibition using small molecule inhibition (SY-5609) across a panel of BTC organoid models.

Methods

PCOs were expanded from patient-derived tissues and shared models provided from the NCI. Organoid response was tracked from growth using Z-stacked high content imaging (Cytation5) to track individual organoid growth and established viability markers of Caspase-3/7 (C3/7) and ToPro3, for induced apoptosis and necrosis for phenotypic screening. Treatment groups included media control, positive control (cycloheximide) 200uM continuous, gemcitabine (gem) 10uM 24h, cisplatin (cis) 5uM 48h, combination gem+cis, and SY-5609 10nM 144h. Glass’s delta was used to standardize effect size relative to media control.

Results

Patient-derived cancer organoids were generated across four unique models including pathogenic (A-B) IDH1 p.R132G, (C) FGFR2-HPGDS fusion and (D) non-targetable molecular profile (CCNE1 amplified, BRCA1 splice variant). In the non-targeted model, CDK7 inhibition achieved growth arrest +2.0% (SY-5607) v. +43.0% (media control) with effect size >1.1. This response was similar to standard of care gem+cis with growth of +1.5% and augmented using the combination of gem+SY-5609 -3.1% with effect size of >1.3. When treated with CDK7 inhibition, persistent growth was seen across models of IDH1 mutant and FGFR2-HPGDS2 fusion cancers. High content imaging revealed subclonal populations with failed induction of apoptosis and necrosis at 144h, suggestive of the critical need to address intrinsic resistant populations to both SOC chemotherapy and novel targeted strategies.

Conclusions

Across a diversity of BTC cancer models, CDK7 inhibition was found to achieve growth arrest in a CCNE1 amplified cancer model. High content imaging of organoids can identify subclonal resistant populations as a critical unmet need in future therapeutic development. Ongoing work is adapting these techniques to multiple small molecule inhibitors that target transcription including EZH1/2 and CDK9.

Background

Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.

Methods

All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).

Discussion

Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).

Background

Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.

Methods

All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).

Discussion

Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).

Background

Many Veterans with cancer experience substantial side effects related to their chemotherapy treatments resulting in impaired quality of life. Prompt management of such symptoms can improve adherence to therapy and potentially clinical outcomes. Previous studies in cancer patients have shown that mobile apps can improve symptom management and quality of life, though there are limited studies using oncology-focused apps in the VA population. The VA Annie App is an optimal platform for Veterans since it relies primarily on SMS-based texting and not on internet capabilities. This would address several well-known barriers to Veterans’ care access (limited internet connectivity, transportation) and enhance symptom reporting between infrequent provider visits. Providers can securely collect app responses within the VA system and there is already considerable VA developer experience with designing complex protocols. The OCTAGON project (Optimizing Cancer Care with Telehealth Assessment for Goal-Oriented Needs) will have the following goals: 1) To develop Annie App protocols to assist in management of cancer and/or chemotherapy-related symptoms (OCTAGON intervention), 2) To examine initial acceptability, feasibility, and Veteran-reported outcomes, 3) To explore short term effects on the utilization of VA encounters.

Methods

All patients who are primarily being managed at the VA Ann Arbor for their cancer therapy and are receiving one of the following therapies are considered eligible: EGFR inhibitors (lung cancer), antiandrogen therapies (prostate cancer), BTK inhibitors (lymphoma).

Discussion

Drug-specific protocols will be developed in conjunction with clinical pharmacists with experience in outpatient oral chemotherapy toxicity monitoring. Questions will have either a Yes/No, or numerical response. Interventions will be administered weekly for the first 3 months after enrollment, then decrease to monthly for a total of 6 months on protocol. Patients will be directed to contact their providers with any significant changes in tolerability. Planned data collected will include intervention question responses, adverse events, demographics, diagnosis, disease response, hospitalizations, treatment dose reductions or interruptions, provider and staff utilization. Survey responses to assess treatment acceptability (Treatment Acceptability/Adherence Scale), usability (System Usability Scale), general health (PROMIS-GH), and patient satisfaction will also be collected. Funding: VA Telehealth Research and Innovation for Veterans with Cancer (THRIVE).

Background

The standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is combination chemoradiotherapy. Platinum-based chemotherapy is used for radiosensitization and significantly improves locoregional control and survival. Cisplatin is the standard of care; however, many patients are cisplatin-ineligible due to underlying comorbidities. Carboplatin is an alternative chemotherapy in these patients, but efficacy data are lacking. Purpose: To evaluate the efficacy and tolerability of weekly carboplatin concurrent with radiation in veterans with locally advanced HNSCC.

Methods

Our tumor registry was used to identify patients who received platinum-based chemoradiotherapy for stage III-IVB HNSCC at a single center between 2007 to 2017. Patients who received carboplatin were identified. Data including dosing, toxicities, and disease response was collected and analyzed.

Results

A total of 26 patients who received weekly carboplatin were analyzed. All patients were male with an average age of 65. A usual dose of carboplatin AUC 2 was utilized. The average cumulative dose for weekly carboplatin was AUC 12, with most patients (65%) receiving 6 doses or more. The mean number of weekly carboplatin doses held was 0.3. 7 patients (27%) had at least one dose held. 21 (81%) patients showed treatment benefit: 19 (73%) had complete response and 2 (8%) had partial response on first scan following treatment. The four most common toxicities were mucositis (69%), nausea/vomiting (23%), oral thrush (19%), and dermatologic toxicities (19%). The most common toxicities causing dose interruption were fatigue (12%), neutropenia (8%), and thrombocytopenia (8%). Grade 3/4 mucositis was experienced in 6 patients (23%). Other grade 3/4 toxicities included neutropenia (8%), anemia (8%), thrombocytopenia (1%), nephrotoxicity (1%) and nausea (1%).

