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Background: Pancreatic cancer (PC) first‐line therapy often consists of polychemotherapy regimens, but choosing a second‐line therapy after disease progression, especially following first‐line FOLFIRINOX, remains a clinical challenge. This study presents results from a large, multicenter, retrospective analysis of Italian patients with metastatic PC (mPC) treated with Nab‐paclitaxel/Gemcitabine (AG) as second or later line of treatment. Main objective of the study is to identify prognostic factors that could inform treatment decisions. Methods: The study included 160 mPC patients treated with AG in 17 Italian institutions. AG was administered according to labelling dose, until disease progression, unacceptable toxicity or patient refusal. Variations in schedules, dose modifications, supportive measures, and response evaluation were determined by individual clinicians' practice. Results: AG was well‐tolerated and exhibited promising clinical activity. The overall response rate (ORR) and the disease control rate (DCR) were 22.5% and 45.6%, respectively. Median progression‐free survival (PFS) and overall survival (OS) were 3.9 and 6.8 months, respectively. Among the patients who received AG as a second‐line therapy (n = 111, 66.9%), median PFS and OS were 4.2 and 7.4 months, respectively. Notably, in the 76 patients (68%) receiving AG after first‐line FOLFIRINOX, an ORR of 19.7% and a DCR of 46.0% were observed, resulting in a median PFS of 3.5 and median OS of 5.7 months. The study identified specific clinical or laboratory parameters (LDH, NLR, fasting serum glucose, liver metastases, ECOG PS, and first‐line PFS) as independent prognostic factors at multivariate level. These factors were used to create a prognostic nomogram that divided patients into three risk classes, helping to predict second‐line OS and PFS. Conclusions: This study represents the largest real‐world population of mPC patients treated with AG as a second or later line of therapy. It supports the feasibility of this regimen following first‐line FOLFIRINOX, particularly in patients with specific clinical and laboratory characteristics who derived prolonged benefit from first‐line therapy. [ABSTRACT FROM AUTHOR]

Background: Undetermined lung nodules are common in locally advanced rectal cancer (LARC) and lack precise risk stratification. This study aimed to develop a radiomic‐based score (Rad‐score) to distinguish metastasis and predict overall survival (OS) in patients with LARC and lung nodules. Methods: Retrospective data from two institutions (July 10, 2006—September 24, 2015) was used to develop and validate the Rad‐score for distinguishing lung nodule malignancy. The prognostic value of the Rad‐score was investigated in LARC cohorts, leading to the construction and validation of a clinical and radiomic score (Cli‐Rad‐score) that incorporates both clinical and radiomic information for the purpose of improving personalized clinical prognosis prediction. Descriptive statistics, survival analysis, and model comparison were performed to assess the results. Results: The Rad‐score demonstrated great performance in distinguishing malignancy, with C‐index values of 0.793 [95% CI: 0.729–0.856] in the training set and 0.730 [95% CI: 0.666–0.874] in the validation set. In independent LARC cohorts, Rad‐score validation achieved C‐index values of 0.794 [95% CI: 0.737–0.851] and 0.747 [95% CI: 0.615–0.879]. Regarding prognostic prediction, Rad‐score effectively stratified patients. Cli‐Rad‐score outperformed the clinicopathological information alone in risk stratification, as evidenced by significantly higher C‐index values (0.735 vs. 0.695 in the internal set and 0.618 vs. 0.595 in the external set). Conclusions: CT‐based radiomics could serve as a reliable and powerful tool for lung nodule malignancy distinction and prognostic prediction in LARC patients. Rad‐score predicts prognosis independently. Incorporation of Cli‐Rad‐score significantly enhances the persionalized clinical prognostic capacity in LARC patients with lung nodules. [ABSTRACT FROM AUTHOR]

Purpose: To assess the efficacy of neoadjuvant endocrine therapy in female HR‐positive/HER2‐negative breast cancer patients. Data and Methods: We identified female patients aged ≥18 years with cT1‐4N0‐XM0, HR(+), and HER2(−) breast cancer from the National Cancer Database. The patients who underwent surgery first were categorized as "surgery‐first," while those who received NET before surgery were classified as "NET." Propensity score‐matching, Cox proportional‐hazard model, variance inflation factors, and interaction analysis were employed to estimate the correlation between NET and survival outcomes. Results: Among 432,387 cases, 2914 NET patients and 2914 surgery‐first patients were matched. Compared with the surgery‐first group, the NET group received less adjuvant chemotherapy (p < 0.001). Furthermore, the NET group exhibited higher survival probabilities compared with the surgery‐first group (3 years: 91.4% vs. 82.1%; 5 years: 82.1% vs. 66.8%). Multivariate Cox analysis indicated that NET was associated with improved OS (surgery‐first vs. NET: HR 2.17, 95% CI: 1.93–2.44). Age over 55 years old, having public insurance, higher CDCC score, higher NSBR grade, ER(+)PR(−), and advanced clinical stage were related to worse OS (all p < 0.05). There was an interaction between age, race, income, and home and treatment regimen (all p < 0.05). Conclusion: NET may be a more effective treatment procedure than surgery‐first in female HR‐positive/HER2‐negative, non‐metastatic breast cancer patients. Future clinical studies with more detailed data will provide higher‐level evidence‐based data. [ABSTRACT FROM AUTHOR]

Background: Although socioeconomic factors are important determinants of population mortality, the effect of educational level on the survival of patients with cancer in China is unclear. This study aimed to assess whether educational level is associated with the prognosis of patients with cancer and to explore the mediators of this association. Methods: This multicentre cohort study included 18,251 patients diagnosed with cancer between May 2013 and December 2018. The main parameters measured were overall survival (OS) and all‐cause mortality. The relationship between educational level and all‐cause mortality was assessed using multifactor‐corrected Cox survival analysis. Logistic regression was used to analyze the association between educational level and patient‐generated subjective global assessment (PG‐SGA). Results: The mean age of the 18,251 participants (men, 9939 [54.4%]) was 57.37 ± 11.66 years. Multifactorial survival analysis showed that patients survived longer with increasing education (university and above vs. elementary school and below; p = p = <0.001, HR = 0.84, 95% CI: 0.77–0.92), and the differences were statistically significant in different subgroups. The potential impact factors included sex, age, TNM stage, and PG‐SGA score. Logistic regression showed a significant negative association between educational level and the modifiable factor PG‐SGA (secondary vs. primary and below; p = 0.004, HR = 0.90, 95% CI: 0.83–0.97; university and above vs. primary and below; p < 0.001, HR = 0.79, 95% CI: 0.71–0.88). Conclusions: Educational level was a significant prognostic factor for patients with cancer, independent of other known prognostic factors. This association was further improved by modifying the nutritional status. [ABSTRACT FROM AUTHOR]

Objective: Buccal mucosa cancer (BMC) is one of the most common oral cancers and has poor prognosis. The study aimed to develop and validate nomograms for predicting the 1‐, 3‐, and 5‐year overall survival (OS) and cancer‐specific survival (CSS) of BMC patients. Methods: We collected and reviewed information on BMC patients diagnosed between 2004 and 2019 from the Surveillance Epidemiology and End Results database. Two nomograms were developed and validated to predict the OS and CSS based on predictors identified by univariate and multivariate Cox regression. An extra external validation was further performed using data from Sun Yat‐sen Memorial Hospital (SYSMH). Results: A total of 3154 BMC patients included in this study were randomly assigned to training and validation groups in a 2:1 ratio. Independent prognostic predictors were identified, confirmed, and fitted into nomograms for OS and CSS, respectively. The C‐indices are 0.767 (Training group OS), 0.801 (Training group CSS), 0.763 (Validation group OS), and 0.781 (Validation group OS), respectively. Moreover, the nomograms exhibited remarkable precision in forecasting and significant clinical significance, as evidenced by receiver operating characteristic (ROC) curves, calibration curves, and decision curve analyses (DCA). The final validation using our data from SYSMH also showed high accuracy and substantial clinical benefits within the nomograms. The C‐indices are 0.849 (SYSMH group OS) and 0.916 (SYSMH group CSS). These indexes are better than tumor, node, and metastasis stage based on prediction results. Conclusions: The nomograms developed with great performance predicted 1‐, 3‐, and 5‐year OS and CSS of BMC patients. Use of the nomograms in clinical practices shall bring significant benefits to BMC patients. [ABSTRACT FROM AUTHOR]

Background: Exposure to paclitaxel and carboplatin has the risk of developing hypersensitivity reactions (HSRs), which could necessitate using less effective treatments to avoid anaphylaxis. Desensitization to platinum and taxane HSRs can be used to complete chemotherapy according to the standard regimen; therefore, this study investigated rates and benefits of successful desensitization in patients with gynecologic cancers (GC). Methods: We collected data from 241 patients with GC who had at least one cycle of platinum or taxane chemotherapy. The rate of HSRs and successful desensitization were evaluated, and an outcome analysis was conducted. Results: The rate of HSRs to platinum and taxane was 6.39% and 13.07%, respectively. We observed a 100% success rate of desensitization in our cohort. Patients with HSR were significantly younger (57.1 vs. 64.9 years, p=0.030) in the taxane cohort. Importantly, the overall survival (OS) of patients with platinum and taxane HSRs who underwent desensitization was comparable to that of patients with no HSRs (platinum vs. controls; median OS 60.36 vs. 60.39months, p=0.31; taxane vs. controls; OS 80.29 vs. 60.00months, p=0.59). Conclusion: Thus, we show that desensitization for platinum and taxane HSRs is safe and effective, resulting in an outcome that is well comparable to patients without HSR. Based on these observations, desensitization procedures might be considered as standard of care before switching to less effective treatment for patients with GC. [ABSTRACT FROM AUTHOR]

