bluuebunny/crossref_metadata_2025_split huggingface dataset:
The use of statins may prolong survival of non-small cell lung cancer patients
Authors: Wang D. , Hanbali A. , Jankowski M. , Duran E. U. , Syed A. , Farhan S. , Chapman R. 
Published: March 2020

7149 Background: Hypercholesterolemia is one of the most common morbidities in United States. Statins have been proven as effective cholesterol-lowering agents and have been widely used in this country. They have been reported reducing the incidence and risk of various cancer types. However, the impact of using statins on the survival of patients with diagnosed non-small cell lung cancer is unknown. Methods: Ongoing retrospective study involves a cohort of 1,233 patients with diagnosed non-small cell lung cancer. Patients were identified from the Tumor Registry at Henry Ford Health System between January 1999 and December 2004. To date, the electronic medical records from 407 of the 1,233 cases were reviewed. Statistical analyses were performed and stratified for statin users versus non statin users. Results: Data from 407 patients were included in this analysis. There were 109 patients with hypercholesterolemia, 54 of them were statin users at the time of their non-small cell lung cancer diagnosis. Average age was 70 (range 46–85) years for statin users and 65 (range 29–93) years for non statin users. Median survival of 407 subjects was 9.82 months. After stratifying for statin use, the median survival of statin users was 12.38 months while the median survival of non statin users was 9.75 months, with a p value of 0.012. Conclusion: Though small sample size, this study is the first time ever suggesting a possible survival benefit of statin use in patients with non-small cell lung cancer who have received their standard anti-tumor regimens. Other variables that may contribute to this result will be further clarified and discussed after completing the data collection and analysis of this entire cohort. Based on our preliminary result, a prospective study of co-morbidity management with statins in patients with non-small cell lung cancer is warranted. No significant financial relationships to disclose.
Randomized phase II study of carboplatin and paclitaxel (CP) versus gemcitabine and vinorelbine (GV) in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC): Preliminary results of West Japan Thoracic Oncology Group 0004
Authors: Kaneda H. , Nakagawa K. , Saito H. , Kashii T. , Iwamoto Y. , Katakami N. , Nakano T. , Kurata T. , Fukuoka M. 
Published: March 2020

7151 Background: A platinum-based chemotherapy is a standard treatment in PS 0–1 patients with advanced NSCLC and a non-platinum doublet is an alternative option. However, the role of combination chemotherapy remains to be defined in PS 2 patients with advanced NSCLC. We have conducted a randomized phase II study to compare the efficacy and safety of CP versus GV in PS 2 patients with NSCLC. Methods: Chemotherapy-naive ECOG PS 2 patients with stage IIIB (malignant effusion) or IV NSCLC were enrolled in this study. Patients were randomized to carboplatin AUC 6 and paclitaxel 200 mg/m2 day 1 every 3 weeks or gemcitabine 1,000 mg/ m2 and vinorelbine 25mg/m2 day 1, 8 every 3 weeks. The primary endpoint was 1-year survival rate and secondary endpoint were response rate, toxicity, time to progression and quality of life. Results: A total of 89 patients were enrolled and 86 were eligible: 42 patients (median age 64 years, male/female 31/11, stage IIIB/IV 7/35) in CP and 44 patients (median age 67 years, male/female 33/11, stage IIIB/IV 7/37) in GV. Of 84 patients evaluable for response, one complete response and 11 partial responses were obtained in CP (29.3%) and 9 partial responses in GV (20.9%). As of 12/05, toxicity data were available in 80 patients. Grade 3/4 toxicity in CP and GV included neutropenia 65.8% vs 63.4%, anemia 13.2% vs 31.7%, thrombocytopenia 7.9% vs 12.2%, liver dysfunction 2.6% vs 9.8%, febrile neutropenia 15.4% vs 12.2%, infection 30.8% vs 22%, nausea/vomiting 15.4% vs 2.4%, constipation 23.1% vs 7.3% pulmonary infiltrates 5.1% vs 12.2% and neuropathy 5.1% vs 0%. Conclusions: CP and GV were feasible and effective in PS 2 patients with advanced NSCLC. GV caused more anemia, thrombocytopenia, liver dysfunction and pulmonary infiltrates, while CP produced more nausea/vomiting, constipation and neuropathy. Response and toxicity data in all pts in each arm will be presented at the meeting. No significant financial relationships to disclose.
Do gender and race influence survival in patients with non-small cell lung cancer brain metastases? An outcomes study utilizing the RTOG RPA class stratification
Authors: Videtic G. M. , Reddy C. A. , Chao S. T. , Rice T. W. , Adelstein D. J. , Barnett G. H. , Mekhail T. M. , Vogelbaum M. A. , Suh J. H. 
Published: March 2020

