ID: 3527213 THIRD SPACE ENDOSCOPY AFTER FORMAL ENDOSCOPY ADVANCED FELLOWSHIP TRAINING IN THE US: ONE YEAR LINEAR FOLLOW UP OF INDEPENDENT PRACTICE

11 Background: The risk of dying of cancer is highest in the first two years after a curative resection for gastric cancer. Therefore, the prognosis of patients who did not recur in the first two years is improved because they survived this critical period, a phenomenon called conditional survival. The US-derived gastric cancer nomogram predicts disease-specific survival (DSS) based on pathological variables. However, a disease-free interval after surgery, which improves the prognosis, is not captured by the nomogram. Therefore, it has only been used directly after surgery and not in the follow-up setting. The purposes of this study were to develop a conditional survival nomogram for 1, 2 and 3-year survivors (step 1) and to test if the introduction of follow-up variables would improve predictive accuracy of the nomogram in the follow-up setting (step 2). Methods: In a combined US-Dutch population of 1642 patients who underwent an R0 resection for gastric cancer and for whom the old nomogram variables were available, a conditional survival nomogram based on the original variables was developed for one (N=1147), two (N=879) and three (N=721) year survivors (step 1). To improve predictive accuracy in the follow-up setting, weight loss, performance status (PS), hemoglobin (HGB), and albumin (ALB) at one year after resection were retrospectively collected and added to the baseline variables in a new nomogram (step 2). Results: The conditional survival nomograms for 1, 2 and 3-year survivors (step 1) showed a high predictive accuracy in the calibration plots. Surviving one, two and three years shows a median improvement of 5-year DSS of 4%, 9% and 14% respectively. The introduction of weight loss, PS, HGB, and ALB at one year after surgery (step 2) did not improve this nomogram, but availability of these variables was limited. Conclusions: A strongly predictive conditional survival nomogram was developed, giving an improved prognosis for 1, 2 and 3-year survivors of gastric cancer. Introduction of variables available at one year after resection did not further improve this nomogram. This might be caused by the limited availability of follow-up data, as well as the strong predictive accuracy of the original variables. No significant financial relationships to disclose.

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Sa1278 THIRD SPACE ENDOSCOPY AFTER FORMAL ENDOSCOPY ADVANCED FELLOWSHIP TRAINING IN THE US: IS IT TIME FOR ESTABLISHED TRAINING?

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2020.03.1074 ◽

2020 ◽

Vol 91 (6) ◽

pp. AB146

Author(s):

Mohamed M. Abdelfatah ◽

Ali M. Ahmed ◽

Kaartik Soota ◽

Shajan Peter ◽

Douglas Morgan ◽

...

Keyword(s):

Third Space ◽

Fellowship Training ◽

The Us

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Long-Term Outcomes of Renal Function in Patients with TTP Associated with Severe ADAMTS13 Deficiency

Blood ◽

10.1182/blood.v118.21.2215.2215 ◽

2011 ◽

Vol 118 (21) ◽

pp. 2215-2215

Author(s):

Jessica A Reese ◽

Cassandra C Deford ◽

Zayd Al-Nouri ◽

Deirdra Terrell ◽

Sara K. Vesely ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Renal Function ◽

