bluuebunny/crossref_metadata_2025_split huggingface dataset:
Use of the SFMA as a measure of overall functionality in patients undergoing hematopoietic stem cell transplantation (HSCT).
Authors: Shatten Charlotte , Wood William Allen , Butler Robert , Battaglini Claudio 
Published: March 2020

7119 Background: The 6 minute walk test (6MW) has been used in research as a measure of overall functionality and has been related to prognosis and quality of life (QOL) in cancer patients. For some clinics, the use of other functional tests may be a timely and space saving option. The selective functional movement assessment (SFMA) is a short, systematic evaluation of 7 fundamental movement patterns which can be conducted in patient rooms. The SFMA can make clinicians aware of deficient, painful movement patterns that may indicate impairment and motor control deficits. The SFMA may help identify functional impairments for pre- and peri-transplant interventions in patients undergoing HSCT. Methods: Patients were assessed prior to HSCT. A composite score (range: 19-38) was given to patients based SFMA performance. A lower score represented improved movement profiles. 6MW was tested by standardized protocol on an established route. Pearson correlations were calculated to evaluate the relationship between 6MW and SFMA. Results: We evaluated 32 patients (10 autologous, 11 myeloablative allogeneic, 11 reduced intensity allogeneic). One patient was unable to complete all portions of the SFMA due to physical limitations; all patients completed the 6MW. The mean SFMA composite score was 24.9± 3. ≥50% of patients exhibited deficient movement patterns during forward flexion and deep squat. Other patterns that showed a high level of deficiency (> 30% of all patients) were back extension, single leg stance, shoulder mobility, and cervical rotation. The mean 6MW was 477± 94 m. There was a moderate negative correlation between 6MW and SFMA composite score (r =-0.46, p<0.001), implying that a shorter 6MW was associated with more deficient movements. Conclusions: The SFMA could be useful for quantifying overall functionality in settings where the 6MW is not ideal. The SFMA may also be useful for identification of functional issues that may be addressed before or during HSCT by interventions to limit disability and maintain QOL. Further research should evaluate the SFMA results pre to post transplant to assess changes in fundamental movement deficits. The use of the SFMA’s prognostic ability should also be evaluated.
A 36-month analysis of treatment patterns and outcomes in patients with lower-risk myelodysplastic syndromes from a prospective observational study.
Authors: Lyons Roger M. , Marek Billie J. , Paley Carole S. , Esposito Jason , Garbo Lawrence E. , DiBella Nicholas J. , Garcia-Manero Guillermo 
Published: March 2020

7122 Background: Many patients (pts) with lower-risk myelodysplastic syndromes (MDS) require chronic red blood cell transfusions for symptomatic anemia, which can result in iron overload. We present a 36-month interim analysis of a 5-year US registry that prospectively collected data on clinical events and survival in chelated vs non-chelated, transfused, lower-risk MDS pts. Methods: This multicenter, non-interventional registry enrolled 600 pts ≥18 yr old with lower-risk MDS (WHO, FAB, and/or IPSS risk stratification criteria) and transfusional iron overload (serum ferritin ≥1,000 ng/mL and/or ≥20 packed red blood cell units and/or ≥6 units every 12 wks). The chelated group included pts who had received any chelation. Results: Median age was 76 yr (range, 21–99), 57.8% were male, and risk status was 38.6% IPSS low risk and 61.4% IPSS INT-1 risk. Baseline demographics and IPSS risk status were similar between groups, although transfusion burden trended higher in chelated pts. As of April 30, 2012, 169 pts continued on the registry, and 431 discontinued (345 died, 57.5%; 61 lost to follow-up, 10.2%; and 25 other, 4.2%). In all, 264 pts (44%) received chelation therapy; 200 had ≥6 mos chelation. Overall survival (OS) and time to acute myeloid leukemia (AML) transformation were significantly longer, and the percentage of deaths was significantly lower, in chelated ≥6 mos vs non-chelated pts (P<0.0001, P=0.011 [median not reached in either group], P=0.0002, respectively. AML transformations appeared to be lower in chelated ≥6 mos pts (not significant [NS]). At baseline in non-chelated vs chelated ≥6 mos pts, there was a higher prevalence of vascular, cardiac, endocrine, and ophthalmologic disorders; this trend continued at 36 mos. Most frequent causes of death were MDS/AML, cardiac events, and infection. Use of MDS therapy was lower among non-chelated pts (non-chelated, 88.4%; ≥6 mos chelation, 93.5%; NS). Conclusions: At 36 mos,chelated pts had significantly longer OS and time to AML, as well as significantly fewer deaths. Trends toward fewer AML transformations and fewer vascular, cardiac, endocrine, and ophthalmologic disorders were observed in chelated pts.
