bluuebunny/crossref_metadata_2025_split huggingface dataset:
Induction gemcitabine and cisplatin followed by radiation therapy in advanced loco-regional head and neck cancer.
Authors: Jamshed Arif , Iqbal Hassan , Hussain Raza , Mehmood Tahir , Saeed Kamran , Sadaf Tabinda , Loya Asif , Masood Asif , Shah Mazhar Ali 
Published: March 2020

e16043 Background: This retrospective study was performed to evaluate the efficacy and toxicity of induction chemotherapy with gemcitabine and cisplatin (GC) followed by radiation / concomitant chemoradiation (RT/CRT) in advanced loco-regional head and neck cancer (LRHANC). Methods: Between 2005 - 2009, 446 newly diagnosed advanced LRHANC patients were treated with induction GC followed by RT/CRT in our institution. M 69%: F 31%. Median age 50 years (range 18 – 81 years). Site; oral cavity 232 (52%), hypopharynx 45 (10%), nasopharynx 63 (14%), larynx 46 (10%), oropharynx 14 (3%), paranasal sinuses 33 (8%) and others 13 (3%). Histology; squamous cell carcinoma 373 (84%), undifferentiated carcinoma 53 (12%), others 20 (4%). Pre treatment AJCC stage (6th edition); T1-3 N0/N+ 139 (31%), T4 N0/N+ 307 (69%). Induction chemotherapy consisted of cisplatin 75 mg / m2 day 1 and gemcitabine 1 gm / m2 day 1 and 8 every 3 weeks. 383 (86%) patients received 2 cycles of induction GC. CRT with 3 weekly cisplatin 75mg/ m2 was given in 299 (67%) and RT alone in 147 (33%) patients. Radiation doses ranged from 55Gy - 70 Gy in 20 - 35 fractions. Results: Minimum follow-up was 2 years. Response to induction chemotherapy; complete response (CR) 58 (13%), partial response (PR) 315 (71%), stable disease (SD) 55 (12%) and progressive disease (PD) 18 (4%). Response to RT/CRT; CR 293 (66%) and persistent disease at 3 months post radiation in 153 (34%) patients. G3/G4 toxicity on induction GC was anemia 2%/0%, neutropenia 17%/4%, thrombocytopenia 2%/1%, vomiting 5%/1% and diarrhea 5%/1%. G1 transient elevation of ALT/ AST was 17% /11%. G3/4 elevation of creatinine was 2 %/1%. Nine patients (2%) had toxicity related hospital admissions during RT/CRT. The 5-year actuarial overall survival and relapse free survival were 67% and 44% respectively. Local control, regional control and distant control rates were 62%, 50% and 49% respectively. Conclusions: Induction GC followed by RT/CRT is a safe and effective approach in untreated head and neck cancer and merits further evaluation in controlled clinical trials.
Retrospective review of patients treated with intensity modulated radiation therapy (IMRT) with or without concurrent chemotherapy for locally advanced thyroid cancer: The Dana-Farber experience.
Authors: Kodali Swati , Limaye Sewanti Atul , Shreenivas Aditya V. , Zhao Dave , Lorch Jochen H. , Tishler Roy B. , Margalit Danielle Nina , Posner Marshall R. , Haddad Robert I. 
Published: March 2020

e16060 Background: Chemotherapy has been used concurrently with radiation for local control as adjuvant treatment or for locally recurrent thyroid cancer. We present our experience using IMRT with or without sensitizing concurrent chemotherapy in this setting. Methods: All patients with thyroid carcinoma with or without minimal metastatic disease treated since 2005 at DFCI were reviewed. We collected data and analyzed the outcomes of patients treated with IMRT with or without concurrent chemotherapy for local control. Results: Twenty-two patients were identified: 13 Males, 9 Female, Median age 60 years There were 11 papillary, 6 medullary, 4 anaplastic, and1 follicular. Thirteen patients were treated adjuvantly, seven for locally recurrent disease and two definitively for unresectable disease. All patients with papillary and follicular thyroid cancer had prior surgery and radioactive iodine therapy. Patients with medullary carcinoma had surgery alone. Two patients with anaplastic carcinoma had surgery and two were found to be unresectable.. Seventeen patients received concurrent weekly carboplatin AUC1.5 and paclitaxel 30mg/m2 with radiation. Five patients did not receive any concurrent chemotherapy and were treated with radiotherapy alone. Radiation fields encompassed the thyroid bed, bilateral neck and in some cases the mediastinum. The radiation dose ranged from 5600cGy to 6600cGy. Mean follow up was 42 months. The overall survival at 36 months was 89.5% (95% CI, 76.7-100). Two patients with unresectable anaplastic thyroid cancer died from progressive disease. Loco-regional control rate at 36 months was 78.9% (95% CI, 62.6-99.6). No grade 3 or 4 toxicities were reported during treatment. Conclusions: IMRT with or without concurrent chemotherapy provided excellent loco regional control and might have contributed to improved overall survival in patients with locally advanced thyroid cancer.
A phase I study of everolimus in combination with cetuximab and cisplatin as first-line therapy inrecurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Authors: Chung Christine H. , Wang Hao , Tsottles Nancy , Gourin Christine Gail , Agrawal Nishant , Molinolo Alfredo , Gutkind Silvio , Forastiere Arlene A. , Marur Shanthi 
Published: March 2020

