Disease-free survival as a predictor of overall survival in localized renal cell carcinoma (RCC) following first nephrectomy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4581-4581
Author(s):  
Naomi B. Haas ◽  
Yan Song ◽  
Jaqueline Willemann Rogerio ◽  
Su Zhang ◽  
Oluwakayode Adejoro ◽  
...  
Keyword(s):  
High Risk ◽  
Rank Correlation ◽  
Disease Free Survival ◽  
Cox Models ◽  
Free Survival ◽  
Risk Of Death ◽  
Kendall’S Τ ◽  
Disease Free ◽  
Time Point

4581 Background: Intermediate endpoints (e.g., disease free survival [DFS]) have gained traction lately as potential surrogates for OS in oncology as they require shorter follow up to show clinical benefit. Given the high post-nephrectomy survival in patients (pts) with localized RCC, evidence on if DFS can be used as a predictor of OS in the disease is warranted. We assessed the association between DFS and OS in pts with newly diagnosed, completely resected, intermediate-high (pT2N0 high grade, pT3N0) or high-risk (pT4N0, pTanyN1) RCC post-nephrectomy. Methods: This retrospective observational study used the SEER-Medicare database (2007–2016). DFS was defined as time from initial nephrectomy date to first recurrence (diagnosis of metastatic disease, additional surgery, starting systemic treatment for advanced RCC) or death, whichever occurred first. OS from time of recurrence in pts with recurrence were compared with OS from comparable time point in pts without, using Kaplan-Meier analyses and adjusted Cox models. OS was also compared between pts with and without recurrence by landmark time points at 1, 2, 3, 4 and 5 years (yrs) post-nephrectomy; hazard ratios (HRs) between the two cohorts were estimated using adjusted Cox models. Correlation between DFS and OS was assessed using the Kendall’s τ rank correlation. Monthly healthcare costs were compared between the two cohorts using generalized linear model. Results: 643 post-nephrectomy RCC pts (269 with recurrence vs 374 without) met the inclusion criteria (Median follow-up: 23 months). The mean age was 75.5 yrs, 61% male, and 86% white. The median post-nephrectomy OS and DFS was 8.61 and 4.44 yrs, respectively. Pts with and without recurrence had comparable baseline characteristics. Pts with recurrence had significantly shorter OS than those without [median: 2.53 yrs vs not reached; adjusted HR (95% confidence interval [CI]): 6.00 (4.24–8.48)]. Pts with recurrence by each landmark time point had significantly shorter OS than those without [1 yr post-nephrectomy median OS: 2.35 vs 9.66 yrs, and the OS 1, 3, and 5 after the 1 yr landmark was 69.9 vs 96.5%, 41.8 vs 83.8%, and 37.0 vs 70.1%, respectively; all Ps (log-rank test) < 0.001]. Cox models indicated that pts with recurrence by each landmark time point had 2.6–3.5 times increased risk of death compared with those without. Kendall’s τ rank correlation model demonstrated a statistically significant correlation between DFS and OS (Kendall’s τ = 0.70; 95% CI: 0.65–0.74; P < 0.001). Pts with recurrence had $4,924 and $1,387 higher adjusted all-cause medical costs and pharmacy costs per month (P < 0.001). Conclusions: Post-nephrectomy recurrence is associated with significantly shorter OS among pts with intermediate-high or high-risk RCC, resulting in a strong positive association between DFS and OS in the population. Higher healthcare cost was also seen among pts with recurrence.

Allogeneic Stem-Cell Transplantation Using a Reduced-Intensity Conditioning Regimen Has the Capacity to Produce Durable Remissions and Long-Term Disease-Free Survival in Patients With High-Risk Acute Myeloid Leukemia and Myelodysplasia

2005 ◽  
Vol 23 (36) ◽  
pp. 9387-9393 ◽  
Author(s):  
Sudhir Tauro ◽  
Charles Craddock ◽  
Karl Peggs ◽  
Gulnaz Begum ◽  
Premini Mahendra ◽  
...  
Keyword(s):  
High Risk ◽  
Myeloid Leukemia ◽  
Disease Free Survival ◽  
Allogeneic Transplantation ◽  
Disease Relapse ◽  
Reduced Intensity Conditioning ◽  
Free Survival ◽  
Disease Free ◽  
Reduced Intensity

