Association between severity of prenatally diagnosed hydronephrosis and receipt of surgical intervention postnatally among patients seen at a fetal-maternal center

Abstract Background Hydronephrosis (HN) is the most common abnormality detected on prenatal ultrasound. This study sought to stratify outcomes of patients by severity of prenatal HN with postnatal outcomes. Methods This was a retrospective review of patients referred to a tertiary care fetal-maternal clinic with diagnosis of prenatal HN from 2004 to 2019. HN severity was categorized as mild, moderate, or severe. Data were analyzed to determine the association between HN severity and surgical intervention. Decision for surgery was based on factors including history of multiple urinary tract infections, evidence of renal scarring, and/or reduced renal function. Surgery-free survival time was represented by the Kaplan–Meier method, and hazard ratios were calculated using the log-rank test. Results 131 kidneys among 101 infants were prenatally diagnosed with hydronephrosis; 35.9% had mild HN, 29.0% had moderate HN, and 35.1% had severe HN. 8.5% of patients with mild HN, 26.3% of patients with moderate HN, and 65.2% of patients with severe HN required surgery. Patients with severe HN were 12.2 (95% CI 6.1–24.4; p < 0.001) times more likely to undergo surgery for HN than patients with mild HN and 2.9 (95% CI 1.5–5.3; p = 0.003) times more likely to undergo surgery than patients with moderate HN. Patients with moderate HN were 4.3 times more likely to require surgery than patients with mild HN (95% CI 1.5–12.9; p = 0.01). Median age at surgery was 11.8 months among patients with mild HN (IQR 11.7–14.1 months), 6.6 months among patients with moderate HN (IQR 4.2–16.4 months), and 5.4 months among patients with severe HN (3.7–12.4 months). Conclusion Among this cohort of referrals from a fetal-maternal clinic, severity of HN correlated with increased likelihood of surgical intervention. Continued assessment of patients with prenatal HN should be evaluated to best determine the role of the pediatric urologist in cases of prenatal HN.

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Independent validation of a predictive nomogram for risk of reinfection in women with recurrent non-complicated urinary tract infections

Therapeutic Advances in Urology ◽

10.1177/1756287220922423 ◽

2020 ◽

Vol 12 ◽

pp. 175628722092242

Author(s):

Marcelo Gonzales Favoreto ◽

Emerson Pereira Gregorio ◽

Marcio Augusto Averbeck ◽

Silvio Henrique Maia de Almeida

Keyword(s):

Urinary Tract ◽

Statistical Significance ◽

External Validation ◽

Rank Test ◽

Multivariate Logistic Regression Model ◽

Predictive Capacity ◽

Time To Recurrence ◽

Kaplan Meier ◽

History Of ◽

Tract Infections

Aims: Independent external validation of a predictive nomogram for risk of reinfection in women with a history of non-complicated recurrent urinary tract infection (UTI). Methods: A retrospective longitudinal study was conducted to validate the LUTIRE nomogram in a Brazilian female cohort. The nomogram was applied to 81 women presenting non-complicated recurring UTI screened at a urological clinic. External validation was performed using the nomogram variables in patients followed up from January 2014 to December 2016 at a urological clinic. Accuracy of the nomogram was obtained by analyzing the predictive capacity observed in the area under the receiver operating characteristic (ROC) curve. A multivariate logistic regression model was used to assess the ability of the nomogram variables to predict the recurrence of UTI over 12 months. The time to recurrence of infection was calculated using a Kaplan–Meier curve and the log-rank test with calculation of the hazard ratio. Results: The mean age of the study population was 42.8 years; 57 women (70.37%) had recurrence. The independent variables with statistical significance in the multivariate analysis were gram-negative bacteria [odds ratio (OR) 18.38; p = 0.03897] and number of UTIs in the past 12 months (OR 25.11; p = 0.00006). The accuracy of the nomogram for discriminating patients who had UTI recurrence was 82.6% (95% CI = 72.5–90.1). Conclusion: The LUTIRE nomogram showed good accuracy among Brazilian women with recurrent UTI.

