tbuckley/cabot-search huggingface dataset:
Cost of cancer care: The impact of disclosure on willingness to pay and treatment preferences.
Authors: Rebecca Howe, Michael J. Hassett, Alyse Wheelock, Cristina M. Thorsen, Celia Kaplan, Elissa Ozanne
Journal: Journal of Clinical Oncology (2012)

15 Background: Little is known about patients’ views regarding the costs of cancer care and its effect on treatment selection. Even less is known about how patients view information about conflicts of interest, such as disclosure of a clinic’s profit from cancer therapy. In the setting of health care reform and rising costs, we sought to understand how out-of-pocket costs and disclosure of profit impact patient treatment preferences. Methods: Previous breast cancer patients were invited to complete a web-based survey that presented four scenarios outlining cancer care treatment benefits and risks (MRI, pegfilgrastim, cold cap, and chemotherapy drugs). Initially, respondents were asked their preference for each treatment over a standard of care alternative and their out-of-pocket willingness to pay. After providing information about first, the total cost per treatment and second, the profit to the clinic, respondents were asked if their preference changed. Results: 40 women responded, all whom had previous diagnoses of breast cancer. In each of the four scenarios, respondents were less interested in the treatment option after being informed about cost or disclosure of a clinic profit. While 45.5% of respondents said they consider costs all or most of the time, only 9.1% considered clinic profit. However, 66.7% of respondents said they would be less interested in a treatment if they knew their provider received a profit from the treatment. Conclusions: Patients are less likely to prefer treatments after disclosure of total cost and clinic profit data. Communication about the costs and profits associated with cancer care may be an essential component of informed decision making in an era of growing patient involvement and escalating health care costs. [Table: see text]
A Randomized, Double-Blind, Placebo-Controlled Trial of Thalidomide Plus Dexamethasone Versus Dexamethasone Alone as Primary Therapy for Newly Diagnosed Multiple Myeloma.
Authors: S. Vincent Rajkumar, Mohamad Hussein, John Catalano, Wieslaw Jedrzejcak, Svetlana Sirkovich, Marta Olesnyckyj, Zhinuan Yu, Robert Knight, Jerry Zeldis, Joan Blade
Journal: Blood (2006)
Prostate cancer patients' adherence to medication while on abiraterone acetate (AA) therapy.
Authors: Chris M. Kozma, Terra L Slaton, Lorie Ellis, R. Scott McKenzie, Marie-Helene Lafeuille, Amanda M. Grittner, Patrick Lefebvre
Journal: Journal of Clinical Oncology (2014)

267 Background: Oral medications have become more widely available for treatment of various cancers, and adherence to dosing/ refill patterns, or medication possession, are important considerations for treatment. Abiraterone acetate (AA), prodrug of aberaterone, is a novel oral androgen biosynthesis inhibitor approved for metastatic castration resistant prostate cancer. This study reports adherence to AA dosing and administration recommendations by prostate cancer (PC) patients as observed in two separate data sources. Methods: PC patients with ≥1 AA prescription fill were identified in two retrospective pharmacy claim data sources: (1) Truven Commercial Claims and Encounters; and (2) Symphony ProMetis. Patients with no evidence of recent chemotherapy (NRC) or with evidence of recent chemotherapy (RC) were identified in the 6 months prior to AA initiation. The average AA daily dose per prescription per patient was reported. To evaluate adherence, the Medication Possession Ratio (MPR), a measure of consistency calculated as the sum of the AA days of supply divided by the total number of days between first and end of last AA fill, was assessed for patients with ≥2 AA fills. Data were summarized by descriptive statistics. Results: In both datasets the mean medication consistency/MPR was greater than 90% and the mean daily dose was within 1% of the recommended daily dose (1,000 mg). Medication consistency and AA daily dose per patient appeared similar between patients with recent chemotherapy and patients without recent chemotherapy (Table). Conclusions: Results from two observational studies representing &gt; 3,700 PC patients reported high levels of AA adherence to AA dosing and administration consistent with prescribing information. Such data support providers’ understanding of the consistency to which AA treated PC patients adhere to AA medication use. [Table: see text]
A phase 1b trial of blood-brain barrier (BBB)-penetrant tyrosine kinase inhibitor (TKI) tesevatinib in combination with trastuzumab for patients with HER2+ metastatic breast cancer (MBC).
Authors: Komal L. Jhaveri, Erika Paige Hamilton, Kathy Miller, Maria Roche, Mark S. Berger, Eric P. Winer, Nancy U. Lin
Journal: Journal of Clinical Oncology (2015)

