bluuebunny/crossref_metadata_2025_split huggingface dataset:
Fractionation of palliative radiotherapy in metastatic breast cancer: Selection and survival.
Authors: Qian Yushen , Dudley Sara , Durkee Ben Y , Kumar Kiran , Chaudhuri Aadel , Pollom Erqi L. , Aggarwal Sonya , Horst Kathleen C. , Chang Daniel Tandel 
Published: February 2017

201 Background: Various schedules of palliative radiotherapy (pRT) are prescribed for metastatic breast cancer (MBC) patients. Length of treatment can vary from a single day to three weeks. Single fraction pRT provides similar pain relief vs. multi-fraction pRT for bone metastases, but retreatment rates are higher. In the era of targeted and hormonal therapy, patients with MBC can survive many years after their initial diagnosis. We investigated whether patients with MBC who were prescribed single fraction pRT had poorer prognoses and experienced shorter survival than patients who were prescribed multi-fraction pRT. Methods: Patients at a single institution with MBC underwent pRT, with fractionation schedules including 8 Gy in 1 fraction (fx), 20 Gy in 5 fx, 30 Gy in 10 fx, 37.5 Gy in 15 fx between 2001-2015. 392 treatments were prescribed (109/241/29/13 in each regimen as above). Date of death was obtained from medical records, Social Security Death Index, or published obituaries. Patients who were alive or whose date of death could not be determined were censored at the date of their last encounter. Survival was calculated from the start of treatment to the date of death or censorship. Results: Patients treated with 37.5 Gy in 15 fx (MS 20 months, p = 0.002) or 30 Gy in 10 fx (MS 22 months, p = 0.03) experienced longer survival than patients treated with 8 Gy in 1 fx (MS 8 months). There was no significant survival difference between patients treated with 20 Gy in 5 fx (MS 18 months, p = 0.49) and patients treated with 8 Gy in 1 fx. There was no significant survival difference between patients treated by the three multi-fractionation schedules. Conclusions: MBC patients who were prescribed 37.5 Gy and 30 Gy lived longer than patients who were prescribed 8 Gy of pRT. No statistically significant difference was found between patients who were prescribed 20 Gy compared to 8 Gy, possibly due to the lower number of patients who received these regimens. Single fraction pRT was more likely to be prescribed to patients who would ultimately have shorter survival. More research is needed, ideally across multiple institutions, to explore the correlation between physician estimation of patient survival and selection of pRT regimen for patients with MBC.
Quality versus queasy: Trends in the use of antiemetics.
Authors: Nair Jayan , Curley Brendan F. , Fong Richard , Hwang Jimmy , Byrne Michael Thomas 
Published: February 2017

203 Background: The American Society of Clinical Oncology (ASCO) launched the Quality Oncology Practice Initiative (QOPI) program in 2010, to promote quality cancer care. Subsequently, ASCO has influenced the use of the neurokinin 1 (NK1) receptor antagonists aprepitant/fosaprepitant through peer-reviewed publications and the Choosing Wisely Campaign. These agents increase cost and, via CYP3A4 inhibition, may lead to drug interactions. Here we report our survey results that explored prescribing patterns of these agents among QOPI-certified and non-certified oncologists. Methods: An anonymous online survey was distributed to oncologists in four states. Respondents were asked 12 questions about the use of aprepitant/fosaprepitant in their clinical practice. Responses were analyzed in aggregate using likelihood ratio Chi-square tests. P-values of < 0.05 are significant. Descriptive statistics describe differences between groups. Results: We analyzed 157 responses and excluded 10 respondents that did not identify themselves as medical oncologists. 62.1% of the practitioners practice in a QOPI-certified practice (90/145). Compared with non-QOPI practitioners, QOPI physicians are significantly more likely to use NK1 antagonists with intermediate/low emetogenicity regimens like weekly cisplatin for head & neck cancer (83.3 vs. 28.0%, p: < 0.001), cervical & bladder cancer (85.2 vs. 34.0%, p: < 0.001), and with CHOP ± rituximab for lymphoma (82.4 vs. 18.0%, p: < 0.001). Significantly, the majority of QOPI-certified physicians report using these agents for the sole purpose of earning/maintaining QOPI certification (81.4-85.4%). QOPI-certified physicians are also significantly more likely to appropriately prescribe NK1 antagonists with doxorubicin ≥ 60 mg/m2 (86.4 vs. 51.9%, p: < 0.001), cisplatin ≥ 50 mg/m2 (96.3 vs. 76.9%, p: < 0.001) and dacarbazine (84.6 vs. 55.8%, p: < 0.001). Conclusions: Although QOPI-certified physicians are significantly more likely to use NK1 antagonists than non-QOPI physicians, our findings indicate that their motivation is to satisfy QOPI guidelines instead of perceived necessity. A prospective study may be beneficial to further define the role of NK1 antagonists with intermediate/low emetogenicity regimens.
Prophylactic use of antidiarrheal agents to control diarrhea associated with lapatinib therapy in breast cancer patients.
Authors: Jamil Muhammad Omer , Rizwan Maira , Carpenter John T. 
Published: February 2017

