tbuckley/cabot-search huggingface dataset:
Does insurance status matter for receipt of newer therapies among cancer patients? The case of immunotherapy and NHL
Authors: M. T. Halpern, Y. T. Shih, A. L. Pavluck
Journal: Journal of Clinical Oncology (2008)

6612 Background: Lack of adequate insurance is associated with barrier to care for individuals with cancer. High costs of recently- approved cancer biologics have raised further concerns about underinsurance even among insured patients (pts). To explore whether insurance status influences treatment with biologic therapies, we evaluated the association between insurance and receipt of immunotherapy among Non-Hodgkin lymphoma (NHL) pts. Methods: B-cell NHL pts (1998–2004) were identified from the National Cancer Data Base, a hospital- based registry jointly sponsored by the American Cancer Society and American College of Surgeons that includes more than 70% of newly diagnosed cancer pts in the US. Logistic regression was used to explore whether receipt of immunotherapy treatment varied by insurance status while controlling for other pts and facility characteristics. B-cell NHL pts with metastatic disease were also evaluated separately. Results: 119,206 pts (30,873 metastatic cases) were identified. Over the 7-year study period, 14.68% of all pts and 18.58% of metastatic pts received immunotherapy. For both groups, private insurance pts were significantly more likely to receive immunotherapy than were uninsured or Medicaid patients (Table). Further, pts with Medicare plus supplemental insurance (Medicare-plus) were more likely than Medicare only pts to receive immunotherapy. Non-Hispanic Black and Hispanic patients were also less likely to receive immunotherapy than were Non-Hispanic Whites. Conclusions: Lower rates of receipt of immunotherapy were found among uninsured, Medicaid, and Medicare only pts. This effect among pts with metastatic disease was even stronger. Actions are needed to ensure access to appropriate treatment among these underserved populations. Comparisons of Immunotherapy Use by Insurance Status and Race/Ethnicity All patients (95% CI) Metastatic patients (95% CI) INSURANCE STATUS (Reference group: private insurance) Uninsured 0.817 (0.735-0.908) 0.758 (0.631-0.910) Medicaid 0.908 (0.832-0.991) 0.779 (0.670-0.906) Medicare-plus 1.082 (1.032-1.134) 1.106 (1.016-1.203) Medicare only 0.845 (0.794-0.899) 0.868 (0.777-0.970) Other insurance 0.756 (0.520-1.098) 0.622 (0.299-1.296) RACE/ETHNICITY (Reference group: Non-Hispanic White) Non-Hispanic Black 0.67 (0.63-0.73) 0.70 (0.61-0.79) Hispanic 0.85 (0.78-0.93) 0.86 (0.73-1.00) CI=confidence interval No significant financial relationships to disclose.
“Ask me, do you want to know the big picture?” Gynecologic oncology patient and provider perspectives on discussing prognosis.
Authors: Carolyn Lefkowits, Dio Kavalieratos, Janet Arida, Winifred Teuteberg, Heidi Donovan, Madeleine Courtney-Brooks, Robert Arnold, Joseph L Kelley
Journal: Journal of Clinical Oncology (2015)

37 Background: Prognosis affects decision making by providers and patients and accurate understanding of prognosis may help avoid futile end-of-life care. Gynecologic oncology (GO) patient and provider perspectives on discussing prognosis have not been described. We sought to analyze patient and provider preferences regarding timing, amount and type of information included in discussions of prognosis. Methods: Semi-structured qualitative interviews regarding palliative care with 19 GO providers (7 physicians, 7 advanced practice providers, 5 nurses) and 29 patients with advanced or recurrent gynecologic cancer at an academic medical center. Communication about prognosis was one interview domain. Two coders independently and iteratively analyzed transcripts using qualitative analysis. Results: Median patient age was 61, the most common cancer was ovary (59%) and 90% had recurrent disease. Providers were 74% female with median 15 years in practice. Themes included patients wanting frank discussions about prognosis, not limited to life expectancy. Further preferences regarding timing and content were individualized. All categories of providers reported having prognosis conversations. Providers saw these conversations as part of their clinical role, though they often found them difficult. Providers commonly equated prognosis purely with life expectancy. Providers recognized variation among patients in preferences regarding these conversations, but did not discuss asking patients directly about their preferences. Conclusions: GO patients want frank discussions about what the future might hold, often including but not limited to life expectancy. Providers see these discussions as being within their scope of practice but often find them difficult. Opportunities exist for provider education regarding communication skills for assessing patient preferences and conducting patient centered prognosis discussions. Education should include GO physicians, advanced practice providers and nurses. Collaboration with specialty palliative care providers could facilitate that education and provide assistance with challenging cases.
Prospective assessment of deep inspiration breath hold to prevent radiation-associated cardiac perfusion defects in patients with left-sided breast cancer.
Authors: Timothy Zagar, Xiaoli lily Tang, Ellen Jones, Jason Matney, Shiva Das, Rebecca L Green, Arif Sheikh, Amir H Khandani, William H McCartney, Terence Z. Wong, Lawrence Bruce Marks
Journal: Journal of Clinical Oncology (2015)

