bluuebunny/crossref_metadata_2025_split huggingface dataset:
Involving cancer patients in clinical practice guidelines (CPGs) development in a French guidelines program: What are the key issues?
Authors: Fervers B. , Bataillard A. , Carretier J. , Kelson M. 
Published: March 2020

16029 Background: The translation of clinical research knowledge into CPGs involves interpretation of the evidence and value judgments. Patients’ preferences are essential in defining optimal cancer treatment because of the uncertain outcomes and important side effects. Their perspective should therefore be integrated into the development of CPGs (one item of the AGREE instrument). The Standards & Options: Recommandations program (SOR), of the French Federation of Comprehensive Cancer Centres has developed evidence-based cancer CPGs since 1993. To improve the quality and relevance of their CPGs the SOR program decided to develop a comprehensive method to involve cancer patients in the process. Methods: We developed an approach for the French context of cancer CPGs based on 3 inputs 1) Review of the literature from relevant databases and websites. 2) Review of the experiences of the National Institute for Health and Clinical Excellence and the Scottish Intercollegiate Network. 3) Multidisciplinary scientific committee (clinicians, patients, psychologists, sociologists, methodologists and healthy volunteers). Results: The data and the work of the experts allowed to identify the key issues for building a French approach 1) “Patient” includes patients under treatment, former patients, carers, members of a patients’ association, healthy volunteers. Patients are recruited through patients’ associations, clinicians, educational groups, newspaper announcements. 2) The patient plays a significant role in defining the clinical question, particularly the outcomes to be considered as well in the drafting of the CPG. They ensure that a patient perspective complements (and sometimes challenges) the views of professional members of the working group. 3) The major method for involving patients is to have them participate in the working group. 4) To train and support the patients is essential. 5) Informing the working group on the importance of taking into account the patient in the drafting of the CPG is a major issue. 6) A preliminary study demonstrates the feasibility and acceptability of patients’ involvement. Conclusions: This process is valuable and will be implemented in the SOR program. No significant financial relationships to disclose.
Quality measures for the diagnosis and management of colorectal cancer
Authors: Patwardhan M. B. , Samsa G. P. , Michael M. A. , Prosnitz R. G. , Fisher D. A. , Mantyh C. R. , McCrory D. C. 
Published: March 2020

16031 Background: The huge burden of illness from colorectal cancer (CRC) can be reduced by improving the quality of care for CRC patients. Identifying appropriate quality measures that can assess the processes of care is the first step in this process. Therefore we conducted a comprehensive literature search to identify process measures available in the United States to assess the quality of care for diagnosing and managing patients with CRC and the extent to which they were field-ready. Methods: We conducted a standard literature search using MEDLINE and the Cochrane Database; also explored gray literature, and identified 3771 abstracts. By sequential exclusion, 74 of them were finally included. We included quality measures from traditional QI literature, and supplemented them with those included in studies where these measures were used as part of their research agenda. All measures were abstracted into evidence tables and evaluated using a set of standard criteria regarding their importance, usability, and scientific acceptability. In order to assess the extent to which they were field-ready, we devised a summary rating scale for each quality measure using three criteria: importance and usability, scientific acceptability, and extent of testing. Results: Overall, the coverage of general process measures in CRC is extensive. Process measures are available for diagnostic imaging, staging, surgical therapy, adjuvant chemotherapy, adjuvant radiation therapy, and colonoscopic surveillance. The highest rated measures were those related to chemotherapy (abstract submitted by Morse et al) and pathology reporting. There were no process measures for assessing the quality of: polyp removal, surgical management of stage IV rectal cancer, hepatic metastasis, chemotherapy for stage II colon cancer, stage IV rectal cancer, radiation for stage IV rectal cancer, and notes for endoscopy, surgery, chemotherapy and radiology - all because of lack of guidelines. Conclusions: Our evidence report suggests that we need to actively pursue the task of developing scientifically accurate quality measures for leverage points in the diagnosis and management of CRC; so we can evaluate the quality of care delivered by providers and initiate quality improvement activities, with the aim of providing better patient care. No significant financial relationships to disclose.
Intravenous busulfan and cyclophosphamide as an autologous transplant conditioning regimen for relapsed non-Hodgkin’s lymphoma
Authors: Escalon M. P. , Pereira D. L. , Santos E. S. , Goodman M. , Byrnes J. J. , Fernandez H. F. 
Published: March 2020

