bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II study of capecitabine (X) as palliative treatment for patients (p) with squamous head and neck cancer (HNC) with locoregional and/or metastatic relapse after previous platinum-based treatment (PBT): An interim analysis
Authors: Martínez-Trufero J. , Isla D. , Adansa J. C. , Hitt R. , Cruz J. J. 
Published: March 2020

6074 Background: PBT is the standard therapy for HNC and is widely used as first line treatment. Nevertheless the incidence of relapse remains still high. Therefore, new non-platinum drugs need to be asses as second line treatment options. Taking into account the results obtained with X in HNC, we proposed this study to evaluate activity and tolerability of X when used as palliative monotherapy for relapsed HNC p previously treated with PBT. Methods: Patients aged 18–75 years, ECOG PS 0–2, with advanced squamous HNC with locoregional and/or metastatic relapse previously treated with PBT and adequate bone marrow, renal and hepatic functions were included. X (1,250 mg/m2 BID) during 14 days was administered every 21 days, for at least 2 cycles. Objective response rate (ORR) was assessed according RECIST criteria and toxicity following NCI-CTC v2 criteria. Results: Sixteen patients with median age 57 years old, all of them male, ECOG 0/1 (33.3% / 66.7%) and with squamous HNC, were analyzed. Twelve p had local disease, 4 p adenopathies and 6 p lung metastases. Median time since HNC diagnosis was 30.4 months and since disease extension diagnosis, 1.8 months. All p received a total of 58 cycles of X (median 3, range 1–6) and the median relative dose intensity was 92%. Four p were not evaluable for response (1 is still on treatment; 3 died, 2 due to unknown reasons and 1 due to an infection). ORR was 16.7%.The median follow-up time was 3.3 months, median TTP was 4.2 months and median OS was 4.7 months. Hematological toxicity G3/4 was reported in 2 p. The only grade 4 non-hematological toxicity was dysphagia in 1 p; grade III toxicities were: asthenia (2 p), anorexia (1 p), dehydratation (1 p), diarrhea (1 p), mucositis (1 p), weight loss (1 p) and palmar-plantar erythrodysesthesia (1 p). The most common grade II toxicity was asthenia (2 p). Conclusions: Capecitabine seems to be an active, feasible and well tolerated palliative treatment for advanced HNC patients that have previously received platinum-based schedules. No significant financial relationships to disclose.
Clinical predictors of larynx preservation (LP) after multiagent concurrent chemoradiotherapy (MCCRT)
Authors: Rodriguez C. P. , Adelstein D. J. , Rybicki L. , Saxton J. P. , Lorenz R. R. , Wood B. G. , Strome M. , Esclamado R. M. , Lavertu P. , Carroll M. 
Published: March 2020

6075 Background: Identification of patients (pts) with larynx and hypopharynx (HP) squamous cell cancer (SCC) most likely to benefit from a LP strategy remains problematic. We retrospectively reviewed the Cleveland Clinic experience using MCCRT to identify potential clinical predictors for success. Methods: Definitive CCRT was considered appropriate for pts with locoregionally confined larynx or HP SCC except for those with cartilage invasion or laryngeal destruction. Cisplatin (20 mg/m2/day) and 5-FU (1,000 mg/m2/day) were given as continuous intravenous infusions on days 1–4 during the first and fourth weeks of either once or twice daily radiation. Laryngectomy was only performed for locally persistent or recurrent disease. Results: Between 1989 and 2006, 115 pts were treated; 87 (76%) were male, and 102 (89%) were white. The median age was 59 (range 31–77) years. The primary site was the HP in 46 pts (40%) , supraglottis in 50 (43%) and glottis in 19 (17%). Tumor was T1 in 4 (3%), T2 in 31 (27%), T3 in 42 (37%), T4 in 37 (32%), and TX in 1 (1%). Disease was stage II in 8 (7%), III in 34 (30%), and IV in 73 (63%). With a median follow up of 62 (range 5–195) months, the 5-year Kaplan-Meier projected local control rate without surgery is 82%. Residual primary site disease was found in only 5 pts after MCCRT. Primary site recurrence developed in 14 more pts. Surgical salvage was successful in 13 of these 19 pts (68%). The 5-year projected local control rate (including surgical salvage) is 94%. Late complications after successful LP included permanent tracheotomy in 3, and feeding tube dependence in 7 pts. For all 115 pts, the 5-year projected freedom from recurrence is 64%, overall survival 58% and laryngectomy-free survival 52%. Local control without surgery was more likely in pts with T1–2 compared to T3–4 tumors (97% vs. 75%, P=0.01), but was not predicted by age, race, tumor differentiation, primary site, nodal status, stage, radiation schedule (daily vs. twice daily), baseline hemoglobin, or continued smoking. Conclusions: This MCCRT regimen can be expected to result in successful LP in all clinical subsets of appropriately selected pts with larynx and HP SCC. Although local failure was more likely in pts with T3 or T4 tumors, it was infrequent, and subsequent surgical salvage was highly effective. No significant financial relationships to disclose.
Efficacy of breast MRI in elderly women
Authors: Yu J. , Morris E. , Park A. , Cody H. , Gemignani M. L. 
Published: March 2020