205 Background: Lapatinib causes diarrhea in about 40-50% of patients treated with it for HER-2 positive breast cancer. It is the major dose and treatment limiting toxicity of lapatinib. Methods: This is a retrospective review of a cohort of patients treated with lapatinib for HER2 positive breast cancer at the Kirklin clinic at the University of Alabama at Birmingham from January 1, 2009 through September 30, 2013. Loperamide 2-8mg before lapatinib dose was recommended for prophylaxis in patients who developed clinically significant diarrhea. Additional doses of loperamide were used if needed. Results: 44 eligible patients were identified, 7 had stage IA, 10 had IIA, 7 had IIB, 5 had IIIA, 5 had IIIB and 6 had stage IV disease. Median age was 52 years (28-72 years) with 75% Caucasians. Starting dose of lapatinib was 1000mg oral daily. Overall 33 patients experienced diarrhea. 14 had NCI grade I, 5 had grade II, 10 had grade III and 3 had grade IV diarrhea. Other side effects encountered included rash, nausea, vomiting, LFT elevation, fatigue and allergic reaction. 17/33 patients received prophylactic loperamide. Median treatment duration with lapatinib for all patients was 6 months, range 1-60 months for patients receiving prophylactic loperamide and 1-22 months for others. 12/17 patients who received prophylactic loperamide had early improvement in diarrhea to NCI grade I or less vs. 4/16 for others. 5/17 patients who received prophylactic antidiarrheals required dose reduction due to diarrhea vs. 8/16 for others. Grade III and IV diarrhea was more common in standard treatment patients (8 vs. 5). 14 patients did not complete expected treatment duration, 5 due to diarrhea, all of whom had not received prophylactic antidiarrheals. Conclusions: Our study suggests that the use of prophylactic antidiarrheal treatment with lapatinib is possibly an effective strategy in getting patient to their therapy goals without interruptions or dose adjustments. The discontinuation rate and dose reduction rate in our population is lower than previously reported. Larger prospective studies will be of interest to evaluate this strategy further. Similar strategy could be applied to other agents causing diarrhea.
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in non–anthracycline/cyclophosphamide (AC)-based moderately emetogenic therapy (MEC).
Authors: Powers Daniel , Hesketh Paul Joseph , Schwartzberg Lee Steven , Modiano Manuel R. , Arora Sujata , Schnadig Ian D. 
Published: February 2017

209 Background: Rolapitant, a novel NK-1 receptor antagonist, showed efficacy in CINV prevention in patients (pts) receiving MEC (anthracycline/cyclophosphamide (AC) and other regimens) in a global phase 3 trial. Recent anti-emetic guidelines consider AC based regimens to be highly emetogenic. In this post hoc analysis, the efficacy and safety of rolapitant was assessed in Cycle 1 in pts receiving non-AC MEC, and in the subset of pts receiving carboplatin-based MEC. Methods: In a double-blind, active-controlled study, pts were randomized to oral rolapitant 180 mg or placebo 1–2 hours before MEC. All pts received granisetron 2 mg oral on days 1-3 and oral dexamethasone 20 mg on day 1. Complete response (CR = no emesis + no use of rescue medication), no emesis, and no nausea were assessed in overall (0-120 h), acute (0-24 h), and delayed ( > 24-120 h) phases. Results: CR was significantly (P < 0.01) higher with rolapitant than active control in overall and delayed phases in the carboplatin subset and in all 3 phases in the non-AC population (Table). No emesis rates were significantly (p < 0.05) higher with rolapitant in the carboplatin subset in the overall phase. No nausea rates were significantly (P < 0.05) higher with rolapitant in the overall and delayed phases in carboplatin-based MEC. Incidences of treatment-related AEs in Cycle 1 with rolapitant vs. active control were 11.3% vs. 6.7% in the carboplatin-based subset. Most common AEs with rolapitant and active control were constipation, fatigue, and headache. Conclusions: Rolapitant was superior to active control in preventing CINV in pts receiving non-AC MEC, including in the subgroup receiving carboplatin. Rolapitant was well tolerated with low incidence of AEs. Clinical trial information: NCT01500226. [Table: see text]
A novel patient-aimed visual tool to aid in decision making in oncology.
Authors: Zanartu Cristian , Camacho Fernando J. , Martin Benjamin 
Published: February 2017