Introduction: Demographics are important prognostic factors in malignant diseases. A nationwide analysis concerning the prognostic impact of demographics in head and neck cancer (HNC) patients (HNCP) has not been performed previously. Methods: A retrospective analysis of data from the Center for Cancer Registry Data (ZfKD) and the Federal Statistical Office (Destatis) between 2002 and 2017 was performed. A total of 212′920 HNCP were included. Incidence, tumor stage, age development, sex distribution, age‐, residence‐, and diagnosis‐time‐specific survival were examined. Results: Mean age of HNCP increased more rapidly than in the general population (slope coefficient: 0.29 vs. 0.20; p < 0.0001). Higher age and male sex were associated with a worse prognosis. Whereas overall survival (OS) increased from the early to the later observation period for HNCP <70 years, no OS improvement for HNCP >70 years was found. Furthermore, an OS disadvantage was observed for East Germany compared to West Germany (median 47 vs. 60 months; p < 0.0001). This disparity was associated with a disproportionately high ratio of men in East Germany (men/women: 4.4 vs. 3.1; p < 0.0001) and a lower mean age (61 vs. 63 years; p < 0.0001). In addition to stage, age and sex, residence in East Germany were confirmed as an independent factor for OS in a multivariate analysis. Conclusion: Finally, three decades after the German reunion, a survival disadvantage for patients in East Germany still exists. This discrepancy may be a result of socioeconomic disparities. [ABSTRACT FROM AUTHOR]

Background: This retrospective cohort study aimed to evaluate the impact of the COVID‐19 pandemic on colorectal cancer care and mortality using a large cancer registry in Hiroshima Prefecture, Japan. The study aimed to estimate the all‐cause mortality rates within 1 year of diagnosis among colorectal cancer patients diagnosed during the pandemic period (2020 and 2021) compared to those diagnosed during the pre‐pandemic period (2018 and 2019). Methods: The day of diagnosis was set as Day 0 and Cox regression models were utilized to estimate crude hazard ratios (HRs) and adjusted HRs, accounting for age, sex, cancer stage, and treatment status. Two sensitivity analyses of overall survival were performed with different cutoffs of the pre‐pandemic/pandemic periods and year‐to‐year comparisons. Subgroup analyses were performed using likelihood ratio tests. Results: A total of 15,085 colorectal cancer patients were included, with 6499 eligible for follow‐up. A median age of included patients was 72 years old, of which 59% were male. The distribution of cancer stages showed little variation between the pre‐pandemic and pandemic periods. With a median follow‐up of 177 days, the number of events was 316/3111 (173 events per 1000 person‐years [E/1000PY], 95% confidence interval [CI]: 154–192 E/1000PY) in the pre‐pandemic period, and 326/2746 (245 E/1000PY, 95% CI: 220–274 E/1000PY) in the pandemic period (crude HR: 1.42, 95% CI: 1.22–1.66; adjusted HR: 1.25, 95% CI: 1.07–1.46). The two sensitivity analyses and subgroup analyses consistently supported these findings. Conclusions: The study revealed an increased colorectal cancer mortality during the pandemic period, suggesting a continuous impact of the COVID‐19 pandemic on the known and unknown risk factors for colorectal cancer for several years. Further studies are necessary to mitigate the adverse effects on patient outcomes. [ABSTRACT FROM AUTHOR]

Background: Notwithstanding that the past decade has witnessed unprecedented medical progress, gastric cancer (GC) remains a leading cause of cancer death, highlighting the need for effective prognostic markers. The Memorial Sloan Kettering Prognostic Score (MPS) has been validated as a valuable prognostic tool for patients with metastatic pancreatic adenocarcinoma (mPDAC). This study aimed to assess the prognostic value of the MPS in advanced GC. Methods: Data from 367 patients were analyzed in the present study. The MPS for each patient was calculated based on the sum of scores based on the neutrophil‐to‐lymphocyte ratio and serum albumin levels. Multivariate analyses were performed to identify the independent clinicopathological parameters associated with overall survival (OS). Further subgroup analyses based on clinicopathological features were conducted. Results: Patients with MPS 0 (n = 161), MPS 1 (n = 158), and MPS 2 (n = 48) exhibited significantly different OS, with a median survival duration of 20.7 (95%CI: 12.2–29.2), 14.9 (95%CI: 12.5–17.3), and 12.7 (95%CI: 9.3–16.0) months, respectively (p < 0.001). Significant differences in survival were observed among different groups of patients receiving chemotherapy (18.5 months vs. 14.7 months vs. 11.0 months, p = 0.03) or the subgroup receiving chemotherapy plus immunotherapy as first‐line treatment (32.6 months vs. 17.7 months vs. 12.7 months, p = 0.02). The MPS was identified as an independent prognostic factor in multivariate analysis. During subgroup analyses, MPS‐low (MPS 0) was consistently associated with a better prognosis than MPS‐high (MPS 1 or 2). Conclusions: MPS is a practical, simple, and useful prognostic tool for patients with advanced GC. Further studies are warranted to validate its prognostic value in advanced GC. [ABSTRACT FROM AUTHOR]

Background: Immune checkpoint inhibitors have revolutionized the treatment of malignancies. However, disproportionate enrollment among races and ethnicities places the generalizability of global trial results in doubt. Methods: In this systematic review, phase 3 randomized controlled trials investigating pembrolizumab in advanced cancers and providing subgroup analyses of Asian and non‐Asian participants were included. The primary and secondary effect measures were the mean differences (MDs) in the natural logarithms of the hazard ratios (HRs) for overall survival (OS) and progression‐free survival (PFS) between these two subgroups, respectively. We used random‐effects meta‐analysis to calculate the pooled ratios of HRs (i.e., exp(MD)) and implemented a meta‐regression analysis to identify significant covariates. Results: A total of 17 and 11 trials were included in the meta‐analyses of OS and PFS, respectively. These trials included 2732 (25.49%) Asian and 7000 (65.32%) non‐Asian participants in the OS analysis and 1438 (22.5%) Asian and 4129 (64.61%) non‐Asian participants in the PFS analysis. The pooled ratio of HRs for OS was 0.87 (95% CI: 0.76–0.99; p = 0.0391), favoring Asian participants, but no significant difference was found in PFS (pooled ratio of HRs: 0.93; 95% CI: 0.82–1.07; p = 0.2391). Both linear meta‐regression analyses revealed an open‐label design as a crucial covariate, which indicated more benefits for non‐Asian participants. Conclusions: Compared with non‐Asian patients, Asian patients with advanced cancers may derive superior OS benefits from pembrolizumab. Although the results warrant further exploration, this meta‐analysis provides insight into clinical research design. [ABSTRACT FROM AUTHOR]

Background: Studies comparing the effectiveness of either adjuvant oral uracil‐tegafur (UFT) or intravenous chemotherapy on early‐stage (stage I and II) non‐small cell lung cancer (NSCLC) patients treated with complete surgical treatment remain limited. Methods: From January 2011 to December 2017, patients with early‐stage NSCLC (defined as tumor size >3 cm without mediastinal lymph node involvement or any distant metastasis) receiving either adjuvant oral UFT or intravenous chemotherapy after surgical resection were identified from the Taiwan Cancer Registry. Overall survival (OS) and relapse‐free survival (RFS) were the primary and secondary outcomes, respectively. Propensity matching was used for controlling confounders. Results: A total of 840 patients receiving adjuvant therapy after surgery (including 595 oral UFT and 245 intravenous chemotherapy) were enrolled. Before matching, patients using oral UFT had significantly longer OS (HR: 0.69, 95% CI: 0.49–0.98, p = 0.0387) and RFS (HR: 0.79, 95% CI: 0.61–0.97, p = 0.0392) than those with intravenous chemotherapy. A matched cohort of 352 patients was created using 1:1 propensity score‐matching. In the Cox regression analysis, the UFT and the matched chemotherapy groups had similar OS (HR: 0.80, 95% CI: 0.48–1.32, p = 0.3753) and RFS (HR: 0.98, 95% CI: 0.72–1.34, p = 0.9149). Among subgroup analysis, oral UFT use was associated with longer RFS among the subgroups of non‐drinker (HR: 0.66, 95% CI: 0.34–0.99, p = 0.0478) and patients with stage IB disease (HR: 0.67, 95% CI: 0.42–0.97, p = 0.0341). Conclusions: This population‐based study in the real‐world setting of Taiwan demonstrates comparable effectiveness between oral UFT and intravenous chemotherapy in terms of clinical outcomes for early‐stage NSCLC patients after surgery. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to develop and validate a nomogram to predict survival in testicular cancer patients. Methods: Testicular cancer patients diagnosed between 2004 and 2015 from the Surveillance, Epidemiology, and End Results (SEER) database were selected for this study. A random sampling method was used to divide patients into training and validation cohorts, which accounted for 30% and 70% of the total sample, respectively. The nomogram was developed using the training cohort and evaluated using the C index, calibration chart, and area under the receiver operating characteristic curve (AUC). Results: Seven risk factors that affect the survival of testicular cancer patients (AJCC stage, marital status, age at diagnosis, race, SEER historic stage A, surgery status, and origin) were identified using Cox proportional hazard regression analysis. The nomogram has a higher C index (0.897) and AUC when compared with the AJCC staging system. The results of the calibration chart of the nomogram show that the predicted survival of testicular cancer patients at 3, 5, and 10 years after diagnosis is very close to their actual survival. Conclusions: We developed and validated a nomogram for predicting the survival rate of testicular cancer patients at 3, 5, and 10 years after diagnosis. This nomogram has better discrimination, calibration, and clinical validity than the AJCC staging system. This indicates that the nomogram can be used to predict the survival of testicular cancer patients effectively, and provide a reference for patient treatment strategies. [ABSTRACT FROM AUTHOR]

