This cohort study uses national surveillance data to describe the incidence and risk of squamous cell carcinoma after postmastectomy implant reconstruction in women with breast cancer.
Previous comparative effectiveness studies have not demonstrated a benefit of proton beam therapy (PBT) compared with intensity-modulated radiation therapy (IMRT) for prostate cancer. An updated ...comparison of GI and genitourinary (GU) toxicity is needed.
We investigated the SEER-Medicare linked database, identifying patients with localized prostate cancer diagnosed from 2010 to 2017. Procedure and diagnosis codes indicative of treatment-related toxicity were identified. As a sensitivity analysis, we also identified toxicity based only on procedure codes. Patients who underwent IMRT and PBT were matched 2:1 on the basis of clinical and sociodemographic characteristics. We then compared GI and GU toxicity at 6, 12, and 24 months after treatment.
The final sample included 772 PBT patients matched to 1,544 IMRT patients. The frequency of GI toxicity for IMRT versus PBT was 3.5% versus 2.5% at 6 months (
= .18), 9.5% versus 10.2% at 12 months (
= .18), and 20.5% versus 23.4% at 24 months (
= .11). The frequency of only procedure codes indicative of GI toxicity for IMRT versus PBT was too low to be reported and not significantly different. The frequency of GU toxicity for IMRT versus PBT was 6.8% versus 5.7% (
= .30), 14.3% versus 12.2% (
= .13), and 28.2% versus 25.8% (
= .21) at 6, 12, and 24 months, respectively. When looking only at procedure codes, the frequency of GU toxicity for IMRT was 1.0% at 6 months, whereas it was too infrequent to report for PBT (
= .64). GU toxicity for IMRT versus PBT was 3.3% versus 2.1% (
= .10), and 8.7% versus 6.7% (
= .10) at 12 and 24 months, respectively.
In this observational study, there were no statistically significant differences between PBT and IMRT in terms of GI or GU toxicity.
The COVID-19 pandemic caused widespread disruptions in cancer care. We hypothesized that the greatest disruptions in diagnosis occurred in screen-detected cancers. We identified patients (≥18 years ...of age) with newly diagnosed cancer from 2019 to 2020 in the US National Cancer Database and calculated the change in proportion of early-stage to late-stage cancers using a weighted linear regression. Disruptions in early-stage diagnosis were greater than in late-stage diagnosis (17% vs 12.5%). Melanoma demonstrated the greatest relative decrease in early-stage vs late-stage diagnosis (22.9% vs 9.2%), whereas the decrease was similar for pancreatic cancer. Compared with breast cancer, cervical, melanoma, prostate, colorectal, and lung cancers showed the greatest disruptions in early-stage diagnosis. Uninsured patients experienced greater disruptions than privately insured patients. Disruptions in cancer diagnosis in 2020 had a larger impact on early-stage disease, particularly screen-detected cancers. Our study supports emerging evidence that primary care visits may play a critical role in early melanoma detection.
This cohort study examines the risk of anaplastic large cell lymphoma (ALCL) following postmastectomy implant reconstruction among US women with breast cancer and ductal carcinoma in situ (DCIS).
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Background: Medicare Advantage accounts for almost 40% of Medicare beneficiaries in 2021. There is limited research evaluating utilization and cost for Medicare Advantage patients ...with metastatic pancreatic cancer (m-PANC) receiving various NCCN Category 1 preferred regimens. Methods: We used ICD-10 diagnosis codes to identify patients with m-PANC without end-stage renal disease in the 2016-2019 Milliman Consolidated Health Cost Guidelines Sources Database (CHSD) claims files. Study patients had 2+ claims with a pancreatic cancer diagnosis and Medicare Advantage coverage for 3 months pre- and 1 month post-metastasis diagnosis. Patients with stand-alone Part D plan coverage or aged<65 years were excluded. Total cost of care (TCOC) was the sum of the average paid by the insurer and patient. Study patients were treated with NCCN Category 1 preferred regimens: 1L gemcitabine/nab-paclitaxel (gem/nab), 1L gemcitabine monotherapy (gem mono), 1L FOLFIRINOX (FFX), and 2L+ liposomal irinotecan (5FU was not included in this analysis; see Limitations for further details). Results: Of the approximately 2.5 million patients covered by Medicare Advantage in CHSD, there were 946 patients that received an NCCN Category 1 chemotherapy regimen between 2016 and 2019. Among NCCN Category 1 preferred regimens, patients receiving 2L+ liposomal irinotecan had the lowest mean admissions per beneficiary and mean readmission rate (0.5 and 8%) compared to patients receiving gem/nab (0.8 and 12%), gem mono (0.6 and 8%), or FFX (0.6 and 9%). Patients receiving 2L+ liposomal irinotecan also had the shortest length of stay per inpatient admission in days (2.9) compared to patients receiving gem/nab (5.1), gem mono (3.6), or FFX (4.3). Mean claims per beneficiary for emergency department observations was lowest among patients receiving 2L+ liposomal irinotecan (0.7), compared to patients receiving gem/nab (0.9), gem mono (1.0), or FFX (0.89). Patients receiving 2L+ liposomal irinotecan had lower median TCOC ($31,885) than patients receiving gem/nab ($39,479) or FFX ($32,632). Conclusions: Patients with Medicare Advantage receiving 2L+ liposomal irinotecan-based regimens to treat m-PANC had lower healthcare resource utilization in key categories and lower median total costs than patients receiving other NCCN Category 1 preferred regimens. Limitations: Analysis of different populations or time periods may yield different results. Our study used claims data and not electronic health records (EHRs), so we could not control for clinical covariates. Patient characteristics and regimen performance might influence which regimens patients receive. We did not adjust TCOC or utilization for LOT durations. We did not study whether liposomal irinotecan-based therapy patients received concomitant 5FU or prior gemcitabine-based therapy.
