bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of the income-based health service types on survival in patients with metastatic gastric cancer
Authors: Oh S. , Oh H. , Yoon S. , Shin D. , Lee K. , Kim I. 
Published: August 2020

e17574 Background: Subscription to National Health Insurance (NHI) is a national obligation for South Korean people. For low-income citizens (about lower 3% of population), Medicaid is applied. Many recipients of Medicaid are vulnerable people such as old age singles, the homeless or the handicapped. These populations are suspected to have worse prognosis. According to one report, on the other hand, patients with Medicaid were more likely to receive chemotherapy than patients with NHI despite the uniform health insurance coverage within the two types of health cost financing. Owing to these conflicting findings, we investigated the relationship between health insurance type and prognosis. Methods: Patients are stage IV advanced gastric cancer patients who received palliative chemotherapy. Medical records were reviewed from January 2006 to November 2008 in Seoul Medical Center (municipal teaching hospital). Results: Total 37 patients were found. Median age was 61 years (range 31–85) and male constituted 75.7%. Platinum (cisplatin or oxaliplatin) combined with 5-FU was the most frequently used regimen (78.4%). Twelve patients (32.4%) were recipients of Medicaid. Median PFS and OS of NHI group were 6.9 (95% CI, 1.7–12.0) and 7.8 (95% CI, 3.4–12.1). And that of Medicaid were 5.6 (95% CI, 2.6–8.6) and 7.8 (95% CI, 3.4–12.2) months. The difference from two groups were not statistically different (p = 0.739 for PFS and 0.466 for OS). When patients were divided into longer or shorter survivors according to mean OS (14.1 ±2.6 months), NHI recipients had more probability for survival (odds ratio 0.72, 95% CI 0.56–0.92). Conclusions: The question is raised whether recipients of Medicaid have poorer prognosis than patients with NHI in metastatic gastric cancer in South Korea. Although it seems that NHI recipients has better prognosis, still we cannot sure. It should be cleared in large scale cohort study whether this is related to low socio-economic status or other uncontrolled confounder. No significant financial relationships to disclose.
Febrile neutropenia during acute myeloid leukemia therapy: Single institution experience from a developing country
Authors: Gupta A. , Singh M. , Singh H. , Kumar L. , Sharma A. , Bakhshi S. , Raina V. , Thulkar S. 
Published: August 2020

e18000 Background: Febrile neutropenia poses a major challenge during treatment of acute myeloid leukaemia (AML). Methods: Episodes of febrile neutropenia in 104 consecutive patients of AML admitted to the medical oncology ward between May 2001 and December 2006 were studied. There were 62 males and 42 females, median age 28 years (2–61 years). Results: 402 febrile episodes including 363 episodes of febrile neutropenia (180 in induction, 183 in consolidation) and 39 non-neutropenic episodes (18 in induction, 21 in consolidation) occurred. Clinical, microbiological and radiological foci could be detected in 51.1%, 22.2 %, and 31.1% episodes of febrile neutropenia during induction and 31.1%, 19.1% and 12.7% episodes during consolidation. Rates of documented infections during induction and consolidation were 74% and 52%. Respiratory (39.2%) and ear, nose, and throat ( 23.9%) were the commonest clinical sites during induction. Respiratory (21%) and central line infections (19.2%) were commonest during consolidation. Gram negative infections predominated (Pseudomonas aeruginosa, Klebsiella pneumoniae: major isolates). 32.5% of microbiologically proven infections during induction and 14.2% during consolidation were polymicrobial. Bronchopneumonia was the commonest radiological focus. There were 60 episodes of fungal infections (47 in induction, 13 in consolidation). There were: 1 definite: mucormycosis, 3 probable (1 case each: Candida krusei, Candida tropicalis in blood, 1 chronic disseminated hepatosplenic candidiasis), and 56 possible infections. Halo sign was seen in 18, sinusitis with bone erosion in 7. Infections accounted for 85% of the 20 deaths (induction: 18). Fungal infections and bronchopneumonia were major causes of mortality (p = 0.001). 3/4 enterococcal bacteremias were associated with mortality (p = 0.001). 6 cases of tuberculosis (5 pneumonias with necrotic mediastinal nodes, 1 Pott's spine) and 3 cases of malaria (1 cerebral malaria) were also detected. Conclusions: Induction was associated with greater morbidity and mortality. Prompt and proper institution of antibiotics and antifungals besides considering alternative diagnosis peculiar to the region (e.g. tuberculosis, malaria) may aid in better management. No significant financial relationships to disclose.
A phase II feasibility study of cytarabine and idarubicin combination in relapsed or refractory adult acute lymphoblastic leukemia
Authors: Hafeez M. , Shaharyar A. , Zia N. , Rasheed H. 
Published: August 2020