e16061 Background: The AKT/mTOR pathway emerged as a promising therapeutic target and as a potential mechanism of EGFR inhibitors in HNSCC. To assess the prevalence of AKT/mTOR pathway activation, HNSCC tumors were stained with phospho-specific AKT (pAKT) antibody. To test a hypothesis that resistance to an EGFR inhibitor, cetuximab, can be overcome by mTOR inhibition, we conducted a phase I clinical trial combining everolimus, cetuximab and cisplatin in R/M HNSCC. Methods: A TMA of 153 cores from 51 HNSCC was stained with a pAKT antibody (Ser473), and digitally quantified with TMAJ software. For the trial, patients with ECOG PS 0-2 with no prior systemic therapy for R/M HNSCC were enrolled and escalating doses of everolimus (2.5, 5, or 10mg) were administered daily, cetuximab 250mg/m2 weekly, and cisplatin 40mg/m2 days 1 and 8. Each cycle was 28 days. Response was evaluated with CT/MRI and PET scans after every 2 cycles. Biospecimens to analyze the EGFR and AKT/mTOR pathways were collected. Results: pAKT staining data were evaluable in 123 cores from 45 tumors. Nine patients were accrued before the study was terminated. Five evaluable patients progressed rapidly within 12 weeks after enrolling in the study (median PFS=2.8 months, 95% CI [1.6, 13.9]). Two patients received everolimus at 5mg, and both patients were dose reduced to 2.5mg for grade 3 hypophosphatemia, infection and mucositis. Among the 7 patients enrolled to receive 2.5mg, 3 patients received the treatment until progression of disease, 2 patients were taken off the study due to grade 4 infusion reaction to the first dose of cetuximab and non-adherence to everolimus, and 2 patients withdrew consent. The 5 evaluable patients had a PET response after 2 cycles. The proposed biomarker results will be available at the time of presentation. Conclusions: While AKT/mTOR is a promising therapeutic target, a combination of everolimus, cetuximab and cisplatin was poorly tolerated even at the lowest dose level of 2.5mg daily with unexpected toxicities suggesting that this combination should be studied with a caution in patients with R/M HNSCC.
Quality of life in cancer survivors compared with the general population.
Authors: Blaes Anne Hudson , Baker Kevin Scott , Benson Brad , Bliss Robin L. , Lee Jill Lunsford , Neglia Joseph Philip , Mulrooney Daniel A. 
Published: March 2020

e16502 Background: Assessments of quality of life (QOL) among cancer survivors have had mixed results. Literature suggests that those treated with cranial irradiation (CNS) or stem cell transplantation (SCT) have a poorer quality of life. Methods: 309 cancer survivors (37 adult and 241 childhood malignancies, 31 SCT survivors) completed the Medical Outcomes Study 36-Item Short Form Healthy Survey (MOS SF-36). Demographic, disease and treatment characteristics were assessed and inter-group heterogeneity tested across three survivor groups (F-test for age; chi-square for disease and treatment characteristics). Aggregate data analysis for SF-36 composite and norm-based scoring measures was undertaken by using the mixed effect model with unequal random effect variances across studies. Treatment characteristics included age at diagnosis, current age, site of disease [cranial (y/n)], chemotherapy (y/n), radiation therapy (y/n), SCT with/without total body irradiation (TBI). All statistical tests were two-sided, P-values < 0.05 considered statistically significant. Results: The mean age at assessment was 33.4 years. 255 (83.9%) received chemotherapy, 187 (60.7%) radiation, 49 (15.9%) underwent SCT. Among those irradiated, 28 (9.1%) had TBI and 62 (20.1%) had CNS irradiation. The MOS SF-36 physical composite score was 50.5 (9.5-73.3) and mental health composite score was 50.2 (9.2-55.9). Pooled results for the MOS SF-36 included: bodily pain 51.9 (19.9-62.1), general health perceptions 46.7 18.6-63.9), mental health 50.6 (16.2-64.1, physical functioning 51.0 (14.9-57.0), role emotion 50.2 (9.2-55.9), role physical 50.2 (17.7-56.9), social functioning 49.5 (13.2-56.9) and vitality 51.9 (20.9-70.8). No significant variation from the general population median normative values (50.0) was identified, including those treated with CNS and SCT. There was no difference in QOL amongst those treated as children, young adults (ages 15-30 years) or adults. Role physical declined significantly with advancing age (p=0.02). Conclusions: In spite of the chronic conditions prevalent among cancer survivors, the overall QOL of most cancer survivors, including those who have received CNS or SCT, is comparable to that of the general population.
Racial disparities in survival of adult T-cell leukemia/lymphoma patients in the United States: A SEER database analysis.
Authors: Raj Renju V. , Basu Sanjib , Boggio Lisa N , Fung Henry C. , Gregory Stephanie A. , Venugopal Parameswaran , Rich Elizabeth Shima 
Published: March 2020