7153 Background: To explore gender, race and their interactions in the setting of NSCLC brain metastases only, a single-institution brain database was analyzed, using the RTOG recursive partitioning analysis (RPA) brain metastases classification. Methods: From 1/82 to 9/04, 831 NSCLC pts with brain metastases were registered. RPA criteria for analysis were: class I- Karnofsky performance status (KPS) ≥ 70, age<65 years, primary tumor controlled, no extracranial metastases; class III- KPS<70; class II- all others. Results: Median follow-up was 5.4 months (m) (range 0–122.9). Median age was 62.4 (range 25–90). Median KPS was 80 (range 20–100). There were 485 males [M] (58.4%) and 346 females [F] (41.6%). 824 pts (99%) were either African-American (AA; n = 142[17%]) or White (W; n = 682[83%]). Pts characteristics were balanced when stratified by RPA class and by treatments. Median survival (MS) in months from time of brain metastasis diagnosis for all pts was 5.8. MS in months by gender [F vs. M] and race [W vs. AA] was: 6.3 vs. 5.5, p = 0.013; 6.0 vs. 5.2, p = 0.08, respectively. By RPA class for gender, MS trends (in months) favored F over M in classes I and II but not III: 17.1 vs. 9.5 (p = 0.11); 6.8 vs. 6.0 (p = 0.09), 2.7 vs. 2.5 (p = 0.42), respectively. By RPA class for gender and race, MS trends (in months) favored AAF over AAM in classes I and II but not III: 30.0 vs. 12.4, p = 0.50; 11.2 vs. 4.6, p = 0.021; 3.2 vs. 3.2, p = 0.64, respectively; and WF over WM in classes I but not II or III: 14.4 vs. 9.5, p = 0.11; 6.6 vs. 6.3, p = 0.38; 2.4 vs. 2.3, p = 0.49, respectively. On multivariable analysis, significant variables were gender (p = 0.041; RR 0.83); RPA class (p < 0.0001; RR 0.28, for I vs. III; p < 0.0001; RR 0.51, for II vs. III). Conclusions: Gender significantly influences NSCLC brain metastasis survival while race trends to significance. MS trends by RTOG RPA class suggest race may interact with genderprimarily in class I but pt numbers limited significance. Further characterization of these factors is warranted. No significant financial relationships to disclose.
Compliance of adjuvant chemotherapy in non-small cell lung cancer (NSCLC); No longer an issue
Authors: Aljubran A. , Leighl N. , Pintilie M. , Feld R. , Burkes R. , Shepherd F. 
Published: March 2020

7154 Background: Poor compliance has been a common feature in clinical trials of adjuvant chemotherapy for NSCLC with only 48%-69% of patients completing all planned cycles. This may have been due to lack of perceived benefit by patients and physicians and toxicity of the regimens employed. We retrospectively evaluated compliance and toxicity of platinum-based chemotherapy in the two years following the recent reports of successful adjuvant chemotherapy trials for NSCLC. Methods: Following institutional ethics approval, patients who received adjuvant chemotherapy after complete resection of NSCLC between May 2003 and May 2005 were analyzed retrospectively. Patients were identified using an institutional cancer registry. Patient demographics, ECOG status, stage, pathologic subtype and type of surgery were recorded. The number of chemotherapy cycles, delays, dose reductions and change of chemotherapy were all reported. Results: A total of 50 patients were identified. The median age was 62. 38% were stage I, 18% stage II, 30% stage III and 14% had multiple primary tumors of variable stages. 20% were ECOG PS2 and the rest ECOG 0–1. Only 12% had undergone pnemonectomy. 41 patients (82%) started cisplatin /vinorelbine (3 switched to carboplatin because of nephrotoxicity, and one switched to carboplatin/paclitaxel because of fatigue and vomiting). 3 patients received other cisplatin-based combinations. 6 received carboplatin-based treatment (one because of advanced age, one because of cardiac dysfunction and 4 because of preexisting neuropathy). 80% completed all treatment. 40% required dose reduction. 58% required delays in treatment. 6 events of febrile neutropenia were reported in 5 patients. 7 patients required admission. There were no toxic deaths. Multivariate analysis showed no effect of age, gender, extent of surgery or ECOG status on compliance, need for treatment modification or toxicity. Conclusions: Compared to historical trials, adjuvant platinum-based chemotherapy for resected NSCLC is well tolerated and is now accepted by patients and physicians with a high degree of compliance. No significant financial relationships to disclose.
Determining incidence and predictors of deep vein thrombosis in patients with non-small cell lung cancer
Authors: Levi D. , Tagalakis V. , Cohen V. , Agulnik J. , Kasymjanova G. , Small D. 
Published: March 2020