e18002 Background: Most patients with adult ALL eventually relapse. Salvage regimens in these patients and in patients with primary refractory disease are generally based on cytarabine in combination with other agents. Exact merit of each combination remains undefined as these continue to be tested in non randomized trials. This study was conducted with the objectives to find out the efficacy and toxicity of cytarabine and idarubicin combination. Methods: From December 2006 to March 2008, 30 patients were enrolled in this prospective, nonrandomized single institution phase II feasibility study. It was empirically decided that the study will only be considered feasible if more then ten patients achieve a complete remission. Patients who relapsed during maintenance therapy or were refractory and were at least 16-years-old were considered eligible provided they have received at least vincristine and prednisone as induction. No prior cytarabine was allowed. Cytarabine 100 mg/m2 continuous infusion for seven days along with idarubicin 12 mg/m2 day 1 to 3, IV bolus was given. Bone marrow examination was done 15 days after the completion of chemotherapy. Results: All thirty patients completed planned treatment. Five patients died of infection during treatment. Eleven patients achieved complete remission. All patients relapsed within eight months. Conclusions: The regimen of cytrarabine and idarubicin is feasible and sufficiently effective in relapsed or refractory adult ALL with manageable toxicity. No significant financial relationships to disclose.
Factors affecting the hematological and nonhematological toxicities in B-cell lymphoma patients during treatment
Authors: Karimi P. , Shokri A. , Etemadi L. , Negar Rezania N. 
Published: August 2020

e18004 Background: Despite recent improvements, toxicities in B-cell lymphoma patients during treatment remains a major challenge for leukemia community. The aim of this study was to determine factors affecting the hematological and non-hematological toxicities in B-cell lymphoma patients during treatment. Methods: This multicentral cross-sectional study was performed on 68 diagnosed B-cell lymphoma patients (17–72 y/o, mean age 53y/o) admitted in three cancer centers for treatment during 2003–2008. Patients with other malignancies, serious illness or infection were not included. Demographic data, clinical and para clinical manifestations were recorded during treatment. Results: 31 (45%) patients developed grade 2 or greater non-hematological toxicities: 11:fever, 8:chills, 6:vomiting, 4:rash, and 3:pruritus. Moreover, 7 patients developed grade 3 non-hematological toxicities. 42 (62%) patients developed grade 2 or greater hematological toxicities. Non-hematological toxicities were more frequent in patients with BM (Bone Marrow) involvement [15/32 (47%) versus 21/60 (35%), p = 0.01] and with extranodal disease [23/48 (48%) versus 11/42 (26%), p = 0.008]. The incidence of grade 3 or 4 hematological toxicity was higher in females than males [17/43 (40%) versus 13/50 (26%), p = 0.001]. Furthermore, being female was significantly associated with the development of grade 3 or 4 neutropenia [17/49 (35%) versus 8/53 (15%), p = 0.003]. In addition, high LDH was also associated with grade 3 or 4 leukopenia [7/27 (26%) versus 9/58 (16%), p = 0.01], but not with neutropenia. Conclusions: Multivariate analysis demonstrate that some factors like female gender, BM involvement, and serum LDH level could be useful for predicting the hematological and nonhematological toxicities in B-cell lymphoma patients during treatment. No significant financial relationships to disclose.
Bevacizumab (Bv) single-agent maintenance following Bv-based chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): Results from an exploratory analysis of the AVAiL study
Authors: Mezger J. , von Pawel J. , Reck M. 
Published: August 2020

