P–636 Anti-Müllerian-Hormone levels are not correlated to the probability of obtaining an ongoing pregnancy and time to pregnancy in women undergoing intra-uterine inseminations with donor sperm

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
M Libarle ◽  
O Goldrat ◽  
I Demeestere ◽  
J Bouziotis ◽  
M Bruynbroeck ◽  
...  
Keyword(s):  
Age Groups ◽  
Oocyte Quality ◽  
Rank Test ◽  
Ongoing Pregnancy ◽  
Time To Pregnancy ◽  
Donor Sperm ◽  
Tubal Patency ◽  
Op Amp ◽  
Kaplan Meier

Abstract Study question Is Anti-Müllerian hormone (AMH) level associated with the probability of obtaining an ongoing pregnancy (OP) and with time to pregnancy (TTP) in women undergoing d-IUI? Summary answer AMH is neither associated with the probability of obtaining an OP nor with time to pregnancy (TTP) in women undergoing d-IUI What is known already Anti-Müllerian hormone (AMH) is a glycoprotein produced by the granulosa cells of preantral and antral follicles. While AMH has been widely recognized as a quantitative marker of ovarian reserve used to predict ovarian responsiveness to ovarian stimulation in IVF, its relationship with fecundability in spontaneous conceptions is still a matter of debate. There is currently no consensus on the role of AMH on time to pregnancy in unassisted conceptions. The question of whether AMH is a qualitative marker of oocyte quality is therefore still unanswered. Study design, size, duration This prospective cohort study was carried out between 9/1/2017 and 12/30/2020 on 592 women aged 19 to 44, who underwent d-IUI in a natural cycle (n = 1788) the day after LH peak. Patients were single, homosexual, or heterosexual with an infertile partner and underwent 1 to maximum 6 d-IUI. All patients had regular ovulatory cycles and bilateral tubal patency confirmed before starting d-IUI. AMH evaluation was performed within the previous 3 months of the first d-IUI. Participants/materials, setting, methods The primary outcomes were the likelihood of obtaining an OP (>14 weeks) and TTP calculated as the number of d-IIU up to an OP. Multivariate logistic regression was used to compare the probability of obtaining an OP according to age and AMH levels. Kaplan-Meier curves with log-rank test were used to assess the TTP stratified by age groups (≤35, >35 to ≤ 39, and > 39 years old) and AMH groups (< 1ng/mL and ≥ 1ng/mL). Main results and the role of chance AMH levels were negatively correlated with age (p < 0.001). OP were significantly lower with increasing age (OR 0.92 (0.89–0.95) p < 0.001) but did not differ according to AMH levels (OR 1.07 (0.97–1.18) p = 0.18). When adjusting for AMH, the association between age and OP remained significant (OR 0.91 (0.88–0.95)). TTP was significantly different between age groups: ≤35 years old (n = 338), >35 to ≤ 39 years old (n = 136) and > 39 years old (n = 118) (p < 0.001), but did not differ significantly according to AMH levels < 1ng/mL (n = 130) and ≥1ng/mL (n = 462)(p = 0.55). Limitations, reasons for caution Our results concern d-IUI and can therefore not be extrapolated to natural conception. However, the study model is close to natural fecundity as there was no history of female infertility and as all IUI were performed on the day of ovulation with donor sperm proven to be fertile. Wider implications of the findings: While measuring AMH seems necessary for gonadotropin dose adjustment in ART, our data suggest that it cannot qualitatively assess fertility outcome and should therefore not be used routinely for preconception counseling in the absence of infertility history. Trial registration number P2017/396

The role of serum carcinoembryonic antigen in predicting objective responses to chemotherapy and overall survival in patients with non-small cell lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18084-e18084
Author(s):  
Hongbing Liu
Keyword(s):  
Protective Factor ◽  
Cox Regression ◽  
Rank Test ◽  
Small Cell Lung ◽  
Baseline Serum ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Serum Cea ◽  
Nsclc Patients

