A single-center retrospective study of patients treated with trabectedin (TRB) with long-term follow up.

11061 Background: TRB is FDA approved drug for the treatment of liposarcoma (Lipo) and leiomyosarcoma (LMS). The aim of this study was to evaluate potential biomarkers associated with prolonged benefit in patients treated with TRB at our center prior to 2016. Methods: We performed a retrospective search of UW/FHCRC CASIS database to identify patients treated with TRB prior to 2016. Demographic variables and clinical variables (such as histology and treatment) were retrieved. Statistics were performed with R 3.4.1 software. Pairwise Pearson’s correlation was calculated for the # of prior chemotherapy regimens with # of TRB cycles. The Kaplan-Meir method was used to evaluate overall survival (OS). Log-rank test was conducted to compare groups in terms of OS. Results: 145 sarcoma patients treated with TRB were identified with a mean follow up of 5 years (generally on NCT01427582 or NCT01343277). Patients averaged 1.9 prior chemotherapy regimens prior to TRB (range 0-7 regimens) and received an average of 5.6 TRB doses (range 1-25 doses). Subtypes are listed on table. The # of prior regimens was negatively correlated with the # of TRB cycles that patients received (pairwise correlation coefficient = -1.77; p=0.034), suggesting that multiple prior treatment lines either made TRB less tolerable or made sarcoma less sensitive to TRB. The median OS for this heavily treated metastatic population was 0.5 years. However, patients who were able to stay on TRB for more than 5 cycles had a significantly higher OS (p=0.001). While only 23% of patients who received less than 5 cycles of TRB were alive at 5 years (95% CI: 0.15, 0.32), 53% of those who received 5 or more cycles of (95% CI: 0.39, 0.65) were alive at 5 years. Conclusions: TRB may be more effective when administered as an earlier line of therapy. Patients who are able to stay on TRB for a longer duration had a significant improvement in OS. Detailed subset analysis will be presented as will initial findings of our biomarker work. These retrospective data warrant further evaluation. Clinical trial information: NCT01427582 or NCT01343277. [Table: see text]

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Re-bleeding and its predictors after capsule endoscopy in patients with obscure gastrointestinal bleeding in long-term follow-up

BMC Gastroenterology ◽

10.1186/s12876-019-1137-3 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

Panu Wetwittayakhlang ◽

Jirapat Wonglhow ◽

Nisa Netinatsunton ◽

Naichaya Chamroonkul ◽

Teerha Piratvisuth

Keyword(s):

Specific Treatment ◽

Rank Test ◽

Gi Bleeding ◽

Free Survival ◽

Log Rank Test ◽

Negative Study ◽

Long Term Follow Up ◽

Bleeding Episodes

Abstract Background Capsule endoscopy (CE) is the preferred diagnostic test of choice in the investigation of obscure gastrointestinal bleeding (OGIB). Although, a conservative strategy is recommended in the short-term, for cases with a negative result from CE, the impact of CE on long-term re-bleeding still remains unclear. Hence, the aim of this study was to determine the long-term re-bleeding rate along with predictors after CE in patients with OGIB. Methods We retrospectively reviewed 216 patients with OGIB, whom had received a CE examination, so as to investigate the cause of obscure GI bleeding; between July 2008 and March 2018. The patient’s characteristics, medication use, CE finding, treatments strategy, re-bleeding episodes and follow-up information were collected from the institutional electronic medical chart and CE database. Re-bleeding free survival was evaluated using Kaplan-Meier curves with log rank test, whilst predictors associated with the re-bleeding episodes were analyzed via the use of Cox proportional hazard model. Results One hundred and thirty-three patients with OGIB, having received CE were enrolled in the analysis. The pool rate of re-bleeding was 26.3% (35/133) during a follow-up duration of 26 months after CE. Patients with positive CE study, without specific treatment, had higher rates of re-bleeding (47.6%) than those with positive study whom received specific treatment (25.7%), and negative study (20.8%) (p = 0.042). Although, the re-bleeding free survival was not significantly different among the groups (log rank test; P = 0.10). Re-bleeding events occurring within 6, 12, and 24 months after CE were 36, 64 and 92%, respectively. The high-frequency re-bleeding etiologies were the small bowel angiodysplasias and abnormal vascular lesions. Furthermore, independent predictors for re-bleeding after CE were patients with cirrhosis (hazard ratio, HR 4.06), incomplete CE visualization (HR 2.97), and a history of previous GI bleeding (HR 2.80). Conclusions The likelihood of re-bleeding after CE was higher in patients with positive CE study than those with negative study. Specific treatments, or therapeutic interventions for patients with detectable lesions reduced the probability of re-bleeding episodes in long-term follow-up. Close follow-up for recurrent bleeding is recommeded for at least 2 years after CE.