e19001 Background: The significant survival benefits observed with Bv plus chemotherapy in pivotal NSCLC trials were generated using treatment to progression. Given that little data on the use of single-agent Bv as maintenance therapy are currently available, we report here the results of an analysis focused on the maintenance phase of the AVAiL study. Methods: AVAiL, a randomized, international, placebo-controlled phase III trial, evaluated Bv plus cisplatin-gemcitabine (CG) in pts with previously untreated advanced, non-squamous NSCLC, with performance status 0/1. 1,043 pts (age 20–83) were randomized to C 80mg/m2 and G 1,250mg/m2 q3w for up to 6 cycles plus either Bv 7.5mg/kg q3w (Bv 7.5; n=345), Bv 15mg/kg q3w (Bv 15; n=351) or placebo (Pl; n=347). Bv/Pl was administered until disease progression. This retrospective analysis focused on progression-free survival (PFS) and overall survival (OS) of the 376 patients who received blinded Bv (n=174 and n=162 for Bv 7.5 and 15) or Pl monotherapy (n=41) after completing 6 cycles of CG + Bv or CG + Pl (as specified in the protocol; most patients received 6 cycles). PFS was measured from last day of last cycle of CG + Bv/Pl to disease progression or death. Results: In the overall population, Bv reduced the risk of progression or death by 25% vs Pl (PFS primary endpoint (HR=0.75 [0.64–0.87] and 0.85 [0.73–1] for Bv 7.5 and Bv 15, respectively). When analyzing the outcome of the post chemotherapy maintenance phase, the use of Bv as single agent yielded median PFS of 3.2 months (95%CI [3–5]) for Pl, 4.6 months (95%CI [4–6]) for Bv 7.5 and 4.6 months (95%CI [4–5]) for Bv 15.The OS results for this maintenance analysis are consistent with those from the overall population in which the PFS findings were not associated with an OS benefit. Conclusions: This post-hoc analysis, focused on the maintenance phase of AVAiL, suggests that Bv used as single-agent maintenance therapy appears to confer clinical benefit beyond the chemotherapy phase. This finding warrants further exploration in future studies. [Table: see text]
Phase II study of irinotecan plus S-1 combination for previously untreated advanced non-small cell lung cancer: Hokkaido Lung Cancer Clinical Study Group 0601
Authors: Oizumi S. , Akie K. , Ogura S. , Shinagawa N. , Fukumoto S. , Harada M. , Kojima T. , Kinoshita I. , Dosaka-Akita H. , Isobe H. , Nishimura M. 
Published: August 2020

e19012 Background: Platinum-containing therapy is a standard first-line treatment for advanced non-small cell lung cancer (NSCLC). Platinum-free regimens can be alternative if they can provide similar efficacy with better tolerability. This study evaluated the efficacy and safety for combination of irinotecan and S-1, a newly developed oral 5-fluorouracil derivative, for chemotherapy-naïve advanced NSCLC. Methods: In this multicenter phase II trial, we initially planned to enroll 40 patients. Chemotherapy consisted of 4-week cycles of irinotecan (100 mg/m2 IV, day 1 and 15) and S-1 (80 mg/m2 orally, day 1–14). Primary end point was response rate; secondary endpoints were overall survival (OS), progression-free survival (PFS), and safety. Association of UGT1A1 genotypes (*6 and *28) with frequency of severe toxicity was also examined. Results: A total of 112 cycles was administered into 40 patients (median, 3 cycles: range, 1–6). Median age was 64 years (range, 42–75); 29 patients (73%) had adenocarcinoma, and 8 patients (20%) had squamous cell carcinoma. Majority of the patients (32 cases, 80%) had stage IV disease. Twelve patients exhibited partial response (PR), and 17 patients exhibited stable disease (SD), resulting in response rate of 30% [95% confidence interval (95% CI), 16.6–46.5] and disease control rate of 72.5% (95% CI, 56.1–85.4). Median OS and PFS were 13.8 months (95% CI, 10.7–16.9) and 4.7 months (95% CI, 3.4–6.0), respectively. Hematological toxicities of grade 3 or 4 were neutropenia (32.5%) and anemia (5.0%). The most common non-hematologic toxicities of grade 3 or 4 included diarrhea (15.0%) and anorexia (17.5%). There were no treatment-related deaths. Among the 40 patients, there were 1 homozygous and 8 heterozygous for UGT1A1*6, whereas 7 heterozygous for UGT1A1*28; none of the patients had both genotypes. Patients with homozygous or heterozygous for UGT1A1*6 showed a trend for high incidence of grade 3 diarrhea (p = 0.055). No association of UGT1A1*28 with severe toxicity was observed in this study. Conclusions: Irinotecan and S-1 combination is an alternative treatment with tolerable toxicity for previously untreated advanced NSCLC. No significant financial relationships to disclose.
Concurrent chemotherapy immediately following erlotinib (E) or gefitinib (G) induced apoptosis in previously untreated patients with advanced or metastatic non-small cell lung cancer (NSCLC)
Authors: Natale R. B. , Natale R. B. 
Published: August 2020

