No Survival Benefit for Patients Compliant with EVAR Follow Up: Bias or The End of Follow up as We Know It?

2022 ◽  
Author(s):  
Frederico Bastos Gonçalves ◽  
Frank Vermassen
Keyword(s):  
Survival Benefit

scholarly journals Cetuximab versus bevacizumab following prior FOLFOXIRI and bevacizumab in postmenopausal women with advanced KRAS and BRAF wild-type colorectal cancer: a retrospective study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chunlong Huang ◽  
Xiaoyuan Gu ◽  
Xianshang Zeng ◽  
Baomin Chen ◽  
Weiguang Yu ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Survival Benefit ◽  
Progression Free Survival ◽  
Wild Type ◽  
Free Survival ◽  
Primary Endpoints ◽  
Significant Difference ◽  
Inductive Treatment ◽  
Advanced Colorectal Carcinoma

Abstract Background An upgraded understanding of factors (sex/estrogen) associated with survival benefit in advanced colorectal carcinoma (CRC) could improve personalised management and provide innovative insights into anti-tumour mechanisms. The aim of this study was to assess the efficacy and safety of cetuximab (CET) versus bevacizumab (BEV) following prior 12 cycles of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus BEV in postmenopausal women with advanced KRAS and BRAF wild-type (wt) CRC. Methods Prospectively maintained databases were reviewed from 2013 to 2017 to assess postmenopausal women with advanced KRAS and BRAF wt CRC who received up to 12 cycles of FOLFOXIRI plus BEV inductive treatment, followed by CET or BEV maintenance treatment. The primary endpoints were overall survival (OS), progression-free survival (PFS), response rate. The secondary endpoint was the rate of adverse events (AEs). Results At a median follow-up of 27.0 months (IQR 25.1–29.2), significant difference was detected in median OS (17.7 months [95% confidence interval [CI], 16.2–18.6] for CET vs. 11.7 months [95% CI, 10.4–12.8] for BEV; hazard ratio [HR], 0.63; 95% CI, 0.44–0.89; p=0.007); Median PFS was 10.7 months (95% CI, 9.8–11.3) for CET vs. 8.4 months (95% CI, 7.2–9.6) for BEV (HR, 0.67; 95% CI 0.47–0.94; p=0.02). Dose reduction due to intolerable AEs occurred in 29 cases (24 [24.0%] for CET vs. 5 [4.8%] for BEV; p< 0.001). Conclusions CET tends to be superior survival benefit when compared with BEV, with tolerated AEs.

The Level of Residual CLL Objectively Predicts the Outcome of Patients Following FCR-Based Therapy with Sequential Benefits per Log Depletion and Improved Post-Treatment Monitoring

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1717-1717 ◽  
Author(s):  
Andy C Rawstron ◽  
Dena Cohen ◽  
Ruth Mary De Tute ◽  
Lucy McParland ◽  
Laura Collett ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Overall Survival ◽  
Disease Progression ◽  
Survival Benefit ◽  
Research Funding ◽  
Residual Disease ◽  
Independent Predictor ◽  
Log Reduction ◽  
End Of Treatment