Background: Small intestine cancer (SIC) is difficult to diagnose early and presents a poor prognosis due to distant metastasis. This study aimed to develop nomograms for diagnosing and assessing the prognosis of SIC with distant metastasis. Methods: Patients diagnosed with SIC between 2010 and 2015 were included from the Surveillance, Epidemiology and End Results database. Univariate and multifactor analysis determined independent risk factors for distant metastasis and prognostic factors for overall and cancer‐specific survival. We then constructed the corresponding three nomograms and assessed the diagnostic accuracy of the nomograms by net reclassification improvement, receiver operating characteristic curves and calibration curves, assessed the clinical utility by decision curve analysis. RESULTS: The cohort consisted of 6697 patients, of whom 1299 had distant metastasis at diagnosis. Tstage, Nstage, age, tumor size, grade, and histological type were independent risk factors for distant metastasis. Age, histological type, T stage, N stage, grade, tumor size, whether receiving surgery, number of lymph nodes removed, and the presence of bone or lung metastases were predictors of both overall survival and cancer‐specific survival. The nomograms showed excellent accuracy in predicting distant metastasis and prognosis. Conclusion: Nomograms were developed and validated for SIC patients with distant metastasis, aiding physicians in making rational and personalized clinical decisions. [ABSTRACT FROM AUTHOR]

Background: In recent years, the survival of patients with breast cancer has improved. However, few published studies have a longer than 10‐year follow‐up. Conditional relative survival (CRS), which is relative survival (RS) of patients who have survived beyond a certain period after diagnosis, is useful for assessing excess mortality among long‐term survivors compared with the general population. Methods: This was a retrospective observational cohort study. Population‐based cancer registry data in Osaka, Japan were used to determine 15‐year RS and 5‐year CRS of women with breast cancer diagnosed between 2001 and 2002 and followed up for at least 15 years. Fifteen‐year RS and age‐standardized RS (ASR) were calculated by Ederer II and cohort methods. Five‐year CRS according to age group and extent of disease (localized, regional, and distant) was estimated for every year from diagnosis to 10 years. Results: In the cohort of 4006 patients, the ASR declined progressively, the 5‐year ASR being 85.8%, 10‐year ASR 77.3%, and 15‐year ASR 71.6%. The overall 5‐year CRS exceeded 90% at 5 years after diagnosis, reflecting a small excess mortality compared with the general population. The 5‐year CRS of patients with regional and distant disease did not reach 90% within 10 years of follow‐up (89.4% for regional and 72.9% for distant disease 10 years after diagnosis), indicating that these patients had substantial excess mortality. Conclusion: Long‐term survival data can help cancer survivors plan their lives and receive better medical care and support. [ABSTRACT FROM AUTHOR]

Purpose: The relationship between mutant KRAS and the risk of disease progression and death in advanced non‐squamous non‐small cell lung cancer (NSCLC) is still controversial among current studies, and the effects of distinct KRAS mutations on prognosis may be different. This study aimed to further investigate the association between them. Patients and Methods: Of the 184 patients eventually included in the study, 108 had KRAS wild type (WT) and 76 had KRAS mutant type (MT). Kaplan–Meier curves were plotted to describe the survival for patients among groups, while log‐rank tests were conducted to evaluate the survival differences. The univariate and multivariate Cox regression were performed to identify predictors, and subgroup analysis was used to verify the interaction effect. Results: Similar efficacy of first‐line therapy was observed for KRAS MT and WT patients (p = 0.830). The association between KRAS mutation and progression‐free survival (PFS) was not significant in univariate analysis (hazard ratio [HR] = 0.94; 95% CI, 0.66–1.35), and no KRAS mutation subtype significantly affected PFS. However, KRAS mutation and KRAS non‐G12C were associated with increased risk of death compared to KRAS WT in univariate and multivariate analysis. Univariate and multivariate analysis also confirmed that chemotherapy combined with antiangiogenesis or immunotherapy in the KRAS mutation group was associated with decreased risk of disease progression. However, the overall survival (OS) among KRAS mutant patients received different first‐line treatments did not significantly differ. Conclusion: KRAS mutations and their subtypes are not independent negative predictors of PFS, while KRAS mutation and KRAS non‐G12C were independent prognostic factors for OS. Chemotherapy combined with antiangiogenesis or immunotherapy conferred decreased risk of disease progression to KRAS mutation patients compared to single chemotherapy. [ABSTRACT FROM AUTHOR]

Background: Patients with certain autoimmune conditions are at a reduced risk of developing breast cancer compared to the general population. Despite this, little is known about outcomes in patients with breast cancer who have a concurrent autoimmune diagnosis. Methods: This study compared differences in outcomes between women with breast cancer who had or did not have an autoimmune diagnosis. The SEER‐Medicare databases (2007–2014) were used to identify patients with breast cancer and diagnosis codes were used to identify those with an autoimmune disorder. Results: The studied autoimmune diseases had a prevalence of 27% among the 137,324 patients with breast cancer. Autoimmune disease was associated with significantly longer overall survival (OS) and significantly lower cancer‐specific mortality (CSM) among stage IV breast cancer patients (p < 0.0001). After controlling for the effects of age, race, chronic kideny disease, chemotherapy, and radiation therapy autoimmune disease was still predictive of improved OS (HR: 1.45, 95% CI: 1.35–1.55, p < 0.0001) and CSM (HR: 1.40, 95% CI: 1.29–1.5, p < 0.0001). By contrast, in patients with stage I–III breast cancer, the presence of an autoimmune diagnosis was associated with a lower OS (p < 0.0001, p < 0.0001, and p = 0.026, respectively), compared to patients without autoimmune disease. Conclusions: We found a higher prevalence of rheumatoid arthritis, Crohn's disease, ulcerative colitis, and systemic lupus erythematosus in patients with breast cancer compared to age matched cohorts in the general population. The presence of an autoimmune diagnosis was associated with a lower OS in stages I–III breast cancer and improved OS and CSM in patients with stage IV disease. These results suggest that anti‐tumor immunity plays an important role in late stage breast cancer and could potentially be exploited to improve the effectiveness of immunotherapy. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) is a malignant tumor of the digestive system that contains high levels of immune cells. Lactic acid, a major metabolite, plays a crucial role in tumor development, maintenance, and therapeutic response. However, the prognostic potential and therapeutic biomarker potential of lactate‐related genes (LRGs) in CRC patients remain to be elucidated. Methods: We collected the mRNA expression profile and clinical data of CRC patients from the Cancer Genome Atlas (TCGA) database and the GSE59382 cohort. Univariate Cox regression, Lasso regression and multivariate Cox regression analysis were used to construct the prognosis model. Combined with the risk score and important clinicopathological features, the nomogram was established. In addition, the relationship between risk score and immune infiltration, immune checkpoint gene expression, and drug sensitivity was investigated. Results: We constructed lactate‐related gene signatures (LRGS) based on four LRGs, which independently predicted the prognosis of CRC. Patients with different risk scores are found to have distinct immune status, tumor mutation load, immune response, and drug sensitivity. In addition, nomogram results determined by risk scores and clinical factors have higher predictive performance. Conclusion: We found that LRGS is a reliable biomarker for predicting clinical outcomes, evaluating immune infiltration and efficacy, and predicting the sensitivity to drugs in patients with CRC. [ABSTRACT FROM AUTHOR]

Background: Bladder tumor‐infiltrating CD56bright NK cells are more tumor cytotoxic than their CD56dim counterparts. Identification of NK cell subsets is labor‐intensive and has limited utility in the clinical setting. Here, we sought to identify a surrogate marker of bladder CD56bright NK cells and to test its prognostic significance. Methods: CD56bright and CD56dim NK cells were characterized with the multiparametric flow (n = 20) and mass cytometry (n = 21) in human bladder tumors. Transcriptome data from bladder tumors (n = 351) profiled by The Cancer Genome Atlas (TCGA) were analyzed. The expression levels of individual markers in intratumoral CD56bright and CD56dim NK cells were visualized in tSNE plots. Expressions of activation markers were also compared between Killer Cell Lectin‐Like Receptor Subfamily F Member 1 (KLRF1)+ and KLRF1− NK cells. Results: Intratumoral CD56bright NK cells displayed a more activated phenotype compared to the CD56dim subset. Multiple intratumoral cell types expressed CD56, including bladder tumor cells and nonspecific intratumoral CD56 expression was associated with worse patient survival. Thus, an alternative to CD56 as a marker of CD56bright NK cells was sought. The activation receptor KLRF1 was significantly increased on CD56bright but not on CD56dim NK cells. Intratumoral KLRF1+ NK cells were more activated and expressed higher levels of activation molecules compared with KLRF1− NK cells, analogous to the distinct effector function of NK cells across CD56 expression. High intratumoral KLRF1 was associated with improved recurrence‐free survival (hazard ratio [HR] 0.53, p = 0.01), cancer‐specific survival (HR 0.47, p = 0.02), and overall survival (HR 0.54, p = 0.02) on multivariable analyses that adjusted for clinical and pathologic variables. Conclusions: KLRF1 is a promising prognostic marker in bladder cancer and may guide treatment decisions upon validation. [ABSTRACT FROM AUTHOR]