21 Background: With up to 15% of Medicare patients receiving chemotherapy during the last two weeks of life, improving specialist-patient communication is a priority. The Help-Hurt Tool (2015) is a very simple patient-language visual aid for decision-making. It consists of two scales, a blue one labeled “from 1 to 5 how much could this therapy help me” and a red one with the same statement ending in “…hurt me”. The tool is held by the specialist and shown to the patient while arrows are moved to a particular point below each scale. That way, two values are given to the patient for the degree of benefit and of harm respectively expected from an offered treatment. Each number corresponds to an outcome in patient-language (i.e. a ‘help’ score of 2 is “small chance of making me feel better...” and of 4: “big chance of making me live at least a year longer”. A ‘hurt’ score of 2 is “likely non-dangerous side effects” and of 5: “likely life threatening therapy”). Methods: Feasibility study in an oncology clinic at an urban area in New York. Adult cancer patients without dementia whose disease had progressed through a previous treatment and were being offered a new line of therapy were enrolled. Results: Thirty encounters were enrolled. The tool was successfully used in 29 of them (96.7%); one patient was confused and could not follow at all. In more than 70% of encounters patients stated that the tool helped them understand their disease and treatments (‘helpful’: 32.3%, ‘very helpful’: 38.7%), and in 90% of encounters patients stated wanting to be approached with a tool like this again. Importantly in 60% of encounters patients were able to recall either the Help or Hurt score, and in 33.3% of encounters both values were perfectly recalled by patients. In 83.3% of encounters oncologists declared that the tool had a positive effect (‘helpful’ (40%) or ‘very helpful’ (43.3%)) in their interactions with the patient. Conclusions: This first-of-its-kind tool is promising for enhancing communication between specialists and patients at the time a therapy is being offered. Future steps for this tool would include a randomized trial to explore if its use can further affect outcomes like use of chemotherapy in the last two weeks of life, earlier hospice enrollment and quality of life, among others.
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of highly or moderately emetogenic chemotherapy (HEC, MEC).
Authors: Rapoport Bernardo Leon , Schwartzberg Lee Steven , Chasen Martin Robert , Powers Daniel , Arora Sujata , Navari Rudolph M. , Schnadig Ian D. 
Published: February 2017

210 Background: The long-acting neurokinin-1 receptor antagonist (NK-1 RA) rolapitant has demonstrated efficacy for CINV prevention in patients receiving HEC and MEC during Cycle 1. The efficacy and safety of rolapitant was examined during subsequent cycles 2–6 in a pooled analysis. Methods: In 4 double-blind, active-controlled studies, patients were randomized to oral rolapitant 180 mg or placebo 1–2 hours before chemotherapy. All patients received active control: 5HT3 receptor antagonist + oral dexamethasone. Patients completing Cycle 1 could receive the same anti-emetic treatment in subsequent cycles. On Days 6-8 of subsequent cycles, patients self-reported the incidence of emesis, or of nausea interfering with normal daily life following Day 1 of chemotherapy. Results: A greater proportion of patients on rolapitant than on active control reported no emesis or interfering nausea separately for each subsequent cycle. Results of individual studies and pooled analysis are shown in the Table. During cycles 2-6, the incidence of treatment-related adverse events (AEs) was similar for rolapitant (5.5%) and control (6.8%). The most common treatment-related AEs were similar in both arms: constipation (rolapitant: 1.2%; control: 0.8%) and fatigue (rolapitant: 1.3%; control: 1.8%). Conclusions: Rolapitant was superior to active control in reducing CINV when administered over multiple cycles of moderately or highly emetogenic chemotherapy, with no increase in toxicity. Clinical trial information: NCT00394966 - NCT01500213 - NCT01500226 - NCT01499849. [Table: see text]
Laser therapy for radio-induced oral mucositis and skin dermatitis: Oral medicine, radiotherapy and oncology shared experience from the University of Trieste.
Authors: Gobbo Margherita , Guglielmi Alessandra , Ottaviani Giulia , Rupel Katia , Zacchigna Serena , Ciriello Francesca , Beorchia Aulo , Di Lenarda Roberto , Biasotto Matteo 
Published: February 2017