16508 Purpose: High-dose chemotherapy and hematopoietic stem cell transplantation has become the standard of care for chemosensitive relapsed Non-Hodgkin’s Lymphoma. Multiple conditioning regimens including CBV, BEAM, and BEAC have been used in the past with success. Limitations on the supply of carmustine have made it important to find other effective conditioning regimens. Methods: We retrospectively evaluated the use of intravenous Busulfan and Cyclophosphamide (IV Bu/Cy) as a conditioning regimen for autologous stem cell transplantation in Non-Hodgkin’s Lymphoma patients. Patients were given Busulfan 3.2 mg/kg total intravenously on days -7 to -4 (either once daily or in 2 or 4 divided doses) followed by Cyclophosphamide 120 mg/kg intravenously on days -2 and -1. Results: Forty-four patients, ages 20 to 68 years (median 50) were treated from January 2000 to April 2005. Most patients had diffuse large B-cell lymphoma (n = 29). Of the remaining patients, 8 had follicular lymphoma, 4 had mantle cell lymphoma and 3 had peripheral T-cell lymphoma. At the time of transplant, 27 patients had attained a complete response (CR or CRu) to salvage chemotherapy, 13 patients had achieved a partial response, and 4 had stable disease. The patients received a median of 3.0 × 106 CD34+ cells/kg (range 1.3–16.6 × 106). There were 4 treatment-related deaths by day 100: 1 from sepsis, 1 from pneumonia, and 2 from veno-occlusive disease (VOD). With a median follow-up of 42 months, 3-year Kaplan-Meier estimates of event free and overall survival for the entire cohort were 44% and 45%. For the patients that attained a CR or CRu prior to transplant, the EFS and OS were 42% and 53%, respectively. Conclusions: IV Bu/Cy is a safe and effective conditioning regimen. Due to the incidence of VOD, this regimen should be used with caution in patients with pre-existing hepatic dysfunction. Overall, our outcomes are comparable to that of other published regimens. Further investigation of Busulfan with Cyclophosphamide or with other chemotherapy combinations is warranted. No significant financial relationships to disclose.
Pilot remission induction therapy with idarubicin, plus intensified dose of Ara-C and priming with granulocyte colony-stimulating factor for acute myeloid leukemia
Authors: Cho Y. , Baek J. , Sohn S. , Chae Y. , Kim D. , Kim J. , Yang D. , Kim Y. , Lee J. , Kim H. 
Published: March 2020

16516 Background: The sensitization of leukemic cells with hematopoietic growth factors can enhance the cytotoxicity of chemotherapy in acute myeloid leukemia (AML). Intensified remission induction (RI) therapy can also improve the treatment results for AML. Therefore, the current trial attempted to evaluate the efficacy and toxicity of granulocyte colony-stimulating factor (G-CSF) priming and a dose intensification of Ara-C in RI chemotherapy for AML. Methods: A total of 29 patients with newly diagnosed AML received G-CSF-priming RI chemotherapy consisting of idarubicin (12 mg/m2, D1–3), G-CSF (150 ug/m2, D3–8), and Ara-C (500 mg/m2, bid, D4–8), and the outcomes were compared with those for a historical group treated with a standard regimen consisting of idarubicin (12 mg/m2, D1–3) and Ara-C (100 mg/m2, D1–7). Results: There was no difference in the sex, age, subtype, and cytogenetic risk between the two groups. The complete remission (CR) rate and treatment-related mortality (TRM) were 72% and 17% for G-CSF-primed group and 71% and 10% for the historical group, respectively (p = 0.89 and p = 0.32). The time to neutrophil and platelet recovery did not differ significantly between the two groups (25 days vs. 24 days, p=0.17; 24 days vs. 23 days, p = 0.23, respectively). Similarly, the duration of fever was also not significantly different (5 days vs. 7 days, p = 0.58). Thirteen patients (45%) experienced fever and 5 patients (17%) manifested skin rashes during the G-CSF priming. After a median follow-up of 336 days, the 1-year overall survival (OS), disease-free survival (DFS), and event-free survival (EFS) rates were 72% vs. 63% (p = 0.83), 74% vs. 56% (p = 0.059), and 53% vs. 38% (p = 0.32), respectively. Conclusion: The G-CSF-priming RI regimen with an intensified dose of Ara-C did not show a superior efficacy when compared with a standard regimen, yet did produce a slightly longer DFS. Therefore, the sensitization of leukemic cells with growth factors and dose intensification would only seem to be a clinically applicable means to enhance the efficacy of RI chemotherapy in selected patients with AML, thereby warranting further studies focusing on specific subgroups of AML patients. No significant financial relationships to disclose.
Phase I/II study of arsenic trioxide (ATO) in combination with cytosine arabinoside (ARA-C) in patients with myelodysplastic syndromes (MDS)
Authors: Batista W. M. , Hineman L. , Seneviratne L. , Bagdasarian B. , Wada J. K. , Aboulafia D. , Malpass T. , Gota C. H. 
Published: March 2020