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Nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for advanced non-small cell lung cancer (NSCLC): 4-year update from CheckMate 227.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.9016 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 9016-9016

Author(s):

Luis G. Paz-Ares ◽

Tudor-Eliade Ciuleanu ◽

Jong-Seok Lee ◽

Laszlo Urban ◽

Reyes Bernabe Caro ◽

...

Keyword(s):

Advanced Nsclc ◽

Performance Status ◽

Stage Iv ◽

Ecog Performance Status ◽

Programmed Death ◽

Long Term Follow Up ◽

To Receive ◽

Clinical Trial Information

9016 Background: 1L NIVO + IPI was shown to provide durable long-term overall survival (OS) benefit vs chemo regardless of tumor programmed death ligand 1 (PD-L1) expression in patients (pts) with advanced NSCLC in CheckMate 227 Part 1 (NCT02477826); 3-year OS rates were 33% vs 22% in pts with PD-L1 ≥ 1% (HR, 0.79 [95% CI, 0.67–0.93]) and 34% vs 15% in pts with PD-L1 < 1% (HR, 0.64 [95% CI, 0.51–0.81]). Here we report updated results from the study with 4 years’ minimum follow-up. Methods: Adults with previously untreated stage IV / recurrent NSCLC, no known EGFR/ ALK alterations , and ECOG performance status ≤ 1 were enrolled; pts were stratified by squamous (SQ) and non-squamous (NSQ) histology. Pts with PD-L1 ≥ 1% (n = 1189) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), NIVO alone (240 mg Q2W), or chemo. Pts with PD-L1 < 1% (n = 550) were randomized 1:1:1 to receive NIVO + IPI, NIVO (360 mg Q3W) + chemo, or chemo. OS with NIVO + IPI vs chemo in pts with PD-L1 ≥ 1% was the primary endpoint. Results: With minimum follow-up of 49.4 months (database lock, Feb 18, 2021), pts were at least 2 years beyond the protocol-specified end of immunotherapy treatment. Pts with PD-L1 ≥ 1% continued to show durable benefit with NIVO + IPI vs chemo (HR, 0.76 [95% CI, 0.65–0.90]); 4-year OS rates were 29% (NIVO + IPI), 21% (NIVO), and 18% (chemo). At 4 years, 14% (NIVO + IPI), 10% (NIVO), and 4% (chemo) remained progression free. Among responders, 34%, 30%, and 7% remained in response, respectively. In an exploratory analysis in pts with PD-L1 ≥ 50%, 4-year OS rates were 37% (NIVO + IPI), 26% (NIVO), and 20% (chemo). In pts with PD-L1 < 1%, OS HR for NIVO + IPI vs chemo was 0.64 (95% CI, 0.51–0.81); 4-year OS rates were 24% (NIVO + IPI), 13% (NIVO + chemo) and 10% (chemo). At 4 years, 12% (NIVO + IPI), 7% (NIVO + chemo), and 0% (chemo) remained progression free. Among responders, 31%, 13%, and 0% remained in response, respectively. Among pts who progressed on NIVO + IPI vs chemo, 7% vs 40% (PD-L1 ≥ 1%), and 9% vs 33% (PD-L1 < 1%), received subsequent immunotherapy. Benefit with NIVO + IPI vs chemo was observed for both SQ and NSQ histology (Table). With long-term follow-up, no new safety signals were identified. Conclusions: With 4 years’ minimum follow-up, 1L NIVO + IPI continued to provide durable, long-term OS benefit vs chemo in pts with advanced NSCLC regardless of PD-L1 expression or histology. Clinical trial information: NCT02477826. [Table: see text]

