bluuebunny/crossref_metadata_2025_split huggingface dataset:
Preliminary results of the validation of a patient (pt) self-administered questionnaire (Oral Mucositis Weekly Questionnaire-Head and Neck [OMWQ-HN]) to assess the impact of OM on pain and functioning in head and neck cancer (HNC)
Authors: Epstein J. B. , Beaumont J. L. , Gwede C. K. , Trotti A. , McDowell M. , Murphy B. , Garden A. , Meredith R. , Quynh-Thu L. , Brizel D. 
Published: March 2020

5548 Background: Pt self-reported questionnaires measuring acute and specific effects of OM are needed to assess effects of interventions and guide patient care. We evaluated the feasibility, validity, and reliability of the OMWQ-HN on OM and its impact on pts’ abilities to perform alimentary and other routine functions. Methods: Validity and reliability of the OMWQ-HN was assessed in 75 pts from a prospective multicenter study receiving radiotherapy ± chemotherapy (RTCT). Assessments included test-retest reliability, internal consistency reliability, and cross-sectional validity. The OMWQ-HN’s sensitivity to detect change was demonstrated by using the changes in the Performance Status Scale for HNC (PSS-HN) and the Functional Assessment of Cancer Therapy (FACT-HN) to form 3 independent groups (better, no change, worse) for comparison. Effect sizes (ES) were calculated for group comparisons to measure the clinical significance of differences. Results: Compliance rates were >90% throughout the study. The OMWQ-HN demonstrated good test-retest reliability (r = 0.89). Cronbach’s alpha was >0.85 and mouth, throat, and pain-related items correlated highly with each other (r>0.7). Cross-sectional analyses to assess validity showed that OMWQ-HN scores were different across levels of pain, with those in the worst pain category reporting the most severe OMWQ-HN scores (ES >0.5 for all comparisons). The OMWQ-HN was sensitive to change in FACT-HN and PSS-HN (p < 0.001 and p = 0.013, respectively). Patients reported increases in mouth and throat soreness (MTS) that corresponded with a steady decline in oral function. Conclusions: These results indicate the OMWQ-HN is a feasible, valid, and reliable instrument for assessing the impact of mucositis on patients receiving RTCT in the HNC patient care setting. [Table: see text]
Re-irradiation with concurrent chemotherapy for recurrent head and neck cancer
Authors: Roman E. , Raez L. , Biagioli M. , Harvey M. , Blaya M. , Tolba K. , Bathia R. , Markoe A. 
Published: March 2020

5559 Background: Despite aggressive therapy, over 70% of locally advanced squamous cell carcinomas of the head and neck (SCCHN) fail primary treatment. Salvage therapy with surgery, chemotherapy or brachytherapy alone or in combination has a 30–40% response rate, but few long-term survivors. Re-irradiation with concurrent chemotherapy for SCCHN has recently become a well established approach after two consecutive cooperative group studies were reported. Intensity Modulated Radiation Therapy (IMRT) is a new and safer way to deliver radiation therapy. This retrospective review evaluated the potential benefit and toxicity using every other week IMRT with concurrent chemotherapy. Design: Thirty-seven patients with locally recurrent SCCHN were evaluated. All patients received re-irradiation with IRMT every other week with concurrent weekly carboplatin (median AUC= 2) or cisplatin (60–100 mg/m2) ± 5-FU (800–1000 mg/m2) or paclitaxel 175mg/m2 every three weeks. Patients received 6000 cGy at 200 cGy per fraction. Results: The median follow-up time was 12 months. The overall response rate was 75.7% with a complete response (CR) and partial response (PR) of 56.8% and 18.9%, respectively. Among complete responders, 33% recurred locally in a median time of 5 months. The Kaplan-Meier estimate of disease-free survival, progression-free survival, and overall survival at 48 months is 58%, 45%, and 28%, respectively. At the time of last follow-up, 51.4% of patients were still alive and 27.8% of patients had no evidence of disease. Grade 3 or 4 acute toxicities occurred in 20% of patients of which 13.3% were hematologic requiring either growth factors or delay in chemotherapy. No deaths occurred during the course of treatment. Long-term complications consisted of one patient with an esophageal stricture requiring repeated dilations, 2 patients with chronic dysphagia, and 2 patients developing a pharyngeal-cutaneous fistula, one of which died from a carotid blowout occurring 6 months after treatment. Conclusions: IMRT delivered every other week with concurrent platinum based chemotherapy produces good responses with only moderate toxicity in patients previously treated with radiation therapy for recurrent head and neck cancer. No significant financial relationships to disclose.
Minimally invasive laser-induced thermal therapy (LITT) for head and neck cancer: A comprehensive review
Authors: Paiva M. B. , Bublik M. , Wong S. , Blackwell K. E. , Sercarz J. A. 
Published: March 2020