Background: Aging is accompanied by muscle loss. In older adults with cancer sarcopenia (OACS), systemic inflammation, reduced food intake, and reduced physical activity led to a poor prognosis. This study was to investigate the prognostic ability of the inflammatory Geriatric Nutritional Risk Index (GNRI), which combines patient's inflammation, diet status, and physical activity status to predict overall survival of OACS. Methods: This prospective multi‐center study enrolled 637 OACS, with an average age of 72.78 ± 5.98 years, of which 408 (64.1%) were males. We constructed the Inflammatory Functional Prognostic Index (IFPI) of OACS based on inflammatory GNRI scores, reduced food intake, and reduced physical activity. According to the IFPI, OACS was divided into high‐, moderate‐, and low‐risk groups. Univariate and multivariate survival analyses analyzed the prognostic ability of the clinical parameters. Results: Compared with OACS with a high GNRI score, the 1‐, 3‐, and 5‐year hazard ratios (95% confidence interval) of OACS with a low GNRI score was 1.816 (1.076–3.063), 1.678 (1.118–2.518), and 1.627 (1.101–2.407), respectively. This result was consistent with that of the calibration curve. The subgroup analysis showed that the low GNRI score had a significant positive relation with patients with gastrointestinal cancer (Pinteraction < 0.001). Notably, the survival analysis of IFPI showed that the mortality risk of moderate‐ and high‐risk patients was 1.722‐and 2.509‐fold higher, respectively, than that of low‐risk patients. Conclusion: The GNRI score was a short‐term and long‐term inflammatory prognostic indicator for OACS. The IFPI score could improve patient survival prediction. [ABSTRACT FROM AUTHOR]

Background: Adults aged 65 years and above account for over half of all cancer diagnoses in the United States, but little is known about trend of elderly cancer survival in the United States. We aimed to assess the survival trend for elderly cancer in the United States from 1995 to 2014. Methods: We used data from Surveillance, Epidemiology, and End Results 12 registries and included 1,112,441 eligible patients aged 65 years or older who were diagnosed between 1995 and 2014 with cancer and followed up until December 2019. Overall and stage‐specific 5‐year relative survival, ratio of observed survival to expected survival, with 95% confidence intervals (CIs) of elderly cancer patients stratified by age were estimated during four periods (1995–1999, 2000–2004, 2005–2009, and 2010–2014). Cox proportional hazards models were used to estimate hazard ratios for cancer‐specific death among patients diagnosed during 2000–2004, 2005–2009, 2010–2014, compared diagnoses in 1995–1999. We also calculated stage distribution and treatment rate during four periods. Results: In the United States, 5‐year relative survival for elderly cancer patients improved from 57.3% (95% CIs 57.0–57.5) in 1995–1999 to 60.7% (60.5–60.9) in 2010–2014. After controlling for sociodemographic and tumor characteristics, about a 19% reduction in cancer‐specific deaths among diagnoses in 2010–2014 compared with 1995–1999. Cancer survival improved for elderly patients in all age groups, with exception of stable survival for patients aged 85 and above. Comparing 1995–1999 with 2010–2014, relative survival improved from 84.7% (84.3–85.1) to 86.7% (86.3–87.0) for localized stage and from 12.4% (12.1–12.7) to 18.7% (18.4–19.0) for distant stage for all cancers combined. The trends in stage distribution and treatment rate for all cancers combined were relatively stable. Conclusions: In the United States, survival for elderly cancer patients has improved slightly from 1995 to 2014, possibly mainly due to advances in treatment. Further studies are warranted to explore interventions to improve elderly cancer survival. [ABSTRACT FROM AUTHOR]

Background: Esophageal cancer (EC) often occurs in the elderly, and approximately 40% of patients are 70 years or older. To investigate the long‐term survival of EC in elderly patients, to provide a theoretical direction for better management and predicting survival of EC based on the hospital‐based multi‐center study in China. Methods: The study was conducted in 18 hospitals including 6 provincial hospitals, 8 municipal hospitals, and 4 county hospitals. We extracted information from medical record homepage, records of admission and discharge, and pathological diagnosis reports from the medical record department of the elderly patients at 70–84 years old to obtain the 3‐year and 5‐year overall survival (OS), and main associated factors, and to analyze the current therapeutic effect of different treatment options for elderly patients. Results: The 3‐year and 5‐year OS rate of the 1013 elderly patients was 44.8% and 32.8%, respectively. Their median survival was 28.00 months. The median survival of patients with squamous cell carcinoma was longer than that of other pathological type (squamous vs. other types: 31.00 vs. 20.00 months, p = 0.018). The median survival of patients with surgery only or combined therapy was longer than that of radiotherapy, chemotherapy, and no therapy (surgery only vs. combined therapy vs. radiotherapy vs. chemotherapy vs. no therapy: 56.00 vs. 33.00 vs. 26.00 vs.18.00 vs. 16.00 months, p < 0.001). The 5‐year OS rate of patients with highly differentiated cancer was higher than that of medium differentiated and poor differentiation/undifferentiated. In multivariate analysis, the older ages, pathological stage, were independent prognostic risk factors for poor EC survival. Treatment method was independent protective factors predictive of a good EC OS. Conclusions: The survival rate of the elderly EC patients was still low in China. Age, therapy method, and pathological stage were mainly associated with the survival rate of EC in elderly patients. [ABSTRACT FROM AUTHOR]

Introduction: While timely assessment of long‐term survival for patients with colorectal cancer (CRC) is essential for evaluation on early detection and screening programs of colorectal cancer, those data are extremely scarce in China. We aimed to timely and accurately assess long‐term survival for CRC patients in eastern China. Methods: Patients diagnosed with CRC during 2004–2018 and followed up until December 31, 2018 from four cancer registries with high‐quality data from Taizhou, eastern China were included. Period analysis was used to calculate 5‐year relative survival (RS) for overall and the stratification by sex, age at diagnosis and region. The projected 5‐year RS of CRC patients during 2019–2023 was also assessed using a model‐based period analysis. Results: Overall 5‐year RS for patients with CRC during 2014–2018 reached 78.8%, being 74.9% for men and 86.1% for women. 5‐year RS declined along with aging, decreasing from 84.1% for age < 45 years to 48.9% for age > 74 years, while 5‐year RS for urban area was higher compared to rural area (83.9% vs. 75.8%). Projected overall 5‐year RS of CRC patients could reach 85.9% during the upcoming period 2019–2023. Conclusions: We provided, for first time in China using period analysis, most up‐to‐date 5‐year RS for patients with CRC from Taizhou, eastern China and also found 5‐year RS for CRC patients have improved greatly during 2004–2018. [ABSTRACT FROM AUTHOR]

Background: The impact of prior cancer history on survival of hypopharyngeal cancer patients remains unknown. The present study assessed the impact of prior cancer history on survival of patients with hypopharyngeal cancer. Methods: Patients with primary hypopharyngeal cancer diagnosed between 2004 and 2015 were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. Propensity score matching (PSM) was conducted to balance baseline characteristics. One‐to‐one PSM, Kaplan–Meier method, and log‐rank test were performed for survival analysis. Results: We included 5017 patients with hypopharyngeal cancer. Prior cancer history had no significant impact on overall survival of hypopharyngeal cancer patients in comparison with those without prior cancer history (p = 0.845, after PSM). Subgroup analysis showed that prior cancer history had no significant effect on overall survival of hypopharyngeal cancer patients. Conclusion: More hypopharyngeal cancer patients with prior cancer history should be considered for clinical trials. However, further prospective studies are needed. [ABSTRACT FROM AUTHOR]

Purpose: Research has demonstrated that solid tumor patients experience high levels of psychological distress at the time of diagnosis. While distress has been associated with many adverse clinical outcomes, little is known about how this symptom may influence the disease trajectory for cancer patients, affecting outcomes such as progression, recurrence, and survival. The purpose of this systematic review was to explore the literature linking distress with survival in solid tumor patients, which may guide future work exploring clinical outcomes as a function of distress. Methods: A systematic search of PubMed, Embase, and Web of Science was performed using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta‐Analyses) guidelines with predefined eligibility criteria. Thirteen studies met the inclusion criteria and were selected for review. Results: Findings from this review demonstrated a weak‐to‐moderate relationship between cancer patients' experience of distress and overall survival, with most included studies (11/13) finding at least one predictive analysis to be significant when controlling for confounders. However, significant heterogeneity in the literature, particularly with study sample characteristics and varying methodologies, made direct comparisons across studies challenging. Conclusion: Findings from this review suggest that psychological distress may have an impact on disease‐related outcomes, including (but not limited to) survival. Future work should consider performing disease‐specific analyses controlling for key prognostic factors to better understand the nuanced relationship between distress and clinical outcomes, which may allow further understanding of the biological underpinnings of this relationship and enable the development of targeted interventions for improving distress. [ABSTRACT FROM AUTHOR]