e18084 Background: Previous studies indicated the carcinoembryonic antigen (CEA) could predict the therapeutic objective response (OR) and overall survival (OS) of patients with cancers, including non-small cell lung cancer (NSCLC). However, the role it could play in evaluating therapeutic responses and OS in patients with NSCLC requires further elucidation. Herein, we investigated the potential role of CEA in predicting OR and OS in patients with NSCLC. Methods: 689 patients with NSCLC were enrolled between January 2000 and August 2011. The correlations between the CEA levels and OR or OS were examined via statistical analyses including the chi-squared test, logistical regression, paired-samples t-test, receiver operator characteristic curve, Kaplan-Meier survival analysis, log-rank test and Cox regression model. Results: The calculated cut-off for predicting an OR to chemotherapy in patients with NSCLC was a reduction of 5.28% in serum CEA. This value demonstrated a sensitivity of 61.3% and a specificity of 62.4%. Serum CEA levels significantly decreased after two cycles of chemotherapy in NSCLC patients (t = 2.196, P = 0.031). The Kaplan-Meier survival analysis indicated no significant correlation between baseline CEA and OS (log rank test =0.079). However, according to the Cox regression analysis the number of distant metastatic organs (=1 and ≥2) was the independent risk factor of the OS (P = 0.026; P =0.003), and the cycle numbers of chemotherapy was the protective factor for OS in patients with NSCLC (P=0.011).More importantly, baseline serum CEA was significantly associated with lung adenocarcinoma and adenosquamous subtypes (P = 0.014; P = 0.017, respectively). Conclusions: Our study shows that baseline serum CEA was significantly associated with lung adenocarcinoma and adenosquamous subtypes. While the baseline level of serum CEA was not a prognostic factor, the post-treatment reduction of serum CEA level can predict the OR in patients with NSCLC,. The number of chemotherapy cycles was the independent protective factor, while the numbers of distant metastatic organs was the independent risk factor for NSCLC patients’ OS.

Associations between regorafenib-induced adverse events (AEs) and efficacy in metastatic colorectal cancer (mCRC).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 556-556 ◽  
Author(s):  
Takeru Wakatsuki ◽  
Eiji Shinozaki ◽  
Mitsukuni Suenaga ◽  
Izuma Nakayama ◽  
Tomohiro Matsushima ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Adverse Events ◽  
Univariate Analysis ◽  
Rank Test ◽  
Multikinase Inhibitor ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Almost All ◽  
Therapy Target

556 Background: It is occasionally recognized that, in molecular targeted therapy, target-specific AEs can surrogate its efficacy, such as skin toxicities and anti-EGFR antibodies. Because of multikinase inhibitor, regorafenib is involved in various kinds of adverse events; however, the clinical associations between AEs and efficacy remain unclear. The aim of this study is to reveal what AEs could surrogate efficacy of regorafenib. Methods: AEs were graded according to CTCAE ver. 4.0. We defined as “CRP increased”, if CRP increased more than 5 mg/dl during treatment compared with the baseline level. Time to treatment failure (TTF) and overall survival (OS) were estimated using Kaplan-Meier methods and compared by the log-rank test. Covariates which were significant in univariate analysis were included in multivariate analysis. Results: One-hundred and two patients were enrolled in this study. Almost all patients were PS 0-1 and received 160mg of regorafenib as an initial dose. The median TTF and the median OS were 2.0 and 8.0 months, respectively. Major AEs were Hand-foot skin reaction (HFSR) in 82.4% (≥Gr3:38.2%), Hypertension (HT) in 39.2% (16.7%), Rash in 23.5% (8.8%), Blood bilirubin increased (BBI) in 58.8% (2.9%), Thrombocytopenia in 48.0% (3.9%), Neutropenia in 20.5% (0%), and CRP increased in 46.1%. Regarding TTF, in univariate analysis, BBI, AST increased Gr0-1, neutropenia, absence of CRP increased, Diarrhea, HFSR, and Rash Gr0-2 were associated with longer TTF. In multivariate analysis, HFSR (HR 0.34 95%CI 0.19-0.63, p = 0.001) and Rash ≥Gr3 (HR 2.43 95%CI 1.13-5.21, p = 0.023) retained to be significant. With respect to OS, in univariate analysis, AST increased Gr0-1, ALT increased Gr0-1, neutropenia, absence of CRP increased, HFSR, and Rash Gr0-2 were associated with longer OS. In multivariate analysis, HFSR (HR 0.47 95%CI 0.24-0.91, p = 0.026), neutropenia (HR 0.54 95%CI 0.30-0.95, p = 0.032) and AST ≥Gr2 (HR 5.72 95%CI 2.11-15.63, p = 0.023) retained to be significant. Conclusions: HFSR and neutropenia might surrogate regorafenib efficacy in mCRC. Elucidation of the mechanisms of these AEs may help to understand which the pathway is the key role of regorafenib treatment in mCRC.

