bluuebunny/crossref_metadata_2025_split huggingface dataset:
Lung cancer in never-smokers: A single institutional experience
Authors: Subramanian J. , Gao F. , Sainani N. , Viswanathan A. K. , Pillot G. A. , Baggstrom M. Q. , Sorscher S. , Govindan R. 
Published: March 2020

17044 Background: Approximately 10% of patients (pts) with lung cancer do not have a history of tobacco smoking. The clinical presentation and outcomes of pts with LCINS have not been well characterized in the Western population. Methods: We reviewed our institutional tumor registry to identify patients with lung cancer from 1992 to 2002. Data regarding tobacco smoking, stage, histology and survival were collected. Results: Of the 5417 consecutive pts diagnosed with lung cancer, 254 were determined to be never-smokers with confirmed pathologic diagnosis of non-small cell lung cancer (NSCLC). The table below describes the patient demographics. The five-year survival for the entire population with LCINS was 22.56%, with 37 pts surviving beyond five years. The median overall survival for women was 21.08 months (95% CI 14.03–23.37) and for men 13.5 months (95% CI 8.5–32.492); p = 0.73. Among the different histologic subtypes, broncho-alveolar carcinoma was associated with better median overall survival of 61.67 months (p < 0.0001). The median overall survival by TNM stage: I (71 months), II (32 months), III (15 months), and IV (6 months). Conclusions: 1. LCINS affects predominantly women. 2. Adenocarcinoma is the most common histological type. 3. Brain and bone are the most common sites of metastases. [Table: see text] No significant financial relationships to disclose.
Multimodality treatment of non small cells lung cancer (NSCLC) brain metastases: Long term outcome
Authors: Cassano A. , Pompucci A. , D’Argento E. , Schinzari G. , Di Chirico A. , De Bonis P. , Quirino M. , Basso M. , Anile C. , Barone C. 
Published: March 2020

17046 Background: Lung cancer is the most common cause of cancer deaths and has the highest incidence for brain metastases of all malignancies. The prognosis of these patients (pts) remain poor with a median survival of 4–5 months. Whole brain radiation therapy (WBRT) in inoperable brain metastases prolongs survival to 3–5 months. In pts with 1 or ≤ 3 brain metastases neurosurgical resection improves median survival to 3.5–8 months. The aim of this study was to evaluate the long-term outcome of patients with brain metastases from NSCLC treated with multimodal strategy, including systemic chemotherapy, neurosurgery and radiotherapy. Methods: From 1997 to 2005, 56 pts were considered. Inclusion criteria were: single or multiple NSCLC brain metastases suitable of surgery; Karnofsky performance status ≥ 70%; controlled extracranial disease with Cisplatin-based chemotherapy; life expectancy > 4 months. Surgery was followed by 40 Gy WBRT. Statistical analysis was performed using the Kaplan-Meier method and Cox-regression analysis. Results: The median age was 58.4 years. The histological types were adenocarcinoma in 35 pts (62.5%), squamous cell carcinoma in 11 pts (19.7%) and large cell carcinoma in 10 pts (17.8%). The lesions were single in 39/56 pts (69.6%) and multiple in the other pts (30.4%). Radical surgery was performed in 37 pts (66%), while surgical citoreduction was possible in 19 pts (34%). The median follow-up period was 22.12 months (range 2–90 months). Overall survival (OS) of the whole group was 12.8 months; OS of pts radically resected was 16.5 months while OS of pts partially resected was 7.2 months. Based on Cox-regression analysis, age < 65 years and radical resection were independent predictors of survival (respectively p = 0.004–95% CI 1.46–7.6 and p = 0.04–95% CI 1.03–4.97), while the number of lesions was not relevant in terms of OS. Conclusions: Analysis of long-term outcome seems to confirm that the combined treatment of NSCLC brain metastases is a primary therapeutic option. In our series of 56 patients, radical surgery, not the number of metastases, was related with prolonged survival. Further randomized studies comparing surgery+WBRT vs gamma-knife-radiosurgery could define the best therapeutic option in the different subsets of pts. No significant financial relationships to disclose.