16525 Background: MDS is a group of myeloid disorders characterized by ineffective erythropoeisis with peripheral pancytopenia. We studied the efficacy and safety of ATO with/without ARA-C. Methods: We enrolled 10 patients with biopsy proven MDS per original FAB classification. See table for treatment design. Response was as follows: for CR the blast count in the BM should be <5% with normal maturation of all cell lines without evidence of dysplasia and PB values of Hemoglobin >11 g/dL, Neutrophils ≥1500/mm3, Platelets ≥100,000/mm3 lasting 2 months without transfusion support. PR was all of CR criteria except blasts decreased by > 50% over pretreatment or a less advanced MDS FAB classification than pretreatment. SD was failure to achieve at least a PR but without evidence of progression for at least 2 months. Results: 3 of 10 patients completed the study. 7 did not complete due to: 1 death from unrelated causes, 1 death from PD, 2 subjects withdrew, 2 were withdrawn at physician’s discretion, 1 withdrawal from toxicity. Of the 3 patients who completed study, 2 had SD and 1 had PR. 1 SD patient is alive 2 years later with transfusion support and another patient lasted 6 months before requiring transfusion. PR patient succumbed to acute myelogenous leukemia 12 months post-treatment. Conclusions: ATO with ARA-C appears to be an active regimen for patients with high risk MDS. Additional studies are warranted to confirm these findings. [Table: see text] [Table: see text]
Variable clinical response of hypereosinophilic syndromes (HES) to current therapeutic options
Authors: Mitra S. , Murphy P. T. , O’Donnell J. R. 
Published: March 2020

16527 The term Hypereosinophilic syndrome (HES) refers to a heterogeneous group of disorders characterised by marked blood (>1500/cu mm) and tissue eosinophilia resulting in end organ damage.Several visceral complications like cardiomyopathies and cerebrovascular accidents are common. Treatment of HES includes corticosteroids,chemotherapeutic agents (hydroxyurea, cyclophosphamide, vincristine), interferon-alpha. Newer treatment modalities,including tyrosine kinase inhibitors (eg Imatinib) and monoclonal anti IL5 antibodies are now available. We report a case series of patients with HES which demonstrate the variable clinical response to above therapeutic options. Case 1: A 43 year old man who presented with a right lacunar infarct had a eosinophil count of 1200/cu mm. No cause was found. He also had Mitral valve endocarditis. Following initial treatment with Methylprednisolone, the eosinophil count came down to 3500/cu mm, but the eosinophilia persisted. He was given a trial of Imatinib. In 2 months time his eosinophilia resolved. However, he was negative for FILIPI-PDGFRa. Case 2: A 37 year old lady with history of Splenectomy (due to trauma) presented with a eosinophil count of 2660/cu mm. Result of the FILIPI-PDGFRa was equivocal. There was no response to Imatinib. A trial of Prednisolone (1 mg/Kg) was ineffective. She did not respond to Interferon-alpha. However when given a combination of Prednisolone (0.5 mg/kg) and Interferon-alfa, her counts were normal in a month. Case 3: A 63 year old man with history of Atrial Fibrillation had persistent eosinophilia (>1500/cu mm). His serum Tryptase was raised but he was negative for FILIPI-PDGFRa. A trial of Imatinib failed He responded partially to high dose of Hydroxyurea. Prednisolone, Interferon-alpha or a combination of both are future options for him. Case 4: A 80 year old man with background history of Alzheimer’s Disease was found to have persistent unexplained eosinophilia. He had no complains of joint symptoms but his ANF was positive in low titres. A bone marrow showed no evidence of lymphoma or a myeloproliferative disorder. Karyotype was normal. He was given a trial of Hydroxyurea to which he responded in two weeks. Thus, response of HES patients to treatment is variable often unpredictable. No significant financial relationships to disclose.
Arsenic trioxide as primary treatment in acute promyelocytic leukemia
Authors: Aziz S. A. 
Published: March 2020

