A retrospective analysis of treatment patterns, overall survival, and real-world disease-free survival in early-stage non-small cell lung cancer following complete resection
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ABSTRACT:
SUBMITTER: Hu X
PROVIDER: S-EPMC11234548 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundEarly-stage colorectal cancer (CRC) patients treated with either endoscopic resection (ER) alone or combined ER with chemoradiotherapy (CRT) have unknown survival rates. A national descriptive epidemiological study was conducted to compare the long-term survival of patients with T1 stage CRC with or without the two different treatment options.MethodsOur study identified the records of patients with T1-stage CRC between 2010 and 2018 by searching the Surveillance, Epidemiology, and End Results (SEER) database. Long-term survival was compared using Kaplan-Meier methods and Cox proportional hazard models based on patient demographic and cancer parameters.ResultsAfter propensity score matching (PSM), 825 T1-stage CRC patients were finally enrolled in this study, with 718 patients treated with ER and 107 patients treated with ER + CRT. The overall survival (OS) and cancer specific survival (CSS) rates were similar between the two treatment options (OS: P=0.47; CSS: P=0.28). According to subgroup analysis, older patients and patients with rectal tumor locations exhibited significantly higher OS and CSS rates in the ER + CRT group than in the ER group (OS: P<0.0001; CSS: P<0.0001).ConclusionsThe findings from the SEER database showed that OS and CSS rates were similar between the ER and ER + CRT treated groups. Older patients and patients with rectal cancer benefited the most from ER + CRT treatment.
| S-EPMC10928597 | biostudies-literature
Project description:PurposeThe utility of real-world data (RWD) for use as external controls in drug development is informed by studies that replicate trial control arms for different endpoints. The purpose of this study was to replicate control arms from four non-small cell lung cancer (NSCLC) randomized controlled trials (RCT) to analyze overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) using RWD.Patients and methodsThis study used RWD from a nationwide de-identified database and a clinico-genomic database to replicate OS, PFS, and ORR endpoints in the chemotherapy control arms of four first-line NSCLC RCTs evaluating atezolizumab [IMpower150-wild-type (WT), IMpower130-WT, IMpower131, and IMpower132]. Additional objectives were to develop a definition of real-world PFS (rwPFS) and to evaluate the real-world response rate (rwRR) endpoint.ResultsBaseline demographic and clinical characteristics were balanced after application of propensity score weighting methods. For rwPFS and OS, RWD external controls were generally similar to their RCT control counterparts. Across all four trials, the hazard ratio (HR) point estimates comparing trial controls with external controls were closer to 1.0 for the PFS endpoint than for the OS endpoint. An exploratory assessment of rwRR in RWD revealed a slight but nonsignificant overestimation of RCT ORR, which was unconfounded by baseline characteristics.ConclusionsRWD can be used to reasonably replicate the OS and PFS of chemotherapy control arms of first-line NSCLC RCTs. Additional studies can provide greater insight into the utility of RWD in drug development.
| S-EPMC9355621 | biostudies-literature
Project description:BackgroundEstablishing surrogate endpoints for overall survival (OS) may expedite assessment of new therapies in esophageal cancer (EC) and gastroesophageal junction cancer (GEJC). This study aimed to evaluate disease-free survival (DFS) as a surrogate endpoint for OS.MethodsPatients from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database aged ≥66 years with resection after primary diagnosis of stage 2 or 3 EC/GEJC between 2009 and 2017 were analyzed (N = 925; median follow-up 26.2 months). Surrogacy was assessed by evaluating individual level associations between DFS and OS using Spearman's rank correlation and the association between treatment effects by Pearson's correlation coefficient. To evaluate the association between treatment effects, patients were classified in synthetic clusters based on treatments received. Propensity score matching addressed imbalances in baseline characteristics between treatment and control groups in the clusters. Predictive performance of the surrogacy equation was assessed internally for the generated clusters via leave-one-out cross-validation and externally via predictions for 26 clinical trials of early-stage EC/GEJC.ResultsPatients were mostly male (84%), non-Hispanic white (89.3%), with median age 71.8 years, and cancer stages 2 (50.4%) and 3 (49.6%). Cancer types were adenocarcinoma (76.1%), squamous cell carcinoma (10.4%), and other types (13.5%). Most patients 766/925 (82.8%) received neoadjuvant therapy (680/766 chemoradiotherapy versus 86/766 chemotherapy alone) while 23.6% of the patients received adjuvant therapy. Within each treatment setting, most [705/766 (92.0%) of neoadjuvant therapy and 178/218 (81.7%) of adjuvant therapy] received multi-agent chemotherapy. The individual level correlation was 0.76 (95% confidence interval 0.70-0.80). The correlation between treatment effects was 0.96 (95% confidence interval 0.80-0.99) with a corresponding surrogate threshold effect of 0.71. Both internal (91%) and external (89%) validation of the model demonstrated high predictive accuracy.ConclusionsCorrelations between DFS and OS were meaningful at both individual and treatment effect level. The derived surrogacy equation enables reliable early assessments of OS benefit from the observed DFS benefit for early-stage EC/GEJC treatments in real-world settings.