Effects of presurgical exercise training on exercise capacity in operable lung cancer: A pilot study
Authors: Peddle C. J. , Eves N. D. , Courneya K. S. , Haykowsky M. , Mackey J. R. , Joy A. A. , Reiman T. J. , Winton T. W. , Jones L. W. 
Published: March 2020

17047 Background: Exercise capacity is a strong independent predictor of surgical outcome in patients with operable NSCLC and thus an established clinical tool to assess preoperative eligibility. The purpose of this study was to determine the effects of preoperative exercise training on exercise capacity in operable lung cancer. Methods: Using a single-group design, participants with suspected operable lung cancer were screened for eligibility at the time of diagnosis. Twenty-six patients were recruited and offered exercise training until surgical resection. Exercise training consisted of 5 endurance cycle ergometry sessions per week at 60 to 100% of patient’s baseline exercise capacity. Patients underwent cardiopulmonary exercise testing (CPET) including peak oxygen consumption (VO2peak), six minute walk distance (6MWD), and a pulmonary function test at baseline, immediately prior and 30 days post surgical resection. Results: The mean time from diagnosis to resection was 67 ± 27 days. During this time, 6 patients were deemed ineligible and were removed from the analysis. Of the remaining 20 patients, 18 completed exercise training and 13 performed CPET post resection. The overall adherence rate was 72% (range 0%–100%) with patients completing a mean of 30 exercise sessions (range 0–75). Intention-to-treat analysis indicated that VO2peak and 6MWD increased by 2.3 mL · kg−1 · min−1 [95% CI, 1.0 to 3.7; p = .002] and 40m [95% CI, 16 to 64; p=.003] respectively, from baseline to presurgery but decreased from pre to post resection [VO2peak, −2.7 mL · kg−1 · min−1, 95% CI, −3.9 to −1.6; p < .001; 6 MWD, −44 m, 95% CI, −94 to 6.4; p = .082]. There were no differences between baseline and postsurgical exercise capacity. Per protocol analyses indicated that patients who achieved acceptable exercise adherence (≥80% of prescribed sessions, n = 12) increased VO2peak and 6MWD by 3.2 mL · kg−1 · min−1 [95% CI, 1.1 to 5.4; p = .005] and 49 meters [95% CI, 12 to 85; p = .013], respectively. Conclusion: Preoperative exercise training is associated with improvements in exercise capacity in patients with operable NSCLC, particularly if acceptable adherence is achieved. This benefit may have important implications for surgical outcome and postsurgical recovery in this population. No significant financial relationships to disclose.
Clinical outcomes of a multi-institutional retrospective study for 419 patients with locally advanced non-small cell lung cancer (NSCLC)
Authors: Ichikawa M. , Mio T. , Teramukai S. , Nakagawa M. , Nagata Y. , Fujita S. , Yanagihara K. , Ishiguro H. , Hiraoka M. , Mishima M. 
