bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prednisone (P) prophylaxis decreases incidence and severity of lenalidomide (L) induced flare reaction (flr) in patients with relapse (rel) or refractory (ref) chronic lymphocytic leukemia
Authors: Musial L. , Miller K. , Depaolo D. , Swinnich D. , Chanan-Khan A. A. 
Published: April 2020

18512 Background: Flare reaction (flr) is a new side effect unique to CLL pts treated with immunomodulating agents both thalidomide (T) and L. It is characterized by tender swelling of disease involved lymph nodes (LN), spleen, rash, low-grade fever and/or increase in absolute lymphocyte counts (ALC). Underlying biologic process remains unknown though it is postulated to be mediated through activation of immune effector cells and/or change in serum concentration of pro-inflammatory cytokines. In a phase II clinical trial of L in rel/ref CLL pts we noted a high incidence of flr. Here we report treatment schema for flr and a new preventive approach employed in this study. Methods: A total of 35 pts are enrolled. No prophylaxis given to initial cohort (A). Pts were treated at onset of symptoms with (1) ibuprofen (Ib) 600 mg po q6 hours (2) oxycodone (oxy) 5–10 mg po prn q 6 hours. In subsequent cohort (B) we are investigating prophylactic use of P 20 mg PO QD starting day −1 × 5 days followed by 10 mg QD × 5 days. Results: All pts had rel or ref disease. Median age 63 (range 48–76) year. In cohort A (n = 29) overall incidence of flr was 79% (n = 23). Of these the severity was graded as I, II and III in 48%, 24%, and 7% respectively. There was no grade IV flr. Symptoms initiated within hours of intake of the 1st dose of L lasting for a median of 14 days (cycle 1 only). Pts were adequately managed with symptom resolution using Ib/oxy. Recurrence in cycle 2 was noted in 1 pt. Pain in LN was the most common complaint. Increase ALC noted in 2 pts. Serum cytokine analysis (n = 5) pre and post 7-days of L treatment showed significant increase in TNF-α, IL-10 and MIG. In cohort B (n = 6) 2 pts had flr (grade I) lasting ≤ 10 days. Conclusions: Prophylactic use of P results in decrease incidence, severity and duration of flr. There was no correlation with clinical response. Elevation of ALC can be part of the flr, pts response should be interpreted cautiously for disease progression. Our findings suggest that use of P may be an effective prophylactic maneuver for prevention of L induced flr. Updated results of cohort B will be presented at this meeting. [Table: see text]
Finding an effective dose of fentanyl effervescent buccal tablets: Combined results of open-label titration
Authors: Wertheim M. S. , Jhangiani H. , Niebler G. , Charu V. 
Published: April 2020

18521 Background: Standard recommendations for short-acting oral opioid doses to manage breakthrough pain (BTP) assume some relation with the stable opioid dose used to treat persistent pain. Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the efficiency of fentanyl absorption through the buccal mucosa. They may provide rapid-onset analgesia. This pooled analysis of data from 3 studies examined the relationship between effective FEBT dose and around-the-clock (ATC) dose in patients who completed open-label titration to an effective FEBT dose. Methods: Patients were 18–80 years of age with cancer, persistent pain, and BTP. Eligible patients experienced an average of 1–4 episodes of BTP per day and were receiving stable doses of opioids (≥60 mg/day of morphine or equivalent) for persistent pain. Titration guidelines were uniform across studies; the maximum allowed dose of FEBT was 800 μg. Results: Of 304 patients enrolled, 208 completed titration to an effective FEBT dose; of these, 100 μg was effective in 21 patients, 200 μg in 32, 400 μg in 45, 600 μg in 49, and 800 μg in 61. The effective dose of FEBT showed no relationship to the dose of either ATC or supplemental opioids. No correlation was found between the effective dose of FEBT and the average dose of prior supplemental opioids (r2 = .0322; Pearson’s coefficient = .1793), the effective dose of FEBT and the dose of ATC opioids in patients using oral ATC opioids (r2 = .0353; Pearson’s coefficient = .1878), or the effective dose of FEBT and the dose of ATC opioids in patients using transdermal fentanyl alone or in combination with other opioids as ATC medication (r2 = .0289; Pearson’s coefficient = .1701). Conclusions: No predictable relationship between the effective dose of FEBT and the dose of ATC opioids was observed. Titration will allow the identification of each patient’s effective dose of FEBT for relief of BTP. [Table: see text]
Quality of life (QoL) measurement in breast cancer patients who were offered an evaluation at the hereditary cancer unit
Authors: Diz M. D. , Snitcovsky I. , Almeida G. F. , Maistro S. , Federico M. H. 
Published: April 2020