Conclusions

Carboplatin was both efficacious and well tolerated in our older veteran population. These findings add to the limited body of evidence examining weekly carboplatin in patients with advanced head and neck cancer. While cisplatin remains standard of care, carboplatin may be a reasonable alternative as evidenced in a real-world veteran population.

Background

The standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is combination chemoradiotherapy. Platinum-based chemotherapy is used for radiosensitization and significantly improves locoregional control and survival. Cisplatin is the standard of care; however, many patients are cisplatin-ineligible due to underlying comorbidities. Carboplatin is an alternative chemotherapy in these patients, but efficacy data are lacking. Purpose: To evaluate the efficacy and tolerability of weekly carboplatin concurrent with radiation in veterans with locally advanced HNSCC.

Methods

Our tumor registry was used to identify patients who received platinum-based chemoradiotherapy for stage III-IVB HNSCC at a single center between 2007 to 2017. Patients who received carboplatin were identified. Data including dosing, toxicities, and disease response was collected and analyzed.

Results

A total of 26 patients who received weekly carboplatin were analyzed. All patients were male with an average age of 65. A usual dose of carboplatin AUC 2 was utilized. The average cumulative dose for weekly carboplatin was AUC 12, with most patients (65%) receiving 6 doses or more. The mean number of weekly carboplatin doses held was 0.3. 7 patients (27%) had at least one dose held. 21 (81%) patients showed treatment benefit: 19 (73%) had complete response and 2 (8%) had partial response on first scan following treatment. The four most common toxicities were mucositis (69%), nausea/vomiting (23%), oral thrush (19%), and dermatologic toxicities (19%). The most common toxicities causing dose interruption were fatigue (12%), neutropenia (8%), and thrombocytopenia (8%). Grade 3/4 mucositis was experienced in 6 patients (23%). Other grade 3/4 toxicities included neutropenia (8%), anemia (8%), thrombocytopenia (1%), nephrotoxicity (1%) and nausea (1%).

Conclusions

Carboplatin was both efficacious and well tolerated in our older veteran population. These findings add to the limited body of evidence examining weekly carboplatin in patients with advanced head and neck cancer. While cisplatin remains standard of care, carboplatin may be a reasonable alternative as evidenced in a real-world veteran population.

Background

The standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) is combination chemoradiotherapy. Platinum-based chemotherapy is used for radiosensitization and significantly improves locoregional control and survival. Cisplatin is the standard of care; however, many patients are cisplatin-ineligible due to underlying comorbidities. Carboplatin is an alternative chemotherapy in these patients, but efficacy data are lacking. Purpose: To evaluate the efficacy and tolerability of weekly carboplatin concurrent with radiation in veterans with locally advanced HNSCC.

Methods

Our tumor registry was used to identify patients who received platinum-based chemoradiotherapy for stage III-IVB HNSCC at a single center between 2007 to 2017. Patients who received carboplatin were identified. Data including dosing, toxicities, and disease response was collected and analyzed.

Results

A total of 26 patients who received weekly carboplatin were analyzed. All patients were male with an average age of 65. A usual dose of carboplatin AUC 2 was utilized. The average cumulative dose for weekly carboplatin was AUC 12, with most patients (65%) receiving 6 doses or more. The mean number of weekly carboplatin doses held was 0.3. 7 patients (27%) had at least one dose held. 21 (81%) patients showed treatment benefit: 19 (73%) had complete response and 2 (8%) had partial response on first scan following treatment. The four most common toxicities were mucositis (69%), nausea/vomiting (23%), oral thrush (19%), and dermatologic toxicities (19%). The most common toxicities causing dose interruption were fatigue (12%), neutropenia (8%), and thrombocytopenia (8%). Grade 3/4 mucositis was experienced in 6 patients (23%). Other grade 3/4 toxicities included neutropenia (8%), anemia (8%), thrombocytopenia (1%), nephrotoxicity (1%) and nausea (1%).

Conclusions

Carboplatin was both efficacious and well tolerated in our older veteran population. These findings add to the limited body of evidence examining weekly carboplatin in patients with advanced head and neck cancer. While cisplatin remains standard of care, carboplatin may be a reasonable alternative as evidenced in a real-world veteran population.

Background

From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.

Methods

DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.

Results

Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).

Conclusions

DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.

Background

From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.

Methods

DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.

Results

Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).

Conclusions

DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.

Background

From 2000-2022 there were over 200 new drug and over 500 indication approvals specific to oncology. The rate of approvals has increased exponentially, making it difficult to maintain an up-to-date, standardized practice. Nationally, Veterans Affairs (VA) formulary decisions can take time given a lengthy approval process. Locally, the need was identified to incorporate new drugs and data into practice more rapidly. When bringing requests to the facility Pharmacy and Therapeutics (P&T) Committee, it was recognized that the membership consisting of non-oncology practitioners did not allow for meaningful discussion of utilization. In 2017, a dedicated oncology drug review committee (DRC) comprised of oncology practitioners and a facility formulary representative was created as a P&T workgroup. Purpose: Evaluate and describe the utility of forming a local oncology DRC to incorporate new drugs and data into practice.

Methods

DRC minutes from December 2017 to May 2023 were reviewed. Discussion items were categorized into type of review. Date of local review was compared to national formulary criteria for use publication dates, and date of FDA approval for new drugs or publication date for new data, where applicable. Items were excluded if crucial information was missing from minutes. Descriptive statistics were used.

Results

Over 65 months, 38 meetings were held. Thirty total members include: pharmacists, physicians, fellows, and advanced practice providers. Items reviewed included: 36 new drugs (ND), 36 new indications/data (NI), 14 institutional preferences, 10 new dosage form/biosimilars, 4 drug shortages and 2 others. The median time from ND approval to discussion was 3 months (n= 36, IQR 3-6) and NI from publication was 3 months (n=30, IQR 1-8). Nearly all (34/36, 94%) ND were reviewed prior to national review. Local review was a median of 7 months before national, with 11 drugs currently having no published national criteria for use (n=25, IQR 2-12).

