Changing paradigm in oncology clinical trials: Cox-TEL—Adjustment made ready for early crossover and tail tale.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15067-e15067
Author(s):  
Emily Pei-Ying Lin ◽  
Chih-Yuan Hsu ◽  
Pan-Chyr Yang ◽  
Yu Shyr
Keyword(s):  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Survival Curve ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Poor Responders ◽  
Term Survival ◽  
Study Results ◽  
Before And After ◽  
Oncology Clinical Trials

e15067 Background: Approvals of immune checkpoint inhibitors (ICI) were made based on positive clinical trial results analyzed by the Cox proportional hazards (PH) model. With ICI data, however, long tails and early crossover in survival curves, which violate the Cox PH assumption, can lead to misinterpretation of clinical significance of findings. Here we introduce the Cox-TEL and show the differences of study results before and after Cox-TEL adjustment using KEYNOTE 042 and 045 as examples. Methods: Cox-TEL is built on the mathematical foundation of Taylor expansion. As an easily implemented alternative of PH cure model, it not only infers associations between survival probabilities of the two study arms among patients without long-term survival (poor-responders), but also estimates differences in proportion (DP) between arms among patients in the long-tail segment of the survival curve (true-responders). Results: In KEYNOTE 042, the Cox-TEL HRs for death were statistically insignificant across all subgroups. The trend of DP, on the other hand, is positively related to that of PD-L1 TPS and inverted related to that of Cox HR when the PD-L1 ≥50% cohort is covered. In KEYNOTE 045, the Cox-TEL HRs suggested that for the poor-responders, pembrolizumab did not do better than chemotherapy in terms of overall survival (OS) and might do harm to the patients in terms of progression-free survival (PFS). For the true-responders, DPs of OS and PFS were both statistically significant (Table). Conclusions: Our data demonstrated the biases derived from insufficient data analyses and strengthened the necessity of analytic model revisits in the new oncology era of which cure for advanced cancers is no longer impossible. [Table: see text]

Impact of timing of antibiotic use on clinical outcomes in patients with urothelial cancer treated with immune checkpoint inhibitors (ICIs).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5045-5045
Author(s):  
Chana Weinstock ◽  
Pradeep Bandaru ◽  
Laura L Fernandes ◽  
Elaine Chang ◽  
Andrew Girvin ◽  
...  
Keyword(s):  
Urothelial Cancer ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Drug Approval ◽  
Antibiotic Use ◽  
Cox Proportional Hazards ◽  
Exploratory Analysis ◽  
Baseline Risk ◽  
Study Results

5045 Background: Although recent evidence has suggested that patients who receive antibiotics (ABX) during the course of ICI treatment might decrease overall survival (OS) (1), our previous analysis did not support a difference in OS in urothelial cancer patients who did and did not use ABX during the course of ICI treatment without regard to timing (2). This updated analysis aims to addresses the question of timing; specifically, use of ABX in the 30-day window pre- or post- initiation of ICI treatment. Methods: We pooled data from 7 trials that led to drug approval and which included 1747 patients with advanced urothelial cancer treated with an ICI. Five trials enrolled patients who received prior platinum and 2 enrolled cisplatin-ineligible patients. Concomitant medication datasets were searched for systemic ABX use. The association between ABX use and survival was evaluated using Kaplan-Meier estimates and Cox proportional hazards regression models stratified by study. Results: Overall, 56% of patients were exposed to antibiotics (ABX+) and 43% were not exposed (ABX-). In an exploratory analysis, median OS was similar between arms: 9.7 vs. 9.3 months in ABX+ vs. ABX- patients, respectively (HR 0.96). However, OS results differed in the 27% of patients who were exposed to antibiotics in the 30-day window pre- or post- initiation of ICI treatment, for whom median OS was 4.7 months vs. 11.5 months in the ABX+ vs. ABX- patients, respectively (HR 1.8). This remained true after controlling for baseline risk prognostic factors (Bajorin and Bellmunt scores). Similar trends were observed for progression-free survival (PFS). Conclusions: Patients treated with ABX while on therapy with an ICI for urothelial cancer had similar OS outcomes to those not treated with ABX. However, in an exploratory analysis looking at ABX use in the 30-day window pre- or post-initiation of ICI treatment, OS appeared decreased in ABX+ vs ABX- patients. Our exploratory analyses appear to show an association of OS/PFS with timing of antibiotics. References: 1) Routy B, Science (2017) 2) Weinstock C, ASCO 2019, abstract. [Table: see text]

scholarly journals Immune Checkpoint Inhibitors versus VEGF Targeted Therapy as Second Line Regimen in Advanced Hepatocellular Carcinoma (HCC): A Retrospective Study