e16503 Background: Adult T cell Leukemia/Lymphoma (ATL) is an aggressive lymphoproliferative disorder etiologically linked to Human T cell Lymphotropic Virus -1 (HTLV-1). HTLV-1 infection is endemic in areas of Japan, the Caribbean, South America, and Africa. ATL runs a very aggressive clinical course. It is a rare malignancy in the United States (US), and epidemiologic data are limited. We undertook a Surveillance Epidemiology and End Results (SEER) based database analysis to identify survival data of ATL patients (pts) with emphasis on race and ethnicity. Methods: We used the SEER 17 Registry data (1973-2008) for pts with a confirmed diagnosis of ATL. ICD-O-3 code 9827/3 was used to identify pts with ATL. The following exclusion criteria were used: diagnosis at death certificate or autopsy, no follow-up records, diagnosis of second malignancies or lack of documentation of sex or age at diagnosis. The Kaplan Meier method was used to evaluate survival in different races. Statistical tests were done utilizing R statistical software. Results: 272 patients were included in the final analysis (126 females; 146 males). Pts were stratified by race: White (155), Black (80), Other (33), Unknown (4). Median age (yr) of diagnosis in Blacks (51.5) was lower than in Whites (65) and other races (65). Average age of diagnosis in Blacks was significantly lower compared to Whites (p=0.002) and non-Blacks (p=0.0008). Survival analysis of the study group showed a median overall survival (OS) of 13 mo (95%CI 10-16). Whites had a higher median OS (21 mo) compared to blacks (5 mo); the difference in survival was strongly significant (Log-rank p-value < 0.001). Differences in survival between blacks or whites compared to other ethnic and unknown racial groups (n=37) were not statistically significant. Conclusions: ATL is a rare malignancy with poor prognosis in the US. Epidemiologic data on survival are limited. Blacks tend to have an earlier onset of disease and a poor prognosis compared to whites. The reasons for this aggressive course and earlier age of diagnosis in blacks are unknown.
Second-year results of the first large-scale, multistate BCBS clinical oncology pathway program.
Authors: Koeller Jim M. , Kreys Eugene 
Published: March 2020

e16522 Background: Clinical pathways (CP) are viewed as valuable practice tools leading to presumed cost savings, however none have been fully implemented on a state-wide scale. CareFirst BCBS partnering with P4 Pathways implemented a multi-state oncology CP program in Aug., 2008. The CP included both chemotherapy (chemo) and supportive care (SC). Our study goals were to determine year (yr) 2 physician (MD) compliance (compl) to CP, their effects on drug and hospitalization (hosp) cost, and their ability to curb projected cost increases. Methods: This study used a retrospective single-group, pretest-posttest design. Data representing pre-CP yr -1 (2007-08) and two years after CP initiation, yr +1 and +2 (08-10) were obtained from claims data. The dataset contained breast, colorectal and lung cancer. One claim from each of the 3 yrs was needed for site eligibility. First and 2nd yr compl was defined as 65% and 80%, respectively, use of chemo regimens according to CP by site. Compl for SC was defined as 80% use of agents per CP for each year. Drug and hosp (occurring within 30 days of chemo regimen) cost were calculated. Savings were determined by extrapolating results on a per patient basis and comparing them to projections cost increases for yr +2. Results: Overall, 46 sites representing 193 MD’s, 4713 pts and 110,203 claims met inclusion criteria. The uncorrected site compl rate for chemo was 83% and 54% for yrs +1 and +2 respectively, while SC site compl was 74% for both yrs. Compared to yr -1, per patient drug expenditures ↑ by 5.8% in yr +1 and 2.7% in yr +2. Per patient hosp costs ↓ by 4.2% in yr +1 and 8.3% in yr +2 compared to yr -1. Total hosp costs ↓ by 28.4% in yr +1 and 63.4% in yr +2 compared to yr -1. Using national data to project drug cost ↑ of 14.5% and hosp cost ↑ of 9.5% yearly over yrs +1 and +2, the CP provided an estimated $36 million in savings by yr +2, with $23 million due to drug and $13 million due to hosp. An absolute $7+ million savings for yr +2 would still have been seen if we assume no ↑ in drug & hosp spending over the 2 yr period. Conclusions: Reasonable MD compliance can be achieved on broad scale use of CP. CP reduce chemotherapy and hosp expenditures, although an increase use in supportive care was seen. Total costs savings can be substantial.
Readability of websites containing information about prostate cancer treatment options.
Authors: Ellimoottil Chandy , Polcari Anthony , Kadlec Adam , Gupta Gopal Nand 
Published: March 2020