Background: Systemic inflammation and handgrip weakness have been used to predict mortality in many cancers. The purpose of current study was to evaluate the association of co‐occurrence of inflammation indicators and handgrip weakness with overall survival (OS) of lung cancer (LC) patients with good performance status. Methods: The cutoff points for handgrip strength (HGS) and the four inflammation indicators were calculated using Maxstat. The time‐dependent receiver operating characteristic curve and C‐index were used to select optimal inflammation indicator for predicting OS of LC patients. The Cox proportional hazard regression model was used to calculate the hazard ratio (HR) of mortality. Kaplan–Meier curves were constructed to evaluate the association of indicators and the OS of LC patients. Results: Among the 1951 patients, the mean ± standard deviation (SD) age was 60.6 ± 9.9 years, and 1300 (66.6%) patients were male. In patients with good performance status (PS), handgrip weakness (HR, 1.49; 95% confidence interval [95% CI], 1.30–1.70, p < 0.001) and low advanced lung cancer inflammation index (ALI) (HR, 2.05; 95%CI, 1.79–2.34, p < 0.001), high systemic immune‐inflammation index (SII) (HR, 1.91; 95%CI, 1.66–2.19, p < 0.001), high platelet: lymphocyte ratio (PLR) (HR, 1.60; 95%CI, 1.40–1.82, p < 0.001), or high neutrophil: lymphocyte ratio (NLR) (HR, 2.01; 95%CI, 1.76–2.30, p < 0.001) were associated with increased mortality risk of LC patients. ALI had better C‐index (0.624) and time‐AUC in the prediction of OS in LC patients with good PS than other three combinations. The co‐occurrence of handgrip weakness and low ALI more than doubled the risk of death in LC with good PS (HR, 2.44; 95% CI, 2.06–2.89, p < 0.001). Conclusion: In LC patients who have good PS, patients with combined handgrip weakness and low ALI have the worst prognosis. The Trial Registration Number: ChiCTR1800020329. [ABSTRACT FROM AUTHOR]

Background: Dysbiosis of the gut microbiota can lead to impaired therapeutic effect of immune checkpoint inhibitors (ICIs). This study aimed to investigate the use of probiotics on the clinical outcomes of cancer patients receiving ICIs therapy. Method: PubMed, EMBASE, and the Cochrane Library database were searched to retrieve relevant studies that exploring the relationship between probiotics and the efficacy of ICIs. The primary endpoints included overall survival (OS) and progression‐free survival (PFS), evaluated by the hazard rations (HRs) with 95% confidence intervals (CI), and the secondary endpoint was objective response rate (ORR), evaluated by the odd ratio (OR) with a 95% CI. Results: A total of five studies including 1031 patients were eligible for analysis. Our results indicated that the use of probiotics was associated with a superior OS (HR = 0.50, 95% CI: 0.30–0.85, p = 0.01) and PFS (HR = 0.51, 95% CI: 0.42–0.61, p < 0.01), but had no relationship with ORR (OR = 2.11, 95%CI: 0.51–8.65, p = 0.30) in non‐small cell lung cancer (NSCLC) patients. Conclusions: Probiotics were positively correlated with OS and PFS in NSCLC patients administrated with ICIs, but had no relationship with ORR. [ABSTRACT FROM AUTHOR]

Background: Previous research suggests that Warburg‐subtypes are related to potentially important survival differences in colorectal cancer (CRC) patients. In the present study, we investigated whether mutational subgroups based on somatic mutations in RAS, BRAF, PIK3CA, and MET, which are known to promote the Warburg‐effect, as well as mismatch repair (MMR) status, hold prognostic value in CRC. In addition, we investigated whether Warburg‐subtypes provide additional prognostic information, independent of known prognostic factors like TNM stage. Methods: CRC patients (n = 2344) from the prospective Netherlands Cohort Study (NLCS) were classified into eight mutually exclusive mutational subgroups, based on observed mutations in RAS, BRAF, PIK3CA, and MET, and MMR status: All‐wild‐type + MMRproficient, KRASmut + MMRproficient, KRASmut + PIK3CAmut + MMRproficient, PIK3CAmut + MMRproficient, BRAFmut + MMRproficient, BRAFmut + MMRdeficient, other + MMRproficient, and other + MMRdeficient. Kaplan–Meier curves and Cox regression models were used to investigate associations between mutational subgroups and survival, as well as associations between our previously established Warburg‐subtypes and survival within these mutational subgroups. Results: Compared to patients with all‐wild‐type + MMRproficient CRC, patients with KRASmut + MMRproficient, KRASmut + PIK3CAmut + MMRproficient, BRAFmut + MMRproficient, or other + MMRproficient CRC had a statistically significant worse survival (HRCRC‐specific ranged from 1.29 to 1.88). In contrast, patients with other + MMRdeficient CRC had the most favorable survival (HRCRC‐specific 0.48). No statistically significant survival differences were observed for the Warburg‐subtypes within mutational subgroups. Conclusion: Our results highlight the prognostic potential of mutational subgroups in CRC. Warburg‐subtypes did not provide additional prognostic information within these mutational subgroups. Future larger‐scale prospective studies are necessary to validate our findings and to examine the potential clinical utility of CRC subtyping based on mutational subgroups. [ABSTRACT FROM AUTHOR]

Objective: NF1 is a tumor suppressor gene that encodes the neurofibromin protein and negatively regulates Ras signaling. This study was aimed to investigate the molecular, clinical characteristics, and prognostic features of NF1 gene in EGFR mutant lung cancer patients. Method: The next‐generation sequencing (NGS) was used to analyze the data from lung cancer patients in the Guangdong Lung Cancer Institute (GLCI) from June 2016 to December 2020. Results: Somatic NF1 mutations were present in 4.2% (135/3220) of Chinese lung cancer patients. NF1 mutations where clearly enriched in older (p < 0.001), male (p < 0.001), and smoking (p < 0.001) patients. Patients with NF1 mutations were more likely to have TP53 (p = 0.003), BRAF (p = 0.001) and RASA1 (p = 0.026) mutations and mutually exclusive with EGFR mutations (p = 0.006). TP53 mutation had worsen prognosis in cases of NF1 mutant (p = 0.026) or EGFR/NF1 co‐mutant (p = 0.031) lung adenocarcinomas (LUAD) patients. There was no effect on overall survival (OS) in LUAD patients with and without NF1 mutations, even in LUAD driver‐gene negative patients. NF1/EGFR co‐mutation patients had a longer OS than a single mutation of either the EGFR gene (median OS: 47.7 m vs. 30.2 m, hazard ratio [95% CI], 0.47 [0.30–0.74], p = 0.004) or NF1 gene (47.7 m vs. 19.0 m, 0.44 [0.27–0.73], p = 0.003). Furthermore, NF1 mutations significantly prolonged OS in EGFR mutant/TP53 wild‐type LUAD patients (106.5 m vs. 25.5 m, 0.28 [0.13–0.59], p = 0.003) but not in patients with EGFR/TP53 co‐mutations (36.8 m vs. 30.2 m, 0.70 [0.39–1.26], p = 0.280). Conclusion: Our results indicated NF1 mutations served as a good prognostic factor in EGFR mutant/TP53 wild‐type lung cancer patients in this single‐center study. TP53 mutation was obviously enriched in NF1 mutant patients and had shorter OS. [ABSTRACT FROM AUTHOR]

Background: Intra-operative use of opioid analgesics might have an impact on cancer recurrence and survival after surgery. The objective of this study was to investigate the association between the intra-operative fentanyl equivalents and survival outcomes in patients with primary liver cancer after receiving hepatectomy. Methods: This was a retrospective single-center cohort study, and clinical data of 700 patients with primary liver cancer who underwent hepatectomy in Harbin Medical University Cancer Hospital from September 2013 to August 2018 were reviewed. After propensity matching, 376 patients were included. Patients were divided into high-dose and low-dose groups according to the median intraoperative fentanyl equivalents (1.500 mg). Kaplan Meier curve and Cox proportional hazards regression model were used. Results: Results of univariable analysis showed there were no significant differences in recurrence- free survival (RFS) (p = 0.136) and overall survival (OS) (p = 0.444) between high-dose fentanyl equivalents and low-dose fentanyl equivalents group. The multivariable Cox regression analysis found that the dose of intra-operative fentanyl equivalents was not associated with RFS (HR: 1.119, 95%CI: 0.851-1.472, p = 0.422) or OS (HR: 0.939, 95%CI: 0.668-1.319, p = 0.715). Conclusions: The amounts of intra-operative fentanyl equivalents had no impact on recurrence- free or overall survival in patients with primary liver cancer after curative hepatectomy. [ABSTRACT FROM AUTHOR]

Pulmonary function can predict all-cause mortality, and chronic obstructive pulmonary disease (COPD) is associated with worse overall survival (OS) in non-small cell lung cancer (NSCLC) patients. Though pre-operative lung function is predictive of in-hospital mortality following lung cancer surgery, its predictive utility for long-term survival is unclear. The prognostic role of commonly used spirometry tests in survival of lung cancer also remains uncertain. This study evaluates the role of spirometry at lung cancer diagnosis in predicting OS of NSCLC patients. This was a retrospective study using data from the Boston Lung Cancer Study on newly diagnosed NSCLC patients with spirometry tests performed before cancer therapy (n = 2805). Spirometric test values, after being categorized using quartiles, were analyzed for association with OS using univariate and risk-adjusted multiple regression models. Further, we analyzed OS by the status of COPD determined by spirometry, and, among those with COPD, by its stage defined by the Global Initiative for Chronic Obstructive Lung Disease criteria. Both univariate and multiple regression models demonstrated that lower quartiles of actual and percent predicted forced expiratory volume in 1 second and forced vital capacity at lung cancer diagnosis were significantly associated with worse OS. Spirometrydetermined COPD, and more advanced stage of COPD at lung cancer diagnosis were associated with worse lung cancer OS. The findings provide evidence that a good pulmonary function at diagnosis may help improve OS in NSCLC patients. [ABSTRACT FROM AUTHOR]