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Background: There is limited research evaluating the share of patients (pts) with metastatic pancreatic cancer (m-PANC) treated according to NCCN guidelines. Methods: We identified ...pts with m-PANC using ICD-10 diagnosis codes in the 2016-2019 Medicare Parts A/B/D 100% Research Identifiable Files. Study pts had 2+ claims with a pancreatic cancer diagnosis and Medicare FFS coverage for 6 months pre- and 3 months post-metastatic disease diagnosis. A line of therapy (LOT) was assigned based on the order and number of therapies used. Pts with one, two, or three LOTs were defined as treated according to NCCN Category 1 guidelines if, in each LOT, pts used one of the following regimens: FOLFIRINOX (FFX), gemcitabine/nab-paclitaxel (gem/nab), gemcitabine + erlotinib, gemcitabine monotherapy, or 5-FU + leucovorin + liposomal irinotecan. Multi-drug LOTs were excluded from the analysis. Results: We identified 31,782 pts with m-PANC. 21,304 received one LOT, 7,352 received two LOTs, and 3,126 received three LOTs between 2016 and 2019. Among pts who received one or two LOTs, a higher portion were treated according to NCCN Category 1 guidelines in 2019 (72% and 43%, respectively) than in 2016 (64% and 33%, respectively). Among pts who received three LOTs, a higher portion were treated according to NCCN Category 1 guidelines in 2019 (17%) than in 2017 (12%); too few pts were treated in 2016 to make a comparison. From 2016 to 2019, FFX had the largest increase in share of pts receiving only one NCCN Category 1 LOT (11% to 27%) and gem-mono had the largest decrease (30% to 17%). Among pts receiving two NCCN Category 1 LOTs, gem/nab to liposomal irinotecan sequences had the largest increase in share of pts (18% to 32%) and gem/nab to FFX had the largest decrease (17% to 10%). Among pts receiving three NCCN Category 1 LOTs, patient share for FFX to gem/nab to Liposomal irinotecan was 35% in 2019, while gem/nab to FFX to Liposomal was 8%; pt counts in earlier years were too small to calculate patient share. Conclusions: The use of NCCN Category 1 therapies increased consistently from 2016 to 2019 among pts that received one, two, and three lines of therapy. FFX drove increases in NCCN Category 1 utilization among patients receiving one line of therapy, and gem/nab to liposomal irinotecan sequences were the primary drivers of the increase among patients receiving two lines of therapy. FFX to gem/nab to liposomal irinotecan was the primary driver of increase among patients receiving three lines of therapy.
Background Peripheral T-cell Lymphoma (PTCL) affects a diverse cohort of patients for which survival disparities are evident in minorities. Clinical trial enrollment does not match the demographic ...diversity represented in PTCL and minorities are historically underrepresented. In this single-center retrospective analysis, we aim to answer if clinical trial enrollment can close the gap in survival outcomes in minorities compared to non-minorities in the modern era. Methods After IRB approval, 225 patients with PTCL were identified between 1991-2022, of which 199 had sufficient data for review. Medical records were reviewed for baseline characteristics, treatment parameters, and demographic data. Income quintile was calculated for the cohort using zip code level census data. The social deprivation index ( SDI) was calculated as a composite measure of demographic characteristics in the 2015-2019 American Community Survey. Overall survival ( OS) was calculated from diagnosis to time of death or last follow-up. Kaplan-Meier method was used to estimate survival probability. Survival difference was tested by log-rank and Cox regression complete case analysis. Due to the small sample size, Black and Hispanic patients were combined ( minority) and White with Asian/unknown/other ( non-minority) to delineate differences between groups. The OS was compared across four groups: ( 1) minority with first-line clinical trial, ( 2) minority without first-line clinical trial, ( 3) non-minority with first-line clinical trial, and ( 4) and non-minority without first-line clinical trial. Results From the initial cohort of 199 patients, 118 (59%) had relapsed/refractory (R/R) disease. The median age of diagnosis was 58 years. A total of 48.2% of patients were White (n=96), 22.1% Black (n=44), 18.5% Hispanic (n=37), and 11.1% Asian/other/unknown (n=22). The major PTCL subtypes included AITL 24% (n=48), ALCL 19% (n=38), PTCL_NOS 17% (n=33), and ATLL 15% (n=29). Importantly, 55% (n=24) of the black patient population had ATLL. Baseline characteristics are shown in Table 1. In total, 27% (n=53) were exposed to a novel agent in the first-line, and 64% (n=76) in second-line. Clinical trial enrollment accounted for 