18532 Background: An Hereditary Cancer Unity was recently established in our service and we aimed to determine how many of our pts with a history of breast cancer would fulfill the criteria for undergoing BRCA1/2 genetic counseling. In addition, we asked whether or not a routine referral for a consultation in this population should impact on QoL. Methods: From September to November 2005, 180 women being followed-up at our service with a history of breast cancer, not in chemotherapy, were invited to schedule a appointment for genetic counseling. 130 pts answered the invitation and were asked to complete QoL questionnaires EORTC QL30 and BR23 (QLQ) validated into Brazilian Portuguese, before and after genetic counseling. Data were analyzed by Wilcoxon test or regression analysis, whatever appropriate, p≤0.05 considered significant. Results: All 130 pts were evaluated and BRCA1/2 mutation risk assessed based on previously published criteria (Frank et al, JCO 20:1480,2002). We evaluated that, as a whole, 25 pts harbor at least 10% probability and 3 were identified that present at least 20% probability. Three additional pts had bilateral cancer. None of these pts had been previously referred to genetic counseling. Regarding EORTC QLQ pre- and post genetic counseling, we found no differences regarding global QoL (75 vs 66), functional scales physical (80 vs 86), role (100 vs 100), cognitive (83 vs 83, social (100 vs 100), sexual function (83 vs 83), sexual pleasure (50 vs 66) or future perspective (33 vs 66) (p > 0.05). Concerning the emotional scale, we found an improvement after counseling (58 vs 75, p = 0.034) which seems to be clinically meaningful. Emotional status and global QoL were positively correlated (p < 0.000, r = 0.473, Pearson correlation). Conclusions: Our impression is that genetic counseling benefit breast cancer pts in terms of QoL, perhaps decreasing emotional distress. Apart from that, we need to define which risk threshold should be adopted in our service. Acknowledgment: to Marcelo Lopes technical assistance. No significant financial relationships to disclose.
Patients with stage IV lung cancer lose 25% of their valuable time in the office visits and hospital stay
Authors: Singh J. , Taylor S. , Huang C. , Malani A. K. , Gupta C. , Pabla M. 
Published: April 2020

18533 Background: Patients with stage IV lung cancer have median survival of 4–6 months. Randomized trials have shown chemotherapy may have small but significant survival benefit. To achieve this small gain,patients may have to spend their last few days of life in the office visits and hospitalization. Last few days of person’s life need to be spent comfortably and most effective manner in accordance to their wishes, desires and priorties.We attempted to study the “Time Lost” in the stage IV lung cancer patients who either did not choose or were not offered the palliative care/Hospice. Methods: We retrospectively reviewed charts of patients diagnosed with stage IV lung cancer (at their initial presentation) from Jan 2002 to Dec 2005 at our institution. We calculated their inpatient and out patient visit hrs and hence “Time Lost” during the last few days of their life. Patients were divided into two groups—Group A (n = 12): Patients who opted to choose palliative/hospice care immediately after the diagnosis and GroupB (n = 46): Patients who either refused or were not offered palliative/hospice care. Results: The median age at diagnosis was similar in both groups (71 vs 69.5 yrs). The median survival was also similar in both groups (4 months vs 4 months). Patients in group B (non hospice) had 1 month “Lost Time” out of their median survival of 4 months. In comparison patients in group A (hospice) had median survival of 4 months with “No Lost Time”. Thus patients who were not offered hospice or refused hospice spent 25% of their precious time during last stages of their life in inpatient stays and outpatient visits. Conclusions: Patients with stage IV lung cancer should be actively offered palliative/Hospice care, though studies with large number of patients is further required. [Table: see text] No significant financial relationships to disclose.
A randomised crossover comparative study of e-diary (electronic diary) versus paper and pencil collection of quality of life data in patients with locally advanced and metastatic non small cell lung cancer
Authors: Ring A. E. , Burbridge S. , Cheong K. , Meddis D. , Underhill L. , Cella D. , Harper P. 
Published: April 2020

