bluuebunny/crossref_metadata_2025_split huggingface dataset:
Induction TPF followed by chemoradiation or radiotherapy-cetuximab in nonresectable advanced head and neck squamous cell carcinoma: A retrospective study in 164 patients.
Authors: Borchiellini Delphine , Dupuis Charlotte , Gal Jocelyn , Lallemant Benjamin , Alfonsi Marc , Benezery Karen , Righini Christian , Guelfucci Bruno , Beltran Michel , Bozec Alexandre , Poissonnet Gilles , Dassonville Olivier , Giovanni Antoine , Morvan Francois , Peyrade Frederic ,   for the GRROC
Published: March 2020

e16044 Background: Induction chemotherapy with docetaxel, cisplatin, and 5FU (TPF) followed by cisplatin-based chemoradiation (CRT) is a valid option for the treatment of advanced head and neck squamous cell carcinoma (LASCC). Radiotherapy (RT) associated with cetuximab (RT-cetux) is superior to RT alone and has less systemic toxicity than CRT. Recent data suggest RT-cetux could be an alternative treatment to CRT after induction TPF. The aim of this study was to report the outcome of these pts in clinical practice. Methods: A multicentric retrospective analysis was conducted in LASCC pts treated with induction TPF (T 75mg/m2 day 1, P 75mg/m2 day 1, F 750mg/m2/d day 1 to 4 – q3w), followed by CRT (cisplatin 100mg/m2 – q3w) or RT-cetux (400mg/m2 loading dose and 250mg/m2 – q1w). Exploratory endpoints were progression-free survival (PFS), cancer specific survival (CSS) and overall survival (OS). Results: 164 pts treated from October 2005 to June 2010 were eligible. 113 pts had TPF followed by CRT and 51 pts had TPF followed by RT-cetux. Clinical characteristics were similar in each group, regarding gender (men 84% vs 92%), mean age (56 vs 57 yrs), BMI (23.4 vs 23 kg/m2), alcohol consumption under treatment (41% vs 49%), non laryngeal tumor site (77% vs 73%), T3-T4 tumor size (84% vs 80%) and N+ status (71% vs 77%). There was a difference in performance status 0 and 1 between pts in CRT group (73% and 26%) and RT-cetux group (47% and 51%) (p=0.005). 2-yr PFS rate was 68% in CRT group vs 42% in RT-cetux group (p=0.002). After a median follow-up of 23 months, the median PFS was not reached in CRT pts vs 13 months (95% CI : 8.1-17.9 months) for RT-cetux group. At 2 years, CSS and OS rate was 84% and 78% vs 54% and 50%, respectively (p<0.0001). Median CSS ans OS were not reached in CRT group as compared to 25 months (95% CI : 14.6-35.4 months) and 23 months (95% CI : 10.7-35.3 months) in the RT-cetux group, respectively. Conclusions: In daily practice, outcome after induction TPF for LASCC pts seems to be superior with standard CRT than RT-cetux. The higher proportion of PS 1 pts in the RT-cetux group could explain this difference. These data suggest that selection of pts should be carefully considered.
A phase II study of cetuximab-based neoadjuvant and adjuvant treatment strategies, with or without surgery, in patients with locally very advanced squamous cell carcinoma of the oral cavity.
Authors: Lou Pei-Jen , Liao Chun-Ta , Wang Cheng-Ping , Huang Shiang-Fu , Cheng Shin-June , Hsu Cheng-Lung , Wang Chun-Wei , Chang Tung-Chieh , Chen Ya-Fang , Lin Chien-Yu , Wang Hung-Ming , Hong Ruey-Long 
Published: March 2020