Defining parameters that can guide public cord blood units (CBUs) in Korea.
Authors: Lee Junglim , Ji Jun Ho 
Published: March 2020

7123 Background: It is well recognized that TNC and CD34 define a superior Cord blood unit (CBU). According to “the Law of Korean CB Banking and Research”, only 40% of collected CBUs meet the criteria. To improve a rate of banking, we analyzed the characteristics of CBUs and assessed predictive factors for numbers of TNC and CD34+ in collected CBUs. Methods: 2004 to 2012, CBUs donated to the Daegu Fatima Hospital Public CB Bank (n = 1074) were analyzed. The associations between TNC, CD34+ and variables including body weight (BW), GA, delivery type, gender, collecting volumes (CV) were analyzed by logistic regression analysis. Results: In our study cohort (n = 1074, male;553, female;521, all Koreans), the median value of TNC, numbers of CD34+, GA, BW and CV were 10.6úI108 /unit (6.0-35.1), 3.41úI106/unit (0.8-27.0), 39 weeks (36-42 weeks), 3310g (1660-4600g) and 75.4ml (35-179ml) respectively. In univariate analysis, maternal /donor (M/D) characteristics that were associated with high TNC (> 10úI108) included higher GA(GA > 39 weeks) [OR 2.02 (95% CI 1.54-2.66 p < 0.001)], normal delivery [OR 3.05 (95% CI 2.21-4.22 p < 0.001)], female [OR 1.46 (95% CI 1.15-1.86 p=0.001)], BW > 3310g [OR 2.05 (95% CI 1.60-2.60 p < 0.001)] and CV> 75ml [OR 6.99 (95% CI 5.34-9.14 p < 0.001)].In multivariate analysis of TNC, CV > 75ml [OR 7.91 (95% CI 5.92-10.56 p < 0.001)] was the best predictor of followed by female [OR 1.73 (95% CI 1.30-2.30 p < 0.001)], BW > 3310g [OR 1.70 (95% CI 1.27-2.26 p < 0.001)] and GA > 39 weeks [OR 1.45 (95% CI 1.04-2.04 p = 0.03)]. In univariate analysis, M/D characteristics that were associated with high numbers of CD34+ (>3x106) included normal delivery [OR 2.09 (95% CI 1.49-2.93 p < 0.001)], BW > 3310g [OR 1.94 (95% CI 1.52-2.47 p < 0.001)] and CV > 75ml [OR 3.22 (95% CI 2.51-4.14 p < 0.001)]. In multivariate analysis of CD34+, CV > 75ml [OR 3.13 (95% CI 2.43-4.05 p < 0.001)] and BW > 3310 [OR 1.84 (95% CI 1.41-2.40 p < 0.001)] were significant predictors. Conclusions: M/D characteristics were associated with CV which is the best predictor followed by BW for both TNC and CD34+ in collected Korean CBUs. These associations could be used to prioritize donations, collections, optimizing and financial modeling in Korean CB banks.
START: A phase III study of L-BLP25 cancer immunotherapy for unresectable stage III non-small cell lung cancer.
