Cushing M

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: To determine which sequence of abiraterone (ABI) and enzalutamide (ENZA) shows better survival outcomes in Veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC) at VA San Diego.

Background: Prostate cancer is the leading cancer diagnosis among American men who eventually develop mCRPC. Therapies for mCRPC include androgen receptor pathway inhibitors like ABI and ENZA. Both improve survival independently; however, the optimal treatment sequence has not been determined. Retrospective studies have shown that the ABI-ENZA sequence significantly improves progression-free survival (PFS) and combined prostate-specific antigen PFS (cPSA-PFS), but not overall survival (OS).

Methods: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA sequentially in either order. Subjects must have received at least one month of each drug; those who had an interruption of treatment sequence were excluded. The primary outcomes were to compare cPSA-PFS and OS between the two sequences; cPSA-PFS represented time from start of drug 1 to > 25% PSA increase from baseline/nadir on drug 2, while OS represented time from start of drug 1 to death from any cause. OS and cPSA-PFS were reported via Kaplan-
Meier curves and hazard ratios (HR). Ninety-eight subjects per group were needed to reach 80% power for an effect size of 0.404 in cPSA-PFS.

Results: Forty subjects were identified and 8 were excluded; of the remaining, 9 received ENZA-ABI and 23 received ABIENZA. Baseline characteristics were similar. There were no differences in cPSA-PFS between ENZA-ABI and ABI-ENZA: median 406 days versus 534 days (HR 1.39, 95% CI 0.59-1.53, P = .59), respectively. OS did not differ between ENZAABI and ABI-ENZA: median 711 days versus 803 days (HR 0.88, 95% CI 0.35-1.59, P = .21), respectively.

Conclusions: There were no significant differences in outcomes between sequences although ABI-ENZA showed longer cPSA-PFS and OS. This is consistent with previous studies where ABI-ENZA had significantly longer PFS and cPSA-PFS; ABI-ENZA OS was longer but not significantly different in those studies. Limitations included a small sample size and uneven groups. Ultimately, ABI-ENZA should be considered as the sequence-of-choice for treatment of mCRPC until prospective studies confirm the optimal sequence.

Purpose: To determine which sequence of abiraterone (ABI) and enzalutamide (ENZA) shows better survival outcomes in Veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC) at VA San Diego.

Background: Prostate cancer is the leading cancer diagnosis among American men who eventually develop mCRPC. Therapies for mCRPC include androgen receptor pathway inhibitors like ABI and ENZA. Both improve survival independently; however, the optimal treatment sequence has not been determined. Retrospective studies have shown that the ABI-ENZA sequence significantly improves progression-free survival (PFS) and combined prostate-specific antigen PFS (cPSA-PFS), but not overall survival (OS).

Methods: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA sequentially in either order. Subjects must have received at least one month of each drug; those who had an interruption of treatment sequence were excluded. The primary outcomes were to compare cPSA-PFS and OS between the two sequences; cPSA-PFS represented time from start of drug 1 to > 25% PSA increase from baseline/nadir on drug 2, while OS represented time from start of drug 1 to death from any cause. OS and cPSA-PFS were reported via Kaplan-
Meier curves and hazard ratios (HR). Ninety-eight subjects per group were needed to reach 80% power for an effect size of 0.404 in cPSA-PFS.

Results: Forty subjects were identified and 8 were excluded; of the remaining, 9 received ENZA-ABI and 23 received ABIENZA. Baseline characteristics were similar. There were no differences in cPSA-PFS between ENZA-ABI and ABI-ENZA: median 406 days versus 534 days (HR 1.39, 95% CI 0.59-1.53, P = .59), respectively. OS did not differ between ENZAABI and ABI-ENZA: median 711 days versus 803 days (HR 0.88, 95% CI 0.35-1.59, P = .21), respectively.