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The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

Acta Haematologica ◽

10.1159/000514920 ◽

2021 ◽

pp. 1-9

Author(s):

Leonard Naymagon ◽

Douglas Tremblay ◽

John Mascarenhas

Keyword(s):

Hemophagocytic Lymphohistiocytosis ◽

Proportional Hazards ◽

Multivariable Analysis ◽

Cox Proportional Hazards ◽

Rank Test ◽

Kaplan Meier ◽

Hazard Ratios ◽

Significant Difference ◽

The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

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The natural history of Canavan disease: 23 new cases and comparison with patients from literature

Orphanet Journal of Rare Diseases ◽

10.1186/s13023-020-01659-3 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Annette Bley ◽

Jonas Denecke ◽

Alfried Kohlschütter ◽

Gerhard Schön ◽

Sandra Hischke ◽

...

Keyword(s):

Severity Score ◽

Canavan Disease ◽

Psychomotor Development ◽

Rank Test ◽

First Year ◽

Study Cohort ◽

Pooled Data ◽

Kaplan Meier ◽

History Of ◽

First Year Of Life

Abstract Background Canavan disease (CD, MIM # 271900) is a rare and devastating leukodystrophy of early childhood. To identify clinical features that could serve as endpoints for treatment trials, the clinical course of CD was studied retrospectively and prospectively in 23 CD patients. Results were compared with data of CD patients reported in three prior large series. Kaplan Meier survival analysis including log rank test was performed for pooled data of 82 CD patients (study cohort and literature patients). Results Onset of symptoms was between 0 and 6 months. Psychomotor development of patients was limited to abilities that are usually gained within the first year of life. Macrocephaly became apparent between 4 and 18 months of age. Seizure frequency was highest towards the end of the first decade. Ethnic background was more diverse than in studies previously reported. A CD severity score with assessment of 11 symptoms and abilities was developed. Conclusions Early hallmarks of CD are severe psychomotor disability and macrocephaly that develop within the first 18 months of life. While rare in the first year of life, seizures increase in frequency over time in most patients. CD occurs more frequently outside Ashkenazi Jewish communities than previously reported. Concordance of phenotypes between siblings but not patients with identical ASPA mutations suggest the influence of yet unknown modifiers. A CD severity score may allow for assessment of CD disease severity both retrospectively and prospectively.

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Effects of antiarrhythmic drugs on atrioventricular conduction in patients with preexisting bundle branch block

European Heart Journal ◽

10.1093/ehjci/ehaa946.3358 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

S Kochav ◽

R.C Chen ◽

J.M.D Dizon ◽

J.A.R Reiffel

Keyword(s):

Proportional Hazards ◽

Cox Proportional Hazards ◽

Class I ◽

Class Iii ◽

Bundle Branch Block ◽

Kaplan Meier ◽

Cox Proportional Hazards Models ◽

Hazard Ratios ◽

History Of ◽

Propensity Score Stratification

Abstract Background Theoretical concern exists regarding AV block (AVB) with class I antiarrhythmics (AADs) when bundle branch block (BBB) is present. Whether this is substantiated in real-world populations is unknown. Purpose To determine the relationship between type of AAD and incidence of AVB in patients with preexisting BBB. Methods We retrospectively studied all patients with BBB who received class I and III AADs between 1997–2019 to compare incidence of AVB. We defined index time as first exposure to either drug class and excluded patients with prior AVB or exposed to both classes. Time-at-risk window ended at first outcome occurrence or when patients were no longer observed in the database. We estimated hazard ratios for incident AVB using Cox proportional hazards models with propensity score stratification, adjusting for over 32,000 covariates from the electronic health record. Kaplan-Meier methods were used to determine treatment effects over time. Results Of 40,120 individuals with BBB, 148 were exposed to a class I AAD and 2401 to a class III AAD. Over nearly 4,200 person-years of follow up, there were 22 and 620 outcome events in the class I and class III cohorts, respectively (Figure). In adjusted analyses, AVB risk was markedly lower in patients exposed to class I AADs compared with class III (HR 0.48 [95% CI 0.30–0.75]). Conclusion Among patients with BBB, exposure to class III AADs was strongly associated with greater risk of incident AVB. This likely reflects differences in natural history of patients receiving class I vs class III AADs rather than adverse class III effects, however, the lack of worse outcomes acutely with class I AADs suggests that they may be safer in BBB than suspected. Funding Acknowledgement Type of funding source: None