608 Background: Breast MRI is useful in evaluating extent of disease and screening of high risk patients, especially younger patients with dense breasts. The utility of MRI in the elderly population is currently unknown. The purpose of this study was to review the use of breast MRI and MRI findings in elderly women. Methods: Retrospective review identified women over the age of 70 who underwent breast MRI at our institution between 11/2000 and 12/2005. Clinicopathologic features, MRI results and mammograms (MMG) were reviewed. Results: 228 patients were identified. The mean age was 73.5 years (range 70–91). Forty-three patients (19%) had no history of breast cancer, 99 (43%) had a history of breast cancer, and 86 (38%) had a current diagnosis of breast cancer at the time of MRI. Ninety-two patients (40%) underwent MRI for screening, 49 (21%) as further workup for an abnormal MMG or physical finding, and 78 (34%) for extent of disease assessment. MRI found 49 additional sites of abnormality and 15 additional cancers (14% false positive). Five cancers were detected in women with no current diagnosis of cancer. In patients with a diagnosis of cancer at the time of MRI, 10 additional cancers were found: 7 in the contralateral breast and 3 additional ipsilateral sites. Conclusions: MRI detected an additional 15 mammographically occult breast cancers in this population of women over the age of 70. MRI was efficacious in screening as well as evaluating extent of disease, with a relatively low false-positive rate of 14%. Breast MRI is a useful tool in the evaluation of elderly patients; further study in the use of MRI for screening in this population is needed. [Table: see text] No significant financial relationships to disclose.
Quantification of a panel of prognostic markers gives a novel method for predicting radiosensitivity in head and neck squamous cell carcinoma cell lines
Authors: Roberg K. B. , Farnebo L. , Norberg-Spaak L. 
Published: March 2020

6082 Background: The present study was undertaken to evaluate the possibility of using the expression of a panel of proteins involved in apoptosis and/or growth control as predictive markers for radiotherapy response. Methods: Nine head and neck squamous cell carcinoma (HNSCC) cell lines were selected to represent different parts of the spectrum of in vitro radiosensitivity. These cell lines have an intrinsic radiosensitivity (IR) between 1.4 and 2.6 measured with a 96 well plate clonogenic assay. Results: Fourteen proteins e.g. Bcl-2, Bcl-XL, Bax, Bad, Bak, Puma, survivin, COX-2, Hsp70, MDM2, p53, EGFR, cyklin D1 and SMAD4 were investigated in above mentioned cell lines and in normal oral keratinocytes (NOK). Each protein was quantified using Western blot analyse and the relative densiometric value from each blot was adjusted for actin and standardized to NOK. The correlation between each protein and IR was analyzed but none significant correlation was found. When combine different proteins, EGFR, Survivin, Bcl-2, Bak, Hsp70 and Smad4 together show the highest significant correlation to the IR. As Western blot is a semi quantitative method we decided that a division into groups depending on the level of protein expression would give a more realistic description of the prognostic value of the detected changes The protein expression was classified into four groups (0–4 point; no, small, middle or large changes compared to NOK) and each p53 mutation got one point. We named this grouping Number of Negative Points (NNP). The NNP for all 15 factors together show a significant correlations to IR, R=0.826 and P= 0.006. A multivariate statistical calculation was carried out to select the combination of factors that had the strongest correlation to IR and the best combination was EGFR, survivin and p53 mutations, R=0.935 and P<0.001. Conclusions: Our results show that it is only possible to predict the IR of tumor cells if combinations of prognostic factors can be analysed. Taken together, we here present a novel method that gives the possibility to combine different prognostic factors and which also enhances the chance to predict the radiosensitivity of HNSCC cells. No significant financial relationships to disclose.
Effect of oral pilocarpine on xerostomia and quality of life in patients receiving curative radiotherapy for head and neck cancers
Authors: Goyal S. , Sharma D. N. , Julka P. K. , Rath G. K. 
Published: March 2020