18536 Background: Electronic diaries have been developed and facilitate collection of quality of life data. However there is concern that their use may alter the properties of the validated quality of life questionnaires which have traditionally been collated using a paper and pencil methodology. This study aimed to compare the results of e-diary and paper and pencil collection of FACT-L and EQ-5D quality of life data, and to ascertain patient preferences for the different modes of collection. Methods: Fifty patients with previously treated locally advanced or metastatic NSCLC were randomised in a 1:1 ratio to either complete a paper version of the questionnaires (FACT-L and EQ-5D) followed by the e-diary (Palm Tungsten W;CRF inc. Helsinki), or e-diary followed by paper questionnaire. Patient preference, ease of use and time for completion were recorded on a separate paper questionnaire. Results: The majority (88%) of the FACT-L and all (100%) of the EQ-5D individual question responses were within ± 1 point by the two methods, although for FACT-L 29% of patients had a total score greater than ± 6 points different by the two methods. There was no significant difference in FACT-L group mean total score for the two methods. The mean completion time was shorter for the paper and pencil than the e-diary (p < 0.0001). However, most patients stated that they preferred the e-diary to paper and pencil (60% vs. 12%). Conclusions: This study suggests that the mode of administration of the FACT-L and EQ-5D had a relatively small effect on the group mean responses given to the questionnaires. However data at the individual patient level looks quite variable between mode of administration. The group results obtained using the e-diary should therefore be comparable to the originally validated paper method, with the advantages of improved patient acceptability and ease of reliable interfacing with trial databases. However care need to be taken in interpreting data at the individual level. No significant financial relationships to disclose.
Quality of life (QoL) in SAKK 19/03: A multicenter phase II study of first-line gefitinib followed by chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Swiss Group for Clinical Cancer Research (SAKK)
Authors: D’Addario G. , Strasser F. , Ribi K. , Rauch D. , Stupp R. , Pless M. , Stahel R. A. , Rufibach K. , Lerch S. , Betticher D. 
Published: April 2020

18559 Background: 63 patients (pts) were accrued in this first study testing first-line tyrosine-kinase inhibitor treatment with gefitinib followed by chemotherapy at disease progression (gemcitabine-cisplatin q3w x6, 41 pts) in stage IIIB/IV NSCLC (ASCO 2005 # 7128). We investigated the longitudinal QoL patterns on both subsequent treatment modalities. Methods: FACT-L including TOI (Trial Outcome Index) and LCS (Lung Cancer Subscale) scores were assessed during both treatment phases (gefitinib: baseline, weeks 3,6,12,18 and every 12 weeks thereafter; chemotherapy: baseline and at d1 of cycle 3 and 5). QoL changes from baseline were descriptively analysed. Improvement was defined as a 6 point (FACT-L, TOI) and 2 point (LCS) increase. Results: QoL-scores are shown in the table below. On gefitinib, at week 6 31/18/32% of pts had improvements of FACT-L, TOI and LCS, respectively and 29/15/41% at week 12 (% based on pts with available data). During chemotherapy the respective improvement rates were 60/60/70% of pts at week 6 and 43/29/43% at week 12. At week 12 of gefitinib, 4 of the pts analysed had partial remission (PR, independently confirmed), 31 pts dropped out (none due to toxicity) and QoL submission rate was 84% based on expected forms. Chemotherapy week 12: 5 PR in analysed pts, 18 drop outs (5 due to toxicity), 43% submission rate. Conclusions: QoL was maintained in pts continuing treatment with gefitinib and decreased at disease progression. QoL and tumor symptoms improved in a considerable part of pts during gefitinib therapy despite low remission rates. Declining submission rate during treatment introduces a potential, unquantifiable bias in QoL. [Table: see text] [Table: see text]
Prevalence of written advance directives (AD) among cancer care providers at a community-based cancer center
Authors: Hammes B. A. , Lee J. A. , Mathiason M. A. , Ertz M. T. , Sheldon L. L. , Go R. S. 
Published: April 2020