Published: March 2020

17058 Background: Chemo-Radiotherapy (CRT) is considered the standard of care in locally advanced NSCLC. However, regimen of chemotherapy (CT), schedule of radiotherapy (RT), and application for surgical interventions (OP) are still controversial. We performed a study to establish clinical outcomes of NSCLC patients treated with CRT in Japan. Methods: A total of 373 consecutive patients (CRT: 307, OP after CRT (OP/CRT): 66) with stage III NSCLC, PS 0–2, no indications of OP at the initial evaluation, treated with CRT between January 1997 and December 2002 were analyzed. We also investigated 46 patients treated with RT alone as control. Results: We investigated a total of 419 patients (354 men and 65 women; average age: 64.5 ± 9.5 years) from nine institutes. Distributions of pathological subtypes were: squamous cell carcinoma: 225; adenocarcinoma: 154; large cell carcinoma: 14; non-small cell carcinoma: 26. In 189 stage IIIA patients, median survival time (MST) was 21.2 M, and MST of CRT, OP/CRT and RT were 19.1 M, 61.7 M, and 18.0 M, respectively. Multivariate analysis with Cox proportional hazards model indicates age, PS, existence of double cancer, existence of diabetes mellitus, stage IIIB, white blood cell counts increase, hemoglobin decrease as significant prognostic factors in CRT or OP/CRT patients. Multivariate analysis in stage IIIA patients indicated BMI decrease, double cancer, body weight loss, white blood cell increase, hemoglobin decrease as prognostic factors. There was a statistically significant difference between overall survival of CRT and OP/CRT in stage IIIA patients (p = 0.038 after adjustment for the effect of prognostic factors). However, there were no differences between CRT and RT, and among any schedules of CRT therapy. Conclusions: This clinical study suggests that OP after CRT could results in good survival compared with CRT alone, and BMI, double cancer, body weight loss, white blood cell, and hemoglobin could be prognostic factors in locally advanced NSCLC. No significant financial relationships to disclose.
Phase I trial of TS-1 plus carboplatin in patients with advanced non-small cell lung cancer: A Central Japan Lung Study Group Trial-CJLSG0402
Authors: Saka H. , Kitagawa C. , Ichikawa M. , Yamada Y. , Saito H. , Taniguchi H. , Yamamoto M. , Shimokata K. 
Published: March 2020

17065 Background: TS-1, a novel oral antimetabolite, is active against advanced non-small cell lung cancer (NSCLC). A response rate of 21.3% was reported in a monotherapy trial. In combination with cisplatin, TS-1 demonstrated a response rate of 47.3% in NSCLC. To develop a clinically relevant combination, we investigated TS-1 plus carboplatin in patients (pts) with advanced NSCLC. This is a report of the phase I section of a phase I/ II trial. In the phase I section, primary endpoints were to determine the maximum tolerated dose (MTD), the recommended dose for the phase II section, and to evaluate the toxic profile. Methods: Pts were enrolled who were chemo-naïve, in stages IIIB and IV, with ages between 20 and 74, PS (ECOG) of 0 or 1, and with adequate bone marrow and major organ functions. Post-surgical relapses and asymptomatic brain metastases were accepted. Pts received a fixed dose of carboplatin (6 mg/mL min) via IV infusion on day 1, once every 3 weeks. TS-1 was given at the initial dose of 60 mg/m2 (level 1) with dose escalation in 10 mg/m2 increments from day 1 to day 14, repeated every 3 weeks. Severe toxicities occurring in cycle 1 were considered dose-limiting toxicities (DLTs). Results: Sixteen pts were enrolled in 3 cohorts receiving 60 (n = 3), 70 (n = 7), and 80 (n = 6) mg/m2. Median age was 65 years (range, 37 to 74 years) and median performance status was 1. Ten pts had stage IV, and 4 pts had stage IIIB disease. Two pts had post-surgical relapses. Adenocarcinoma (n = 11) was the dominant histology. DLT was observed in 1 pt in level 1, 2 pts in level 2 (TS-1, 70 mg/m2), and 3 pts in level 3 (TS-1, 80 mg/m2). DLTs were grade-4 thrombocytopenia (n = 3), grade-4 neutropenia (n = 1), grade-3 liver dysfunction (n = 1), and grade-3 anorexia (n = 1). Conclusions: The MTD was level 3 (TS-1 80 mg/m2, carboplatin 6 mg/mL min). According to the total delivered doses, the recommended dose for phase II study was determined to level 2 (TS-1 70 mg/m2, carboplatin 6 mg/mL min). The phase II study is currently underway. [Table: see text] No significant financial relationships to disclose.
