bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adjuvant chemotherapy with cisplatin and gemcitabine in resected non-small cell lung cancer: A single institutional experience.
Authors: Carrera Sergio , Rubio Itziar , Sancho Aintzane , Marrodan Ines , Muñoz Alberto , Iza Estibaliz , Iruarrizaga Eluska , Buque Aitziber , Calvo Begoña , Aresti Unai , Lopez-Vivanco Guillermo 
Published: March 2020

e17522 Background: Adjuvant chemotherapy in operable non small cell lung cancer (NSCLC) has been shown to improve overall survival in many meta-analysis. The use of cisplatin and gemcitabine combination is considered one of the standard regimens for first-line treatment of advanced NSCLC, with mild side effects. The aim of the study was to evaluate the clinical feasibility and toxicity of the cisplatin-gemcitabine combination in adjuvant setting. Methods: Resected NSCLC patients who met criteria for recommending adjuvant chemotherapy received treatment with cisplatin 75 mg/m2 on day 1 and gemcitabine 1.200 mg/m2 on days 1 and 8 of each 21 days cycle. A maximum of four cycles were delivered. Main objectives were clinical feasibility, drug delivery, and efficacy. Results: From November-2004 to July-2011 a total of 89 patients (73 male/16 female, median age 57) were included. Surgery: lobectomy 62.9%, pneumonectomy 29.2%, bilobectomy 5.6%, wedge resection 2.2%. Tumor stages: 19.1% IB, 55.1% II, 23.6% III, 2.2% IV; histology: 48.3% squamous, 43.8 % adenocarcinoma, 3.4 % large cell carcinoma and 4.5% NSCLC not otherwise specified. ECOG 0: 62.9%, ECOG 1: 37.1%. Toxicity: grade 3/4 neutropenia 19.1%/6.7 %; grade 3 febrile neutropenia 3.4%; grade 3/4 anaemia 6.7%/1.1%; grade 3/4 thrombocytopenia 6.7%/4.5%; grade 3 ototoxicity 1.1%; no grade 3/4 nephrotoxicity was reported. There was one toxic death. Compliance: 85.4% of the patients received 4 cycles of the combination chemotherapy. Cisplatin dose intensity was 24.6 mg/m2/wk and gemcitabine dose intensity was 773.6 mg/m2/wk. Median overall survival and progression free survival has not yet been reached. With a median follow up of 36 months, 77.5% of the patients are still alive and 61.8% without documented relapse. Reported 3 year overall survival in patients with ECOG 0 was 82%, and in patients with ECOG 1 54%, being this difference statistically significant. Conclusions: Combination chemotherapy with cisplatin and gemcitabine in adjuvant setting is safe and feasible with a good toxicity profile. Those patients with ECOG 0 benefit most. Our data are similar to those obtained in previously reported trials.
Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small cell lung cancer (NSCLC): COVeRT study.
Authors: Singhal Nimit , Pittman Kenneth B. , Karapetis Christos Stelios , Stephens Sonya , Borg Martin 
Published: March 2020

e17544 Background: Chemoradiation is standard of care for the treatment of stage III NSCLC. Vinorelbine has been widely used for the treatment in NSCLC and it has been established, either as single agent or in combination with platinum, as one of the standard reference treatments. Oral vinorelbine is a new formulation which has achieved comparable results to the IV vinorelbine. The present trial is evaluating combination of oral vinorelbine, cisplatin with radical radiation for management of stage III NSCLC. Methods: Patients with diagnosis of stage III NSCLC with PS 0-1 and adequate cardio-respiratory function. Primary objective: progression-free survival. Secondary objectives: response rate, overall survival and safety profile. Treatment - chemotherapy (2 cycles q 21 days): vinorelbine oral 50 mg/m2 d1, d8. Cisplatin 100 mg/m2/ cycle (given as either 20mg/m2 D1-5 or 50mg/m2 D1 and D8) - radiotherapy: 60 Gy in 30 fractions at 2 Gy/ fraction to the isocentre, treating all fields daily, 5 days a week over 6 weeks using 10 MV photons and 3-D CRT. Results: Since May 2008, 33 patients have been enrolled with 31 patients having completed treatment so far. The data is presented for these 25 patients. 16 were male with age ranging from 50-89. The median age was 66. 13 patients had stage IIIa. There were 11 squamous cell carcinoma and 10 adenocarcinoma. The side effects were generally mild and included Gr I, II nausea, constipation and esophagitis. Serious adverse events requiring admission included dehydration, fever with grade I neutropenia, atrial fibrillation and UTI in one patient each. One patient had tracheo-esophageal fistula resulting in death within 30 days of completing chemoRT and was attributed to treatment. The confirmed radiological response assessment is available for 22 patients with 1 CR, 13 PR, 7 SD and 1 PD giving a total response rate of 64%. Conclusions: Two cycles of chemotherapy with oral vinorelbine and cisplatin plus radical radiation appears to be well tolerated with significant activity in stage III NSCLC.
