scholarly journals Integrated exposure–response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer

2021 ◽  
Author(s):  
Carlos Fernández-Teruel ◽  
Salvador Fudio ◽  
Rubin Lubomirov
Keyword(s):  
Dose Regimen ◽  
Logistic Model ◽  
Cox Regression ◽  
Single Agent ◽  
Maximal Response ◽  
Response Analysis ◽  
Efficacy And Safety ◽  
Cox Regression Analysis ◽  
Exposure Response ◽  
Wide Range

Abstract Purpose These exposure–response (E–R) analyses integrated lurbinectedin effects on key efficacy and safety variables in relapsed SCLC to determine the adequacy of the dose regimen of 3.2 mg/m2 1-h intravenous infusion every 3 weeks (q3wk). Methods Logistic models and Cox regression analyses were applied to correlate lurbinectedin exposure metrics (AUCtot and AUCu) with efficacy and safety endpoints: objective response rate (ORR) and overall survival (OS) in SCLC patients (n = 99) treated in study B-005 with 3.2 mg/m2 q3wk, and incidence of grade 4 (G4) neutropenia and grade 3–4 (G ≥ 3) thrombocytopenia in a pool of cancer patients from single-agent phase I to III studies (n = 692) treated at a wide range of doses. A clinical utility index was used to assess the appropriateness of the selected dose. Results Effect of lurbinectedin AUCu on ORR best fitted to a sigmoid-maximal response (Emax) logistic model, where Emax was dependent on chemotherapy-free interval (CTFI). Cox regression analysis with OS found relationships with both CTFI and AUCu. An Emax logistic model for G4 neutropenia and a linear logistic model for G ≥ 3 thrombocytopenia, which retained platelets and albumin at baseline and body surface area, best fitted to AUCtot and AUCu. AUCu between approximately 1000 and 1700 ng·h/L provided the best benefit/risk ratio, and the dose of 3.2 mg/m2 provided median AUCu of 1400 ng·h/L, thus maximizing the proportion of patients within that lurbinectedin target exposure range. Conclusions The relationships evidenced in this integrated E–R analysis support a favorable benefit-risk profile for lurbinectedin 3.2 mg/m2 q3wk. Trial registration Clinicaltrials.gov: NCT02454972; registered May 27, 2015.

scholarly journals The Influence of KDR Genetic Variation on the Efficacy and Safety of Patients With Advanced NSCLC Receiving First-Line Bevacizumab Plus Chemotherapy Regimen

2021 ◽  
Vol 20 ◽  
pp. 153303382110194
Author(s):  
Nan Geng ◽  
Jingwei Su ◽  
Zhikun Liu ◽  
Cuimin Ding ◽  
Shaonan Xie ◽  
...  
Keyword(s):  
Genetic Variation ◽  
Regression Analysis ◽  
Mrna Expression ◽  
Advanced Nsclc ◽  
Cox Regression ◽  
Chemotherapy Regimen ◽  
Efficacy And Safety ◽  
First Line ◽  
Cox Regression Analysis ◽  
Tissue Specimens