scholarly journals BOND FAILURE RATE OF AMORPHOUS CALCIUM PHOSPHATE CONTAINING (AEGIS ORTHO) AND FLUORIDE RELEASING (TRANSBOND PLUS COLOUR CHANGE) ORTHODONTIC ADHESIVES-A RANDOMIZED CLINICAL TRIAL

2019 ◽  
Author(s):  
Shyamala Naidu ◽  
Anand Suresh
Keyword(s):  
Calcium Phosphate ◽  
Failure Rate ◽  
Amorphous Calcium Phosphate ◽  
Age Groups ◽  
Colour Change ◽  
White Spot ◽  
Rank Test ◽  
White Spot Lesions ◽  
Bond Failure ◽  
Kaplan Meier

Background: The aim of the study was to compare the survival rate of brackets bonded with amorphous calcium phosphate containing adhesive and fluoride releasing orthodontic adhesive over 6 months period. White spot lesions were also evaluated prior to bonding, 3 months and 6 months from the date of bonding. Methods: Thirty six orthodontic patients were randomly divided into two equal groups using split mouth design. 592 brackets were bonded up to the premolars with either Aegis Ortho or Transbond Colour Change(TPCCA). Bracket failure rate and survival distribution were evaluated and compared using Kaplan- meier analysis and Log rank test with respect to adhesives, dental arches, segments , tooth types, gender and age groups. White spot lesion was assessed using WSL index. Results: There was no significant difference between the failure rate of Aegis Ortho(3.0%) and TPCCA(1.4%). Kaplan Meier analysis, Log rank test showed that the difference in the overall failure rate and survival time between the arches, gender, and different age groups were not statistically significant. Both adhesives had a high bond failure rate in the posterior segment especially in the premolar region. Three patients had white spot lesions in the upper premolar region bonded with Aegis ortho. Conclusion: Both Aegis ortho and Transbond plus colour change adhesive with a low bond failure rate can be used as an alternative orthodontic adhesive. Key words : bond failure, amorphous calcium phosphate, transbond colour change adhesive, white spot lesions.

scholarly journals Overhydration and low serum prealbumin predict peritoneal dialysis-related peritonitis in continuous ambulatory peritoneal dialysis patients

2020 ◽  
Author(s):  
Quyen Dao Bui Quy ◽  
Tuan Pham Ngoc Huy ◽  
Loc Nguyen Duc ◽  
My Pham Van ◽  
Dung Nguyen Huu ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
High Sensitivity ◽  
Rank Test ◽  
Reactive Protein ◽  
Kaplan Meier ◽  
Independent Risk Factors ◽  
Hs Crp ◽  
Low Serum

Abstract Background: In this study, we focused on the role of overhydration (OH) and low serum prealbumin concentration in predicting peritonitis in continuous ambulatory peritoneal dialysis (CAPD) patients over a 3-year period.Methods: We measured serum prealbumin concentration and OH by body composition monitor in 278 CAPD patients (159 males and 119 females) with a mean age of 46 years and a median peritoneal dialysis (PD) duration of 21 months. Cases of PD-related peritonitis were collected over 3 years.Results: After the 3-year follow-up, 44 patients were diagnosed with PD-related peritonitis (15.8%). Low education, serum albumin, and prealbumin, as well as high high-sensitivity C- Reactive Protein (hs-CRP) and OH, were independent risk factors for predicting peritonitis over 36 months in CAPD patients. Based on the ROC curve model and Kaplan-Meier analysis, we realized that low prealbumin and high OH were independent predictors of 3-year peritonitis in CAPD patients (Prealbumin: AUC = 0.838, cut-off value = 32.5 mg/dL, Se= 90.9%, Sp = 32.9%; OH: AUC = 0.851, cut-off value = 1.33 L, Se = 79.5%, Sp = 85.5%; and log-rank test p < 0.001, respectively).Conclusion: Overhydration and low serum prealbumin were the independent predictors of PD-related peritonitis in CAPD patients.

scholarly journals Overhydration and low serum prealbumin predict peritoneal dialysis-related peritonitis in continuous ambulatory peritoneal dialysis patients

2020 ◽  
Author(s):  
Quyen Dao Bui Quy ◽  
Tuan Pham Ngoc Huy ◽  
Loc Nguyen Duc ◽  
My Pham Van ◽  
Dung Nguyen Huu ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Rank Test ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Low Education ◽  
Curve Model ◽  
Independent Risk Factors ◽  
Low Serum