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The impact of prior urethral sling on artificial urinary sphincter outcomes

Canadian Urological Association Journal ◽

10.5489/cuaj.3922 ◽

2016 ◽

Vol 10 (11-12) ◽

pp. 405 ◽

Cited By ~ 6

Author(s):

Matthew J. Ziegelmann ◽

Brian J. Linder ◽

Marcelino E. Rivera ◽

Boyd R. Viers ◽

Daniel S. Elliott

Keyword(s):

Retrospective Chart Review ◽

Artificial Urinary Sphincter ◽

Device Failure ◽

Kaplan Meier ◽

Hazard Ratios ◽

Urinary Sphincter ◽

Device Infection ◽

Significant Difference ◽

History Of ◽

The Impact

Introduction: We sought to evaluate device outcomes in men who underwent primary artificial urinary sphincter (AUS) placement after failed male urethral sling (MUS).Methods: We performed a retrospective chart review of 990 men who underwent an AUS procedure between 2003 and 2014. Of these, 540 were primary AUS placements, including 30 (5.5%) with a history of MUS. AUS revisions and explantations were compared between men stratified by the presence of prior sling. Hazard ratios (HR) adjusting for competing risks were used to determine the association with prior sling and AUS outcomes (infection/ erosion, urethral atrophy, and mechanical malfunction), while overall device failure was estimated using Kaplan-Meier and Coxregression analysis.Results: There was no significant difference in age, body mass index, prior prostatectomy, or pelvic radiation when stratified by history of MUS. However, patients with a history of MUS were more likely to have undergone prior collagen injection (p=0.01). On univariate and multivariate analysis, prior MUS was not associated with device failure (HR 1.54; p=0.27). Three-year overall device survival did not significantly differ between those with and without prior MUS (70% vs. 85%; p=0.21). Also, there were no significant differences in the incidence of device infection/erosion, mechanical malfunction, and urethral atrophy.Conclusions: AUS remains a viable treatment option for men with persistent or recurrent stress urinary incontinence after MUS. However, while not statistically significant, we identified a trend towards lower three-year device outcomes in patients with prior urethral sling. These findings indicate the need for longer-term studies to determine if slings pose an increased hazard.

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071 Natalizumab extended interval dosing (EID) is associated with a significant reduction in progressive multifocal leukoencephalopathy (PML) risk compared with standard interval dosing (SID) in the touch® prescribing program

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2018-anzan.70 ◽

2018 ◽

Vol 89 (6) ◽

pp. A29.2-A29 ◽

Cited By ~ 4

Author(s):

Lana Zhovtis Ryerson ◽

John Foley ◽

Ih Chang ◽

Ilya Kister ◽

Gary Cutter ◽

...

Keyword(s):

