Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E.) Registry: Analysis of outcomes and costs of epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment in cancer patients

16009 Background: NCCN anemia treatment guidelines recommend hemoglobin (Hb) levels be maintained between 11 and12 g/dL. To understand erythropoiesis-stimulating therapy (EST) dosing, outcomes and costs in cancer patients, data were analyzed from an ongoing prospective, observational registry (D.O.S.E. Registry) collecting real-world data on cancer patients treated for anemia in U.S. oncology clinics. Methods: Data were collected from participating hospital- and community-based outpatient oncology practices between 1/2004 and 11/2005. This analysis included adult patients who had received ≥2 doses of either EPO or DARB. Outcomes assessed included Hb values at weeks 4, 8, 12, and 16 following EST initiation. Drug cost was based on EST utilization and 2005 wholesale acquisition cost. Results: 652 patients (235 EPO, 417 DARB) from 32 sites were identified. Baseline characteristics of age, gender, Hb, tumor type and ferritin level were similar between treatment groups. The proportion of patients with iron supplementation at baseline was significantly higher in the DARB-treated group (EPO 18% v. DARB 31%, p < 0.001). EPO-treated patients were maintained between 11 and 12 g/dL throughout the therapeutic duration ( Table ). Mean cumulative administered dose of EPO was 393,047 Units and DARB 1205 mcg, corresponding to an overall drug cost of $4,783 for EPO and $5253 for DARB (p = 0.001). Conclusions: These results demonstrate that EPO-treated patients maintained target Hb levels consistent with NCCN guidelines, which was not observed in the DARB-treated patients. Drug cost was significantly higher in the DARB group compared to the EPO group without considering the costs of iron supplementation. [Table: see text] [Table: see text]

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Identification and management of pathogenic mutations in BRCA1, BRCA2, and PALB2 in a tumor-only genomic testing program.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.10528 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 10528-10528

Author(s):

Brittany L. Bychkovsky ◽

Tianyu Li ◽

Jilliane Sotelo ◽

Nabihah Tayob ◽

Joanna Mercado ◽

...

Keyword(s):

Cancer Patients ◽

Familial Cancer ◽

Clinical Indication ◽

Genomic Testing ◽

Tumor Type ◽

Nccn Guidelines ◽

Somatic Alterations ◽

Prostate Cancers ◽

Brca1 Brca2 ◽

Germline Testing

10528 Background: Tumor-genomic testing is increasingly used to guide treatment decisions in cancer patients. Although tumor-only testing cannot definitively distinguish between germline versus somatic alterations, the identification of pathogenic or likely pathogenic (P/LP) variants in certain genes should prompt consideration of germline testing. Germline P/LPs in BRCA1, BRCA2 and PALB2 ( B1B2PAL) are associated with hereditary cancer syndromes. Methods: We reviewed tumor-only genomic data (Dana-Farber Oncopanel) between 10/2016 and 6/2018 to examine the prevalence of P/LPs in BRCA1, BRCA2, PALB2 among adult cancer patients at Dana-Farber Cancer Institute/Brigham and Women’s Hospital. We characterized the frequency of P/LPs by primary tumor type, confirmation by germline testing before or within 12 months after Oncopanel testing or not, and factors associated with germline testing. Results: Among 7,575 patients, the median age was 62 (range 18-99); 53.9% were female. A total of 272 (3.6%) had P/LPs in BRCA1 (n = 90), BRCA2 (n = 162) and/or PALB2 (n = 29). P/LPs in B1B2PAL were detected in 5.3% (38/712) of breast, 11.9% (34/285) of ovarian, 6.6% (18/272) of pancreatic, and 5.1% (12/234) of prostate cancers. P/LPs in B1B2PAL were also detected in other neoplasms (12.9% (8/62) of non-melanoma skin, 5.0% (43/855) of colorectal, 7.6% (20/264) of endometrial, and 4.6% (10/216) of head and neck cancers). Of 169 patients who had not had prior germline testing, 29/169 (17.2%) completed germline testing within 12 months after Oncopanel; 13 (7.7%) referred for testing declined or did not complete testing within 12 months, 14 (8.3%) died before or within 3 months of the Oncopanel results, and 113 (66.9%) had no documented germline testing within 12 months. Among 132 patients who had germline testing, 117 (88.6%) had a clinical indication based on personal or family history compared to 66/140 (47.1%) who did not undergo germline testing. Among 132/272 (48.5%) germline-tested patients, 70.5% were positive for a germline mutation in B1B2PAL; the remainder had somatic B1B2PAL mutations only. Germline testing was more often performed in patients with B1B2PAL-associated tumors (breast, ovarian, pancreatic and prostate cancers) or other clinical indications for germline testing. Conclusions: A low but clinically meaningful rate of P/LPs in BRCA1, BRCA2 and PALB2 was detected by tumor-only genomic testing in diverse malignancies. Given the implications of B1B2PAL alterations on treatment and familial cancer risk, our data support current NCCN guidelines recommending germline testing among patients with cancer and P/LPs in B1B2PAL detected on tumor-genomic testing and highlights the need for systems to ensure germline testing when indicated.