Survival benefit from combined chemoradiation (CRT) in elderly patients with unresectable stage III non-small cell lung cancer (NSCLC).
Authors: Domingues Pedro Masson , Zylberberg Ricardo , Matta-Castro Thalita , Baldotto Clarissa Serodio , de Lima Araujo Luiz Henrique 
Published: March 2020

e17548 Background: CRT is the standard therapy in locally advanced NSCLC. Nevertheless, the best approach in the elderly population is still poorly defined. Methods: We retrospectively reviewed the charts of elderly (≥ 65 years) patients (pts) with diagnosed stage III (6th AJCC), unresectable, NSCLC, treated at the Brazilian National Cancer Institute (INCA) between 2003 and 2005. Pts with malignant pleural effusion were excluded. The primary outcome was overall survival (OS), measured from diagnosis until death. Prognostic factors were analyzed using log-rank and stepwise Cox model. Palliative therapy (PT) included best supportive care, radiation therapy (RT; ≤ 40 Gy), and palliative chemotherapy. Among pts treated with radical RT, OS was measured from date of treatment beginning until death (OST). Results: One hundred fifteen pts were included. Median age was 71 (range 65-83), 76% were male, 51% had squamous histology, and 82% stage IIIB. Seventy percent had more than 5% weigh loss at diagnosis, 44% had PS 0-1, while 29% and 26% had PS 2 and 3, respectively. Ninety percent were current/former-smokers, and Charlson comorbidity index (CCI) was 0 in 66% and 1-2 in 34%. Thirty-six percent received PT, 32% exclusive RT (>40 Gy), and 32% CRT (concomitant or sequential). Post-radiation surgery was not performed in this cohort. The median OS was 9.9 months (ms; 95% CI, 7.2-12.6). Survival was significantly longer among pts with PS 0-1 (p<0.0001) and no weigh loss (p=0.026), while histology (p=0.15), tumor stage (p=0.51), CCI (p=0.37), and age (p=0.54) were not prognostic factors. Pts treated with exclusive RT and CRT had better OS (median 14.3 ms [95% CI, 11.7-16.9] and 17.0 ms [95% CI, 14.1-19.9], respectively) than PT (median 4.1 ms [95% CI, 3.5-4.8]; p<0.0001). In the multivariate analysis, RT (HR 0.25 [95% CI, 0.15-0.42]; p<0.0001) and CRT (HR 0.16 [95% CI, 0.09-0.27]; p<0.0001) were independently associated with better survival in comparison to PT. Among pts receiving radical RT, the addition of chemotherapy was associated with longer OST (median 14.1 vs 10.7 ms; p=0.025). Conclusions: CRT was independently associated with longer survival in elderly pts with locally advanced NSCLC.
γ-H2AX as a novel prognostic marker in patients with non-small lung cancer.