Cox Regression ◽

Jc Virus ◽

Secondary Analysis ◽

Statistical Analysis Plan ◽

Rank Test ◽

Primary Analysis ◽

Standard Interval ◽

Kaplan Meier ◽

Hazard Ratios ◽

Dosing Intervals

IntroductionNatalizumab, approved for 300 mg intravenous every-4-weeks dosing, is associated with PML risk. Prior studies have been inconclusive regarding EID’s impact on PML risk. The US REMS program (TOUCH) offers the largest data source that can inform on PML risk in patients on EID. This analysis aimed to determine whether natalizumab EID is associated with reduced PML risk compared with SID.MethodsInvestigators developed SID and EID definitions and finalised the statistical analysis plan while blinded to PML events. Average dosing intervals (ADIs) were ≥3 to<5 weeks for SID and >5 to≤12 weeks for EID. The primary analysis assessed ADI in the last 18 months of infusion history. The secondary analysis identified any prolonged period of EID at any time in the infusion history. The tertiary analysis assessed ADI over the full infusion history. Only anti-JC virus antibody positive (JCV Ab+) patients with dosing intervals≥3 to≤12 weeks were included. PML hazard ratios (HRs) were compared using adjusted Cox regression models and Kaplan-Meier estimates.ResultsAnalyses included 13,132 SID and 1988 EID patients (primary), 15,424 SID and 3331 EID patients (secondary), and 23,168 SID and 815 EID patients (tertiary). In primary analyses, ADI (days) was 30 for SID and 37 for EID; median exposure (months) was 44 for SID and 59 for EID. Most EID patients received >2 years SID prior to EID. The PML HR (95% CI) was 0.06 (0.01–0.22; p<0.001) for primary analysis and 0.12 (0.05–0.29; p<0.001) for secondary analysis (both in favour of EID); no EID PML cases were observed in tertiary analyses (Kaplan-Meier log-rank test p=0.02).ConclusionIn JCV Ab +patients, natalizumab EID is associated with a clinically and statistically significant reduction in PML risk as compared with SID. As TOUCH does not collect effectiveness data, further studies are needed.Study supportBiogen

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Mortality in Patients with Diabetic Foot Ulcers: Causes, Risk Factors, and Their Association with Evolution and Severity of Ulcer

Journal of Clinical Medicine ◽

10.3390/jcm9093009 ◽

2020 ◽

Vol 9 (9) ◽

pp. 3009

Author(s):

José Antonio Rubio ◽

Sara Jiménez ◽

José Luis Lázaro-Martínez

Keyword(s):

Diabetic Foot ◽

Cox Regression ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Cox Regression Analysis ◽

Kaplan Meier ◽

Hazard Ratios ◽

History Of

Background: This study reviews the mortality of patients with diabetic foot ulcers (DFU) from the first consultation with a Multidisciplinary Diabetic Foot Team (MDFT) and analyzes the main cause of death, as well as the relevant clinical factors associated with survival. Methods: Data of 338 consecutive patients referred to the MDFT center for a new DFU during the 2008–2014 period were analyzed. Follow-up: until death or until 30 April 2020, for up to 12.2 years. Results: Clinical characteristics: median age was 71 years, 92.9% had type 2 diabetes, and about 50% had micro-macrovascular complications. Ulcer characteristics: Wagner grade 1–2 (82.3%), ischemic (49.2%), and infected ulcers (56.2%). During follow-up, 201 patients died (59.5%), 110 (54.7%) due to cardiovascular disease. Kaplan—Meier curves estimated a reduction in survival of 60% with a 95% confidence interval (95% CI), (54.7–65.3) at 5 years. Cox regression analysis adjusted to a multivariate model showed the following associations with mortality, with hazard ratios (HRs) (95% CI): age, 1.07 (1.05–1.08); HbA1c value < 7% (53 mmol/mol), 1.43 (1.02–2.0); active smoking, 1.59 (1.02–2.47); ischemic heart or cerebrovascular disease, 1.55 (1.15–2.11); chronic kidney disease, 1.86 (1.37–2.53); and ulcer severity (SINBAD system) 1.12 (1.02–1.26). Conclusion: Patients with a history of DFU have high mortality. Two less known predictors of mortality were identified: HbA1c value < 7% (53 mmol/mol) and ulcer severity.

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Efficient Stroke Prevention Based on Early Detection of Cerebral Vasculopathy by Transcranial Doppler: The Creteil Newborn-Screened Sickle Cell Cohort.

Blood ◽

10.1182/blood.v108.11.1212.1212 ◽

2006 ◽

Vol 108 (11) ◽

pp. 1212-1212

Author(s):

Francoise Bernaudin ◽

Suzanne Verlhac ◽

Lena Coic ◽

Emmanuelle Lesprit ◽

Cecile Arnaud ◽

...

