Search

OBJECTIVES We investigated differences in quality of life (QoL) in patients enrolled on a phase I/II dose-escalation study of 3-fraction resection cavity stereotactic radiosurgery (SRS) for large brain metastases. METHODS Eligible patients had 1 to 4 brain metastases, one of which was a resection cavity 4.2 to 33.5 cm3. European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires core-30 (QLQ-30) and brain cancer specific module (QLQ-BN20) were obtained before SRS and at each follow-up. Nine scales were analyzed (global health status; physical, social, and emotional functioning; motor dysfunction, communication deficit, fatigue, insomnia, and future uncertainty). QoL was assessed with mixed effects models. Differences ≥10 points with q-value (adjusted P-value to account for multiplicity of testing)

IMPORTANCE: In the 15 years since dermatology access was last investigated on a national scale, the practice landscape has changed with the rise of private equity (PE) investment and increased use of nonphysician clinicians (NPCs). OBJECTIVE: To determine appointment success and wait times for patients with various insurance types at clinics with and without PE ownership. DESIGN, SETTING, AND PARTICIPANTS: In this study, PE-owned US clinics were randomly selected and matched with 2 geographically proximate clinics without PE ownership. Researchers called each clinic 3 times over a 5-day period to assess appointment/clinician availability for a fictitious patient with a new and changing mole. The 3 calls differed by insurance type specified, which were Blue Cross Blue Shield (BCBS) preferred provider organization, Medicare, or Medicaid. MAIN OUTCOMES AND MEASURES: Appointment success and wait times among insurance types and between PE-owned clinics and control clinics. Secondary outcomes were the provision of accurate referrals to other clinics when appointments were denied and clinician and next-day appointment availability. RESULTS: A total of 1833 calls were made to 204 PE-owned and 407 control clinics without PE ownership across 28 states. Overall appointment success rates for BCBS, Medicare, and Medicaid were 96%, 94%, and 17%, respectively. Acceptance of BCBS (98.5%; 95% CI, 96%-99%; P = .03) and Medicare (97.5%; 95% CI, 94%-99%; P = .02) were slightly higher at PE-owned clinics (compared with 94.6% [95% CI, 92%-96%] and 92.8% [95% CI, 90%-95%], respectively, at control clinics). Wait times (median days, interquartile range [IQR]) were similar for patients with BCBS (7 days; IQR, 2-22 days) and Medicare (7 days; IQR, 2-25 days; P > .99), whereas Medicaid patients waited significantly longer (13 days; IQR, 4-33 days; P = .002). Clinic ownership did not significantly affect wait times. Private equity–owned clinics were more likely than controls to offer a new patient appointment with an NPC (80% vs 63%; P = .001) and to not have an opening with a dermatologist (16% vs 6%; P

Background/objectives Store-and-forward teledermatology provides pediatricians with specialist guidance in managing skin disease. This study evaluates wait times and face-to-face (FTF) dermatology visit avoidance associated with a pediatric dermatology eConsult program at an urban academic medical center. Methods In this retrospective cohort study, electronic medical records were reviewed for patients under age 18 for whom a dermatology eConsult was completed between November 1, 2014, and December 31, 2017. Wait times for eConsult completion and initial FTF dermatology appointments were calculated and compared to average wait times for new patient dermatology office appointments from 2016 to 2017. Recommendations for FTF dermatology visits were assessed, along with FTF visit attendance and potential cost savings. Results One hundred eighty pediatric patients with 188 unrelated skin conditions ("cases") were referred to the program. Of 188 cases, FTF dermatology visits were recommended for 60 (31.9%). Actual FTF dermatology visit avoidance was 53.7% of total cases (n = 101 for whom FTF visit was not recommended and no dermatology visit occurred within 90 days after eConsult submission). The program generated potential savings of $24 059 ($9840 out-of-pocket) in 2016 dollars. Average turnaround for eConsult completion was 1.8 calendar days (median: 1 calendar day, target: 2 business days). Average wait time to initial FTF dermatology evaluation was 37.3 calendar days (versus 54.1 days for pediatric patients referred directly to dermatology clinic between 2016 and 2017). Conclusion Pediatric dermatology eConsults reduce wait times for specialist care, triage cases for in-office evaluation, reduce need for FTF dermatology visits, and offer potential cost savings for payers and patients.

