bluuebunny/crossref_metadata_2025_split huggingface dataset:
Poor risk assessment in the elderly receiving cloretazine induction for AML or MDS
Authors: Geller R. , Rizzieri D. , Vey N. , O’Brien S. , Johnson B. , Karp J. , Mufti G. , Giles F. 
Published: April 2020

18562 Background: Elderly patients (pts) ≥60 years with acute myelogenous leukemia (AML) have lower response rates, and higher morbidity and mortality than younger pts when treated with cytotoxic induction therapy. Common disease-related factors that predict poor response in the elderly are adverse cytogenetics and secondary leukemia (following antecedent hematologic disorder or exposure to chemotherapy). Pt-related factors such as ECOG performance status (PS) and organ dysfunction affect treatment decisions due to poor tolerability and early death. Cloretazine, a novel alkylating agent has significant activity in AML and MDS with a favorable safety profile. A Phase II study of monotherapy induction was conducted in elderly pts with AML or high risk MDS (N = 105, median age 72, range 60–88), with a 31% complete response rate and minimal non-hematologic toxicity. To describe the pts in this study considered “unfit” for 7+3 induction, disease-related and pt-related information was obtained. The Hematopoietic Cell Transplantation Comorbidity Index (Sorrer et al, 2005) (HCT-CI) is a modification of the Charlson Comorbidity Index (Charlson et al.1987), for pts considered for stem cell transplant. Seventeen medical conditions are included with weighted values predicting non-relapse mortality (NRM). Methods: Baseline demographic and pt-related data was obtained from case report forms. In addition to disease-related prognostic indicators, pt-related data was scored by the HCT-CI. Pts were grouped in risk categories for NRM by HCT-CI scores (low = 0, intermediate = 1 or 2; high ≥3). Results: Either or both disease-related poor risk factors were present in 68 pts (65%): 42 pts (40%) had unfavorable cytogenetics and 45 pts (43%) had secondary AML. No pt had favorable cytogenetics. Ninety-four (89%) pts had at least one HCT-CI comorbidity. The most common were cardiac (46%), psychiatric (28%); hepatic (25%) and controlled infection (24%). By HCT-CI, the risk for NRM was low in 10%, intermediate in 32%, and high in 57% of pts. Conclusions: The majority of these elderly pts were poor-risk by disease-related criteria or comorbidities measured by the HCT-CI. This index warrants further testing for determining NRM risk of induction regimens for elderly pts with AML. [Table: see text]
Diagnostics and therapy of Merkel cell carcinoma (MCC) in Germany— Guidelines and reality
Authors: Becker J. C. 
Published: April 2020

18564 Background: Merkel cell carcinoma (MCC) is a rare, aggressive cutaneous malignancy of the elderly. Due to its low incidence, current guidelines for diagnostic and therapeutic interventions are based on low levels of evidence. Moreover, it is unclear how strictly these guidelines are followed in the management of MCC patients. Methods: A review of MCC patients treated in 15 selected centres of the Dermatologic Cooperative Oncology Group between 1998 and 2004, i.e. when the initial version of national guidelines were valid, identified 150 patients of whom tumor- and treatment-related factors were analyzed for association with recurrence. Results: Initial tumour staging was completed in about 1/3rd of MCC patients in accordance with the guidelines (i.e. ultrasound of the abdomen and the regional lymph nodes, chest X-ray), in 1/3rd using an intensified regimen, and in the remaining patients was incomplete. Staging revealed that 82.5% of the patients were in stage I, 16.1% in stage II and 1.4% in stage III at the time of primary diagnosis of MCC. With respect to initial therapy, the mean surgical excision margin was 1.86 cm (instead of 3 cm) and adjuvant radiation was applied in 40% of the patients. Pathologic staging of the draining nodal basin was performed in 37 patients (24.6%), and 24.2% of these had node-positive disease. 56 patients (37.3%) recurred and the median time to recurrence was 10 months. Local and/or loco-regional recurrence developed in 29 and 33 patients, respectively; in 22 patients distant metastases occurred. While age, gender, tumour diameter and histological type were not significantly correlated with recurrence, therapeutic measures were, i.e. lower surgical margins and lack of adjuvant radiation were associated with an increased recurrence rate. Conclusions: Our study demonstrates that the current guidelines were only partially implemented in the clinical routine. This is particularly worrisome as our data indicate that MCC treatment in accordance to the guidelines results in an improved control of the disease. No significant financial relationships to disclose.
What are the important health-related quality of life issues in patients diagnosed with indolent lymphoma?
Authors: Mathias S. D. , Cimms T. A. , Colwell H. H. , Lubeck D. P. , Dawson K. L. , Huang J. E. 
Published: April 2020

