Final follow up survey of the randomized Pbo-controlled study of oregovomab (Ov) as a consolidation treatment for advanced ovarian cancer (OC): Insights into surveillance approaches

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5079-5079 ◽  
Author(s):  
C. F. Nicodemus ◽  
J. S. Berek ◽  
B. C. Schultes ◽  
J. P. Balser ◽  
P. T. Taylor
Keyword(s):  
Phase Iii ◽  
Controlled Study ◽  
Front Line ◽  
Term Survival ◽  
Long Term Survival ◽  
Time To Relapse ◽  
Phase Iii Studies ◽  
Ongoing Phase

5079 Background: Ov is a monoclonal antibody specific for CA125 currently in two phase III studies as a consolidation immunotherapy for OC. A five year outcome follow up for patients participating in the prior randomized phase II study used to design the current pivotal trials has been completed. An assessment of survival post relapse (SPR) as a function of identifiable risk factors, and implications for long term survival survey methodology were reviewed. Methods: OC patients with no evaluable disease post front-line chemotherapy were randomized to IV infusions of OV or Pbo Q4 wks × 3, then Q12 wks. At relapse, therapy was stopped and second-line Rx was initiated without restriction. All patients were surveyed quarterly for long term outcomes for a pre-specified 5 years from initial randomization. A Kaplan-Meier (KM) analysis of overall survival and Cox multivariate analysis of SPR was completed. Results: 145 randomized participants were followed, including 67 designated as the successful front-line (SFLT) subpopulation identified to have characteristics favorable for intervention with immunotherapy (basis of ongoing phase III program). At five years, 47% of Ov (n = 73) and 37% of Pbo (n = 72) patients were alive overall, and 56% of Ov (n = 34) and 32% of Pbo (n = 33) were alive in the SFLT population. KM estimates of median survival are 57.5 mo [44.5-non-estimable (ne)] for Ov and 48.6 mo [30.9-ne] for Pbo in the overall population and ne mo [50.5-ne] for Ov and 48.6 mo [24-ne] for Pbo (p = 0.11) in the subpopulation. For relapsed patients, improved survival post relapse was most associated (Cox regression p < 0.10) with lower CA125 velocity at relapse, treatment (Ov), and longer time to relapse. Conclusions: Survival data was consistent with previously reported time to relapse data in this study. For the SFLT, the 5 yr duration of survival survey and sample size were insufficient for a definitive outcome. However, results support the hypothesis that treatment with OvaRex may provide clinical benefit. The ongoing phase III studies will include a 10 year survival survey of 354 patients to definitively assess the impact of this treatment on long term survival. [Table: see text]

scholarly journals LTBK-12. EORTC 26951, RANDOMIZED STUDY OF ADJUVANT PCV AFTER 59.4 GY RADIOTHERAPY: VERY LONG TERM FOLLOW-UP

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi285-vi285
Author(s):  
Martin van den Bent ◽  
Khe Hoang-Xuan ◽  
Alba Brandes ◽  
Johan Kros ◽  
M C M Kouwenhoven ◽  
...  
Keyword(s):  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Term Survival ◽  
Long Term Survival ◽  
Kaplan Meier ◽  
Tumor Group ◽  
Long Term Follow Up

Abstract BACKGROUND Between 1995 and 2002 the EORTC Brain Tumor Group conducted a prospective phase III study on adjuvant procarbazine, CCNU and vincristine (PCV) chemotherapy in anaplastic oligodendroglioma (AOD). A mature follow-up presented in 2012 showed survival benefit of the addition of PCV, in particular in 1p/19q co-deleted tumors and tumors with MGMT promoter methylation. We now present very long term follow-up. MATERIALS AND METHODS Patients were eligible if locally diagnosed with a newly diagnosed AOD. They were randomized between radiotherapy (RT, 33 x 1.8 Gy) and the same RT followed by 6 cycles PCV (RT/PCV). Primary endpoints were overall survival (OS) and progression free survival (PFS). 1p/19q status (FISH) was determined in 300 patient. Kaplan- Meier technique and Cox modeling were used for long term survival analysis. Primary analyses were adjusted for known prognostic factors. For other analyses no adjustment was performed. RESULTS With 368 patients included, a median follow-up of 18.4 years and 307 (83%) survival events, median and 20-year survival after RT/PCV versus RT alone were 42.3 mo and 16.8% vs 30.6 months and 10.1% (HR 0.78; 95% CI (0.63, 0.98), adjusted p=0.06). Eighty patients were 1p/19q codel of which 26 (33%) were still alive, in this subgroup median and 20-year survival after RT/PCV versus RT alone were 14 years and 37.1% versus 9.3 years and 13.6% (HR 0.60, 95% CI (0.35, 1.03), unadjusted p=0.06). Twenty year PFS in 1p/19q codel was 31.3% in RT/PCV treated patients and 10.8% in RT only treated patients (HR 0.49, 95% CI (0.29, 0.83), unadjusted p=0.007). In the 1p/19q codel subgroup age, WHO PS and necrosis at pathology were identified to be of independent prognostic value for OS. CONCLUSION This long term analysis confirms the earlier conclusions and provides data on long term survival in this patient group. In 1p/19q codel patients treated with RT/PCV, the 20-year PFS and OS rates are 31% and 37% respectively.