e16050 Background: The purpose is to evaluate the efficacy of sequential regimen using cetuximab-based doublet neoadjuvant chemotherapy, followed by surgery, if tumors resectable, and adjuvant cetuximab-based chemoradiotherapy in locally very advanced OSCC patients. Methods: Patients with T4a/b or N2b/c or N3 OSCC were enrolled to determine the response rate of cetuximab, cisplatin, and 5-FU neo-adjuvant chemotherapy. Cetuximab (400 mg/m2 loading, followed by 250 mg/m2 weekly x 6 weeks) was combined with 2 3-weekly cycles of cisplatin (100 mg/m2) and 5-FU (1000 mg/m2 x 3 days) as neo-adjuvant. Patients whose tumors became operable after neoadjuvant underwent radical surgery followed by adjuvant weekly cetuximab (250 mg/m2), cisplatin (30 mg/m2) and XRT (up to 70 Gy). Patients whose tumors remained inoperable after neoadjuvant received weekly cetuximab (250 mg/m2), cisplatin (30 mg/m2) and XRT (up to 70 Gy). Results: 33 patients were enrolled from Dec. 2009 to Jan. 2011. Average age was 47.3 years. 51.5% had primary lesion in buccal mucosa and 21.2% on tongue. 66.7% and 27.2% had T4b or T4a disease respectively, while 72.7% had N2b/N2c/N3 disease. 28/33 completed treatment course. On ITT analysis, 39.4% (13/33) had partial response and 48.5% (16/33) had stable disease after neoadjuvant. 42.4% (14/33) underwent radical surgery after neoadjuvant, while another 9% (3/33) underwent surgery after bio-chemoradiation. The 1 year disease free survival (resected group), progression free survival (ITT group), and overall survival (ITT group) were 48.8%, 73.2%, and 51.7% respectively. The most common grade 3/ 4 adverse event in neo-adjuvant phase was vomiting (16.1%), while mucositis (75%) and dermatitis (42.8%) accounted for major grade 3/ 4 adverse events during bio-chemoradiation. Conclusions: Cetuximab based sequential regimen was efficacious and well tolerated in improving treatment outcomes in locally very advanced OSCC patients with manageable side effects.
Safety and feasibility of outpatient TPX regimen.
Authors: Pendharkar Dinesh , Ahmad Hilal 
Published: March 2020

e16057 Background: TPF has emerged as standard induction regimen in head and neck cancers. Along with docetaxel and platinum it involves continuous infusion of 5FU, which requires a prolonged admission or use of infusional devices, with added cost of treatment, not practical in many clinical situations and situations with limited resources. Keeping this in view, to make the schedule cost effective and outpatient based, we attempted to replace 5FU with oral capecitabine and study the safety and feasibility of TPX regimen (docetaxel, carboplatin and capecitabine) in advanced cancer patients. Methods: 12 patients (8 male, 4 female, age 51-67, median 58) with advanced metastatic disease, where palliative TPF regimen is generally used ,were prospectively planned to receive fixed dose combination of TPX regimen- docetaxel 120 mg day 1, carboplatin 450 mg day 2 and tab capecitabine 2000mg per day, in two divided doses, for five days q 3 weeks. There were 2 cases of cervical cancer, 3- GI tract and rest 7 had head and neck cancer. They were analysed for toxicity and tolerability. Results: In all 12 patients were given 39 courses of TPX regimen. The toxicities included weakness in 2/39 courses, loss of appetite 2/39, neutropenia grade 1 in 3/39, grade 2 in 3/39. During two course grade 3 neutropenia requiring intervention was recorded. The mucositis grade 1-2 was seen only on two occasions in previously radiated patients. There was no incidence of diarrhea. The treatment was well tolerated. All courses were given on time, and there were no treatment delays related to toxicity. Conclusions: TPX appears to be safe and feasible outpatient alternative to TPF. It has no infusional component allowing it to be used in day care setting. Efficacy data in bigger cohort is warranted.
Oral anticancer therapy: Does the patient understand?
Authors: Graham Donna M. , Bambury Richard Martin , Ismail Jeffri R. M. , O'Keefe Margaret , Drake Catherine , O'Shea Alan , Moylan Eugene J. , Power Derek Gerard , O'Reilly Seamus 
Published: March 2020