18574 Background: Numerous treatment options are available for indolent lymphoma (IL), including watchful waiting, each with unique, longer term therapeutic and health-related quality of life (HRQL) issues. No validated HRQL questionnaire currently exists to assess the full range of issues that impact an IL patient’s QoL. We sought to fully assess these important areas to inform decisions about the use of a HRQL questionnaire in clinical studies. Methods: Five focus groups (n = 33), supplemented by in-depth one-on-one telephone interviews (n = 19) were conducted with IL patients across the US. Results: A total of 52 IL patients (65% female; mean age 53 years) participated and completed a questionnaire. Mean time since diagnosis was 51 months; 83% had received active treatment since diagnosis. Participants belonged to one of the following treatment categories: Watchful Waiting (17%), Actively Being Treated (50%), and Previously Treated (33%). Patients identified 4 domains and issues (see Table ) common across all patients regardless of treatment category. Treatment-specific issues included lack of control over the disease with watchful waiting vs. taking control, and actively fighting the disease with a specific treatment. Results from the questionnaire will be presented. Conclusions: Further elucidation of these issues is needed to facilitate HRQL evaluation in future studies and better inform treatment decisions. [Table: see text] [Table: see text]
The efficacy of hyperbaric oxygen therapy (HBOT) in the treatment of pelvic radiation-induced late side effects
Authors: Inbar M. , Grisaru D. , Fishlev G. , Lessing J. , Almog R. , Gall N. , Safra T. 
Published: April 2020

18576 Background: The treatment of pelvic malignancies (uterine, cervix, rectum, etc) often include radiation. Radiation-induced late side effects (longer than 3 months) are developed in 5–10% of those patients. We wanted to investigate the efficacy of hyperbaric oxygen therapy (HBOT) in the management of those patients. Methods: Thirteen women were evaluated. The primary cancer sources were: cervix (7), vagina (2), uterus (2), rectum (1) and bladder (1). All patients were treated with a full pelvic dose of radiotherapy. Eight patients also underwent post-radiation surgery (4 post-hysterectomy, 1 post-colectomy, 1 post-vaginectomy, 1 post-cystectomy and 1 post-exanteration). Eleven patients suffered from pelvic pain, 7 from chronic cystitis (including 2 with vesico-vaginal fistulas), 7 had chronic proctitis (including 2 with recto-vaginal fistulas), 3 had long-standing vaginal ulcers, and one presented with a long-standing open skin wound following surgery. All patients underwent imaging studies and biopsies to rule out active malignant disease, and all received HBOT 100% oxygen, at 2 absolute atmospheres, for 90 minutes (2ATA 90 min). Results: The mean patient age was 61 years (range 32–88). The mean time between completion of radiation therapy and onset of symptoms was 32 months (range 4–60). The patients received an average of 27 HBOTs (range 16–40). Twelve patients reported improvement in pelvic pain, bladder and bowel symptoms and decrease in vaginal discharge. One patient developed lung metastasis and another developed pelvic recurrence. No patient reported side effects associated with HBOT. Conclusion: HBOT appears to be safe and effective in the management of pelvic radiation-induced late side effects, such as soft tissue necrosis (skin and vagina), cystitis, proctitis and fistulas. No significant financial relationships to disclose.
Assessing rectal toxicity in a pilot study using intrarectal amifostine and concurrent radiation
Authors: Simone N. L. , Soule B. P. , Menard C. , Albert P. , Guion P. , Smith S. , Godette D. , Coleman C. N. , Singh A. K. 
Published: April 2020