Authors: Butts Charles Andrew , Socinski Mark A. , Mitchell Paul , Thatcher Nick , Havel Libor , Krzakowski Maciej Jerzy , Nawrocki Sergiusz , Ciuleanu Tudor-Eliade , Bosquée Lionel , Trigo Perez Jose Manuel , Spira Alexander I. , Tremblay Lise , Nyman Jan , Ramlau Rodryg , Helwig Christoph , Falk Martin H. , Shepherd Frances A. 
Published: March 2020

7500 Background: L-BLP25 is a MUC1 antigen specific cancer immunotherapy. We report results from the phase III START study of L-BLP25 in patients (pts) not progressing after primary chemoradiotherapy (CRT) for stage III NSCLC. Methods: From Jan 2007 to Nov 2011, 1513 pts with unresectable stage III NSCLC that did not progress after CRT (platinum based chemo and ≥50 Gy) were randomized (2:1; double-blind) to L-BLP25 (806 µg lipopeptide) or placebo (PBO) SC weekly x 8 then Q6 weeks until disease progression or withdrawal. Cyclophosphamide 300 mg/m2 x 1 or saline was given 3 days prior to first L-BLP25/PBO dose. Primary endpoint was overall survival (OS). Results: The primary analysis population (n=1239) was defined prospectively to try to account for a clinical hold by excluding pts randomized 6 months (m) before the hold. Arms were balanced for baseline characteristics. Median age was 61 y; 38.2% had stage IIIA and 61.3% IIIB; 65% had concurrent and 35% sequential CRT. Median OS was 25.6 m with L-BLP25 vs. 22.3 m with PBO (adjusted HR 0.88, 95% CI 0.75-1.03, p=0.123). Secondary endpoints time-to-progression and time-to-symptom-progression support consistency of results: HR 0.87 (95% CI 0.75-1.00, p=0.053) and 0.85 (95% CI 0.73-0.98, p=0.023). In predefined subgroup analyses, pts with concurrent CRT (n=806) had median OS of 30.8 m (L-BLP25) vs. 20.6 m (PBO; HR 0.78, 95% CI 0.64-0.95, p=0.016), while median OS with sequential CRT was 19.4 m (L-BLP25) vs. 24.6 m (PBO; HR 1.12, 95% CI 0.87-1.44, p=0.38; interaction p=0.032, Cox PH model). Sensitivity analyses revealed that there was no OS benefit in pts randomized 6 m before the hold (HR 1.09, CI 0.75-1.56, p=0.663). LEBLP25 was well tolerated with no safety concerns identified and no emergent evidence of immune related adverse events. Conclusions: L-BLP25 maintenance therapy in stage III NSCLC was well tolerated, but did not significantly prolong OS. Sensitivity analyses showed a smaller treatment effect due to the clinical hold, suggesting that longer uninterrupted treatment with L-BLP25 is required. Clinically meaningful prolongation of OS was observed in the predefined subgroup of pts with primary concurrent CRT. Clinical trial information: NCT00409188.
Surgery for NSCLC stages T1-3N2M0 having preoperative pathologically verified N2 involvement: A prospective randomized multinational phase III trial by the Nordic Thoracic Oncology Group.