7159 Background: The risk of deep vein thrombosis (DVT) among patients with non-small cell lung cancer (NSCLC) has not been well studied. We conducted a retrospective cohort study of patients with NSCLC to determine the incidence of DVT and characterize predictors of DVT in NSCLC patients. Methods: The pulmonary oncology database of the SMBD-Jewish General Hospital contains prospectively collected clinical data on all lung cancer patients followed in the pulmonary oncology clinic since January 1, 1997. We identified all consecutive patients with a histologically confirmed new diagnosis of NSCLC between January 1, 1997 and December 31, 2004 and determined the occurrence of an objectively defined DVT. Data on age, gender, NSCLC type and stage, Eastern Cooperative Oncology Group (ECOG) performance status, exposure to surgery and chemotherapy, and death was collected and compared among patients with DVT and patients without DVT. Results: Of the 493 NSCLC patients included in the cohort for a total of 634 person-years, 67 (13.6%) patients developed an objectively confirmed DVT. We calculated an incidence rate of 110 cases (95% confidence interval (CI) 80, 130) per 1000 person-years. Risk factors associated with occurrence of DVT were advanced stage (p = 0.0006) and male sex (p = 0.04). A multivariable regression analysis adjusted for recent surgery and performance status showed that advanced stage (Rate ratio 2.55, 95% CI 1.33–4.89) and male sex (Rate ratio 1.75, 95% CI 1.03–2.94) were independent predictors of DVT. Age, type of NSCLC, and chemotherapy did not predict DVT. The risk of dying was 1.7-fold increased (Hazard Ratio 1.73, 95% CI 1.29–2.32, adjusted for age, sex, stage, surgery, performance status, and date of lung cancer diagnosis) among patients with DVT compared to patients without DVT. Conclusions: Our results show a high incidence of DVT in NSCLC patients and that advanced stage and male sex are important predictors of DVT. Moreover, NSCLC patients with DVT have a 1.7 fold increased risk of dying than patients without DVT. Confirmation of our results by prospective studies may provide the necessary evidence for targeted use of prophylactic anticoagulants in NSCLC patients to prevent development of DVT and improve related survival. No significant financial relationships to disclose.
Erlotinib in patients with advanced squamous cell carcinoma of the lung
Authors: Gúrpide A. , Massutí B. , Pallares C. , Salinas P. , Montes A. , López-Vivanco G. , González Barón M. , Cobo M. , Amador M. L. , Paz-Ares L. 
Published: March 2020

7174 Background: Erlotinib is a potent HER1/EGFR TKI that is approved for the treatment as a single agent in 2nd and 3rd line NSCLC. Several phase II studies have shown that adenocarcinoma histology together with female gender, Asian origin, and never having smoked are associated with responsiveness of NSCLC to erlotinib. The purpose of the analyisis we present here was to describe the outcome in a group of patients with squamous carcinoma of the lung treated with erlotinib. Methods: Eligilibility criteria included stage IIIB-IV chemotherapy-naive patients with confirmed NSCLC, PS 0–2, age ≥ 18 years, adequate organ functions, measurable disease and written informed consent. Patients with diagnosis of squamous cell lung cancer that received erlotinib 150 mgr/day p.o until disease progression or withdrawal were the subject of this analysis. Results: From June 2004 to March 2005, 121 patients with histological diagnosis of squamous cell lung cacer from more than 100 different Spanish hospitals were included in the TARGET study. Median age was 66 yrs. All patients in our analysis were Caucasian. 111 patients were male (92%) and 113 (93%) were current smokers or have smoke sometime in their life. 88% of them have stage IV carcinoma and 74% have received previous treatment for metastatic disease. PS 0/1/≥2 18 (15%)/68 (56%)/32 (29%). In the evaluable population for response (69 pts) 5 PR and 0 CR were observed for an overall RR of 7.25%. Clinical benefit defined as CR+PR+SD was 54%. In the ITT populations median TTP was 3.6 months [95% CI 2.7–5.3]. Median OS was 5,7 m [95% CI 4.0–6.7]. Erlotinib was well tolerated.No unexpected toxicities were observed. Conclusions: This subgroup analysis confirms that erlotinib is active and well tolerated in patients with advanced or metastatic squamous cell carcinoma of the lung. Responses were seen in both genders and in patients with or without smoking history. At this moment histology should not be used as the only selection criteria for treatment of patients with NSCLC after failure to chemotherapy. [Table: see text]
Quantitative RT-PCR analysing expression of gefitinib resistance related genes predicts clinical outcome of non-small cell lung cancer patients treated with gefitinib
Authors: Kakiuchi S. , Yano S. , Ogino H. , Nakamura Y. , Tsuruo T. , Sone S. 
Published: March 2020