Objective: We aimed to investigate whether (1) psychological and social indicators influence survival in patients diagnosed with cancer or haematologic malignancies when important biological aspects are controlled for, (2) psychological, social and biological indicators can be utilised to design one collated index for survival, usable in clinical practice to identify patients at risk of shorter survival and to improve personalised healthcare provision. Methods: In this cross‐sectional study, 2263 patients with cancer or haematologic malignancies participated. We analysed 15 biological, psychological and social indicators as risk factors for survival with a Cox proportional hazards model. Indicators significantly associated with survival were combined to compute models for the identification of patient groups with different risks of death. The training sample contained 1122 patients. Validation samples included the remaining 1141 patients, the total sample, as well as groups with different cancer entities. Results: Five indicators were found to significantly impact survival: Cancer site (HR: 3.56), metastatic disease (HR: 1.88), symptoms of depression (HR: 1.34), female sex (HR: 0.73) and anaemia (HR: 0.48). Combining these indicators to a model, we developed the Cancer Survival Index, identifying three distinct groups of patients with estimated survival times of 47.2 months, 141 months and 198.2 months (p < 0.001). Post hoc analysis of the influence of depression on survival showed a mediating effect of the following four factors, related to both depression and survival: previous psychiatric conditions, employment status, metastatic disease and haemoglobin levels. Conclusions: Psychosocial and biological factors impact survival in various malignancies and can be utilised jointly to compute an index for estimating the survival of each patient individually—the Cancer Survival Index. [ABSTRACT FROM AUTHOR]

Purpose: To study the prognostic value of the prognostic nutritional index (PNI) in advanced cancers receiving programmed death‐1/programmed death‐ligand 1 (PD‐1/L1) inhibitors. Methods: Online electronic databases were comprehensively searched and available literature was retrieved. We extracted available data from included researches and pooled the hazard ratios (HRs) and 95% confidence intervals (CIs) to learn the prognostic value of PNI on overall survival (OS) or progression‐free survival (PFS); and meanwhile calculated the relative risk (RR) with 95% CI to study the relationship between PNI and treatment efficacy (objective response rate [ORR] or disease control rate [DCR]) in late staged cancer receiving PD‐1/L1 inhibitors. Results: Nine studies were finally selected for this meta‐analysis. We obtained data regarding PNI on OS from all nine studies, and the pooled HR was 2.31 (95% CI 1.81–2.94, p = 0.000), showing a correlation between low PNI and worse OS. Eight studies reported a relationship between PNI and PFS, and combined results revealed shorter PFS in patients with lower PNI, with an HR of 1.75 (95% CI 1.40–2.18, p = 0.000). Four studies explored the association between PNI and ORR and two studies explored the influence of PNI on DCR. An association between PNI and ORR (RR = 0.47, p = 0.003) was observed, while no association between PNI and DCR (RR = 0.49, p = 0.103) was observed by pooling these studies. Conclusion: In summary, this meta‐analysis indicated that a lower PNI was significantly correlated with decreased OS and PFS and played adverse roles in ORR in advanced cancer patients receiving PD‐1/L1 inhibitors. Therefore, PNI could be promising for predicting prognosis and treatment response in advanced malignancies treated with PD‐1/L1 inhibitors. [ABSTRACT FROM AUTHOR]

Background: Stereotactic body radiation therapy (SBRT) for patients with borderline resectable and locally advanced pancreatic adenocarcinoma (BRPC/LAPC) remains controversial. Herein, we report on surgical, pathologic, and survival outcomes in BRPC/LAPC patients treated at a high‐volume institution with induction chemotherapy (CTX) followed by 5‐fraction SBRT. Methods: BRPC/LAPC patients treated between 2016 and 2019 were retrospectively reviewed. Surgical and pathological outcomes were descriptively characterized. Overall survival (OS) and progression‐free survival (PFS) were analyzed using Cox proportional hazard regression. Locoregional failure and distant failure were analyzed with Fine–Gray competing risk model. Results: Of 155 patients, 91 (59%) had LAPC and 64 (41%) had BRPC. Almost all were treated with induction multi‐agent CTX with either FOLFIRINOX (75%) or gemcitabine and nab‐paclitaxel (24%) for a median duration of 4.0 months (1–18 months). All received SBRT to a median dose of 33 Gy. Among 64 BRPC patients, 50 (78%) underwent resection, of whom 48 (96%) achieved margin‐negative (R0) resection. Among 91 LAPC patients, 57 (63%) underwent resection, of whom 50 (88%) achieved R0 resection. Despite the high R0 rate, 33% of patients experienced locoregional failure, which was a component of 44% of all failures. After SBRT, median OS and PFS were 18.7 and 7.7 months, respectively. After SBRT, 1‐ and 2‐year OS probabilities were 70% and 45%, whereas, from diagnosis, they were 93% and 51%. Conclusions: Although a high proportion of BRPC/LAPC patients treated with induction multi‐agent CTX followed by SBRT successfully achieved R0 resection, locoregional failure remained common, highlighting the need to continue to optimize radiation delivery in this context. [ABSTRACT FROM AUTHOR]

Background: Chemotherapy for advanced gastric cancer is recommended in the guidelines; however, later‐line treatment remains controversial. Since immune checkpoint inhibitors have been used for the treatment of various malignancies, trials have been performed for gastric cancer. A phase 3 trial indicated the survival benefit of nivolumab monotherapy for gastric cancer patients treated with prior chemotherapy regimens. Patients and methods: A regional cohort study was undertaken to determine the real‐world data of nivolumab treatment for patients with advanced or recurrent gastric cancer. The patients were enrolled for 2 years from October 2017 to October 2019 and were prospectively followed for 1 year to examine the overall survival (OS). The patient characteristics were analyzed in a multivariate analysis and a nomogram to predict the probability of survival was generated. Results: In total, 70 patients who received nivolumab as ≥third‐line chemotherapy were included in the Asahikawa Gastric Cancer Cohort. The median OS was 7.5 (95% CI, 4.8–10.2) months and the response rate was 18.6%. Diffuse type classification, bone metastasis, high neutrophil/lymphocyte ratio, and high CRP were associated with poor OS/prognosis in the multivariate analysis. A nomogram was developed based on these clinical parameters and the concordance index was 0.80 (95% CI, 0.68–0.91). The responders were aged and were frequently diagnosed with intestinal type gastric cancer, including patients with a HER2‐positive status (27.3%) or microsatellite instability‐high (27.3%) status. Conclusions: The regional cohort study of nivolumab monotherapy for gastric cancer patients revealed prognostic factors and a nomogram was developed that could predict the probability of survival. [ABSTRACT FROM AUTHOR]

Background: Ovarian cancer (OV) is deemed the most lethal gynecological cancer in women. The aim of this study was to construct an effective gene prognostic model for predicting overall survival (OS) in patients with OV. Methods: The expression profiles of glycolysis‐related genes (GRGs) and clinical data of patients with OV were extracted from The Cancer Genome Atlas (TCGA) database. Univariate, multivariate, and least absolute shrinkage and selection operator Cox regression analyses were conducted, and a prognostic signature based on GRGs was constructed. The predictive ability of the signature was analyzed using training and test sets. Results: A gene risk signature based on nine GRGs (ISG20, CITED2, PYGB, IRS2, ANGPTL4, TGFBI, LHX9, PC, and DDIT4) was identified to predict the survival outcome of patients with OV. The signature showed a good prognostic ability for OV, particularly high‐grade OV, in the TCGA dataset, with areas under the curve (AUC) of 0.709 and 0.762 for 3‐ and 5‐year survival, respectively. Similar results were found in the test sets, and the AUCs of 3‐, 5‐year OS were 0.714 and 0.772 in the combined test set. And our signature was an independent prognostic factor. Moreover, a nomogram combining the prediction model and clinical factors was developed. Conclusion: Our study established a nine‐GRG risk model and nomogram to better predict OS in patients with OV. The risk model represents a promising and independent prognostic predictor for patients with OV. Moreover, our study on GRGs could offer guidance for the elucidation of underlying mechanisms in future studies. [ABSTRACT FROM AUTHOR]

Background: The majority of patients with small‐cell lung cancer (SCLC) show a good response in the early stages of treatment, but more than 90% of patients will develop drug resistance. Therefore, biomarkers are urgently needed to identify patients who can benefit from systemic treatment. Methods: We prospectively enrolled 52 extensive‐stage SCLC patients before treatment from a local hospital to identify mutations related to patient prognosis, and verified them in the published Jiang's cohort and George's cohort. Results: We found that patients with high mutations (mut‐high) in the fatty acid (FA) metabolism pathway had a longer progression‐free survival (PFS) in the local hospital cohort (HR = 0.446, 95% CI, 0.207–0.959, p = 0.0387) and a longer overall survival (OS) in Jiang's cohort (HR = 0.549, 95% CI, 0.314–0.960, p = 0.0351) than patients with low mutations (mut‐low). Multivariate analysis suggested that mut‐high status was an independent prognostic factor in both cohorts. George's cohort verified that mut‐high status was associated with a longer OS than mut‐low status (HR = 0.730, 95% CI 0.440–1.220, p = 0.2277). The possible mechanisms were as follows: the frequency of mutated FA synthase (FASN) in the mut‐high group was greater than that in the mut‐low group, and pathways related to the cell cycle, DNA repair, and oxidative phosphorylation were enriched in the mut‐high group. Conclusions: The prognosis of SCLC patients treated with chemotherapy was better among patients with more mutations in the FA metabolism pathway, and the underlying mechanisms could be found at the genome and transcriptome levels. [ABSTRACT FROM AUTHOR]

