Randomized trial of amifostine in locally advanced non-small cell lung cancer (NSCLC) patients receiving chemotherapy and hyperfractionated radiation (HRT): Long-term survival results of Radiation Therapy Oncology Group (RTOG) 9801

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7529-7529
Author(s):  
B. Movsas ◽  
J. Moughan ◽  
C. Langer ◽  
M. Werner-Wasik ◽  
N. Nicolaou ◽  
...  

7529 Purpose: This analysis was conducted to address the potential antitumor effect of amifostine (AM) in NSCLC patients enrolled on RTOG-9801. The long-term survival results of RTOG-9801 are presented here. Methods: 243 patients (pts) with stage II/IIIAB NSCLC received induction paclitaxel (P) 225 mg/m2IV days 1, 22 and carboplatin (C) AUC 6 days 1, 22 and then concurrent weekly P (50 mg/m2) and C (AUC 2) and HRT (69.6 Gy at 1.2 Gy BID). Pts were randomly assigned to AM 500 mg IV 4x/week or no-AM during chemoradiation. Treatment differences for overall and disease-free survival (OS & DFS) were analyzed with the log-rank test; Gray's test was used for time to progression (TTP). Results: 118 pts were randomly assigned to receive AM and 121 to no-AM (4 pts were ineligible). The median follow-up for pts still alive is 52.3 months (mo) for the AM-arm and 58.3 mo for the no-AM arm (16.6 vs 17.9 for all pts). There are no significant differences in OS, DFS or TTP between arms. The median survival, 3-yr, and 5-yr OS are 17.1 mo, 27% and 17% (AM-arm) vs 18.4 mo, 28% and 16% (no-AM arm) (p=0.97). Grade 3/4/5 late-RT toxicities are similar (11%/3%/2% AM-arm vs 14%/4%/2% no-AM arm). Conclusion: While an earlier publication reported that amifostine did not reduce objective measures of severe esophagitis in RTOG-9801, patient-reported outcome analyses suggested a possible advantage to AM with decreased pain and swallowing symptoms (J Clin Oncol 23:2145–2154, 2005). This long-term follow-up analysis on survival shows no evidence of tumor radioprotection due to amifostine. The promising 5-yr OS suggests that induction paclitaxel/carboplatin (P/C) followed by concurrent RT and weekly low-dose P/C is comparable to other regimens using cisplatin doublets at higher dosages every 3–4 weeks. Research supported by NCI and Medimmune Oncology. No significant financial relationships to disclose.

2015 ◽  
Vol 18 (4) ◽  
pp. 129 ◽  
Author(s):  
Torsten Christ ◽  
Benjamin Claus ◽  
Robin Borck ◽  
Wolfgang Konertz ◽  
Herko Grubitzsch

<p><strong>Background:</strong>A retrospective long-term evaluation of the St. Jude Toronto stentless bioprosthesis in patients aged 60 years or younger.</p><p><strong>Methods:</strong>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.</p><p><strong>Results:</strong>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&gt;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.</p><p><strong>Conclusion:</strong>In younger patients the Toronto-bioprosthesis provided reliable long-term survival despite limited durability.</p>


1994 ◽  
Vol 12 (5) ◽  
pp. 970-974 ◽  
Author(s):  
T Sautner ◽  
F Hofbauer ◽  
D Depisch ◽  
R Schiessel ◽  
R Jakesz

PURPOSE The long-term survival probability of patients who undergo surgery for stage 3 and 4 gastric cancer is poor, predominantly due to metastatic spread of the tumor. Depending on the type of tumor histology, the pathway of metastases is mainly peritoneal or hepatic dissemination. Interruption of this mechanism may be possible by intraperitoneal chemotherapy (IPT). PATIENTS AND METHODS In a prospective randomized trial of 67 patients undergoing surgery for stage 3 and 4 gastric cancer, 33 patients underwent adjuvant postoperative IPT with cisplatin, while 34 control subjects remained untreated. RESULTS Patients in the treatment group received a median of four IPT perfusions. Apart from frequent nausea, no adverse reactions or complications were noted. The median disease-free survival durations were 12.7 months and 9.7 months in treated patients and controls, respectively (P = .8). After a median follow-up duration of 72 months, 54 patients (80%) had died of primary disease or related complications. The median survival duration for IPT patients was 17.3 months as compared with 16.0 months for controls (P = .6). Autopsies were performed on 12 (18%) of 54 patients who died, and showed tumor spread to the peritoneal cavity and/or to the liver, irrespective of the application of IPT. CONCLUSION IPT with cisplatin monotherapy does not improve survival probability after surgery for stage 3 and 4 gastric cancer. The reasons for ineffectiveness of IPT may be the choice of an unsuitable chemotherapeutic agent, an inefficient modus of application, or a lack of sufficient drug penetration into the serosa or peritoneal metastasis.