608 Background: Patients with HER2+ breast cancer (BC) have a high incidence of brain metastases (mets). Tesevatinib (formerly KD019) is a TKI with potent activity against EGFR, HER2, and SRC. In contrast to all of the approved anti-HER2 agents in BC, tesevatinib crosses the intact BBB in mouse and rat models and achieves levels in the brain similar to plasma levels. Single-agent trials of tesevatinib in NSCLC defined the maximum tolerated dose as 300 mg daily due to QTc prolongation. Methods: This study was designed tofind the Recommended Phase 2 Dose for tesevatinib given daily combined with trastuzumab 6 mg/kg IV every 3 weeks. Secondary endpoints include pharmacokinetic evaluation of the combination. Eligible patients have HER2+ MBC with disease progression with or without brain mets. Three cohorts (tesevatinib 150 mg, 250 mg, and 300 mg/day) were planned. A 3 + 3 design was utilized for evaluating safety during the 21 days of Cycle (C) 1 to determine dose escalation. Results: 7 patients were enrolled into 2 dosing cohorts (median age 47). In Cohort 1 (150 mg) there was 1 patient with Gr 3 asymptomatic increased amylase, which resolved to Gr 1; not a DLT by protocol. There was 1 occurrence each of the following Gr 2 adverse events (AEs), all of which resolved: Gr 2 mouth sensitivity, acneiform rash, nausea, & vomiting. One patient in Cohort 1 missed doses of tesevatinib for 7/21 days (not due to AEs), and thus was not evaluable for dose escalation (but all AEs for this patient are included). The only Grade 2 or higher AE during C1 in Cohort 2 (250 mg) was a Gr 2 diarrhea that resolved to Gr 1 after 2 days with anti-diarrheal medications. Enrollment in the final dose cohort (300 mg) is ongoing. Conclusions: The combination of tesevatinib and trastuzumab appears to be well tolerated with no QTc prolongation so far and enrollment into the final dose cohort in Phase 1b is proceeding. Tesevatinib is a TKI with anti-HER2 activity that freely crosses the BBB and therefore has promise in the treatment of brain mets in patients with HER2+ MBC. Clinical trial information: NCT02154529.
Progression-free survival (PFS) and overall survival (OS) in patients receiving three targeted therapies (TTs) for metastatic renal cell carcinoma (mRCC).
Authors: Elena Verzoni, Roberto Iacovelli, Mimma Rizzo, Alessandra Felici, Stefano Cascinu, Giuseppe Di Lorenzo, Linda Cerbone, Cinzia Ortega, Cristina Masini, Maria Olga Giganti, Vito Lorusso, Caterina Messina, Francesco Atzori, Fabio De Vincenzo, Cosimo Sacco, Francesco Boccardo, Francesco Valduga, Francesco Massari, Renato Tassi, Giuseppe Procopio
Journal: Journal of Clinical Oncology (2013)

431 Background: In recent years, TTs have improved the prognosis of mRCC patients (pts). Despite a non-negligible number of pts received 3 TTs in clinical practice, no TTs have been evaluated as third-line. Aim of this study is to investigate the clinical outcome in pts who received 3 TTs. Methods: Pts with clear-cell mRCC who received 3 TTs were included. A questionnaire was sent to main Italian centers involved in the treatment of mRCC. Demographic data, history of RCC, type and length of first-, second- and third-line were collected; MSKCC risk class was calculated before starting the first-line. Sequences were evaluated by class (TKI-TKI-mTOR vs. TKI-mTOR-TKI) or by drug (Su-So-Ev vs. Su-Ev-So). Median PFS, OS and Time to Strategy Failure (TTSF: from start of first- to end of thrid-line) were estimated with the Kaplan-Meyer method with 95% CI and curves were compared with log-rank test. Cox model was used to explore predictors of TTSF and OS. The study had the ethical approval. Results: 2,065 pts were screened and 281 pts (13%) were treated with 3 TTs. No differences were found between TKI-TKI-mTOR and TKI-mTOR-TKI groups. The TTSF was 36.5 (30.5–42.6) mos vs. 29.3 (23.6–34.9) mos (p=0.059), and the OS was 50.7 (40.6–60.8) vs. 37.8 (34.2–41.5) mos (p=0.004), for TKI-TKI-mTOR and and TKI-mTOR-TKI, respectively. TTSF for Su-So-Ev was 32.1 vs. 30.4 mos for Su-Ev-So (p=0.006). The median OS was not reached in the group treated with Su-So-Ev compared to 35.6 (95%CI, 31.6–39.6) mos in the group treated with Su-Ev-So (p&lt;0.001). The univariate and multivariable Cox analyses for TTSF and OS showed that the only predictive factor is the primary resistance to 1st line (HR: 3.15, 95%CI, 1.98-4.99; p&lt;0.001). The Prognostic factors are the initial MSKCC group (HR: 2.07, 95% CI, 1.41 -3.05; p&lt;0.001), the sequence of therapy (HR: 2.59, 95% CI, 1.59-4.22; p&lt;0.001) and the primary resistance to first line (HR: 2.20, 95% CI, 1.16-4.11; p&lt;0.001). Conclusions: We report as the sequential treatment with two antiangiogenic inhibitors followed by an mTOR inhibitor could increase survival and the control disease in metastatic renal cell carcinoma.
Phase II trial of sunitinib in renal cell cancer with untreated brain metastases.
Authors: C. Chevreau, A. Ravaud, B. Escudier, A. Caty, R. Delva, F. Rolland, S. Oudard, R. Herve, E. Blanc, C. Ferlay, N. Lignon, S. Negrier
Journal: Journal of Clinical Oncology (2011)