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Cetuximab and chemotherapy in the treatment of patients with initially “nonresectable” colorectal (CRC) liver metastases: Long-term follow-up of the CELIM trial.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.3538 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 3538-3538 ◽

Cited By ~ 2

Author(s):

Gunnar Folprecht ◽

Thomas Gruenberger ◽

Wolf Bechstein ◽

Hans-Rudolf Raab ◽

Juergen Weitz ◽

...

Keyword(s):

Liver Metastases ◽

Tumor Response ◽

Progression Free Survival ◽

R0 Resection ◽

Term Survival ◽

Free Survival ◽

Long Term Follow Up ◽

Clinical Trial Information

3538 Background: CRC liver metastases can be resected after downsizing with intensive chemotherapy schedules, with a strong correlation between the response and resection rates. Cetuximab plus chemotherapy has been shown to increase the rates of tumor response and resection of liver metastases. (Van Cutsem et al, JCO 2011). Methods: Patients (pts) with technically non-resectable and/or with > 4 liver metastases were randomized to treatment with FOLFOX/cetuximab (arm A) or FOLFIRI/cetuximab (arm B) and evaluated regarding resectability every 2 months. Resection was offered to all patients who became resectable during the study. K-ras and b-raf status were retrospectively evaluated. Data on tumor response and resection were reported earlier (Folprecht et al, Lancet Oncol 2010). Overall and progression free survival were analyzed in December 2012. Results: Between Dec 2004 and March 2008, 56 pts were randomized to arm A, 55 to arm B. For the current analysis, 109 pts were evaluable for overall survival (OS), and 106 patients for PFS. The median OS was 35.7 [95% CI: 27.2-44.2] months (arm A: 35.8 [28.1-43.6], arm B: 29.0 [16.0-41.9], HR 1.03 [0.66-1.61], p=0.9). The median PFS was 10.8 [9.3-12.2] months (Arm A: 11.2 [7.2-15.3], Arm B: 10.5 [8.9-12.2], HR 1.18 [0.79-1.74], p=0.4). Patients with R0 resection had a better OS (median: 53.9 [35.9-71.9] mo) than patients without R0 resection (27.3 [21.1-33.4] mo, p=0.002) and a better PFS (median 15.4 [11.4-19.5] and 8.9 [6.7-11.1] mo in R0 resected and not R0 resected pts, p<0.001). The 5 year survival in R0 resected patients is 46.2% [29.5-62.9%]. Conclusions: This study confirmed a favourable long term survival of patients with initially “nonresectable” CRC liver metastases treated in a multidisciplinary approach of neoadjuvant chemotherapy with cetuximab and subsequent metastasectomy in pts who became resectable. Clinical trial information: NCT00153998. [Table: see text]

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10-year clinical outcomes after radiofrequency catheter ablation for atrial fibrillation. A single center experience

European Heart Journal ◽

10.1093/eurheartj/ehab724.0518 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

J.F Alderete Martinez ◽

S Shizuta ◽

F Yoneda ◽

S Nishiwaki ◽

M Tanaka ◽

...

Keyword(s):