A phase II study for selection of clinical and molecular predictors for survival in patients (pts) with advanced NSCLC treated with erlotinib
Authors: Rohr U. P. , Rohrbeck A. , Schwalen A. , Kliszewski S. , Haas R. , Kronenwett R. , Kappes R. , Von Haeseler A. , Rosskopf M. , Meckenstock G. 
Published: March 2020

17066 Background: The primary objective of the ongoing phase II study was to find clinical and molecular predictors for survival. Consequently, we prospectively examined gene and protein expression and EGFR mutation profiles of tumor cells, and clinical variables. Methods: Pts with advanced NSCLC (stage IIIb/IV) previously treated with platinum-based chemotherapy received 150mg/day erlotinib (Tarceva an EGFR tyrosine-kinase inhibitor) orally until disease progression. For molecular analyses, biopsies were taken from the primary lung tumor prior to erlotinib treatment. Pure tumor cells were isolated using laser-capture microdissection. For expression analysis, a microarray of 8793 genes (Human Focus Array, Affymetrix) was used. Data were analyzed using VSN method and significance analysis of microarrays. Results: In an interim analysis, clinical data were available for 36 of 43 so far included pts in the ongoing phase II study. For 36 pts, the tumor responses were: 1 CR (3%), 4 PR (11%), 11 SD (30%) and 19 PD (53%), and the median survival was 20 wks. Overall survival was significantly better in pts with rash than without rash: 9.2 vs 4.3 months. In a 14 months follow up, all of the responding pts survived while the median survival for pts with SD or PD was 11.4 and 4.0 months, respectively. Comparing gene expression profiles of tumors from 6 pts with a response or SD with those from 13 pts with tumor progression, we could not identify genes that were differentially expressed with sufficient significance. In 20 tumor samples evaluated for EGFR protein expression and mutation analysis, 19 expressed EGFR (IHC). A base exchange in exon 18 (2166G>A; A722A) and 20 (2547A>G; Q787Q) of the EGFR already described as a single nucleotide polymorphism was seen in 4 samples performing SSCP gel electrophoresis and sequencing. Conclusions: Rash, a side effect with erlotinib, was significantly associated with better survival. No activating EGFR mutations were found indicating that the response in 14% of pts is independent of mutations. For identification of genes predictive for response to erlotinib, a larger sample number is necessary. No significant financial relationships to disclose.
The benefits of a restaging PET scan after two cycles of neoadjuvant chemotherapy for resectable non-small cell lung cancer
Authors: Tanvetyanon T. , Eikman E. , Robinson L. , Sommers E. , Cantor A. , Bepler G. 
Published: March 2020

17092 Background: Neoadjuvant chemotherapy can potentially improve the outlook of resectable non-small cell lung cancer (NSCLC). Whole-body 2-deoxy-2-[18F] fluoro-D-glucose (FDG)-PET is often used as an initial test to determine tumor resectability, but its role as a restaging test after neoadjuvant chemotherapy is unclear. Restaging PET after neoadjuvant chemoradiation helps identify unexpected distant metastasis and avoid unnecessary thoracotomy. We explored its benefits after neoadjuvant chemotherapy. Methods: Patients with stage IB-IIIA and selected IIIB resectable NSCLC received induction gemcitabine (1,000 mg/m2) and vinorelbine (25 mg/m2) on days 1, 8, 22, and 29. PET and CT scan were performed before enrollment and between day 43–50. Response from CT scan was defined by RECIST criteria; from PET, defined as >20% reduction in the SUVmax (a decrease of > 2 SD of spontaneous change in FDG uptake, previously validated). This abstract explores patients participated in a published prospective trial with available both pre- and post-treatment PET scans. Results: There were 19 patients: stage IB-7, stage IIB-2, and stage III-10. Median age was 67 years. Mean interval between staging and restaging PET scan was 59 days. By PET, 10 patients responded. By RECIST criteria, complete response occurred in 0, partial response in 6, and stable disease in 13 patients. Most successfully underwent a complete resection, but positive margins were present in 3; multi-station lymph node involvement was found intraoperatively in 1 patient. Overall median survival was 20.5 months. We found that restaging PET did not help identify any distant metastasis. Moreover, no survival difference was observed between PET responders and non-responders, though PET responders had more advanced stage than their counterparts: median survival 16 months vs. not reached (p = 0.08 adjusted for stage). PET response was correlated with RECIST response (p = 0.05) as well as the response as obtained by SUV max divided by the activity of contralateral lung or aorta ratio. Conclusion: Based on this small group of patients, a restaging PET scan obtained after two cycles of neoadjuvant chemotherapy among patients with resectable NSCLC did not appear to impact the decision on a planned thoracotomy. No significant financial relationships to disclose.