Background: There are limited data from low‐ to middle‐income countries (LMIC) on the incidence, risk factors, treatment outcomes, and antibiotic susceptibility spectrum of aspiration pneumonia (AsP). Methods: We conducted a post hoc analysis of a randomized control trial in which adult patients with locally advanced head and neck cancers had received 66–70 Gy of radiation combined with cisplatin 30 mg/m2 weekly for 6–7 weeks or cisplatin at the same dose with nimotuzumab 200 mg once weekly till the completion of radiation. The following data were extracted and analyzed—the incidence of AsP, time to the onset of AsP, risk factors, treatment outcomes of AsP, and its impact on progression‐free survival (PFS), locoregional control (LRC) rates, and overall survival (OS). Results: Out of 536 patients enrolled in the study, 151 (28.3%, 95% confidence interval [CI] 24.5–2.1) patients developed AsP. The median time to develop AsP was 39 days (95% CI 34–44). Only baseline dysphagia (odds ratio = 3.76, 95% CI 1.05–13.51, p = 0.042) was associated with a significant risk of development of AsP. Among the patients in which pathogenic organism was isolated (69 patients), gram‐negative species was isolated in 63 patients (89%). Cisplatin at 200 mg/m2 or more was delivered in 312 (81%) patients in the non‐AsP cohort versus 107 (70.9%) patients in AsP cohort (p = 0.014). There was no statistical difference in LRC (hazard ratio [HR] = 1.057; 95% CI 0.771–1.448), PFS (HR = 1.176; 95% CI 0.89–1.553), and OS (HR = 1.233; 95% CI 0.939–1.618) between the two cohorts. Conclusion: Aspiration pneumonia is a common complication in head and neck malignancies and patients with baseline dysphagia are at high risk. Gram‐negative bacteria are the predominant causative agents. The use of broad‐spectrum antibiotics results in resolution of symptoms. [ABSTRACT FROM AUTHOR]

Background: Primary tumor resection (PTR) as a treatment option for patients with stage IV pancreatic cancer (PC) is controversial. Patients and methods: Stage IV PC patients, with treatment data from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER), were screened. The main outcomes were overall survival (OS) and cancer‐specific survival (CSS). Results: We enrolled 15,836 stage IV PC patients in this study. Propensity score‐matched analyses revealed improved OS and CSS of patients receiving chemotherapy plus PTR versus chemotherapy (median survival time [MSTOS]: 13 vs. 9 months, p = 0.024; MSTCSS: 14 vs. 10 months, p = 0.035), and chemoradiotherapy plus PTR versus chemoradiotherapy (MSTOS: 14 vs. 7 months, p = 0.044; MSTCSS: 14 vs. 7 months, p = 0.066). Multivariate adjusted analyses further confirmed these results. Stratified with different metastatic modalities, multivariate analyses suggested that PTR significantly improved the OS and CSS among patients with ≤1 metastatic organ, and that patients with brain metastasis might not benefit from chemotherapy treatment. Conclusion: PTR improves the OS and CSS of stage IV PC patients on the basis of chemotherapy or chemoradiotherapy, provided that the metastases involve ≤1 organ. Chemotherapy, however, should be carefully considered in patients with metastases involving the brain. [ABSTRACT FROM AUTHOR]

Background: The impact of socioeconomic status (SES) has been described for screening and accessing treatment for colon cancer. However, little is known about the “downstream” effect in patients who receive guideline-concordant treatment. This study assessed the impact of SES on cancer-specific survival (CSS) and overall survival (OS) for stage III colon cancer patients. Methods: The SEER Census Tract-Level SES Dataset from 2004 to 2015 was used to identify stage III colon adenocarcinoma patients who received curative-intent surgery and adjuvant chemotherapy. The predictor variable was census tract SES. SES was analyzed as quintiles. The outcome variables were OR and CSS. Statistical analysis included chi square tests for association, Kaplan–Meier, Cox, Fine and Gray regression for survival analysis. Results: In total, 27,222 patients met inclusion criteria. Lower SES was associated with younger age, Black or Hispanic race/ethnicity, Medicaid/uninsured, higher T stage, and lower grade tumors. CSS at the 25th percentile was 54 months for the lowest SES quintile and 80 for the highest. Median OS was 113 months for the lowest SES quintile and not reached for highest. The 5-year CSS rate was 72.4% for the lowest SES quintile compared to 78.9% in the highest (p < 0.001). The 5-year OS rate was 66.5% for the lowest SES quintile and 74.6% in the highest (p < 0.001). Conclusion: This is the first study to evaluate CSS and OS in an incidence-based cohort of stage III colon cancer patients using a granular, standardized measure of SES. Despite receipt of guideline-based treatment, SES was associated with disparities in CSS and OS. [ABSTRACT FROM AUTHOR]

Background: The incidence of colorectal cancer in adults younger than age 50 has increased with rates expected to continue to increase over the next decade. The objective of this study is to examine the survival benefit of surgical resection (primary and/or metastatic) versus palliative therapy in this patient population. Methods: We identified 6708 young adults aged 18–45 years diagnosed with metastatic colorectal cancer (mCRC) from 2004 to 2015 from the SEER database. Overall survival (OS) was analyzed using Kaplan–Meier estimation, log rank test, and multivariate Cox proportional hazards model. Results: Sixty‐three percent of patients in our study underwent primary tumor resection (PTR), with 40% undergoing PTR alone and 23% undergoing both resection of primary disease and metastasectomy. The median OS for patients who underwent both PTR and metastasectomy was 36 months, compared to 13 months for those who did not receive any surgical intervention. The multivariate analysis showed significant OS benefit of receiving both PTR and metastasectomy (HR 0.34, 95% CI: 0.31–0.37, p < 0.001) compared to palliative therapy. Undergoing PTR only and metastasectomy only were also associated with improved OS (HR 0.46, 95% CI: 0.43–0.49, p < 0.001 and HR 0.64, 95% CI: 0.55–0.76, p < 0.001, respectively). Conclusion: This is the largest observational study to evaluate survival outcomes in young‐onset mCRC patients and the role of surgical intervention of the primary and/or metastatic site. Our study provides evidence of statistically significant increase in OS for young mCRC patients who undergo surgical intervention of the primary and/or metastatic site. [ABSTRACT FROM AUTHOR]

Background: The effect of long‐term surveillance for asymptomatic patients after curative resection of gastric cancer is being debated. We compared the prognosis of Korean patients with recurrent gastric cancer according to the presence or absence of cancer‐related symptoms at the time of recurrence detection. Methods: We retrospectively reviewed the medical records of 305 Korean patients who experienced recurrence after curative resection of primary gastric cancer between March 2002 and February 2017 at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Results: The median follow‐up duration was 169.8 months (1–267.2), and the median age at first recurrence was 58.1 years (23.4–81.9). Among 305 patients with recurrence, 97 of 231 (42.0%) patients with early recurrence (≤5 years after curative surgical resection) and 47 of 74 (63.5%) patients with late recurrence (>5 years after curative surgical resection) had cancer‐related symptoms at recurrence (p = 0.001). For survival after recurrence, detection of asymptomatic recurrence was an independent favorable factor (hazard ratio, 0.527; 95% confidence interval, 0.409–0.681; p < 0.001) accompanied with the possibility of subsequent treatment, targeted‐, or immunotherapy for recurrent disease, and locoregional recurrence only. In the late‐recurrence group, the patients with asymptomatic detection of recurrence showed favorable post‐recurrence survival (median, 33.3 months vs. 14.7 months; p = 0.002), overall survival (median, 136.3 months vs. 106.1 months; p = 0.010), and cancer‐specific survival (median, 177.5 months vs. 106.1 months; p = 0.005) than the patients with symptomatic detection. Conclusion: The detection of gastric cancer recurrence in patients without cancer‐related symptoms may be related to improved survival, suggesting the potential benefit of long‐term surveillance. [ABSTRACT FROM AUTHOR]

Objectives: Pancreatic cancer (PC) is one of the most lethal malignancies with an increasing death rate over the years. We performed targeted sequencing and survival analyses on 90 Chinese pancreatic cancer patients, hoping to identify genomic biomarkers associated with clinical outcomes and therapeutic options. Method: Genomic DNA was extracted from formalin‐fixed paraffin‐embedded (FFPE) tissue specimens of 90 pancreatic cancer patients and sequenced. The associations with clinicopathological factors were analyzed. Result: High prevalence of driver mutations in KRAS, TP53, CDKN2A, SMAD4, and ARID1A genes were found. Most mutated genes in PC belonged to cell cycle and DNA damage repair pathways. Tumors that arise from the pancreas' body and tail (BT tumors) displayed a higher ratio of mutated KRAS and TP53 than those that arise from the pancreas' head and neck (HN tumors), who showed less diverse KRAS subtypes. Patients with a KRAS p.G12R mutated tumor tended to have a prolonged disease‐free survival (DFS) and overall survival (OS) than other KRAS subtypes. Those with an altered ARID1A gene and more than two mutated driver genes tended to have a shorter DFS and OS. Conclusion: HN and BT tumors of the pancreas displayed different mutational profiles, which had prognostic significances and indicated different potential therapeutic options. [ABSTRACT FROM AUTHOR]