2020 ◽  
Vol 9 (9) ◽  
pp. 2682
Author(s):  
Anwaar Saeed ◽  
Hannah Hildebrand ◽  
Robin Park ◽  
Mohammed Al-Jumayli ◽  
Saqib Abbasi ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Kinase Inhibitors ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Survival Curve ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line ◽  
Treatment Optimization

Several targeted agents including multi-tyrosine kinase inhibitors (mTKIs) and immunotherapy (IO) agents have been approved for use beyond the frontline setting in patients with advanced hepatocellular carcinoma (HCC). Due to lack of prospective head-to-head comparative trials, there is no standardized way for alternating those agents beyond frontline. Therefore, we performed a retrospective review of the Kansas University (KU) cancer registry to determine whether IO may be superior to non-IO therapy. Patients with advanced HCC were divided into two groups based on the second-line systemic regimen received (IO vs. non-IO). Progression-free survival (PFS) and overall survival (OS) were calculated under the Kaplan–Meier and Cox proportional hazards models. No statistically significant differences in PFS and OS were found, although a non-significant delayed separation in the survival curve favoring IO was identified (median PFS 3.9 months vs. 3 months; median OS 10 months vs. 10 months respectively for IO vs. non-IO). This retrospective analysis is one of the earliest and largest studies comparing second-line IO and non-IO therapies thus far reported. Future studies should aim to define specific biomarkers for response prediction and treatment optimization based on individual patient and tumor characteristics. Furthermore, combinatorial therapeutic strategies is an evolving approach showing early promising signal.

The Relationship of Diabetes Mellitus to Efficacy of Immune Checkpoint Inhibitors in Patients with Advanced Non-Small Cell Lung Cancer

Oncology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Oded Jacobi ◽  
Yosef Landman ◽  
Daniel Reinhorn ◽  
Oded Icht ◽  
Michal Sternschuss ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Negative Relationship ◽  
Progression Free Survival ◽  
Significant Negative Correlation ◽  
Cox Proportional Hazards ◽  
Diabetic Patients

<b><i>Introduction:</i></b> Immune checkpoint inhibitors (ICI) are the new standard therapy in patients with metastatic NSCLC (mNSCLC). Metformin, previously associated with improved chemotherapy efficacy in diabetic and nondiabetic cancer patients, was recently associated with increased ICI efficacy. In this study, we aimed to explore the correlations between diabetes mellitus (DM), metformin use, and benefit from ICI in mNSCLC patients. <b><i>Methods:</i></b> All mNSCLC patients treated with ICI in our center between February 2015 and April 2018 were identified. Demographic and clinical data were extracted retrospectively. Cox proportional hazards regression, <i>t</i> tests, and χ<sup>2</sup> tests were employed to evaluate associations of progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and disease control rate (DCR), with DM status, metformin use, and HbA1c levels, as appropriate. <b><i>Results:</i></b> Of 249 mNSCLC patients treated with ICI, 57 (22.8%) had DM. Thirty-seven (64.9% of all diabetic patients) patients were treated with metformin. A significant negative correlation of DM with PFS and OS was demonstrated (HR 1.5 [1.01–2.06], <i>p</i> = 0.011, and HR 1.5 [1.08–2.08], <i>p</i> = 0.017, respectively). Metformin exposure had no significant correlation with PFS or OS in diabetic mNSCLC patients (HR 1.08 [0.61–1.93], <i>p</i> = 0.79, and HR 1.29 [0.69–2.39], <i>p</i> = 0.42, respectively). There were no differences between groups with respect to ORR and DCR. <b><i>Conclusion:</i></b> Our data show a potential negative relationship between DM and ICI efficacy in mNSCLC patients. In contrast to reports with chemotherapy, we found no positive relationship between metformin use and ICI therapy in diabetic patients with mNSCLC. Further studies are needed to evaluate the effect of metformin in nondiabetic mNSCLC patients.