e16544 Background: 90 million adults have literacy skills that test below a high school reading level. Websites written above this level can pose a challenge for those seeking more information about prostate cancer treatment options. In this study, we determine the readability of selected websites, using a systematic search process and validated readability formulas. Methods: We identified the three most popular keywords (“prostate cancer,” “prostatectomy,” and “prostate cancer treatment”) from 513 terms related to prostate cancer treatment options. Three physician searchers (CE, AP, AK) systematically collected 270 websites from the top three search engines, representing 95 % of all internet searches (Google, Yahoo, and Bing). We excluded sites that were non-English, not primarily text, irrelevant and/or duplicated, and then categorized the remaining sites by source (government, academic practice, nonacademic practice, commercial, nonprofit, news, health website, other) and treatment type. We used validated readability instruments, the Flesch-Kincaid (FK) grade level and Flesch reading ease, to calculate scores for each site. We also calculated an intraclass correlation coefficient, in order to assess inter-rater agreement among our three searchers. Results: Sixty-two unique websites were available for analysis. The mean FK grade level of all sites was 11.4 (SD +/- 0.95, range 8.0-12.0), indicating that on average, passages were written at an eleventh grade reading level. The mean Flesch reading ease score on all sites was 35.6 (SD +/- 15.7, range 0.0-65.5), indicating that on average, passages were slightly easier to read than passages more suited for university graduates (0-30). Only three sites (4.8%) were written below a high school reading level (< 9.0). The intraclass correlation coefficient between the three searchers was 0.96 for grade level and 0.97 for reading ease. Conclusions: Few websites with discussions on prostate cancer treatment options are written below a high school reading level. This is problematic for patients with a low literacy level who search online for more information. Clinicans should be aware of this finding and guide patients to websites written at their patient's reading level.
Geographic disparities in care: The Maryland gynecologic oncology experience.
Authors: Fleming Saroj , Amrane Selma , Rao Gautam G. , Temkin Sarah Madhu 
Published: March 2020

e16546 Background: Women with gynecologic malignancies require highly specialized care that is often unavailable at local centers. Prior reports have suggested that distance from residence to treatment facility is a barrier to care. We hypothesize that insurance status influences the distance women travel to receive gynecologic cancer care. Methods: Patients with incident gynecologic cancer diagnoses at a single urban, academic Institution were identified. Distance from the patients’ homes to the hospital was calculated in miles as well as time. Insurance status at diagnosis was captured as private (P), Medicaid (MA), Medicare (MC) or uninsured (UI). Results: 153 patients were identified. The median distance travelled to the hospital was 18.1 miles with a median time travel of 28 minutes. 48 (31%) of patients were insured by P, 42 (27%) by MA, 35 (23%) by MC and 28 (18%) were UI. Patients with MC were older than those with MA, P or UI (p<0.01). Patients with P were more likely to present with cancer of the uterine corpus (p<0.01). African American women were more likely to be covered by MA than other racial groups (p<0.01). Rates of medical comorbidities (obesity, diabetes and hypertension) were similar between insurance groups, although there was a trend towards higher body mass index in UI (p=0.08). Mean distance and time to the hospital by insurance category is shown in Table 1. The distances and times were different between groups (p=0.04, p=0.03 respectively). These differences remained significant when adjusted for site of primary disease and race (p<0.01). Adherence with treatment recommendations was similar regardless of insurance status or distance travelled. Conclusions: Insurance status plays a role in the distance women travel to receive gynecologic cancer care. The neediest patients may be shouldering an unfair burden in terms of access to specialty oncology treatments. [Table: see text]
Correlation between 21-gene recurrence score assay with Nottingham prognostic index (NPI) and Adjuvant! Online (AO) prognostic tools in newly diagnosed patients with early-stage breast cancer in midwestern Ireland.
Authors: Quintyne Keith Ian , Woulfe Bernie , Gupta Rajnish K. 
Published: March 2020