Abstract Background: In this study, we focused on the role of overhydration (OH) and low serum prealbumin concentration in predicting 3-year peritonitis in continuous ambulatory peritoneal dialysis (CAPD) patients.Methods: We measured serum prealbumin concentration and OH by body composition monitor on 278 CAPD patients (159 males and 119 females) with mean age of 46 years and the median peritoneal dialysis (PD) duration of 21 months. PD-related peritonitis was collected for 3 years. Results: After the 3-year follow-up, 44 patients diagnosed PD-related peritonitis (15.8%). Low education, serum albumin, prealbumin, high CRP-hs and OH were independent risk factors for predicting peritonitis during 36 months in CAPD patients. Based on the ROC curve model and Kaplan–Meier analysis, we realized that patients with low prealbumin and high OH were the independent predictors of 3-year peritonitis in CAPD patients (Prealbumin: AUC = 0.838, cut-off value = 32.5 mg/dL, Se= 90.9%, Sp = 32.9%; OH: AUC = 0.851, cut-off value = 1.33 L, Se = 79.5%, Sp = 85.5%; and Log-rank test p < 0.001, respectively). Conclusion: Overhydration and low serum prealbumin level were the independent predictors of PD-related peritonitis in CAPD patients.

scholarly journals Resection of intrahepatic cholangiocarcinoma in elderly patients – is it reasonable?

BMC Surgery ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Fabian Bartsch ◽  
Janine Baumgart ◽  
Verena Tripke ◽  
Maria Hoppe-Lotichius ◽  
Stefan Heinrich ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Middle Age ◽  
Age Groups ◽  
Young Group ◽  
Rank Test ◽  
Term Outcome ◽  
Old Patients ◽  
Long Term Outcome ◽  
Kaplan Meier ◽  
Extent Of Surgery

Abstract Background Intrahepatic cholangiocarinoma (ICC) has a rising incidence in western countries. Often major or extended resections are necessary for complete tumor removal. Due to demographical trends the number of elderly patients diagnosed with ICC is rising accordingly. Aim of this study is to show whether resection of ICC in elderly patients is reasonable or not. Methods Between January 2008 and June 2018 all consecutive patients with ICC were collected. Analyses were focussed on the performed resection, its extent, postoperative morbidity and mortality as well as survival. Statistics were performed with Chi2 test for categorical data and for survival analyses the Kaplan Meier model with log rank test was used. Results In total 210 patients underwent surgical exploration with 150 resections (71.4%). Patients were divided in 70-years cut-off groups (> 70 vs < 70 years of age) as well as a young (age 30–50, n = 23), middle-age (50–70, n = 76) and old (> 70, n = 51) group, whose results are presented here. Resectability (p = 0.709), extent of surgery (p = 0.765), morbidity (p = 0.420) and mortality (p = 0.965) was comparable between the different age groups. Neither visceral (p = 0.991) nor vascular (p = 0.614) extension differed significantly, likewise tumor recurrence (p = 0.300) or the localisation of recurrence (p = 0.722). In comparison of patients > or < 70 years of age, recurrence-free survival (RFS) was significantly better for the younger group (p = 0.047). For overall survival (OS) a benefit could be shown, but without reaching significance (p = 0.072). In subgroup analysis the middle-age group had significant better OS (p = 0.020) and RFS (p = 0.038) compared to the old group. Additionally, a better OS (p = 0.076) and RFS (p = 0.179) was shown in comparison with the young group as well, but without reaching significance. The young compared to the old group had analogous OS (p = 0.931) and RFS (p = 0.845). Conclusion Resection of ICC in elderly patients is not associated with an increased perioperative risk. Even extended resections can be performed in elderly patients without obvious disadvantages. Middle-age patients have a clear benefit for OS and RFS, while young and old patients have a comparable and worse long-term outcome.

