Bruce A. Feinberg

Angiogenesis inhibitor therapies for advanced renal cell carcinoma: Toxicity and treatment patterns in clinical practice from a global medical chart review

The aim of this study was to assess the treatment patterns and safety of sunitinib, sorafenib and bevacizumab in real-world clinical settings in US, Europe and Asia. Medical records were abstracted at 18 community oncology clinics in the US and at 21 tertiary oncology centers in US, Europe and Asia for 883 patients ≥18 years who had histologically/cytologically confirmed diagnosis of advanced RCC and received sunitinib (n=631), sorafenib (n=207) or bevacizumab (n=45) as first-line treatment. No prior treatment was permitted. Data were collected on all adverse events (AEs) and treatment modifications, including discontinuation, interruption and dose reduction. Treatment duration was estimated using Kaplan-Meier analysis. Demographics were similar across treatment groups and regions. Median treatment duration ranged from 6.1 to 10.7 months, 5.1 to 8.5 months and 7.5 to 9.8 months for sunitinib, sorafenib and bevacizumab patients, respectively. Grade 3/4 AEs were experienced by 26.0, 28.0 and 15.6% of sunitinib, sorafenib and bevacizumab patients, respectively. Treatment discontinuations occurred in 62.4 (Asia) to 63.1% (US) sunitinib, 68.8 (Asia) to 90.0% (Europe) sorafenib, and 66.7 (Asia) to 81.8% (US) bevacizumab patients. Globally, treatment modifications due to AEs occurred in 55.1, 54.2 and 50.0% sunitinib, sorafenib and bevacizumab patients, respectively. This study in a large, global cohort of advanced RCC patients found that angiogenesis inhibitors are associated with high rates of AEs and treatment modifications. Findings suggest an unmet need for more tolerable agents for RCC treatment.

Implementation of Cancer Clinical Care Pathways: A Successful Model of Collaboration Between Payers and Providers

Despite rising medical costs within the US health care system, quality and outcomes are not improving. Without significant policy reform, the cost-quality imbalance will reach unsustainable proportions in the foreseeable future. The rising cost of health care in part results from an expanding aging population with an increasing number of life-threatening diseases. This is further compounded by a growing arsenal of high-cost therapies. In no medical specialty is this more apparent than in the area of oncology. Numerous attempts to reduce costs have been attempted, often with limited benefit and brief duration. Because physicians directly or indirectly control or influence the majority of medical care costs, physician behavioral changes must occur to bend the health care cost curve in a sustainable fashion. Experts within academia, health policy, and business agree that a significant paradigm change in stakeholder collaboration will be necessary to accomplish behavioral change. Such a collaboration has been pioneered by Blue Cross Blue Shield of Michigan and Physician Resource Management, a highly specialized oncology health care consulting firm with developmental and ongoing technical, analytic, and consultative support from Cardinal Health Specialty Solutions, a division of Cardinal Health. We describe a successful statewide collaboration between payers and providers to create a cancer clinical care pathways program. We show that aligned stakeholder incentives can drive high levels of provider participation and compliance in the pathways that lead to physician behavioral changes. In addition, claims-based data can be collected, analyzed, and used to create and maintain such a program.

Hemoglobin Trends and Anemia Treatment Resulting From Concomitant Chemotherapy in Community Oncology Clinics

PURPOSE This study describes changes in hemoglobin (Hb) levels in patients during chemotherapy before anemia treatment and in those who received no treatment, measuring time from chemotherapy initiation to Hb less than 10 g/dL and anemia treatment initiation. PATIENTS AND METHODS This retrospective longitudinal cohort study used a database of outpatient oncology practice electronic medical records from January 1, 2006, to August 6, 2009. Unit of analysis was episode of chemotherapy care, beginning at initiation and including consecutive administrations within the next 60 days. Patients received two or more administrations of conventional chemotherapeutic agents, had a cancer diagnosis with at least 60 days of follow-up, and had no myelodysplastic syndrome. A total of 4,864 episodes (4,021 patients) met selection criteria, 73% with baseline Hb of 11 g/dL or greater and 60% receiving no anemia treatment. RESULTS Episodes without anemia treatment increased from 44.6% (2006) to 77.8% (2009). Erythropoiesis-stimulating agent (ESA) use decreased from 45.4% (2006) to 11.5% (2009). Patients receiving transfusions increased from 3.4% to 8.7% (2006 to 2009; all P < .001). Total proportion of episodes with Hb less than 10 g/dL at anemia treatment increased from 16.2% to 93.1% during the same period (P < .001). Mean Hb values before anemia treatment decreased over time from 10.8 to 8.9 g/dL (2006 to 2009; P < .001). Overall, time from chemotherapy initiation to first anemia treatment increased from 24.7 to 36.9 days (2006 to 2009; P < .01). CONCLUSION Results suggest increased restrictions were associated with decreased use of ESAs and increased use of transfusions as well as delays in anemia treatment and lower Hb levels before anemia treatment. Additional investigation of the overall impact of delayed treatments on long-term patient outcomes is warranted.