Conclusions

DRC formation has enabled faster incorporation of new drugs/indications into practice. It has also created an appropriate forum for in-depth utilization discussions, pharmacoeconomic stewardship, and sharing of formulary and medication related information. VA Health Systems could consider implementing similar committees to review and implement up-to-date oncology practices.

Background

In December of 2023, the Survivorship Coordinator at VA Connecticut spearheaded a multidisciplinary collaboration to offer PHASER testing to all patients newly diagnosed with a GI malignancy and/ or patients with a known GI malignancy and a new recurrence that might necessitate chemotherapy. The PHASER panel includes two genes that are involved in the metabolism of two commonly used chemotherapy drugs in this patient population.

Methods

By identifying patients who may have impaired metabolism prior to starting treatment, the doses of the appropriate drugs, 5FU and irinotecan, can be adjusted if appropriate, leading to less toxicity for patients while on treatment and fewer lingering side-effects from treatment. We are tracking all of the patients who are being tested and will report quarterly to the Cancer Committee on any findings with a specific focus on whether any dose-adjustments were made to Veteran’s chemotherapy regimens as the result of this testing.

Discussion

We have developed a systematic process centered around GI tumor boards to ensure that testing is done at least two weeks prior to planned chemotherapy start-date to ensure adequate time for testing results to be received. We have developed a systematic process whereby primary care providers and pharmacists are alerted to the PHASER results and patients’ non-oncology medications are reviewed for any recommended adjustments. We will have 9 months of data to report on at AVAHO as well as lessons learned from this new quality improvement process. Despite access to pharmacogenomic testing at VA, there can be variations between VA sites in terms of uptake of this new testing. VA Connecticut’s PHASER testing initiative for patients with GI malignancies is a model that can be replicated throughout the VA. This initiative is part of a broader focus at VA Connecticut on “pre-habilitation” and pre-treatment testing that is designed to reduce toxicity of treatment and improve quality of life for cancer survivors.

Background

In December of 2023, the Survivorship Coordinator at VA Connecticut spearheaded a multidisciplinary collaboration to offer PHASER testing to all patients newly diagnosed with a GI malignancy and/ or patients with a known GI malignancy and a new recurrence that might necessitate chemotherapy. The PHASER panel includes two genes that are involved in the metabolism of two commonly used chemotherapy drugs in this patient population.

Methods

By identifying patients who may have impaired metabolism prior to starting treatment, the doses of the appropriate drugs, 5FU and irinotecan, can be adjusted if appropriate, leading to less toxicity for patients while on treatment and fewer lingering side-effects from treatment. We are tracking all of the patients who are being tested and will report quarterly to the Cancer Committee on any findings with a specific focus on whether any dose-adjustments were made to Veteran’s chemotherapy regimens as the result of this testing.

Discussion

We have developed a systematic process centered around GI tumor boards to ensure that testing is done at least two weeks prior to planned chemotherapy start-date to ensure adequate time for testing results to be received. We have developed a systematic process whereby primary care providers and pharmacists are alerted to the PHASER results and patients’ non-oncology medications are reviewed for any recommended adjustments. We will have 9 months of data to report on at AVAHO as well as lessons learned from this new quality improvement process. Despite access to pharmacogenomic testing at VA, there can be variations between VA sites in terms of uptake of this new testing. VA Connecticut’s PHASER testing initiative for patients with GI malignancies is a model that can be replicated throughout the VA. This initiative is part of a broader focus at VA Connecticut on “pre-habilitation” and pre-treatment testing that is designed to reduce toxicity of treatment and improve quality of life for cancer survivors.

Background

In December of 2023, the Survivorship Coordinator at VA Connecticut spearheaded a multidisciplinary collaboration to offer PHASER testing to all patients newly diagnosed with a GI malignancy and/ or patients with a known GI malignancy and a new recurrence that might necessitate chemotherapy. The PHASER panel includes two genes that are involved in the metabolism of two commonly used chemotherapy drugs in this patient population.

Methods

By identifying patients who may have impaired metabolism prior to starting treatment, the doses of the appropriate drugs, 5FU and irinotecan, can be adjusted if appropriate, leading to less toxicity for patients while on treatment and fewer lingering side-effects from treatment. We are tracking all of the patients who are being tested and will report quarterly to the Cancer Committee on any findings with a specific focus on whether any dose-adjustments were made to Veteran’s chemotherapy regimens as the result of this testing.

Discussion

We have developed a systematic process centered around GI tumor boards to ensure that testing is done at least two weeks prior to planned chemotherapy start-date to ensure adequate time for testing results to be received. We have developed a systematic process whereby primary care providers and pharmacists are alerted to the PHASER results and patients’ non-oncology medications are reviewed for any recommended adjustments. We will have 9 months of data to report on at AVAHO as well as lessons learned from this new quality improvement process. Despite access to pharmacogenomic testing at VA, there can be variations between VA sites in terms of uptake of this new testing. VA Connecticut’s PHASER testing initiative for patients with GI malignancies is a model that can be replicated throughout the VA. This initiative is part of a broader focus at VA Connecticut on “pre-habilitation” and pre-treatment testing that is designed to reduce toxicity of treatment and improve quality of life for cancer survivors.

Background

Lung cancer is the leading cause of cancer related deaths in the United States. The impact of treatment delay proves difficult to quantify, but increased time to treatment and subsequent progression can limit a patient’s chance for curative intent therapy. Reducing time to treatment aims to improve patient outcome and experience. This study aims to identify the median timeframes that occur in the diagnosis and treatment of lung cancer patients within a single Veteran Affair (VA) Medical Center.