Conclusions: There were no significant differences in outcomes between sequences although ABI-ENZA showed longer cPSA-PFS and OS. This is consistent with previous studies where ABI-ENZA had significantly longer PFS and cPSA-PFS; ABI-ENZA OS was longer but not significantly different in those studies. Limitations included a small sample size and uneven groups. Ultimately, ABI-ENZA should be considered as the sequence-of-choice for treatment of mCRPC until prospective studies confirm the optimal sequence.

Purpose: To determine which sequence of abiraterone (ABI) and enzalutamide (ENZA) shows better survival outcomes in Veterans diagnosed with metastatic castration-resistant prostate cancer (mCRPC) at VA San Diego.

Background: Prostate cancer is the leading cancer diagnosis among American men who eventually develop mCRPC. Therapies for mCRPC include androgen receptor pathway inhibitors like ABI and ENZA. Both improve survival independently; however, the optimal treatment sequence has not been determined. Retrospective studies have shown that the ABI-ENZA sequence significantly improves progression-free survival (PFS) and combined prostate-specific antigen PFS (cPSA-PFS), but not overall survival (OS).

Methods: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA sequentially in either order. Subjects must have received at least one month of each drug; those who had an interruption of treatment sequence were excluded. The primary outcomes were to compare cPSA-PFS and OS between the two sequences; cPSA-PFS represented time from start of drug 1 to > 25% PSA increase from baseline/nadir on drug 2, while OS represented time from start of drug 1 to death from any cause. OS and cPSA-PFS were reported via Kaplan-
Meier curves and hazard ratios (HR). Ninety-eight subjects per group were needed to reach 80% power for an effect size of 0.404 in cPSA-PFS.

Results: Forty subjects were identified and 8 were excluded; of the remaining, 9 received ENZA-ABI and 23 received ABIENZA. Baseline characteristics were similar. There were no differences in cPSA-PFS between ENZA-ABI and ABI-ENZA: median 406 days versus 534 days (HR 1.39, 95% CI 0.59-1.53, P = .59), respectively. OS did not differ between ENZAABI and ABI-ENZA: median 711 days versus 803 days (HR 0.88, 95% CI 0.35-1.59, P = .21), respectively.

Conclusions: There were no significant differences in outcomes between sequences although ABI-ENZA showed longer cPSA-PFS and OS. This is consistent with previous studies where ABI-ENZA had significantly longer PFS and cPSA-PFS; ABI-ENZA OS was longer but not significantly different in those studies. Limitations included a small sample size and uneven groups. Ultimately, ABI-ENZA should be considered as the sequence-of-choice for treatment of mCRPC until prospective studies confirm the optimal sequence.

Purpose: To determine the efficacy and toxicity of fluorouracil/leucovorin/oxaliplatin (FOLFOX) vs capecitabine/oxaliplatin (XELOX or CAPOX) in the treatment of colorectal cancer (CRC) in both the adjuvant (aCRC) and metastatic (mCRC) setting in Veterans at the Southern Arizona Veteran Affairs Health Care System (SAVAHCS).

Methods: A retrospective chart review was conducted to collect efficacy and toxicity data. Subjects were included based on age, treatment setting, and regimen in the preset 5-year period, and appropriate diagnosis via International Classification of Diseases-Revision 9 (ICD-9) codes. Efficacy was measured via 1-year disease-free survival (DFS) for aCRC, progression-free survival (PFS) for mCRC, and overall survival (OS) for both settings.

Results: A total of 79 subjects were initially evaluatedwith 51 and 54 all-male subjects included in the efficacy and toxicity analysis, respectively. Mean range of age was 63-72 years old. Subjects were divided into four groups: FOLFOX aCRC (N = 17) and mCRC (N = 19), XELOX aCRC (N = 10) and mCRC (N = 8). No difference was found in 1-year DFS and OS between aCRC treatment groups, and PFS between mCRC groups. A higher incidence of 1-year OS with FOLFOX in the mCRC setting was noted (P = .03). No difference was found in the incidence of most of the toxicities between FOLFOX and XELOX, except a higher incidence of hand-foot syndrome was seen in XELOX (P = .0007) treated patients.