Keyword(s):

High Risk ◽

Transcranial Doppler ◽

Stroke Prevention ◽

High Risk Group ◽

Rank Test ◽

Kaplan Meier ◽

Single Center Study ◽

History Of ◽

Related Donor ◽

The Right

Abstract About 11% of SS patients will have a first stroke by age 18–20 years. Abnormal high velocities are associated with a high risk of stroke, which can be significantly reduced by a long-term transfusion program. The stroke rate in Californian SCD children has declined since the advent of transcranial doppler (TCD), but there are no reports on the outcome of patients screened from birth by TCD. Since 1992, TCD has been systematically performed from the age of 12–18 months in the Creteil cohort. MRI/MRA was performed annually after the age of 5 years, or earlier in case of abnormal TCD. Patients with abn. high velocities (TAMMX >= 200 cm/s) were offered transfusion regimens for stroke prevention, but hydroxyurea was proposed secondarily to patients who had normal MRA findings and whose velocities normalized (< 170 cm/s). TCD was performed every three months in these patients, and a transfusion program was resumed if the findings were again abnormal. We report the cerebrovascular outcome of patients born after 1988 who were regularly followed in our center and screened by TCD. This cohort consisted of 242 SCD patients (178 SS, 9 Sb0, 41 SC, and 14 Sb+). Mean follow-up was 6.2 y (range 0.1–17.8), representing 1498 patient-years overall and 1139 patient-years in the SS/Sb0 population. Alpha gene deletion was present in 41% of patients (71/175). The beta genotype was available in 165 patients, and was homozygous Bantou (n=56, 34%), Senegal (n=9, 5.5%), Benin (n=35, 21.2%), or "other" (n=65, 39.4%). Four deaths occurred, all involving SS patients, at 1.2 y (enteritis in 1995), 1.8 y (trip to Africa in 2003), 1.9 y (pneumo. meningitis in 1997) and 3.7 y (ACS and curare allergy in 1998). The mortality rate was 0.27 per 100 patient-years overall and 0.35 in SS/Sb0 patients. The Kaplan-Meier (KM) estimate of the risk of abn. velocities (> 200 cm/s) was 15.7% at 5 y and 22.7% at 10 y of age in SS/Sb0 patients. No SC/Sb+ patients had abn. velocities. Strokes occurred in only two SS patients: the first patient had abn. high velocities detected at the age of 1.5 years and had a stroke at the age of 1.6 years, just before the TCD control and initiation of the transfusion program. The second patient had normal left-sided velocities but no available temporal window on the right side after the age of 1.4 y; this patient had a stroke at age 4.4 y. These observations prompted us to begin TP after the first abn. TCD and to perform MRI/MRA when no window was available. The rates of stroke were 0.13 per 100 patient-years overall, and and 0.18 per 100 patients-years in SS/Sb0 patients. The KM estimate of the risk of stroke was 1.02% at 5 y and 18 y of age in SS/Sb0 patients. KM estimates of the risk of ischemic lesions at 5 and 10 y were respectively 6.4% and 17.7% in SS/Sb0 patients with normal TCD and 20.9% and 43.5% in patients with a history of abn. TCD (Log Rank test 0.0035). This single-center study shows that a strategy based on early and regular TCD can efficiently prevent stroke in a newborn screened cohort: the rate of stroke and the KM risk of stroke were far lower than recently reported (Quinn CT Blood 2004). However, the risk of ischemic lesions remained high particularly in patients with a history of abn. velocities. Abn. TCD velocities identify a high-risk group who may qualify for matched related donor stem cell transplantation.

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Plasmacytoma: 10 years experience at a tertiary care center in India.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e18573 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e18573-e18573

Author(s):

Saphalta Baghmar ◽

Vinod Raina ◽

Atul Sharma ◽

Lalit Kumar

Keyword(s):