18563 Background: Cancer care providers frequently discuss AD with their patients. The providers’ own attitudes toward end-of-life planning likely influence the choices and actions of their patients. We investigated the prevalence of written AD among the care providers at our community-based cancer center. Methods: All cancer center employees who have face-to-face contacts with patients (N=170) were sent an email survey in October 2005. This included medical (physicians, 15), associate (physician assistants and nurse practitioners, 7), and support (nurses, radiation therapists, medical or nurse assistants, and patient liaisons; 148) staffs. We collected data on demographics, work history, and AD. Results: A reply was obtained from 136 (80%) individuals. There were more females (90.2%) and the median age was 43 years (range, 20–63). While 82.8% reported to have discussed their wishes regarding future life-sustaining medical care with those closest to them, only 35.1% had a written AD: medical (58.3%), associate (50%), and support staffs (32.2%). Among those with AD, only 66% had made their own care providers aware of this. The top 5 factors that influenced providers whether to have or not to have AD were: experience at work (36.6%), spouse/domestic partner (25.4%), time to complete written AD (23.9%), family members/friends (21.6%) and children (19.4%). Interestingly, no one considered medical condition or illness as a factor. Increased age was significantly associated with having AD (odds ratio: 1.068; 95% CI:1.029–1.108), while the sex, number of years working with cancer patients, provider role, and marital/living status were not. Among the medical and associate staffs, 55.6% reported routinely discussing AD with their patients. Although all medical/associate staffs rated themselves as knowledgeable about and comfortable with discussing AD, the group who had AD was more apt to rate themselves as very knowledgeable and very comfortable. Conclusions: Only about a third of all cancer care providers and about half of cancer physicians at our institution have a written AD. Despite work experience with a patient population having a high mortality rate, cancer care providers do not adequately communicate end-of-life planning to their own health care providers. No significant financial relationships to disclose.
Is gabapentin effective for preventing delayed nausea and vomiting (NV) after moderately and highly emetogenic chemotherapy (CT)?
Authors: Menendez-Leal A. , Quijano C. , Menendez-Rivera A. G. 
Published: April 2020

18575 Background: Following previous institutional observations,this protocol was designed to evaluate the efficacy of Gabapentin in the prophylaxis of delayed CT induced NV. Methods: The main elegibility criteria was moderate and severe NV on previous CT cycles.Gabapentin 300 mg caps. was given as follows: One capsule day -2, two capsules day -1 and one capsule tid from days 1 to 5. 24 pats. were evaluated; 22 (92%) female, 2 (8%) male.CT included Doxorubicin/Ciclofosfamide 15 (62.5%), Cis-Platin 5 (21%), Other regimens 4 (17%). Previous prophylaxis for all pats. included a 5-HT3 Antagonist plus Dexametasone. Pats. were instructed to complete a two-page Questionaire: On page 1 pats. indicated the intensity of nausea according a scale shown there. On page two they indicated the number of vomits they had.This was made three times daily for five days. The primary endpoint was reduction of NV aftyer CT. Results: The reduction observed in the number of vomits was as follows: Number of pats. that experienced 0 Vomits: day 1 (CT): 14 (58.3%); day 2: 18 (75%); day 3: 20 (83.3%); day 4: 18 (75%); day 5: 22 (91.7%). On the other hand, pats. that did not respond and had three or more vomits daily: day 1: 5 (20.8%); day 2: 2 (8.3%); day 3: 1 (4.2%); day 4: 3 (12.5%); day 5: 2 (8.3%).Most pats. experienced a decrease in the intensity of nausea as well. No significant side effects were seen. Conclusions: Gabapentin seems to have some efficacy preventing delayed NV after moderately and highly emetogenic CT. These results together with it’s possible effect on acute NV and good tolerability warrant further studies. No significant financial relationships to disclose.
Quality of life intervention for men with biochemical recurrence of prostate cancer
Authors: Tan W. , Ames S. , Gretchen A. , Stone R. , Rizzo T. , Covil E. , Olmos J. , Clark M. M. , Rummans T. 
Published: April 2020

