bluuebunny/crossref_metadata_2025_split huggingface dataset:
Wood-smoke exposure as a survival predictor in non-small cell lung cancer with response to erlotinib: An open label phase II study
Authors: Arrieta Rodriguez O. G. , Tellez E. , Martinez-Barrera L. , Castillo P. , Reyes-Contreras J. , Flores-Estrada D. , Hernandez- Pedro N. , Morales-Espinosa D. , Ceron-Lizarraga T. , De la Garza-Salazar J. 
Published: March 2020

18029 Background: Erlotinib, a tyrosine kinase inhibitor, has improved survival and quality of life in patients with non-small cell lung cancer (NSCLC) after fist-line or second-line chemotherapy. Asian origin, adenocarcinoma histology, female gender, lack of tobacco use and expression of EGFR are significant independent predictors of response to erlotinib. Although tobacco use is considered a major cause of NSCLC, other factors are involved in its pathogenesis. In underdeveloped countries such as Mexico, wood and other solid fuels are still used for cooking and heating. The physiopathological mechanisms of wood smoke exposure (WSE) as a potential risk factor for the development of NSCLC are still unknown. Methods: 125 patients with the diagnosis of NSCLC with poor performance status and after first or second-line chemotherapy were treated with erlotinib. Clinical and pathological characteristics were associated with response. Results: We found a global response to erlotinib in 39 patients (31.2%; IC 95% 23–39.3), stable disease in 33.6% and progression in 33.6%. Clinical improvement and favorable changes in status performance were observed in 54.4 and 33.6%, respectively. The clinical features associated with response to erlotinib in the univariate analysis were female gender (44 vs 15.7% p=0.001), non-smokers (45.6 vs 19%, p=0.001), adenocarcinoma (33.8 vs 16% p=0.009) and WSE (81 vs 14% p=0.001). Only the histological type (p=0.049) and WSE (p=0.001) were of statistical significance in the logistic regression analysis. The factors associated to an improved progression-free survival (PFS) in the Cox multivariate analysis were: adenocarcinoma histology (7.6 ±0.7 vs 2.7 ±0.4 months, p=0.002), female gender (7.6 ±1.3 vs 3.97 ±1.5, p=0.027) and WSE (8.43 ±0.5 vs 4.8 ±0.9, p=0.011). Conclusions: Conclusion: WSE is associated with response to erlotinib in patients with NSCLC and may indicate an improved PFS. The EGFR mutation is probably involved in the development of NSCLC in non-smokers with WSE. No significant financial relationships to disclose.
Single agent bevacizumab and bevacizumab in combination with docetaxel and cisplatin as induction therapy for resectable IB-IIIA non-small cell lung cancer
Authors: Rizvi N. A. , Rusch V. , Zhao B. , Senturk E. , Schwartz L. , Fury M. , Downey R. , Rizk N. , Krug L. , Kris M. G. 