Methods

A retrospective chart review was conducted on 123 new primary lung cancer cases detected by imaging between January 1, 2019 and December 31, 2022 within a single VA medical center. Exclusions were preexisting lung cancer or other malignancy. The following data was collected: time to PET scan, referrals, and treatment initiation. KruskalWallis test and Mann-Whitney U test was employed to assess differences in treatment times based on treatment modality and disease stage, respectively

Results

The median time from first abnormal image to PET scan was 26 days. The median time from initial abnormal scan to treatment was 91 days. Treatment initiation was significantly shorter in late-state disease (IV, extensive stage) at 57 days compared to early-stage disease (I-III, limited stage) at 98.5 days (p= 0.00008). There was a difference in the median time from abnormal scan to treatment initiation based on treatment modality: chemotherapy, radiation therapy, and surgical intervention occurred at 60 days, 86 days, and 98 days, respectively (p= 0.005).

Conclusions

At our institution, patients with latestage lung cancer initiate therapy significantly faster than those diagnosed with early-stage cancer. We feel this is largely due to complex, multidisciplinary coordination of early-stage disease, in contrast to those diagnosed at later stage disease who are treated in a palliative, systemic fashion. This study was instrumental at identifying key areas along the process that can be improved upon. Based on this data, changes will be implemented and studied in effort to shorten time to treatment.

Background

Lung cancer is the leading cause of cancer related deaths in the United States. The impact of treatment delay proves difficult to quantify, but increased time to treatment and subsequent progression can limit a patient’s chance for curative intent therapy. Reducing time to treatment aims to improve patient outcome and experience. This study aims to identify the median timeframes that occur in the diagnosis and treatment of lung cancer patients within a single Veteran Affair (VA) Medical Center.

Methods

A retrospective chart review was conducted on 123 new primary lung cancer cases detected by imaging between January 1, 2019 and December 31, 2022 within a single VA medical center. Exclusions were preexisting lung cancer or other malignancy. The following data was collected: time to PET scan, referrals, and treatment initiation. KruskalWallis test and Mann-Whitney U test was employed to assess differences in treatment times based on treatment modality and disease stage, respectively

Results

The median time from first abnormal image to PET scan was 26 days. The median time from initial abnormal scan to treatment was 91 days. Treatment initiation was significantly shorter in late-state disease (IV, extensive stage) at 57 days compared to early-stage disease (I-III, limited stage) at 98.5 days (p= 0.00008). There was a difference in the median time from abnormal scan to treatment initiation based on treatment modality: chemotherapy, radiation therapy, and surgical intervention occurred at 60 days, 86 days, and 98 days, respectively (p= 0.005).

Conclusions

At our institution, patients with latestage lung cancer initiate therapy significantly faster than those diagnosed with early-stage cancer. We feel this is largely due to complex, multidisciplinary coordination of early-stage disease, in contrast to those diagnosed at later stage disease who are treated in a palliative, systemic fashion. This study was instrumental at identifying key areas along the process that can be improved upon. Based on this data, changes will be implemented and studied in effort to shorten time to treatment.

Background

Lung cancer is the leading cause of cancer related deaths in the United States. The impact of treatment delay proves difficult to quantify, but increased time to treatment and subsequent progression can limit a patient’s chance for curative intent therapy. Reducing time to treatment aims to improve patient outcome and experience. This study aims to identify the median timeframes that occur in the diagnosis and treatment of lung cancer patients within a single Veteran Affair (VA) Medical Center.

Methods

A retrospective chart review was conducted on 123 new primary lung cancer cases detected by imaging between January 1, 2019 and December 31, 2022 within a single VA medical center. Exclusions were preexisting lung cancer or other malignancy. The following data was collected: time to PET scan, referrals, and treatment initiation. KruskalWallis test and Mann-Whitney U test was employed to assess differences in treatment times based on treatment modality and disease stage, respectively

Results

The median time from first abnormal image to PET scan was 26 days. The median time from initial abnormal scan to treatment was 91 days. Treatment initiation was significantly shorter in late-state disease (IV, extensive stage) at 57 days compared to early-stage disease (I-III, limited stage) at 98.5 days (p= 0.00008). There was a difference in the median time from abnormal scan to treatment initiation based on treatment modality: chemotherapy, radiation therapy, and surgical intervention occurred at 60 days, 86 days, and 98 days, respectively (p= 0.005).

Conclusions

At our institution, patients with latestage lung cancer initiate therapy significantly faster than those diagnosed with early-stage cancer. We feel this is largely due to complex, multidisciplinary coordination of early-stage disease, in contrast to those diagnosed at later stage disease who are treated in a palliative, systemic fashion. This study was instrumental at identifying key areas along the process that can be improved upon. Based on this data, changes will be implemented and studied in effort to shorten time to treatment.

Background

Goblet cell adenocarcinoma (GCA), also known as goblet cell carcinoid, is a rare and distinct type of cancer originating from the appendix. It is characterized by cells that exhibit both mucinous and neuroendocrine differentiation, presenting a more aggressive nature compared to conventional carcinoids and a higher propensity for metastasis.

Case Presentation

A 60-year-old male presented with complaints of abdominal pain, nausea, vomiting, constipation, and weight loss worsening in the last month. He had a history of heavy alcohol intake, smoking, and family history of colon cancer in his grandfather. Initial workup with abdominal CT revealed findings suggestive of early bowel obstruction and possible malignancy. Subsequent EGD showed esophagitis, and colonoscopy identified a cecal mass. Biopsies confirmed malignant cells of enteric type with goblet cell features. Staging CT during hospitalization did not reveal distant metastasis initially. However, diagnostic laparoscopy later identified widespread peritoneal carcinomatosis, precluding surgical intervention. The case was discussed in tumor boards, leading to the initiation of palliative FOLFOX + Bevacizumab chemotherapy. After completing 7 cycles, restaging imaging showed stable disease. Subsequently, the patient experienced worsening obstructive symptoms with CT abdomen and pelvis demonstrating disease progression. Given his condition, decompressive gastrostomy was not feasible. The patient decided to transition to comfort measures only.