4625 Background: Treatment of brain metastases (BM) remains a major concern among patients (pts) with metastatic renal cell cancer (mRCC). Previous retrospective reports suggest that TKI (especially sunitinib) can be safely used in patients with asymptomatic or previously treated BM. This prospective trial evaluates efficacy and safety in pts with non pretreated BM. Methods: mRCC pts with measurable and non-operable BM, no prior sunitinib, ECOG PS ≤2 and adequate organ function were included. Sunitinib was given at 50mg/day for 4 weeks cycles followed by 2 weeks off treatment until disease progression or unacceptable toxicity. The primary end point is objective response (OR) rate on central nervous system (CNS) after 2 cycles of treatment according to RECIST criteria. Using a Simon's optimal two-stage design with a OR rate of 35% as the minimum needed to warrant further investigation and an uninteresting rate of 15%, 28 evaluable patients were needed (15 in the first stage). Grade ≥ 3 neurologic toxicities were tracked down. Results: 17 pts were enrolled from April 2009 to January 2011. All but one had a clear cell histology. One patient died before treatment start because of a cerebral hemorrhage, 16 pts were evaluable after 2 cycles. Best responses on CNS were stabilisation of the disease in 5 pts and no OR was observed. Accrual was stopped after the first step of the trial. 20 grade ≥ 3 adverse events were observed in 12 pts. One toxic death was observed (peritonitis with gastric perforation). In addition, 3 other pts presented at least 1 grade ≥ 3 toxicity related to sunitinib (pulmonary embolism, neutropenia and hypertension). However, no neurological complication related to sunitinib was registered. Conclusions: Sunitinib treatment in pts with untreated brain metastases of mRCC cannot be recommended as a valid option, due to a limited efficacy on BM; notably no neurologic complication was observed under this treatment. Supported by Pfizer.
Ability of serum alkaline phosphatase (ALP) changes to complement PSA changes and predict survival in men with metastatic castration-resistant prostate cancer (mCRPC) receiving docetaxel and prednisone (DP).
Authors: M. T. Fleming, G. R. Pond, A. J. Armstrong, B. A. Wood, M. Brookes, L. H. Leopold, V. B. Matveev, J. M. Burke, J. R. Caton, G. Sonpavde
Journal: Journal of Clinical Oncology (2011)

e15019 Background: PSA decline ≥30% and ≥50% within 90 days of starting chemotherapy are suboptimal surrogates for overall survival (OS) and only capture a proportion of total benefit. Changes in ALP were shown to complement PSA changes as prognostic factors for overall survival [OS] in men treated with chemotherapy in the TAX327 trial dataset. This analysis was performed to independently validate these findings in a different dataset. Methods: 221 men recruited to a randomized phase II trial of DP+AT-101 (bcl-2 inhibitor) versus DP+placebo were studied. No significant differences in outcomes were observed; hence, both arms were combined for analysis. Changes in ALP and PSA prior to day 90 were measured and evaluated for prognostic ability to predict OS from day 90 using the Kaplan-Meir method and Cox proportional hazards regression. For inclusion, patients were required to have bony metastases at baseline, ALP ≥120 u/L and survival beyond day 90. ALP normalization was defined as an ALP of <120 and PSA response was defined as decline ≥30% from baseline within 90 days of randomization. Results: 100 men were eligible for analysis h ALP≥120 and 45 had normalization of ALP by day 90. OS from day 90 was significantly improved (HR: 0.38, 95% CI: 0.21-0.68) among those with normalization (1-year OS: 71.5%, 95% CI: 55.3-82.7) compared with those not having normalization (47.3%, 95% CI: 33.1-60.2). ALP normalization was independent of PSA response as a prognostic factor. 1-year OS for men with ALP normalization and with/without PSA-response was 76.9% / 62.5%, and for men without ALP normalization and with/without PSA-response was 56.6% / 30.0%. 29 men had increased ALP at day 90 from baseline and these men had significantly worse survival (9.7 months vs. 17.4 months) even after adjusting for PSA progression (hazard ratio:2.43; 95% CI: 1.48-4.00). Conclusions: ALP changes on DP based therapy complement PSA changes as prognostic factors associated with OS. Although not a surrogate for OS, ALP changes may be useful in estimating prognosis and facilitating treatment decisions in the setting of PSA flare or lack of PSA response to docetaxel.
Chasing the proverbial unicorn of relative value units (RVU) and block time.
Authors: Rahul Rajeev, Fabian McCartney Johnston, T. Clark Gamblin, Kiran Turaga
Journal: Journal of Clinical Oncology (2016)