Long-Term Follow-Up Confirms the Benefit of All-Trans Retinoic Acid (ATRA) and Arsenic Trioxide (As2O3) as Front Line Therapy for Newly Diagnosed Acute Promyelocytic Leukemia (APL).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 565-565 ◽  
Author(s):  
Yuan-Fang Liu ◽  
Yong-Mei Zhu ◽  
Zhan-Zhong Shi ◽  
Jun-Min Li ◽  
Li Wang ◽  
...  
Keyword(s):  
Remission Induction ◽  
Newly Diagnosed ◽  
Front Line ◽  
Current Group ◽  
Historical Cohort ◽  
Term Survival ◽  
Long Term Survival ◽  
Historical Group

Abstract PURPOSE: To further confirm the benifit of front-line use of all-trans retinoic acid (ATRA) combined with arsenic trioxide (As2O3) in patients with newly diagnosed acute promyelocytic leukemia (APL), we observed the long-term survival of the current group (median follow-up: 48 months) and compared it with our historical control. PATIENTS AND METHODS: There were two groups of patients with newly diagnosed APL enrolled in this analysis. The current cohort of patients includes 60 patients since April 2001. The historical cohort of patients included 56 patients from May 1998 to March 2001. No statistically significant differences were found between these two groups in terms of clinical characteristics including sex and age distribution or hematological data before treatment. For the current cohort of patients, all patients received 25mg/m2 ATRA orally and 0.16mg/kg As2O3 intravenously per day till CR. Once CR achieved, they were given 3 courses of consolidation chemotherapy and then 5 cycles of sequential treatment of ATRA, As2O3 and 6-MP/MTX. For the historical group, ATRA was given either 25mg/m2 daily till CR, chemotherapy was added in case of leukocytosis. The post-remission therapy consists of chemotherapy with or without ATRA. Quantitative real-time reverse transcription-polymerase chain reaction (RQ-RT-PCR) measurements of PML-RARa mRNA were retrospectively assessed before treatment, after CR, after consolidation, after maintenance and during follow-up period. The efficacy of these two protocol in terms of remission induction, molecular response and long-term survival were compared with our historical control. RESULT: In the current group, 56 (93.3%) patients achieved CR, and the median time to CR was 27 days. Compared with the historical group, the combined therapy induced an early hematological response. Till the last follow-up at April 2006, two patients underwent extramedullary relapse, one of them also relapsed in marrow thereafter, one patient died from CNS leukemia, and all the other patients were alive and remained in hematological remission. With a median follow-up of 48 months (25 to 60 months), the 4-year OS and EFS was estimated 98.1%±1.8% and 94.2%±3.3%. For the historical group, after a median follow-up of 56 months (12 to 79 months), the 4-year OS and EFS was estimated 83.4%±5.4% (P=0.012) and 45.6%±7.6% (P<0.00001). For the current group, PML-RARa normalized dose was more significantly decreased after remission induction and after consolidation as compared with the historical cohort. In the last follow-up, all of the available event-free patients of the current group remain in molecular remission (PML-RARa DoseN undetectable). CONCLUSION: These 4-year data of follow-up demonstated a benefit of front-line combination of ATRA and As2O3 regarding long-term survival (OS or EFS) of patients with newly diagnosed APL. With prolonged follow-up, we might be able to find a better chance of curing the disease.