Atrial Fibrillation ◽

Catheter Ablation ◽

Adverse Events ◽

Confidence Interval ◽

Clinical Outcomes ◽

Radiofrequency Catheter Ablation ◽

Rank Test ◽

Log Rank Test

Abstract Background Radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) is becoming a routine procedure to treat patients with drug-refractory symptomatic AF. However, data regarding very long-term clinical outcomes is limited. The aim of the present study was to evaluate the 10-year clinical outcomes of patients who underwent RFCA for paroxysmal and persistent AF. Methods We retrospectively enrolled 503 consecutive patients (mean age 66,9±9,51 years; 71,6% male) who underwent RFCA for drug-refractory symptomatic AF between February 2004 and June 2011. Follow-up information was obtained using medical records and/or telephonic interviews with the patient, relatives and/or referring physicians. Results Among 503 patients enrolled in this study, 362 had paroxysmal atrial fibrillation (PAF) and 141 had persistent atrial fibrillation (PeAF) (72% and 28%, respectively). Mean follow-up was 8,84±3,05 years. The 10-year event-free rate for recurrent atrial tachyarrhythmia (AT) after the first procedure was 44,5% (49,4% for PAF vs 31,9% for PeAF; p=0,002 by log-rank test) and 81,9% after the last procedure (87,3% for PAF and 67,9% for PeAF; p≤0,001 by log-rank test). AT recurrence was observed most commonly during the first 12 months of the initial procedure (56%), with only 18% of them occurring after 60 months. Multivariate analysis revealed that persistent AF (hazard ratio=1,366; 95% confidence interval 1,058–1,76; p=0,017) and duration of AF >5 years (hazard ratio=1,357; 95% confidence interval 1,064–1,732; p=0,005) were independent risk factors for AT recurrence. Regarding adverse events, there were 24 (4,8%) hospitalizations for acute decompensated heart failure, 20 (4%) ischemic strokes and 14 (2,8%) bleeding complications requiring hospital admissions. Patients taking oral anticoagulation and antiarrhythmic drugs at the end of the study accounted for 32,8% and 16,7% respectively. Conclusions RFCA for AF provided favorable results in terms of arrhythmia event-free survival in long-term follow-up with better results in patients with paroxysmal AF. Persistent AF and long-standing AF (beyond 5 years) were associated with AT recurrence. Despite the large number of patients who discontinued oral anticoagulation, thromboembolic adverse events were rare. FUNDunding Acknowledgement Type of funding sources: None.

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Impact of monitoring on detection of arrhythmia recurrences in the ESC-EHRA EORP atrial fibrillation ablation long-term registry

EP Europace ◽

10.1093/europace/euz216 ◽

2019 ◽

Vol 21 (12) ◽

pp. 1802-1808

Author(s):

Tosho Balabanski ◽

Josep Brugada ◽

Elena Arbelo ◽

Cécile Laroche ◽

Aldo Maggioni ◽

...

Keyword(s):

Atrial Fibrillation ◽

Atrial Fibrillation Ablation ◽

Rank Test ◽

Lower Probability ◽

Monitoring Methods ◽

Holter Ecg ◽

Af Ablation ◽

Log Rank Test

Abstract Aims Monitoring of patients after ablation had wide variations in the ESC-EHRA atrial fibrillation ablation long-term (AFA-LT) registry. We aimed to compare four different monitoring strategies after catheter AF ablation. Methods and results The ESC-EHRA AFA-LT registry included 3593 patients who underwent ablation. Arrhythmia monitoring during follow-up was performed by 12-lead electrocardiogram (ECG), Holter ECG, trans-telephonic ECG monitoring (TTMON), or an implanted cardiac monitoring (ICM) system. Patients were selected to a given monitoring group according to the most extensive ECG tool used in each of them. Comparison of the probability of freedom from recurrences was performed by censored log-rank test and presented by Kaplan–Meier curves. The rhythm monitoring methods were used among 2658 patients: ECG (N = 578), Holter ECG (N = 1874), TTMON (N = 101), and ICM (N = 105). A total of 767 of 2658 patients (28.9%) had AF recurrences during follow-up. Censored log-rank test discovered a lower probability of freedom from relapses, which was detected with ICM compared to TTMON, ECG, and Holter ECG (P < 0.001). The rate of freedom from AF recurrences was 50.5% among patients using the ICM while it was 65.4%, 70.6%, and 72.8% using the TTMON, ECG, and Holter ECG, respectively. Conclusion Comparing all main electrocardiographic monitoring methods in a large patient sample, our results suggest that post-ablation recurrences of AF are significantly underreported by TTMON, ECG, and Holter ECG. The ICM estimates AF ablation recurrences most reliably and should be a preferred mode of monitoring for trials evaluating novel AF ablation techniques.