Purpose: Prior studies suggest email communication between patients and providers may improve patient engagement and health outcomes. The purpose of this study was to determine whether patient‐initiated emails are associated with overall survival benefits among cancer patients undergoing chemotherapy. Patients and methods: We identified patient‐initiated emails through the patient portal in electronic health records (EHR) among 9900 cancer patients receiving chemotherapy between 2013 and 2018. Email users were defined as patients who sent at least one email 12 months before to 2 months after chemotherapy started. A propensity score‐matched cohort analysis was carried out to reduce bias due to confounding (age, primary cancer type, gender, insurance payor, ethnicity, race, stage, income, Charlson score, county of residence). The cohort included 3223 email users and 3223 non‐email users. The primary outcome was overall 2‐year survival stratified by email use. Secondary outcomes included number of face‐to‐face visits, prescriptions, and telephone calls. The healthcare teams' response to emails and other forms of communication was also investigated. Finally, a quality measure related to chemotherapy‐related inpatient and emergency department visits was evaluated. Results: Overall 2‐year survival was higher in patients who were email users, with an adjusted hazard ratio of 0.80 (95 CI 0.72–0.90; p < 0.001). Email users had higher rates of healthcare utilization, including face‐to‐face visits (63 vs. 50; p < 0.001), drug prescriptions (28 vs. 21; p < 0.001), and phone calls (18 vs. 16; p < 0.001). Clinical quality outcome measure of inpatient use was better among email users (p = 0.015). Conclusion: Patient‐initiated emails are associated with a survival benefit among cancer patients receiving chemotherapy and may be a proxy for patient engagement. As value‐based payment models emphasize incorporating the patients' voice into their care, email communications could serve as a novel source of patient‐generated data. [ABSTRACT FROM AUTHOR]

Background: To compare the predictive value of the current AJCC stage grouping for renal cell carcinoma (RCC) to our modifications. Patients and methods: A total of 2120 patients with RCC from Fudan University Shanghai Cancer Center (FUSCC) database and 74 506 counterparts from SEER database were included. Cox regression was used to calculate the relative impacts between prognostic groups. The predictive accuracy of overall survival (OS) was assessed using the concordance index (C‐index), which was compared by likelihood ratio test. Results: In FUSCC cohort, the 5‐year‐OS rate for T3N0M0 patients was higher than T1‐3N1M0 (72.7% vs 38.1%). The 5‐year‐OS rate for T4N0M0 was 36.2%, which was close to T1‐3N1M0 but not to T4N1M0 (0%) and TanyNanyM1 (12.6%). The elements of AJCC groups were regrouped according to the ranks of hazard ratios. The modified stages II (T3N0M0), III (T1‐3N1M0, T4N0M0), and IV (T4N1M0, TanyNanyM1) exhibited greater survival stratification than AJCC groups. The modifications were validated in SEER cohort and yielded similar survival outcomes. The predictive accuracy of OS in modified prognostic groups was significantly higher than AJCC groups in stages II‐IV subgroups in both FUSCC (C‐index: 0.801 vs 0.779, P < 0.001) and SEER cohort (C‐index: 0.770 vs 0.764, P < 0.001). Conclusions: The modified AJCC prognostic groups for RCC provided significantly improved survival prediction compared with the 8th AJCC edition. A precise risk stratification of modified stages II‐IV disease provides an important basis for risk‐equivalent treatment recommendation. (a) We refined AJCC prognostic groups for RCC and proved it to be a more precise prediction of overall survival. (b) The modification of 8th AJCC staging systems brings new insights on the next version of the AJCC Staging System and adjuvant therapies in future RCTs. [ABSTRACT FROM AUTHOR]

Abstract: The relationship between marital status and glioblastoma multiforme (GBM) has not been addressed in depth. Here, we aimed to investigate the association between marital status and survival in GBM. We searched the Surveillance, Epidemiology, and End Results (SEER) database and extracted the data of eligible patients diagnosed with GBM after 2004. Marital status was classified as married, divorced/separated, widowed, and single. A Kaplan‐Meier test was conducted to compare the survival curves of different groups. Multivariate Cox regression was performed to evaluate overall survival (OS) and cause‐specific survival (CSS) in different groups. Subgroup analysis was applied according to demographics, typical education and income levels in the locale, and insurance status. A total of 30 767 eligible patients were included. The median OS values were 9, 7, 3, 9 months in married, divorced/separated, widowed, and single patients, respectively. After adjustment for other covariates, married patients had better OS and CSS than other patients had. In addition to marital status, demographic factors, disease progression factors, local educational level, and insurance status were also associated with survival in GBM. Furthermore, subgroup analyses revealed the protective effect of marriage in most of the comparisons. Notably, the protective effect of marriage becomes more and more apparent as time goes on. The advantageous effect of marriage on GBM survival is especially prominent in patients who are male, older than 60 years of age, White, or living in middle‐income counties. In conclusion, marital status is an independent prognostic factor for GBM. [ABSTRACT FROM AUTHOR]

Abstract: Follicular lymphoma (FL) is the most frequent indolent lymphoma in Western countries, but it is less frequent in Asia. Several trials have demonstrated the progression‐free benefit of rituximab maintenance for FL patients in Western countries. However, the overall survival (OS) benefits and effectiveness of rituximab maintenance in Asian FL patients remain uncertain. We utilized the Taiwan Cancer Registry Database and the National Health Insurance Research Database to investigate the roles of rituximab maintenance for newly diagnosed FL patients in Taiwan. Among 836 patients with newly diagnosed FL during 2009‐2012, we enrolled patients with stage II‐IV diseases receiving 4‐8 cycles of rituximab‐containing induction chemotherapies (R‐induction). We excluded those who died or received additional chemotherapy within 180 days after R‐induction. Among the 396 enrolled patients, 260 underwent rituximab maintenance (R‐maintenance group), and 136 served as the observation group. The R‐maintenance group received less anthracycline and fewer cycles of R‐induction than the observation group, but they exhibited a significantly better OS both in the univariate and multivariate analyses [hazard ratio, 0.42; 95% confidence interval, 0.19‐0.91] after adjusting for age, sex, and Ann Arbor stages. Meanwhile, we also found more patients required further therapies in the first 6 months after the cease of rituximab maintenance. In the subgroup analysis, patients older than 60 years or with stage IV diseases benefited more from rituximab maintenance. Conclusively, our nationwide study is the first one to demonstrate the OS benefit of rituximab maintenance after induction therapies in newly diagnosed FL patients from Asian populations. [ABSTRACT FROM AUTHOR]

There are controversies in the comparison of overall survival between invasive micropapillary carcinoma of the breast ( IMPC) and invasive ductal carcinoma ( IDC). The objective of this study was to compare the long-term survival outcome between non-metastatic IMPC and IDC. The Surveillance, Epidemiology, and End Results database was searched to identify women with non-metastatic IMPC and IDC diagnosed between 2001 and 2013. Comparisons of patient and tumor characteristics were performed using Pearson's chi-square. The propensity score matching method was applied with each IMPC matched to one IDC. Breast cancer-specific survival ( BCSS) and overall survival ( OS) were estimated using the Kaplan-Meier product limit method and compared across groups using the log-rank statistic. Multivariate analysis was performed through Cox models. IMPC was presented with aggressive clinical presentations such as larger tumor, more positive lymph nodes, and more advanced stage compared with IDC. A higher rate of estrogen receptor ( ER)/progesterone receptor ( PR) positivity was also observed in IMPC. With a median follow-up of 64 months, IMPC had a better BCSS ( P = 0.031) and OS ( P = 0.012) compared with IDC. In a case-control analysis IMPC was still an independent favorable prognostic factor for BCSS ( HR = 0.410, P < 0.001, 95% CI: 0.293-0.572) and OS ( HR = 0.497, P < 0.001, 95% CI: 0.387-0.637). In subgroup analysis, IMPC always showed a better survival outcome compared with IDC except in AJCC stage I and histologic grade I disease. IMPC has a better long-term survival outcome compared with IDC in spite of its highly aggressive clinical presentation. [ABSTRACT FROM AUTHOR]

PIK3 CA mutation represents a clinical subset of diverse carcinomas. We explored the status of PIK3 CA mutation and evaluated its genetic variability, treatment, and prognosis in patients with lung adenocarcinoma. A total of 810 patients with completely resected lung adenocarcinoma were recruited between 2008 and 2013. The status of PIK3 CA mutation and other three genes, that is, EGFR mutation, KRAS mutation and ALK fusion were examined by reverse transcription-polymerase chain reaction ( RT- PCR). Survival curves were plotted with the Kaplan-Meier method and log-rank for comparison. Cox proportional hazard model was performed for multivariate analysis. Among the 810 patients, 23 cases of PIK3 CA mutation were identified with a frequency of 2.8%. There were 14 men and 9 women with a median age of 61 years. Seventeen tumors revealed concurrent gene abnormalities of EGFR mutation ( n = 12), KRAS mutation ( n = 3), and ALK fusion ( n = 2). Seven patients with EGFR & PIK3CA mutations recurred and administrated of EGFR-TKIs yielded a median progression free-survival of 6.0 months. Among four eviromous-treated patients, stable disease was observed in three patients with a median Progression-free survival ( PFS) of 3.5 months. Patients with and without PIK3 CA mutation had different overall survivals (32.2 vs. 49.6 months, P = 0.003). Multivariate analysis revealed that PIK3 CA mutation was an independent predictor of poor overall survival ( HR = 2.37, P = 0.017). The frequency of PIK3 CA mutation was around 2.8% in the Chinese patients of lung adenocarcinoma. PIK3 CA mutation was associated with reduced PFS of EGFR- TKIs treatment and shorter overall survival. [ABSTRACT FROM AUTHOR]