660 Background: Competitive market forces on healthcare have led to increasing demands on work effort of academic surgical oncologists. This has to be balanced against resource constraints of limited operating room space and block time availability. We hypothesized that current work RVU (wRVU) requirements pose an unrealistic expectation of practicing surgical oncologists. Methods: University HealthSystem Consortium (UHC) median wRVUs were utilized to determine the effort expected of a surgical oncologist. Surgical oncology subspecialties were divided into breast, colorectal, melanoma, sarcoma, liver and pancreas. Representative procedures from each specialty were determined using Healthcare Common Procedure Coding System and median wRVUs were obtained per procedure including a single consultation cost without incorporating modifiers and adjustments for multiple procedures. A work year was assumed to include 48 weeks of work time to account for CME, and vacation. Night and weekend call was excluded from the analysis. Results: The median UHC wRVU for a surgical oncologist is 7800 wRVU, which corresponds to a theoretical reimbursement of $383,387-493,459 in a pure Medicare population. In order to meet the work RVU requirements, the number of annual major procedures performed varied from 124-1625 procedures (breast 365-701, colorectal 192- 324, melanoma 677-1625, sarcoma 234-334, liver 124-571, pancreas 139-264). The number of major procedures performed per day varied from 3 procedures/day for a 4 day block time to 12 procedures/day for a single day block time. Conclusions: Current wRVU expectations and block time schedules need to be better aligned to account for increasing demands on surgical oncologists. Society driven surveys as recently conducted by ASBS might be effective ways to truly understand workforce demands in the nation.
Prediction of pathologic complete response to neoadjuvant chemotherapy in urothelial cancer by genetic determinants of platinum sensitivity.
Authors: Peter H. O'Donnell, Shaheen Alanee, Hongyuan Cao, Irina Ostrovnaya, Ilana Rebecca Garcia-Grossman, Cory Ganshert, Norm D. Smith, Gary D. Steinberg, Kenneth Offit, Walter Michael Stadler, Dean F. Bajorin
Journal: Journal of Clinical Oncology (2013)

290 Background: Despite level 1 evidence demonstrating survival benefit for cisplatin-based neoadjuvant chemotherapy in urothelial cancer, its utilization remains low, likely due to the modest benefit and potentially significant toxicities. To improve selection of patients (pts) most likely to benefit, we evaluated the association of pharmacogenomic markers of cisplatin sensitivity with neoadjuvant therapy outcome. Methods: Pts receiving standard neoadjuvant cisplatin-based chemotherapy for muscle-invasive disease were recruited to provide a germline DNA sample. Nine single nucleotide polymorphisms (SNPs) selected for their associations with platinum sensitivity in various clinical and pre-clinical studies were tested for association with complete pathologic response (pT0) rate at cystectomy. Results: Sixty-three Caucasian pts were analyzed (median age=64; 67% male; all bladder primary and cN0). The overall pT0 rate was 27%; 52% were &lt;pT2. Using a multivariate, recessive genetic model, rs244898 in RARS (odds ratio [OR] 6.8 [95% CI 1.6-32.6], P=0.01) and rs7937567 in GALNTL4 (OR 5.2 [95% CI 1.1-26.2], P=0.03) were associated with likelihood of achieving pT0. For each SNP, pts carrying the favorable genotype achieved pT0 in &gt;58% of cases. Demonstrating the apparent independent nature of the two SNPs, pts carrying either favorable genotype had pT0 OR=8.5 (95% CI 2.5-31.8, P=0.0008). The combined effect of detecting both SNPs was most informative, as 2/3 pts with both favorable genotypes achieved pT0 (67%), compared to 9/15 pts with one favorable genotype (60%), and only 6/43 lacking both favorable genotypes (14%). The negative predictive value considering both SNPs was 86%. Conclusions: Two germline SNPs having prior evidence of governing platinum sensitivity in pre-clinical and clinical models were demonstrated to confer strong associations with complete response to cisplatin-based neoadjuvant chemotherapy. Validation testing in an independent, multi-institutional cohort of urothelial cancer pts is underway. If reproducible, these SNPs deserve consideration as predictive clinical biomarkers to inform the use of neoadjuvant chemotherapy in this disease.
Program development through compilation of patient self-reported symptom burden.
Authors: Diane Denny, Brandon Bosch, Kayla Alston, Maurie Markman
Journal: Journal of Clinical Oncology (2014)