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Drug Utilization Patterns and Cost Considerations for Erythropoiesis Stimulating Agents in Cancer Chemotherapy Patients in a Managed Care Setting.

Blood ◽

10.1182/blood.v110.11.5157.5157 ◽

2007 ◽

Vol 110 (11) ◽

pp. 5157-5157

Author(s):

Alyson Mandel ◽

Richard Weininger ◽

Scott R. McKenzie ◽

Brahim K. Bookhart ◽

Catherine T. Piech

Keyword(s):

Cancer Patients ◽

Cancer Chemotherapy ◽

Drug Cost ◽

Cumulative Dose ◽

Real World ◽

Treatment Duration ◽

Treated Group ◽

Dose Ratio ◽

Utilization Patterns ◽

Chemotherapy Patients

Abstract Objective and Purpose: To understand current utilization patterns, this study examined real-world dosing and drug costs for erythropoiesis-stimulating agents (ESAs), epoetin alfa (EPO) and darbepoetin alfa (DARB) in cancer patients receiving chemotherapy. Methods: An analysis of ESA utilization in chemotherapy patients using adjudicated medical claims between 2004 and 2006 from seven health plans was conducted. Patients with ≥1 ESA claim, receiving concurrent chemotherapy identified through alphanumeric HCPCS codes, and newly initiated on EPO or DARB (no ESA administration within 90 days prior to initiation), and receiving chemotherapy were included. Those patients who received both EPO and DARB or who had myelodysplastic syndromes or end-stage renal disease were excluded. Treatment duration was defined as time from first to last ESA administration. Mean cumulative ESA dose was used to calculate drug cost (based on 1/2007 wholesale acquisition cost: EPO $12.52/1000 Units; DARB: $4.576/mcg) and dose ratio (Units EPO: mcg DARB). Results: 1,446 EPO and 2,729 DARB patients were included. Mean treatment duration was longer in the DARB-treated group by three days (EPO:49 days; DARB:52 days; p= 0.037). The EPO-treated group reported 5.8 administrations with a mean administered dose of 42,603 Units (median 40,000, interquartile range 40,000–45,714) corresponding to a mean cumulative dose of 247,097 Units. The DARB-treated group reported 5.0 administrations with mean administered dose of 262 mcg (median 250, interquartile range 200–300) corresponding to a mean cumulative dose of 1,310 mcg. Drug costs were $2,901 lower in the EPO group compared to the DARB group (EPO $3,094; DARB $5,995) and utilization reflected a dose ratio of 189:1 (Units EPO: mcg DARB). Conclusions: This observational study of over 4,100 cancer patients receiving chemotherapy found 48% lower drug cost in the EPO group compared to the DARB group. These findings provide greater understanding of current real-world ESA utilization and are consistent with other studies in the cancer chemotherapy population.