5572 Background: Laser induced thermal therapy (LITT) has been developed in a step-wise fashion at UCLA as a minimally invasive treatment for head and neck cancer. Initial Phase-I studies demonstrated the feasibility and safety of using the Nd:YAG laser (near infra-red nm) for thermal ablation of tumors as a palliative treatment in 62 patients. This was followed by the current Phase II study that confirmed such finding using higher laser power densities (P.D. = 1,600–2,200 J/cm2). Patients and Methods: This was a single group study in patients with recurrent carcinoma of the head and neck, who failed at least one treatment modality, and had a Karnofsky performance status ≥ 70%, and ECOG performance status ≤ 2. The primary end points of the study were objective tumor response, and survival. Prognostic values were assessed by uni- and multivariate analysis using the Kaplan-Meier method and Cox model, respectively. Results: In this Phase II study, we review our results on 104 patients with recurrent head and neck cancer that were treated by LITT. Best results were seen in oral cavity tumors where Kaplan Meyer curves showed average survival of 20.3 months (10.7–30 mo; 95% CI) compared to neck (avg. = 14.4 months, 7.5–20.7 mo; 95% CI) and other tumor sites, (avg. = 18 months, 13.8–22.3 mo; 95% CI). Further analysis of neck treatments showed that tumors away from the common carotid in cervical lymph nodes located in levels I, IV, and V had median survival of 25.9 months (mean = 37.7 mo), compared to 11.4 months (mean = 10.9 mo) in patients with tumors near, or encroaching the carotid in upper and lower jugular levels II and III. In univariate analysis, a trend toward a better survival was observed when tumor proximity to carotid artery was considered prognostic categories (log-rank P = .0007). However, in multivariate analysis, TNM stage, and reconstruction using free flap transfer, but not age and histology, were retained as independent prognostic variables (P < .001). Conclusion: LITT Patients tolerated LITT well on an outpatient basis, and were successfully palliated for periods ranging from 39 days to 90 months post-treatment. Based on the findings of this study it was possible to show that proximity to the carotid artery was the most relevant factor in projecting patient survival. No significant financial relationships to disclose.
Role of endocrine responsiveness and adjuvant therapy in very young women (< 35 years) with operable breast cancer and node negative disease
Authors: Orlando L. , Cardillo A. , Ghisini R. , Rotmensz N. , Peruzzotti G. , Maisonneuve P. , Viale G. , Goldhirsch A. , Colleoni M. 
Published: March 2020

558 Background: Breast cancer rarely occurs in young women. There is limited knowledge about prognosis, and treatment effects in the population with node negative disease, largely dependent upon older series and extrapolation of data from older age cohorts. Methods: We evaluated biological features and adjuvant treatment recommendations for 841 premenopausal consecutive patients with pT1–3, pN0 and M0, operated and counseled for medical therapy from April 1997 to December 2001. We evaluated also, the prognostic role of age and adjuvant treatment. Median follow-up was 49.9. Results: Very young women (101, 12%) were more likely to have tumors with absent ER (42% v 17.6%, p < .0001) and PgR (48% v 23.2%, p < .0001), > 2 cm (36.7% v 24.8%; p = .002), grade 3 (53.9% v 33.5%; p = .0009) and elevated Ki-67 (68.5% v 51.6%; p = .002), when compared with older patients (740, 88%). Younger patients (compared with older patients) with endocrine responsive disease were prescribed more chemotherapy (67.2% v 44.3%; p = .0009) but endocrine adjuvant therapy was prescribed in a similar percentage in both groups (93.1% v 96% p = .30). A statistically significant difference in disease-free survival (DFS), risk of distant metastases and overall survival (OS) was observed at the multivariate analysis for younger patients (HR = 4.44; 95% CI, 2.53 to 7.78, p < .0001 for DFS; HR = 3.23; 95% CI, 1.32 to 7.94, p = .011 for distant metastases; HR = 2.89; 95% CI, 1.06 to 7.87, p = .038 for OS). An increased risk for younger age was observed for patients with endocrine responsive disease (ER ≥ 1%) (HR = 5.17; 95% CI, 2.72 to 9.83, p < .0001 for DFS) in particular if endocrine therapy was not performed (HR = 7.77; 95% CI, 1.98 to 30.6, p = .003 for DFS). Conclusions: We conclude that compared with less young premenopausal patients, the very young women presenting with breast cancer and ipsilateral axilla negative for disease, are at larger chance of relapse. Endocrine therapies are crucial in patients with endocrine responsive disease. No significant financial relationships to disclose.
Longitudinal Oncology Registry of Head and Neck Carcinoma (LORHAN), a new national cancer registry
Authors: Curran W. , Chen A. , Harari P. , Murphy B. , Wong S. , Bellm L. , Gamber D. , Dawson D. , Ang K. 
Published: March 2020