Authors: Matthaios Dimitrios , Hountis Panagiotis , Trypsianis Grigorios , Zissimopoulos Athanasios , Bouros Demosthenes , Karakitsos Petros , Kakolyris Stylianos 
Published: March 2020

e17553 Background: Phosphorylation of the H2AX histone is an early indicator of DNA double-strand breaks and of the resulting DNA damage response. In the present study we assessed the expression of γ-Η2ΑΧ in a cohort of 96 patients with non-small cell lung carcinoma and evaluated its role as a prognostic indicator in resectable NCSLC patients. Methods: 96 parafin-embedded specimens of non-small lung cancer patients were examined. All patients underwent radical thoracic surgery of primary tumor (lobectomy or pneumonectomy) and regional lymph nodes dissection. γ-Η2ΑΧ expression was assessed by standard immunohistochemistry.Multivariate Cox proportional hazards regression analysis, using a backward selection approach, were performed to explore the independent effect of variables on survival. All tests were two tailed and statistical significance was considered for p values <0.05. Results: Follow-up was available for all patients; mean duration of follow-up was 27.50 ± 14.07 months (range 0.2-57 months, median 24 months). Sixty-three patients (65.2%) died during the follow-up period. The mean survival time was 32.2 ± 1.9 months (95% CI = 28.5 to 35.8 months; median 30.0 months); one, two and three-year survival rates were 86.5 ± 3.5%, 57.3 ± 5.1% and 37.1 ± 5.4% respectively. Low γ-H2AX expression was associated with a significant better survival as compared with those having high γ-H2AX expression (23.2 months for high γ-Η2ΑΧ expressin vs 35.3 months for low γ-H2AX expression, p=0.009; HR=1.95, 95% CI=1.15-3.30). Further investigation with multivariate Cox proportional hazards regression analysis revealed that high expression of γ-H2AX remained independent prognostic factors of worse overall survival (HR=2.15, 95% CI=1.22-3.79, p=0.026). Conclusions: Our study is the first study to demonstrate that overexpression of γ-Η2ΑΧ is an independent prognostic indicator of worse overall survival in patients with non-small lung cancer. Further studies are needed to confirm our results.
How safe is surgery in obese lung cancer patients?
Authors: Dhakal Binod , Sukumaran Sunitha , Santana-Davila Rafael , Haasler George , Eastwood Daniel , Tisol William , Gasparri Mario , Choong Nicholas W. 
Published: March 2020

e17555 Background: Obesity is a risk factor for increased peri-operative morbidity and mortality in surgery. There have been limited studies to correlate morbidity of lung cancer resection with obesity. Methods: We performed a retrospective study of patients who underwent surgical resection for lung cancer at the Medical College of Wisconsin from 2006 to 2010. Data on patient demographics, weight, pathology findings and hospital course were abstracted after appropriate IRB approval. Peri-operative morbidity was defined as atrial fibrillation, heart failure, respiratory failure, pulmonary embolism or any medical complications arising within 30 days after surgery. Fisher’s exact test was used to test the association between BMI and perioperative morbidities. Results: Between 2006 and 2010, 320 lung resections were performed for lung cancer. Median age was 67 (25-88) years and 185 (57.8%) were females. The body mass index (BMI) distribution was 121 (37.8%) in BMI<25 and 199(62.18%) in BMI≥25. In patients with BMI < 25, surgical procedures consisted 76 (23.75%) lobectomy, 38 (11.8%) wedge resection and 7 (2.18%) pneumonectomy. In patients with BMI ≥ 25, surgical procedures consisted: 131 (40.93%) lobectomy, 61 (19.06%) wedge resection and 7 (2.18%) pneumonectomy. Tumor histology was: adenocarcinoma 138 (42.9%), squamous cell cancer 107 (33.3%), bronchoalveolar 25 (7.7%), large cell 19 (5.9%) and mixed 31 (9.68%). The 30-day mortality rate was 1.8 % (6 patients), out of which only 2 had BMI ≥ 25. Peri-operative morbidity occurred in 28 (23.14%) of normal BMI patients and 47 (23.6%) of BMI ≥ 25 patients (p=0.54). Specific morbidities encountered by patients with normal vs. BMI ≥ 25 were: atrial fibrillation 11(9.09%) vs. 24(12.06%) (p=0.46), pulmonary embolism 1(0.83%) vs. 3(1.51%) (p=1.0), congestive heart failure 2(1.65%) vs. 2(1.01%) (p=0.63), respiratory failure 12(9.92%) vs. 17(8.54%) (p=0.69) and ARDS 2(1.65%) vs. 1(0.50%) (p=0.55).Median hospital stay was 5 days in lower BMI group and 4 days in BMI ≥25 groups (p=0.52). Conclusions: Potential curative surgical resections can be offered to even significantly overweight patients as there is no significant difference in the peri-operative morbidities and length of stay as compared to normal BMI patients.