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Real-World Data on Apatinib Efficacy - Results of a Retrospective Study in Metastatic Breast Cancer Patients Pretreated With Multiline Treatment

Frontiers in Oncology ◽

10.3389/fonc.2021.643654 ◽

2021 ◽

Vol 11 ◽

Author(s):

Zhaoyun Liu ◽

Jing Shan ◽

Qian Yu ◽

Xinzhao Wang ◽

Xiang Song ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Cancer Patients ◽

Real World ◽

Metastatic Breast ◽

Breast Cancers ◽

Breast Cancer Patients ◽

Real World Data ◽

Significant Treatment ◽

Nccn Guidelines

ObjectivesThe NCCN guidelines recommend that the addition of bevacizumab should be considered in metastatic breast cancers in some circumstances, but there are no recommendations for the similar antiangiogenic drug apatinib. The aim of this study was to evaluate the safety and efficacy of apatinib in metastatic breast cancer patients pretreated with multiline treatment in a real-world setting.Materials and MethodsMetastatic breast cancer patients pretreated with multiline treatment who had apatinib treatment initiated from September 2015 to August 2019 at Shandong Cancer Hospital and Institute were included. The primary endpoints included PFS and OS, and the secondary endpoint was treatment-related toxicity.ResultsA total of 66 patients with metastatic breast cancer received apatinib treatment after failure of multiline chemotherapy in this study. The median PFS and OS of all 66 patients were 6.0 months and 10.0 months, respectively. The clinical beneficial rate was 40.9%. All patients tolerated treatment well, and no patients died of toxicity. The common toxicities of apatinib were hand and foot syndrome, secondary hypertension and fatigue events. The number of prior chemotherapy regimens was significantly associated with DFS and OS. Capecitabine may be a better choice for combination with a longer median OS of 19 months, while apatinib combined with other drugs was 9 months, and the apatinib monotherapy was 10 months.ConclusionApatinib produced moderate efficacy in metastatic breast cancer patients pretreated with multiline treatment with no significant treatment-related adverse events. Apatinib might be a choice for women as a maintenance salvage therapy following multiline chemotherapy failure.

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Genomic testing and treatment landscape in patients with advanced non-small cell lung cancer (aNSCLC) using real-world data from community oncology practices.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.1585 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 1585-1585 ◽

Cited By ~ 3

Author(s):

Hinco Jasper Gierman ◽

Seth Goldfarb ◽

Monica Labrador ◽

Caroline M. Weipert ◽

Bill Getty ◽

...

Keyword(s):

Targeted Therapy ◽

Targeted Therapies ◽

Checkpoint Inhibitors ◽

Treatment Options ◽

P Value ◽

Genomic Testing ◽

Tumor Type ◽

Real World Data ◽

Nccn Guidelines ◽

Community Oncology

1585 Background: While aNSCLC is a leading cause of US cancer deaths, targeted therapies and immune checkpoint inhibitors (ICPi) have emerged as important new treatment options for these pts NCCN guidelines recommend testing of eight genes in aNSCLC patients at diagnosis. Targetable alterations (TA) in four genes, EGFR, ALK, ROS1, and BRAF, are associated with FDA-approved therapies. The labels for ICPis indicate that pts with TAs in EGFR and ALK are not candidates for first line treatment with ICPi. Methods: The Integra Connect database, which includes electronic medical record (EMR) and claims data on approximately 600,000 cancer patients, was queried across five community oncology practices (289 oncologists) to identify aNSCLC patients (stage 3B or 4) treated since January 2017. Manual review of charts was done to abstract tumor type/stage, drug regimens, and evidence of somatic genetic testing. A Wilcoxon rank sum test was used to test difference in time to results (TTR) for blood- vs tissue-based tests. Results: A total of 1,203 aNSCLC patients were identified. Testing rates varied from 54% for EGFR to 22% for all 4 genes (table). 163 patients had a TA in EGFR, ALK, ROS1 or BRAF, and 55% of these pts did not receive targeted therapy. 84 pts with TA’s in EGFR or ALK had no evidence of progression on targeted therapy, yet 31 (37%) received an ICPi; 24% had the TA test result prior to ICPi use and 13% received the TA result after starting ICPi. Median TTR for blood-based somatic tests was shorter than tissue-based tests (4 vs 14 days, p-value= 3.5-e07). Conclusions: Our analysis in the community oncology setting for aNSCLC pts finds evidence of underutilization of genomic testing, underutilization of targeted therapies, and ICPi use outside of label. Further research is needed to identify strategies to increase testing in aNSCLC pts to provide physicians with the information needed to make optimal treatment decisions. [Table: see text]

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Hematologic Outcomes and Erythropoiesis-Stimulating Therapy Costs in Epoetin Alfa (EPO)- and Darbepoetin Alfa (DARB)-Treated Cancer Patients: Results of the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E. Registry).