18585 Background: The Quality of life (QOL) and psychosocial needs of the 30–40% of prostate cancer patients who experience biochemical recurrence are not known. The impact of having a rising PSA, anticipation of undergoing PSA testing, and living with prostate cancer may increase psychological distress and decrease QOL. Aim: to evaluate the psychosocial treatment needs of men with biochemical recurrence of prostate cancer (br-PCa) and to develop a treatment to address these needs. Methods: 28 men with br-PCa, 58–87 years, were enrolled. A qualitative research approach was used, consisting of six, 2 hour, semi-structured, focus groups containing 4–6 men per group. Data were content coded and grouped into categories following the structure of the focus group guide. The major conceptual themes were then summarized by 2 independent reviewers. Discrepancies were discussed with a third researcher until a consensus was reached. These results were used to guide development of a multi-disciplinary quality of life intervention. Results: Participants defined QOL as the ability to stay active both physically and mentally without limitation in the performance of usual activities. There was a consensus that prostate cancer led to substantial anxiety related to PSA testing, treatment side effects, and fear of recurrence. Participants were enthusiastic about receiving adjuvant multidisciplinary treatment for prostate cancer focusing on anxiety management, nutrition, exercise, management of treatment side effects, and medical education. Participants desired a male group leader and feedback was mixed regarding whether spouses should be involved. Conclusions: Men with br-PCa report experiencing substantial anxiety and were enthusiastic about receiving a structured intervention to these needs. Based on our findings an intervention has been developed and is currently being compared to usual care. No significant financial relationships to disclose.
Piperacillin/tazobactam monotherapy versus combination ceftazidime plus amikacin for the treatment of febrile neutropenia in patients with cancer: A Hellenic Co-Operative Oncology Group Study
Authors: Pectasides D. , Fountzilas G. , Samonis G. , Panidis D. , Grimani I. , Bafaloukos D. , Pavlidis N. , Pectasides M. , Kyroudi-Markantoni S. , Aravantinos G. 
Published: April 2020

18590 Background: Combinations of β-lactam antibiotics and aminoglycosides are considered standard therapy for febrile neutropenia. Monotherapies have been proposed as standard treatments, demonstrating equal efficacy and better safety. Methods: This is a prospective, multi-centre, randomized clinical trial. Cancer patients with absolute neutrophil count (ANC) <1,000/mm3 and fever >38oC for ≥ 2 hours were randomized to either piperacillin/tazobactam 4.5 g every 8 h i.v. (group A) or ceftazidime 2 g every 8 h plus amikacin 15 mg/kg i.v. per day (group B). In case of fever >38oC 48 h after initiation of the therapy, vancomycin 500 mg every 6 h i.v. was added. Minimal duration of treatment was 72 hours. Treatment was continued for 7 days in case of improvement, otherwise vancomycin was added or the study therapy was discontinued. Early efficacy was assessed on day 3 and overall response 4 days after the end of treatment. Complete success was defined the patient to become afebrile and no other antibiotics to be added. Treatment failures were classified in two categories, those in which vancomycin was added to the study regimen, and those in which other antibiotics were used. Categorical variables were compared between treatment groups with the use of Fisher’s exact test, while for continuous Wilcoxon’s rank sum test was used. Results: One hundred twenty-seven febrile episodes were treated (group A: 66, group B: 61). Patient characteristics were well balanced in terms of age, underlying malignancies, ANC, and granulocyte-colony stimulating factor (G-CSF) support. Both treatments were well tolerated. No significant differences were seen in terms of success to treatment. Complete success was achieved in 45 (68%) of patients in group A and 40 (66%) in group B, while another 8 patients in group A (12%) and 6 in group B (10%) required addition of pre-defined anti-staphyloccocci antibiotic. Conclusions: Empirical treatment of febrile neutropenic episodes with piperacillin/tazobactam monotherapy appears to be as effective as the “standard” ceftazidime/amikacin combination. No significant financial relationships to disclose.