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Patterns of mortality after prolonged follow-up of a randomized trial using granulocyte colony-stimulating factor (G-CSF) to maintain chemotherapy dose intensity in non-Hodgkin lymphoma (NHL)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.7590 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 7590-7590

Author(s):

A. R. Clamp ◽

S. Bhattacharya ◽

D. W. Ryder ◽

R. Pettengell ◽

J. A. Radford

Keyword(s):

Randomized Trial ◽

Dose Intensity ◽

Rank Test ◽

Second Malignancies ◽

Term Survival ◽

Log Rank Test ◽

Chemotherapy Dose ◽

Chemotherapy Dose Intensity

7590 Background: Recombinant G-CSF is commonly used to maintain chemotherapy dose intensity and reduce the incidence of infective complications in the management of NHL. The possible impact of this effect on mortality patterns after prolonged follow-up is worthy of investigation. We investigated the long-term survival and incidence of second malignancies in the first randomized trial utilising recombinant G-CSF in NHL (Pettengell R et al Blood 1992, 80: 1430–1436). Methods: Data on overall survival (OS), progression-free survival (PFS), freedom from progression (FFP) and the incidence of second malignancies were extracted from medical records and cancer registry databases for 80 patients with aggressive subtypes of NHL, who had previously been randomised to receive either VAPEC-B chemotherapy alone (39 patients) or VAPEC-B with G-CSF (41 patients). 10 year survival figures were extracted and Kaplan-Meier survival curves were drawn for the above parameters and compared between treatment groups using the log-rank test. Results: Median follow-up was 11.8 years for surviving patients (range 7.8–13.1 yrs). Patients receiving G-CSF achieved a 12% higher median dose intensity of chemotherapy. No significant differences were found in PFS or OS but 10 year FFP appeared to be better in the G-CSF arm (60.8%) compared with the control arm (45.6%) (log-rank test p=0.12). Eleven deaths from non-NHL causes occurred in the G-CSF arm compared with three in the control arm (log- rank test p=0.06). Five second malignancies were detected on long-term follow-up in the G-CSF arm compared with two in the control arm. Conclusions: The demonstration of different mortality patterns in the two arms may be related to the greater dose intensity of chemotherapy received in the G-CSF arm. Although, our study has insufficient statistical power to draw definite conclusions, this finding warrants further investigation. No significant financial relationships to disclose.

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Results after long-term follow-up from the CAN2007 phase I/II study of weekly or twice-weekly bortezomib in patients (pts) with relapsed systemic light-chain (AL) amyloidosis.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.8545 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 8545-8545

Author(s):

Donna Ellen Reece ◽

Ute Hegenbart ◽

Vaishali Sanchorawala ◽

Giampaolo Merlini ◽

Giovanni Palladini ◽

...

Keyword(s):

Single Agent ◽

Maximum Tolerated Dose ◽

Outcome Data ◽

Al Amyloidosis ◽

Background Data ◽

Long Term Follow Up ◽

Combination Regimens ◽

Clinical Trial Information

8545 Background: Data from multiple studies suggest that bortezomib alone or in combination regimens is active in newly diagnosed and relapsed AL. CAN2007 (NCT00298766) was the first prospective study of single-agent bortezomib in relapsed AL. Here we report outcome data at study closure after a median follow-up of 51.8 mos (median 46.1–66.1 mos). Methods: 70 pts received bortezomib 0.7, 1.0, 1.3, or 1.6 mg/m2 on days 1, 8, 15, and 22 of 35-day cycles (QW) or 0.7, 1.0, or 1.3 mg/m2 on days 1, 4, 8, and 11 of 21-day cycles (BIW) for up to 8 cycles (or longer in pts with evidence of ongoing clinical benefit). The maximum tolerated dose was not reached on either schedule; 18 and 34 pts were treated at the maximum planned doses of 1.6 mg/m2 QW and 1.3 mg/m2BIW, respectively, and 18 pts were treated at lower doses. Post-treatment, pts were followed every 6 weeks until disease progression, and then every 3 mos for survival during the long-term follow-up phase. Results: Pts received a median (range) of 8 (1–39), 6 (1–57), and 8 (3–57) cycles of bortezomib in the 1.6 mg/m2 QW, 1.3 mg/m2 BIW, and lower-dose groups, respectively; overall, 32 (46%) pts received ≥8 cycles, and 4 pts were still on treatment and had received ≥39 cycles at study closure. Hematologic responses and outcomes are summarized below. Median (range) follow-up for survival was 51.8 (1–68), 46.1 (1–61), and 66.1 (2–80) mos, and 7, 12, and 9 pts have died, in the 1.6 mg/m2 QW, 1.3 mg/m2BIW, and lower-dose groups, respectively. Median overall survival (OS) in all 70 pts was 62.7 mos, and 4-yr OS rate was 67.3%; data by dose group are shown below. Conclusions: Single-agent bortezomib produces durable hematologic responses and promising long-term OS data in pts with relapsed AL. Clinical trial information: NCT00298766. [Table: see text]