2021 ◽  
Vol 108 (Supplement_4) ◽  
Author(s):  
E Zandirad ◽  
H Teixeira-Farinha ◽  
N Demartines ◽  
M Schäfer ◽  
S Mantziari

Abstract Objective The current treatment for locally advanced gastroesophageal junction (GEJ) adenocarcinoma consists of neoadjuvant treatment (NAT) followed by surgery. Preoperative chemotherapy (CT) and radio-chemotherapy (RCT) are both valid options, but comparative data for their efficacy remain scarce. This study aimed to assess the efficacy of RCT and CT to achieve a complete pathologic response (CPR) for locally advanced GEJ adenocarcinoma. Secondary endpoints were R0 resection rates, postoperative complications, long-term survival and recurrence. Methods All consecutive patients with locally advanced GEJ adenocarcinoma treated with CT or RCT and oncologic resection from 2009 to 2018 were included. A CPR was defined with the Mandard tumor regression score. Standard statistical tests were used as appropriate. Overall and disease-free survival were compared with the Kaplan Meier method and log-rank test. Multivariate analysis was performed to define independent predictors of CPR, and long-term survival. Results Among the 94 patients (84%male, median age 62 years [IQR 9.7]), 67 (71.3%) received preoperative RCT and 27 (28.7%) CT. Patient’s characteristics and pretreatment tumor stages were comparable. Surgical approach was thoracoabdominal Lewis resection in 95.5% RCT and 81.5% CT patients (P = 0.085). CPR was more frequent in the RCT than the CT group (13.4% vs 7.4%, P = 0.009), but R0 resection rates were similar (72.1% vs 66.7%, P = 0.628). There was a trend to higher ypN0 stage in the RCT group (55.2% vs 33.3%; P = 0.057). Postoperatively, RCT patients presented more cardiovascular complications (35.8% vs 11.1%; P = 0.017), although overall morbidity was similar (68.6% vs 62.9%, P = 0.988). 5-year overall survival was comparable (61.1% RCT vs 75.7% CT, P = 0.259), as was 5-year disease-free survival (33.5% RCT vs 22.8% CT, P = 0.763). Isolated loco-regional recurrence occurred in 2.9% RCT vs 3.7% CT patients (P = 0.976). NAT type was not an independent predictor for complete pathologic response nor long-term survival in the multivariate analysis. Median follow-up was 30 months [95%CI 21.3-38.8] for all patients. Conclusion Patients with locally advanced GEJ adenocarcinoma demonstrated higher rates of CPR after RCT than CT, and a trend to a better lymph node sterilization, although this did not translate in a significant survival benefit or decreased recurrence rate.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 437-437
Author(s):  
Michael Cecchini ◽  
Joseph Miccio ◽  
Jay Pahade ◽  
Jill Lacy ◽  
Ronald R Salem ◽  
...  

437 Background: Induction FFX for PC deemed either BR or LA at diagnosis provides an opportunity to downstage pts with the aim of an R0 surgery. The addition of RT after induction FFX may further downstage. However, there is a paucity of data regarding long-term survival for BR and LA patients successfully downstaged and resected. We performed a retrospective review of BR and LA PC treated with induction FFX +/- RT followed by surgery or consolidative RT at the Yale Cancer Center (YCC) to assess survival in these two cohorts. Methods: Clinical data was abstracted for pts with BR or LA PC who had surgery or received consolidative RT without surgery after induction FFX +/- RT at the YCC from 2010-2018. Surgical pts were re-reviewed by a radiologist to assess vascular involvement (BR vs. LA) using NCCN criteria. PFS and OS for surgery and consolidative RT were analyzed by the Kaplan-Meier method. Survival was compared via the log rank test. Results: 102 pts met inclusion criteria (BR=47, LA=55), 41 pts had surgery [BR=29/47 (62%) LA=12/55 (22%)] and 61 pts had consolidative RT [(BR= 18/47 (38%), LA= 43/55 (78%)] after induction FFX. 18 surgery pts received RT prior to resection and all surgery pts had R0 resection. Median follow up was 25 mo (range 5 – 97). Median PFS with surgery was 22 mo (95% CI 15 – 59) vs 14 mo (95% CI 10.9 – 20.1) with consolidative RT (p<0.001), while OS with surgery was 42 mo (95% CI 25-NR) vs 20 mo (95% CI 17-25) without surgery (p<0.001). For pts with ≥ 2 yr follow up, 12/22 (55%) surgery pts and 17/18 (94%) consolidative RT pts relapsed. For pts with ≥ 3 yr follow up, 6/12 (50%) surgery pts and 10/10 (100%) consolidative RT pts relapsed. 2 yr PFS and OS was 45% (95% CI 28-61) and 74% (95% CI 57 – 86) with surgery versus 15% (95% CI 7-27) and 40% (95% CI 26-53) with consolidative RT. Conclusions: Surgery was associated with a high R0 rate and prolonged PFS and OS compared to consolidative RT in pts with BR and LA PC after FFX +/- RT. However, survival benefit was not statistically significant when selecting only LA pts although numbers are limited.