Authors: Sorensen Jens Benn , Ravn Jesper , Pilegaard Han Kristian , Palshof Torben , Sundstrom Stein , Bergman Bengt , Jakobsen Jan Nyrop , Aasebø Ulf , Hansen Olfred , Meldgaard Peter , Soerensen Bente Thornfeldt , Jakobsen Erik , Jonsson Per , Ryberg Marianne , Salo Jarmo , Haverstad Rune , Riska Henrik 
Published: March 2020

7504 Background: Surgery is not generally considered standard of care in preoperative pathological verified spread to N2 mediastinal lymph nodes in NSCLC. Methods: Previously untreated histologically verified NSCLC stages T1-3N2M0 were randomized to reg. A (Paclitaxel 225 mg/m2 + Carboplatin AUC6 day 1 q 3 wks for 3 courses, followed by surgery with ipsilateral mediastinal lymph node sampling followed by radiotherapy 2Gy x 30 fractions, 5F/W) or reg. B: same as A without surgery (sequential chemo-radiotherapy). 406 pts were needed to detect a 10% 5-year survival increase with 80% power and type 1-error of 5%. The study was approved by ethical committees. Pts gave informed consent. Results: 170 pts were randomized to A and 171 to B from 1998-2009 when study closed due to concomitant chemo-radiotherapy becoming standard instead of sequential treatment. Median age was 61 years (range 33-76 yrs), 59% were males, 43% had performance status 0. Stages T1N2M0, T2N2M0, and T3N2M0 occurred in 19%, 60%, and 21%, respectively. Adenocarcinoma (ADC) and squamous cell carcinoma occurred in 50% and 29%, respectively. In reg. A, surgery was possible in 132 out of 170 pts (78%), 121 pts (71%) had complete resection while 11 pts (6%) had incomplete resection. Pathological-surgical stage pT0 occurred in 4%. Median progression free survival (PFS), OS and 5-years survival rate were 10 mths, 17 mths, and 20% for A (+ surgery) compared to 8 mths (p=0.144), 15 mths (p=0.172), and 16% (p=0.310) for B, respectively. ADC pts had better OS in A than in B (HR 0.60; p=0.002), and 5-year survivals 20% and 7% (p=0.017) respectively. Stage T1N2 had better OS in A than in B (HR 0.47; p=0.010), 5-year survivals 36% and 17%. Conclusions: There were no statistical overall significant advantage for surgery in addition to chemo-radiotherapy (A) compared to chemo-radiotherapy alone (B) but ADC pts and pts with T1N2 had significantly improved OS and 5-year survival rates in the surgery arm. Current standard treatment for T1-3N2M0 NSCLC is concomitant chemo-radiotherapy which was not used in this study, hence conclusions should be further tested with use of such treatment as reference arm.
Results of the prospective, randomized, and customized NSCLC adjuvant phase II trial (IFCT-0801, TASTE trial) from the French Collaborative Intergroup.
Authors: Soria Jean-Charles , Barlesi Fabrice , Besse Benjamin , Mazieres Julien , Merle Patrick , Cadranel Jacques , Audigier-Valette Clarisse , Moro-Sibilot Denis , Gautier-Felizot Laure , Goupil Francois , Renault Patrick , Quoix Elisabeth A. , Souquet Pierre Jean , Madroszyk Anne , Corre Romain , Pérol David , Baudrin Laurence , Morin Franck , Zalcman Gerard , Wislez Marie ,   Intergroupe Francophone de Cancérologie Thoracique (IFCT)
Published: March 2020

7505 Background: Surgical resection followed by adjuvant platinum-based CT is the standard of care in stages II and III of NSCLC. ERCC1 is considered as a molecular determinant of benefit to platin-based CT and is an independent good prognostic marker in resected NSCLC. EGFR mutations predict for erlotinib efficacy. We included ERCC1 IHC status and EGFR mutational status in a prospective randomized multicentric phase II/III customized adjuvant CT trial. Methods: Completely resected patients (pts) with non-squamous tumors, mediastinal lymph node dissection and pathological stage IIA, IIB or IIIA (N2 excluded) (6th TNM edition) were randomized either to a control arm (A) or a customized arm (B). Surgical blocks were centralized for biomarkers analyses. The control arm encompassed 4 cycles of standard dose cisplatin-pemetrexed (CP). In the experimental arm, EGFR mutated pts received erlotinib 150 mg for one year. ERCC1 negative pts received four cycles of CP. ERCC1 positive pts were closely monitored. The Fleming’s single stage phase II primary endpoint was feasibility (ie % of patients able to start therapy within 2 months of surgery and for which the biomarker’s status was readily available) (H0 64%, H180%, α 5% and β 95%). Results: 150 pts were randomized between May 2009 and July 2012, 74 in arm A and 76 in arm B. Most pts were male (61%), ≤ 60 years (51%), and smokers (91%). Pathological stage was IIA in 69 pt, IIB in 48 pt and IIIA in 32 pt. ERCC1 was positive in 38 pts (19 in each arm), EGFR mutation was identified in 10 pts (3 in arm A, 7 in arm B). In arm A, all pts received CP. In arm B, 7 pts received erlotinib, 53 pts received CP and 16 were followed-up. The median exposure time to erlotinib was 276 days (10-365). Out of 127 pts allocated to CP, 82% received the expected 4 cycles with a very good tolerability profile (no febrile neutropenia). The success rate was 80% (120 out of 150 pts). Conclusions: This adjuvant trial met its primary end point for its phase II component, demonstrating the feasibility of a national biology-driven trial in the adjuvant setting. Nevertheless the phase III was canceled due to the unexpected unreliability of the ERCC1 IHC read-out. Clinical trial information: NCT00775385.