e16551 Background: Prognostic tools such as NPI and AO have been used to help stratify early stage breast cancer patients into specific risk-related groupings. With the development of molecular biological gene expression assays, both predictive and prognostic information for patients with early stage endocrine positive breast cancer can be determined. We herein report our experience with the use of a 21-gene recurrence score (RS) assay, it’s correlation with NPI and AO, and explore the comparative outcome for patients in MWCC, Limerick, Ireland. Methods: Study period: 01/09/2008 – 31/12/2012. Data was derived from (1) MWCC Oncology database (2) MWRH pathology reports (3) MWRH patient files (4) RS assay reports. Data was collated and entered into an Access database and exported into Predictive Analytics Software for analysis. Results: Seventy-seven (77) patients with early stage endocrine positive breast cancer were analysed. Median age: 55.9 years (range: 30.6 – 72.3 years). Median follow-up: 15.4 months. NPI distribution was: excellent – 9%, good – 53%, moderate – 38% and poor – 0%, with median NPI score – 3.36. RS distribution was: low – 49%, intermediate – 43% and high – 8%, with median RS – 18. The RS correlated poorly with NPI predictions. The median AO benefit 10-year survival with no additional therapy – 81.4%, the median AO additional benefit 10-year survival of chemotherapy (CT) – 1.2% and median AO additional benefit 10-year survival of CT and hormonal therapy (HT) – 3.9%. The RS also correlated poorly with AO predictions. Conclusions: Prognostic tools are useful in evaluating and predicting the possible outcome, but they do not correlate well with this 21-gene RS molecular assay, as seen with our cohort. These tools should therefore be used in tandem, together with good clinical judgement on an individual basis when advising patients on potential treatment pathways. Further long term evaluation is required.
Early-phase (EP) clinical trials (CTs) in the community: Results from the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) Early-Phase Working Group (EPWG) Baseline Assessment Study (BAS).
Authors: Go Ronald S. , Zaren Howard , Nair Suresh G , Lanier Keith S. , Thompson Michael A. , Enos Rebecca A. , Zhao Jinxiu , Fleming Deborah L. , Leighton John Charles , Gribbin Thomas Edward , Bryant Donna M. , Carrigan Angela , Corpening Jennifer C. , Csapo Kimberly A. , Dimond Eileen P. , Ellison Christie , Gonzalez Maria Magdalena , Harr Jodi L. , Wilkinson Kathy , Denicoff Andrea ,   NCCCP Early-Phase Working Group
Published: March 2020

e16561 Background: The NCCCP is a network of 30 community cancer center (CCC) sites that strive to expand cancer research capacity and deliver advanced care in the community. The EPWG was formed to facilitate NCCCP site participation in EP (phase I-II) CTs, thus allowing patients (pts) to be treated within their communities. This study describes the CT infrastructure at NCCCP sites and its association with EP accrual. Methods: A BAS was conducted to obtain data on NCCCP site CT infrastructure, funding, sponsor affiliations, and barriers to EP CTs. To evaluate EP performance, EP accruals during July 2010-June 2011 were obtained. High accruing sites were those with EP accrual above the median EP accrual per 1,000 new analytical cases seen in 2009 or 2010. Results: 27 sites, caring for ~56,000 new cancer pts annually, participated in the study. Median number of accruing EP trials/site was 6 (mean 7.4). Median EP accrual/site was 14 (mean 16). Median EP accrual rate was 7/1,000. Trials with a phase I component were open at 21 sites. Most sites (24) are members of multiple CGs (median 4) and enroll pts via the CTSU (70%). The more common barriers to EP trial implementation were related to infrastructure (59%), cost (52%), and access to trials (41%). When accrual rates to NCCCP CTEP EP trials only were analyzed, we found that between high vs low accruing sites, respectively, higher accrual rates were associated with higher number of CRAs devoted to EP trials (median 3.25 vs 1; P= .05) and lower proportion of funding from industry (median 18% vs 40%; P=.02). We did not, however, find significant associations when EP trials were examined across all sponsors. Conclusions: CCCs are capable of conducting, and actively participating in, EP trials. Infrastructure and collaborations are critical components of success. Our study provides useful information for those planning to begin EP trials in the community setting. [Table: see text]