Predisposing factors of blood brain barrier penetration from docetaxel during lung cancer treatment: Preliminary study
Authors: Zarogoulidis K. , Chatzopoulou A. , Kontakiotis T. , Theodoridis G. , Pousinis P. , Patakas D. 
Published: March 2020

17102 Background: Patients with lung cancer account for approximately 50% of brain metastasis cases. On the other hand the majority of active cytotoxic agents (like taxanes) in lung cancer treatment, are unable to penetrate blood brain barrier (BBB) so the role of chemotherapy in management of brain metastasis from lung cancer remain controversial. To investigate predisposing factors (if any) of penetration of BBB from cytotoxic agents we measured concentation levels of Docetaxel in serum and cerebrospinal fluid (CSF) during first line chemotherapy. Methods: Twelve lung cancer patients receiving chemotherapy consisted of Docetaxel (100 mg/m2) and Carboplatin AUC 6 were included in this study. CSF and plasma samples were withdrawn half an hour after termination of chemotherapy infusion. Measurements were performed with high performance liquid chromatography and UV detection was at 227 nm. Results: Mean levels of docetaxel in blood was 2,5530 ± 0,53 mg/l and in CSF 0,7397 ± 0,22 mg/l. Three out of twelve patient had SCLC (2 with ED and 1 with LD) and 9 with NSCLC (2 stage IIIB and 7 stage IV). In three patients without metastasis no detectible level of docetaxel was measured. We were also unable to detect Docetaxel in CSF of the patient with NSCLC and metastasis in the ipsilateral lung. On the other hand in 9 patients with metastatic disease (4 brain metastasis 2 with bone metastasis 1 with metastasis in liver and adrenal and 2 with liver and bone metastasis) had detectable levels of docetaxel in CSF. There was not statistically significant correlation of docetaxel in plasma and CSF. Only one patient without any evidence of metastasis had a detectable level of Docetaxel in CSF (0,33229) but in 6 weeks a brain metastasis was apparent in brain MRI. Conclusions: Metastasis development seems to be associated with a modification of BBB penetration. If Docetaxel penetrates BBB (especially in the presence of brain metastasis) it would be probable to accelerate radiotherapy sensitivity of brain metastasis. No significant financial relationships to disclose.
Hb-level stabilisation with epoetin alfa in patients with advanced NSCLC undergoing concurrent neoadjuvant chemo-radiation therapy (phase III study)
Authors: Wagner W. , Granetzny A. , Hilejan L. , Marra A. , Koch O. M. , Krukemeyer M. G. , Wiedemann G. J. 