213 Background: Oral mucositis (OM) and dermatitis (RD) are serious side effects of radiotherapy (RT), often leading to its suspension, need for analgesics and enteral/parenteral nutrition. Laser-therapy is becoming a recommended option for mucosal lesions and has also been tested for skin affections. This prospective study investigates the effect of Laser-therapy (HPLT) on RT-induced OM and proposes an off-label use of HPLT to treat RD in breast-cancer patients and in RT-treated anal-carcinoma patients Methods: 53 cancer patients, during/after RT and/or chemotherapy, affected by OM, were treated with HPLT during 4 consecutive days (970nm, 2,5W, 35-6000Hz, 240s). Assessment of OM (WHO-SCALE: Grading objective Scale), pain (VAS: Visual Analogue Scale), functional ability, subjective parameters, site/severity of OM were recorded weekly for 21 days. 27 breast-cancer patients and 2 anal-carcinoma patients affected by RD were treated by HPLT every other day for 2 weeks (970nm/660nm, 2-1000Hz, 6W, 480s) and monitored weekly for one month for grade, discomfort, itching and bleeding. Results: Regarding OM, regressive improvement of WHO- SCALE from day 7 on, and of VAS from day 2 on (p < 0.000) was registered. All patients’ functional capacity improved on day 4 (p < 0.05). All subjective parameters improved on day 14 (p < 0.001) except voice, which improved on day 21 (p < 0.000). Ulcerations’ dimension and erythema’s severity decreased in all sites (p < 0.05). Regarding breast and anal RD, after 6 HPLT’s sessions, complete and progressive resolution of pain, bleeding and itching was registered (p < 0.002). All patients referred maximum satisfaction for receiving HPLT. Conclusions: Regardless of OM grade/site and of kind/site of tumor, HPLT was effective in healing OM. Moreover, HPLT resulted an innovative and highly effective therapy for RD, both in breast and anal lesions. To establish an effective treatment strategy for OM and RD is of paramount importance to improve life-quality of patients but can also be beneficial for the continuation of cancer therapy. Consequently, HPLT may become integral part of everyday-practice in the management of RT adverse effects.
Quality of life and depression during hospitalization for hematopoietic stem cell transplantation to predict quality of life and post-traumatic stress disorder symptoms at 6 months post-transplant.
Authors: El-Jawahri Areej , VanDusen Harry , Traeger Lara , Fishbein Joel , Keenan Tanya , Greer Joseph A. , Pirl William F. , Jackson Vicki A. , Eusebio Justin , Gallagher Emily R. , Spitzer Thomas R. , Ballen Karen K. , McAfee Steven L. , Dey Bimalangshu , Chen Yi-Bin Albert , Temel Jennifer S. 
Published: February 2017

215 Background: Patients undergoinghematopoietic stem cell transplantation (HCT) experience a steep deterioration in quality of life (QOL) and mood during hospitalization for HCT. The impact of this deterioration on patients’ long-term QOL and post-traumatic stress disorder (PTSD) symptoms is unknown. Methods: We conducted a prospective longitudinal study of patients hospitalized for HCT. At baseline (day-6), day+1, day+8, and 6 months post-HCT, we assessed QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplantation [FACT-BMT]) and mood (Hospital Anxiety and Depression Scale [HADS]). We used the PTSD Checklist to assess for PTSD symptoms at 6 months. We used multivariable linear regression models to identify predictors of QOL and PTSD symptoms at 6 months post-HCT. Results: We enrolled 97% (90/93) of consecutively eligible patients undergoing autologous (n = 30), myeloablative allogeneic (n = 30), or reduced intensity allogeneic (n = 30) HCT. Overall, patients’ QOL at 6 months (mean FACT-BMT: 110, 95%CI [104-116]) recovered to baseline pre-transplant values (mean FACT-BMT: 110, 95% CI [107-115]). At 6 months, 28.4% of participants met provisional diagnostic criteria for PTSD, and 43.3% had clinically significant depression. In multivariable regression analyses adjusting for baseline QOL, mood, other covariates, change in QOL and depression scores during hospitalization for HCT predicted impaired QOL (DQOL β = 1.13, P < 0.0001, D HADS-depression β = 2.51, P = 0.001) and PTSD symptoms (DQOL β = 0.50, P < 0.0001, DHADS-depression β = 1.22, P < 0.0001) at 6 months post-HCT. Conclusions: While patients’ overall QOL at 6 months post-HCT returned to baseline values, a significant proportion met provisional diagnostic criteria for PTSD and depression. The decline in QOL and increase in depressive symptoms during hospitalization for HCT were the most important predictors of long-term QOL impairment and PTSD symptoms. Future studies should evaluate whether interventions to improve QOL and reduce psychological distress during HCT may improve long-term QOL and reduce the risk of PTSD symptoms.
Addressing psychiatric needs in an adult comprehensive cancer center.
Authors: Underwood Jody A. , McDonald Elaine , Higginbotham Kathleen , Korber Susan F. 
Published: February 2017