Published: March 2020

18045 Background: Bevacizumab (Bev) improves response and survival in patients with advanced non-squamous lung cancer with chemotherapy however there are limited data as single agent therapy and in early stage NSCLC. Methods: Patients with resectable stage IB-IIIA NSCLC were eligible. Patients with adenocarcinoma (Cohort 1) received preoperative Bev and docetaxel and cisplatin (DC). Patients with squamous histology, central location or recent hemoptysis received DC induction therapy without Bev (Cohort 2). Cohort 1 received Bev (15 mg/kg) followed by CT 2 weeks later to assess single agent Bev response. Subsequently D (75 mg/m2) and C (75 mg/m2) were given q 3 weeks; an additional 2 cycles of Bev was administered with C2 and C3 of DC (total of 3 preoperative doses of Bev). Cohort 2 received DC alone followed by resection. Both cohorts received adjuvant Bev x 1 year. Study endpoints included response to single agent Bev, downstaging, safety and survival. Results: 19 patients of planned 70 were enrolled (11 Cohort 1 and 8 Cohort 2). On Cohort 1, there were 2 clinical stage IIB and 9 IIIA patients. After single agent Bev (by bimensional measurement), > 10% reduction in tumor size was observed after 2 weeks in 6/11 patients (- 20%, 15%, 16%, 15%, 13% and 20%). After Bev + DC, there were 6/10 (60%) PRs and DC delivery was 96%. 6/10 patient underwent R0 resection; 1 R2 and 2 were unresectable. 1 patient developed hemoptysis preoperatively and 1 patient developed an upper GI bleed post-operatively. There were otherwise no Bev related operative complications observed. 5/9 patients were downstaged by induction treatment. 3 patients received adjuvant bevacizumab to date (median 5.7 cycles). 8 patients were treated on Cohort 2 (3 with stage IB, 1 with IIB and 4 with IIIA). All 8 patients underwent R0 resection. DC delivery was 94% and there were 6/8 PRs. Downstaging was observed in 5/8 patients and 6/8 are receiving adjuvant Bev (median # cycles to date = 6.7). Conclusions: Bev as a single agent demonstrates regression of tumors after 2 weeks. To date, Bev has been safely administered in the neoadjuvant and adjuvant setting. Preoperative chemotherapy is well tolerated with more than 90% full dose drug delivery. The study is ongoing. Supported by Genentech, Inc. [Table: see text]
Survival and prognostic factors in patients with malignant pleural mesothelioma (MPM) treated with neoadjuvant cisplatin- based chemotherapy and extrapleural pneumonectomy (EPP) (SITMP Study)
Authors: Mutri V. , Pinto C. , Marino A. , Di Bisceglie M. , Dell’Amore D. , Sacco R. , Boaron M. , Colucci G. , Martoni A. A. 
Published: March 2020

18061 Background: The aim of this study is to evaluate the impact on survival of preoperative chemotherapy in potentially resectable MPM and correlations with prognostic factors. Methods: The eligibility criteria were: histologically MPM, stage T1–3N0–2M0, age =75 years, KPS = 80, adequate organ function. A first group of pts (group A) received cisplatin 75 mg/m2 d1 and gemcitabine 1,200 mg/m2 d1,8, every 3 weeks for 4 courses, followed by EPP and by 6 courses of adjuvant chemotherapy with mitoxantrone 10 mg/m2 d1, methotrexate 35 mg/m2 d1 and mitomycin 7 mg/m2 d1, every 3 weeks with mitomycin in alternate cycles. A second group of pts (group B) received cisplatin 75 mg/m2 d1 plus pemetrexed 500 mg/m2 d1 for 4 cycles. In each group, only those pts with metastatic lymph nodes and/or positive resection margins received radiotherapy after EPP. The prognostic factors evaluated were: sex, histotype, stage at diagnosis, clinical objective response. Results: Between February 2000 and December 2006, 32 pts were enrolled (8 group A, 24 group B). Pt characteristics were: 27M (84.4%), 5F (15.6%), median age 64 years (51–72), median KPS 100 (80–100), histological subtype: 27 (84.4%) epithelial, 2 (6.3%) sarcomatous, 3 (9.4%) mixed; IMIG stage: 6 (18.8%) I, 16 (50%) II, 10 (31.2%) III. The clinical response to neoadjuvant chemotherapy was: 10 (31.3%) CR + PR, 16 (50%) SD and 6 (18.7%) PD. Eighteen (56.3%) pts underwent EPP. In the 14 pts who did not undergo EPP: 5 (15.6%) were treated with pleurectomy and 9 (28.1%) were not treated with surgery. Two postoperative deaths (1 contralateral pneumonia and 1 ARDS) occurred after EPP. No pts were treated with radiotherapy after EPP. The estimated median overall survival, 1-year and 2-year survival rates in the pts treated with EPP and not treated with EPP were 20 and 12 months (p=0.468), 60 and 41%, 42 and 20%, respectively. In the multivariate analysis (Cox regression analysis), none of evaluated prognostic factors was significantly associated with an improved OS. Conclusions: These data show that preoperative chemotherapy followed by EPP is a feasible approach, while initial analysis suggests favourable survival. No significant prognostic factors were identified. No significant financial relationships to disclose.