Abstract BACKGROUND: Minimal residual disease (MRD) in CLL is an independent predictor of progression-free and overall survival after chemo-immunotherapy. Data from the DCLLSG trials indicate that a high, intermediate and low risk of disease progression is seen in patients with >1%, 0.01-1%, or <0.01% MRD respectively. The survival benefit per log reduction is informative in other disorders and may be a more informative measure for comparing different treatments. AIM: To apply the ERIC consensus 1-tube multiparameter MRD strategy prospectively in two UK clinical trials of FCR-based treatment (ADMIRE and ARCTIC) to determine the survival benefit per log depletion. METHODS: The level of residual disease was determined using multi-parameter flow cytometry according to the ERIC consensus protocol with a limit of quantification of 10-4 / 0.01% or better on 415 patients at 3 months after end of treatment. RESULTS: The level of MRD at end of treatment was a powerful predictor of PFS and OS independent of age, stage, IWCLL response, FISH and IGHV mutation status. Per log reduction in CLL level, the hazard of disease progression decreased by 33% (95%CI 27-38%) and the hazard of dying decreased by 22% (95%CI 13-29%). Although there were statistically significant improvements per log reduction, the DCLLSG 2-log model showed more meaningful differences in outcome over the period of follow-up. The median PFS for patients with >1% vs. 0.01-1% vs <0.01% BM MRD was 24 months vs. 48 months vs. not reached (NR, 82% progression-free at 48 months, figure 1a) respectively and the median OS was 49 months vs. NR (78% alive at 48M) vs. NR (85% alive at 48M) respectively. Median PFS and OS for all patients achieving a PR or worse was 41M and 51M respectively indicating that the presence of >1% MRD predicts equivalent or worse outcome than a clinical PR. PB MRD analysis at 18 months after randomisation (~1 year after treatment) was also strongly predictive of outcome: 98% of patients with <0.01% PB CLL at the 18M timepoint remain alive and treatment-free for the subsequent year (Figure 1b). CONCLUSIONS: Prospective enumeration of MRD using the ERIC consensus 1-tube multiparameter protocol confirms that MRD at end of treatment is a powerful independent predictor of progression-free and overall survival. Post-treatment follow-up using peripheral blood MRD could be more informative than clinic assessments because patients with <0.01%MRD are highly unlikely to require treatment within the following year while in patients with ≥0.01%MRD the rate of disease progression can be accurately predicted. Patients with >1% MRD at end of treatment in the peripheral blood have a similar outcome to those with a clinical PR and a bone marrow assessment is not informative in these cases. The level of MRD is highly informative with sequential improvements in outcome per log depletion. The DCLLSG 2-log categorisation (>1%, 0.01-1%, or <0.01%) is simple and effective for discriminating patients with PFS of <2yrs vs. >6yrs. Figure 1. the level of MRD in the bone marrow at 3 months after treatment is highly predictive of outcome with >1% MRD equating to <2yrs PFS and <0.01% MRD predicting >5yrs median PFS Figure 1. the level of MRD in the bone marrow at 3 months after treatment is highly predictive of outcome with >1% MRD equating to <2yrs PFS and <0.01% MRD predicting >5yrs median PFS Figure 2. sequential PB MRD analysis identifies patients with negligible risk of requiring treatment within the following 12 months. Figure 2. sequential PB MRD analysis identifies patients with negligible risk of requiring treatment within the following 12 months. Disclosures Rawstron: BD Biosciences: Patents & Royalties; Roche: Honoraria; Celgene: Honoraria; Abbvie: Honoraria; Gilead: Honoraria, Research Funding; Pharmacyclics: Research Funding. Gregory:Celgene: Honoraria; Janssen: Honoraria. Hillmen:Roche: Consultancy, Honoraria, Research Funding; Novartis: Honoraria, Research Funding; GSK: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Gilead: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; Celgene: Research Funding.

Perioperative immunomodulation with interferon-alpha in patients with renal cell carcinoma: Early results of a controlled phase II trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14525-14525
Author(s):  
T. Klatte ◽  
A. Ittenson ◽  
F. Röhl ◽  
M. Ecke ◽  
E. P. Allhoff ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
T Cell ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Survival Benefit ◽  
Phase Ii Trial ◽  
Study Groups ◽  
Hla Dr

14525 Background: Complex perioperative immunodysfunction occurs in patients with renal cell carcinoma undergoing surgery. Earlier, we presented evidence of a survival benefit in patients, who received perioperative immunomodulation with interleukin-2 (JCO 23 (16S):4601, 2005). Here, we report on the effect of interferon-alpha (IFN-α). Methods: Fifty-four consecutive patients, who underwent tumor nephrectomy, were enrolled into this prospective one stage phase II trial from June 2003 to May 2005. Patients were alternately assigned to the two study groups: 27 received immunomodulation with IFN-α (4 doses 9 million IU s.c a week before operation, followed by a daily dose of 3 million IU until a day before the operation), 27 did not. Parameters of immunity (differential blood count, CD3, CD4, CD8, CD16, CD19, CD28, CD56, HLA-DR, VEGF, IL-10) were measured in venous blood before and during IFN-α, one day before and immediately after the operation, and on the 1., 3., 5., and 10. postoperative day. The primary endpoint was tumor-specific survival. T-test, χ2-test and the log-rank test were used for statistical analysis. Results: The study groups did not differ with respect to age, sex, tumor stage and grade, histological type, operation time and technique. IFN-α related toxicity was WHO grade 0 (11%), 1 (59%), 2 (26%), and 3 (4%). During IFN-α administration leukocytes, CD19, HLA-DR and VEGF dropped significantly, while no difference was observed in T-cell and NK-cell markers, and IL-10. All patients showed postoperatively elevated leukocyte counts. T-cell and activation markers decreased, but CD3, CD4 and CD28 alterations were significantly less accentuated in patients who had been treated with IFN-α. Median follow-up was 14 months. The 1- and 2-year rates (±SE) of tumor-specific survival were 96% (±4%) and 83% (±12%) in the IFN-α group and 85% (±7%) and 85% (±7%) in the control group, respectively (p = 0.52). Also, no difference was seen in progression-free survival (p = 0.32). Conclusions: In this study with limited follow-up, perioperative IFN-α medication was not associated with a survival benefit, but was well tolerated. Interestingly, the decline in VEGF during administration suggests a role of IFN-α in the inhibition of angiogenesis. No significant financial relationships to disclose.