Background We sought to determine the maximum tolerated dose (MTD) of 5-fraction stereotactic radiosurgery (SRS) with 5-mm margins delivered with concurrent temozolomide in newly diagnosed glioblastoma (GBM). Methods We enrolled adult patients with newly diagnosed glioblastoma to 5 days of SRS in a 3 + 3 design on 4 escalating dose levels: 25, 30, 35, and 40 Gy. Dose limiting toxicity (DLT) was defined as Common Terminology Criteria for Adverse Events grades 3–5 acute or late CNS toxicity, including adverse radiation effect (ARE), the imaging correlate of radiation necrosis. Results From 2010 to 2015, thirty patients were enrolled. The median age was 66 years (range, 51–86 y). The median target volume was 60 cm3 (range, 14.7–137.3 cm3). DLT occurred in 2 patients: one for posttreatment cerebral edema and progressive disease at 3 weeks (grade 4, dose 40 Gy); another patient died 1.5 weeks following SRS from postoperative complications (grade 5, dose 40 Gy). Late grades 1–2 ARE occurred in 8 patients at a median of 7.6 months (range 3.2–12.6 mo). No grades 3–5 ARE occurred. With a median follow-up of 13.8 months (range 1.7–64.4 mo), the median survival times were: progression-free survival, 8.2 months (95% CI: 4.6–10.5); overall survival, 14.8 months (95% CI: 10.9–19.9); O6-methylguanine-DNA methyltransferase hypermethylated, 19.9 months (95% CI: 10.5–33.5) versus 11.3 months (95% CI: 8.9–17.6) for no/unknown hypermethylation (P = 0.03), and 27.2 months (95% CI: 11.2–48.3) if late ARE occurred versus 11.7 months (95% CI: 8.9–17.6) for no ARE (P = 0.08). Conclusions The per-protocol MTD of 5-fraction SRS with 5-mm margins with concurrent temozolomide was 40 Gy in 5 fractions. ARE was limited to grades 1–2 and did not statistically impact survival.

The development of cavernous malformations many years following conventionally fractionated brain irradiation is well recognized and commonly reported. However, cavernous malformation induction following stereotactic radiosurgery (SRS) is largely unreported. Herein, we describe two cases of cavernous malformation formation years following SRS for brain metastases. A 20-year-old woman with breast cancer brain metastases received treatment with whole brain radiotherapy (WBRT), then salvage SRS 1.4 years later for progression of a previously treated metastasis. This lesion treated with SRS had hemorrhagic enlargement 3.0 years after SRS. Resection revealed a cavernous malformation. A 25-year-old woman had SRS for a brain metastasis from papillary thyroid carcinoma. Resection of a progressive, hemorrhagic lesion within the SRS field 2 years later revealed both recurrent carcinoma as well as cavernous malformation. As patients with brain metastases live longer following SRS, our cases highlight that the differential diagnosis of an enlarging enhancing lesion within a previous SRS field includes not only cerebral necrosis and tumor progression but also cavernous malformation induction.

Patients with tumors adjacent to the optic nerves and chiasm are frequently not candidates for single-fraction stereotactic radiosurgery (SRS) due to concern for radiation-induced optic neuropathy. However, these patients have been successfully treated with hypofractionated SRS over 2-5 days, though dose constraints have not yet been well defined. We reviewed the literature on optic tolerance to radiation and constructed a dose-response model for visual pathway tolerance to SRS delivered in 1-5 fractions. We analyzed optic nerve and chiasm dose-volume histogram (DVH) data from perioptic tumors, defined as those within 3mm of the optic nerves or chiasm, treated with SRS from 2000-2013 at our institution. Tumors with subsequent local progression were excluded from the primary analysis of vision outcome. A total of 262 evaluable cases (26 with malignant and 236 with benign tumors) with visual field and clinical outcomes were analyzed. Median patient follow-up was 37 months (range: 2-142 months). The median number of fractions was 3 (1 fraction n = 47, 2 fraction n = 28, 3 fraction n = 111, 4 fraction n = 10, and 5 fraction n = 66); doses were converted to 3-fraction equivalent doses with the linear quadratic model using α/β = 2Gy prior to modeling. Optic structure dose parameters analyzed included Dmin, Dmedian, Dmean, Dmax, V30Gy, V25Gy, V20Gy, V15Gy, V10Gy, V5Gy, D50%, D10%, D5%, D1%, D1cc, D0.50cc, D0.25cc, D0.20cc, D0.10cc, D0.05cc, D0.03cc. From the plan DVHs, a maximum-likelihood parameter fitting of the probit dose-response model was performed using DVH Evaluator software. The 68% CIs, corresponding to one standard deviation, were calculated using the profile likelihood method. Of the 262 analyzed, 2 (0.8%) patients experienced common terminology criteria for adverse events grade 4 vision loss in one eye, defined as vision of 20/200 or worse in the affected eye. One of these patients had received 2 previous courses of radiotherapy to the optic structures. Both cases were meningiomas treated with 25Gy in 5 fractions, with a 3-fraction equivalent optic nerve Dmax of 19.2 and 22.2Gy. Fitting these data to a probit dose-response model enabled risk estimates to be made for these previously unvalidated optic pathway constraints: the Dmax limits of 12Gy in 1 fraction from QUANTEC, 19.5Gy in 3 fractions from Timmerman 2008, and 25Gy in 5 fractions from AAPM Task Group 101 all had less than 1% risk. In 262 patients with perioptic tumors treated with SRS, we found a risk of optic complications of less than 1%. These data support previously unvalidated estimates as safe guidelines, which may in fact underestimate the tolerance of the optic structures, particularly in patients without prior radiation. Further investigation would refine the estimated normal tissue complication probability for SRS near the optic apparatus.