18579 Background: There is evidence that daily intrarectal amifostine can protect rectal mucosa during prostate cancer treatment. Instruments more sensitive than the RTOG score may discriminate small but clinically important reductions in proctitis, however these tools need further evaluation. This study used both the RTOG GI toxicity score and expanded prostate cancer index composite (EPIC), a patient-administered quality of life instrument, to evaluate toxicity. Methods: In this pilot study, patients with localized prostate cancer were given daily amifostine (MedImmune, INC., Gaithersburg, MD) which was placed per rectum 30–45 min before 3D conformal radiation (66–76 Gy in 2 Gy fractions to a volume based on PSA, Gleason score and clinical stage). The first 18 patients enrolled received 1gram of amifostine and the next 12 patients were given 2 grams. Toxicity was assessed at baseline, 5, and 7 weeks during treatment and 3, 6, 12, 18, and 24 months after radiation and amifostine treatment. RTOG grading, an EPIC score and proctoscopic examination were done. The EPIC questionaire is a validated instrument that consists of 50 quality of life questions related to urinary, bowel, sexual and hormonal domains. Two subsets of the bowel domain were used: “bowel function” (BF) targets symptom severity and “bowel bother,” (BB) assesses quality of life subscales. Results: Previously reported results demonstrate a clear trend towards protection from rectal toxicity using 2 gm as compared to a 1 gm amifostine dose. Here, we report that the EPIC-BF and EPIC-BB scores are both highly correlated with the RTOG toxicity score with a pearsons coefficient of 0.98 and 0.97 respectively at a median follow up of 24 mos. There was no significant change in the RTOG GI toxicity score over the course of treatment for either amifostine dose group. There was a statistically significant decrease in EPIC-BF score at 7 weeks (p = 0.04) and the EPIC-BB score showed a trend toward improvement (p = 0.07) at the same time point. The EPIC scores at all other time points were not statistically different from baseline. Conclusions: The EPIC score may be a more sensitive measure to detect acute toxicity associated with prostate cancer treatment but needs further investigation in the acute setting. No significant financial relationships to disclose.
Loading dose ibandronate in rapid pain management of metastatic bone disease (MBD)
Authors: Pendharkar D. , Goyal H. 
Published: April 2020

18580 Background: MBD is common complication in many malignancies. Pain is common presentation of MBD. It is major cause of morbidity, major determinant of quality of life and an important reason for emergency medical referral. Acute pain necessitates emergency pain relief measures. Besides conventional radiation and pain killers, bisphosphonates are indicated in MBD. They contribute towards pain relief. Literature suggests that ibandronate may be effective in acute pain relief. The aim of this study was to study the efficacy of ibandronate in acute pain relief. This should obviate the need for local radiation and or increase in dose of pain killers. Methods: Patients with severe pain were given inj. ibandronate 6 mg iv over 2 hrs for 3 consecutive days. Pain was assessed by direct questioning the patient . Pain was assessed on first four days and after four weeks. Patients were continued with single dose ibandronate once in a month there after. Response was assessed as excellent-more than 90% disappearance of pain, good -more than 50% but less than 90%, satisfactory -between 25– 50% and no response-if less than 25%. Results: A total 9 patients were treated using loading dose ibandronate. There were 4 patients of carcinoma prostate, 3- carcinoma lung, 2- multiple myeloma. All had intolerable bone pain and this was the main reason for this particular admission to hospital. All patients had shown satisfactory response on day 2. On day three 6/9 patients shown a good response. On day four, 4/9 patients shown an excellent response, 4/9 -good response and 1/9 satisfactory response. At the end of four weeks 6/9 patients shown an excellent response, 2/9 good response and 1/9 satisfactory response. The pain response improved over four weeks. On questioning, all patients communicated there strong willingness to continue the same treatment. Conclusion: Loading dose, consecutive three day administration of ibandronate appears to be the ideal strategy for rapid pain relief in patients with MBD. There is an excellent response to such an intervention. In compromised patients with reduced bone marrow reserves this may form the standard of care. Broader data acquisition is warranted. No significant financial relationships to disclose.
Comparison of the use of cefepime (cefp) monotherapy vs. piperacillin/tazobactam (pip/tazo) plus a fluroquinolone or aminoglycoside for the empiric treatment of febrile neutropenia (FN)
Authors: Gordon S. , Stuntebeck E. , Collins C. , Streetman D. , Ward A. , Erba H. 
Published: April 2020