Local Control ◽

Vertebral Column ◽

Care Center ◽

Univariate Analysis ◽

Tertiary Care ◽

Initial Response ◽

Rank Test ◽

Solitary Plasmacytoma ◽

Kaplan Meier ◽

Plasma Cell Dyscrasias

e18573 Background: To evaluate the clinical features, diagnoses, prognostic factors, progression to MM of the patients of solitary plasmacytoma (SP) treated at AIIMS in last 10 years(2001-2010). Methods: From 2001-2010, we identified 57 patients with SP. OS, EFS, progression to myeloma were calculated using the Kaplan-Meier method and log rank test. Results: Out of 57 patients; 48 patients were evaluable. The M:F ratio was 3.5:1 with the median age of 49 years. The primary site was osseous(SBP) in 49 patients, extramedullary(EMP) in 8; 5 lesions were located in the upper respiratory passages, ie nasal cavity and maxillary sinus and rest of the 3 were one each in bronchus, gluteal region and intracranial. 43.8% of the lesions involved the vertebral column. The thoracic spine was the single most commonly involved site (12/57 patients). Out of 25 patients with lesions in vertebral column, 12 presented with paraparesis. Monoclonal protein was present in 48% patients and Urine M- Band in additional 2 patients. Treatment consisted of RT [45 Gy (8-50 Gy)] alone in 27, excision in 2 and excision and RT(n=9) and combined modality(n=10). The median follow-up was 28 months(range 3-160 months). Local control was achieved in 41(85%) while progressive disease was seen in 4. Serum M protein became undetectable after treatment in 60% patients. 17(41%) patients progressed to MM after initial response. The median duration of progression to MM was 21 months. Even though there was a trend towards a better EFS and OS for EMP than SBP, in univariate analysis this was not statistically significant. Patients having vertebral lesion showed trend towards progression to MM (p=.057). 5 yr EFS & OS were 44.4% and 89 % respectively. Median EFS and OS were 38 and 122 months respectively. 5 yr survival rate in patients who developed MM and those who did not were 81% and 100% respectively. None of the baseline characteristics were predictive of survival. Conclusions: Out of 1129 patients of plasma cell dyscrasias registered between 2001-2010; 5% were of SP. Bone was the most common site. Attainment of local control is the predictor of significant EFS (p<0.0001) and OS (p<0.05). Progression to MM is the commonest pattern of failure. Vertebrae involvement was predictor for disease progression to MM.

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Right-sided colorectal cancer (RC): Response to first-line chemotherapy in FIRE-3 (AIO KRK-0306) with focus on early tumor shrinkage (ETS) and depth of response (DpR).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.3586 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 3586-3586 ◽

Cited By ~ 3

Author(s):

Julian Walter Holch ◽

Sebastian Stintzing ◽

Swantje Held ◽

Ludwig Fischer von Weikersthal ◽

Thomas Decker ◽

...

Keyword(s):

Colorectal Cancer ◽

Rank Test ◽

Tumor Shrinkage ◽

First Line ◽

Depth Of Response ◽

Kaplan Meier ◽

Hazard Ratios ◽

Radiological Data ◽

Early Tumor Shrinkage ◽

Early Tumor

3586 Background: Recent evidence suggests that benefit from anti-EGFR treatment is restricted to RAS wild-type left-sided colorectal cancer (LC) (Holch JW et al. Eur J Cancer 2017). However, these results are preliminary. We therefore investigated patients with RC enrolled in the FIRE-3 trial, which evaluated the efficacy of first-line FOLFIRI plus either cetuximab (cet) or bevacizumab (bev) in RAS wildtype mCRC. New metrics of tumor dynamics were used to characterize the patients. Methods: The splenic flexure was used to differentiate LC from RC. Survival analysis was done using Kaplan-Meier estimation and differences were expressed using Log-Rank test, hazard ratios (HR) and corresponding 95% confidence intervals. Central independent radiological data was used to calculate early tumor shrinkage ≥20% (ETS) and depth of response (DpR). Results: In total, 330 patients were assessable for central radiological evaluation. In patients with LC (n = 257), treatment with FOLFIRI + cet led to longer overall survival (OS) compared to FOLFIRI + bev (HR = 0.68, p = 0.016). In patients with RC (n = 68), OS was comparable between treatment arms (HR = 1.11, p = 0.715). In patients with RC and ETS < 20%, OS was inferior in patients treated with FOLFIRI + cet. In patients who reached ETS ≥20%, a comparable OS was evident between treatment arms (for further details of efficacy in patients with RC see table). Conclusions: Patients with RC do not represent a uniform population. ETS ≥20% defines a subgroup of patients where comparable treatment efficacy was observed with regard to OS, ORR and DpR by addition of cetuximab vs. bevacizumab to FOLFIRI. [Table: see text]

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