This cross-sectional study weighs the proportional associations of rising drug costs and use with increased Medicare Part D spending for a cohort of oral anticancer drugs used from 2013 through 2017.

Purpose We report a longitudinal assessment of health-related quality of life (HRQOL) in patients with glioblastoma (GBM) treated on a prospective dose escalation trial of 5-fraction stereotactic radiosurgery (25-40 Gy in 5 fractions) with concurrent and adjuvant temozolomide. Methods HRQOL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) general, the EORTC quality of life questionnaire-brain cancer specific module (QLQ-BN20), and the M.D. Anderson Symptom Inventory–Brain Tumor (MDASI-BT). Questionnaires were completed at baseline and at every follow-up visit after completion of radiosurgery. Changes from baseline for 9 predefined HRQOL measures (global quality of life, physical functioning, social functioning, emotional functioning, motor dysfunction, communication deficit, fatigue, insomnia, and future uncertainty) were calculated at every time point. Results With a median follow-up time of 10.4 months (range, 0.4-52 months), 139 total HRQOL questionnaires were completed by the 30 patients on trial. Compliance with HRQOL assessment was 76% at 12 months. Communication deficit significantly worsened over time, with a decline of 1.7 points per month ( P =.008). No significant changes over time were detected in the other 8 scales of our primary analysis, including global quality of life. Although 8 patients (27%) experienced adverse radiation effects (ARE) on this dose escalation trial, it was not associated with a statistically significant decline in any of the primary HRQOL scales. Disease progression was associated with communication deficit, with patients experiencing an average worsening of 13.9 points per month after progression compared with 0.7 points per month before progression ( P =.01). Conclusion On this 5-fraction dose escalation protocol for newly diagnosed GBM, overall HRQOL remained stable and appears similar to historical controls of 30 fractions of radiation therapy. Tumor recurrence was associated with worsening communication deficit, and ARE did not correlate with a decline in HRQOL.

Importance Private equity (PE) firms invest in dermatology management groups (DMGs), which are physician practice management firms that operate multiple clinics and often acquire smaller, physician-owned practices. Consolidation of dermatology practices as a result of PE investment may be associated with changes in practice management in the United States. Objective To describe the scope of PE-backed dermatology practice acquisitions geographically over time. Design, Setting, and Participants This cross-sectional study examined acquisitions of dermatology practices by PE-backed DMGs in the United States. Acquisition and investment data through May 31, 2018, were compiled using information from 5 financial databases. Transaction data were supplemented with publicly available information from 2 additional financial databases, 2 financial news outlets, and press releases from DMGs. All dermatology practices acquired by PE-backed DMGs were included. Acquisitions were verified to be dermatology practices that provided medical, surgical, and/or cosmetic clinical care. Private equity financing data were included when available. The addresses of clinics associated with acquired practices were mapped using spatial analytics software. Main Outcomes and Measures The number and location of PE practice acquisitions over time were measured based on the date of deal closure, the geographic footprint of each DMG’s acquisition, and the financing of each DMG. Results Seventeen PE-backed DMGs acquired 184 practices between May 1, 2012, and May 22, 2018. These acquired practices accounted for an estimated 381 dermatology clinics as of mid-2018 (assessment period from May 1 to August 31). The total number of PE-owned dermatology clinics in the United States was substantially larger because these data did not reflect DMGs that opened new clinics (organic growth); acquisitions data represented only the ownership transfer of existing practices from physician to PE-backed DMG. Practice acquisitions increased each year, from 5 in 2012 to 59 in 2017. An additional 34 acquisitions took place from January 1 to May 31, 2018. The number of financing rounds to sustain transactions mirrored the aforementioned trends in practice acquisitions. Clinics associated with acquired practices spanned at least 30 states, with 138 of 381 clinics (36%) located in Texas and Florida. Conclusion and Relevance The study findings suggest that PE firms have a financial stake in an increasing number of dermatology practices throughout the United States. Further research is needed to assess whether and how PE-backed ownership influences clinical decision-making, health care expenditures, and patient outcomes.