scholarly journals Individualized Prediction of Survival Benefits of Pancreatectomy Plus Chemotherapy in Patients With Simultaneous Metastatic Pancreatic Cancer

2021 ◽  
Vol 11 ◽  
Author(s):  
Duorui Nie ◽  
Guihua Lai ◽  
Guilin An ◽  
Zhuojun Wu ◽  
Shujun Lei ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Tumor Size ◽  
Proportional Hazards ◽  
Survival Curve ◽  
Characteristic Curve ◽  
Cox Proportional Hazards ◽  
Metastatic Pancreatic Cancer ◽  
Calibration Plot ◽  
Term Survival ◽  
Good Ability

BackgroundMetastatic pancreatic cancer (mPC) is a highly lethal malignancy with poorer survival. However, chemotherapy alone was unable to maintain long‐term survival. This study aimed to evaluate the individualized survival benefits of pancreatectomy plus chemotherapy (PCT) for mPC.MethodsA total of 4546 patients with mPC from 2004 to 2015 were retrieved from the Surveillance, Epidemiology, and End Results database. The survival curve was calculated using the Kaplan-Meier method and differences in survival curves were tested using log-rank tests. Cox proportional hazards regression analyses were performed to evaluate the prognostic value of involved variables. A new nomogram was constructed to predict overall survival based on independent prognosis factors. The performance of the nomogram was measured by concordance index, calibration plot, and area under the receiver operating characteristic curve.ResultsCompared to pancreatectomy or chemotherapy alone, PCT can significantly improve the prognosis of patients with mPC. In addition, patients with well/moderately differentiated tumors, age ≤66 years, tumor size ≤42 mm, or female patients were more likely to benefit from PCT. Multivariate analysis showed that age at diagnosis, sex, marital status, grade, tumor size, and treatment were independent prognostic factors. The established nomogram has a good ability to distinguish and calibrating.ConclusionPCT can prolong survival in some patients with mPC. Our nomogram can individualize predict OS of pancreatectomy combined with chemotherapy in patients with concurrent mPC.

scholarly journals Reductions in AFP and PIVKA-II can predict the efficiency of anti-PD-1 immunotherapy in HCC patients

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xuqi Sun ◽  
Jie Mei ◽  
Wenping Lin ◽  
Ziliang Yang ◽  
Wei Peng ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Objective Response ◽  
Binary Logistic Regression ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Related Factors ◽  
Hazards Model ◽  
Before And After

Abstract Background Few biomarkers can predict the efficiency of PD-1 blockade in patients with hepatocellular carcinoma (HCC). This study aimed to investigate the prognostic role of AFP and PIVKA-II in HCC patients receiving anti-PD-1 immunotherapy. Methods A total of 235 HCC patients treated with PD-1 blockade were enrolled. Serum AFP and PIVKA-II levels were collected before and after treatments. The patients were divided into groups based on the reduction in AFP and PIVKA-II: AFP reduction ≤50% vs AFP reduction > 50% and PIVKA-II reduction ≤50% vs PIVKA-II reduction > 50%. The primary endpoints included objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Binary logistic regression analyses were used to explore the related factors of ORR. A Cox proportional hazards model was employed to identify the potential prognostic factors of PFS and OS. Results Among all the patients, 34.9% (82/235) achieved a complete or partial response. There was a positive correlation between AFP reduction > 50% or PIVKA-II reduction> 50% and the ORR of PD-1 blockade (P < 0.001 and = 0.003). PFS was significantly improved in patients with AFP reduction > 50% and PIVKA-II reduction > 50% (p < 0.001 and = 0.021). In addition, AFP reduction > 50% and PIVKA-II reduction> 50% were positively correlated with longer OS (p = 0.003 and 0.006). Conclusion Early reductions in AFP and PIVKA-II can be predictors of the efficacy of PD-1 blockade in HCC patients.