6088 Background: Xerostomia is the most debilitating condition following irradiation (RT) in patients with head and neck cancers. The present study intended to evaluate the effect of salivary stimulants such as pilocarpine given concurrent with RT on xerostomia and quality of life in these patients. Methods: In a prospective study conducted between July 2004 and May 2006, 60 patients receiving curative (radical or postoperative) RT for squamous cell head and neck carcinoma were randomized into two groups; group A (n=30) received concurrent pilocarpine 5 mg thrice daily for 12 weeks starting on day 1 of RT while group B (n=30) did not receive pilocarpine. Xerostomia was assessed using RTOG/EORTC criteria, and Quality of life (QOL) using EORTC QLQ-C30 version 3.0 and QLQ-H&N35 questionnaires in phases I-V: preradiation, week 4 of RT, and at 1, 3 and 6 months following completion of RT. Results: Oral dryness was the commonest toxicity, its incidence in phase II being 80% in group A and 89% in group B. By phase V, 13% patients in group A and none in group B had recovered to their pretreatment status. When compared with group B, group A had a significantly lower incidence of oral dryness in phases III (p=0.001), IV (p=0.014) and V (p=0.009) and lesser speech difficulty in phase V (p=0.021). QOL evaluation showed a decline in functional scores and rise in symptom scores during radiation with subsequent improvement to pretreatment levels in phase V. Group A had a significantly higher physical functioning score than group B in phases III (p=0.037) and IV (p=0.027), a better emotional functioning score in phases III (p=0.046) and IV (p=0.008), and a higher global health score, especially in phases II (p=0.012) and III (p=0.001). QLQ-C30 symptom scores were comparable between the 2 groups while H&N35 symptom scores were higher in group B with higher painkiller use in phase II (p=0.043) and IV (p=0.011), and higher dryness (p=0.025), sticky saliva (p=0.021) and constipation (p=0.011) in phase IV. Conclusions: Concurrent pilocarpine during head and neck RT helps maintain salivary function, reduces xerostomia and improves the quality of life in these patients, both during and after RT, especially in terms of parameters related directly to xerostomia. No significant financial relationships to disclose.
Cost-effectiveness analysis of the EORTC 24971 (TAX 323) trial comparing docetaxel plus cisplatin and 5-fluorouracil versus standard treatment (cisplatin and 5-fluorouracil) as induction chemotherapy followed by radiation therapy in locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN)
Authors: Jansen J. , Vermorken J. B. , Boote D. , Joulain F. , Parthan A. 
Published: March 2020

6090 Background: The phase III EORTC 24971 clinical trial (TAX 323) showed that induction chemotherapy followed by radiation therapy increases time to progression and improves outcomes in unresectable SCCHN patients. [Remenar et al. ASCO 2006; Abs 5516] Induction chemotherapy with cisplatin/5-FU (PF) is a standard regimen for patients with locally advanced SCCHN. The economic impact of adding docetaxel to cisplatin/5-FU (TPF) in this setting was assessed using a Markov state-transition model. Methods: The Markov model includes four health states (based on WHO criteria for measuring objective response): stable, response, progression, and death. Efficacy data from the TAX 323 clinical trial were used to derive transition probabilities between the health states. Adverse event rates were also derived from TAX 323. Data for resource utilization and costs for the UK were derived from the literature and from an advisory board of clinicians. In order to calculate quality adjusted life years (QALYs), utilities were derived by mapping the global score on the Health Related Quality of Life Questionnaire Core-30 (QLQ-C30) to the EQ-5D. Results: Patients survived longer in the TPF arm versus PF (2.5 vs. 2.0 years). Total costs for TPF and PF were £31,203 and £26,944, respectively. The incremental discounted cost per QALY gained for TPF versus PF was £9,859/QALY, which is below the £20,000 cost-effectiveness threshold suggested by NICE as a guide to the acceptability of a technology. Conclusion: Docetaxel, when given as induction chemotherapy in combination with cisplatin/5-FU, is cost-effective compared with PF in locally advanced unresectable SCCHN patients. Treating SCCHN patients with TPF followed by radiation represents good value for money based on the results of the analysis. No significant financial relationships to disclose.
The journey from cancer patient to cancer survivor: A 5-year longitudinal study
Authors: Snyder C. F. , Earle C. C. , Herbert R. J. , Neville B. A. , Frick K. D. 
Published: March 2020