Relevance of platinum (plat) sensitivity status in previously treated extensive-stage small cell lung cancer (ES-SCLC) in the modern era: A patient level analysis of SWOG trials.
Authors: Lara Primo , Moon James , Redman Mary Weber , Kelly Karen , Allen Jeffrey Warren , Gitlitz Barbara Jennifer , Mack Philip C. , Gandara David R. 
Published: March 2020

7511 Background: ES-SCLC patients (pts) with progressive disease (PD) following plat-based chemo are traditionally categorized as plat-sensitive (PD >/= 90 days from last plat dose) or refractory (PD < 90 days). This practice arose from seminal observations in the early 1980s of worse survival in refractory pts. Subsequent trial designs accounted for plat-sensitivity status, resulting in higher sample sizes and increased resource use. Whether this relationship holds in the modern era is less clear. Methods: Updated data from recent SWOG trials in 2nd and/or 3rd line ES-SCLC (S0802: topotecan + aflibercept: S0435: sorafenib; and S0327: PS-341) were pooled. Accrual goals were specified for sensitive and refractory in each trial. Hazard ratios (HRs) for overall (OS) and progression-free survival (PFS) were calculated using Cox Proportional Hazard (PH) models [unadjusted and adjusted]. Results: Of 329 pts, 151 were classified as sensitive, 178 refractory; median age = 63 years; males = 52%; PS 1 = 67%; weight loss >5% = 28%; > 2 prior chemo = 16%; and elevated LDH = 43%. HRs from unadjusted Cox models for OS for refractory vs. sensitive were 1.0 (95% CI 0.81-1.25, p=0.98) and 1.24 (95% CI 0.99, 1.57; p=0.06). Cox PH models adjusted for baseline prognostic factors for PFS and OS are shown. Conclusions: In this large database analysis, plat-sensitivity status is no longer a significant independent variable for OS or PFS. Baseline PS, sex, LDH, and weight loss remain independent OS variables. These data have critical implications in the design of future trials in ES-SCLC. [Table: see text]
Biomarker analysis of WJOG4107, a randomized phase II trial of adjuvant chemotherapy with S-1 versus CDDP+S-1 for resected stage II-IIIA non-small cell lung cancer (NSCLC).