Hematologic Outcomes of Myelodysplastic Syndromes Treatment With Hypomethylating Agents in Community Practice

INTRODUCTION Hypomethylating agents (HMAs) treat myelodysplastic syndromes (MDS) through suppression of abnormal clones that may cause low hemoglobin (Hgb), platelet (PLT) deficiencies, and reduced absolute neutrophil count (ANC). Our study examined hematologic outcomes in MDS among patients treated with HMAs in a large community hematology-oncology practice. MATERIALS AND METHODS A retrospective study using electronic medical record data studied patients who received at least one cycle of a single HMA (decitabine [DAC] or azacitidine [AZA]) for MDS from June 1, 2006, to May 31, 2009, who had pretreatment and end-of-treatment Hgb, PLT counts, and ANC available. Multivariate logistic regression assessed predictors of end-of-treatment response (Hgb ≥ 11 g/dL without transfusion or erythrocyte stimulating agent; PLT ≥ 100,000 cells/μL without transfusion; ANC ≥ 1000 cells/mm(3) without colony stimulating factor) adjusting for baseline laboratory values, age, gender, and comorbidities. HMA choice was studied as a predictor of outcome. RESULTS A total of 137 patients (mean age, 72.2 years; 57% male) met full inclusion criteria (DAC = 84, AZA = 53). Mean number of cycles was four (range, 1-16 cycles) for DAC and five (range, 1-23 cycles) for AZA. Total number of cycles significantly predicted Hgb, PLT, and ANC response (odds ratio [OR] 1.19, P = .029; OR 1.15, P = .031; OR 1.16, P = .047, respectively). Growth factor use at any point during HMA treatment was negatively associated with Hgb and ANC response (OR 0.85, P = .007; OR 0.96, P = .046). There was no difference between treatments in likelihood of PLT or ANC response. CONCLUSIONS Patients treated with HMAs for MDS are more likely to achieve hematologic response when treated with a greater number of cycles.

Value-Based Calculators in Cancer: Current State and Challenges

The ASCO Value Framework, National Comprehensive Cancer Network Evidence Blocks, Memorial Sloan Ketterings DrugAbacus, and Institute for Clinical and Economic Review incremental cost-effectiveness ratio calculator are value-based methodologies that attempt to address the disproportionate increase in cancer care spending. These calculators can be used as an initial step for discussing cost versus value, but they fall short in recognizing the importance of the cancer journey because they do not fully factor the patients perspective or the global cost of care. This timely review highlights both the limitations and the advantages of each value calculator and suggests opportunities for refinement. Practicing oncologists, payers, and manufacturers should be familiar with value-based calculators because the role these tools play in cost containment is likely to be hotly debated.

Biosimilars in Oncology in the United States: A Review

Importance Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for, as well as their impact in a value-based care environment, is essential for physicians and other stakeholders in oncology. Observations Important structural and regulatory differences exist between biosimilar and generic medications. Minor differences in clinically inactive components with no clinically meaningful differences between biosimilars and their reference biologic are allowed. A biosimilar uses the same mechanism of action as the reference biologic, and its condition of use is the same as the approved indication, although extrapolation is permitted across indications under regulatory guidance. A biosimilar has to have a similar route of administration, dosage, and strength as the reference biologic. As patent expiration of multiple cancer biologics will occur in the next few years, more biosimilars might enter the market. Whether the approval and use of biosmilars as replacements for these heavily prescribed reference biologics will ultimately lead to cost savings is unknown and requires longer follow-up. Two biosimilars with an oncology supportive care indication are currently approved in the United States; both are myeloid growth factors. Conclusions and Relevance The financial impact of generic drug competition can be dramatic, but significant differences in regulatory and development processes between generics and biosimilars limit such comparisons and likely present significant challenges for biosimilar approval and adoption in the US market. However, a value-based care environment and their cost-savings potential make biosimilars an attractive option for the therapeutic arsenal. Oncologists’ understanding of biosimilars is critical to moving forward.

Barriers to Oncology Biosimilars Uptake in the United States

Biosimilars are biological compounds that contain an active substance that is similar to the active substance in an already approved biologic. This commentary focuses on the barriers to the use of biosimilars in the United States.

Real-world evidence (RWE) to show improved time to progression among resected pancreatic cancer (RPC) patients receiving adjuvant chemotherapy (adjch).

242Background: Two recent clinical trials (IMPRESS and APACT) suggest the overall survival (OS) of patients with resected pancreatic cancer (RPC) is far longer than previously believed. Improvements in patient selection, intra/post-operative surgical care adjch are suggested as explanations for the improved OS. RWE of time to progression (TTP) from surgery were calculated to assess if the results of these trials are generalizable. Methods: RPC patients (ICD-9=157.x, excluding 157.4; CPT=48140, 48146, 48150, 48152-5) diagnosed between 03/2012-06/2015 were selected from the Inovalon More2 administrative claims database. Adjch was defined as initiating chemotherapy within 90 days of surgery. TTP was the time from surgery until the first claim for metastatic disease (ICD-9 =196.0-.3, .5-.6, 197.0-.8, 198.0-.8) using the Kaplan-Meier method. Patients without a metastatic diagnosis during their follow-up were censored at 12 months to adjust for underreporting of metastatic disease codes in claims. Results: 1,01...

Risk factors for nausea and vomiting (NV) following highly or moderately emetogenic chemotherapy (HEC or MEC) in U.S. community oncology practice.

e19531 Background: Our objectives were to identify independent risk factors for NV among patients receiving HEC or MEC, and to estimate the percent with NV among those with vs. without aprepitant prophylaxis. Methods: This was a retrospective cohort study using the Georgia Cancer Specialists (GCS) Electronic Medical Record database. GCS is a community-based medical oncology network of 30 clinics in Georgia. Chemotherapy-naive adult patients administered single day HEC or MEC (NCCN criteria) between Jul-07 and Jun-09 were included. NV was defined as 1) patient-reported NV, or 2) NV resource use (office visits with NV ICD-9 code, new oral antiemetic class or IV/IM antiemetic rescue) within 7 days following HEC/MEC. Backwards logistic regression was used to identify risk factors for NV in cycle 1. The percent with NV was predicted using the final logistic model. Model inputs were risk factor distribution(s) for scenarios with and without aprepitant. Results: 3,110 patients were included. The mean age was 59....