Purpose The toxicity of allogeneic stem-cell transplantation can be substantially reduced using a reduced-intensity conditioning (RIC) regimen. This has increased the proportion of patients with myeloid malignancies eligible for allogeneic transplantation. However, the capacity of RIC allografts to produce durable remissions in patients with acute myeloid leukemia (AML) and myelodysplasia (MDS) has not yet been defined, and consequently, the role of RIC allografts in the management of these diseases remains conjectural. Patients and Methods Seventy-six patients with high-risk AML or MDS received an allograft using a fludarabine/melphalan RIC regimen incorporating alemtuzumab. The median age of the cohort was 52 years (range, 18 to 71 years). Results The 100-day transplantation-related mortality rate was 9%, and no patient developed greater than grade 2 graft-versus-host disease. With a median follow-up of 36 months (range, 13 to 70 months), 27 patients were alive and in remission, with 3-year actuarial overall survival (OS) and disease-free survival (DFS) rates of 41% and 37%, respectively. The 3-year OS and DFS rates of patients with AML in complete remission at the time of transplantation were 48% and 42%, respectively. Disease relapse was the most common cause of treatment failure and occurred at a median time of 6 months after transplantation. All but one patient destined to relapse did so within 24 months of transplantation. Conclusion The extended follow-up in this series identifies a high risk of early disease relapse but provides evidence that RIC allografts can produce sustained DFS in a significant number of patients with AML who would be ineligible for allogeneic transplantation with myeloablative conditioning.

Allogeneic Stem Cell Transplantation Using a Reduced Intensity Conditioning (RIC) Regimen Has the Capacity To Produce Durable Remissions and Long Term Disease-Free Survival in Patients with High Risk Acute Myeloid Leukemia (AML).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1141-1141
Author(s):  
S. Tauro ◽  
S. Mackinnon ◽  
K. Peggs ◽  
G. Begum ◽  
P. Mahendra ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Disease Free Survival ◽  
Allogeneic Transplantation ◽  
Disease Relapse ◽  
Reduced Intensity Conditioning ◽  
Free Survival ◽  
Disease Free ◽  
Reduced Intensity

Abstract The toxicity of allogeneic stem cell transplantation (SCT) can be substantially reduced by the use of a reduced intensity conditioning (RIC) regimen and this has increased the proportion of patients with myeloid malignancies eligible for allogeneic transplantation. However, the capacity of RIC allografts to produce durable remissions in patients with AML and MDS has not yet been defined and consequently their role in the management of these diseases remains conjectural. Seventy-six patients with high risk AML or MDS were allografted using a fludarabine/melphalan RIC regimen incorporating alemtuzumab. The median age of the cohort was 52 years (range 18–71 years). There were 46 males and 30 females; 41 patients received an allograft from an unrelated donor and 35 from a matched sibling donor. The 100 day transplant related mortality was 9% and no patient developed greater than Grade 2 graft-versus-host disease (GVHD). With a median follow-up of 36 months (range 13–70 months) 27 patients were alive and in remission with a 3y actuarial overall survival (OS) and disease-free survival (DFS) rate of 41% and 37% respectively. The 3y OS and DFS of patients with AML in complete remission (CR) at the time of transplantation was 48% and 42% respectively. In a multivariate setting, Cox regression analysis demonstrated prognostic significance of disease stage at the time of transplant with improved DFS in patients with AML in CR at the time of transplantation (HR=2.03, 95% CI=1.02–4.07). Disease relapse was the commonest cause of treatment failure occurring at a median time of 6 months post-transplant. Fourteen out of 27 (52%) patients relapsed within 6 months and 23/27 (85%) within twelve months defining a relatively narrow window for therapeutic intervention to prevent disease recurrence. The extended follow-up in this series identifies a high risk of early disease relapse but provides evidence that RIC allografts are capable of producing sustained disease free survival in a significant number of patients with AML who would be ineligible for allogeneic transplantation using a myeloablative conditioning regimen.

Disease-free survival as a surrogate endpoint for overall survival in an adjuvant trial of curatively resected stomach cancer using individual patient data meta-analysis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4517-4517
Author(s):  
T. Burzykowski ◽  
Y. Bang ◽  
Keyword(s):  
Stomach Cancer ◽  
Meta Analysis ◽  
Rank Correlation ◽  
Disease Free Survival ◽  
Resected Stomach ◽  
Free Survival ◽  
Spearman’S Rank Correlation ◽  
Hazard Ratios ◽  
Disease Free