Cytology- versus histology-based diagnosis in small cell lung cancer: Is there any clinical implication?
Authors: Strimpakos Alexios S , Ramfidis Vassilios , Maragkos Charilaos , Panagiotarakou Meropi , Gkiozos Ioannis , Syrigos Kostas N 
Published: March 2020

e17557 Background: Small cell lung cancer (SCLC) is a common disease representing around 15% of all lung cancer patients. Unlike other solid tumours, SCLC is staged as limited or extensive depending on whether the disease can be confined to a radiation field or not. Diagnosis is confirmed either on histology (H) or cytological (C) examination, but it has not been studied yet whether there is a clinically significant difference between them. This study aimed to highlight possible differences and clinical significance of SCLC diagnosis made by H or C. Methods: Medical records of 422 patients (pts) diagnosed with SCLC between 2000 and 2011 were screened. Complete demographic, clinical and treatment data were available for 414 patients. Results: 274/414 pts (66,2%) were diagnosed by histology and 140/414 (33,8%) by cytology. Male:female ratio was 224:50 and 122:18 in H and C groups whereas median age 64 years in both. Limited:extensive stage was established in 89:185 pts in the H group and 41:99 in the C group. Chemotherapy was received by most patients in both groups but radiotherapy only in 110/274 pts (40%) in H and 59/140 pts (42%) in the C group. Median survival (OS) for the H and C groups were 7,7 and 7,3 months respectively. Conclusions: SCLC is a common and aggressive disease with poor prognosis. Early diagnosis offers the best chances for a longer survival and treatment should be commenced promptly. Diagnosis based on histology or cytology shares similar demographic and clinical characteristics without difference in treatment outcomes and survival.
Survival benefit from maintenance therapy after first-line chemotherapy in advanced non-small cell lung cancer: A meta-analysis.
Authors: Chouahnia Kader , Des Guetz Gaetan , Uzzan Bernard , Nicolas Patrick , Morere Jean F. 
Published: March 2020

e18003 Background: Maintenance therapy corresponds to a prolonged treatment after induction chemotherapy (CT) for patients with advanced non-small cell lung cancer (NSCLC). Several recent randomized controlled trials (RCTs) showed a survival benefit for maintenance therapy, especially for EGFR tyrosine-kinase inhibitors (TKIs), but conflicting results have been published. We performed a meta-analysis of all RCTs published either as articles or in abstract form. Since its presentation at ESMO 2011, this meta-analysis has been updated with one additional study (AVAPERL) and the preliminary data of PARAMOUNT on Overall Survival (OS). Methods: A PubMed query using several keywords simultaneously (NSCLC, maintenance, RCT, survival) found 79 references. Abstracts from ASCO and ESMO proceedings were also reviewed. References were cross-checked. Outcomes were OS and PFS (Progression Free Survival). We used a fixed-effect model when heterogeneity was absent and a random-effect model when present. We used EasyMA software. Results: Thirteen RCTs were included with IFCT-GFPC trial used twice since it assessed 2 maintenance therapies in parallel, gemcitabine and erlotinib. These 13 RCTs included 5251 patients (median age 61 years, 4261 stage IV, 913 stage III diseases, 2929 adenocarcinomas, 983 squamous cell carcinomas). For OS (14 sub-studies), the overall HR was 0.85 (95 % Confidence Interval or CI 0.80-0.91; fixed effect model). For PFS (13 sub-studies), the overall HR was 0.65 (CI 0.58-0.73; random effect model). Both continuation maintenance (6 RCTs, HR 0.87, CI 0.76-0.99) and switch maintenance (3 RCTs, HR 0.85, CI 0.75-0.98) significantly improved OS. Targeted therapies also significantly increased OS (5 RCTs, HR 0.85, CI 0.77-0.93). Anaemia, thrombocytopenia and neutropenia were significantly more frequent after maintenance chemotherapy, and skin rashes and diarrhoea after biotherapies. Conclusions: Maintenance therapy with either continuation or switch chemotherapy or EGFR TKIs significantly improved OS and PFS. The benefit-to-risks ratios of these 3 types of maintenance should be compared more precisely thanks to additional RCTs.