5583 Background: Registries can be invaluable for describing patterns of care for a population of patients (pts). Most cancer registries, however, do not possess sufficient breadth or depth to provide a complete and reliable picture of clinical practice. We report the launch of LORHAN, a new national registry of head and neck carcinoma (HNC) pts. LORHAN is designed to extend current cancer registries by providing detailed data on radiation and/or cancer drugs delivered to HNC pts in all practice settings. Methods: This is a prospective, multi-center, longitudinal, observational registry. Pts with newly diagnosed HNC, scheduled to receive radiotherapy or drug therapy, ≥18 years of age and providing written informed consent are being enrolled. Patients participating in clinical trials are eligible for LORHAN. The primary objective of the registry is to describe, in detail, patterns of care for HNC pts. The secondary objectives are to document outcome by treatment regimen, determine the incidence and severity of major toxicities and to identify supportive care received for managing treatment-related complications. Pts are entered in the registry from the time of initial diagnosis and are followed for at least 2 years and up to 10 years. Detailed information on initial treatment and re-treatment is collected. Data entry is electronic and incorporates encrypted point-to-point data transfer via secure HTTP protocols. Physician and patient confidentiality are strictly maintained. Participating practitioners can review and compare their data on a real-time basis to the database. Registry pts may be linked to the NDI to minimize lost to follow-up. Analyses of data are primarily descriptive. Results: LORHAN was launched in Oct. 2005, and as of Dec., 7 sites have received IRB approval and 3 pts have been enrolled. Of the 7 sites, 1 is an academic site and the remaining are community-based practices. An additional 21 sites (17 academic, 4 community) are at various stages of participation. More than 100 medical oncologists and radiation oncologists are anticipated to participate and approximately 26,000 pts will be eligible each year. Accrual status will be updated. Conclusions: LORHAN is a new national initiative that may further the understanding of the care of HNC pts across practice settings. [Table: see text]
Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): Sequential vs. combined therapy results from a MOSG randomized phase III trial
Authors: Soto C. , Torrecillas L. , Reyes S. , Ramirez M. , Perez L. , Cervantes G. , Gonzalez F. , Tellez E. , Cortes P. , Benitez H. 
Published: March 2020

570 Introduction: Capecitabine (Xeloda [X]) shows synergy with taxanes and adding X to docetaxel (T) extends overall survival (OS), response rate (RR) and progression free-survival (PFS) beyond T alone. Sequential single-agent therapy could confer convenience benefits and may be more appropriate than combination chemotherapy for some pts. Methods: Pts with anthracycline-pretreated MBC received 3-weekly cycles of 1 of the following regimens: X→taxane (X 1250mg/m2 bid d1–14, followed after progression (PD) by T 100mg/m2 or paclitaxel [P] 175mg/m2 day 1; X+P (X 825mg/m2 bid days 1–14 + P 175mg/m2 day 1) or X+T (X 825mg/m2 bid days 1–14 + T 75mg/m2 day 1). Results: Of the 368 pts enrolled, 91 are either still on therapy or not evaluable. The table shows baseline characteristics, efficacy and safety in evaluable pts. Median follow up is 15.5 months. Median doses for X in each arm (1st cycle vs. 8th cycle, mg/m2 bid): 1218 vs. 1054; 948 vs. 900; 846 vs. 751. Median doses for P and T (1st cycle vs. 8th cycle, mg/m2): 173 vs. 169 and 75 vs. 72, respectively. In the X→taxane arm, 58 pts (64%) received sequential taxane; the remainder did not receive a taxane, either because they were still on X, had CR or had rapid PD. Conclusions: RR is higher with XP and XT, but PFS and OS are similar at a median follow-up of 15.5 months. All regimens were well tolerated with minimal grade 4 AEs. Because there is no clear superiority of sequential vs. combined therapy, pt characteristics are likely to be used to decide which regimen is the most appropriate. [Table: see text] [Table: see text]
Results of an analysis of cardiac function in 2,812 patients treated with lapatinib
Authors: Perez E. A. , Byrne J. A. , Hammond I. W. , Rafi R. , Martin A. M. , Berger M. S. , Zaks T. Z. , Oliva C. R. , Roychowdhury D. F. , Stein S. H. 
Published: March 2020