Published: March 2020

17110 Background: Patients suffering from advanced stage IIIA/B NSCLC still have a bad prognosis despite the development of new and more effective treatment methods. Improved therapy options include multi-modal treatment approaches with sequential and/or concurrent chemo-radiation therapy and, alternatively, subsequent surgery. The patients have to accept a higher incidence of side effects and longer therapy cycles, which can last up to six months. This means that most patients spend a considerable part of their survival time undergoing therapy, where, in the short or medium term, they are likely to die of a relapse or haematogenous metastatic spread. Therefore we have decided to offer patients with unfavourable prognostic factors (poor general health, high age, comorbidity) a shortened, three-week neoadjuvant and concomitant chemo-radiation therapy plus possible surgery. This form of treatment is expected to produce more positive outcomes than the purely palliative radiation therapy at 40–50 Gy. Preventive dosing with Epoetin alfa as part of an intensive therapy regimen might lead to higher compliance, increased quality of life and possibly even to a better prognosis as a result of stabilising patients’ Hb levels. Methods: 51 stage IIIA/B NSCLC patients received neoadjuvant concurrent chemo-radiation therapy (daily cisplatin (6 mg/m2), 45 Gy hyperfractionated accelerated radiotherapy). 25 patients received additional treatment with Epoetin alfa 3 times a week (10,000 IU sc). Results: While Hb levels dropped significantly (−0.54 g/dL) during therapy in the control group, the Epoetin-alfa group showed a significant rise after only three weeks (+1,35 g/dL). There were no significant differences in remission rates between the goups. Conclusions: In this patient group, preventive treatment with Epoetin alfa stabilises Hb levels at a target level of around 12 g/dL even under intensive therapy. To what extent treatment with erythropoietin affects prognosis should be examined in further studies. No significant financial relationships to disclose.
Tolerability of a weekly schedule of docetaxel-cisplatin as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer (NSCLC)
Authors: Binder D. , Hackenthal M. , Graseck L. , Schweisfurth H. , Schäper C. , Temmesfeld-Wollbrück B. , Suttorp N. , Beinert T. , Hellriegel K. 
Published: March 2020

17112 Background: Recent trials have shown that the combination docetaxel-cisplatin is an effective first-line treatment in locally advanced or metastatic NSCLC. However, the regimen can be associated with a marked rate of neutropenia. The present study tests the efficacy and tolerability of a weekly schedule of docetaxel and cisplatin. Methods: Patients (pts) with histologically confirmed NSCLC stages UICC IIIB (malignant effusion) or IV were treated with docetaxel (35 mg/m2, 30 min. infusion) and cisplatin (25 mg/m2, 30 min. infusion) on days 1, 8 and 15 repeated every 4 weeks for 4 to 6 cycles. This phase II study is scheduled to include 50 pts and primary endpoint is tumour response rate. Pts received 8 mg of ondansetron and 8 mg of dexamethasone i.v. preceding every day of therapy and oral dexamethasone 2 × 4 mg from the day before until the day after chemotherapy. NK1-antagonists were given at discretion of the investigator. In total, 2750 ml of volume were infused on each day of therapy. Most of the pts were treated in an outpatient department. Safety was assessed via common terminology criteria for adverse events v3.0 (CTCAE 3.0). Interim tolerability data is presented. Results: Currently, 28 pts were evaluable for this interim tolerability analysis. Pts received a median of 3 full cycles. There were no treatment-related deaths. Dose reductions of docetaxel and cisplatin due to poor tolerability were necessary in 3 pts (11%). No pts suffered from neutropenic fever while grade 3 neutropenia occurred in only 2 pts (7%). There was no grade 2/3/4 thrombocytopenia. 5 pts (18%) had grade 2 anemia, and 2 pts (7%) had an elevation of the plasma creatinine (both grade 1). Other toxicities were non-neutropenic infections (5/1/1 pts with grade 2, 3, 4, respectively), diarrhea (3 pts [11%] with grade 3), constipation (5 pts [18%] with grade 2) and mucositis (4 pts [14%] with grade 2/3). There was no grade 3/4 nausea or vomiting; 3 pts [11%] had grade 2 nausea/vomiting. Conclusions: In the present study, the combination of docetaxel and cisplatin appears well tolerated. It was associated with a very low frequency of severe hematologic toxicity or neutropenic fever. With relatively low hydration volumes it can be safely administered in an outpatient setting. [Table: see text]