Clinical and prognostic significance of serum carcinoembryonic antigen level in patients with IIIB and IV stage lung cancer: A prospective study
Authors: Martinez-Velazco A. , Flores-Estrada D. , Silva-Godinez J. C. , Javier F. , Enrique G. , Martinez L. , De la Garza J. , Arrieta O. 
Published: March 2020

18063 Previous studies have shown pre and post-operative serum CEA levels are a prognostic factor in patients with lung cancer (LC). We prospectively investigated the clinical and pathological characteristics, as well as, prognostic significance of patients with IIIB and IV stage LC and the CEA serum elevation. From March of 2005 to January of 2007, 307 patients with IIIB and IV stage were included; several chemotherapy protocols including gemcitabine, vinorelbine or paclitaxel combined with cisplatin, carboplatin, or erlotinib were used. Serum CEA levels were obtained before and after 2 cycles of treatment. Stage was determined by CT and bone scans; 120 patients had brain CT scan at diagnosis due to neurological symptoms. 28.6% of the patients were stage IIIB and 61.4% stage IV and 18% of patients had CNS metastasis at diagnosis. Histology was adenocarcinoma in 69.1% and epidermoid in 30.9%. Mean CEA was 11.3 ng/ml ± 24.5 with median of 6.7 (range 0.2 to 4,578). Patients with CEA levels > 10, 20, 50 and 100 were 43.6, 32.5, 24 and 17.9%; respectively. Associated factors with CEA >20 were age >62 (p=0.02), stage (p=0.05), CNS metastasis (p=0.0001) and histology (p=0.01). However, in the logistic regression analysis the only associated factors were histology (p=0.0001) and CNS metastasis (p=0.0001). Patients with CEA elevation >20 had a hazard ratio of 26.3 (CI 11.2 to 61.6) for the development of brain metastases. Overall survival associated factors were poor status performance (p=0.006), tobacco use (p=0.05), CEA elevation (p=0.0022), CNS metastases (p=0.01), male gender (p=0.08). There were no differences between stage IIIB, IV and CNS metastasis. The associated factors with survival by Cox proportional hazards regression multivariate analysis were poor performance status (p=0.05) and CEA elevation (p=0.008). The independent factors associated with CEA elevation were histology adenocarcinoma and brain metastasis. Patients with CEA >20 without neurological symptoms could benefit from early CT brain scan with stage IIIB and IV. In this group of patients, the 2 most important independent factors for survival were poor performance status and CEA elevation. No significant financial relationships to disclose.
Feasibility of adjuvant carboplatin/docetaxel (C/D) in patients (pts) resected stage I-IIIB non-small cell lung cancer (NSCLC): Preliminary report of a phase II trial
Authors: Stinchcombe T. E. , Socinski M. A. , Harper H. D. , Hensing T. A. , Moore D. , Crane J. M. , Atkins J. N. , Willard E. M. , Tynan M. T. , Gulino S. E. 