583 Background: Lapatinib is an orally bioavailable reversible, dual tyrosine kinase ErbB1 and ErbB2 inhibitor. Trastuzumab, an ErbB2 inhibitor, has been associated with cardiotoxicity. Methods: Left ventricular ejection fraction (LVEF) was monitored every 8 weeks using MUGA or echocardiogram. Cardiac risk factors including age, underlying cardiovascular disease, previous exposure to AC, trastuzumab, or mediastinal/left sided radiation (XRT) were also collected. LVEF data were evaluated for ≥ NCI CTC grade 3, or ≥ 20% decline relative to baseline (& below institutional LLN). Results: 1.3%, 37 of the 2812 subjects who have received lapatinib in all trials to date have experienced decreased LVEF. 22 of 37 patients received lapatinib monotherapy, the remaining 15 received lapatinib in combination with other chemotherapeutic agents. 68% (25/37) of patients were female, median age was 59 years. Decreased LVEF occurred within 9 weeks of treatment onset in 68% of cases. The event resolved/improved in 57% of cases: in 50% of these, lapatinib treatment was continued. Average event duration was 5 weeks. Four of 37 patients were symptomatic (0.1% incidence). Most symptomatic events responded promptly to standard CHF therapy. The majority of patients (92%, 34/37) had confounding factors that may have contributed to the event, including previous exposure to AC, trastuzumab or XRT, and/or medical history. 8 of 34 patients had a positive lapatinib dechallenge (LVEF recovered): 3 were symptomatic (signs of CHF) and 5 asymptomatic. 3 patients had no contributing factors: 1 experienced symptomatic decreased LVEF, the remaining 2 died due to disease progression whilst LVEF decrease was ongoing. 16 of 1307 patients participating in placebo controlled studies experienced decreased LVEF. Of these 8 are known to have received lapatinib, giving an incidence of 1.2% (8/654). Conclusions: Lapatinib-associated LVEF decrease is rarely symptomatic and generally reversible/non-progressive. Incidence was 1.3% in our population, less than the 3–6% incidence of asymptomatic LVEF decreases observed in the general population. Pharmacogenetic studies are ongoing to determine whether there is a link between ErbB2 polymorphisms and lapatinib cardiotoxicity. [Table: see text]
Understanding and preferences for receiving prognostic information: A comparison of the views of Australian and Canadian patients with metastatic cancer
Authors: Dimitry S. , Ellis P. M. , Butow P. N. , Hagerty R. G. , Tattersall M. H. 
Published: March 2020

6014 Background: Previous research suggests that the majority of cancer patients desire full disclosure of their prognosis and treatment options. The current study compares the views of Australian (A) and Canadian (C) patients with metastatic cancer towards disclosure of prognostic information. Methods: Cross sectional studies were undertaken with A and C patients with newly diagnosed metastatic cancer to assess their preferences for and understanding of prognostic information. The primary outcome was patients’ preferences for the mode of delivery of prognostic information. Remaining analyses were primarily descriptive. Results: Survey response rate was A: 58% (n = 126) and C: 57% (n = 117). Patient mean age was 62.8yrs (A), 63.2yrs (C). 56% (A) and 39% (C) of patients were male. There were some differences in type of cancer: breast (25%A, 30%C), colorectal (18%A, 44%C), lung (10%A, 26%C) and other cancers (47%A). The main outcomes of the A and C surveys were very similar. The majority of all patients surveyed wanted to know prognostic information. Most patients preferred both words and numbers (46%A, 52%C), or words only (28%A, 31%C) for presenting prognostic information. Respondents were more likely to like words (66%A, 47%C), percentages (65%A, 45%C), or fractions (60%A, 47%C) for presenting prognostic information, than diagrams (37%A, 33%C), pie charts (42%A, 32%C) or graphs (33%A, 29%C). The majority of patients want to receive information on treatment goals and options when first given a metastatic diagnosis (84%A, 86%C). Fewer patients want to receive information on life expectancy at this time (59%A, 56%C) and only the minority want to discuss information about dying at this time (34%A, 36%C). Respondents indicated the specialist should just tell the patient (83%A, 74%C) rather than check first if the patient wants to know (15%A, 22%C). Conclusions: A and C patients have similar and strong preferences for receiving prognostic and treatment option information. However, more research is needed on the timing of delivery of this information. No significant financial relationships to disclose.
Effect of distance to radiation treatment facility on use of radiation therapy after mastectomy in elderly women
Authors: Punglia R. S. , Weeks J. C. , Neville B. A. , Earle C. C. 
Published: March 2020