Objective: Angiogenesis plays an important role in the growth and metastasis of non-small cell lung cancer (NSCLC). Bevacizumab is a humanized monoclonal antibody that mainly acts on vascular endothelial growth factor A (VEGFA). Kinase insert domain receptor (KDR) is the most important target of VEGFA. The aim of present study was to investigate the influence of KDR genetic variation on the efficacy and safety of patients with advanced NSCLC receiving first-line bevacizumab plus chemotherapy regimen. Methods: A total of 169 patients with advanced NSCLC who received bevacizumab combined with chemotherapy were recruited in this study. Clinical outcome of the regimens was evaluated in the hospital. Peripheral blood and biopsy tissue specimens of patients were collected for the genotyping of KDR genetic variation and KDR mRNA expression, respectively. The association between KDR genotype status and other variables were analyzed. Univariate analysis of genotype status and prognosis was implemented using the Kaplan-Meier survival analysis method. Multivariate Cox regression analysis was performed to adjust the confounding factors. Results: Of the polymorphisms analyzed, only V297 L was of clinical significance. The prevalence of V297 L among the study population were as follows: CC genotype 123 cases (72.8%), CT genotype 41 cases (24.3%), TT genotype 5 cases (2.9%). The minimum allele frequency is 0.15. The distribution frequencies of the 3 genotypes corresponded with Hardy-Weinberg equilibrium ( P = 0.489). Patients with TT and CT genotypes were merged in the subsequent comparison of clinical outcomes. The analysis of efficacy exhibited that the objective response rates (ORR) of patients with CC genotype and CT/TT genotypes were 52.8% and 47.8% ( P = 0.561), respectively. Prognosis indicated that the median progression free survival (PFS) of patients with CC genotype and CT/TT genotype were 8.9 and 5.5 months, respectively ( P = 0.006). The median OS of the 2 genotypes were 20.0 and 14.9 months, respectively ( P = 0.021). Adjusted in multivariate Cox regression analysis of PFS, CT/TT genotypes were an independent factor for PFS [hazard ratio (HR) = 1.59, P = 0.011). Safety profile according to genotype status of V297 L failed to find significant difference. Interestingly, the expression of KDR mRNA of patients with CT/TT genotype was significantly higher than that of patients with CC genotype in the 58 cancer tissue specimens ( P < 0.001). Conclusion: The clinical comes of patients with advanced NSCLC receiving first-line bevacizumab plus chemotherapy regimens might be impacted by polymorphism V297 L through mediating the mRNA expression of KDR.

An Experience on Pomalidomide in Patients within Relapsed/Refractory Multiple Myeloma - A Multicenter Study in Turkey

2021 ◽  
pp. 92-98
Author(s):  
Mehmet Ali Erkurt ◽  
Fehmi Hindilerden ◽  
Omer Ekinci ◽  
Jale Yildiz ◽  
Mehmet Sinan Dal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Side Effects ◽  
Cox Regression ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
Cox Regression Analysis ◽  
Refractory Multiple Myeloma ◽  
Thalidomide Analogue ◽  
New Generation

Objective: Pomalidomide is a new generation thalidomide analogue. Effectiveness as a single agent or combination with low dose dexamethasone has been in the treatment of relapse/refractory Multiple Myeloma (MM). The aim of the present study was to share the experience of different oncology centres with pomalidomide treatment in patients with relapsed/refractory MM. Materials and Methods: Seventy-three patients from 16 centres were enrolled into the study. The patients were followed for a median of 6 months. Relapsed/refractory MM patients who received at least one line of treatment before pomalidomide were included into the study.  ISS, R-ISS and Eastern Cooperative Oncology Group (ECOG) scores of the patients and treatment-related side effects were evaluated. Results: As a result of the median follow-up for 6 months, 36% (26/72) of the patients presented progression. The estimated median PFS was found 29 months. The Cox regression analysis revealed that ECOG affected PFS only, myeloma subtype; ISS and R-ISS scores did not affect PFS. The most common side effects with pomalidomide treatment in our population include neutropenia, infections, anaemia and thrombocytopenia. Conclusion: In our study, it was statistically shown that the ECOG score was effective in survival in relapsed / refractory MM patients treated by pomalidomide. Therefore, we recommend evaluation of the ECOG score for each patient before treatment in eligible cases.

Effect of adding immunotherapy (IT) to treatment regimen of mantle cell lymphoma (MCL): Analysis of the National Cancer Data Base (NCDB).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19022-e19022
Author(s):  
Alaa Altahan ◽  
Eric Vick ◽  
Upama Giri ◽  
Eric Wiedower ◽  
Michael Gary Martin
Keyword(s):  
Cox Regression ◽  
Statistical Significance ◽  
Clinical Stage ◽  
Single Agent ◽  
National Cancer Data Base ◽  
Cox Regression Analysis ◽  
Cancer Data ◽  
Treatment Regimens ◽  
Significant Difference ◽  
A Prospective Study