Discussion

Goblet cell adenocarcinoma is a rare appendiceal tumor with amphicrine differentiation, occurring at a rate of 0.01–0.05 per 100,000 individuals annually and comprising approximately 15% of all appendiceal neoplasms. These tumors often disseminate within the peritoneum, contributing to their aggressive behavior and challenging management.

Conclusions

Metastatic goblet cell adenocarcinoma presents significant treatment challenges and is associated with a poor prognosis. Tailored treatment strategies, vigilant monitoring, and ongoing research efforts are essential for optimizing patient outcomes and enhancing quality of life in this aggressive cancer

Background

Goblet cell adenocarcinoma (GCA), also known as goblet cell carcinoid, is a rare and distinct type of cancer originating from the appendix. It is characterized by cells that exhibit both mucinous and neuroendocrine differentiation, presenting a more aggressive nature compared to conventional carcinoids and a higher propensity for metastasis.

Case Presentation

A 60-year-old male presented with complaints of abdominal pain, nausea, vomiting, constipation, and weight loss worsening in the last month. He had a history of heavy alcohol intake, smoking, and family history of colon cancer in his grandfather. Initial workup with abdominal CT revealed findings suggestive of early bowel obstruction and possible malignancy. Subsequent EGD showed esophagitis, and colonoscopy identified a cecal mass. Biopsies confirmed malignant cells of enteric type with goblet cell features. Staging CT during hospitalization did not reveal distant metastasis initially. However, diagnostic laparoscopy later identified widespread peritoneal carcinomatosis, precluding surgical intervention. The case was discussed in tumor boards, leading to the initiation of palliative FOLFOX + Bevacizumab chemotherapy. After completing 7 cycles, restaging imaging showed stable disease. Subsequently, the patient experienced worsening obstructive symptoms with CT abdomen and pelvis demonstrating disease progression. Given his condition, decompressive gastrostomy was not feasible. The patient decided to transition to comfort measures only.

Discussion

Goblet cell adenocarcinoma is a rare appendiceal tumor with amphicrine differentiation, occurring at a rate of 0.01–0.05 per 100,000 individuals annually and comprising approximately 15% of all appendiceal neoplasms. These tumors often disseminate within the peritoneum, contributing to their aggressive behavior and challenging management.

Conclusions

Metastatic goblet cell adenocarcinoma presents significant treatment challenges and is associated with a poor prognosis. Tailored treatment strategies, vigilant monitoring, and ongoing research efforts are essential for optimizing patient outcomes and enhancing quality of life in this aggressive cancer

Background

Goblet cell adenocarcinoma (GCA), also known as goblet cell carcinoid, is a rare and distinct type of cancer originating from the appendix. It is characterized by cells that exhibit both mucinous and neuroendocrine differentiation, presenting a more aggressive nature compared to conventional carcinoids and a higher propensity for metastasis.

Case Presentation

A 60-year-old male presented with complaints of abdominal pain, nausea, vomiting, constipation, and weight loss worsening in the last month. He had a history of heavy alcohol intake, smoking, and family history of colon cancer in his grandfather. Initial workup with abdominal CT revealed findings suggestive of early bowel obstruction and possible malignancy. Subsequent EGD showed esophagitis, and colonoscopy identified a cecal mass. Biopsies confirmed malignant cells of enteric type with goblet cell features. Staging CT during hospitalization did not reveal distant metastasis initially. However, diagnostic laparoscopy later identified widespread peritoneal carcinomatosis, precluding surgical intervention. The case was discussed in tumor boards, leading to the initiation of palliative FOLFOX + Bevacizumab chemotherapy. After completing 7 cycles, restaging imaging showed stable disease. Subsequently, the patient experienced worsening obstructive symptoms with CT abdomen and pelvis demonstrating disease progression. Given his condition, decompressive gastrostomy was not feasible. The patient decided to transition to comfort measures only.

Discussion

Goblet cell adenocarcinoma is a rare appendiceal tumor with amphicrine differentiation, occurring at a rate of 0.01–0.05 per 100,000 individuals annually and comprising approximately 15% of all appendiceal neoplasms. These tumors often disseminate within the peritoneum, contributing to their aggressive behavior and challenging management.

Conclusions

Metastatic goblet cell adenocarcinoma presents significant treatment challenges and is associated with a poor prognosis. Tailored treatment strategies, vigilant monitoring, and ongoing research efforts are essential for optimizing patient outcomes and enhancing quality of life in this aggressive cancer

Background

Cholangiocarcinoma (CCA) is a rare and aggressive cancer of the biliary system, accounting for 15% of primary liver cancers. Most CCAs arise spontaneously, with risk factors including primary biliary cirrhosis, liver fluke infection, and biliary malformations. A newly described variant, Inhibin-positive Cholangioblastic (solid-tubulocystic) intrahepatic cholangiocarcinoma (iCCA), mimics neuroendocrine tumors (NET). This report presents a case of this new variant.

Case Presentation

A 53-year-old female with a history of alcohol use disorder and no family history of liver cancer presented with watery diarrhea for a month. Blood tests, including tumor markers, were normal. An ultrasound revealed a large mass in the right hepatic lobe. CT and MRI scans suggested a hemangioma. Due to the mass’s size and spontaneous bleeding risk, she underwent surgical resection. The mass was initially thought to be a hemangioma but was later identified as poorly differentiated intrahepatic CCA with a solid and tubulocystic structure. Pathology showed strong staining for Cytokeratin (CK) 7, CK-19, and Inhibin, and weak staining for synaptophysin, confirming a diagnosis of cholangioblastic iCCA. Genetic testing revealed no actionable variations. She was started on capecitabine for 8 cycles. Follow-up imaging showed no disease recurrence or metastasis.