Updated overall survival (OS) results from the phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2- advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1001-1001
Author(s):  
Dennis J. Slamon ◽  
Patrick Neven ◽  
Stephen K. L. Chia ◽  
Guy Heinrich Maria Jerusalem ◽  
Michelino De Laurentiis ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Term Survival ◽  
Free Survival ◽  
Hazards Model

1001 Background: The Phase III MONALEESA-3 trial (NCT02422615) previously demonstrated a statistically significant improvement in OS with RIB, a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i), plus FUL compared with placebo (PBO) plus FUL as first-line (1L) or second-line (2L) treatment in postmenopausal pts with HR+/HER2− ABC (median, not reached vs 40.0 mo; hazard ratio [HR], 0.72; 95% CI, 0.57-0.92, P =.00455). This analysis was final per the protocol; following the unblinding of the study, pts still on study treatment in the PBO arm were allowed to cross over to the RIB arm. We report an exploratory analysis of OS after an additional median 16.9 mo of follow-up, allowing for further characterization of long-term survival benefits of RIB. Methods: Postmenopausal pts with HR+/HER2− ABC were randomized 2:1 to receive RIB + FUL or PBO + FUL in 1L and 2L settings. Updated OS was evaluated by Cox proportional hazards model and summarized using Kaplan-Meier methods. Additional postprogression endpoints such as progression-free survival 2 (PFS2), time to chemotherapy (CT), and CT-free survival were also evaluated and summarized. Results: At the data cutoff (Oct 30, 2020), the median follow-up was 56.3 mo (min, 52.7 mo) and 68 (14.0%) and 21 (8.7%) patients were still on treatment in the RIB vs PBO arms, respectively. With this extended follow-up, RIB + FUL continued to demonstrate an OS benefit vs PBO + FUL (median, 53.7 vs 41.5 mo; HR, 0.73; 95% CI, 0.59-0.90). RIB + FUL had prolonged OS vs PBO + FUL in the 1L (median, not reached vs 51.8 mo; HR, 0.64; 95% CI, 0.46-0.88) and 2L subgroups (median, 39.7 vs 33.7 mo; HR, 0.78; 95% CI, 0.59-1.04). Subgroup analyses also showed a consistent OS benefit compared with the intent-to-treat (ITT) population for most subgroups. PFS2, time to CT, and CT-free survival for the ITT population favored RIB + FUL (Table). Among pts who discontinued study treatment, 81.9% and 86.4% received a next-line subsequent antineoplastic therapy, while 14.0% and 30.0% received a CDK4/6i as any subsequent line in the RIB vs PBO arms, respectively. No new safety signals were observed. Conclusions: The previously demonstrated robust and clinically meaningful OS benefit with RIB + FUL compared with PBO + FUL was maintained after almost 5 years of follow-up in postmenopausal pts with HR+/HER2− ABC. The OS benefit of RIB was observed in the 1L and 2L subgroups, which further supports the use of RIB in these populations. The results also demonstrated a significant delay in the use of subsequent CT with RIB vs PBO. Clinical trial information: NCT02422615 .[Table: see text]

Recurrent glioblastoma: Stratification of patient survival using tumor volume before and after antiangiogenic treatment.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 2075-2075 ◽  
Author(s):  
Raymond Huang ◽  
Rifaquat Rahman ◽  
Alhafidz Hamdan ◽  
Caroline Kane ◽  
Christina Chen ◽  
...  
Keyword(s):  
Overall Survival ◽  
Tumor Volume ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Recurrent Glioblastoma ◽  
Cox Proportional Hazards Model ◽  
Percentage Change ◽  
Before And After