| S-EPMC11574803 | biostudies-literature
Project description:BackgroundThe surrogacy of progression-free survival (PFS) for overall survival (OS) in esophageal squamous cell carcinoma (ESCC) remains unelucidated. This study aimed to determine the validity of PFS as a surrogate endpoint for OS in ESCC patients treated with definitive radiotherapy or definitive chemoradiotherapy (dRT/dCRT), as well as characterize the prognostic factors and survival of such patients.MethodsA total of 3662 patients from 10 cancer centers were enrolled. One-, 2-, and 3-year PFS (PFS12, PFS24, and PSF36, respectively) were used as time points for analysis. At each time point, ESCC-specific mortality and OS were characterized using competing risk and conditional survival models, while correlation between PFS and OS was evaluated by linear regression.ResultsAt PFS12, PFS24, and PFS36, a progressive decrease in 5-year ESCC-specific mortality (35.2%-13.4%) and increase in 5-year OS (46.6%-62.9%) were observed. Regardless, the OS of patients remained markedly lower than those of the age- and sex-matched Chinese general population. TNM stage remained a significant prognostic factor at PFS36. Strong correlation was found between 3-year PFS and 5-year OS, which was further externally validated.ConclusionsThree-year PFS may act as a potential surrogate endpoint for 5-year OS. TNM stage was considered a significant prognostic factor for OS, and may represent the optimal prognostic tool to guide clinical decision-making and post-treatment follow-up.
| S-EPMC9619262 | biostudies-literature
Project description: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.
| S-EPMC6089160 | biostudies-literature
Project description:PurposeThis study aimed to analyze the risk factors and survival prognosis of local recurrence in stage II-III colorectal cancer (CRC) and develop a clinical risk calculator and nomograms to predict local recurrence and survival in treated patients.MethodsPatients who underwent radical surgery between January 2009 and December 2019 at the China National Cancer Center were included. Multivariate nomograms and a clinical risk calculator based on Cox regression were developed. Discrimination was measured with an area under curve (AUC) and variability in individual predictions was assessed with calibration curves. We stratified patients into different risk groups according to the established model to predict their prognosis and guide clinical practice.ResultsThe clinical risk calculator incorporated six variables: tumor thrombus, perineural invasion, tumor grade, pathology T-stage, pathology N-stage, and whether more than 12 lymph nodes were harvested. Our clinical risk calculator provided good discrimination, with AUC values of local recurrence-free survival (LRFS) (0.764) and overall survival (OS) (0.815) in the training cohort and LRFS (0.740) and OS (0.730) in the test cohort. Calibration plots illustrated excellent agreement between the clinical risk calculator predictions and actual observations for 3- and 5-year LRFS and OS. Recurrence risk-stratified analysis showed that low-risk patients were more likely to undergo salvage radical surgery when recurrent disease existed.ConclusionThe clinical calculator can better account for tumor and patient heterogeneity, providing a more individualized outcome prognostication. The model is expected to aid in treatment planning, such as resectability evaluation, and it can be used in postoperative surveillance (https://oldcoloncancer.shinyapps.io/dynnomapp/).