16533 Acute Promyelocytic Leukemia (APL) is a separate, distinct and biologically unique subset of Acute Myelogenous Leukemia (AML). The affordability of ATRA is detrimental for its use especially in the developing world. The use of Arsenic trioxide (As2O3) has radically changed the treatment, initially for relapsed APL and now is being used upfront as first line therapy in APL some studies. We accrued 11 cases (6 males, 5 females) of APL for the past 1 year. 2 patients of these had been already treated with ATRA + chemotherapy (Daunorubicin and Cytosine Arabanoside). These relapsed patients were switched over to Arsenic trioxide. One of these relapsed patients has completed the treatment and is in CR for the past 6 months after completing treatment. The other patient has recently completed the treatment and is in remission. 9 of our patients are newly diagnosed and could not afford ATRA and chemotherapy. All these patients were explained the treatment protocol and after obtaining a formal consent, patients were put on Arsenic trioxide. The protocol consists of Induction therapy with Arsenic trioxide given in a dose of 0.15 mg/kg/day till CR is achieved or to a maximum of 60 doses, followed by Consolidation treatment with Arsenic trioxide in the similar dose schedule but only for 28 days, and finally Maintenance therapy with Arsenic trioxide every 10 days a month for a total of 6 months with an interval of 4–6 weeks in between the cycles. Of the remaining patients (n = 7), 2 patients did not respond to Arsenic trioxide after 60 doses. The remaining patients (n = 5) are in different phases of treatment (all having completed Induction therapy) and are presently in CR (Mean duration to avhieve CR-57 days, documented by bone marrow examination). There were no major morbidities and none of our patients exhibited APL syndrome. The lower cost of treatment with Arsenic trioxide (Approx. Rs. 50–60,000) compared to ATRA + chemotherapy (Approx. Rs. 90,000–1,10,000), the magnitude of response and the least encountered adverse effects seem awesome in this treatment especially in the developing countries. No significant financial relationships to disclose.
Topotecan—Single agent activity in a weekly intravenous (IV) schedule for first-line therapy in poor prognosis extensive stage small cell lung cancer (SCLC): A Minnie Pearl Cancer Research Network phase II trial
Authors: Murphy P. B. , Hainsworth J. D. , Spigel D. R. , Gray J. R. , Liggett W. H. , Shipley D. L. , Switzer A. , Gandhi J. G. , Dannaher C. L. , Greco F. A. 
Published: March 2020

17000 Background: Topotecan IV weekly produces significantly less myelotoxicity than the standard 5-day IV schedule and appears as active in patients (pts) with relapsed ovarian cancer. Topotecan 5-day IV schedule is the standard for second-line therapy for pts with sensitive relapse SCLC. Methods: The primary endpoints were to determine the response rate and toxicity of weekly topotecan IV in pts with previously untreated extensive stage SCLC who were elderly, with poor performance status (PS), or severe coexistent medical illness. Topotecan 4mg/m2 IV over 30 minutes for 12 consecutive weeks was planned. Dose modifications were made based on toxicity. Pts were evaluated for response after 4 weeks; at least 3 weekly treatments were required to be eligible. Results: 39 pts were enrolled: 21 men, 18 women; age range 60–90 (median 71); PS 0 = 2, 1 = 18, 2 = 19). 31 pts were evaluable by WHO criteria for response. 4 pts had partial responses (13%, 95% CI 4%-30%); 20 pts (65%) had stable disease (4 had minor responses with tumor shrinkage of 29%, 19%, 12%, and 5%); 7 pts had progressive disease (22%). 15 pts completed 12 weeks of therapy. Grade 3/4 neutropenia/thrombocytopenia was seen in 11 pts and 3 pts; grade 3 infection 4 pts; grade 3/4 fatigue 12 pts. A total of 225 weeks of therapy was administered with 32 weeks of treatment delay and 10% required dose reduction. There were no treatment-related deaths. The median and 1-year survival of PR/stable pts were 5.6 months and 24%. Conclusions: Topotecan IV weekly has activity and was relatively well tolerated as first-line therapy in this very poor prognostic group of pts with extensive stage SCLC. The therapeutic index is improved with weekly topotecan IV schedule in contrast to the 5-day IV schedule. Additional study of weekly topotecan in combination with other agents in SCLC is warranted. [Table: see text]
A randomized phase II trial comparing carboplatin pleurodesis with cisplatin pleurodesis in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) with malignant pleural effusions (MPE)
Authors: Sasaki T. , Yasuda H. , Nakayama K. , Okinaga S. , Suzuki T. , Asada M. , Kanda A. , Shindo T. , Ohuchi Y. , Yamaya M. 
Published: March 2020