Long-term survival from pembrolizumab (pembro) completion and pembro retreatment: Phase III KEYNOTE-006 in advanced melanoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10013-10013 ◽  
Author(s):  
Georgina V. Long ◽  
Jacob Schachter ◽  
Ana Arance ◽  
Jean-Jacques Grob ◽  
Laurent Mortier ◽  
...  
Keyword(s):  
Clinical Care ◽  
Advanced Melanoma ◽  
Phase Iii ◽  
Term Survival ◽  
Long Term Survival ◽  
Prior Therapy ◽  
Additional Clinical Benefit ◽  
Ecog Ps

10013 Background: 5-year follow-up of the phase 3 KEYNOTE-006 study (NCT01866319) showed pembro improved OS vs ipilimumab (ipi) in patients (pts) with advanced melanoma. 3-y OS rate from pembro completion for pts who completed 2 y of pembro was 93.8%. Results with 8 mo of additional follow-up are presented to inform clinical care. Methods: Eligible pts with ipi-naive advanced melanoma, ≤1 prior therapy for BRAF-mutant disease, and ECOG PS 0 or 1 were randomized to pembro 10 mg/kg Q2W or Q3W for ≤2 y or ipi 3 mg/kg Q3W for 4 doses. Pts discontinuing pembro with CR, PR, or SD after ≥94 weeks were considered pts with 2-y pembro. Pts who stopped pembro with SD, PR or CR could receive ≤12 mo of additional pembro (2nd course) upon disease progression if still eligible. ORR was assessed per immune-related response criteria by investigator review. OS was estimated using the Kaplan-Meier method. Pembro arm data were pooled. Post hoc ITT efficacy analyses are shown. Results: Median follow-up from randomization to data cutoff (Jul 31, 2019) was 66.7 mo in the pembro and 66.9 mo in the ipi arms. OS outcomes are shown in Table. For the 103 pts with 2-y pembro (30 CR, 63 PR, 10 SD), median follow-up from completion was 42.9 mo (95% CI, 39.9-46.3).Median DOR was not reached. 36-mo OS from pembro completion was 100% (95% CI, 100.0-100.0) for pts with CR, 94.8% (95% CI, 84.7-98.3) for pts with PR, and 66.7% (95% CI, 28.2-87.8) for pts with SD. 15 pts received 2nd-course pembro; BOR in 1st course was 6 CR, 6 PR, and 3 SD. Median time from end of 1st course to start of 2ndcourse was 24.5 mo (range, 4.9-41.4). Median follow-up in pts who received 2nd-course pembro was 25.3 mo (range, 3.5-39.4). Median duration of 2nd-course pembro was 8.3 mo (range, 1.4-12.6). BOR on 2ndcourse was 3 CR, 5 PR (ongoing responses, 7 pts), 3 SD (ongoing, 2 pts), and 2 PD (1 death); 2 pts pending. Conclusions: Pembro improves the long-term survival vs ipi in pts with advanced melanoma, with all pts who completed therapy in CR still alive at 5 years. Retreatment with pembro at progression in pts who stopped at SD or better can provide additional clinical benefit in a majority of pts. Clinical trial information: NCT01866319. [Table: see text]

Long-term survival in patients with metastatic melanoma who received ipilimumab in four phase II trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9053-9053 ◽  
Author(s):  
Celeste Lebbé ◽  
Jeffrey S. Weber ◽  
Michele Maio ◽  
Bart Neyns ◽  
Kaan Harmankaya ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Disease Progression ◽  
Phase Ii ◽  
Survival Data ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Term Survival ◽  
Long Term Survival

9053 Background: Ipilimumab (Ipi) has shown improved overall survival (OS) in two phase III trials of patients (pts) with metastatic melanoma (MM), with survival follow-up of >4 years in one trial. The present analyses provide survival follow-up of >5 years in four phase II trials of Ipi in MM. Methods: Pts with MM were enrolled in one of four phase II trials: (1) CA184-004, a biomarker study with Ipi at 3 or 10 mg/kg in treatment-naive (TN) and previously treated (PT) pts; (2) CA184-007, with Ipi at 10 mg/kg +/- prophylactic budesonide in TN and PT pts; (3) CA184-008, a single-arm study with Ipi at 10 mg/kg in PT pts; and (4) CA184-022, a dose-ranging study of Ipi at 0.3, 3, or 10 mg/kg in PT pts (crossover from lower dose groups to 10 mg/kg was allowed upon disease progression). Ipi was administered q3 wk x4 (induction), followed by maintenance (q12 wk from week 24) in eligible pts. Some pts were retreated with Ipi at 10 mg/kg upon disease progression. Along with survival data collected through March 2012 for studies 007, 008, and 022, we report updated 5-year OS data for study 004 collected through September 2012. Results: Five-year OS rates for TN and PT pts are reported in studies 007, 008, and 022, with combined analyses for TN and PT pts within each dose group in study 004 (Table). The results show that survival rates reach a plateau beginning at year 3. Conclusions: In pts who received Ipi at 3 or 10 mg/kg in phase II studies, regardless of prior treatment, a proportion (12.3–49.5%) remained alive 5 years after the start of treatment. These results demonstrate long-term survival with Ipi therapy in MM. An ongoing phase III trial will compare OS for Ipi at 3 vs 10 mg/kg in pts with MM. Clinical trial information: NCT00162123. [Table: see text]