| S-EPMC11835698 | biostudies-literature
Project description:Importance:Adjuvant chemotherapy (AC) in patients with rectal cancer with pathologic complete response following neoadjuvant chemoradiotherapy (nCRT) and resection is recommended by treatment guidelines. However, its role in this setting is equivocal because data supporting benefits are lacking. Objective:To compare the overall survival (OS) between AC and postoperative observation (OB) in patients with rectal cancer with pathologic complete response following nCRT and resection. Design, Setting, and Participants:We identified a cohort of patients with rectal cancer and a complete pathological response (ypT0N0) after nCRT in the National Cancer Database between 2006 and 2012. Patients who received AC were compared with OB patients by propensity score matching. Overall survival was compared using the stratified log-rank test and stratified Cox regression model. The outcomes after AC vs OB were also evaluated in patient subgroups. The data analysis was completed in June 2017. Exposures:Adjuvant chemotherapy and OB. Main Outcomes and Measures:Overall survival. Results:We identified 2764 patients (mean [SD] age, 60.0 [12.3] years; 40% female) with clinical stage II or III resected adenocarcinoma of the rectum who had received nCRT and were complete responders (ypT0N0M0). Of this cohort, 741 patients in the AC group were matched by propensity score to 741 patients who underwent OB. The AC cohort had better OS compared with the OB cohort (hazard ratio, 0.50; 95% CI, 0.32-0.79). The 1-, 3-, and 5-year OS rates were 99.7%, 97.1%, and 94.7% for the AC group and 99.2%, 93.6%, and 88.4% for the OB group (P = .005). In subgroup analysis, patients with clinical stage T3/T4 and node-positive disease benefited most from AC (hazard ratio, 0.47; 95% CI, 0.25-0.91). Conclusions and Relevance:Adjuvant chemotherapy was associated with improved OS in patients with pathologic complete response after nCRT for resected locally advanced rectal cancer. This study supports the use of AC in this setting where there is currently paucity of data.
| S-EPMC6145733 | biostudies-literature
Project description:BackgroundThe efficacy of prophylactic cranial irradiation (PCI) is still controversial in small cell lung cancer (SCLC) patients with pT1-2N0M0 disease after complete resection. The majority of previous studies haven't discerned the potential benefit of PCI in this subgroup of patients, probably due to the paucity of these patients and distinct treating modalities. The aim of this study is to demonstrate the potential medical benefit of PCI in these patients.MethodsA retrospective study was conducted to evaluate the potential benefit of PCI in pT1-2N0M0 SCLC patients after complete resection. We retrospectively reviewed 112 pT1-2N0M0 SCLCs after complete resection and adjuvant chemotherapy between January 2013 and January 2022. Survival and Cox regression analysis were conducted to elucidate the potential medical benefit of PCI in these patients.ResultsThe median overall survival (OS) has not been reached. The 2-year, 5-year, 8-year OS rate was 93.7%, 73.2%, and 65.7%, respectively. Brain metastasis (BM) was observed in 17.0% (19/112) patients during the process of follow-up. PCI significantly decreased the BM actuarial risk from 23.9 to 4.9% (log-rank p = 0.0097, HR = 0.180, 95% CI: 0.041-0.778). The brain metastasis free survival (BMFS, log-rank p = 0.02) and OS (log-rank p = 0.05) in PCI cohort were also significantly longer than that of non_PCI group. Cox analysis demonstrated that PCI was an independent prognostic factor in both BM actuarial risk (HR = 0.198, 95% CI: 0.046-0.859, p = 0.031) and BMFS (HR = 0.387, 95% CI: 0.169-0.890, p = 0.025). Moreover, T2 patients showed a significant superior prognosis in terms of BM actuarial risk with comparison to those with T1 disease in non_PCI cohort (log-rank p = 0.016, HR = 3.345, 95% CI: 1.177-9.511), whereas the difference could not be observed in PCI cohort.ConclusionsPCI was significantly associated with a better clinical outcome in pT1-2N0M0 SCLC patients who received complete resection and adjuvant chemotherapy, especially in T2 patients.