2021 ◽  
Author(s):  
Wenxing Cui ◽  
Tian Li ◽  
Yingwu Shi ◽  
Chen Yang ◽  
Shunnan Ge ◽  
...  

Abstract Objective: To assess the association between immediate postoperative coagulopathy and the long-term survival of traumatic brain injury (TBI) patients undergoing surgery, as well as to explore predisposing risk factors of immediate postoperative coagulopathy.Methods: This retrospective study included 352 TBI patients from January 1, 2015, to April 25, 2019. The log-rank test and a Cox proportional hazard model were conducted to assess the relationship between immediate postoperative coagulopathy and the long-term survival of TBI patients. Furthermore, a multivariate logistic regression model was performed to identify the underlying risk factors for postoperative coagulopathy.Results: Of the 352 patients analyzed, the median age was 50 (41,60) years, and 82 (23%) patients were female. By May 26, 2019, 117 (33.24%) patients had died, 195 (55.40%) had survived, and 40 (11.36%) had been lost to follow-up. The median follow-up time was 773 days. In the log-rank test, immediate postoperative coagulopathy was significantly associated with the survival of TBI patients (P = 0.002). A Cox proportional hazard model identified immediate postoperative coagulopathy (HR, 1.471; 95% CI, 1.011-2.141; P = 0.044) as an independent risk factor for survival following TBI. According to multivariate logistic regression analysis, abnormal ALT and RBC at admission, intraoperative infusion of crystalloid solution > 2900 mL, infusion of colloidal solution > 1100 mL and intraoperative bleeding > 950 mL were identified as independent risk factors for immediate postoperative coagulopathy.Conclusions: Those who suffered from immediate postoperative coagulopathy due to TBI were at higher risk of poor prognosis than those who did not.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Ayyaz Ali ◽  
Amit Patel ◽  
Yasir Abu-Omar ◽  
Anila Mehta ◽  
Ziad Ali ◽  
...  

Background Aortic valve replacement (AVR) is followed by regression of LVH. More complete resolution of LVH is suggested to be associated with superior clinical outcomes, however its impact on long-term survival following AVR has not been investigated. Methods Demographic and clinical data were obtained retrospectively through casenote review. Transthoracic echocardiography was used to measure LVM pre-operatively and at annual follow-up visits. Patients were grouped according to their reduction in LVM at late follow-up: Group A < 25 grams, Group B 25–150 grams and Group C > 150 grams. Results 211 patients underwent AVR between 1 st January 1991 and 1 st January 2001. Pre-operative LVM was 295 ± 118 g in A (n=63), 346 ± 97 g in B (n=75) and 539 ± 175 g in C (n=73), P <0.001. Mean time to last echocardiogram was 6.4 ± 3.3 years. LVM at late follow-up was 351 ± 160 g in A, 265 ± 95 g in B and 270 ± 90 g in C, P <0.001. Transvalvular gradients at follow-up were not significantly differerent between groups (A: 21 ± 21 mm Hg, B: 20 ± 15 mm Hg, C: 14 ± 11 mm Hg), P = 0.10. There was no difference in the prevalence of other factors influencing LVM regression such as IHD or hypertension. Ten year actuarial survival was significantly greater in patients with enhanced LVM regression when compared with the log-rank test (A: 49% ± 7, B: 67%± 6, C: 75% ± 6), P =0.03 (Figure 1 ). LVM reduction > 150 grams was an independent predictor of long-term survival on multivariate analysis (P = 0.03). Conclusion Enhanced LVM regression at late follow-up in patients undergoing AVR is associated with improved long-term survival. Strategies to optimize post-operative LVM regression should be considered in view of potential prognostic benefit.


2021 ◽  
Vol 14 (8) ◽  
pp. 705
Author(s):  
Hideki Houzen ◽  
Takahiro Kano ◽  
Kazuhiro Horiuchi ◽  
Masahiro Wakita ◽  
Azusa Nagai ◽  
...  

Reports on the long-term survival effect of edaravone, which was approved for the treatment of amyotrophic lateral sclerosis (ALS) in 2015 in Japan, are rare. Herein, we report our retrospective analysis of 45 consecutive patients with ALS who initially visited our hospital between 2013 and 2018. Of these, 22 patients were treated with edaravone for an average duration of 26.6 (range, 2–64) months, whereas the remaining patients were not treated with edaravone and comprised the control group. There were no differences in baseline demographics between the two groups. The primary endpoint was tracheostomy positive-pressure ventilation (TPPV) or death, and the follow-up period ended in December 2020. The survival rate was significantly better in the edaravone group than in the control group based on the Kaplan–Meier analysis, which revealed that the median survival durations were 49 (9–88) and 25 (8–41) months in the edaravone and control groups, respectively (p = 0.001, log-rank test). There were no serious edaravone-associated adverse effects during the study period. Overall, the findings of this single-center retrospective study suggest that edaravone might prolong survival in patients with ALS.


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