78 Background: Cancer Treatment Centers of America, (CTCA) is a national network of five hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer. The Symptom Inventory Tool (SIT) is an assessment tool that captures the patients’ perceived symptom burden for real time clinical intervention and provides longitudinal data to demonstrate how effectively we meet our patient’s needs, from the point of no intervention (baseline) and every 21 days or greater. The SIT is comprised of 27 questions utilizing the MD Anderson Symptom Inventory tool, a validated assessment instrument with 8 questions added and a free text box by CTCA. The SIT became an integral part of patient care at CTCA in September 2012. Methods: A multidisciplinary team convened to evaluate how best to deliver the SIT data to facility leadership to assist with program development. The data needed to perform each calculation was obtained using analytical software that interfaces the database, electronic health record, and cancer registry. A Quality Research Associate prepares the operational summary providing a monthly update for the leadership at each facility with data included for the previous month, cumulatively for the facility, and cumulatively for the network. Results: The summary includes mean time to complete an assessment, assessments by timeframe (i.e. baseline, 2nd, 3rd assessments, etc.), gender and age percentages, and patients categorized by cancer type. The top three average scoring symptoms and interference issues by baseline, 2nd, and 3rd assessment are highlighted along with the top areas of improvement and diminishment in score defined by a change of 2 or more points reflecting clinical relevance. The top areas scored at 8 or greater that improved and the top areas where patients continued to score at 8 or greater on return are presented to focus upon the most severe needs. Graphs and tables are accompanied by explanation. Conclusions: In addition to consistency in presentation of the data across centers, the SIT operational summary provides visibility and insight on key emerging trends. Meaningful discussion of programmatic opportunities for focus on the most problematic and severe symptom by patient group has occurred.
Prognostic factor analysis of third-line chemotherapy in patients with advanced gastric cancer.
Authors: D. H. Yang, W. K. Bae, J. Hwang, J. Yoon, I. Chung, H. Shim
Journal: Journal of Clinical Oncology (2011)

e14613 Background: Almost all patients with advanced gastric cancer will eventually develop progressive disease after first-line chemotherapy. However, the role of subsequent salvage chemotherapy remains controversial. The purpose of this study was to evaluate the prognostic factors of the survival of advanced gastric cancer patients who received third-line chemotherapy. Methods: We reviewed 502 advanced gastric cancer patients who received palliative chemotherapy at the Onocology Department of Hwasun Chonnam National University Hospital (2004–2008). Among them, 174 received third-line chemotherapy. To evaluate the clinicopathologic factors that affect overall survival, uni- and multivariate analyses were performed on the baseline factors before beginning third-line chemotherapy. Results: Multivariate analysis found 4 prognostic factors affecting poor survival following third-line chemotherapy: a performance status of 2 to 3 (HR, 1.46; 95% CI, 1.06–2.02; P = 0.022), serum albumin level <4 mg/dL (HR, 1.82; 95% CI, 1.32–2.53; P < 0.00), poor histologic type (HR, 1.77; 95% CI, 1.27–2.47; P = 0.001), and a progression-free survival of <2.7 months following second-line chemotherapy (HR, 1.51; 95% CI, 1.09–2.08; P = 0.012). A prognostic index was constructed, dividing patients into low- (0 to 1 factor), intermediate- (2 or 3 risk factors), or high- (4 risk factors) risk groups. Median survival times for each group were 11.8, 6.7, and 3.3 months, respectively (P < 0.00). Conclusions: This analysis suggests that some clinicopathologic factors might be helpful in identifying the subgroup of patients most likely to benefit from third-line chemotherapy for advanced gastric cancer.