7181 Background: Gefitinib, an inhibitor of epidermal growth factor receptor-tyrosine kinase, has shown favorable anti-tumor activity to a subset of patients with advanced non-small cell lung cancer (NSCLC). However, gefitinib failed to significantly prolong survival in comparison to placebo in unselected population. Consequently, selection of patients who will benefit from this treatment is clinically important. In the previous study, we identified gefitinib-resistance related genes (GRRGs) by cDNA microarray analyses and reported that the responsiveness of individual patients with NSCLC to gefitinib could be predicted by expression of GRRGs. The goal of this study is to establish clinically adoptive prediction system of clinical outcome of NSCLC patients treated by gefitinib. Methods: Tumors from 30 NSCLC patients treated daily with 250mg of gefitinib were evaluated for the expression of GRRGs by quantitative RT-PCR. Gefitinib response score (GRS) reflecting gene expression was calculated based on weighted vote method and this numerical scoring system was validated by leave-one-out approach and independent test cases. Results: The sensitivity of 15 learning cases (five partial response (PR) cases and 10 progressive disease (PD) cases) were predicted by leave-one-out cross validation with 93.3% (14/15) accuracy. This numerical scoring system correctly predicted responses to the drug in all of nine additional test cases (three PR cases and six PD cases). Notably, this system also could predict two stable disease (SD) cases who successfully controlled by gefitinib more than four months as responder. On the other hand, four patients who had been judged as SD but showed progression of the disease within three months were judged as non-responders. Moreover, gefitinib-treated patients with good signature had a statistically significant improvement in time to progression, and survival compared with patients with bad signature (13.0 vs 1.7 months, P < .0001; 27.7 vs 6.6 months, P = .0007, respectively). Conclusions: Our results suggest that clinical outcome of NSCLC patients treated with gefitinib could be predicted by expression levels of GRRGs determined by quantitative RT-PCR analyses. No significant financial relationships to disclose.
EGFR mutations and the correlation with gefitinib therapy in Chinese NSCLC—A systematic review based on individual patient data from 5 medical centers in China
Authors: Wu Y. , Zhong W. , Li L. , Zhang L. , Zhou C. , Liu W. , Lin J. , Zhou Q. , Xu C. , Zhang G. , Mok T. 
Published: March 2020

7187 Background: EGFR mutations were found to have a significant association with response to gefitinib. To date, information on status of EGFR mutation in Chinese remains scanty. Comprehensive review of existing information on EGFR mutations is essential for treatment selection in Chinese patients with advanced NSCLC. Methods: We published 4 abstracts on EGFR mutation in Chinese patients at the 41st ASCO. We performed an IPD-meta-analysis on the data from the above investigators plus another one. The original individual EGFR mutations (exon 18,19,21) data was collected. Gefitinib was given with 250 mg/d until disease progression. Results: Total 407 cases were into the IPD review. The patient characteristic was male: female = 258:149; adenocarcinoma: other = 259:148; smoker: nonsmoker =178:153. The EGFR mutation rate was 3.05% (124/407). For adeno subgroup the EGFR mutation rate was 42.5% (110/259), non- adeno was 9.5% (14/148). In female the EGFR mutation rate was 41.6% (62/149), male was 24.0% (62/258). Non-smoker was 39.2% (60/153), smoker was 18.5% (33/178). In univariate analysis adeno, smoking, gender was significant predictive factors for EGFR mutation but in logistic regression only adeno is independent correlation factor (p = 0.000, 95% CI 2.078—9.001). Conclusions: The EGFR mutation is more common in no-smoking female adeno patients with NSCLC. The EGFR mutation group has a tendency of response rate to gefitinib compare to the EGFR wild group in NSCLC patients. [Table: see text] No significant financial relationships to disclose.
Correlation between epidermal growth factor receptor gene status and clinical outcome of gefitinib in Japanese patients with non-small cell lung cancer
Authors: Kasahara K. , Sone T. , Kimura H. , Nishio K. , Tamura T. , Shibata K. , Mizuguchi M. , Yoshimoto A. , Fujimura M. , Nakao S. 
Published: March 2020