EGFR variant III expression in Chinese patients with non-small cell lung cancer.
Authors: Wang Jie , Duan Jianchun , Bai Hua , Yang Lu , An Tongtong , Wang Zhijie , Zhuo Minglei 
Published: March 2020

e18022 Background: Patients with advanced squamous cell lung carcinoma (SCC), even though harboring the EGFR mutation, showed an inferior response to EGFR-TKI. The aim of this retrospective study was to determine the clinicopathologic characteristics and distribution profiles of EGFRv III in Chinese NSCLC patients, and to explore the likely relationship between EGFRv III mRNA levels and the response to EGFR-TKI. Methods: Frozen tissues were retrospectively obtained from 114 NSCLC patients who received surgery resection and 13 advanced NSCLC patients who received EGFR-TKI treatment in Peking Universuty Cancer Hospital. EGFRv III expression was detected by RT-PCR and EGFR mutation was detected by denaturing high-performance liquid chromatography (DHPLC). The association between EGFRv III and clinicopathologic features was investigated by statistical analysis. Results: frequency of EGFRv III in 114 post-surgery NSCLC patients was 7.02% (8/114), including 11.11% (6/54) in SCC and 3.64% (2/55) in adenocarcinomas (ADC). The frequency of EGFRv III expression was higher in SCC than in ADC, but the difference didn’t reach statistical significance (p = 0.269). In the subgroup of 8 EGFRv III-positive patients, 7 (87.5%) were male, 6 patients (75.0%) were smokers or former smokers,. No EGFR mutation was detected. In 13 advanced SCC patients who received treatment with EGFR-TKI, no patient harboring EGFRv III was found, and 3 patients (23.08%) were tested for EGFR mutation. Conclusions: The frequency of EGFRv III in Chinese NSCLC was low and squamous histology, smokers or former- smokers, and male gender might be related to EGFRv III and have effects exclusive of EGFR mutation.
Retrospective analysis of nanoparticle albumin-bound paclitaxel (nabP) administered as a single agent in the treatment of recurrent stage IV (st4) non-small cell lung cancer (NSCLC).
Authors: Saxena Ashish , Christos Paul J. , Cagney Jennifer M. , Scheff Ronald J. 