| S-EPMC11829441 | biostudies-literature
Project description:ImportanceAdrenocortical carcinoma (ACC) is a rare but aggressive endocrine tumor, and the prognostic factors associated with long-term outcomes after surgical resection remain poorly defined.ObjectivesTo define clinicopathological variables associated with recurrence-free survival (RFS) and overall survival (OS) after curative surgical resection of ACC and to propose nomograms for individual risk prediction.Design, setting, and participantsNomograms to predict RFS and OS after surgical resection of ACC were proposed using a multi-institutional cohort of patients who underwent curative-intent surgery for ACC at 13 major institutions in the United States between March 17, 1994, and December 22, 2014. The dates of our study analysis were April 15, 2015, to May 12, 2015.Main outcomes and measuresThe discriminative ability and calibration of the nomograms to predict RFS and OS were tested using C statistics, calibration plots, and Kaplan-Meier curves.ResultsIn total, 148 patients who underwent surgery for ACC were included in the study. The median patient age was 53 years, and 65.5% (97 of 148) of the patients were female. One-third of the patients (35.1% [52 of 148]) had a functional tumor, and the median tumor size was 11.2 cm. Most patients (77.7% [115 of 148]) underwent R0 resection, and 8.8% (13 of 148) of the patients had N1 disease. Using backward stepwise selection of clinically important variables with the Akaike information criterion, the following variables were incorporated in the prediction of RFS: tumor size of at least 12 cm (hazard ratio [HR], 3.00; 95% CI, 1.63-5.70; P < .001), positive nodal status (HR, 4.78; 95% CI, 1.47-15.50; P = .01), stage III/IV (HR, 1.80; 95% CI, 0.95-3.39; P = .07), cortisol-secreting tumor (HR, 2.38; 95% CI, 1.27-4.48; P = .01), and capsular invasion (HR, 1.96; 95% CI, 1.02-3.74; P = .04). Factors selected as predicting OS were tumor size of at least 12 cm (HR, 1.78; 95% CI, 1.00-3.17; P = .05), positive nodal status (HR, 5.89; 95% CI, 2.05-16.87; P = .001), and R1 margin (HR, 2.83; 95% CI, 1.51-5.30; P = .001). The discriminative ability and calibration of the nomograms revealed good predictive ability as indicated by the C statistics (0.74 for RFS and 0.70 for OS).Conclusions and relevanceIndependent predictors of survival and recurrence risk after curative-intent surgery for ACC were selected to create nomograms predicting RFS and OS. The nomograms were able to stratify patients into prognostic groups and performed well on internal validation.
| S-EPMC4967352 | biostudies-literature
Project description:BackgroundSupratotal resection is advocated in lower-grade gliomas (LGGs) based on theoretical advantages but with limited verification of functional risk and data on oncological outcomes. We assessed the association of supratotal resection in molecularly defined LGGs with oncological outcomes.MethodsIncluded were 460 presumptive LGGs; 404 resected; 347 were LGGs, 319 isocitrate dehydrogenase (IDH)-mutated, 28 wildtype. All patients had clinical, imaging, and molecular data. Resection aimed at supratotal resection without any patient or tumor a priori selection. The association of extent of resection (EOR), categorized on volumetric fluid attenuated inversion recovery images as residual tumor volume, along with postsurgical management with progression-free survival (PFS), malignant (M)PFS, and overall survival (OS) assessed by univariate, multivariate, and propensity score analysis. The study mainly focused on IDH-mutated LGGs, the "typical LGGs."ResultsMedian follow-up was 6.8 years (interquartile range, 5-8). Out of 319 IDH-mutated LGGs, 190 (59.6%) progressed, median PFS: 4.7 years (95% CI: 4-5.3). Total and supratotal resection obtained in 39% and 35% of patients with IDH1-mutated tumors. In IDH-mutated tumors, most patients in the partial/subtotal group progressed, 82.4% in total, only 6 (5.4%) in supratotal. Median PFS was 29 months (95% CI: 25-36) in subtotal, 46 months (95% CI: 38-48) in total, while at 92 months, PFS in supratotal was 94.0%. There was no association with molecular subtypes and grade. At random forest analysis, PFS strongly associated with EOR, radiotherapy, and previous treatment. In the propensity score analysis, EOR associated with PFS (hazard ratio, 0.03; 95% CI: 0.01-0.13). MPFS occurred in 32.1% of subtotal total groups; 1 event in supratotal. EOR, grade III, previous treatment correlated to MPFS. At random forest analysis, OS associated with EOR as well.ConclusionsSupratotal resection strongly associated with PFS, MPFS, and OS in LGGs, regardless of molecular subtypes and grade, right from the beginning of clinical presentation.
| S-EPMC8099476 | biostudies-literature