Kidney Disease ◽

Long Term Outcomes ◽

The Us ◽

Adamts13 Deficiency ◽

Initial Episode ◽

One Year

Abstract Abstract 2215 Introduction: Among survivors of TTP associated with severe ADAMTS13 deficiency, long-term outcomes other than relapse are not well documented. The recent report of persistent minor neurocognitive abnormalities attributed to subcortical microvascular thrombosis (Transfusion 2009;49:1092) suggested that other organs may also be affected by subclinical abnormalities. Therefore we documented renal function in patients in the Oklahoma TTP-HUS Registry who survived acute episodes of TTP associated with severe ADAMTS13 deficiency (activity <10%). Methods: ADAMTS13 activity has been measured in 299 of 321 (93%) patients, 1995–2010. Glomerular filtration rate (GFR) was calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation (Ann Int Med 2009;150:604). Urine protein was measured by dipstick. Patient GFRs were compared to GFRs for the US population using data from the National Health and Nutrition Examination Survey (NHANES), 1998–2006, that had been analyzed in the CKD-EPI study. Results: 68 of 299 (23%) patients from the Oklahoma TTP-HUS Registry had severe ADAMTS13 deficiency. Fifty-five of the 68 (81%) patients with severe ADAMTS13 deficiency survived their initial episode of TTP. Among the 55 survivors, 48 (87%) have had ≥1 year of follow-up (median, 6.4 years; range, 1.0 – 14.9 years). The 7 patients whose follow-up was less than 1 year included 3 patients whose initial episode was within the past year; 2 with systemic lupus erythematosus who died within one year; 1 who relapsed and died at one year; 1 lost to follow-up. Sixteen (33%) of the 48 patients had 1–4 relapses. None of the 48 patients developed end stage renal disease and none developed severe chronic kidney disease (GFR <30 ml/min/1.73m2). Three of the 48 patients had chronic kidney disease with moderately decreased GFR (GFR 30–59 ml/min/1.73m2); two of these patients had hypertension and one had hypertension and diabetes prior to their initial episodes of TTP. The median GFR was 97 ml/min/1.73m2 (range, 30 – 139 ml/min/1.73m2). The GFR for the ADAMTS13 deficient TTP patients was not different from the GFR of the U.S. population (p=0.289) (Figure 1). Urine protein was measured on 34 patients (median follow-up, 6.7 years; range, 1.2–14.9 years): 32 (94%) were negative; 2 (6%) were trace, equivalent to <30 μg albumin/mg creatinine. Conclusion: Renal function of TTP patients with severe ADAMTS13 deficiency who had been followed for a median of 6.4 years following recovery from their initial episode was not different from the US population. Disclosures: No relevant conflicts of interest to declare.

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Efficacy and safety of the hedgehog pathway inhibitor vismodegib in patients with advanced basal cell carcinoma (BCC): ERIVANCE BCC study update.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.8579 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 8579-8579 ◽

Cited By ~ 1

Author(s):

Aleksandar Sekulic ◽

Michael R Migden ◽

Anthony E Oro ◽

Karl D Lewis ◽

John D Hainsworth ◽

...

Keyword(s):

Hedgehog Signaling ◽

Locally Advanced ◽

Efficacy And Safety ◽

Primary Analysis ◽

Molecule Inhibitor ◽

The Us ◽

Independent Review ◽

One Year ◽

Weight Decrease

8579 Background: The ERIVANCE BCC study is the pivotal trial of vismodegib (GDC-0449), a first-in-class small-molecule inhibitor of Hedgehog signaling, for treatment of locally advanced (laBCC) and metastatic BCC (mBCC), for whom there are no other effective therapy options. The study met the primary endpoint of overall response rate by independent review (Sekulic, Melanoma Res 2011). Here we report a 6-mo update of investigator-assessed (I-A) efficacy and safety endpoints as of May 26, 2011. Methods: This multicenter, international, nonrandomized 2-cohort study enrolled patients (pts) with laBCC (deemed inoperable or for whom surgery would be significantly disfiguring), and mBCC pts with RECIST-measurable disease. Pts received 150 mg oral vismodegib daily. Results: 104 pts (71 laBCC/33 mBCC) enrolled at 31 sites in the US, Europe, and Australia. I-A efficacy endpoints are shown in the table. One-year survival rate was 77.3% (95% CI 62.48–92.09%) for mBCC and 93.1% (95% CI 86.49–99.63%) for laBCC. Adverse events (AEs) in >30% of pts were muscle spasms, alopecia, dysgeusia, weight decrease, fatigue, nausea, and amenorrhea (33.3%; 2/6 pts). Serious AEs were reported in 32 pts (31%). No additional fatal AEs were reported since the prior data cut (n=7, 7%; none considered related to vismodegib). Conclusions: This 6-mo update of I-A efficacy and safety endpoints from the ERIVANCE BCC study supports the significant clinical benefit of vismodegib in both laBCC and mBCC reported at the primary analysis. Median DOR and PFS increased numerically with follow-up. The AE profile was consistent with the prior data cut. These results further support the efficacy of vismodegib for treatment of advanced BCC. [Table: see text]

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