Discussion

CCA often presents at advanced stages with symptoms like weight loss and jaundice. Diagnosis involves clinical assessment, lab work, and imaging, particularly MRI. Cholangioblastic Intrahepatic CCA (iCCA) is a newly described variant of cholangiocarcinoma. There have been 16 reported cases of the disease. Initially, it was thought to be a NET as it expressed Chromogranin, insulinoma-associated protein-1, and Synaptophysin. Almost half of the reported cases were diagnosed as NET initially. One tool clinicians can use to differentiate them is inhibin. Inhibin has been documented in all of the reported cases of Cholangioblastic iCCA. A novel inhibin-positive cholangioblastic iCCA variant with a Nipped-B-like protein and nucleus accumbens associated-1 (NIPBL-NACC1) fusion transcript has been reported recently, further helping differentiate the two. There is no standard of therapy for this variant. It’s managed similarly to CCAs, relying on surgical resection as the primary treatment. Limited data shows varied responses to neoadjuvant and adjuvant therapy.

Background

Cholangiocarcinoma (CCA) is a rare and aggressive cancer of the biliary system, accounting for 15% of primary liver cancers. Most CCAs arise spontaneously, with risk factors including primary biliary cirrhosis, liver fluke infection, and biliary malformations. A newly described variant, Inhibin-positive Cholangioblastic (solid-tubulocystic) intrahepatic cholangiocarcinoma (iCCA), mimics neuroendocrine tumors (NET). This report presents a case of this new variant.

Case Presentation

A 53-year-old female with a history of alcohol use disorder and no family history of liver cancer presented with watery diarrhea for a month. Blood tests, including tumor markers, were normal. An ultrasound revealed a large mass in the right hepatic lobe. CT and MRI scans suggested a hemangioma. Due to the mass’s size and spontaneous bleeding risk, she underwent surgical resection. The mass was initially thought to be a hemangioma but was later identified as poorly differentiated intrahepatic CCA with a solid and tubulocystic structure. Pathology showed strong staining for Cytokeratin (CK) 7, CK-19, and Inhibin, and weak staining for synaptophysin, confirming a diagnosis of cholangioblastic iCCA. Genetic testing revealed no actionable variations. She was started on capecitabine for 8 cycles. Follow-up imaging showed no disease recurrence or metastasis.

Discussion

CCA often presents at advanced stages with symptoms like weight loss and jaundice. Diagnosis involves clinical assessment, lab work, and imaging, particularly MRI. Cholangioblastic Intrahepatic CCA (iCCA) is a newly described variant of cholangiocarcinoma. There have been 16 reported cases of the disease. Initially, it was thought to be a NET as it expressed Chromogranin, insulinoma-associated protein-1, and Synaptophysin. Almost half of the reported cases were diagnosed as NET initially. One tool clinicians can use to differentiate them is inhibin. Inhibin has been documented in all of the reported cases of Cholangioblastic iCCA. A novel inhibin-positive cholangioblastic iCCA variant with a Nipped-B-like protein and nucleus accumbens associated-1 (NIPBL-NACC1) fusion transcript has been reported recently, further helping differentiate the two. There is no standard of therapy for this variant. It’s managed similarly to CCAs, relying on surgical resection as the primary treatment. Limited data shows varied responses to neoadjuvant and adjuvant therapy.

Background

Cholangiocarcinoma (CCA) is a rare and aggressive cancer of the biliary system, accounting for 15% of primary liver cancers. Most CCAs arise spontaneously, with risk factors including primary biliary cirrhosis, liver fluke infection, and biliary malformations. A newly described variant, Inhibin-positive Cholangioblastic (solid-tubulocystic) intrahepatic cholangiocarcinoma (iCCA), mimics neuroendocrine tumors (NET). This report presents a case of this new variant.

Case Presentation

A 53-year-old female with a history of alcohol use disorder and no family history of liver cancer presented with watery diarrhea for a month. Blood tests, including tumor markers, were normal. An ultrasound revealed a large mass in the right hepatic lobe. CT and MRI scans suggested a hemangioma. Due to the mass’s size and spontaneous bleeding risk, she underwent surgical resection. The mass was initially thought to be a hemangioma but was later identified as poorly differentiated intrahepatic CCA with a solid and tubulocystic structure. Pathology showed strong staining for Cytokeratin (CK) 7, CK-19, and Inhibin, and weak staining for synaptophysin, confirming a diagnosis of cholangioblastic iCCA. Genetic testing revealed no actionable variations. She was started on capecitabine for 8 cycles. Follow-up imaging showed no disease recurrence or metastasis.

Discussion

CCA often presents at advanced stages with symptoms like weight loss and jaundice. Diagnosis involves clinical assessment, lab work, and imaging, particularly MRI. Cholangioblastic Intrahepatic CCA (iCCA) is a newly described variant of cholangiocarcinoma. There have been 16 reported cases of the disease. Initially, it was thought to be a NET as it expressed Chromogranin, insulinoma-associated protein-1, and Synaptophysin. Almost half of the reported cases were diagnosed as NET initially. One tool clinicians can use to differentiate them is inhibin. Inhibin has been documented in all of the reported cases of Cholangioblastic iCCA. A novel inhibin-positive cholangioblastic iCCA variant with a Nipped-B-like protein and nucleus accumbens associated-1 (NIPBL-NACC1) fusion transcript has been reported recently, further helping differentiate the two. There is no standard of therapy for this variant. It’s managed similarly to CCAs, relying on surgical resection as the primary treatment. Limited data shows varied responses to neoadjuvant and adjuvant therapy.

Background

Despite the benefit of cancer clinical trials (CTs) in increasing medical knowledge and broadening treatment options, VA oncologists face challenges referring or enrolling Veterans in CTs including identifying appropriate CTs and navigating the referral process especially for non-VA CTs. To address these challenges, the VA National Oncology Program (NOP) provided guidance regarding community care referral for CT participation and established the Cancer Clinical Trial Nurse Navigation (CTN) service.