e19014 Background: The EGFR-TKIs, E and G, block EGFR-mediated proliferative and anti-apoptotic signaling. The predominance of anti-proliferative effects over the latter mechanism is postulated as the reason that no additional benefit was observed when either agent was given concurrently with 1st line chemotherapy in unselected NSCLC pts (INTACT 1 & 2, TALENT & TRIBUTE trials). However, a subset analysis of TRIBUTE pts with a never smoking history suggested that improved survival may occur when the pt population is partially enriched to increase the proportion with an EGFR-TKI induced apoptotic effect (Miller VA. Proc ASCO, 2004). We therefore hypothesized that pts demonstrating rapid tumor regression within a 3–4 week exposure to E or G represented a population highly enriched for the apoptotic effect and that immediate concurrent administration of chemotherapy would produce prolonged survival. Methods: Forty-one stage IIIB/IV pts, including 27 women and 14 men, median age 67 (range 41 to 88) with limited smoking history (21 never smokers, 20 former light smokers) were treated with E 100–150 mg/day (39 pts) or G 250 mg/day (2 pts) for an average of 26 days (range, 21–34) before response assessment. Twenty-two pts achieved objective tumor responses (2 CRs, 20 PRs) and immediately received 4–6 cycles of platinum-based chemotherapy concurrently with continued E or G (group A). E or G was discontinued in 19 pts not achieving objective response and platinum-based chemotherapy alone was given after a 10–14 day washout. Results: With a median follow-up of 24 mos, the median TTPs are 21+ mos and 7 mos and the median survivals are 31+ and 12 mos in groups A and B, respectively. Thus far, only 5 deaths have occurred in 22 group A pts. Results of EGFR mutation and other analyses in tumor tissue from 27 pts will be presented. Conclusions: These data suggest that EGFR-TKI induced apoptosis may act synergistically with concurrent 1st line chemotherapy in pts with advanced or metastatic NSCLC and a new paradigm for incorporation of biologically targeted agents into chemotherapy regimens. [Table: see text]
Phase II study of dasatinib in non-small cell lung cancer (NSCLC)
Authors: Johnson F. M. , Tang X. , Tran H. , Saigal B. , Erasmus J. , Kurie J. , Hwang L. , Oh Y. , Lippman S. , Stewart D. J. 
Published: August 2020

e19015 Background: Lung cancer is the leading cause of cancer-related deaths. Better systemic therapies are needed. One potential therapeutic target is c-Src which is expressed and activated in NSCLC patient tumors where it can mediate invasion, angiogenesis, and proliferation. Additionally, epidermal growth factor receptor (EGFR) and c-Src cooperate to promote NSCLC survival. We are conducting a phase II study of dasatinib, a tyrosine kinase inhibitor of c-Src, Abl, c-Kit, PDGFR, Btk, and EphA2. The primary objective is to determine the rate of progression free survival at 12 weeks in patients with metastatic NSCLC treated with dasatinib as front line therapy. Methods: Patients with metastatic NSCLC were treated with dasatinib (100 mg BID), with PET/CT scans every 6 weeks. KRAS and EGFR mutations, EGFR copy number, and pSrc expression were measured in pre-treatment biopsies. Blood was collected pretreatment and on day 21 to measure drug exposure (PK), pharmacodynamics (PD), and serum cytokine levels. Results: Twenty five patients have enrolled on study. Of the 16 patients evaluable for response: 1 had a partial response (PR) with no evidence of recurrence for at least 18 months (male smoker with adenocarcinoma and KRAS mutation); 6 patients had stable disease (SD) which includes 3 patients with prolonged stable disease for 4, 6, and 18 months; 9 had progressive disease (PD). Only 4 patients had a significant change in SUV (>25%): decreased in 2 with PR and SD and increased in 2 with PD and SD. There is currently no clear association between EGFR and KRAS mutational analysis and response, although the sample number is small. Only 2 patients have activating EGFR mutations: one with SD and one with PD. PK, PD, and cytokine data will be presented. The most common grade 3/4 toxicity is dyspnea/pleural effusion that has led to a reduced dasatinib starting dose in subsequent patients. Conclusions: Dasatinib as a single agent has activity in a subset of patients with NSCLC. Planned correlative studies may lead to the discovery of biomarkers that predict response. Toxicities observed were consistent with prior dasatinib phase I studies in solid tumor patients. Supported by NCI/CTEP (NIH contract N01-CM-62202), The Commonwealth Foundation for Cancer Research and Bristol-Myers Squibb. [Table: see text]
Amrubicin (AMR) and cardiotoxicity in second-line treatment of small cell lung cancer (SCLC): A pooled analysis of left ventricular ejection fraction (LVEF) in two phase II trials
Authors: Spigel D. R. , Shah C. , Lorigan P. , McNally R. , Renschler M. , Oliver J. 
Published: August 2020