Predictive role of FAS for trabectedin in second lines of advanced soft tissue sarcoma (ASTS): A Spanish group for research on sarcoma (GEIS) study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11071-11071 ◽  
Author(s):  
Javier Martin Broto ◽  
David Marcilla ◽  
Rafael Ramos ◽  
David Silva Moura ◽  
Ramiro Alvarez ◽  
...  
Keyword(s):  
Selection Criteria ◽  
Unmet Need ◽  
Predictive Biomarkers ◽  
Rank Test ◽  
Second Line ◽  
Kaplan Meier ◽  
Diagnostic Time ◽  
Predictive Role ◽  
Set Up

11071 Background: There are currently several second-line options for the treatment of ASTS as gemcitabine combinations, trabectedin, pazopanib, eribulin or olaratumab plus doxorubicin in cases where anthracyclins are still possible. There is an unmet need for predictive biomarkers which hinders the rational selection of the best sequence in second line. We already published the prognostic value of FAS in first line of ASTS while this study analyzes its predictive role in different second line schemes. Methods: Most relevant selection criteria for this study were having received trabectedin in 2nd line or beyond for ASTS, progressive disease after at least one previous line for ASTS and signed CI. A TMA was set up for FAS staining (Cell Signaling) with blocks from diagnostic time. Two expert blinded pathologists reviewed and classified the cases as negative, weak or strong. Kaplan–Meier estimations were used for time-to-event variables and the log-rank test was used to compare groups. Results: A series of 198 patients accomplished selection criteria. Metastases at diagnosis occurred in 46 (24%) and median time to metastases was 18.8 months (CI 16,3; 21.3). Previous line to trabectedin consisted of gemcitabine combination 83 (42%), Doxorubicin-based 65 (33%) and others 50 (25%). Median PFS for previous and trabectedin lines were 3.5 (2.8-4.2) and 3.4 (2.8-4) months respectively. FAS positive entailed significantly better PFS for the previous trabectedin line: 4.1 (1.5-6.7) vs 3.0 (2.5-3.5) months, p = 0.01 whereas FAS positive was related with worse PFS for the trabectedin line 2.5 (2.2-2.8) vs 3.7 (2.7-4.8) months, p = 0.028. These results were more notorious for L-sarcoma cases: 7.0 (3.6-10.5) vs 4.3 (1.9-6.6) months, p = 0.017 in previous line and 2.4 (2.2-2.6) vs 6.5 (3.8-9.3) months, p < 0.001 in trabectedin. From trabectedin administration, FAS+ had significantly worse OS especially in L-sarcomas: 11.9 (5.2-18.7) vs 21.7 (12.7-30.8) months, p = 0.002. Conclusions: FAS showed predictive value in PFS and OS for trabectedin administration in ASTS. The different prognostic role of FAS across distinct lines and its relevance in L-sarcomas deserve further attention.

RADT-27. EFFECTIVENESS ANALYSIS OF RADIOTHERAPY FOR INTRACRANIAL RECURRENT EPENDYMOMA

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi47-vi47
Author(s):  
Qingjun Hu ◽  
Mingyao Lai ◽  
Juan Li ◽  
Linbo Cai
Keyword(s):  
Survival Time ◽  
Rank Test ◽  
Who Grade ◽  
Radiotherapy Group ◽  
Log Rank Test ◽  
Kaplan Meier ◽  
Recurrent Ependymoma ◽  
Grade Ii

Abstract OBJECTIVE There is no standard treatment for recurrent ependymoma. This study aimed to investigated the role of radiotherapy in recurrent ependymoma. METHODS Retrospective analysis was performed on 49 cases of recurrent ependymoma diagnosed in Guangdong Sanjiu Brain Hospital from January 2008 to July 2020. Overall survival (OS) was calculated by Kaplan-Meier method and tested by Log-rank test. P &lt; 0.05 was considered statistically significant. RESULTS The median age was 7 years (range:1-57 yrs). Nineteen patients were with ependymoma WHO grade II while 30 were with grade III, respectively. Recurrence treatment: 14 cases received re-surgery, 23 cases received radiotherapy, among them 16 cases received re-radiotherapy. To May, 2021, the median follow-up time was 35 months (range 3-153). Median PFS time was 17 months after initial diagnosis, median PFS time was 8 months after treatment to recurrence disease, Median OS time is 39 months, and median OS time is 20 months after recurrence. The median survival time for recurrence was 48 months vs. 11 months (P =0.001) in the radiotherapy group vs. non-radiotherapy group,res; Re-radiotherapy combined with chemotherapy vs reradiotherapy alone (0.194); RRT combined with anti-angiogenesis therapy vs. RRT alone (0.688). CONCLUSION Radiotherapy can prolong the survival time of recurrent ependymoma, and concurrent therapy as chemotherapy or anti-angiogenesis therapy with RT does not seem to improve the prognosis. Therefore, radiotherapy can be used as the main treatment for recurrent ependymoma.

scholarly journals Survival in a cohort of patients with lung cancer: the role of age and gender in prognosis