Published: March 2020

18069 Background: Adjuvant cisplatin-based chemotherapy has been shown to improve survival in patients with resected NSCLC; however, compliance with chemotherapy has been problematic. Carboplatin (C) is better tolerated than cisplatin, and therefore may improve adjuvant chemotherapy compliance. C/D is a commonly used treatment for advanced NSCLC with an acceptable toxicity profile. Methods: Pts with resected NSCLC with a good functional status, preserved renal, hepatic, and bone marrow function were enrolled. Therapy was initiated 2–8 weeks from surgery, and consisted of 4 cycles C (AUC=6), and docetaxel (D) 75 mg/m2 every 3 weeks. The primary end-point was the feasibility of delivering C/D. An “adequate exposure” was defined as receiving 4 cycles of C/D within 12 weeks of initiating therapy. A sample size of 72 pts provided 88% power to detect a true adequate exposure of rate of at least 80%. Results: 72 pts have been enrolled on the protocol, and 64 patients have completed therapy, 7 patients are currently receiving therapy, and data is incomplete on 1 patient. Pt demographics are: median age=65 years (range 47–84); gender: female 34%, male 66%, race: white 86%, African American 10%, other minorities 4%; performance status: 0 (38%), 1 (58%), 2 (1%), unknown (3%). The stage distribution was: I (41%), stage II (32%) stage IIIA (25%), stage IIIB (1%). To date, 45/64 pts (70%) have completed 4 cycles within 12 weeks, and total of 50 (78%) of pts completed 4 cycles within 14 weeks. 11 pts have had D dose reduced, and 2 pts have had C dose reduced. 35 pts (55%) completed the 4 cycles at full dose within 12 weeks, and 38 patients (59%) within 14 weeks. Reasons for discontinuing treatment: withdrew from treatment (n=3), withdrew consent prior to initiating therapy (n=2), disease progression (n=2, brain metastases), adverse events (n=5), complication of other medical conditions (n=1), unknown reasons (n=1). Therapy was well tolerated and no treatment-related deaths were observed. Conclusions: Preliminary results indicate that adjuvant therapy with CD results in a similar rate of chemotherapy compliance to that of cisplatin-based chemotherapy. No significant financial relationships to disclose.
Effect of race on the safety and efficacy of pemetrexed (P) therapy in locally advanced and metastatic non-small cell lung cancer (NSCLC)
Authors: Tai D. F. , Kulkarni P. , Wang Y. , Gill J. , Obasaju C. 
Published: March 2020

18082 Background: P is a multitargeted antifolate active in NSCLC. While a number of clinical trials have evaluated P safety and efficacy in general patient populations, little is known of the possible impact of race on the utility of P therapy in NSCLC. The objective of this post-hoc analysis was to evaluate the effect of race on the safety and efficacy of P (single-agent or in combination) in patients with locally advanced and metastatic NSCLC. Methods: Data from 6 trials with at least 5% non-Caucasian patients were pooled for analyses. One Phase III trial evaluated P in a second-line setting. All other trials used P in Phase II first-line settings. Patients were given at least one dose of P (single-agent or in combination) at 600 mg/m2 (59 patients) or 500 mg/m2 (469 patients) every 21 days. Demographic, safety, and efficacy data were stratified broadly by race, to either Caucasian or non-Caucasian groups. Kaplan-Meier method was used to estimate median survival. The Cox model was used to calculate the hazard ratio (HR) for survival, adjusting for significant prognostic factors, including disease stage, performance status, gender, and line of treatment. Results: Results are summarized in the data table below. The adjusted HR for survival (non-Caucasian versus Caucasian) was 0.89 (p=0.365). Conclusions: In this post-hoc analysis of results from clinical trials using P therapy in NSCLC, race did not have a statistically significant impact on response rate, disease control rate, or survival. However, P therapy appeared to be better tolerated by non-Caucasian patients. [Table: see text] No significant financial relationships to disclose.
Touch prep (TP) cytology as a tool for determining pulmonary parenchymal resection margin status
Authors: Brown K. M. , Flaherty J. , Ciocca V. , Ehya H. , Scott W. , Goldberg M. 