Phase II trial of erlotinib in elderly patients (age > 70) with previously untreated advanced non-small cell lung cancer (NSCLC): An analysis of quality of life and symptom response

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7168-7168 ◽  
Author(s):  
D. M. Jackman ◽  
B. Yeap ◽  
J. Lucca ◽  
P. A. Ostler ◽  
L. K. Morse ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Survival Benefit ◽  
Rank Test ◽  
Symptom Improvement ◽  
First Line Therapy ◽  
Signed Rank Test ◽  
Symptom Response

7168 Background: Elderly patients derive survival benefit but significant toxicity from chemotherapy for NSCLC. Erlotinib is associated with reasonable toxicity and has a survival benefit for relapsed patients previously treated with 1–2 chemotherapy regimens. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced disease. Methods: 80 patients (chemo-naïve, age ≥ 70, PS 0–2, stage IIIB/IV NSCLC) were treated with erlotinib 150 mg/d as part of a phase II study. Primary endpoint was survival. QoL was a secondary endpoint, as assessed by LCSS at baseline and q4 weeks until progression. The primary endpoint of QoL analysis was to determine changes from baseline in LCSS score. Patients were eligible for QoL analysis if they completed an LCSS questionnaire at baseline and ≥ 1 other monthly follow-up visit. Each of 9 items was assessed on a 100mm visual analog scale from 0 (best) to 100 (worst); symptom improvement or worsening was based on a change of ≥ 10mm, with decreased scores implying improvement. Score differences between the baseline and best follow-up response of each subscale and total LCSS are assessed by the signed rank test. Results: 64 patients (80%) were eligible for QoL analysis. There was a trend towards improvement in QoL, based on the total LCSS score. Statistically significant improvements in dyspnea, cough, fatigue, and pain were seen, both in terms of median changes from baseline and the proportion of patients improved (Table). No patients were symptomatic for hemoptysis at baseline, so improvement could not be calculated. Conclusions: Erlotinib in elderly patients with advanced NSCLC was associated with encouraging survival (10.9 mo), a trend towards improved QoL, and statistically significant improvements in key symptoms of dyspnea, cough, fatigue, and pain. Mixed effects longitudinal modeling showing changes in LCSS over time will be presented at the conference. [Table: see text] [Table: see text]

Embolization versus embolization and systemic therapy in patients with hepatocellular carcinoma and metastatic disease: A retrospective analysis.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 363-363 ◽  
Author(s):  
Sunnie Kim ◽  
Karen T. Brown ◽  
Yuman Fong ◽  
Stephen Barnett Solomon ◽  
Joanne F. Chou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Retrospective Analysis ◽  
Systemic Therapy ◽  
Survival Benefit ◽  
Combined Modality Therapy ◽  
Locally Advanced ◽  
Arterial Embolization ◽  
Combined Modality ◽  
Kaplan Meier

363 Background: Transarterial chemoembolization (TACE) provides a survival benefit in a subset of patients with unresectable hepatocellular carcinoma (HCC). Even though data are lacking, patients with metastatic HCC (mHCC) are sometimes treated with transarterial therapies to address the hepatic disease. Sorafenib is a standard treatment for patients with mHCC. Methods: A retrospective analysis was conducted on patients diagnosed with HCC who had undergone hepatic arterial embolization (HAE) between 2006 and until 2013. Overall survival (OS) was calculated from date of HAE to date of death and estimated by Kaplan Meier Methods. Patients alive at their last follow up date were censored. Results: Of 243 patients who had undergone HAE at MSKCC during the study period, 36 patients had mHCC on initial diagnosis. Of these, 22 received HAE only, while 14 received HAE plus systemic therapy at some time during their whole treatment course. Conclusions: Patients with mHCC who underwent HAE alone had a poor OS. These data suggest that there maybe a survival benefit in patients with mHCC treated with transarterial therapies add to systemic therapy that is given at some time during their whole treatment course. These results contrast with recent data on the use of combined modality in locally advanced disease. Further studies of combined modality therapy in the setting of mHCC may be warranted. [Table: see text]