e19022 Background: There has been some improvement in overall survival (OS) for patients with MCL over the past years [Gordon 2014]. However, side effects of treatment remain a major concern. With introduction of novel therapies like IT, it is imperative to optimize treatment regimens to improve survival while minimizing toxicity. Methods: MCL patients (pts) who were diagnosed in 2013 or later with information available about chemotherapy (CT) and IT and did not receive transplant were extracted from NCDB. Pts were assigned to age categories and were sorted into six groups based on different combinations of CT (none, single agent (SA), and multi-agent (MA)) with or without IT. Cox regression analysis was used to perform multivariate analysis that included age category, sex, race, clinical stage, Charlson/Deyo score, CT, radiation, and IT for each group. Multivariate p values (p) were used to analyze statistical significance. Kaplan Meier method was utilized to analyze OS. T-test was used to compare means (t-p). Results: 1438 total pts were identified with a mean age of 70 (range 24-90); 71% male; 93% white, 4% black, 3% others; 42% with stage III/IV disease. 667 pts did not receive CT or IT, and 40 received IT alone and both of these groups were excluded from further analysis. 52 pts received SA- (without) IT, 206 received SA+(with) IT and 260 pts received MA-IT and 213 MA+IT. Mean age was 72 and 66 for SA and MA groups, respectively (t-p<0.01). Mean OS for SA+IT was 27 months (m) vs SA-IT 16 m (p < 0.01). MA+IT v MA-IT showed no difference in mean OS (25 vs 26 m, respectively, p =0.49). Although there was a significant difference in OS between SA and MA groups without IT (16 vs 25 months, p < 0.01). SA + IT group showed comparable mean OS time to MA + IT (27 vs 26 m, p =0.145). Conclusions: For MCL pts, MA has superior OS to SA group. However, adding IT significantly improves OS for SA group and makes it comparable to MA. Adding IT to MA did not provide significant difference in OS. These results highlight the possibility of achieving same OS with less toxic regimens. Hence further evaluation in a prospective study to optimize treatment while reducing toxicity is warranted.

Clinical predictors of efficacy for immune checkpoint inhibition in lung cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20600-e20600 ◽  
Author(s):  
Shijia Zhang ◽  
Daniel Fellows Pease ◽  
Shilvi Joshi ◽  
Yucai Wang ◽  
Manish Patel
Keyword(s):  
Lung Cancer ◽  
Autoimmune Disease ◽  
Brain Metastasis ◽  
Immune Checkpoint ◽  
Clinical Benefit ◽  
Cox Regression ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Cox Regression Analysis ◽  
Heavily Pretreated

e20600 Background: Immune checkpoint inhibitors (ICIs) have changed the treatment paradigm of advanced NSCLC and SCLC. The populations in clinical trials generally were composed of patients (pts) with excellent performance status (PS), a minimal number of prior lines of therapy, and no history of (h/o) autoimmune disease (AD). The aim of this retrospective study was to investigate the predictors of survival in less fit and more heavily pretreated lung cancer pts at our institution. Methods: Medical records of lung cancer pts who started single-agent ICI from 2015 to 2018 were reviewed for data collection. Progression-free survival (PFS) and overall survival (OS) were compared by age, PS, smoking, PD-L1 expression, brain metastasis, prior lines of systemic therapy, h/o AD, and immune-related adverse events (irAE). Results: We included 150 pts who received at least 1 dose of nivolumab, pembrolizumab, or atezolizumab (median age 66, range 36-92, 56% female, 89% NSCLC, 97% stage 4, 13% never smoker, 34% ECOG ≥ 2, 37% ≥ 2 prior lines of therapy, 29% developed irAE). The overall response rate was 30% and clinical benefit rate 51% (3% CR, 27% PR, 21% SD). The median PFS was 3.7 months (m) overall and 12.3 m for those with ≥ 4 cycles of therapy. The median OS was 12.4 m overall and 26.0 m for those with ≥ 4 cycles. The median PFS and OS were not significantly different by age, PS, smoking, PD-L1, brain metastasis, prior lines of therapy, or h/o AD. The median OS was longer for pts with ECOG 0-1 than those ≥ 2 (14.6 vs 7.5 m, p < .001). The median PFS and OS for pts with irAE were longer compared to those without irAE (12.3 vs 2.6 m, p < .001 for PFS and 28.9 vs 9.1 m, p = .001 for OS). Multiple Cox regression analysis identified ECOG 0-1 (HR 0.54, p = .007) and irAE (HR 0.48, p = .003) to be independently associated with improved OS. 27 pts (18%) required steroids for irAE. There were no treatment-related deaths. Of 11 pts with h/o AD, only 1 experienced disease flare. Conclusions: The clinical benefit of ICIs persists in older or heavily pretreated pts. ECOG 0-1 and incident irAE predicted for improved survival. Survival for pts with ECOG ≥ 2 is very limited, suggesting ICIs should be used judiciously in this group. Therapy was well tolerated, with a low risk for flare of previous autoimmune disease.