7192 Background: Epidermal growth factor receptor (EGFR) gene amplification and mutation have been reported to be predictors of response to EGFR inhibitors. We evaluated EGFR gene copy number and mutations in biopsy samples of non-small cell lung cancer (NSCLC) treated with gefitinib (G) and analyzed the correlation between gene status and clinical outcome. Methods: EGFR gene copy numbers in biopsy samples were evaluated using FISH and categorized as described by Cappuzzo et al. We also performed mutational analysesof exons 18, 19 and 21 of EGFR by PCR and direct sequencing. Response was judged using the RECIST guidelines. Time to progression (TTP) and overall survival (OS) were calculated and evaluated by the Kaplan-Meier method. Groups were compared using the log-rank test. Risk factors associated with survival were evaluated using Cox proportional hazards regression modeling and multivariable analysis. Results: Of 59 patients (pts) enrolled in this investigation, 24 pts (41%) were female and 21 pts (35%) had never smoked. The most common histological subtype was adenocarcinoma (73%) and 36 pts (61%) had good PS 0–1. Gene copy numbers could be analyzed in 54 pts. Gene amplification was observed in 21 pts, high polysomy in 5 pts, low polysomy in 18 pts, low trisomy in 5 pts and disomy in 5 pts. FISH positivity was observed in 26 pts (48%). EGFR mutations were detected in 18 pts (31%); point mutations in exon 21 were observed in 5 pts, in-frame deletions in exon 19 in 12 pts, a point mutation in exon 18 in 1 pt. Response rate in pts with EGFR mutations was significantly higher than in pts without mutations (56% vs. 15%, p = .0011). Response rate in FISH-positive pts was 31% and that in FISH-negative pts was 21%, the association with response was not significant. EGFR mutations were also correlated with improved TTP (median 8.3 m vs. 1.8 m, p = .0014) and OS (median 18.8 m vs. 6.4 m, p = .0059). There were no significant differences in TTP and OS based on FISH positivity. On multivariable analysis, EGFR mutations remained significantly associated with improved TTP and OS. Conclusions: Our results suggest that EGFR mutations are a better predictor of clinical benfit of G when compared with gene copy number in Japanese NSCLC pts. [Table: see text]
The influence of tumor size, histological differentiation and smoking history in patients with completely resected stage I adenocarcinoma of the lung
Authors: Tsuboi M. , Kato H. , Ichinose Y. , Ohta M. , Hata E. , Tsubota N. , Tada H. , Wada H. , Hamajima N. , Ohta M. 
Published: March 2020

7197 Background: To test the hypothesis that patients with completely resected p-stage I adenocarcinoma [Ad.] of the lung contain a favorable subgroup of patients with well differentiated histology and tumor 2.0 cm or less in greatest dimension, we analyzed the results of the JLCRG trial (a randomized prospective trial of adjuvant chemotherapy with Uracil-Tegaful for stage I adenocarcinoma of the lung) by tumor size, smoking history, degree of histological differentiation and more. Methods: Patients were randomized to receive either oral uracil-tegaful (250 mg of tegaful /m2/day) for 2 years postoperatively or no adjuvant treatment. Multivariate analyses and interactions with the Cox proportional-hazards model were used to estimate the simultaneous effects of prognostic factors on survival. Results: The 5-year survival rate of the 412 patients with tumor 2cm or less in size was 89.8% (95% confidence interval [CI]: 86.8 to 92.8) versus 84.4% (95% CI: 81.3–87.4) for the 569 patients with tumor more than 2cm in size (median follow-up 72 months, p = 0.002). Although univariate analysis demonstrated improved survival for the patients with no smoking history and female gender, the selected covariates by multivariate analysis were as follows: age (hazard ratio [HR] for patients aged 70 years or more, 2.25; 95% CI: 1.58 to 3.14, p < 0.0001), tumor size (HR for more than 2cm in size, 1.55; 95% CI: 1.10 to 2.21, p = 0.012), histological differentiation (HR for moderate and poor differentiation, 1.75, 95% CI: 1.25 to 2.47, p = 0.001), and treatment group (HR for the uracil-tegaful group, 0.68; 95% CI: 0.49 to 0.94, p = 0.02). For these prognostic factors, there was only one significant interaction between tumor size and the adjuvant treatment. Conclusions: 1) Patients with completely resected stage I Ad. of the lung contain a favorable subgroup of patients with aged less than 70 years, well differentiated histology, and a maximum tumor dimension of 2.0 cm or less. 2) Adjuvant chemotherapy with oral uracil-tegaful should also be considered for stage I Ad. patients more than 2 cm in tumor size. 3) 2cm in tumor size might be a good benchmark candidate of the description of T factor to facilitate treatment strategies and revisions of the TNM staging system. No significant financial relationships to disclose.