Effect of chemotherapy on survival of patients with recurrent pancreatic ductal adenocarcinoma (PDAC) following surgical therapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15748-e15748
Author(s):  
Olumide B. Gbolahan ◽  
Yan Tong ◽  
Bert H. O'Neil ◽  
Safi Shahda
Keyword(s):  
Adjuvant Therapy ◽  
Metastatic Disease ◽  
Survival Benefit ◽  
De Novo ◽  
Univariate Analysis ◽  
Ductal Adenocarcinoma ◽  
Tumor Characteristics ◽  
Curative Therapy ◽  
Kaplan Meier

e15748 Background: Patients with recurrent PDAC are treated similarly to patients with de novo metastatic disease. The aim of this study is to report the outcome of patients with recurrent PDAC following initial definitive resection and adjuvant therapy. Methods: Patients were identified from an IRB approved, retrospective database at Indiana University that contained patient and tumor characteristics, adjuvant therapy and all treatment for metastatic disease. Follow-up was updated as of 6/2014. Overall survival (OS) from recurrence until death or last follow up was estimated using the Kaplan Meier method. Results: Between 2008-2014, 451 patients with resectable PDAC and available follow up data were identified, of whom 234 had documented relapse. Patient/tumor characteristics were as follows: median age: 64.2 years (25-89), 54% male, 76% LN+, 24% positive margins, 66% and 85% with lymphovascular and perineural invasion respectively. 69% of patients received adjuvant gemcitabine (GEM). Median time to relapse was 10 months. 60% of patients received at least 1 line of systemic therapy and 18% received 2 lines. Chemotherapy was GEM-based: 33%, 5FU-based 33%, or both 33% and 1% other treatment. Median OS from time of relapse was significantly improved following chemotherapy compared to no chemotherapy (10 months vs 3 months, P < 0.0001). Median OS for 5FU based and GEM based treatment was 6 and 8 months, respectively (P = 0.09). Those who received both had mOS of 14 months (95% C.I 10-17months, P < 0.0001). On univariate analysis, chemotherapy, regardless of type was associated with a survival benefit. Conclusions: Chemotherapy appears to be associated with survival benefit for patients with relapsed PDAC following initial curative therapy. Survival in our retrospective study appears similar to reported literature for de novo metastatic disease.

Effect of administration of systemic steroids on survival benefit associated with immunotherapy-induced skin toxicity.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22046-e22046
Author(s):  
Nicholas Gulati ◽  
Douglas M. Donnelly ◽  
Yingzhi Qian ◽  
Una Moran ◽  
Paul Johannet ◽  
...  
Keyword(s):  
Survival Benefit ◽  
Progression Free Survival ◽  
Skin Toxicity ◽  
Common Side Effect ◽  
Relative Reduction ◽  
Systemic Steroids ◽  
Reported Data ◽  
Metastatic Sites ◽  
Positive Effect

e22046 Background: Immune checkpoint inhibition (ICI) improves progression-free survival (PFS) and overall survival (OS) for patients with metastatic melanoma (MM), but treatment may cause serious immune-related adverse events (irAEs) that require the use of immunosuppressive steroids. Skin toxicity (ST), the most common side effect, has been reported to be associated with better response to ICI in some studies but not others. Herein, we tested the hypothesis that the portended survival benefit associated with ICI-related ST reaches a threshold in MM patients, dependent on the severity of the ST. Methods: We analyzed MM patients enrolled prospectively in a clinicopathological database with protocol-driven follow up and treated with ICI at NYULH. The patient and/or physician reported the ST, and an immunologist-dermatologist independently confirmed the event was ICI-related. Severe ST was defined as a skin event that required treatment with systemic steroids. Other site-specific toxicities were recorded using the CTCAE v5.0. We tested the associations between ST and PFS and OS, stratified by no, mild, and severe ST, adjusting for age, gender, number of metastatic sites, LDH, and ECOG score at treatment initiation. Results: The cohort included 256 MM patients (387 lines of ICI treatments). ST was the most common irAE (34%), and was significantly associated with development of endocrine toxicity (P = 0.007). Of the ST events (n = 130), 66% were mild and 34% were severe. Compared to none, mild ST was significantly associated with improved PFS (adjusted hazard ratio [aHR] = 0.58 [0.38, 0.89], P = 0.01), and a similar trend was observed with OS (aHR = 0.68 [0.45, 1.03], P = 0.06). However, the positive effect was reduced to insignificant (PFS P = 0.53; OS P = 0.25) in patients who developed severe ST irAEs that required systemic steroids. Conclusions: Our data demonstrate that ICI-induced ST is a complex phenomenon and might explain the discordance of reported data. While the worse outcome in patients with severe ST compared to mild may stem from steroidal immunosuppression, a threshold may also exist wherein severe ST itself might contribute to a relative reduction in ICI efficacy. More research is needed to elucidate the mechanisms that link ST and response to ICI in order to better characterize and treat skin irAEs without systemically suppressing anti-tumor immunity.