Conclusions: In this patient population, the efficacy between FOLFOX and XELOX in aCRC and mCRC was similar, while toxicity was slightly more prevalent with XELOX treatment due to increased hand-foot syndrome incidence. These findings are consistent with the results reported by previous larger prospective clinical trials.

Purpose: To determine the efficacy and toxicity of fluorouracil/leucovorin/oxaliplatin (FOLFOX) vs capecitabine/oxaliplatin (XELOX or CAPOX) in the treatment of colorectal cancer (CRC) in both the adjuvant (aCRC) and metastatic (mCRC) setting in Veterans at the Southern Arizona Veteran Affairs Health Care System (SAVAHCS).

Methods: A retrospective chart review was conducted to collect efficacy and toxicity data. Subjects were included based on age, treatment setting, and regimen in the preset 5-year period, and appropriate diagnosis via International Classification of Diseases-Revision 9 (ICD-9) codes. Efficacy was measured via 1-year disease-free survival (DFS) for aCRC, progression-free survival (PFS) for mCRC, and overall survival (OS) for both settings.

Results: A total of 79 subjects were initially evaluatedwith 51 and 54 all-male subjects included in the efficacy and toxicity analysis, respectively. Mean range of age was 63-72 years old. Subjects were divided into four groups: FOLFOX aCRC (N = 17) and mCRC (N = 19), XELOX aCRC (N = 10) and mCRC (N = 8). No difference was found in 1-year DFS and OS between aCRC treatment groups, and PFS between mCRC groups. A higher incidence of 1-year OS with FOLFOX in the mCRC setting was noted (P = .03). No difference was found in the incidence of most of the toxicities between FOLFOX and XELOX, except a higher incidence of hand-foot syndrome was seen in XELOX (P = .0007) treated patients.

Conclusions: In this patient population, the efficacy between FOLFOX and XELOX in aCRC and mCRC was similar, while toxicity was slightly more prevalent with XELOX treatment due to increased hand-foot syndrome incidence. These findings are consistent with the results reported by previous larger prospective clinical trials.

Purpose: To determine the efficacy and toxicity of fluorouracil/leucovorin/oxaliplatin (FOLFOX) vs capecitabine/oxaliplatin (XELOX or CAPOX) in the treatment of colorectal cancer (CRC) in both the adjuvant (aCRC) and metastatic (mCRC) setting in Veterans at the Southern Arizona Veteran Affairs Health Care System (SAVAHCS).

Methods: A retrospective chart review was conducted to collect efficacy and toxicity data. Subjects were included based on age, treatment setting, and regimen in the preset 5-year period, and appropriate diagnosis via International Classification of Diseases-Revision 9 (ICD-9) codes. Efficacy was measured via 1-year disease-free survival (DFS) for aCRC, progression-free survival (PFS) for mCRC, and overall survival (OS) for both settings.

Results: A total of 79 subjects were initially evaluatedwith 51 and 54 all-male subjects included in the efficacy and toxicity analysis, respectively. Mean range of age was 63-72 years old. Subjects were divided into four groups: FOLFOX aCRC (N = 17) and mCRC (N = 19), XELOX aCRC (N = 10) and mCRC (N = 8). No difference was found in 1-year DFS and OS between aCRC treatment groups, and PFS between mCRC groups. A higher incidence of 1-year OS with FOLFOX in the mCRC setting was noted (P = .03). No difference was found in the incidence of most of the toxicities between FOLFOX and XELOX, except a higher incidence of hand-foot syndrome was seen in XELOX (P = .0007) treated patients.

Conclusions: In this patient population, the efficacy between FOLFOX and XELOX in aCRC and mCRC was similar, while toxicity was slightly more prevalent with XELOX treatment due to increased hand-foot syndrome incidence. These findings are consistent with the results reported by previous larger prospective clinical trials.