bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and pattern failures of early SBRT to primary tumor in advanced EGFR mutation lung cancer (Target-SBRT): A single-arm phase 2 study.
Authors: Lv Dongqing , Xu Hailing , Ding Jiapei , Lin Ling , Zhou Chao , Wu Xiaomai , Meng Yinnan , Wang Wei , Kong Feng-Ming Spring , Yang Haihua 
Published: June 2021

e21130 Background: It is evitable for advanced NSCLC harboring EGFR mutation with 1st TKI to develop resistance with 9-13 months of PFS and 19-27 months of OS. Initial progression of TKI treatment in NSCLC was 47.2% from the primary sites, 20.4% from the new sites and 32.6% from the primary and new sites. We hypothesized that early stereotactic body radiation therapy (SBRT) to primary tumor in advanced EGFR mutation NSCLC combined with EFGR-TKI treatment could prolong targeted resistance and explored its pattern failures. Methods: Eligible patients pathologically confirmed advanced NSCLC with Exon19 deletion or Exon21 L858R mutation were enrolled (ChiCTR-OIN-17013920). Each patient received EGFR TKI (Icotinib 125mg tid or gefitinib 250mg qd) and early SBRT (40-60 Gy/5-8F/5-10d) for primary tumor about 1 months from the beginning of EGFR TKI until disease progressed. Initial progression in sites of original disease (primary/metastatic) was defined as original site failure (OF) and appearance of new lesions as distant site failure (DF). Simultaneous OF/DF was labeled as ODF. The primary endpoint was PFS and the second endpoints were pattern failures, OS as well as adverse effects (AEs). Study was designed to enroll 50 patients to detect 6 months’ extension of PFS. Results: The study was closed after 41 patients enrolled due to the use of more effective 3rd EGFR-TKI.There were 37 PR and 4 SD after one month of TKI treatment and the average tumor shrinkage rate was 42.5%. The average interval from TKI to SBRT was 1.43 months (0.87-2.77 months). Median PFS and OS were 15.2 months (95% CI 13.1-17.4) and 27.6 months (95% CI 23.1-32.1), respectively. Of 37 patients who progressed, 6 (16.2%) had OF, 21 (56.8%) had DF, and 10 (27.0%) had ODF. The lung was the most common site of initial progression. As for toxicity, there was no ≥Grade 3 AEs and Grade 1-2 radiation Pneumonitis was the most frequent AEs. Conclusions: Early SBRT for primary tumor generated prolonged PFS without serious radiation pneumonitis in advanced EGFR mutation NSCLC patients with TKI treatment. This combined therapy obtained remarkably lower primary tumor progression rate and favorable OS. Clinical trial information: ChiCTR-OIN-17013920.
Effects of a mucosal coating spray in non-small cell lung cancer patients with nasal mucositis.
Authors: Wang Fang , Liu Hui , Zeng Zhen , Wang Shasha , Qin Haifeng 
Published: June 2021

e21160 Background: Targeted therapy opens a new era in the treatment of non-small cell lung cancer (NSCLC). At the same time, it also faces a serious problem, that is, the adverse events brought by new drugs, which not only affect the quality of patients’ life, but may even endanger their lives. Nasal mucositis (NM) may cause significant discomfort for the patients, and even result in the interruption of treatment. Episil (mucosal coating spray) oral liquid is a preservative-free oral liquid gel that can be used for the management of pain associated with oral lesions of various etiologies. Our study prospectively assessed effects of mucosal coating spray oral liquid in NSCLC patients with NM. There is no similar studies at home and abroad. Methods: Our study enrolled 15 patients who experience nasal mucositis after targeted therapy (Table). We designed a specific questionnaire according to Oral Mucositis Daily QuestionnaireOMDQ), Oral Mucositis Assessment Scale (OMAS), and the Patient-Reported Oral Mucositis Symptom (PROMS) to evaluate the change of life quality in NSCLC patients. All the patients needed to complete the questionnaire included in the statistical analysis. Evaluations were made before and after 5 treatment days. Results: All the patients were evaluated. Among patients, 87% suffered from NM grade 2 and 33% were with bleeding at study start, quality of life scores improved significantly after 5 treatment days with mucosal coating spray. Only 1 patient’s pain score reduced not that well because of nonstandard medication. No drug-related adverse reactions were found. Conclusions: Mucosal coating spray can effectively improve the nasal mucositis caused by targeted therapy in NSCLC patients. It may provide a new and effective therapy strategy for them, but large sample and additional clinical trials are also needed, especially for bevacizumab as one agent of combination protocol.
Effect of excess weight on immune-related adverse events from immune checkpoint inhibitor in lung cancer.
Authors: Osataphan Soravis , Jan Yu Jen , Stafford Katherine A. , Lam Prudence B. 
Published: June 2021