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Association of improved survival (OS) and tumor control (TC) with interleukin-2 (IL2) with development of immune-related events (IREs): Data from the PROCLAIMSM registry.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.9528 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 9528-9528

Author(s):

Brendan D. Curti ◽

Gregory A. Daniels ◽

David F. McDermott ◽

Joseph Clark ◽

Howard Kaufman ◽

...

Keyword(s):

Interleukin 2 ◽

Rank Test ◽

Tumor Control ◽

Test Results ◽

Exact Test ◽

Log Rank Test ◽

Kaplan Meier ◽

Long Term Impact

9528 Background: IREs are associated with immunotherapy (IT) for cancer and while reports suggest improvement in TC and OS with induced IREs, the long-term impact is unclear. IL2 has been the major IT for patients (pts) with renal cell carcinoma (RCC) and melanoma (MM) since 1992. We evaluated IREs reports in the PROCLAIMSM data base (2008-2016) of IL2-treated pts. Methods: Reports on 614 (MM) and 843 (RCC) pts were queried for IREs. IREs were categorized as occurring before, during, or after IL-2 and related to any checkpoint inhibitor (CPI). TC (CR+PR+SD) was compared between no IRE and IRE, using Fisher’s exact test. OS curves were estimated by Kaplan-Meier method, and comparison of no IRE/before IL2 with during/after IL2, was analyzed by log-rank test. Results: With a median (med) follow-up of 3.5+ years (range 1-8+ year), 140 IREs were reported in 118 pts (9.6% of all PROCLAIMSM pts): 93 (15%) in MM; 47 (5.6%) in RCC. 25 IREs were prior to IL2; 13 IREs were during IL2; 102 were after IL2. Of the latter 102, 31 were after IL2 and after subsequent CPI; 71 were attributed to IL2 only; and in 13, IREs were due to either IL2 or CPI. TC was 73% for IRE group vs 56% for no IRE group (p = 0.0054). OS was significantly greater for IRE group during/after IL2 compared to no IRE/before IL2 in MM, med 46 months (mo) vs 18 mo (p = 0.0001) and in RCC, med 61 mo vs 43 mo (p = 0.0196), independent of CPI IREs. Med # of IL2 doses was 19 in no IRE group, 39 in IRE during IL2 group, and 25 in IRE after IL2 group. IL2-related IREs were primarily vitiligo and thyroid dysfunction (70% of IL2 IREs), with limited further impact, while CPI-related IREs were often serious, requiring intervention (hypophysitis, colitis, hepatitis, uveitis) (52% of CPI IREs) and possibly chronic management. Conclusions: IREs following IL2 are associated with improved TC and OS. IREs resulting from IL2 and from CPIs are qualitatively different and likely reflect different mechanisms of action of immune activation and response.

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Durability of complete response (CR) with atezolizumab (atezo) in locally advanced/metastatic urothelial carcinoma (mUC).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.4527 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 4527-4527

Author(s):

Yohann Loriot ◽

Arjun Vasant Balar ◽

Robert Dreicer ◽

Jean H. Hoffman-Censits ◽

Jose Luis Perez-Gracia ◽

...