Blood ◽

10.1182/blood.v108.11.3340.3340 ◽

2006 ◽

Vol 108 (11) ◽

pp. 3340-3340

Author(s):

Er Chen ◽

Cyrus Peake ◽

Erminia Buscaino ◽

Jamie Forlenza ◽

Brahim Bookhart ◽

...

Keyword(s):

Cancer Patients ◽

Treatment Duration ◽

Treatment Guidelines ◽

Treated Group ◽

Community Based ◽

Entire Cohort ◽

Therapy Costs ◽

Acquisition Costs ◽

Cancer Network ◽

Anemia Treatment

Abstract Background: National Comprehensive Cancer Network (NCCN) anemia treatment guidelines recommend maintenance of hemoglobin (Hb) levels between 11–12 g/dL. To investigate hematologic outcomes and costs of erythropoiesis-stimulating therapies (ESTs), data were analyzed from the D.O.S.E. Registry, an ongoing, prospective registry collecting data on real-world practice patterns and outcomes in cancer patients treated with ESTs. Methods: Data come from U.S. hospital and community-based outpatient practices assessed from 1/04–6/06. Adult patients with a non-myeloid malignancy and receipt of at least 2 doses of either EPO or DARB were included. Outcomes assessed included mean treatment duration; mean cumulative dose; maintenance of Hb between 11–12g/dL; mean Hb level at Weeks 4, 8, 12, and 16; and proportion of patients receiving blood transfusions. EST costs were based on May 2006 wholesale acquisition costs. Results: 861 patients (312 EPO, 549 DARB) from 45 sites were identified. Mean baseline characteristics were similar between the groups (entire cohort: age 62.4 years, 64.1% women, weight 75.9 kg, and Hb 10.4 g/dL) with the exception of a significantly higher proportion of patients receiving iron supplementation in the DARB-treated group (EPO 18%, DARB 29%, p<0.01). The most common malignancies were breast, lung and gastrointestinal. Both groups had similar mean treatment duration (approximately 8 weeks), number of Hb assessments (approximately 8) and proportion of patients requiring blood transfusion following the initial four weeks of treatment (EPO 9%, DARB 11%, p=0.32). The mean cumulative doses for EPO (373,827 Units) and DARB (1,185 mcg) were associated with EST drug costs of $4,550 for EPO and $5,267 for DARB, (p<0.001). Mean Hb level was ≥ 11 g/dL at all post-baseline time points in the EPO-treated group, however <11 g/dL in the DARB-treated group at Weeks 12 and 16. Mean Hb level was significantly higher in the EPO-treated group at Week 12 (EPO 11.3 g/dL, DARB 10.8 g/dL, p=0.03). Conclusions: In this prospective observational study, EPO-treated patients achieved and maintained NCCN target Hb levels at all timepoints. These findings also showed EST cost to be 16% higher in the DARB-treated group than in the EPO-treated group.

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Real world data on adjuvant treatment of older HER2-positive breast cancer patients - a single institution experience through 8 years

Cancer Treatment and Research Communications ◽

10.1016/j.ctarc.2021.100430 ◽

2021 ◽

pp. 100430

Author(s):

L Klint ◽

A Kovács ◽

E Rönnerman ◽

B Linderholm

Keyword(s):

Breast Cancer ◽

Cancer Patients ◽

Adjuvant Treatment ◽

Real World ◽

Breast Cancer Patients ◽

Single Institution ◽

Her2 Positive ◽

Real World Data ◽

Her2 Positive Breast Cancer ◽

Positive Breast Cancer

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Palliative Care and COVID-19 Pandemic: Retrospective Study of Factors Associated With Infection and Death at an Oncological Palliative Care Reference Center

American Journal of Hospice and Palliative Medicine® ◽

10.1177/1049909120986962 ◽

2021 ◽

pp. 104990912098696

Author(s):

Livia Costa de Oliveira ◽

Karla Santos da Costa Rosa ◽

Ana Luísa Durante ◽

Luciana de Oliveira Ramadas Rodrigues ◽

Daianny Arrais de Oliveira da Cunha ◽

...