e21183 Background: Immune checkpoint inhibitors (ICIs) are effective therapies for advanced lung cancer however they are also associated with immune-related adverse events (irAEs). Obesity has been shown to be correlated with both ICIs’ anti-tumor efficacy particularly in melanoma and non-small cell lung cancer (NSCLC). However, there have been conflicting reports between the relationship between BMI and the incidence of irAEs. Methods: We conducted a retrospective cohort study on the use of immune checkpoint inhibitor in advance lung cancer from Mount Auburn Hospital, a community-based teaching hospital in the United States, between 2016 to 2020. We studied the association between overweight (BMI of more than 25 kg/m2) versus normal weight patients (BMI 18.5 - 24.99 kg/m2) and incidence of irAEs or progression free survival. Results: A total of 51 patients with advanced lung cancer were treated with either Pembrolizumab, Nivolumab, Durvalumab or Atezolizumab. NSCLC accounted for 90.2% of the histological findings and adenocarcinoma represented 45.0% of the cohort. Among these patients 61.0% were classified as. There was a trend to increase in the incidence of irAEs in overweight compared to normal weight patients (48.3% vs. 25.0%, OR 1.91, 95% CI 0.56-6.99, p = 0.308). The most common irAEs in this cohort was thyroid dysfunction. The overweight group also had a higher baseline blood glucose level (120.5 ± 39.9 mg/dL vs. 92.9 ± 13.8 mg/dL, p < 0.01). However, no difference in progression free survival was found between the two groups (HR 1.19, 95%CI 0.58-2.42, p = 0.6). Conclusions: Although limited by sample size, here we reported a real-world experience where excessive weight may be an important predictor of irAEs development in patients with lung cancer.
Pulmonary sarcomatoid carcinoma: Retrospective analysis from a single center.
Authors: Kumar Suresh Kumar , Nandhana Ravindra , Dhanawat Aditya , Noronha Vanita , Patil Vijay Maruti , Menon Nandini , Kumar Rajiv , Joshi Amit , Tibdewal Anil , Jiwnani Sabita S. , Choughule Anuradha , Mahajan Abhishek , Janu Amit , Banavali Shripad Dinanath , Prabhash Kumar 
Published: June 2021

e21188 Background: Pulmonary sarcomatoid carcinoma (PSC) constitutes a heterogeneous group of poorly differentiated non-small cell lung cancer (NSCLC). Since these are rare tumors, no definitive randomized trials or clinical guidelines are available for management. This is the largest single centre study of patients with pulmonary sarcomatoid carcinoma. Methods: We retrospectively evaluated all patients with pulmonary sarcomatoid carcinoma between January 2013 to September 2020 at the Tata Memorial Hospital, Mumbai, India. Cases were identified from the pathology database. Baseline demographic, treatment data and outcomes were obtained from a prospectively maintained database in the Department of Medical Oncology. Results: A total of 151 patients with PSC were diagnosed during this period. Among these, 129 patients were included for survival analysis. The median age at diagnosis was 61 years (range, 18-87) with a majority of them being males (81.5%) and smokers (73%). A significant percentage of patients presented with poor performance status (PS was 2-4 in 48%). A majority of patients had T4 (73%) or N3 nodal status (44%). The clinical stage was stage I in 2%, stage II in 2.7%, stage III in 25.9%, and stage IV in 69.4%. The initial treatment modalities include surgery (10.9%), radical chemoradiotherapy (CRT, 3.9%), palliative chemotherapy (46.5%), palliative radiotherapy (7%), and best supportive care (31.8%). The median follow-up duration for the entire cohort was 32 months (95% CI 15.0 to 48.9). The median OS for the entire patient cohort was 5 months (95% CI 3.4 to 6.5). The median OS of patients who received curative surgery was 18 months (95% CI: 2.59 to 33.4) and the corresponding 1- and 5-year survival rates for patients who underwent surgery were 64% and 33% respectively. The median OS for patients who received CRT was 11 months (95% CI: 2.99 to 19). The median OS for the patients who received palliative radiotherapy alone was 4 months (95% CI: 1.91 to 6.08), for palliative chemotherapy was 8 months (95% CI: 5.24 to 10.75) and for patients who received only best supportive care was 1 month (95% CI: 0.43 to 1.57, p = 0.001). The median PFS and ORR for first, second- and third-line palliative chemotherapies were 4 months (95% CI: 2.95 to 5.04) and 15.1%, 4 months (95% CI: 0.33 to 7.67) and 13.3%, and 1 month (95% CI 0.21 to 1.78) and 0%. In a multivariate analysis, independent prognostic factors included the presence of brain metastasis (p 0.018, HR, 2.47, 95% CI 1.34-4.49) and administration of palliative chemotherapy (p = 0.037, HR2.2, 95% CI 1.04-4.94). Conclusions: PSC usually presents in advanced stages and carries a poor prognosis. Effective therapeutic options are required to improve the outcomes.
Survival outcomes with the use of immunotherapy (IO) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) at a large hybrid cancer institute.
Authors: Young Joanna Alyse , Clarkson Christina , He Jiaxian , Slaughter Daniel , Haggstrom Daniel Ernest , Carrizosa Daniel R. , Mileham Kathryn Finch 
Published: June 2021