17012 Background: We previously reported that carboplatin pleurodesis in patients with advanced lung adenocarcinoma with MPE, renal insufficiency, and poor performance status (PS) was an effective palliative therapy. However, the efficacy and toxicity profile of carboplatin pleurodesis in patients with NSCLC with MPE in comparison with those of cisplatin pleurodesis have not been reported. Methods: Thirty patients with stage IIIB/IV NSCLC accompanied with MPE who did not have an indication for systemic chemotherapy because of poor PS more than 2 were randomized to carboplatin pleurodesis (target area under the curve as 5 μg-min/ml using Calvert’s formula) and cisplatin pleurodesis (80 mg/m2) in a single-blind and controlled trial. Enrollment took place between Oct 2004 and Dec 2005. Primary efficacy endpoints were the best confirmed response rate, time to progression (TTP) in controlling MPE and adverse effects. Results: Fifteen of 30 patients were treated by carboplatin pleurodesis, and resting 15 of 30 patients were treated by cisplatin pleurodesis to control MPE. The response rate in carboplatin pleurodesis was not statistically different from that for patients in cisplatin pleurodesis (P = .226). The use of anticancer drugs for pleurodesis was not significantly associated with response rate in logistic regression analysis (relative risk = 14.2, 95% CI: 0.6–320.5, P = .095). Median TTP in carboplatin pleurodesis was not different from that in cisplatin pleurodesis (96 days vs 83 days). The use of carboplatin for pleurodesis (P = .016) and gender (P = .005) were associated with prolongation of TTP in the Cox regression method. Kaplan-Meier analysis showed that the progression free probability curve in carboplatin pleurodesis was not different from that in cisplatin pleurodesis (P = .275). The rate of Grade 3 thrombocytopenia in carboplatin pleurodesis (25%) was higher than that in cisplatin pleurodesis (0%), but there was no statistical significance (P = .096). Conclusions: Carboplatin pleurodesis and cisplatin pleurodesis may be feasible and acceptable toxicity profiles. No significant financial relationships to disclose.
Second line chemotherapy with topotecan and gemcitabine in small cell lung cancer (SCLC) patients: An Alpe-Adria Thoracic Oncology Multidisciplinary group phase II study (ATOM 012)
Authors: Belvedere O. , Sacco C. , Ardizzoni A. , Rossetto C. , Follador A. , Sibau A. , Tumolo S. , Defferrari C. , Fasola G. , Grossi F. 
Published: March 2020

17014 Background: Topotecan is the only single agent currently approved for the treatment of relapsed or recurrent SCLC, showing activity both in chemotherapy-refractory (RR 2–14%) and in chemotherapy-sensitive patients (RR 14–38%). The role of topotecan in combination with other active agents is still under investigation. Methods: Aim of this phase II study is to assess the activity and safety of topotecan (1mg/sqm iv d1–5) plus gemcitabine (1250 mg/sqm iv d1) in relapsed or recurrent SCLC patients. Treatment is repeated every 4 weeks, up to a maximum of 6 cycles. Eligibility criteria: histologically or cytologically confirmed SCLC; documented progressive disease after ≥ 1 chemotherapy regimen; age ≥ 18 yrs; ECOG PS 0–2; measurable disease (RECIST); no prior treatment with topotecan or gemcitabine; adequate hematologic, hepatic and renal function; brain metastases are allowed. Results: A total of 44 patients have been enrolled. Patient characteristics are as follows: median age, 64 yrs (range 35–77); male/female, 35/9; ECOG PS 0/1/2, 12/21/11 patients; 68% patients had sensitive disease (recurrence > 3 months after first-line chemotherapy) and 32% patients had refractory disease (failure ≤3 months after first-line chemotherapy). One-hundred and seventeen chemotherapy courses have been administered (median 2, range 1–6). The following preliminary results refer to 37 patients. Grade 3–4 toxicities: 54% neutropenia, 16% anemia, 46% thrombocytopenia, 13% neutropenic fever, 27% fatigue. One toxic death was observed. Objective responses have been documented in 9 patients, for an overall response rate of 24% (3% CR, 21% PR); SD was observed in 7 patients (19%), PD in 17 patients (46%). Four early deaths were reported. Median time to progression is 8.9 weeks. Median survival time is 16.3 weeks, and 1-year survival rate is 14%. Conclusions: Based on these preliminary results, the combination of topotecan plus gemcitabine shows moderate activity and an acceptable toxicity profile in previously treated SCLC patients. However, it is unlikely that the addition of gemcitabine improves the outcome compared to single agent topotecan. No significant financial relationships to disclose.