Effect of ipilimumab treatment on 18-month survival: Update of patients (pts) with advanced melanoma treated with 10 mg/kg ipilimumab in three phase II clinical trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9033-9033
Author(s):  
S. O'Day ◽  
J. Weber ◽  
C. Lebbe ◽  
M. Maio ◽  
H. Pehamberger ◽  
...  
Keyword(s):  
Phase Ii ◽  
Survival Data ◽  
Survival Benefit ◽  
Survival Rates ◽  
Advanced Melanoma ◽  
Controlled Study ◽  
Term Survival ◽  
Long Term Survival

9033 Background: The monoclonal antibody ipilimumab targets cytotoxic T lymphocyte antigen-4. Updated survival data (≤32.5 months follow-up) from 3 Phase II trials of ipilimumab in pts with mostly pretreated advanced melanoma are reported. Methods: Study CA184008 was an open-label, single-arm study of ipilimumab 10 mg/kg. Study CA184022 was a randomized, dose-ranging study of ipilimumab 0.3, 3, or 10 mg/kg. Study CA184007 was a randomized, placebo-controlled study of the effect of budesonide on gastrointestinal immune-related adverse events in pts receiving ipilimumab 10 mg/kg. In all studies, ipilimumab was given every 3 weeks (Q3W) × 4 (induction); eligible pts could continue to receive maintenance ipilimumab Q12W from week 24. Pts continue to be followed-up to determine long-term survival. Results: With a median follow-up ranging from 10.1 to 16.3 months and reaching up to 32.5+ months, pts receiving 10 mg/kg ipilimumab showed durable survival; 12- and 18-month survival rates are presented [ Table ]. The tail of the Kaplan-Meier curve flattened at 18 months, indicating that a substantial proportion of patients continued to survive beyond the updated follow-up period in all three studies. Long-term survivors include pts with disease progression (PD) per modified World Health Organization (mWHO) criteria. Conclusions: Ipilimumab may result in a long-term survival benefit in pts with advanced melanoma, where 18-month survival rates across 3 Phase II studies range from 34.5% to 39.4% for previously treated pts. These results indicate that more than 1/3 of ipilimumab-treated pts with advanced melanoma experience a long-term survival benefit, including some pts characterized as PD by mWHO. The survival data continue to mature, and follow-up is ongoing. [Table: see text] [Table: see text]

scholarly journals Multicenter, Phase III Trial Comparing Selenium Supplementation With Observation in Gynecologic Radiation Oncology

2014 ◽  
Vol 13 (6) ◽  
pp. 463-467 ◽  
Author(s):  
Ralph Muecke ◽  
Oliver Micke ◽  
Lutz Schomburg ◽  
Michael Glatzel ◽  
Berthold Reichl ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Survival Rate ◽  
Cancer Patients ◽  
Uterine Cancer ◽  
Phase Iii ◽  
Term Survival ◽  
Long Term Survival ◽  
Positive Effects

Purpose. In 2010, we reported that selenium (Se) supplementation during radiation therapy (RT) is effective for increasing blood Se levels in Se-deficient cervical and uterine cancer patients, and reduced the number of episodes and severity of RT-induced diarrhea. In the current study, we examine whether of Se supplementation during adjuvant RT affects long-term survival of these patients. Patients and Methods. Former patients were identified and questioned with respect to their health and well-being. Results. A total of 81 patients were randomized in the initial supplementation study, 39 of whom received Se (selenium group, SeG) and 42 of whom served as controls (control group, CG). When former patients were reidentified after a median follow-up of 70 months (range = 0-136), the actuarial 10-year disease-free survival rate in the SeG was 80.1% compared to 83.2% in the CG ( P = .65), and the actuarial 10-year overall survival rate of patients in the SeG was 55.3% compared to 42.7% in the CG ( P = .09). Conclusions. Our extended follow-up analysis demonstrates that Se supplementation had no influence on the effectiveness of the anticancer irradiation therapy and did not negatively affect patients’ long-term survival. In view of its positive effects on RT-induced diarrhea, we consider Se supplementation to be a meaningful and beneficial adjuvant treatment in Se-deficient cervical and uterine cancer patients while undergoing pelvic radiation therapy.