e21192 Background: Landmark trials have shown increased survival in pts who receive IO for NSCLC as compared to chemotherapy (chemo). Median overall survival (mOS) ranged from 17-26 months (mo); however, mOS in several published “real-world” retrospective studies are lower, ranging from 8-12 mo, with about 4-5 months on IO treatment. We sought to define mOS of pts with mNSCLC who received IO as monotherapy or in combination with chemo as first line therapy at Levine Cancer Institute. Methods: We retrospectively reviewed 315 adult pts with mNSCLC without driver mutations diagnosed between 2016 and 2019. The Kaplan-Meier method was used to estimate and compare OS between IO and IO + chemo. Univariate and multivariate Cox models were used to evaluate risk factors (RF) for OS. RFs considered included age, sex, race, smoking status, histology, first-line treatment type, and metastatic (mets) sites. Results: Baseline pt characteristics were: 40% female, 77% white, 20% Black, 34% current smokers and 60% former smokers. Median age was 69 years (45-88) in pts receiving IO alone and 63 years (28-84) in pts receiving IO + chemo. Tumor characteristics were: 76% adenocarcinoma and 17% squamous cell carcinoma. PD-L1 TPS distribution was: 39% for 0%, 22% for 1-49%, and 39% for ≥50%. Distribution of mets was 10% adrenal, 40% bone, 30% brain, 14% liver, 31% lung. mOS for pts receiving IO and IO + chemo as first line therapy was 17 and 14.8 mos, respectively (P = .209). Median duration of IO received was 4.25 months (0 to 43.6). mOS as stratified by PD-L1 TPS was 14.5 mos for PD-L1 0%, 13.3 mos for PD-L1 1-49%, and 19.5 mos for PD-L1 ≥50% (P = .163). OS was significantly different between IO and IO + chemo after adjusting for age. No OS differences were seen between white and Black or between all pts vs pts with brain mets (brain-specific interventions not reviewed). The table summarizes significant findings only (P < 0.05). Conclusions: Pts with mNSCLC treated first-line with IO either alone or with chemo at Levine Cancer Institute lived longer than those in similar published “real-world” cohorts. Median OS was highest in patients with PD-L1 TPS ≥50%, although not statistically significant. While not unusual to identify worse outcomes in those with bone and liver mets, interestingly brain metastasis was not associated with worse survival. In this cohort, when adjusted for age, IO alone trends toward improved survival. Although there was no OS difference based on race, further investigation will seek to uncover any other disparities contributing to outcomes, such as insurance status and zip code mapping. To our knowledge, this provides the largest analysis of this patient population outside of a clinical trial.[Table: see text]
Treatment pattern post-osimertinib failure in EGFR mutated NSCLC in India-CRSF202002 study.
Authors: Gupta Kushal , Raut Nirmal Vivek , Goyal Gautam , Talele Avinash , Karpe Ashay , Poladia Bhavesh Pradip , Goel Alok , Kannan Ram Abhinav , Talreja Vikas , Prasad Manu , Basu Trinanjan , Singh Ashish , Kothari Rushab , Chandrasekharan Arun , Rajamanickam K. Deepan , Ramaswamy Anant , Ghosh Joydeep , Doshi Vipul , Bhosale Bharatsinha Baburao 
Published: June 2021