6501 Background: The appropriate care for cancer survivors after active treatment ends is unclear. This study explores the mix of physician specialties survivors see and how this mix affects their receipt of preventive care. Methods: We conducted a retrospective, longitudinal cohort study of stage 1–3 colorectal cancer survivors age 65+ diagnosed in 1997. The cohort was followed for a 5-year survivorship period, starting 365 days after diagnosis. Using the SEER-Medicare database, we examined physician visits and preventive care services for each year during the five year survivorship period. We investigated how receipt of preventive services relates to the mix of physician specialties seen: primary care provider (PCP) only, oncologist only, both PCP and oncologist, neither PCP nor oncologist. Results: 1,541 patients met the eligibility criteria (mean age 76, 43% male, 85% White). Over the five years of survivorship, the mean numbers of PCP visits increased (4.2, 4.1, 4.5, 4.6, 4.7) while the mean number of oncology visits decreased (1.3, 1.0, 0.8, 0.7, 0.5). In year 1 of survivorship, 37% of patients saw both a PCP and oncologist, 44% only a PCP, and 8% only an oncologist. By year 5, the respective numbers were 21%, 62%, and 4%. The rates of cholesterol screening (33%), mammography (43%), and cervical cancer screening (19%) were highest during the first year of survivorship. Compared to patients who saw only a PCP, only an oncologist, or neither, patients who had visits to both a PCP and oncologist were more likely to get flu shots, cholesterol screening, mammograms, cervical cancer screening, and bone densitometry (all p<.0001). Conclusions: The mix of providers seen and preventive care received evolves during the first 5 years of survivorship. As shared care between PCPs and oncologists shifts to care by PCPs only, the rate of preventive care drops, particularly for cancer screenings. These results support the need for a survivorship care plan that explicitly outlines the roles of PCPs and oncologists and ensures proper preventive care. No significant financial relationships to disclose. [Table: see text]
Reliability of data collection for the National Comprehensive Cancer Network (NCCN) non-Hodgkin lymphoma (NHL) multi-center outcomes database: A methodological approach
Authors: Kho M. E. , Lepisto E. M. , Niland J. C. , terVeer A. , LaCasce A. S. , Friedberg J. W. , Weeks J. C. 
Published: March 2020

6525 Background: Clinical trials and outcomes studies often rely on non-physicians to abstract complex data from medical records. We assessed the reliability of chart abstraction among personnel groups in a multi-center outcomes study of indolent/aggressive NHL treated in NCCN centers. Methods: We developed 20 standardized charts of patients with newly-diagnosed NHL. Raters included 6 Clinical Research Associates from participating sites (CRAs), 3 project staff who conduct CRA training, and 3 medical oncologists. Raters each received a set of standardized charts, detailed instructions and training on a sample chart and abstracted all charts independently. We assessed reliability on 5 variables: MD-reported and rater-determined disease stage; International Prognostic Index (IPI- low-low intermediate, intermediate-high, high); Charlson comorbidity index score; and presence of any item from the Charlson index. We used intraclass correlation coefficients (ICCs) to calculate reliability. We considered coefficients from 0–0.20 ‘slight’, 0.21–0.40 ‘fair’, 0.41–0.60 ‘moderate’, 0.61–0.80 ‘substantial’ and >0.80 ‘almost perfect’(1). Results: Overall reliability was “almost perfect/substantial” for MD-reported stage, rater-determined stage, and IPI, but only “moderate” for the 2 Charlson-based comorbidity measures (Table). Reliability varied by rater group; no rater group was consistently more reliable than others. Conclusions: Trained CRAs abstracted key clinical variables with a very high degree of reliability, and performed at a level similar to study trainers and oncologists. Elements of the Charlson index were less reliable than other data types, possibly due to inherent ambiguity in the index itself. Use of trained CRA staff is reasonable to collect stage and IPI scores in a multi-center outcomes study, however abstracted Charlson scores should be interpreted with caution. (1)Biometrics. 1977. 33:159–74. No significant financial relationships to disclose. [Table: see text]
Preferences for adjuvant chemotherapy (ACT) in early breast cancer: The benefits needed to make extended treatment with docetaxel, doxorubicin, and CMF worthwhile
Authors: Duric V. , Francis P. , Simard-Lebrun J. , Chan A. , Chirgwin J. , Harvey V. , Sullivan A. , Simes R. , Coates A. S. , Stockler M. 
Published: March 2020