21% (n=42) first-line, and 34% (n=40) second-line. Black and Hispanic patients were more likely to be in the lower income quintile, 30% and 38%, respectively. The SDI score (0-100; higher score indicates more deprivation) was higher for Black (88), and Hispanic (95) patients compared to White (42) and Asian/other/unknown (63). However, SDI score was not associated with survival in cox models. In the first-line setting, there was a survival difference for both minorities and non-minorities enrolled in a clinical trial compared to those who were not ( Figure 1, p=0.0045), but there was no difference for novel agents (p=0.18).Given the aggressive nature of ATLL and differences in baseline covariates, a cox model was used to compare the four groups and OS was analyzed controlling for age, sex, insurance, stage, ECOG, and ATLL. Minorities performed similarly to non-minorities when participating in a clinical trial ( HR: 1.19 95% CI: 0.32, 4.4), while minorities and non-minorities not enrolled on a clinical trial performed worse overall ( HR: 1.97, 95% CI: 0.77, 5.0, and HR: 1.49, 95% CI: 0.64, 3.4, respectively). In the second-line setting, both minorities and non-minorities appeared to experience OS benefit favoring clinical trials compared to those without (p=0.026). Conclusion Black and Hispanic patients have inferior outcomes compared to Whites across most subtypes of PTCL in data published by Adams et al. over a decade ago. Our data represents a trend toward similar outcomes in minoritized compared to non-minoritized patients with clinical trial enrollment in the first-line and second-line settings. Clinical trial enrollment may close the gap in survival outcomes; however interpretation is limited by small sample size. Multi-center efforts are needed to better elucidate these findings. It is imperative to place emphasis on improved clinical trial enrollment in diverse patient populations. *This work has been funded by ASH RTAF
6597
Background: Advances in breast cancer treatment have led to improvements in survival among patients with metastatic breast cancer (MBC). Nevertheless, Black patients and patients with lower ...socioeconomic status (SES) continue to bear a disproportionate mortality burden. Furthermore, because landmark trials for novel anticancer agents lacked racial diversity, their toxicity profile for minority patients remains uncertain. Our study examines the impact of race and other sociodemographic characteristics in the use and toxicity outcomes of PI3K and mTOR inhibitors (PI3K/mTORi). Methods: We conducted a retrospective analysis of EHR-derived data from the Flatiron Health Database (FHD). A dataset was constructed to include patients with hormone receptor-positive, HER2-negative MBC diagnosed between 1/1/2011 and 1/31/2022. Outcomes included PI3K/mTORi use, rates of hyperglycemia and dose reduction, and time on treatment. Multivariable logistic regression was used to evaluate factors associated with use and outcomes. Results: A total of 13,388 patients with MBC were included in our analysis, of which 2,620 (19.6%) received PI3K/mTORi (78.3% everolimus, 14.7% alpelisib, 6.9% both agents). Overall, 67.5% of all patients were categorized as White, 9.8% as Black/African-American (Black/AA); 18.9% were >75 years old; 10.1% were treated at an academic site; 4.0% had Medicaid insurance. Insurance through Medicaid was associated with lower use of PI3K/mTORi compared to commercial insurance (15.6% vs 18.8%; OR: 0.76, 95% CI: 0.59-0.99, p=0.04), as was advanced age (10.9% for >75 years old vs 22.9% for <60 years old; OR: 0.68, 95% CI: 0.58-0.80, p<0.001) and poorer performance status at diagnosis (15.1% for ECOG ≥2+ vs 22.9% for ECOG 0; OR: 0.84, CI: 0.72-0.98, p=0.03). Odds of PI3K/mTORi use were almost 50% higher for patients treated at an academic center (OR: 1.46, CI: 1.06-2.05, p=0.02). While Black/AA patient had lower rates of use than White patients (17.4% vs 20.1%), they had similar odds of receiving PI3K/mTORi on multivariable analysis (OR: 1.00, CI: 0.85-1.17, p>0.9). Black/AA patients experienced higher rates of hyperglycemia on PI3K/mTORi than White patients (67.6% vs 52.5%). On multivariable analysis, odds of hyperglycemia were twice as high for Black/AA patients (OR: 2.1, CI: 1.33-3.35, p<0.01). However, rates of dose reductions and time on PI3K/mTORi therapy did not differ significantly among White vs Black/AA patients. Conclusions: This analysis of real-world data suggests that lower SES is associated with decreased PI3K/mTORi use. Efforts to improve access to these life-prolonging agents are warranted. Of concern, we also found racial disparities in toxicity outcomes, with Black patients having twice the risk of hyperglycemia. Greater attention to the tolerability of novel agents in diverse populations is warranted.