Keyword(s):

Diabetes Mellitus ◽

Palliative Care ◽

Cancer Patients ◽

Advanced Cancer ◽

Karnofsky Performance Status ◽

Performance Status ◽

Tumor Type ◽

Advanced Cancer Patients ◽

Factors Associated ◽

Reactive Protein

Background: Advanced cancer patients are part of a group likely to be more susceptible to COVID-19. Aims: To describe the profile of advanced cancer inpatients to an exclusive Palliative Care Unit (PCU) with the diagnosis of COVID-19, and to evaluate the factors associated with death in these cases. Design: Retrospective cohort study with data from advanced cancer inpatients to an exclusive PCU, from March to July 2020, with severe acute respiratory syndrome. Diagnostic of COVID-19 and death were the dependent variables. Logistic regression analyses were performed, with the odds ratio (OR) and 95% confidence interval (CI). Results: One hundred fifty-five patients were selected. The mean age was 60.9 (±13.4) years old and the most prevalent tumor type was breast (30.3%). Eighty-three (53.5%) patients had a diagnostic confirmation of COVID-19. Having diabetes mellitus (OR: 2.2; 95% CI: 1.1-6.6) and having received chemotherapy in less than 30 days before admission (OR: 3.8; 95% CI: 1.2-12.2) were associated factors to diagnosis of COVID-19. Among those infected, 81.9% died and, patients with Karnofsky Performance Status (KPS) < 30% (OR: 14.8; 95% CI 2.7-21.6) and C-reactive protein (CRP) >21.6mg/L (OR: 9.3; 95% CI 1.1-27.8), had a greater chance of achieving this outcome. Conclusion: Advanced cancer patients who underwent chemotherapy in less than 30 days before admission and who had diabetes mellitus were more likely to develop Coronavirus 2019 disease. Among the confirmed cases, those hospitalized with worse KPS and bigger CRP were more likely to die.

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Mycoplasma genitalium: test positivity in syndromic presentations and clinicians’ adherence with treatment guidelines at Sydney Sexual Health Centre

International Journal of STD & AIDS ◽

10.1177/09564624211022583 ◽

2021 ◽

pp. 095646242110225

Author(s):

Calvin Cheung ◽

Christopher Bourne ◽

Rick Varma

Keyword(s):

Decision Making ◽

Antimicrobial Resistance ◽

Sexual Health ◽

Treatment Guidelines ◽

Health Centre ◽

Diagnostic Testing ◽

Mycoplasma Genitalium ◽

Macrolide Resistance ◽

Adherence To Treatment ◽

Real World Data

Mycoplasma genitalium ( M.genitalium) is associated with urethritis, cervicitis, pelvic inflammatory disease, proctitis and epididymitis. Its treatment is complicated by antimicrobial resistance. To assess clinicians’ adherence to M.genitalium diagnostic testing recommendations for syndromic presentations, as well as resistance-guided management of M.genitalium at Sydney Sexual Health Centre, we reviewed patients presenting between August and December 2018. 349/372 (94%) syndromic presentations were tested for M.genitalium with 16% M.genitalium test positivity and 81% macrolide resistance. 16/27 (59%) macrolide-sensitive infections and 65/77 (84%) macrolide-resistant infections received resistance-guided treatment. Tests of cure (TOCs) were unnecessarily ordered for 82% macrolide-sensitive cases, while 88% macrolide-resistant cases were correctly ordered TOCs. Co-existing STIs at the time of macrolide-sensitive ( p = 0.30) or macrolide-resistant M.genitalium ( p = 0.94) diagnosis did not significantly affect adherence to treatment guidelines. This study confirms the expected prevalence of M.genitalium and macrolide resistance in syndromic presentations while our real-world data highlight the decision-making challenges involved with managing M.genitalium, offering insights for further research.

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