Datta P

Background: Prostate cancer is the most common cancer in men in the United States. Death in prostate cancer patients is often reported to be non-prostate cancer related, attributed to other medical conditions, cardiovascular disease, or malignancies. As prostate cancer is associated with a prolonged survival, especially in those with low burden of disease, care of these patients includes not only treating their malignancy, but also optimizing their other co-morbidities, such as cardiovascular disease. Statins are lipid-lowering medications, proven to reduce mortality in cardiovascular disease. There are multiple reports and epidemiological studies of statins decreasing the risk, progression, and overall mortality of prostate cancer. Methods: This is a retrospective observational study with chart review of 300 patients diagnosed with prostate cancer from 1995 to 2010, in a VA Hospital in San Antonio, Texas. Variables included age of diagnosis, statin use, type of statin (1st, 2nd, or 3rd generation), dose of statin (6 levels of dosage were identified), length of statin use, time followed in months (from time of diagnosis to either death or the end of the study period), death, and cause of death. The Cox proportional hazards regression model was used to estimate the hazard function, with age at diagnosis used as a covariate. Primary end point was death by prostate cancer (21 patients) and secondary end points- death by any cancer (52 patients patients), and death by all causes (136 patients). Results: The hazard ratio for use of statins at least 6 months was 0.33, with 95% confidence limits of 0.13 to 0.83, and P = 0.018, indicating that using statins has a statistically significant positive effect at delaying death by prostate cancer. Secondary endpoints of death by any cancer and death by all causes were also significantly affected by the statins. The study was unable to conclude if the type of statin, dose of statin or the length of statin use had a significant effect in reaching the different end points.

Conclusion: Concomitant statin use may prevent death from prostate cancer, death from any cancer, as well as death from all causes.

Background: Prostate cancer is the most common cancer in men in the United States. Death in prostate cancer patients is often reported to be non-prostate cancer related, attributed to other medical conditions, cardiovascular disease, or malignancies. As prostate cancer is associated with a prolonged survival, especially in those with low burden of disease, care of these patients includes not only treating their malignancy, but also optimizing their other co-morbidities, such as cardiovascular disease. Statins are lipid-lowering medications, proven to reduce mortality in cardiovascular disease. There are multiple reports and epidemiological studies of statins decreasing the risk, progression, and overall mortality of prostate cancer. Methods: This is a retrospective observational study with chart review of 300 patients diagnosed with prostate cancer from 1995 to 2010, in a VA Hospital in San Antonio, Texas. Variables included age of diagnosis, statin use, type of statin (1st, 2nd, or 3rd generation), dose of statin (6 levels of dosage were identified), length of statin use, time followed in months (from time of diagnosis to either death or the end of the study period), death, and cause of death. The Cox proportional hazards regression model was used to estimate the hazard function, with age at diagnosis used as a covariate. Primary end point was death by prostate cancer (21 patients) and secondary end points- death by any cancer (52 patients patients), and death by all causes (136 patients). Results: The hazard ratio for use of statins at least 6 months was 0.33, with 95% confidence limits of 0.13 to 0.83, and P = 0.018, indicating that using statins has a statistically significant positive effect at delaying death by prostate cancer. Secondary endpoints of death by any cancer and death by all causes were also significantly affected by the statins. The study was unable to conclude if the type of statin, dose of statin or the length of statin use had a significant effect in reaching the different end points.

Conclusion: Concomitant statin use may prevent death from prostate cancer, death from any cancer, as well as death from all causes.

Background: Prostate cancer is the most common cancer in men in the United States. Death in prostate cancer patients is often reported to be non-prostate cancer related, attributed to other medical conditions, cardiovascular disease, or malignancies. As prostate cancer is associated with a prolonged survival, especially in those with low burden of disease, care of these patients includes not only treating their malignancy, but also optimizing their other co-morbidities, such as cardiovascular disease. Statins are lipid-lowering medications, proven to reduce mortality in cardiovascular disease. There are multiple reports and epidemiological studies of statins decreasing the risk, progression, and overall mortality of prostate cancer. Methods: This is a retrospective observational study with chart review of 300 patients diagnosed with prostate cancer from 1995 to 2010, in a VA Hospital in San Antonio, Texas. Variables included age of diagnosis, statin use, type of statin (1st, 2nd, or 3rd generation), dose of statin (6 levels of dosage were identified), length of statin use, time followed in months (from time of diagnosis to either death or the end of the study period), death, and cause of death. The Cox proportional hazards regression model was used to estimate the hazard function, with age at diagnosis used as a covariate. Primary end point was death by prostate cancer (21 patients) and secondary end points- death by any cancer (52 patients patients), and death by all causes (136 patients). Results: The hazard ratio for use of statins at least 6 months was 0.33, with 95% confidence limits of 0.13 to 0.83, and P = 0.018, indicating that using statins has a statistically significant positive effect at delaying death by prostate cancer. Secondary endpoints of death by any cancer and death by all causes were also significantly affected by the statins. The study was unable to conclude if the type of statin, dose of statin or the length of statin use had a significant effect in reaching the different end points.

Conclusion: Concomitant statin use may prevent death from prostate cancer, death from any cancer, as well as death from all causes.

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.

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.