218 Background: The Rhode Island Hospital Comprehensive Cancer Center (RIH-CCC) sought to develop collaboration between psychiatry and social work to ensure comprehensive mental health care for the Centers’ adult patients. New patients are screened for distress using the NCCN Screening Tool for Measuring Distress. The NCCN Distress Thermometer measures patient’s distress using a 0-10 scale and documents the contributing psychosocial factors. The Cancer Center, in collaboration with psychiatry, developed standards for follow-up care. Those patients who indicate their distress as 4-7 are contacted by social work within 3 business days. The patients who identify their distress as 8-10 have social work follow up within 1 business day. Methods: The RIH-CCC mental health team consists of 4 full time clinical social workers and 2 psychiatrists. The social workers receive the patient’s distress scale after which they complete a comprehensive psychosocial assessment and develop a plan of care based on the urgency and complexity of the required interventions. The patients who require psychiatric evaluation are scheduled by the social work team to meet with the RIH-CCC psychiatrist for further assessment and evaluation. Results: Data was analyzed for the quarter of November 2014 to January 2015. The Center evaluated 1033 new patients. Of those, 119 completed a distress thermometer indicating a level of distress greater than 4 (average score of 6.6). Of the 119 patients seen by social work, 88 (74%) were in need of follow up care which often included further assessment by the on-site psychiatrists. Conclusions: Depression is estimated to occur in approximately 25-30% of adult cancer patients. Untreated and undiagnosed distress can have an adverse effect on cancer treatment. Our Centers’ results indicate that a significant number of those patients who identified as distressed were in need of further psychiatric evaluation and treatment. The strong collaborative relationship between on-site psychiatry and clinical social work promote early access and intervention to this challenged population.
PI-REAL: A study of informed consent (IC) communication in real-time during phase I clinical trial encounters.
Authors: Sharma Manish , Hlubocky Fay J. , Ratain Mark J. , Siegler Mark , Daugherty Christopher 
Published: February 2017

22 Background: Advanced cancer patients (ACP) in phase I clinical trials are unable to recall significant elements of IC, yet the actual verbal and non-verbal content of trial discussion between oncology fellows and ACP consenting in real time to such trials has not been well described. Methods: Phase I Communication in Real Time Fellow-ACP Encounters (PI-REAL) study is an evidence-based intervention designed to improve communication about phase I clinical trial IC. ACP completed follow-up questionnaires after new patient visits to assess understanding of IC elements, such as research purpose. Video recordings were analyzed using CanCode for verbal and non-verbal skills associated with IC elements. Results: To date, 61 ACP-fellow clinical encounter video recordings were available for analysis. Average length of encounters: 45.4 min (range: 5.7-87.8 min). ACP demographics included: median age 60y (33-83); 55% male; 89% Caucasian; 55% median income > $60,000. Fellows were coded as verbally disclosing: 1. Purpose of phase I trial as dose-determining in 49% of encounters; 2. Physical risks of trial in 75% of encounters; 3. Potential benefits (e.g. improved QOL) gained by ACP participation in trial in 70% of encounters; 4. Alternatives to trial entry (e.g. other trials, palliative/supportive care) in 55% of encounters. A significant association existedbetween coded fellow empathic statements and ACP subsequently recalling the purpose of the trial as dose-determining, with 72% of subjects who heard empathic statements identifying “dosage” compared to 10% of subjects who did not (72% v. 10%, p < 0.05). Regarding non-verbal skills, fellows: leaned toward ACP in 64% of encounters; observed ACP face directly in 72% of encounters; had relaxed body posture in 55% of encounters; and displayed responsive facial expressions in 77% of encounters. Conclusions: Empathic statements by fellows appear to be associated with improved ACP understanding of Phase I trial research purpose as dose-determining. Additional encounters continue to undergo video recording and analysis.