e21201 Background: Osimertinib is one of the favoured treatment options in EGFR mutated NSCLC and was established as a treatment option in last 2-3 years. However the treatment pattern post-osimertinib failure is not established. Hence we conducted this audit to study the pattern of treatment post-osimertinib failure in India. Methods: This was a retrospective multi-centric audit of adult (age ≥18 years) EGFR mutated NSCLC patients who were treated with osimertinib and had failed. The treatment pattern of these patients was noted. Descriptive statistics were performed. Median with range was estimated for continuous variables while the percentage with 95% CI were estimated for ordinal and nominal variables. Results: We had 25 patients who had failed on osimertinib. Oligo-progression versus widespread progression was seen in 5 (20%) and 20 (80%) patients respectively. The median age was years 56.5 year (Range-26-71) with 4/25 (16%) of patients were elderly (≥65 years). Male-to-female ratio was 18:7 (72% males, 28% females).The ECOG PS at failure were 0-1 in 12 patients (48%), 2 in 11 patients(44%) and 3-4 in 2 patients (8%) patients. The treatment offered were platinum doublet in 14 patients (56%) with variable combinations with TKIs in 5 patients (20%) and bevacizumab in 4 patients(16%). A repeat NGS for assessing the mechanism of resistance was done in patients revealed new mutations in 6 patients (24%) with EGFR Exon 20 T790M being most common in 3 patients (12%). Conclusions: We conclude that, in real-world practice, platinum-doublet formed the backbone of treatment post-osimertinib progression, with variable combinations, most commonly, along with TKIs or bevacizumab. No standard guidelines for the treatment of patients post-osimertinib progression are available with variable responses and tolerability. Larger and prospective studies are needed to identify the best options of therapies in such patients.
Associated factors for poor response in advanced EGFR-mutated NSCLC patients under tirosine kinasa inhibitors: Peruvian real-world data.
Authors: Motta Guerrero Rodrigo , Aliaga Carlos , Runciman Gozzer Thanya Katherine , Carracedo Carlos F. , Failoc Virgilio , Leon Alejandro 
Published: June 2021

e21214 Background: Although tirosine kinasa inhibitors (TKI) are the first line of therapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations, some patients do not have benefit with TKI. The aim of this study is to determinate if there are associated factors with poor response with TKI. Methods: This is an observational study of a single institution patient cohort. Clinical records of advanced NSCLC patients harboring EGFR mutations that have received TKI as first line therapy in ALIADA cancer center since january 2015 until december 2019 were evaluated. Clinical records with incomplete data were excluded. Type of EGFR mutation, type of TKI agent, BMI, neutrophil, lymphocyte, platelets, neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) were evaluated in all cases. Poor responders where defined as NSCLC patients who progressed within 3 months with erlotinib or afatinib and 6 months within osimertinib. The statistical analysis was performed with SPSS version 20 and MINITAB 14. Results: 46 patients were finally included. Mean age was 63.6 ± 11.7 years, 54.4% of patients were female and 93% had adenocarcinoma histology. Mean neutrophil, lymphocyte and platelet counts were 4.82, 1.96 and 396.07 respectively; meanwhile mean NLR was 4.85 and mean PLR 282.36. 45% of patients were overweight or obese. 65.2% of all mutations were EGFR exon 19 deletions, 19.6% were exon21 L858R substitution and 10% EGFR uncommon mutations (de novo exon20 T790 mutations and exon18 G719X substitution). 45.7% of patients received erlotinib, 37% received afatinib and 17.3% osimertinib. 61.5% of patients achieved partial response, 17.3% achieved complete response, 9.6% stable disease and 28.3% of patients were poor responders to TKI treatment. In bivariate analysis, odds ratio for poor response was more associated with uncommon mutations (OR = 8.21, IC95% = 1.94-97.18; p = 0.025) and patients with neutrophil > 4.82 (OR = 1.65, IC 95% = 1.08-2.52; p = 0.020). Odds ratio for poor response decreases 95% with erlotinib (OR = 0.05, IC95% = 0.00-0.58; p = 0.016). There was no statistical association with the rest factors. In the logistic regression model, poor response to TKI are related to uncommon EGFR mutations (OR = 8.21, 95% CI = 1.3-51.99; p = 0.009) and neutrophils > 4.82 (OR: 1.85, 1.13 -3.05). Conclusions: Disease progression is a phenomenon present in patients with EGFR-mutated NSCLC. According to our data, poor response is associated with uncommon EGFR mutations, TKI agent (erlotinib) and neutrophil count level. We need larger studies to validate our results.
Adjuvant PD-1 inhibitor versus high-dose interferon α-2b for Chinese patients with cutaneous and acral melanoma: A retrospective cohort analysis.
Authors: Wang Jiuhong , Li Jingjing , Liu Xing , Wen Xizhi , Li Dandan , Ding Ya , Jiang Hang , Huang Fuxue , Zhang Xiaoshi 
Published: June 2021