Long-Term Survival in a Patient With Abdominal Sarcomatosis From Uterine Leiomyosarcoma: Role of Repeated Laparoscopic Surgery in Treatment and Follow-Up

2016 ◽  
Vol 23 (6) ◽  
pp. 1003-1008 ◽  
Author(s):  
Antonio Macciò ◽  
Paraskevas Kotsonis ◽  
Giacomo Chiappe ◽  
Luca Melis ◽  
Fausto Zamboni ◽  
...  
Keyword(s):  
Laparoscopic Surgery ◽  
Uterine Leiomyosarcoma ◽  
Term Survival ◽  
Long Term Survival

scholarly journals Post-surgical depressive symptoms and long-term survival in non-metastatic breast cancer patients at 11-year follow-up

2017 ◽  
Vol 44 ◽  
pp. 16-21 ◽  
Author(s):  
Michael H. Antoni ◽  
Jamie M. Jacobs ◽  
Laura C. Bouchard ◽  
Suzanne C. Lechner ◽  
Devika R. Jutagir ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Depressive Symptoms ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Term Survival ◽  
Long Term Survival

scholarly journals Reconstruction of the Aortic Arch in Newborns and Infants Using an Extended End-to-End Anastomosis

2021 ◽  
pp. 63-68
Author(s):  
Iaroslav P. Truba ◽  
Ivan V. Dziuryi ◽  
Roman I. Sekelyk ◽  
Oleksandr S. Golovenko
Keyword(s):  
Hospital Mortality ◽  
Aortic Arch ◽  
Median Sternotomy ◽  
Term Survival ◽  
Long Term Survival ◽  
The Mean ◽  
End To End ◽  
Aortic Arch Hypoplasia

The problem of the effectiveness of obstruction at the level of the aortic arch is still a matter of discus-sion in the modern literature. Traditionally, by excision of the coarctation part, in the presence of hypoplasia, the incision is extended to a narrowed area and a modification of the classical end-to-end anastomosis is applied in the form of an elongated or expanded variant. Recently, when proximal part is involved in the pathological process, cardiac surgeons have been more likely to use median sternotomy using other types of plastic surgery, including dilation of the narrowed area with a pericardial patch, or pulmonary artery tissue. Accordingly, the analysis of the results of the use of end-to-end anastomosis in young children with aortic arch hypoplasia, especially in view of long-term survival and the level of reoperation, is an important issue of neonatal cardiac surgery. The aim. To evaluate the effectiveness of the use of an extended end-to-end anastomosis after reconstruction of the aortic arch in children under 1 year of age. Materials and methods. The study material included 348 infants who underwent surgical correction of aortic arch hypoplasia through the method of extended end-to-end anastomosis from 2010 to 2020. The operations were performed at the National Amosov Institute of Cardiovascular Surgery of the NAMS of Ukraine and the Ukrainian Children’s Cardiac Center. The study group included only patients with two-ventricular physiology. There were 233 male patients (67%) and 115 female patients (33%). The mean age was 1.07 (0.20; 2.30) months, the mean weight was 3.89 (3.30; 4.90) kg, the mean body surface area was 0.23 (0.20; 0.28) m2. Diagnosis of aortic arch hypoplasia was based on two-dimensional echocardiography. Results. According to echocardiography, after surgery there was a significant decrease in the pressure gradient in the aortic arch from 48.3 ± 20.3 to 16 ± 6.9 (p<0.05), left ventricular PV increased significantly from 61.6 ± 12% to 66.3 ± 6.4% (p> 0.05). The hospital mortality was 1.7% (n = 6). The causes of mortality were not related to the end-to-end aortic arch technique. The duration of follow-up period ranged from 1 month to 9.3 years. Two deaths occurred in the follow-up period. Thirty-two (9.1%) patients developed aortic arch restenosis in the postoperative period. Balloon dilatation of restenosis was performed in 21 patients. Eleven patients underwent repeated aortic arch repair surgery through the median sternotomy. There were no central nervous system complications in the follow-up period. Conclusions. The use of an extended end-to-end anastomosis in the surgical treatment of aortic arch hypoplasia demon strates low hospital mortality and high long-term survival. Indications for the effective use of this type of reconstruction are hypoplasia of the isthmus and distal aortic arch.

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