Published: March 2020

18095 Background: Accurate determination of parenchymal resection margins is critical in excision of primary and metastatic lung cancers. Complete microscopic examination of the entire margin is difficult and may not give timely results. Staple-line excision may compromise the accuracy of histologic margin exam (HME). TP offers a novel method to obtain pulmonary parenchymal margin status intraoperatively. Methods: Patients undergoing wedge resection for a known malignant lung lesion were studied prospectively. At the time of resection, the specimen stapled margin underwent TP on 3 glass slides for cytological analysis. The presence or absence of malignant cells on TP was correlated to final HME. Local recurrence and overall survival by TP and HME status were compared using logrank test. Results: Thirty specimens from 29 patients were studied between December 2002 and April 2006. Fifteen specimens (50%) were right- sided; 9/29 patients (31%) were male. Median age was 66 years (range 28 - 81). Histologies included non-small cell lung cancer (NSCLC) in 22 (73%), and metastases from colorectal cancer (4/30, 13%), sarcoma (2/20, 7%), and breast (1/30, 3%). All TP negative specimens had negative HME. TP was positive in 10 of 30 (33%) specimens, 6 of which had negative HME. These included 4 NSCLC and metastases from sarcoma (1) and colon (1). Mean margin distance was 4 ± 1.7 mm for TP/HME negative specimens, 0.5 ± 0 mm for TP/HME positive specimens, and 5 ± 1.7 mm for TP positive/HME negative patients. There was no difference in time to local recurrence between patients with positive margins by TP vs HME (18.6 and 18.63 months), or in TP and HME negative patients (30.1 and 30.6 months). Conclusion: TP analysis of lung parenchymal margins is safe and feasible. A negative TP is highly predictive of negative HME. Factors contributing to false-positive TP remain unresolved. Multi-institutional prospective studies are indicated for further characterization of this promising tool. No significant financial relationships to disclose.
Biweekly docetaxel (Doc) followed by gemcitabine (Gem) and cisplatin (Cis) in patients (pts) with advanced non-small cell lung cancer (NSCLC): A clinical proteomic study
Authors: De Castro J. , Belda- Iniesta C. , Casado Saenz E. , Feliu Batlle J. , Sereno Moyano M. , Gomez Raposo C. , Pinto Marin A. , Alvar J. , González-Barón M. 
Published: March 2020

18096 Background: This phase II trial was carried out to test the feasibility and efficacy of sequential chemotherapy. The scheme was based on the concept of taxane sequencing in cisplatin-based doublet. Finally, we evaluated the predictive value of proteomic profile determined by SELDI-TOF for Doc responses. Methods: Eligible chemonaive stage IV and selected stage IIIB (pleural effusion) NSCLC pts received Doc 50 mg/m2 IV day 1, every 14 days for 4 cycles followed by Gem 1,000 mg/m2 on days 1, 8 and Cis 75 mg/m2 on day 1, every 21 days for 4 cycles. Primary endpoints were response rate and progression-free survival. Overall survival, toxicity and predictive value of the proteomic profile were secondary endpoints. Plasma for proteomic biomarker analysis (SELDI-TOF) was taken at screening and after Doc treatment. Results: From February-05 to December-05, 39 pts were enrolled with 37 being evaluable for efficacy. Pts characteristics: Median Age: 60 years(44–82); Sex: M/F:76%/24%; Stage:IIIB/IV:32%/68%; Performance status 0/1/2:24%/65%/11%; Pathological subtypes: squamous (38%), adenocarcinoma (30%) and large cell carcinoma(32%). 15 pts showed partial response and 1 pt a complete response (objective response rate of 43%) and 14 pts had stable disease (37%). The median survival time (intent-to-treat) was 13 months with an estimated 1-year survival rate of 53%. The median time to progression was 10 months in the evaluable population. Most common grade 3–4 toxicities: After Doc treatment: anemia G3 (2 pts) and asthenia G3 (1 pt); After Gem-Cis: anemia G3 (4 pts), nausea/vomiting G3 (4 pt), neutropenia G3 (4 pts) and asthenia G3 (2 pts). There were no treatment-related deaths. Conclusions: Doc followed by Gem-Cis in sequential setting is an active, feasible and well tolerated regimen. Proteomic profile for Doc responders and no responders will be presented at the time of the meeting. No significant financial relationships to disclose.
Phase II study of simultaneous radiochemotherapy (RCT) with cisplatin/etoposide followed by consolidation chemotherapy (CT) with platin/gemcitabine for unresectable non-small cell lung cancer (NSCLC)
Authors: Fink T. H. , Melzner W. , Strnad V. , Sauer R. , Albrecht C. , Birkenhake S. , Ficker J. H. 