41 Background: Radiation therapy (RT) for left-sided breast cancer can cause regional cardiac perfusion abnormalities in nearly half of patients at 6 months post-RT. While the significance of these perfusion abnormalities remains unclear, RT is a well-accepted risk factor for heart disease. We herein report the results of a single-arm prospective clinical study to assess deep inspiratory breath hold (DIBH; using AlignRT) as a means to prevent the development of perfusion abnormalities in patients with left-sided breast cancer. Methods: Patients about to receive left-sided tangential RT had a pre-RT cardiocentric single photon emission computed tomography with CT based attenuation correction (IQ SPECT-CT) rest-cardiac gated perfusion scan (to assure a normal baseline). DIBH and conformal blocking was used to assure that the heart was excluded from the primary RT beam. Doses to the heart were computed. At 6-months post-RT, the SPECT-CT was repeated. The perfusion and motion images were assessed qualitatively by a nuclear medicine physician. Results: Twenty-four patients have been enrolled. Four were not evaluable (e.g. due to an abnormal pre-RT SPECT scan); one has been lost to follow-up. All patients received tangential radiation to the breast/chest wall (typical doses 200 cGy x 25 or 267 cGy x 16); five also received regional nodal RT as well; and 18/19 received a tumor bed boost. The mean heart dose ranged from 42-160cGy for all 19 patients (mean of the means = 78 cGy). Of the 19 potentially evaluable patients, post-RT SPECTs have been obtained in ten. All ten have a normal post-RT SPECT scan; and/or no change from pre-RT scan. Conclusions: In patients receiving tangential RT for left-sided breast cancer, cardiac avoidance with DIBH (e.g. with AlignRT) and conformal field shaping, appears to be able to prevent the development of RT-associated cardiac perfusion abnormalities. The mean dosages to the heart are quite low. Updated information on the remaining patients will be presented. Funded in part by VisionRT. Clinical trial information: NCT01849614.
Disparities in receipt of supportive/palliative care services among women with breast cancer.
Authors: M. T. Halpern, D. J. Holden, A. Larsen
Journal: Journal of Clinical Oncology (2010)

9142 Background: Patient-centered care includes addressing all symptoms experienced by individuals with cancer. However, reports suggest disparities in receipt of care for symptoms such as pain, decreased levels of functioning, and psychological distress. We used data from NCI's Surveillance, Epidemiology and End Results cancer registry linked to Medicare claims data (SEER-Medicare) from 2000 to 2002 to examine factors associated with supportive/palliative care services among women with breast cancer. Methods: All female SEER patients with a breast cancer diagnosis continuously enrolled in Medicare parts A and B for at least 12 month following diagnosis were included. Separate multivariate logistic regressions were performed to assess factors associated with receipt of pain management, physical/occupational therapy (PT), and psychological/psychiatric testing or treatment services during the 1st or 2nd year after diagnosis. Regressions controlled for cancer stage; age at diagnosis; race/ethnicity; rural/urban residence; dual Medicare-Medicaid enrollment; comorbidities; and area-based socioeconomic status and medical care availability. Results: Among 39,500 women diagnosed with breast cancer, those with regional or distant stage disease at diagnosis (compared to local disease) were less likely to receive pain management or PT during the 1st or 2nd year after diagnosis; those with distant stage disease were also less likely to receive psychological treatment. Black women were less likely to receive pain management either year compared with White women, and less likely to receive psychological testing or treatment in the 2nd year. Dual Medicare-Medicaid enrollees were less likely to receive pain management but more likely to receive PT or psychological therapy. Older patients were less likely to pain management, PT, or psychological therapy, but more likely to receive psychological testing. Conclusions: Significant disparities were observed in receipt of supportive and palliative care services among women with breast cancer. Further research is needed to understand the role of patient and physician preferences in these disparities and assure access to desired services among all cancer patients. No significant financial relationships to disclose.
Added value of pre- and on-treatment tumor growth kinetics assessment to RECIST in patients (pts) treated with molecularly targeted agents (MTAs).
Authors: C. Le Tourneau, V. Servois, L. Ollivier, X. Paoletti
Journal: Journal of Clinical Oncology (2011)