2075 Background: Although antiangiogenic therapies can induce a dramatic clinical and imaging response in patients with recurrent glioblastoma, their benefit on overall survival is less pronounced. We assessed whether tumor volume based on magnetic resonance imaging (MRI) before and after treatment with bevacizumab can stratify patients in terms of progression-free survival (PFS) and overall survival (OS). Methods: Baseline and post-treatment MRI scans of 93 patients with recurrent glioblastoma treated with bevacizumab were evaluated for volume of the enhancing tumor, as well as volume of the T2/FLAIR hyperintensity. The Cox proportional hazards model was used in univariate and multivariate settings to identify volume parameters prognostic and predictive for PFS and OS. Results: Our results show that baseline enhancing tumor volume were predictive of PFS (p = 0.047) and OS (p = 0.011). Specifically, patients with pretreatment enhancing tumor volume less than 18 cm3 have a median OS of 45 weeks, while patients with tumor volume greater than 18 cm3 have a median OS of 26 weeks. In addition, enhancing tumor volume 3 to 6 weeks after treatment, as well as percentage change in volume, are independent predictors of PFS and OS. Neither T2/FLAIR volume nor percentage change in T2/FLAIR volume was associated with survival. Conclusions: These results indicate that measurement of enhancing tumor volume can help identify patients more likely to benefit from bevacizumab therapy.

Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 110-110 ◽  
Author(s):  
Sean Khozin ◽  
Mark S. Walker ◽  
Monika Jun ◽  
Li Chen ◽  
Edward Stepanski ◽  
...  
Keyword(s):  
Autoimmune Disease ◽  
Real World ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
The Impact

110 Background: Anecdotal and early evidence suggest ICIs are being used in patients with advanced malignancies and history of AD, despite such patients being typically excluded from traditional clinical trials. We compared the outcomes of patients with or without AD, all of whom had ICI treatment for aNSCLC. Methods: We conducted a retrospective, observational cohort study using de-identified, curated data in ASCO’s CancerLinQ. Patients with Stage III or IV NSCLC who received ≥1 dose of an ICI and had ≥2 visits from Jan 2011 to Nov 2018 were included. AD status prior to ICI treatment was identified using ICD-9/ICD-10 codes or AD medications (including steroids). Symphony claims data were linked via tokenization to build cohorts. Time to treatment discontinuation (TTD), time to next treatment (TTNT), real-world progression-free survival (rwPFS) and overall survival (OS) were compared across the two cohorts using the log-rank test. Cox Proportional Hazards Model was used to adjust for covariates. Adverse events (AEs) were compared using Chi-Square and Fisher’s Exact Test. Active AD was defined as evidence of autoimmune disease in the year prior to starting ICIs. Results: Among 2425 patients with aNSCLC treated with ICIs, AD was present in 22% (N=538). Median OS in all patients was 12.4 months (95% CI 11.3-13.5). TTD, TTNT, rwPFS and OS did not differ between the two cohorts (Table). There was no association between AD status and outcomes. There was no increased incidence of AEs in the AD group; however a sub-analysis among patients with active AD showed higher rates of select AEs including endocrine, GI and blood disorders. Conclusions: This analysis demonstrates that patients with evidence of AD prior to receiving ICI have similar outcomes compared to patients with no evidence of AD. Further research is needed to better understand the impact of active AD on the risk of AEs and patient outcomes. [Table: see text]

Response and outcomes to immune checkpoint inhibitors (ICI) in advanced urothelial cancer (aUC) based on prior intravesical BCG.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4537-4537
Author(s):  
Rafee Talukder ◽  
Dimitrios Makrakis ◽  
Daniel Castellano ◽  
Vadim S Koshkin ◽  
Ajjai Shivaram Alva ◽  
...  
Keyword(s):  
Risk Score ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Prior Exposure ◽  
Treatment Line ◽  
Intravesical Bcg ◽  
Selection For