Published: March 2020

18103 Background: This phase II study has been conducted to determine the feasibility, toxicity, response rate, local control, distant metastases, and survival of simultaneous RCT (3D conformal radiotherapy with cisplatin/etoposide) followed by consolidation CT with platin/gemcitabine in unresectable NSCLC. Methods: From April 2001 to April 2005, 30 patients with unresectable NSCLC were entered into this trial. All patients had a histological confirmed unresectable non-small cell lung cancer. One patient had stage II, but was functionally unresectable; all other patients had locally advanced NSCLC (IIIA and IIIB). Noncoplanar 3D conformal radiotherapy was given to a total dose of 66.6 Gy (1.4 - 1.8 Gy per day) together with 2 cycles of CT (cisplatin 20 mg/m2 d1–5, d29–33 plus etoposide 90 mg/m2 d1–3, d29- 31). After completion of RCT patients received 4 courses of gemcitabine 900 mg/m2 d1 and d8 with cisplatin 70 mg/m2 d2 (or carboplatin AUC 5 d1) every 21 days. Results: 27 patients went through RCT, 22 patients received consolidation CT. The predominant hematological toxicity was grade 3/4 leukopenia, reported in 33% of patients during the RCT and 36% during the consolidation CT. One patient showed grade 3 radiation pneumonitis during concurrent RCT. No patient died of treatment related toxicity. The response rate was 83% with 2 CR and 23 PR. With a follow up of 24 months median survival was 17.5 months, 2 year survival rate was 40%. We will present median survival and 3 year survival rate with a follow up of 36 months. Conclusions: The simultaneous RCT with cisplatin/etoposide followed by consolidation CT with platin/gemcitabine is feasible and well tolerated. This study should prompt further investigation in a phase III randomized trial. No significant financial relationships to disclose.
Brain metastases in locally advanced NSCLC treated with radical radiotherapy (RT) in a single institution
Authors: Hansen O. , Hansen K. H. , Stolberg-Rohr A. , Sorensen P. 
Published: March 2020

18107 Background: Brain metastases (BM) is a major problem in NSCLC. To evaluate the influence on survival in locally advanced NSCLC treated with radical RT, a retrospective analyses was performed of the patients treated at our institution. Methods: From June 1995 to Dec. 2003 200 patients with non-resectable NSCLC stage IIB-IIIAB received radical 3-D conformal radiotherapy with a planned dose =60Gy/30 F. Data on brain metastases were retrospectively obtained from the patient files. All patients were followed to death except in few cases in which data was obtained from other hospitals. End points were occurrence of BM and BM free survival (BM-RFS). A Cox multivariate analysis was performed including possible prognostic factors. Results: Stage at RT: IIB 8 (4%), IIIA 66(33%), IIIB+recurrent disease 126 (63%). Male/female ratio was 126 /74. The median survival was 15.5 months. The 2 yrs. survival was 34%. 42 (21%) cases of BM were observed. The median time to BM was 8.5 ms. with 86% occurring within 2 yrs. In 28 (67%) of the cases BM was the first site of failure, and in 10 (24%) BM remained the only site of failure. More women than men experienced BM 25 (34%) vs. 17 (14%), p= 0.0013. The survival after diagnosis of BM was 2.8 ms. The patients having BM as and these had better prognosis then patients experiencing BM at a later stage 5.3 vs 1.9 ms. (p<0.0001). The prognosis after BM as first failure were no worse than patients having other sites as first distant failure (3.6 ms, p=0.3). In a Cox multivariate analysis only female gender was associated with poorer BM-RFS while use of neoadjuvant chemotherapy, adeno.-histologi, age, stage at RT, and performance status at RT were insignificant factors. Conclusions: A significant number of cases with locally advanced NSCLC experienced BM especially in females. The survival after diagnosis of BM as first failure were no worse than patients experiencing other distant sites as first failure. The results indicates a that PCI should be considered to this group of patients No significant financial relationships to disclose.