scholarly journals Clinical implication of plasma exchange on life-threatening antineutrophil cytoplasmic antibody-associated vasculitis

2020 ◽  
Author(s):  
Pil Gyu Park ◽  
Byung-Woo Yoo ◽  
Jason Jungsik Song ◽  
Yong-Beom Park ◽  
Sang-Won Lee
Keyword(s):  
Plasma Exchange ◽  
Survival Benefit ◽  
Laboratory Data ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Alveolar Haemorrhage ◽  
Anca Associated Vasculitis ◽  
Kaplan Meier ◽  
All Cause Mortality ◽  
Life Threatening

Abstract Background: We assessed the rate of and the predictor for all-cause mortality in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) patients receiving plasma exchange (PLEX) and evaluated the survival-benefit of PLEX for diffuse alveolar haemorrhage (DAH) between AAV patients receiving PLEX and those not receiving. Methods: We retrospectively reviewed the medical records of 212 AAV patients. Demographic, clinical and laboratory data at the time of PLEX was collected from both 9 patients receiving PLEX and 10 AAV patients with DAH. The follow-up duration was defined as the period from the time of PLEX or DAH occurrence to death for the deceased patients and as that to the last visit for the survived patients. Results: The median age of 9 AAV patients receiving PLEX was 71.0 years and 5 patients were men. Four of 9 patients receiving PLEX died at a median follow-up duration of 92.0 days. Three died of sepsis and one died of no response to PLEX. When patients with DAH receiving PLEX and those not receiving were compared, there were no significant differences in variables between the two groups. The cumulative patients’ survival rate between patients with DAH receiving PLEX and those not receiving were also compared using the Kaplan-Meier survival analysis but no survival-benefit of PLEX for DAH was observed. Conclusion: The rate of all-cause mortality in 9 AAV patients receiving PLEX was assessed as 44.4% and it was controversial that PLEX is beneficial for the improvement of prognosis of AAV-related DAH.

scholarly journals Surgical Approach to Recurrent Cholangiocarcinoma

2020 ◽  
pp. 1-6
Author(s):  
Hauke Lang
Keyword(s):  
Survival Benefit ◽  
Systemic Chemotherapy ◽  
Tumor Biology ◽  
Standard Of Care ◽  
Distal Cholangiocarcinoma ◽  
Careful Patient ◽  
Repeated Surgery ◽  
Biological Heterogeneity ◽  
Patterns Of Recurrence

<b><i>Background:</i></b> For recurrent cholangiocarcinoma, systemic chemotherapy is the standard of care. Repeated resection is a potential curative treatment, but data are scarce and outcomes are not well defined so far. <b><i>Summary:</i></b> In the last decade there has been an increasing number of reports suggesting a survival benefit and even cure after repeated surgery. This is particularly true for intrahepatic cholangiocarcinoma, where repeated resections offer similar or even better results than the first resection. In selected cases even a third liver resection is possible. In contrast, in perihilar and distal cholangiocarcinoma, repeated resection is only rarely possible. Although the improved outcome might be attributed to a careful patient selection and a favorable tumor biology, repeated surgical treatment should be attempted whenever possible. This necessitates a structured follow-up after resection. <b><i>Key Message:</i></b> Surgical resection offers the chance for prolonged survival and even for cure in recurrent cholangiocarcinoma. Hence, it is of the utmost importance to better understand the routes of metastases and to define factors qualifying for resection. Whether different patterns of recurrence reflect biological heterogeneity requires further investigation.

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