Methods

Referrals to CTN occur via Precision Oncology consult or email to [email protected]. The CT nurse navigator educates Veterans about CTs, identifies CTs for Veterans based on disease and geographic area, provides written summaries to Veterans and VA oncologists, and facilitates communication between clinical and research teams. Descriptive statistics were used to summarize characteristics of Veterans referred to CTN and results of the CTN searches. A semi-structured survey was used to assess satisfaction from 50 VA oncologists who had used the CTN service.

Results

Between June 2023 and May 2024, 72 Veterans were referred to CTN. Patient characteristics include male (94%), non-rural (65%), median age 66.5 (range 27-80), self-reported race as White (74%) and Black (22%), cancer type as solid tumor (73%) and blood cancer (27%). The median number of CTs found for each Veteran was two (range 0 - 12). No referred Veterans enrolled in CTs, with the most common causes being CT ineligibility and desire to receive standard therapy in the VA. Twenty oncologists were educated about NOP CT guidance. The response rate to the feedback survey was modest (34%) but 94% of survey respondents rated their overall satisfaction as highly satisfied or satisfied.

Conclusions

The CTN assists Veterans and VA oncologists in connecting with CTs. The high satisfaction rate and ability to reach a racially and geographically diverse Veteran population are measures of early program success. By lowering the barriers for VA oncologists to consider CTs for their patients, the CTN expects increased and earlier referrals of Veterans, which may improve CT eligibility and participation. Future efforts to provide disease-directed education about CTs to Veterans and VA oncologists is intended to encourage early consideration of CTs.

Background

Despite the benefit of cancer clinical trials (CTs) in increasing medical knowledge and broadening treatment options, VA oncologists face challenges referring or enrolling Veterans in CTs including identifying appropriate CTs and navigating the referral process especially for non-VA CTs. To address these challenges, the VA National Oncology Program (NOP) provided guidance regarding community care referral for CT participation and established the Cancer Clinical Trial Nurse Navigation (CTN) service.

Methods

Referrals to CTN occur via Precision Oncology consult or email to [email protected]. The CT nurse navigator educates Veterans about CTs, identifies CTs for Veterans based on disease and geographic area, provides written summaries to Veterans and VA oncologists, and facilitates communication between clinical and research teams. Descriptive statistics were used to summarize characteristics of Veterans referred to CTN and results of the CTN searches. A semi-structured survey was used to assess satisfaction from 50 VA oncologists who had used the CTN service.

Results

Between June 2023 and May 2024, 72 Veterans were referred to CTN. Patient characteristics include male (94%), non-rural (65%), median age 66.5 (range 27-80), self-reported race as White (74%) and Black (22%), cancer type as solid tumor (73%) and blood cancer (27%). The median number of CTs found for each Veteran was two (range 0 - 12). No referred Veterans enrolled in CTs, with the most common causes being CT ineligibility and desire to receive standard therapy in the VA. Twenty oncologists were educated about NOP CT guidance. The response rate to the feedback survey was modest (34%) but 94% of survey respondents rated their overall satisfaction as highly satisfied or satisfied.

Conclusions

The CTN assists Veterans and VA oncologists in connecting with CTs. The high satisfaction rate and ability to reach a racially and geographically diverse Veteran population are measures of early program success. By lowering the barriers for VA oncologists to consider CTs for their patients, the CTN expects increased and earlier referrals of Veterans, which may improve CT eligibility and participation. Future efforts to provide disease-directed education about CTs to Veterans and VA oncologists is intended to encourage early consideration of CTs.

Background

Despite the benefit of cancer clinical trials (CTs) in increasing medical knowledge and broadening treatment options, VA oncologists face challenges referring or enrolling Veterans in CTs including identifying appropriate CTs and navigating the referral process especially for non-VA CTs. To address these challenges, the VA National Oncology Program (NOP) provided guidance regarding community care referral for CT participation and established the Cancer Clinical Trial Nurse Navigation (CTN) service.

Methods

Referrals to CTN occur via Precision Oncology consult or email to [email protected]. The CT nurse navigator educates Veterans about CTs, identifies CTs for Veterans based on disease and geographic area, provides written summaries to Veterans and VA oncologists, and facilitates communication between clinical and research teams. Descriptive statistics were used to summarize characteristics of Veterans referred to CTN and results of the CTN searches. A semi-structured survey was used to assess satisfaction from 50 VA oncologists who had used the CTN service.

Results

Between June 2023 and May 2024, 72 Veterans were referred to CTN. Patient characteristics include male (94%), non-rural (65%), median age 66.5 (range 27-80), self-reported race as White (74%) and Black (22%), cancer type as solid tumor (73%) and blood cancer (27%). The median number of CTs found for each Veteran was two (range 0 - 12). No referred Veterans enrolled in CTs, with the most common causes being CT ineligibility and desire to receive standard therapy in the VA. Twenty oncologists were educated about NOP CT guidance. The response rate to the feedback survey was modest (34%) but 94% of survey respondents rated their overall satisfaction as highly satisfied or satisfied.

Conclusions

The CTN assists Veterans and VA oncologists in connecting with CTs. The high satisfaction rate and ability to reach a racially and geographically diverse Veteran population are measures of early program success. By lowering the barriers for VA oncologists to consider CTs for their patients, the CTN expects increased and earlier referrals of Veterans, which may improve CT eligibility and participation. Future efforts to provide disease-directed education about CTs to Veterans and VA oncologists is intended to encourage early consideration of CTs.

Background

Oral anti-cancer therapies have quickly moved to the forefront of cancer treatment for several oncologic disease states. While these treatments have led to improvements in prognosis and ease of administration, many of these agents carry the risk of serious short- and long-term toxicities affecting the cardiovascular system. This prompted the Journal of the American Heart Association (JAHA) to release special guidance focused on cardiovascular monitoring strategies for anti-cancer agents. The primary objective of this retrospective review was to evaluate compliance with cardiovascular monitoring based on JAHA cardio-oncologic guidelines. The secondary objective was to assess disparities in cardiovascular monitoring based on markers of equity such as race/ ethnicity, rurality, socioeconomic status and gender.