e16506 Background: Oral anti-cancer therapy (OAT) prescribing is increasing. Safety and adherence issues surrounding OAT are causing a shift in the traditional roles and responsibilities of oncologists, nurses and pharmacists. This study aims to investigate patients’ perception of education and safety surrounding OAT use. Methods: Over a 6-month period an anonymous cross-sectional survey was offered to all patients (pts) attending for cancer treatment with OAT at Irish hospitals with cancer services in the South-West region. Data was prospectively analyzed using standard statistical tools for non-parametric data. Results: A total of 172 surveys were distributed and 101 pts responded (59%). Of these, 53 (54%) were female. Median age was 62 (range 29-80 yrs). Diagnosis was colorectal cancer in 49 pts (48%), breast cancer in 13 (13%) and glioma in 12 (12%). Of treatments used, 85% were oral chemotherapy and 15% oral biological therapy. The most commonly used agent was capecitabine (61%). When commencing OAT, 17 (17%) of respondents felt they did not understand it. Understanding was improved by pt education by a doctor (p=0.03) or hospital-based nurse (p=0.04) and provision of information booklets (p=0.04). Pts were unaware of interactions in 30% of cases and 20% were not aware of any safety issues. Pts who had been given information leaflets were significantly more aware of safety including careful handling (p<0.001), storage conditions (p=0.02) and safe disposal (p<0.001). Pts attending nurse-led oral chemotherapy clinics (NOCC) were significantly more aware of safety issues (p=0.04). Of respondents, 1% reported taking too many tablets and 15% had forgotten to take OAT on ≥1 occasion. NOCC improved adherence (p=0.03). Conclusions: OAT, when indicated, is an option for selected pts who are compliant and educated about complications. This study highlights issues with pt education and safety awareness. To our knowledge the factors influencing this have not been previously explored. A significant proportion of our pts were sub-optimally educated regarding medication interactions, storage needs, handling and disposal precautions. Educational tools to aid healthcare professionals in pt instruction and NOCC significantly improve patient understanding.
Strategies to increase efficiency in protocol development.
Authors: Stoermer Kati M ,   SWOG
Published: March 2020

e16508 Background: In 2010, the NCI’s Operational Efficiency Working Group recommended changes aimed at compressing the timeline for cancer clinical trial activation. SWOG implemented multiple changes prior to and since that report, intended to increase protocol development efficiency. Two protocol development interventions were piloted; weekly meetings of SWOG leadership and the study team, or SWOG Activation Team (“SWAT”), which began in 2007, and intensive RaPID Protocol Development Meetings, beginning in 2010. Methods: The highest priority developing trial was selected for SWAT, with only one trial using this mechanism at a time. RaPID trials were chosen based on trial complexity and urgency. We reviewed all protocol development milestones across SWOG protocols activated between 2007 and 2011. Results of the review were compared and contrasted for 1) the two piloted interventions 2) pre- and post-OEWG implementation and 3) time from trial activation to first patient entered. Results: Time to activation results are outlined in the table. Within SWAT, the median time to activation was 400 days, 190 days sooner that all trials developed in the same time period. RaPID trials median time to activation was 225 days, 365 days sooner than others developed in the same timeframe. Regardless of intervention type, median time from concept submission to trial activation was 724 days pre-OEWG and 286 days post-OEWG. The median time from trial activation to first patient accrued was 106 days pre-OEWG implementation and 75 days post-OEWG. Conclusions: While barriers to timely trial activation still exist, SWOG programs aimed at enhancing the efficiency of protocol development, in partnership with the implemented OEWG recommendations, have been successful. SWOG has developed effective and timely protocol develop strategies among diverse, and geographically dispersed, study teams with only modest increases in effort and cost. Supported in part by PHS Cooperative Agreement grant awarded by the National Cancer Institute, DHHS: CA032102. [Table: see text]
The 2010 National Comprehensive Cancer Network (NCCN) risk assessment and genetic counseling (RA/GC) study: Operational aspects of RA/GC programs at academic medical centers.
Authors: Sherman Stephen L. , Crawford Beth , Giammicchio Karen , Kimbro Lisa , Masny Agnes , Mahoney Shannon Kristen 
Published: March 2020

e16510 Background: In 2010 NCCN conducted a Risk Assessment and Genetic Counseling (RA/GC) study focused on the operational aspects of RA/GC programs and services at NCCN Member Institutions (MIs). The primary aims were benchmarking of RA/GC operations and practice patterns. Methods: A survey instrument was developed by NCCN staff in consultation with RA/GC leaders at NCCN MIs. The survey collected quantitative and descriptive data on RA/GC program organization, staffing, and patient volume and also included questions on patient referral, test disclosure, and program funding. Results: 19/21 (90%) NCCN MIs participated. The mean number of patients seen annually for 17 MIs reporting data was 872 (range 130 – 2,200). The mean number of patients seen annually per 1.0 genetic counseling full-time equivalent was 272 (range 152 – 422). RA/GC services are made available to patients by scheduled appointment only at 5 MIs (26%) versus by appointment or with on-call genetic counselors at 14 MIs (74%). However, 11/19 (58%) MIs reported the time between initial patient contact and appointment was greater than 2 weeks. Self-sufficient RA/GC program funding was consistently cited by survey respondents as one of the greatest challenges, with 18 MIs indicating that they require institutional support, whereas only 11 indicated that reimbursement from third-party payors contributed to funding. Pertaining to disclosure, respondents estimated that 48% of test results were disclosed to patients via telephone and 39% in-person. The remaining disclosures were made based on patient preference. Conclusions: The availability of on-call RA/GC resources at most NCCN MIs likely indicates an effort to increase the number of patients that receive RA/GC services, but based on times to first appointment, access remains an issue. The 2011 recommendations of the National Society of Genetic Counselors state that the disclosure of test results in-person is often very helpful. However, the percentage given by telephone remains substantial. Dissemination of RA/GC benchmark data and identification of best practices will promote enhanced operations and patient access at NCCN MIs.
The burden of radiation therapy to the bone in patients with prostate cancer and bone metastases.
Authors: Hess Gregory P. , Barlev Arie , Hill Jerrold W. , Fonseca Eileen , Chung Karen 
Published: March 2020