2603 Background: As opposed to cytotoxic agents, MTAs do not always induce tumor shrinkage, but only tumor stabilisation. RECIST defines progressive disease (PD) as the occurrence of new lesions or a >20% increase in the sum of target lesions (as compared to the nadir), irrespective of tumor growth kinetics before and during treatment. We hypothesized that PD according to RECIST may occur in some pts treated with MTAs, although tumor growth kinetics has been reduced after treatment initiation, potentially leading to inappropriate treatment discontinuation. We aimed at estimating the proportion of pts with PD according to RECIST who experienced a slowdown of tumor growth kinetics while treated with a MTA. Methods: Baseline and on-treatment imaging, along with pre-baseline imaging, of pts treated with a MTA as single agent or with a combination of MTAs in phase I and II clinical trials at Institut Curie were retrospectively reviewed. Pts with non-measurable disease were excluded, as were pts lacking pre-baseline imaging or pts evaluated with different imaging techniques. Tumor measurements on imaging were performed by 2 radiologists. Results: 50 pts included in 19 trials were included in the study. Median number of prior lines of treatment was 3 [range: 0-8]. Medical treatment prior study entry was chemotherapy +/- MTA in 32 pts (64%), a MTA in 5 pts (10%), hormone therapy in 3 pts (6%), and none in 10 pts (20%). Median number of available imaging exams was 4 [range: 3-12]. Median time between pre-baseline and baseline imaging was 10 weeks [range: 2-28]. Three pts are still on treatment. Of the 47 remaining pts who went off-study, treatment was discontinued because of toxicity/clinical PD/radiological PD according to RECIST in 2 (47%)/18 (38%)/27 (57%) pts. Eight pts with radiological PD according to RECIST had new lesions at the time of PD, while 19 pts had not. In 5 pts among these 19 pts (26%), the slope of tumor growth on-treatment (based on the nadir) was reduced by 10% or more as compared to the slope before treatment. Conclusions: Our preliminary results suggest that a substantial proportion of pts treated with MTAs are early discontinued treatment while benefiting from it.
Frequency of cardiovascular events in patients with metastatic renal cell carcinoma under sunitinib treatment.
Authors: I. Yildiz, F. Sen, M. Basaran, S. E. Bavbek
Journal: Journal of Clinical Oncology (2011)