6030 Background: Post-mastectomy radiation therapy (PMRT) has been shown to improve survival in patients at high risk for local or regional recurrence. However, radiation therapy necessitates daily travel to treatment centers for several weeks. We sought to study the effect of distance to the nearest radiation treatment facility on receipt of PMRT in elderly women. Methods: Using the linked Surveillance, Epidemiology, and End Results-Medicare (SEER-Medicare) database, we analyzed 19,787 women with Stage I or II breast cancer who received mastectomy as definitive surgery between 1991 and 1999. Multivariable logistic regression was used to investigate the association of travel distance with receipt of PMRT after adjusting for clinical and sociodemographic factors. Results: Overall, 2,075 (10.5%) patients treated with mastectomy received PMRT. In addition to cancer and patient characteristics, increasing distance from the nearest radiation treatment facility was independently associated with a decreased likelihood of receiving PMRT, (OR = 0.996 per additional mile, p = 0.01). The decline in PMRT use appeared at distances greater than 25 miles and was statistically significant for those patients living greater than 75 miles from the nearest radiation facility (odds of receiving PMRT of 0.58 [95% CI: 0.34–0.99] versus those living within 25 miles of such a facility). In secondary analyses, the effect of distance was only significant in women aged 75–80 years (OR = 0.992 per additional mile, p = 0.03), and those above the age of 80 (OR = 0.989, p = 0.02). When analyses were conducted separately by geographic region, the effect of distance was only significant in the Midwest (OR = 0.992, p = 0.014). The effect of distance was not significant (OR = 1.00, p = 0.87) among women with positive nodes, but was significant in women with no positive nodes (OR = 0.992, p = 0.013). Conclusions: Oncologists must be cognizant of the potential barrier to quality care that is posed by travel distance, especially for elderly patients. Mechanisms to ameliorate the effect of distance on receipt of radiation therapy by assisting individuals with transportation limitations or policies to decrease the centralization of RT services, may help to remove barriers to potentially life-saving treatment. No significant financial relationships to disclose.
Direct-to-consumer advertising in oncology: A content analysis of print media
Authors: Abel G. A. , Lee S. J. , Viswanath V. , Weeks J. C. 
Published: March 2020

6034 Background: Direct-to-consumer advertising (DTCA) is an increasingly prevalent and contentious medium of medical communication. Content analysis of cancer-related DTCA, with a focus on how benefit and risk/side effect information is presented, is essential to understanding its potential effect on oncology outcomes. Methods: We reviewed all product-specific DTCA for oncology-related medications appearing in the patient-focused cancer magazines CURE, Coping with Cancer, and MAMM: Women, Cancer and Community during 2005. We assessed the Flesch reading ease score (FRES), calculated with the formula [206.835 - (1.015 x average sentence length) - (84.6 x average syllables per word)], for the benefit and risk/side effect information presented in each advertisement. Ranging from 0 to 100, a FRES of 65 or higher is considered understandable for the average person. We also assessed the largest type size (in mm) and the placement (first, middle or final third of text) of benefits and risks/side effects, as well as the ads’ use of appeals to clinical trial data, cost, celebrity endorsement, physician endorsement, and implied patient testimonials (visual and written). Results: Of 75 ads reviewed, many were repeated, such that 15 unique ads were analyzed. The mean FRES for benefit information was 40.64, while the mean FRES for risks/side effects was 32.30, a difference of 8.34 [95% CI: 1.16, 15.52]. The mean largest benefit type size was 7.10 mm, while the mean largest risk/side effect type size was 2.33 mm, a difference of 4.77 mm [95% CI: 2.35, 7.17]. No ads mentioned cost, and none contained a celebrity or physician endorsement. 53% referenced clinical trials, and 60% offered an implied patient testimonial. In their first third of text, 93% presented benefits; 13% presented risks/side effects. In their final third of text, 27% presented benefits; 93% presented risks/side effects. Conclusion: Oncology print DTCA is difficult to read, as assessed by a standard readability measure. Moreover, compared to risks/side effects, benefits are presented in a larger typeface, earlier in the text, and in language that is modestly easier to read. Oncology providers should be aware of such differences, as they may influence patients’ perceptions of cancer-related medications. No significant financial relationships to disclose.