e16512 Background: Bone metastases (mets) occur in up to 80% of patients (pts) with advanced prostate cancer and are associated with considerable skeletal morbidity. Radiation therapy is often used to treat spinal cord compression, pathologic fractures, and pain associated with bone mets. However, the burden of radiation therapy, such as dosing, number of fractions, exposure period, and frequency has not been well described. We present the treatment patterns of radiation episodes of care (REOCs) in pts with bone mets secondary to prostate cancer. Methods: Claims-linked medical records at 98 US cancer centers in 16 states were analyzed. Key inclusion criteria included a diagnosis of prostate cancer and bone mets; ≥1 visit to a radiation center on or after bone met diagnosis date (study period: 1 Jul 2008 to 31 Dec 2009); and radiation therapy to ≥1 bone site. Pts with unknown age or REOCs including non-bone site radiation were excluded. Visits and procedures were stratified into radiation and radiation-related categories. Results: A total of 233 REOCs in 213 pts were analyzed. The mean (SD) age was 74 (8.4) years and the mean (SD) Charlson Comorbidity index was 6 (1.1). The mean (SD) number of visits for a REOC was 13 (5.8), over a mean (SD) of 30 (16.7) days (from planning visit to follow-up). 71.7% of REOC visits involved radiation therapy, with the remaining visits for radiation-related procedures (table). The mean (SD) number of fractions per REOC was 10 (4). Conclusions: Radiation to the bone is a well recognized treatment for management of bone mets. The use of multi-fraction schedules is common and is associated with substantial burden to pts and healthcare providers. [Table: see text]
Management of octogenarians with female breast cancer in a rural oncology program.
Authors: Alikhan Mir Asif , Limesand Dianne L , Schmelzel Mark , McGlone Thomas , Powers David , Khawaja Osmaan , Johnson Russell F. , Pikul Frank 
Published: March 2020

e16513 Background: Despite the fact that chronological age alone does not determine tolerance to cancer treatment, there is a general perception that elderly cancer patients do not receive standard treatment. We sought to review breast cancer patients above 80 years in our practice. Methods: Retrospective analysis was performed ofall women with breast cancer over the age of 80 either at the time of diagnosis or at the time of relapse since July 2005 till July 2011. Results: There were total of 492 breast cancer patients seen during the study period, 207 below 65, 213 between 66-79 and 70 above 80. 59 women met the study criteria. The median age was 86 (81to 99 years). 47 had activities of independent living, 8 were in an assisted living facility and 4 in nursing homes. Median Charlson Co morbidity Index was 2 (0-5). Pathological types: DCIS 2, Invasive ductal carcinoma 50, invasive lobular carcinoma 6 and 1 had apocrine carcinoma. 50 had ER+, PR+ and Her-, 2 patients had triple negative disease and 4 Her+. 2 patients had stage 0, 22 stage I, 23 Stage II, 7 stage III and 5 stage IV. All patients stage 0-III had surgical management, 39 had breast conservative surgery with sentinel node biopsy and 15 had mastectomy. Out of 28 patients referred for adjuvant radiation therapy 17 received it. 49 patients received hormone treatment (39 aromatase inhibitors- AIs and 14 tamoxifen) Chemotherapy was offered but refused by two stage III patients. 2 Her + patients received and tolerated well trastuzumab based chemotherapy. After a median follow up of 48 months (8-120 months) there was 1 local recurrence, 1 distant relapse and 14 deaths ( 11 from other causes 3 from breast cancer). Conclusions: In ourpractice, a majority of octogenarians and nonagenarians live independently and have minimal co morbidities and tolerate standard surgical and hormonal treatment. Although radiation therapy would be considered optional in this group of women, it was offered based on predicted longevity. Mortality form other causes was higher than that from breast cancer ( 18% vs 5%).
Sociodemographic disparities in treatment receipt for prostate cancer: A population-based study.
Authors: De Camargo Cancela Marianna , Sharp Linda , Kelly Maria , Comber Harry 
Published: March 2020