Published: March 2020

e18029 Background: NabP is a formulation of P designed to reduce toxicity of therapy and increase drug delivery to tumor cells. An established therapy for st4 breast cancer, single-agent nabP has also been shown to produce responses in frontline therapy of st4 NSCLC. Its role in relapsed NSCLC has not been well reported. Methods: We analyzed the records of st4 NSCLC patients (pts) treated with single-agent nabP at our institution. Cases were assessed with regard to age, sex, KPS, histology, line of systemic therapy, prior taxane exposure, # of cycles administered, dose attenuation, and progression-free survival (PFS) estimated by Kaplan-Meier analysis. Standard dosing of nabP was considered to be 260 mg/m2 IV Q 21 days. Disease was considered to have progressed on the date of any clinical assessment (typically CT scan) that led the treating oncologist to conclude that disease had progressed. All pts completed nabP therapy except 1, who was assessed at 427 days of follow up. Results: From Oct 2008 to Jan 2012, 15 st4 NSCLC pts (median age 67, range 48 to 82; 8 F, 7 M; KPS 60-80%; 12 adenocarcinoma, 2 squamous cell, 1 unspecified) received a median of 3 cycles (range 1-17) of single-agent nabP. All pts received at least 1 prior line of systemic therapy in the st4 setting: 6 received nabP as 2nd line therapy, 4 as 3rd line, and 5 as 4th line. 5 pts had also received prior chemotherapy for early stage NSCLC. 9 pts were taxane-naïve; 6 had received prior taxane therapy. 10 pts began nabP at standard dose; 5 began on an attenuated dose or schedule. Subsequent dose reduction occurred in 3 pts due to toxicity (fatigue, myelosuppression). Only 1 patient discontinued treatment due to toxicity (myalgias, arthralgias). Median PFS for all pts was 82 days (95% CI 35 to 205 days). Older age reduced risk of progression [hazard ratio 0.93 per 1-year age increase (95% CI 0.86 to 0.99), P=0.04]. Prior taxane exposure decreased PFS (median 39 vs. 113 days, P=0.07 by log-rank test). PFS did not vary by KPS, histology, or line of therapy. Conclusions: Single-agent nabP administered in relapsed St4 NSCLC is well tolerated and associated with extension of PFS, particularly in older and taxane-naïve pts.
Phase II study of bevacizumab in combination with S-1 plus cisplatin in patients with advanced nonsquamous non-small cell lung cancer.
Authors: Yoshino Reiko , Kaira Kyoichi , Tomizawa Yoshio , Kazama Toshifumi , Yoshii Akihiro , Miura Yousuke , Ishihara Shinichi , Fueki Naoto , Minato Koichi , Sunaga Noriaki 
Published: March 2020

e18037 Background: Cisplatin combined with S-1 is an active regimen for patients with advanced non-small cell lung cancer (NSCLC). Although the addition of bevacizumab to platinum based regimens significantly improved outcome, it remains unknown about the safety and efficacy of first-line cisplatin plus S-1 with bevacizumab. Therefore, we conducted a phase II study to evaluate the efficacy and tolerability of bevacizumab in combination with S-1 plus cisplatin regimen in patients with advanced non-squamous NSCLC. Methods: Patient with ages ranging from 20 to 74 years, non-squamous NSCLC, no prior systemic therapy, no brain metastases and ECOG PS 0-1 were enrolled. Patients received cisplatin 60mg/m2 and bevacizumab 15mg/kg on day 1 of each cycle, and S-1 80mg/m2 orally twice daily for 14 days every 21 days. After 4-6 courses, patients were continued on bevacizumab until progression disease (PD). Primary end point was response rate (RR). Secondary end points included overall survival (OS), PFS, time to treatment failure (TTF), and safety. Results: Twenty-nine patients were enrolled in this study. Median age was 67 years (range: 42 to 74); male/female=17(58%)/12(42%); ECOG PS 0/ 1 = 18 (62%) / 11(38%); stageIIIB/IV=3(10%)/26(90%); adeno / NSCLC = 26 (90%) / 3 (10%). The median courses of the induction therapy was 4 (range: 2 to 6), and that of the maintenance therapy was 3 courses (range: 1 to 15). Response rate (RR) was 65.5%, and disease control rate (DCR) was 100%. Median PFS was 5.39 months (95%CI, 125-265 days). Hematological adverse events reaching grade 3 or 4 were leukocytopenia (6.8%), neutropenia (20.9%), anemia (3.4%), thrombocytopenia (6.9%), and febrile neutropenia (3.4%). Nonhematological toxicities of grade3/4 were hypertension (17.2%), appetite loss (3.4%), mucositis oral (3.4%), alkaline phosphatase elvation (3.4%), serum amylase elevation (3.4%), and hyponatremia (3.4%). Seven patients delayed the start of next course because of adverse events. Conclusions: Bevacizumab in combination with S-1 plus cisplatin was effective in disease control and well-tolerated regimen for the treatment of patients with advanced non-squamous NSCLC.