Authors: Mitsudomi Tetsuya , Iwamoto Yasuo , Nishio Kazuto , Yamanaka Takeharu , Yoshioka Hiroshige , Tada Hirohito , Yoshimura Masahiro , Yoshino Ichiro , Okamoto Isamu , Sugawara Shunichi , Kudoh Shinzoh , Yamamoto Nobuyuki , Ohta Mitsunori , Ichinose Yukito , Atagi Shinji , Okada Morihito , Saka Hideo , Katakami Nobuyuki , Nakagawa Kazuhiko , Nakanishi Yoichi ,   West Japan Oncology Group
Published: March 2020

7518 Background: We conducted a randomized phase II trial for patients with resected stage II-IIIA NSCLC comparing postoperative oral S-1 (80 mg/m2/day for consecutive 2 weeks q3w for 1 year) (S) (N=100) or cisplatin (CDDP) (60 mg/m2 day1) plus oral S-1, (80 mg/m2/day for 2 weeks) q3w for 4 cycles (PS)(N=100). We reported that the disease-free survival rate at 2 years (DFS@2) (95% confidence interval: CI), a primary endpoint, was 66 (55-74) % for S and 58 (48-67)% for PS. Here, we report the preliminary results of preplanned biomarker analysis, a co-primary endpoint, to identify molecules whose expression is significantly associated with patient outcome. Methods: cDNA extracted from macro-dissected formalin-fixed paraffin-embedded specimens were available for 197/200 patients. Thirty-one genes including those whose expressions have been potentially associated withCDDP (e.g. ERCC1, XRCC1, BRCA1, GSTpi, HMG1, TBP) or fluorouracil (FU) sensitivity (TS, DHFR, DPD, UMPS, UPP1) were measured by QGE analysis (MassArray, Sequenom, CA). Expression of each gene was dichotomized according to its median value of expression. Results: The only gene with interaction P<0.05 after adjustment with sex, histology, age, stage was UMPS (uridine monophosphate synthase) (P=0.0348). UMPS catalyzes the conversion of fluoro UMP from 5FU and thus high UMPS expression is implicated to enhance 5FU effect. DFS@2 % (95% CI) for UMPS high/S, UMPS high/CS, UMPS low/S, UMPS low/CS were 69 (54-80), 53 (37-66), 64 (49-76), 61 (46-73)%, respectively. However, molecules such as ERCC1 and GSTpi whose expression have been previously associated with CDDP sensitivity did not emerge as predictive markers (P=0.7908, 0.6406, respectively). Conclusions: UMPS expression may define patient subset that would benefit from postoperative S-1 therapy. Clinical trial information: 000001658.
A phase II trial of mid-treatment FDG-PET adaptive, individualized radiation therapy plus concurrent chemotherapy in patients with non-small cell lung cancer (NSCLC).
Authors: Kong Fengming , Ten Haken Randall K , Schipper Matthew J , Hayman James , Ramnath Nithya , Hassan Khaled Aref , Matuszak Martha , Ritter Timothy , Bi Nan , Wang Weili , Orringer Mark , Cease Kemp Bailey , Lawrence Theodore Steven , Kalemkerian Gregory Peter 
Published: March 2020

7522 Background: We have found that FDG-PET response during chemoradiation for patients with NSCLC is heterogeneous and predicts outcome. We hypothesized that dose escalated treatment targeted to the FDG-avid tumor would improve local tumor control. Methods: This is a phase II trial for patients with locally advanced, inoperable/unresectable NSCLC. Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy. Patients had concurrent weekly followed by consolidation carboplatin/paclitaxel. The primary endpoint was local-regional tumor control (LRTC) at 2 years. Survival was calculated from RT start. Results were compared to stage-matched patients treated during the same time period with standard RT dosing (60-66 Gy). The data are presented as median (95% CI) unless otherwise specified. Results: 42 patients were enrolled: median age 63 years (range 45-83); 28 (67%) male; 39 (93%) smokers; 39 (93%) stage III; and 45% squamous cell. The mean gross tumor volume was 154 cc (range 10-617 cc). Median physical dose reached was 84 Gy (range 63-86 Gy), equivalent to 90 Gy in 2 Gy fractions (biological effective dose 108 Gy). 8 patients (19%) had RT-induced lung toxicity and 13 (31%) grade ≥2 esophagitis. Minimum and median follow-up were 10 and 25 months, respectively. The 2-year rates of in-field LRTC, overall LRTC, and LR-PFS were 84% (63-94%), 68% (47-82%), and 43% (27-58%), respectively. 14 patients progressed: 7 (50%) first at distant sites; 5 (36%) at nodal regions; 2 (14%) at primary tumor. Median overall survival was 26 months and 2-year overall survival rate was 51% (34-65%). These results compared favorably to stage-matched patients treated with standard-dose RT [2-year overall survival 23% (8-41%)]. Conclusions: These results support our hypothesis that adapting RT by escalating dose to the FDG avid region detected mid-tx improves 2-year local-regional tumor control. Adaptive RT may also improve overall survival. RTOG 1106 is currently testing this regimen in a randomized fashion. Clinical trial information: NCT01190527.