e21516 Background: The clinical efficacy of PD-1 inhibitors as an adjuvant treatment for Asian melanoma patients has not yet been determined. Methods: Thus, this single-centre, retrospective study analysed the clinical data of 90 Chinese patients with completely resected, stage III cutaneous or acral melanoma who received either adjuvant PD-1 inhibitor or high-dose interferon α-2b (HDI). Propensity score matching (PSM) was used to control baseline differences between the two treatment groups. The primary end point was recurrence-free survival (RFS), and the secondary end points included distance metastasis-free survival (DMFS) and incidence of first distant metastatic sites. Results: Anti-PD-1 treatment resulted in significantly longer RFS (18-month RFS, 53.3% versus 26.7%; 95% CI, 0.097-0.975; P < 0.05) and DMFS (18-month DMFS, 70.9% versus 46.1%; 95% CI, 0.13-0.945; P < 0.05) than HDI in cutaneous melanoma patients. However, adjuvant anti-PD-1 treatment had no advantage over HDI in acral melanoma patients (18-month RFS, 30.0% versus 35.9%; P > 0.05; 18-month DMFS, 36.5% versus 63.6%; P > 0.05). The incidence of lung metastasis at first in the anti-PD-1 group was found to be significantly lower (12.5% versus 48.5%; P < 0.05) in cutaneous melanoma patients than in acral melanoma patients, but no difference in metastatic sites were observed between the two treatment groups among acral melanoma patients. The incidence of treatment-related AEs was similar between the two treatment groups. Conclusions: In conclusion, adjuvant anti-PD-1 treatment was well tolerated and yielded a significantly better prognosis than HDI in Chinese patients with stage IIIB/C cutaneous melanoma, but a significant difference was not observed in those with acral melanoma.
Outcomes of stage IV melanoma in the era of immunotherapy (IO): A National Cancer Database (NCDB) analysis.
Authors: Sussman Tamara A. , Wei Wei , Funchain Pauline , Gastman Brian 
Published: June 2021

e21520 Background: The majority of data for IO in melanoma stems from trials that have specific inclusion criteria and often exclude important populations. In this analysis, we present the first real-world evidence of outcomes for stage IV patients (pts) with cutaneous melanoma receiving IO from 2015–2017 (addition of anti-PD-1 therapies) and factors associated with receipt of IO, and compare these outcomes with pts receiving IO (likely interferon and interleukin-2) from 2004–2010, and IO (addition of ipilimumab) from 2011–2014. Methods: The NCDB was analyzed to identify pts with stage IV melanoma from 2004–2017. Pts were categorized into receipt of IO or not during time periods 2004–2010, 2011–2014, and 2015–2017. Overall survival (OS) was analyzed by Kaplan-Meier, log-rank, and Cox proportional hazard models; IO status was analyzed using logistic regression. Results: 24,544 pts were analyzed from 2004–2017. Overall, 5,238 pts (21.3%) that received IO had improved median OS compared to those that did not (20.2 vs. 7.4 mos; p<0.0001). 4.1% received IO from 2004-2010, 7.8% from 2011-2014, and 9.4% from 2015-2017. Three-year OS significantly improved in pts treated with IO across treatment years; p<0.0001 (Table). Similarly, median time to IO initiation improved over time: 62 days in 2011-2014 vs. 49 days in 2015-2017 (p<0.0001). In the overall cohort, age<65 years, female gender, private insurance, no comorbidities, residence in metropolitan area, and treatment at academic centers were associated with better OS (p<0.0001 for all). Race was not associated with differences in OS (p=0.07). Multivariate analysis for 2015-2017 demonstrated that lack of treatment with IO [HR 1.98, 95%CI 1.81-2.17], radiation therapy [HR 1.20, 95%CI 1.09-1.32], presence of liver metastases [HR 1.87, 95%CI 1.63-2.13], and lack of surgery [HR 1.68, 95%CI 1.45-1.93] were independently associated with worse OS (p<0.0001 for all). In multivariate analysis, receipt of IO from 2015-2017, was associated with age<65 years [OR 1.27, 95%CI 1.08-1.50], African American race [OR 5.88, 95%CI 1.60-28.58], lack of comorbidities [OR 1.43, 95%CI 1.23-1.66], and treatment at academic centers [OR 1.44, 95%CI 1.26-1.65] (p<0.05 for all). Conclusions: OS was improved in stage IV melanoma pts receiving IO, with the highest OS rate in 2015-2017. Our findings that represent a real-world population are consistent with recent trials, like KEYNOTE 006 and CheckMate 067 where 3-year OS for anti-PD-1 therapy was 50% and 52%, respectively. In our study, African Americans demonstrate a 5-fold increase in likelihood of receiving IO, a population underrepresented in clinical trials. Significant socioeconomic factors may impact receipt of IO and survival.[Table: see text]