e15112 Background: Recent data have shown that cardiotoxicity represents a potentially important side-effect in patients treated with sunitinib. We reviewed cardiac adverse events in patients with metastatic renal cell carcinoma (RCC) who underwent treatment with this agent. Methods: The medical records of 74 patients with metastatic RCC, treated with sunitinib at Institute of Oncology, Istanbul University, were retrospectively reviewed. Sunitnib was administered continuosly at a dose of 37, 5 mg (92% of patients) or 25 mg (8% of patients) daily without interruption as second-line treatment after interferone or as first-line treatment. Baseline echocardiography and ECG were performed. All patients had their blood pressure measured at baseline and mountly at the time of clinic visits. For patients experiencing symptomatic cardiotoxicity, clinical evaluations and laboratory, radiographic and cardiac tests carried out at the time of diagnosis of cardiotoxicity were reviewed in detail. Median follow-up was 12 months. Results: Median age of patients was 58 (26-80) years. Thirty seven (56%) patients have been using at least one type of antihypertensive drugs. Before initiation of sunitinib, history of smoking, hypertension, diabetes mellitus, coronary artery diesase and chronic renal failure, were present in 26 (38%), 27 (37%), 12 (16%), 8 (11%) and 4 (6%) patients respectively. Two patients had myocardial infarction, one patient had long QT syndrome, 2 patients had grade 3 systolic cardiac dysfunction under suntinib treatment. In patients with history of hypertension, hypertensive pulmonary edema (1 patient) and grade 3-4 hypertension (4 patients) occurred. Cardiac tamponade developed in a patient without hypothyroidism and with cytologically confirmed uninvolvement of pericardial effusion. Conclusions: Patients undergoing sunitinib, especially those with a previous history of hypertension and coronary heart disease, are at increased risk for cardiovascular events and should be monitored for exacerbations of their hypertension and for evidence of LVEF dysfunction and myocardial ischemia during treatment.
Treatment and outcomes of patients with metastatic colorectal cancer (mCRC) with epidermal growth factor receptor (EGFR) therapy in the third-line setting.
Authors: Maria Yi Ho, Daniel John Renouf, Winson Y. Cheung, Chen Zhou, Ozge Goktepe, Howard John Lim, Hagen F. Kennecke
Journal: Journal of Clinical Oncology (2013)

579 Background: Monoclonal antibodies targeting the EGFR improve outcomes of patients with mCRC in the first-, second-, and third-line settings. The optimal treatment setting for use of these agents is not yet defined. In British Columbia, cetuximab and panitumumab are limited to patients with KRAS wild type (wt) mCRC previously treated with 5-fluorouracil (5-FU), oxaliplatin (Ox), and irinotecan (Iri). The objective of this study was to describe the treatment and outcomes of patients with mCRC after the introduction of EGFR targeted therapy in the third-line setting. Methods: All patients with newly diagnosed mCRC and referred to 1 of 5 BC Cancer Agency clinics in 2009 were included. Prognostic and treatment information was prospectively collected while KRAS testing information was determined by chart review. Results: 443 patients with a median age of 66 were included of which 59% were men, 73% received any systemic therapy for metastatic disease of which 13% underwent hepatic resection of metastatic disease. Of 117 patients who received 5-FU, Ox and Iri, 10% were not tested for KRAS. Among those tested, 38% were KRAS mutant. In patients who were KRAS wt, 23% did not receive EGFR therapy. On chart review, poor performance status was the dominant reason for not receiving KRAS testing and anti-EGFR therapy in 67% and 50% of cases, respectively. Median survival of 321 patients who received any systemic therapy for metastatic disease was 22.3 months. Conclusions: In this study, when EGFR therapy is limited to patients with KRAS wt mCRC previously treated with 5-FU, Ox and Iri, only 15% received such therapy and poor performance status was the dominant reason for non-treatment. Earlier initiation of EGFR therapy may increase the proportion of patients treated with all active systemic agents. [Table: see text]
Food as medicine: A randomized controlled trial (RCT) of home delivered, medically tailored meals (HDMTM) on quality of life (QoL) in metastatic lung and non-colorectal GI cancer patients.
Authors: Omar Ishaq, Raymond Mailhot Vega, Lisa Zullig, Alissa Wassung, Dorella Walters, Noah Berland, Kevin Lee Du, Jiyoung Ahn, Cynthia G. Leichman, Deirdre Jill Cohen, Ping Gu, Abraham Chachoua, Lawrence P. Leichman, Karen Pearl, Peter B. Schiff
Journal: Journal of Clinical Oncology (2016)