Systemic therapy for advanced appendiceal adenocarcinoma: An analysis from the National Comprehensive Cancer Network (NCCN) database.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 562-562
Author(s):  
Mohamedtaki Abdulaziz Tejani ◽  
Anna ter Veer ◽  
Dana Milne ◽  
Rebecca Ottsesen ◽  
Tanios S. Bekaii-Saab ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Cox Regression ◽  
Single Agent ◽  
The United States ◽  
High Grade ◽  
Debulking Surgery ◽  
Cox Models ◽  
Cox Regression Analysis ◽  
Mucinous Histology ◽  
Appendiceal Adenocarcinoma

562 Background: Appendiceal neoplasms are rare and represent 1% of intestinal tumors in the United States. The role and efficacy of modern systemic therapy in advanced appendiceal adenocarcinoma has not been established. Methods: Patients with recurrent or metastatic appendiceal adenocarcinoma in the NCCN Colorectal Database (2005-2010) were analyzed. Study objectives were to describe and evaluate the efficacy of systemic therapy and investigate relationships with clinicopathologic features. Cox regression analysis was performed to identify predictors of PFS and OS. The hazard ratio and 95% CI from Cox models and median PFS and OS from Kaplan-Meier curves were reported. Results: Of 177 patients with advanced appendiceal carcinoma, 81 (46%) received systemic therapy for measurable disease and are the focus of this report (patients undergoing IP chemotherapy excluded). Patient/tumor characteristics: median age 50 (range 20-82), ECOG PS 0/1 (67%/22%), mucinous/non-mucinous (44 %/ 51%), 91% peritoneal and 15% liver metastases. 70% of patients had primary surgical debulking. Common chemotherapy regimens included FOLFOX with or without bevacizumab (n=30 and n=28), FOLFIRI (n=11), and single-agent fluoropyrimidine (n=7). Among 70 patients with a recorded best response, the response rate (RR) was 46% with 31% stable disease. Median PFS was 1.0 year (95% CI: 0.7-1.9) and OS was 2.1 years (95% CI: 1.7-2.6). Patients with non-mucinous histology, high grade tumors and non-debulking surgery had worse PFS and OS (Table). Conclusions: Treatment of advanced appendiceal adenocarcinoma at NCCN centers commonly incorporates agents utilized for colorectal cancer. RR, PFS and OS are comparable to those achieved in the treatment of metastatic CRC and support routine use of these regimens in clinical practice. Poor prognostic factors include non-mucinous histology, high grade and not undergoing debulking surgery. [Table: see text]

Ramucirumab (RAM) as second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): Analysis of patients with elevated α-fetoprotein (AFP) from the randomized phase III REACH study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 232-232 ◽  
Author(s):  
Andrew X. Zhu ◽  
Baek-Yeol Ryoo ◽  
Chia-Jui Yen ◽  
Masatoshi Kudo ◽  
Ronnie Tung-Ping Poon ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Subgroup Analysis ◽  
Cox Regression ◽  
Single Agent ◽  
Predictive Marker ◽  
Phase Iii ◽  
Rank Test ◽  
Advanced Hepatocellular Carcinoma ◽  
Meaningful Improvement ◽  
Wide Range