6528 Background: Small benefits are judged sufficient to make ACT worthwhile by women who have had either 6 cycles of CMF or 4 cycles of AC. We sought to determine the benefits needed to make longer and more intensive regimens worthwhile. Methods: 293 women who completed ACT 3 to 39 months earlier were presented 4 hypothetical scenarios based on known survival times (5 and 15 years) and rates (65% and 85% at 5 years) without ACT using validated, standardised interviews. 179 were in a randomized trial (BIG 02–98) testing addition of docetaxel (T) to a standard regimen including doxorubicin (A) and classical CMF; 114 were treated outside of the trial at the same centres. Women also rated their recollections of health-related quality of life during ACT. Results: The median age was 55 (range 25 to 78), 36% had a college or university degree, and 62% had dependants. The regimens (and their duration) in the trial were: 4 cycles of A or AC then 3 cycles of CMF (24w) in 31% of the women; 4 cycles of AT followed by 4 cycles of CMF (24w) in 29%; and 3 cycles of A then 3 cycles of T then 3 cycles of CMF (30w) in 40%. The regimens outside of the trial were: 4 cycles of AC (12w) in 52%; 6 cycles of CMF (24w) in 20%; and 4 cycles of AC then 3 cycles of CMF (24w) in 23%. A 2% gain in 5-year survival rates or a 6-month gain in survival duration was judged sufficient to make ACT worthwhile by 62–67% of women. Gains of more than 5% in 5-year survival rates or more than 2 years in survival duration were judged necessary to make ACT worthwhile by 10–20% of women. Women's preferences were strongly associated with the aversiveness of their treatment. Women who had more problems with physical well-being, coping with treatment, and nausea or vomiting judged larger benefits necessary to make their ACT worthwhile (p<.0001). Preferences were unaffected by chemotherapy regimen, duration, context in a trial, age, time between treatment and interview, and social circumstances (p>.2). Conclusions: As in previous studies, small benefits were judged sufficient to make ACT worthwhile, even if it lasted 6–7 months, and included docetaxel, doxorubicin and CMF. No significant financial relationships to disclose.
Estimating the real cost of adjuvant (adj) trastuzumab (T) in patients (pts) with HER-2+ (H+) early stage breast cancer (ESBC): Potential impact of reduced use of expensive oncology drugs (EOD) in metastatic breast cancer (MBC)
Authors: O'Cearbhaill R. , Wilson E. , deFrein A. , Qadir Z. , McDonnell D. , Crown J. 
Published: March 2020

6534 Background: Pts with H+ early stage BC have an approximately 35% risk of developing MBC (BCIRG001). T has been reported to reduce this risk by 33–50%, but costs approximately €;30k per pt, a burden some health systems deem unsustainable. This risk reduction might however result in decreased utilization of EOD in MBC, lowering the societal cost of adjT. We attempted to estimate the cost per relapse prevented (Crp), and the real cost of adjT, allowing for potential savings in prevented cases of MBC. Methods: We conducted a retrospective analysis of the mean cost per pt of AdjT (1 year) and of EOD in MBC in St. Vincent's University Hospital. We devised an equation to calculate the Crp for adj T. Crp=[A-M(NRA/104)]/[NRA/104] where A = cost per pt for adjT, M = EOD cost per pt with MBC, N = % of pts relapsing after standard adj treatment, RA = % reduction in the risk of relapse after adjT (over standard adj). Results: H+ pts with MBC received T (average 34 cycles €;2,400 each) with a combination of the following drugs: docetaxel (x8 €;1,500), gemcitabine (x5 €;1,215), capecitabine (x8 €;400), vinorelbine ( x19 €;187). Only 2 pts received bevacizumab (Bev) (x15 €;3,000). In our unit the mean EOD cost per pt with MBC was €;108k. The cost per relapse prevented for a 33% and a 50% reduction in relapse rate would be €;152k and €;63k, respectively. Furthermore, assuming a 50% reduction in the rate of relapse (from 35 to 17.5%) the real cost of adjT per pt treated is not €;30k, but approximates €;11k (€;30k×100-{17.5x €;108k}). Conclusions: The reduced utilization of EOD in MBC likely has a very beneficial impact on the societal cost of adjT. Confirmation of the efficacy of shorter adjT (e.g. FinnHer) would produce further benefit. The increasing use of novel EOD in MBC e.g. Bev would make adjT even more cost-effective. No significant financial relationships to disclose.