2017 ◽  
Vol 43 (6) ◽  
pp. 431-436 ◽  
Author(s):  
Juliana Pereira Franceschini ◽  
Sérgio Jamnik ◽  
Ilka Lopes Santoro
Keyword(s):  
Lung Cancer ◽  
Age Distribution ◽  
Age Groups ◽  
Rank Test ◽  
Age Group ◽  
Tertiary Referral Hospital ◽  
Kaplan Meier ◽  
Stage Disease ◽  
And Gender ◽  
Disease Stages

ABSTRACT Objective: To determine the demographic and clinical characteristics of patients with non-small cell lung cancer (NSCLC), as well as their disease course, by age group and gender. Methods: This was a retrospective cohort study of patients diagnosed with NSCLC from 2000 to 2012 and followed until July 2015 in a tertiary referral hospital in the city of São Paulo, Brazil. Based on the 25th and 75th percentiles of the age distribution, patients were stratified into three age groups: < 55 years; ≥ 55 and < 72 years; and ≥ 72 years. Survival time was evaluated during the follow-up period of the study. Functions of overall and gender-specific survival stratified by age groups (event: all-cause mortality) were calculated using the Kaplan-Meier method. Differences among survival curves were assessed via the log-rank test. Results: We included 790 patients with the following age distribution: < 55 years, 165 patients; ≥ 55 and < 72 years, 423; and ≥ 72 years, 202. In the entire sample, there were 493 men (62.4%). Adenocarcinoma was the most common histological pattern in the < 72-year age groups; 575 patients (73%) presented with advanced disease (stages IIIB-IV). The median 5-year survival was 12 months (95% CI: 4-46 months), with no significant differences among the age groups studied. Conclusions: NSCLC remains more common in men, although we found an increase in the proportion of the disease in women in the < 55-year age group. Adenocarcinoma predominated in women. In men, squamous cell carcinoma predominated in the ≥ 72-year age group. Most patients presented with advanced-stage disease at diagnosis. There were no statistical differences in survival between genders or among age groups.

Epidemiological trends in metastatic renal cell carcinoma in the era of targeted therapies: An analysis of the SEER registry.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 516-516
Author(s):  
Arpit Rao ◽  
Charles Wiggins ◽  
Richard C. Lauer
Keyword(s):  
Kinase Inhibitors ◽  
Age Groups ◽  
Rank Test ◽  
Kaplan Meier ◽  
Time Period ◽  
Long Term Impact ◽  
Epidemiological Trends ◽  
Improvement In Survival ◽  
The Impact ◽  
Cause Specific Survival

516 Background: Clear cell RCC (ccRCC) accounts for 70-75% of all kidney and renal pelvis cancers with approximately 16% of patients presenting with distant (metastatic) disease. Five year overall survival (OS) remains dismal at 11.2% for patients with distant disease. Several tyrosine kinase inhibitors (TKI) were approved by US Food and Drug Administration for use in metastatic RCC between 2005 and 2012. While these therapies have been shown to improve outcomes in metastatic ccRCC, the long term impact remains unknown. Methods: The Surveillance, Epidemiology and End-Results (SEER) database was queried for patients aged 18 years and older diagnosed with distant stage (metastatic) ccRCC between 2001 and 2012 in the nine core SEER registries. Analyses were restricted to histologically confirmed cases. Study period was divided into 3-year intervals: 2001-03 (pre-TKI era); 2004-06 (TKI trials era); 2007-09 (early TKI era); and 2010-12 (sequential TKI era). Patients were stratified by age at diagnosis: 18-60 years, 60-69 years, and 70+ years. One, two, and three year, and median cause-specific survival were calculated by Kaplan-Meier method. Differences in cause-specific survival by time period were assessed with the Log-Rank test. Results: A total of 3,747 eligible patients were included in the analysis. For all ages combined, cause-specific survival at three years post-diagnosis was 18.8% for those diagnosed during the period 2001-03 (median 8 months), 22.7% in 2004-06 (median 10 months), 23.2% in 2007-09 (median 9 months), and 28.9% in 2010-12 (median 11.0 months) (p= 0.0004). No statistically significant improvement in survival was observed in patients aged 70 years and above (p= 0.1302). Conclusions: Our analysis quantifies the improvement in survival outcomes in metastatic ccRCC that correlate with TKI use in this setting. While there is evidence that all age groups may have benefitted from these therapies, the impact is least pronounced in patients aged 70 years and above. A SEER-Medicare analysis is planned to evaluate disparities in TKI use in this age group.

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