232 Background: REACH was a global, multicenter, randomized, double-blind, phase 3 study evaluating the efficacy and safety of RAM as a single agent for the treatment of pts with advanced HCC after prior sorafenib therapy. The primary outcome for REACH was presented at ESMO 2014. The overall survival (OS) HR for the ITT population (RAM 283; placebo [PBO] 282) was 0.866 (95% CI 0.717, 1.046; p=0.1391); median OS was 9.2m for RAM vs 7.6m for PBO. The pre-specified subgroup analysis of baseline AFP (cutoff 400 ng/mL) suggested AFP is a predictive marker for RAM survival benefit. Methods: Pre-specified subgroup analysis was performed based on baseline AFP with a cutoff of 400 ng/mL. Additional analyses were conducted using stratified/unstratified cox regression models and corresponding log rank test to evaluate the relationship between baseline AFP and RAM treatment effect. Results: In 250 pts with baseline AFP ≥400 ng/mL (RAM 119; PBO 131), OS HR was 0.67 (95% CI 0.51–0.90; p=0.0059). Median OS was 7.8m for RAM vs 4.2m for PBO. In 417 pts with a baseline AFP ≥1.5 × upper limit of normal (ULN; RAM 205; PBO 212), mOS was 8.6m for RAM vs 5.7m for PBO and the HR was 0.749 (95% CI: 0.603, 0.930) (p=0.0088). The interaction testing of baseline AFP and RAM treatment effect on OS using both cutoffs (400 ng/mL and 1.5 xULN) are significant (p-value = 0.0272 and 0.0372, respectively). The safety profile in these pt populations was similar to that observed in the overall safety population. Additional REACH analyses demonstrating the predictive value of baseline AFP for RAM treatment effect on OS will be presented. Conclusions: A clinically meaningful improvement in OS was observed in populations with a baseline AFP ≥400 ng/mL or ≥1.5 × ULN. Additional analyses demonstrated a consistent RAM OS benefit for the pt population with baseline AFP over a wide range of values above the normal range. Baseline AFP is a likely predictive marker for RAM OS benefit. Clinical trial information: NCT01140347.

scholarly journals Risk Factors for Dental Restoration Survival: A Practice-Based Study

2019 ◽  
Vol 98 (4) ◽  
pp. 414-422 ◽  
Author(s):  
M. Laske ◽  
N.J.M. Opdam ◽  
E.M. Bronkhorst ◽  
J.C.C. Braspenning ◽  
M.C.D.N.J.M. Huysmans
Keyword(s):  
Risk Factors ◽  
Dental Care ◽  
Cox Regression ◽  
Class Ii ◽  
Observation Time ◽  
Dental Restoration ◽  
Endodontically Treated Teeth ◽  
Cox Regression Analysis ◽  
Wide Range ◽  
Practice Patient

To improve patient dental care, it is necessary to identify possible risk factors for the failing of restorations. This practice-based cohort study investigated the performance and influence of possible risk factors at the level of the practice, patient, tooth, and restoration on survival of direct class II restorations. Electronic patient files from 11 Dutch general practices were collected, and 31,472 restorations placed between January 2015 and October 2017 were analyzed. Kaplan-Meier statistics were performed; annual failure rates (AFRs) were calculated; and variables were assessed by multivariable Cox regression analysis. The observation time of restorations varied from 0 to 2.7 y, resulting in a mean AFR of 7.8% at 2 y. However, wide variation in AFRs existed among the operators, varying between 3.6% and 11.4%. A wide range of patient-related variables is related to a high risk for reintervention: patient age (elderly: hazard ratio [HR], 1.372), general health (medically compromised: HR, 1.478), periodontal status (periodontal problems: HR, 1.207), caries risk and risk for parafunctional habits (high: HR, 1.687), restorations in molar teeth (HR, 1.383), restorations placed in endodontically treated teeth (HR, 1.890), and multisurface restorations (≥4 surfaces: HR, 1.345). Restorations placed due to fracture were more prone to fail than restorations placed due to caries. When patient-related risk factors were excluded, remaining risk factors considerably changed in their effect and significance: the effect of operator, age of the patient, and endodontic treatment increased; the effect of the diagnosis decreased; and the socioeconomic status became significant (high: HR, 0.873). This study demonstrated that a wide variation of risk factors on the practice, patient, and tooth levels influences the survival of class II restorations. To provide personalized dental care, it is important to identify and record potential risk factors. Therefore, we recommend further clinical studies to include these patient risk factors in data collection and analysis.

scholarly journals Tacrolimus as Single-Agent Immunotherapy and Minimal Manifestation Status in Nonthymoma Myasthenia Gravis

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Weiwei Duan ◽  
Yuyao Peng ◽  
Wanlin Jin ◽  
Song Ouyang ◽  
Huan Yang
Keyword(s):  
Myasthenia Gravis ◽  
Cox Regression ◽  
Single Agent ◽  
Clinical Factors ◽  
Factors Affecting ◽  
Cox Regression Analysis ◽  
Steroid Dose ◽  
One Year ◽  
Seronegative Mg ◽  
Treatment Sensitivity