18581 Background: Practice guidelines for empiric therapy of FN were created and implemented at our institution in January 2003, prior to which empiric therapy often included the use of cefp. These guidelines recommend the combination of pip/tazo with gentamicin or levofloxacin for most patients. This retrospective chart review compared the efficacy of pip/tazo combination therapy versus historical controls treated with cefp. Methods: 183 patients met eligibility criteria. 87 patients were treated with pip/tazo, with 92% receiving levofloxacin as the second agent. 75 patients received cefp, 16 of which initially also received either a fluoroquinolone or an aminoglycoside. Endpoints included a difference in the addition of vancomycin and antifungals, incidence of breakthrough infections, trends in antibiotic resistance, and survival until discharge. Groups were compared using chi-square or Student’s t-test as appropriate. Results: The two groups were not significantly different in any measured demographic or clinical characteristic. No statistical difference was found between groups for the addition of vancomycin (cefp 43%, pip/tazo 41%; p = 0.9898) or antifungals (cefp 45%, pip/tazo 51%; p = 0.1346). The incidence of breakthrough infections was comparable (cefp 25%, pip/tazo 26%; p = 0.7461), and microorganism eradication rates were not different between groups (cefp 48%, pip/tazo 54%; p = 0.41). However, of those who developed a breakthrough infection, survival was lower in the cefp group (37% vs. 63%; p = 0.0389). Additionally, the rate of overall survival to discharge was significantly lower in patients initially treated with cefp (83% vs. 94%; p = 0.0193). The antibiograms of the hematology floors were compared for the 2 years prior to and after implementation of our FN guidelines; no change in susceptibilities was observed. Conclusions: From these results, we conclude that pip/tazo combination therapy is a reasonable alternative to cefp for empiric treatment of FN. [Table: see text]
A prospective, observational study of the effectiveness, safety and impact on quality of life (QoL) of a weekly fixed dose of darbepoetin alfa (DA) for the treatment of chemotherapy-induced anemia (CIA) in patients (pts) with non-myeloid malignancies
Authors: Mel J. R. , Salar A. , Rodríguez C. A. , Alegre A. , González A. , Cassinello J. , Montesinos J. , Gasquet J. A. , Sánchez J. , Saigí E. 
Published: April 2020

18588 Background: CIA in cancer pts results in fatigue and reduction of QoL. DA is a unique erythropoiesis-stimulating agent (ESA) effective for the treatment of CIA when administered weekly (QW), every 2 weeks (wks, Q2W) or every 3 wks(Q3W).Fixed dosing of DA is routinely used in clinical practice, but little data are available on its patterns of use and effectiveness. Methods: Prospective, observational, multicenter study performed in 30 centres across Spain. Eligible pts: ≥18 yrs, anemic(Hb ≤11 g/dL), with non-myeloid malignancies, and scheduled to receive ≥12 wks of chemotherapy. Data were collected from pts starting treatment with DA 150mcgQW for a maximum of 16 wks (dose to be doubled if Hb increased <1 g/dL after 4 wks). Primary endpoint: hematopoietic response (Hb increase ≥2 g/dL or Hb ≥12 g/dL without transfusions in the previous 28 days). Secondary endpoints include QoL measured by FACT-F score and safety. QoL was evaluated by changes in FACT-F score from baseline to 6 wks (sc0-sc6), 12 wks (sc0 - sc12) and to the end of treatment (EOT) (sc0-sc16). Results: A total of 293 pts were recruited. Most pts were women (56.4%), median age: 64.9 yrs (range: 20.6–88.4), median weight: 67.0 Kg (range: 40.5–115.0) with lymphoproliferative malignancies (44.3%) and solid tumours (55.7%). Stage III/IV: 75.6%. Most (83.7%) pts had baseline Hb between 9–11 g/dL; 16.3% with Hb <9 g/dL. DA was administered for a median of 15.0 wks (range: 1–16). At wk 5, 21% pts had dose doubled to 300 mcg QW. Hematopoietic response: 63.8% (95% CI: 58.1; 69.4). Proportion of pts transfused from wk 5 to EOT: 12%, median: 2 units (range 1–3). DA was well-tolerated with only 6 pts experiencing adverse events considered related to the study drug (thromboembolic events, 3pts (1.03%)). Changes in FACT-F score showed significant improvement in sc0-sc6 (mean difference: −1.73, p = 0.0083), in sc0-sc12 (−1.98, p = 0.0088) and particularly in sc0-sc16 (−3.75, p < 0.001). Conclusions: Fixed dose of DA is an effective and well-tolerated treatment for CIA in pts with non-myeloid malignancies. DA significantly improved health-related quality of life in this clinical practice-based study. [Table: see text]
The safety profile of eltrombopag, a novel oral platelet growth factor, in thrombocytopenic patients and healthy subjects
Authors: Provan D. , Saleh M. , Goodison S. , Rafi R. , Stone N. , Hamilton J. M. , Hassani H. , Mayer B. , Uhl J. , Jenkins J. 
Published: April 2020