Keyword(s):

Locally Advanced ◽

Complete Response ◽

First Response ◽

Long Term Follow Up ◽

Metastatic Urothelial Carcinoma ◽

Post Hoc ◽

Clinical Trial Information ◽

Disposition Time

4527 Background: Atezo (anti–PD-L1) has been shown to elicit CRs in a number of mUC patients (pts) in clinical trials. We sought to describe the kinetics, durability and outcomes associated with these CRs in Ph I (PCD) and II (IMvigor210) atezo studies, each with long-term follow-up. Methods: In PCD (pre-treated mUC) and IMvigor210 (Cohort 1, cisplatin-ineligible untreated mUC; Cohort 2, platinum-treated mUC), pts received atezo per protocol (Petrylak JAMA Oncol 2018; Balar Lancet 2017; Rosenberg Lancet 2016). This post hoc analysis descriptively assessed pt disposition, time to and duration of RECIST 1.1 response and overall survival in pts with CR. Results: CR rates were 13%, 8% and 7% in PCD, IMvigor210 Cohort 1 and Cohort 2, respectively. First response was PR in most pts with CR. Median CR duration was > 3 y in PCD, not estimable (NE) in IMvigor210 Cohort 1 and > 2 y in Cohort 2 (Table). At data cutoff, all but 2, 0 and 1 pts were alive, respectively; across studies, ≥ 40% of pts with CR were on treatment. CR pts had a first response (PR/CR) by a median of 3.5 cycles. Further pt characteristics and survival outcomes will be reported. Conclusions: Across Ph I/II atezo mUC studies, CRs appeared durable (median duration > 2 y) despite small pt numbers. Most pts with CR were alive, with responses ongoing after long-term follow-up (median follow-up > 30 mo). Clinical trial information: NCT01375842, NCT02951767, NCT02108652. [Table: see text]

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The St. Jude Toronto stentless bioprosthesis: Up to 20 years follow-up in younger patients

The Heart Surgery Forum ◽

10.1532/hsf.1252 ◽

2015 ◽

Vol 18 (4) ◽

pp. 129 ◽

Cited By ~ 8

Author(s):

Torsten Christ ◽

Benjamin Claus ◽

Robin Borck ◽

Wolfgang Konertz ◽

Herko Grubitzsch

Keyword(s):

Valve Replacement ◽

Artery Bypass ◽

Rank Test ◽

Term Survival ◽

Younger Patients ◽

Long Term Survival ◽

Stentless Bioprosthesis ◽

Log Rank Test

Background:A retrospective long-term evaluation of the St. Jude Toronto stentless bioprosthesis in patients aged 60 years or younger.Methods:From 1994 to 1997, 50 patients underwent aortic valve replacement with the prosthesis. Patients mean age at surgery was 54.5±6.3 years. Follow-up data were acquired by patient file research and telephone interviews. Morbidity and mortality were evaluated with time-to-event analyses using the Kaplan-Meier-method. The log-rank test was used to determine influencing factors for long-term survival and reoperation.Results:Mean follow-up was 13.5±6.3 years with a total follow-up of 661.8 patient-years and a maximum of 20.0 years. Follow-up was 97.8% complete. Associated procedures were performed in 12 patients (24%), including coronary artery bypass grafting, mitral valve replacement and replacement of the ascending aorta. Freedom from reoperation at 10 and 15 years was 76.0±6.7% and 44.1±8.9%, respectively. Reoperations (n=26) started 4.4 years after implantation and were necessary due to: valve degeneration with regurgitation in 79.2% and stenosis in 12.5%, endocarditis in 4.2% and sinus valsalva aneurysm in 4.2% of the cases. The log-rank test revealed that only body-mass-index>25 lowered freedom-from-reoperation, while renal dysfunction, diabetes mellitus and arterial hypertension were not. Overall long-term survival at 10 and 20 years was 82.3±5.7% and 49.9±8.9%, respectively.Conclusion:In younger patients the Toronto-bioprosthesis provided reliable long-term survival despite limited durability.

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