Background. Tacrolimus is a second-line immunosuppressant in myasthenia gravis (MG) therapy, which is mainly used in combination with corticosteroids to reduce steroid dose and maintain the effect of immunotherapy. However, few studies have focused on the effect of tacrolimus as single-agent immunotherapy on achieving minimal manifestation status (MMS). Thus, this study is aimed at exploring the efficacy and influencing factors of tacrolimus as single-agent immunotherapy in MG. Methods. Clinical data of 75 nonthymoma MG patients treated with tacrolimus single-agent as initial immunotherapy were retrospectively analyzed. The therapeutic effect was evaluated by Myasthenia Gravis Foundation of America postintervention status. Clinical factors affecting the achievement of MMS and treatment reactivity of different MG subtypes were determined by Cox regression analysis. Results. Tacrolimus was generally safe, with only two patients (2.7%) switching medications due to side effects. 32% of patients had improved symptoms after 1 month of treatment. 69.2% of patients achieved MMS or better after one year. The age < 39 years old, QMG   score < 11 points, and AChR − Ab   titer < 8.07   nmol / L were indicative of a favorable response, which was independent of gender, course of the disease. As for MG subtypes, ocular and seronegative MG showed better treatment sensitivity. Conclusions. Tacrolimus as single-agent immunotherapy takes effect quickly and can effectively enable nonthymoma MG patients to achieve MMS. Tacrolimus can be used alone for the initial immunotherapy of MG patients, especially for young, mild, and low antibody titer patients.

A multicenter, retrospective study on impact of immunotherapy in urothelial carcinoma with bone metastases (Meet-Uro01 Study).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 401-401
Author(s):  
Patrizia Giannatempo ◽  
Laura Marandino ◽  
Daniele Raggi ◽  
Francesco Pierantoni ◽  
Marco Maruzzo ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Urothelial Carcinoma ◽  
Cox Regression ◽  
Advanced Disease ◽  
Performance Status ◽  
Single Agent ◽  
Cox Regression Analysis ◽  
Kaplan Meier ◽  
Dismal Prognosis ◽  
Ecog Ps

401 Background: Considerable numbers of patients (pts) with metastatic urothelial carcinoma (mUC) (approximately 25-47%) develop bone metastases (BoM). Their impact on the efficacy of immunotherapy (IO) is not yet sufficiently investigated. We developed a national collaboration on this issue, with the aim to assess the effect of BoM on survival outcomes of immunotherapy-treated pts in a large retrospective cohort. Methods: Data on pts diagnosed with mUC and treated between 07/14 and 08/20 with single-agent immunotherapy (IO) after failure of at least 1 previous line of chemotherapy (CT) for advanced disease, or (neo-)adjuvant CT within 12 months were retrospectively collected across 14 centers. PFS and OS were analyzed using the Kaplan-Meier method. Cox regression analysis was performed evaluating potential prognostic factors for OS and PFS. Each factor was evaluated in univariable (UV) and multivariable (MVA) analysis. Results: A total of 208 evaluable pts treated with single-agent immunotherapy (anti PD-1 n=42; anti PD-L1 n=166) were identified, including 122 without BoM (59% BoM-) and 86 (41%) BoM+. 13% of pts had progressed within 12 months after (neo-)adjuvant CT and 79% after a previous line of platinum-based CT for advanced disease (cisplatin 42.8%; carboplatin 36.5%). The presence of BoM negatively affected performance status (PS) of patients at baseline (ECOG PS 0/1/2 in 58% / 37% / 5% in BoM- vs 38% / 52% / 9% in BoM+; p=0.017). Other baseline characteristics were comparable. BoM+ showed shorter PFS (median 2.0 vs 2.6 months, HR 1.76 [95%CI, 1.31-2.37], p<0.001) and OS (median 3.9 vs 7.8 months, HR 1.59 [95%CI, 1.15-2.20], p=0.005) than BoM-. Probability of being alive was 62% vs 40% after 6 months, 38% vs 23% after 1 year and 24% vs 13% after 2 years, in BoM- and BoM+ respectively. Within each Bellmunt score, PFS and OS of BoM+ pts were shorter compared to BoM-. Both BoM and higher Bellmunt risk score were significantly associated with shorter PFS and OS in UV and MV analyses (Table). Conclusions: Patients with mUC treated with single-agent immunotherapy for BoM+ advanced disease have a dismal prognosis compared with BoM-. Further research is needed to understand the mechanism behind these clinical outcomes. [Table: see text]

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