e19019 Background: Amrubicin (AMR) is a third-generation synthetic anthracycline and a potent topoisomerase II inhibitor approved in Japan for the treatment of lung cancer. In Japanese pre and postmarking studies, AMR treatment was not associated with cardiotoxicity. The purpose of this analysis was to determine if AMR treatment of Western patients (pts) is associated with anthracycline-induced cardiomyopathy. Methods: To evaluate risk of cardiomyopathy, LVEF was measured by echocardiogram or by multiple gated acquisition (MUGA) scan and pooled from pts enrolled in 2 trials of IV AMR, 40 mg/m2/day x 3 days q 21 days for second-line treatment of sensitive or refractory SCLC. Pts with measurable disease, ECOG PS 0–2, LVEF ≥50%, and prior platinum-based treatment were assessed at baseline (BL), cycles 3, 6, then every 2 cycles, and end of treatment. Pts were to be assessed by the same method (ECHO or MUGA) throughout the study. Pts with a persistent ≥20% decrease in LVEF during treatment were to be removed from the study. Results: 112 patients were treated (sensitive n=43, median 6 cycles; refractory, n=69, median 5 cycles) and had at least 1 LVEF assessment. Median age was 63 years and median BL LVEF was 60%. Changes in LVEF from baseline were minimal ( Table ) and similar across cumulative dosing groups including 15 pts who received a cumulative dose of >1,000 mg/m2 AMR. Two refractory pts (1.8%) experienced drops in LVEF >20%. One had BL LVEF of 85%, then 60% at cycle 3, and 70% subsequently with ongoing therapy. The second, with a history of cardiomegaly, had LVEF of 55% at BL, cycle 3, and 5 by ECHO, and 29% at the time of progression after cycle 9 (cumulative AMR dose 840 mg/m2) by MUGA. The patient died due to progressive disease with no evidence of CHF. Conclusions: In this pooled analysis of SCLC pts, LVEF remained stable even in pts with cumulative AMR dosing >1,000 mg/m2. AMR for second-line treatment of SCLC does not appear to cause anthracycline-related cardiomyopathy. [Table: see text] [Table: see text]
Urine PGE-M to assess prostaglandin E2 (PGE2) levels in non-small cell lung cancer (NSCLC)
Authors: Horn L. , Milne G. , Sandler A. , Morrow J. , Carbone D. , Shyr Y. , Hayes A. , Campbell N. , Johnson D. H. 
Published: August 2020

e19026 Background: COX-2 is often overexpressed in NSCLC leading to high systemic PGE2 levels that in turn play a role in NSCLC pathogenesis. Changes in urine PGE-M (the major PGE2 metabolite) reflect changes in systemic & intratumoral PGE2 [Csiki et al. Clin Cancer Res 11:6634, 2005]. A ≥70% decline in PGE-M in NSCLC patients (pts) treated with celecoxib (C) (400 mg bid) + docetaxel (D) was associated with an apparent survival benefit [Ibid]. To effect maximum COX-2 inhibition we tested a higher C dose in a subsequent phase II trial. Methods: Eligibility: previously treated NSCLC, PS 0–2, evaluable/measurable disease, adequate marrow, renal & hepatic function, no current NSAID or sulfa allergy. Urine PGE-M measured prior to & 5–10 days after C 600 mg PO bid. Pts with ≥70% decline in PGE-M continued on C + D 75 mg/m2 or pemetrexed 500 mg/m2 q3wk x 4 cycles followed by maintenance C 400 mg PO bid until PD or drug intolerance. Results: 21 pts enrolled; F=7, M=14; 2 ineligible (1 carcinoid; 1 elevated LFT); 2 stopped C early (1 ARF; 1 pruritus). Mean PGE-M levels decreased from 38.9 to 7.8 ng/mg Cr pre- & post-C (mean change = 80%; P=0.002). The mean decline was greater in current & former smokers (81%; P=0.002) compared to never smokers (46%; P=0.19). Males had higher pre- treatment PGE-M (44 vs. 28.8 ng/mg Cr; P=0.21). Males had a significant decrease in mean PGE-M levels after C (78%; P=0.011); a similar albeit not significant change occurred in females (P=0.12). 12 screened pts (57%) had a ≥70% decline in PGE-M & received treatment with C + chemotherapy; 8 pts are evaluable for response; SD = 6; PD = 2. Treatment was well tolerated with no cardiac toxicities noted. Conclusions: These preliminary data indicate C 600 mg bid effectively inhibits intratumoral COX-2 in >50% NSCLC pts, a higher percentage than our previous trial using C 400 mg bid. The effect is greatest in former & current smokers & males compared to never smokers & females. Toxicities are acceptable. Accrual is ongoing. [Funding: VICC Lung Cancer SPORE CA90949]. No significant financial relationships to disclose.