Methods

Patients who initiated pazopanib, cabozantinib, lenvatinib, axitinib, regorafenib, nilotinib, ibrutinib, sorafenib, sunitinib, ponatinib or everolimus between January 1, 2019 and December 31, 2022 at a VHA VISN 12 site with oncology services were followed forward until treatment discontinuation or 12 months of therapy had been completed. Data was acquired utilizing the VA Informatics and Computing Infrastructure (VINCI) and the Corporate Data Warehouse (CDW). The following cardiovascular monitoring markers were recorded at baseline and months 3, 6, 9 and 12 after initiation anti-cancer therapy: blood pressure, blood glucose, cholesterol, ECG and echocardiogram. Descriptive statistics were used to examine all continuous variables, while frequencies were used to examine categorical variables. Univariate statistics were performed on all items respectively.

Results

A total of 219 patients were identified initiating pre-specified oral anti-cancer therapies during the study time period. Of these, a total of n=145 met study inclusion criteria. 97% were male (n=141), 80% (n=116) had a racial background of white, 36% (n=52) live in rural or highly rural locations and 23% (n=34) lived in a high poverty area. Based on the primary endpoint, the mean compliance with recommended cardiovascular monitoring was 44.95% [IQR 12]. There was no statistically significant difference in cardiovascular monitoring based on equity.

Conclusions

Overall uptake of cardiovascular monitoring markers recommended by JAHA guidance is low. We plan to evaluate methods to increase these measures, utilizing clinical pharmacy provider support throughout VISN 12.

Background

Oral anti-cancer therapies have quickly moved to the forefront of cancer treatment for several oncologic disease states. While these treatments have led to improvements in prognosis and ease of administration, many of these agents carry the risk of serious short- and long-term toxicities affecting the cardiovascular system. This prompted the Journal of the American Heart Association (JAHA) to release special guidance focused on cardiovascular monitoring strategies for anti-cancer agents. The primary objective of this retrospective review was to evaluate compliance with cardiovascular monitoring based on JAHA cardio-oncologic guidelines. The secondary objective was to assess disparities in cardiovascular monitoring based on markers of equity such as race/ ethnicity, rurality, socioeconomic status and gender.

Methods

Patients who initiated pazopanib, cabozantinib, lenvatinib, axitinib, regorafenib, nilotinib, ibrutinib, sorafenib, sunitinib, ponatinib or everolimus between January 1, 2019 and December 31, 2022 at a VHA VISN 12 site with oncology services were followed forward until treatment discontinuation or 12 months of therapy had been completed. Data was acquired utilizing the VA Informatics and Computing Infrastructure (VINCI) and the Corporate Data Warehouse (CDW). The following cardiovascular monitoring markers were recorded at baseline and months 3, 6, 9 and 12 after initiation anti-cancer therapy: blood pressure, blood glucose, cholesterol, ECG and echocardiogram. Descriptive statistics were used to examine all continuous variables, while frequencies were used to examine categorical variables. Univariate statistics were performed on all items respectively.

Results

A total of 219 patients were identified initiating pre-specified oral anti-cancer therapies during the study time period. Of these, a total of n=145 met study inclusion criteria. 97% were male (n=141), 80% (n=116) had a racial background of white, 36% (n=52) live in rural or highly rural locations and 23% (n=34) lived in a high poverty area. Based on the primary endpoint, the mean compliance with recommended cardiovascular monitoring was 44.95% [IQR 12]. There was no statistically significant difference in cardiovascular monitoring based on equity.

Conclusions

Overall uptake of cardiovascular monitoring markers recommended by JAHA guidance is low. We plan to evaluate methods to increase these measures, utilizing clinical pharmacy provider support throughout VISN 12.

Background

Oral anti-cancer therapies have quickly moved to the forefront of cancer treatment for several oncologic disease states. While these treatments have led to improvements in prognosis and ease of administration, many of these agents carry the risk of serious short- and long-term toxicities affecting the cardiovascular system. This prompted the Journal of the American Heart Association (JAHA) to release special guidance focused on cardiovascular monitoring strategies for anti-cancer agents. The primary objective of this retrospective review was to evaluate compliance with cardiovascular monitoring based on JAHA cardio-oncologic guidelines. The secondary objective was to assess disparities in cardiovascular monitoring based on markers of equity such as race/ ethnicity, rurality, socioeconomic status and gender.

Methods

Patients who initiated pazopanib, cabozantinib, lenvatinib, axitinib, regorafenib, nilotinib, ibrutinib, sorafenib, sunitinib, ponatinib or everolimus between January 1, 2019 and December 31, 2022 at a VHA VISN 12 site with oncology services were followed forward until treatment discontinuation or 12 months of therapy had been completed. Data was acquired utilizing the VA Informatics and Computing Infrastructure (VINCI) and the Corporate Data Warehouse (CDW). The following cardiovascular monitoring markers were recorded at baseline and months 3, 6, 9 and 12 after initiation anti-cancer therapy: blood pressure, blood glucose, cholesterol, ECG and echocardiogram. Descriptive statistics were used to examine all continuous variables, while frequencies were used to examine categorical variables. Univariate statistics were performed on all items respectively.

Results

A total of 219 patients were identified initiating pre-specified oral anti-cancer therapies during the study time period. Of these, a total of n=145 met study inclusion criteria. 97% were male (n=141), 80% (n=116) had a racial background of white, 36% (n=52) live in rural or highly rural locations and 23% (n=34) lived in a high poverty area. Based on the primary endpoint, the mean compliance with recommended cardiovascular monitoring was 44.95% [IQR 12]. There was no statistically significant difference in cardiovascular monitoring based on equity.

Conclusions

Overall uptake of cardiovascular monitoring markers recommended by JAHA guidance is low. We plan to evaluate methods to increase these measures, utilizing clinical pharmacy provider support throughout VISN 12.