6631 Background: Rising pharmaceutical costs threaten affordability and access to cancer care. Methods: The 2013 and 2015 Medicare Part D claims databases were queried for CareFirst’s 2017 list of oral cancer drugs. Drugs with on-label indications for conditions other than cancer were excluded. Cost in 2013 were adjusted for inflation to 2015 dollars according to the Bureau of Labor Statistics consumer price index. Results: The total cost of oral cancer drugs paid by Medicare nearly doubled from 2013 to 2015, rising from over $4.8 billion to over $9.1 billion. The number of prescriptions increased by 21.6% from 640,193 to 778,357, suggesting that increased spending is driven more by rising drug prices than by increased utilization. Cost per patient increased for 81% (46) of the 57 drugs prescribed in both years and decreased for the remaining 19% (11). While only seven drugs cost more than $50,000 per patient in 2013, more than fifteen drugs cost more than $50,000 per patient in 2015. The overall average cost per beneficiary increased by 56% from $7,521.64 to $11,734.68, and seven drugs more than doubled in per patient cost. Cost per patient increased by 4.5 times for imbruvica (ibrutinib), 3.5 times for targretin (bexarotene), 3.2 times for soltamox (tamoxifen citrate), 3.1 times for nilandron (nilutamide), 2.6 times for gilotrif (afatinib dimaleate), 2.6 times for cyclophosphamide, and 2.5 times for iclusig (ponatinib hydrochloride). Conclusions: Medicare costs for oral cancer drug nearly doubled from 2013 to 2015, largely due to increased per patient costs. [Table: see text]

6647 Background: Cancer is the second leading killer in the United States, but there is no comprehensive analysis evaluating total cancer costs by cancer and treatment modality. Methods: Data from the 2013 inpatient (100%), outpatient (100%), and carrier (5%) Medicare Limited Data Set Standard Analytic Files were queried for claims filed for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for all cancer diagnoses. Claims associated with the ICD-9 codes for professional fees were analyzed by Current Procedure Terminology (CPT) code to determine resource allocation by disease. Outpatient oral chemotherapy costs were obtained from the National Average Drug Acquisition Cost database for 50 drugs used for cancer treatment in 2013. Results: $27.9 billion was spent on cancer treatment of which $12 billion (43%), $6.5 billion (23%), and $1.1 billion (4%) was allocated to professional, inpatient facility, and outpatient facility fees, respectively. Oral and hospital-based chemotherapy accounted for 17% ($4.7 billion) and 15% ($4.3 billion) of all cancer costs, respectively. Lung/thoracic cancer ($2.9 billion) had the highest total annual cost and multiple myeloma ($9,019, SD $19,962) is the most expensive cancers to treat annually per patient. Average out-of-pocket expenses are $470 (SD 287), which is 12% of the annualized per patient costs. Conclusions: In 2013, cancer accounted for only 5% of Medicare spending. Chemotherapy costs accounted for approximately a third of total spending and are likely to rise as innovation continues. Out-of-pocket spending can place a financial burden on cancer patients requiring more expensive treatments.

Author(s): Soltys, SG; Seiger, K; Modlin, LA; Gibbs, IC; Hara, W; Kidd, EA; Hancock, SL; Diehn, M; Chang, SD; Adler, JR; Harsh, GR; Li, G; Choi, CYH

129 Background: As of October 2012, both embryo and oocyte cryopreservation are considered non-experimental fertility preservation (FP) options for cancer patients facing potentially gonadotoxic therapy. This study aims to assess the historical referral frequency of reproductive aged breast cancer patients from a major cancer center to an associated reproductive endocrinology and infertility (REI) clinic for counseling regarding FP and also assess how frequently these patients underwent FP after referral. Methods: Using the Stanford Cancer Center Research Database in conjunction with our EMR, a query was made for patients of reproductive age (13-45) who were seen at the Stanford Cancer Center for a new breast cancer diagnosis between 2004 and 2012. These patients’ records were then searched for referral encounters in the REI department. Those who were seen by REI were assessed for having undergone FP via embryo or oocyte cryopreservation prior to starting chemotherapy. Results: 420 women, ages 20 to 45, were seen at our cancer center for a new diagnosis of breast cancer between 2004 and 2012. Sixty (14.3%) of these patients, ages 20 to 42 at diagnosis, were referred to the REI department for FP counseling. Patients who were referred for FP counseling were 5.1 years younger at diagnosis than those who were not (p