18596 Background: Eltrombopag (SB-497115) is an oral, non-peptide, small molecule, thrombopoietin receptor agonist being tested as a potential treatment for thrombocytopenia. Eltrombopag has been shown to increase platelet counts in both healthy subjects and thrombocytopenic patients. Methods: Safety and tolerability data for eltrombopag (3–75 mg for up to 6 weeks) is presented from randomized, placebo-controlled, parallel group clinical trials involving 115 healthy subjects and 104 immune thrombocytopenic purpura (ITP) patients. Safety and tolerability endpoints involved assessment of adverse events (AE) and clinical laboratory parameters, including ECGs and platelet function. Results: In 3 Phase I trials, 98 healthy males received active eltrombopag QD for up to 10 days at 3–75 mg. In the Phase II dose ranging study, 78 chronic ITP patients (28 male/50 female) received active eltrombopag QD for 6 weeks at doses of 30–75 mg. There was no apparent relationship between active and control arms, the dose of eltrombopag and the incidence or severity of AEs, changes in laboratory values, platelet function or cardiac parameters in any of the studies. There were no serious adverse events (SAEs) reported by subjects in the 3 Phase I studies. 5 SAEs were reported in 1 patient in the ITP study that were considered by the investigator as possibly associated with administration of 50 mg eltrombopag. No SAEs were related to 30 mg or 75 mg eltrombopag, and 2 SAEs in 2 patients were related to placebo. Conclusions: There was no apparent relationship between eltrombopag dose and safety endpoints in these studies. These encouraging safety and tolerability data support the further testing of eltrombopag in phase II and III studies involving patients with ITP and chronic liver disease, and cancer patients receiving thrombocytopenic chemotherapy. [Table: see text]
Pulmonary lymphangitis and cancer: Prospective series of 37 patients in palliative care
Authors: Dettino A. A. , Negri E. M. , Pagano T. 
Published: April 2020

18600 Background: Lymphangitis of the lungs is an uncommon type of metastasis, mainly in breast, lung and gastric cancers, and has major impact in quality of life and an unfavorable prognosis. Survival is very poor: 50% in 3 and 15% in 6 months. Our objective was to evaluate prospectively quality of life in cancer patients with pulmonary lymphangitis, under palliative care. Methods: Patients with pulmonary lymphangitis, diagnosed either by lung biopsy (major criteria) or 3 minor criteria (cyto or histotologically proven cancer, clinical picture and image exam) were followed in 3 tertiary services, in a cohort series study. Primary end point was quality of life (QoL), measured with questionnaires in the beginning of the study and monthly afterwards (Saint George Respiratory Questionnaire -SGRQ- and Medical Outcomes Study 36-Item Short-Form Health Survey -SF36). Clinical and complementary aspects were also followed, in addition to treatment and outcome. Results: Thirty-seven patients were included from Aug/2004 to Jan/2006 - 23 female and 14 male; age from 41 to 84 (mean: 62) years. Primary tumors were: lung (20), breast (11), esophagus (2), pancreas, rectum and bone. Of those patients, 33 were able to respond QoL questionnaires in the beginning of follow-up and monthly thereafter. Median follow-up was of one month (range: 0–13); at the moment, 9 patients are still alive. Median survival was 2.5 months (range: 0,1–33), with 38% with a survival of at least 6 months. In general, QoL was poor, but improved after palliative care. Notice that values get higher as QoL improves in SF-36; however, they get lower as QoL improves in SGRQ - values were 61.5, 50.5, 61.7, and 47.5% for SGRQ and 38.1, 32.1, 32.8, 61.6 for SF36 in 0, 1, 3 and 6 months, respectively. Palliative care included: corticosteroids (65%), oxygen (51%), opioids (51%), diuretics (47%), inhalations with beta2-agonists and/or ipatropium (57%), chemo and/or hormonotherapy (51%), physical therapy (43%), antidepressants and benzodiazepines (37% each), thoracocentesis (35%), and blood transfusions. Conclusions: Even though QoL is poor and survival is short for patients with cancer lymphangitis in lungs, some improvement is possible with active palliative care. No significant financial relationships to disclose.