e16514 Background: Prostate cancer (PC) treatment remains controversial. Little is known about how this controversy plays out in routine clinical practice. Most studies of treatment patterns are from the US, specialist centres, and/or involve selected patients. In a national, population-based analysis, using linked cancer registration and hospital in-patient data, we investigated associations between socio-demographic and clinical factors and PC treatment in Ireland. Methods: PC cases (ICD10 C61) diagnosed 2002-2008, and with a hospital in-patient episode within one year of diagnosis (n=9658) were included. Comorbidity (assessed by Charlson and Elixhauser indices) was determined from diagnoses on hospital episodes. Multinomial logistic regression was used to investigate associations between age, marital status, smoking status, area of residence, deprivation category, comorbidity, diagnosis period, stage and Gleason score, and receipt of different treatment modalities. Results: Age was a significant determinant of treatment receipt, after adjusting for socio-demographic and clinical factors. Compared to younger men, men aged ≥70 were significantly less likely to undergo radical prostatectomy (RP), and significantly more likely to be treated by TURPS, androgen deprivation therapy (ADT) or radiotherapy with ADT. Within the 40-69 age-group, likelihood of RP decreased with increasing age. After adjusting for age and other factors, presence of comorbidities, overall, had a moderate impact on treatment receipt. Some conditions had a stronger effect (e.g. congestive heart failure). There were strong variations in treatment by area of residence, which persisted after adjustment for age, comorbidity and other factors. Conclusions: These results suggest socio-demographic factors, including patient age and area of residence, strongly influence PC treatment. Strategies to reduce these disparities have potential to improve PC survival and mortality in the population.
Implementation of a team training program in the treatment of breast cancer patients.
Authors: Bunnell Craig A. , Gross Anne , Kalfin Michael , Partridge Ann H. , Lane Sharon , Burstein Harold J. , Fine Barbara , Hilton Nancy , Sullivan Clare , Colicchio Lynn , Hagemeister Erin , Kelly Anne , Szabatura Audrea , Winer Eric , Mann Susan , Weingart Saul 
Published: March 2020

e16515 Background: Team Training (TT) principles, used in high-risk industries to reduce errors and improve communication and task coordination, have been applied in other areas of medicine, but never in an outpatient subspecialty setting. We piloted a TT program in a large, academic breast cancer program. Methods: Observations, interviews and anonymous adverse event reporting systems were used to identify areas of vulnerability warranting intervention: 1) communication of changes in chemotherapy orders on the day of treatment ("change orders") 2) missing orders on treatment days that patients were not also scheduled to see their physician (“unlinked” visits) 3) follow-up and communication to other team members on important patient issues (e.g. pending test results or changes in patient status) 4) conflict resolution between providers and staff. For each area, agreements about roles, responsibilities and behaviors were made. Using a train-the-trainer model, clinical leaders trained all providers and staff in TT principles, the agreements, and the tools to support them. Results: The program was evaluated six months after implementation. There was insufficient power to detect a significant difference in communication of change orders because of the infrequency of events (< 2% pre and post-training). However, 100% of providers reported it was easier to communicate change orders and 87% of infusion nurses reported a decrease in non-communicated changes. The incidence of missing orders for unlinked visits decreased from 30% to 2%. Press-Ganey patient satisfaction scores suggested improvement in patient perception of care coordination. Providers, infusion nurses and support staff reported strongly positive perceptions of improvement in efficiency (75%, 86%, 90%), quality (82%, 93%, 93%) and safety (92%, 92%, 90%) of patient care. Similarly, all groups reported improved relationships and more respectful behavior among team members (91%, 85%, 93%). Conclusions: Team Training improved communication, task coordination and perceptions of efficiency, quality, safety and interactions among team members as well as patient perception of care coordination. Widespread implementation of this strategy is ongoing at our institution.