155 Background: Malnutrition incidence in cancer approaches 85%, disproportionately burdening those with lung, GI, and advanced stage cancers. Malnourished patients have impaired chemotherapy response, shorter survival, longer hospital stays, and decreased QoL. Home delivered meals are nutritional interventions that improve patient well-being, nutrition, and lower healthcare costs in the elderly but have not been studied as an intervention in cancer patients. HDMTM are nutritionist prescribed home delivered meals tailored to patient’s symptoms, co-morbidities, and health needs. Preliminary data in 211 cancer patients showed with HDMTM 87% ate more than half of meals, 91% lived more independently, 89% ate more nutritiously, and 70% had less fatigue. HDMTM may be a strategy to reduce financial toxicity and healthcare utilization and improve QoL in cancer patients, but no primary data exists evaluating its efficacy. Methods: We sought to develop the first RCT evaluating patient-centered QoL improvement from nutritional intervention with HDMTM in those with metastatic lung and non-colorectal GI cancer. We established a partnership with God’s Love We Deliver, a 501c3 non-profit specializing in HDMTM. Results: We developed a protocol for a single-institution RCT of standard of care (SoC) versus SoC and HDMTM in metastatic lung and non-colorectal GI cancer patients with primary aim comparing QoL between arms at 12 weeks using the FACT-G questionnaire. Sample size is 180. Secondary aims assess HDMTM’s impact on nutritional status, weight, mood, survival, food security, financial toxicity, healthcare utilization, and cost effectiveness. Eligible patients tolerate oral alimentation, have PS 0-3, and newly diagnosed (&lt; 6 weeks) metastatic cancer. All patients have pre-randomization nutritional evaluation by an oncologic dietician. Conclusions: We present the first PRMC reviewed and IRB approved RCT evaluating the efficacy of HDMTM in metastatic cancer patients with primary endpoint of patient reported QoL. Investigating HDMTM expands our knowledge of nutrition as an effective arm of palliative oncology.
Phase II clinical study of radium-223 chloride (BAY 88-8223) in Japanese patients with symptomatic castration-resistant prostate cancer (CRPC) with bone metastases.
Authors: Hiroji Uemura, Satoshi Nagamori, Yoshiaki Wakumoto, Hirotsugu Uemura, Go Kimura, Akira Yokomizo, Hiroaki Kikukawa, Atsushi Mizokami, Takeo Kosaka, Naoya Masumori, Yoshihide Kawasaki, Junji Yonese, Yasutomo Nasu, Satoshi Fukasawa, Takayuki Sugiyama, Motohide Uemura, Iku Yamaguchi, Hirokazu Tsutsui, Eisuke Matsunaga, Nobuaki Matsubara
Journal: Journal of Clinical Oncology (2016)

167 Background: The ALSYMPCA study was conducted to evaluate the alpha-emitting radiopharmaceutical Radium-223 Chloride (BAY 88-8223) in patients with symptomatic bone metastases in Castration resistant prostate cancer (CRPC). This trial met its primary endpoint of overall survival at the time of pre-planned interim analysis. Post hoc analysis showed a reduction from baseline in total ALP at 12 weeks (32% reduction in the BAY 88-8223 arm vs. 37% increase in placebo arm, P &lt; 0.001) (Sartor et al. ASCO 2013). We are reporting here a single-arm, open-label, multicenter, phase II clinical study of BAY 88-8223 in Japanese patients with symptomatic CRPC with bone metastases. Methods: Eligible patients had progressive, symptomatic CRPC with at least 2 bone metastases on bone scintigraphy and no known visceral metastases; were receiving Best Standard of Care; and either had previously received docetaxel, were docetaxel ineligible, or had refused docetaxel. Patients received 6 injections of radium-223 (50 kBq/kg IV) every 4 weeks. The primary endpoint was percentage of change in total ALP from baseline at 12 weeks. Secondary endpoints included overall survival, time to symptomatic skeletal event, percentage of change in bone ALP/PSA/biomarkers, and safety. Results: A total of 67 subjects were enrolled; 18 were screening failures, and 49 were received to the study treatment and received at least one administration from September 2013 to May 2014. The mean percent change in total ALP from baseline at 12 weeks was -19.3% (95%CI: -28.0% to -10.7%). The results of secondary endpoints will be presented. The safety and tolerability profile for BAY 88-8223 were highly favorable and only 1 subject (2.0%) experienced lymphocyte count decreased as a Grade 4 adverse event, and there was no death during the study treatment and within 30 days after the last injection of study treatment. Conclusions: The reduction from baseline in total ALP at 12 weeks seen in this phase II study is consistent with the results shown in ALSYMPCA study. Overall, BAY 88-8223 was well tolerated in Japanese patients with CRPC and bone metastases. Clinical trial information: NCT01929655.