4537 Background: Little is known regarding response and outcomes to ICI for patients (pts) with aUC who were previously treated with BCG for non-muscle invasive bladder cancer. We hypothesized that prior intravesical BCG would not be associated with changes in objective response or survival in pts with aUC treated with ICI. Methods: We performed a retrospective cohort study across 25 institutions. Demographic, intravesical BCG history, treatment and outcomes data were collected for pts with aUC who received ICI. Pts with aUC treated with ICIs were included, pts with pure non-UC, those treated with combination or on clinical trials, pts with multiple ICI treatment lines and those with upper tract UC were excluded. Pts were stratified to prior exposure versus no exposure to BCG. We compared overall response rate (ORR) using logistic regression; and progression-free survival (PFS) and overall survival (OS) using Kaplan-Meier and Cox proportional hazards. All analyses were performed in the overall population and further stratified by treatment line (first-line [1L] vs salvage [2+L]) and multivariable models. The stratified analysis was also adjusted for an internally developed risk score for 1L and Bellmunt risk score for 2+L; p<0.05 was significant. Results: 1026 aUC pts treated with ICI were identified; 614 pts, 617 pts, and 641 pts were included in ORR, OS and PFS analyses, respectively. Overall, mean age at CPI initiation was 70, 76% were men, 70% were current or former smokers, 75% White, 29% with mixed histology, and 24% had prior exposure to BCG. ORR to ICI in pts with or without prior exposure to BCG was similar, 27% and 28% respectively (OR=0.93 [95% CI 0.61-1.42], p=0.73). Median OS (mOS) for pts with vs without prior BCG exposure was 9 vs 10 mo (HR=1.13 [95% CI 0.88-1.44], p=0.35). Median PFS (mPFS) was 4 months (mo) in both groups (HR=1.02 [95% CI 0.82-1.27], p=0.83). ORR, PFS and OS analyses stratified by ICI treatment line (1L vs 2+L) are listed in the table. Conclusions: In this multi-institutional retrospective analysis, prior intravesical BCG was not associated with objective response or survival in pts with aUC treated with ICI. Limitations of this study include retrospective nature, lack of randomization and possible confounding, but it does provide important preliminary data that selection for ICI treatment should not be impacted by prior exposure to BCG. Further clinical and molecular biomarker exploration is needed to refine patient selection for ICI in aUC.[Table: see text]

Dynamic contrast-enhanced MRI histogram parameters predict progression-free survival in patients with advanced esophageal squamous carcinoma receiving concurrent chemoradiotherapy

2020 ◽  
Vol 61 (10) ◽  
pp. 1316-1325
Author(s):  
Lulu Xu ◽  
Xiaolin Ge ◽  
Nana Sun ◽  
Xisheng Liu
Keyword(s):  
Proportional Hazards ◽  
Squamous Carcinoma ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Poor Responders ◽  
Free Survival ◽  
Dce Mri ◽  
Dynamic Contrast Enhanced ◽  
Contrast Enhanced ◽  
Esophageal Squamous Carcinoma

Background There is increased interest in dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for predicting the outcomes of patients with advanced esophageal cancer. Purpose To explore whether DCE-MRI histogram parameters can predict 12-month progression-free survival (PFS) in patients with advanced esophageal squamous carcinoma receiving concurrent chemoradiation therapy (CRT). Material and Methods This retrospective study enrolled 134 patients with advanced esophageal squamous carcinoma who were receiving CRT. The pre-CRT DCE-MRI histogram parameters (median, mean, SD, skewness, kurtosis, and 10th and 90th percentiles) of Ktrans, Kep, and Ve were collected. PFS analyses were performed using the Kaplan–Meier method and log-rank tests to compute the survival curves. The significant prognostic predictors among the data characteristics and DCE-MRI parameters were determined using multivariate Cox proportional hazards regression analyses. Results There were 65 good responders (PFS ≥ 12 months) and 69 poor responders (PFS < 12 months). The median and mean values of Ktrans were higher, and the kurtosis value of Ktrans was lower in good responders. The median, mean, and 10th and 90th percentile values of Ktrans were higher, and the kurtosis values of Ktrans and Ve were lower in good responders. The PFS of patients aged ≥60 years, a CR effect, or a 10th percentile value of Ktrans ≥0.13 was increased ( P < 0.001, <0.001, and 0.014, respectively). Conclusion DCE-MRI histogram parameters can be used to evaluate the response to CRT in patients with advanced esophageal squamous carcinoma. The 10th percentile value of Ktrans has significant prognostic value for 12-month PFS.

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