4517 Background: In investigations of the effectiveness of oncology drugs, overall survival (OS) is considered as the gold standard end point. However, the disadvantage of OS is that it requires an extended follow-up. A reasonable candidate for a surrogate for OS in the adjuvant setting is disease free survival (DFS). DFS is defined as recurrence of stomach cancer, all second cancers, or death from any cause. Recently, some evidence has been offered for the use of DFS as a surrogate for OS in, e.g., colorectal cancer. We evaluated 3 year DFS as a surrogate for 5 year OS in adjuvant trials of stomach cancer by using individual-patient data (IPD) meta- analysis validation criteria. Methods: The GASTRIC group initiated an IPD meta-analysis of all randomized clinical trials comparing chemotherapy versus surgery alone for patients with curatively resected stomach cancer. The validity of DFS at 3 years as a surrogate for OS at 5 years was investigated by using multiple analysis techniques, which included measures of correlation between the endpoints and between the treatment effects, and the percentage of agreement in the log-rank tests for the two endpoints at the trial level. Results: Among the 31 eligible trials, at most 25 collected the date of recurrence (5,014 pts). As of December 2008, IPD were available from 13 randomized controlled trials (3,161 patients). Seventy-seven percent of patients (1,280/1,652 pts) who recurred during the follow-up period, recurred within the first 3 years after study enrollment. At the trial level, 12 out of the 13 trials yielded the same conclusions for both endpoints at the 0.05 significance level. The R2 value between both endpoints was equal to 0.97 and Spearman's rank correlation was equal to 0.92. The R2 value between hazard ratios for OS and DFS was equal to 0.85 and Spearman's rank correlation was equal to 0.87. Conclusions: Our preliminary results, which are based on 63% of the targeted data, show that the 5-year OS and the 3-year DFS are highly correlated. Additionally, the hazard ratios for DFS and OS are also strongly associated. This suggests that 3-year DFS may be a good surrogate for a 5-year OS. The results based on the most recent update of the IPD will be presented during the conference. No significant financial relationships to disclose.

scholarly journals Efficacy of Maintenance Therapy after Autologous Hematopoietic Stem Cell Transplantation in High-Risk Aggressive Lymphoma: A Single-Center Prospective Non-Randomized Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5753-5753
Author(s):  
Yongquan Chen ◽  
Zhihong Zheng ◽  
Xiaofeng Luo ◽  
Jinhua Ren ◽  
Haili Geng ◽  
...  
Keyword(s):  
High Risk ◽  
Maintenance Therapy ◽  
Disease Free Survival ◽  
Aggressive Lymphoma ◽  
Observation Group ◽  
Hematopoietic Stem ◽  
Free Survival ◽  
Disease Free ◽  
Maintenance Group

Abstract OBJECTIVE: Relapse after autologous hematopoietic stem cell transplantation (ASCT) is still challenging for high-risk aggressive lymphoma. This study was to investigate the efficacy and safety of maintenance therapy post-ASCT. METHODS: From June 2009 to March 2018, patients with high-risk aggressive lymphoma in our hospital were treated with maintenance therapy post-ASCT according to the patient's wishes, and then assigned to maintenance group or observation group. The end point of follow-up was disease progression or death. The 3-year overall survival (OS) and disease-free survival (DFS) were compared between these two groups. RESULTS: A total of 79 patients were enrolled, with a median age of 38 years (8-64 years), 50 males and 29 females. IPI score ≥2 points in 28 cases, stage III-IV in 58 cases, B symptoms in 21 cases, Extranodal lesions ≥ 2 in 17 cases, bone marrow infiltration in 15 cases, and 24 cases with partial remission (PR) prior to ASCT. In addition to 2 cases of early death, the remaining 77 patients with lymphoma were underwent successfully transplantation and achieved CR post-ASCT. 54 patients were assigned to the observation group, and 23 patients to the maintenance group, including 17 with rituximab and 6 with DPP/DCEP-G alternation regimen. There were no s ignificant differences in gender, age, pre-transplant disease status, and hematopoietic reconstitution between the two groups. The main causes of death were disease recurrence. No serious adverse reactions occurred during the maintenance treatment period. After a median follow-up of 616 days (12-2854 days), the relapse rates of the observation group and the maintenance group were 49.1% vs 12.9%, and the DFS of the 1st, 2nd, and 3rd years were 62.8% VS 93.8%, 48.1% VS 87.1%, and 45.3% VS 87.1% (P = 0.007), respectively. The OS of the 1st, 2nd, and 3rd years were 89.3% VS 100%, 83.2% VS 92.9%, and 76.2% VS 92.9% (P=0.212), respectively. Conclusion: Maintenance therapy post-ASCT could reduce the risk of relapse and promote disease-free survival, which deserves further investigation. Disclosures No relevant conflicts of interest to declare.

scholarly journals Disease-free survival after autologous bone marrow transplantation in patients with acute myelogenous leukemia

Blood ◽  
1989 ◽  
Vol 74 (6) ◽  
pp. 1898-1904 ◽  
Author(s):  
M Korbling ◽  
W Hunstein ◽  
TM Fliedner ◽  
S Cayeux ◽  
B Dorken ◽  
...  
Keyword(s):  
High Risk ◽  
Autologous Bone Marrow Transplantation ◽  
Disease Free Survival ◽  
Autologous Bone Marrow ◽  
Myelogenous Leukemia ◽  
Free Survival ◽  
Acute Myelogenous ◽  
Autologous Bone ◽  
Disease Free

Autologous bone marrow transplantation (ABMT) makes it possible to escalate the dose of cytotoxic treatment to a lethal range. Disease- free survival (DFS) following myeloablative therapy and ABMT has been shown to be superior to conventional treatment in high risk patients with acute myelogenous leukemia (AML). It was the purpose of the present study to compare hematopoietic reconstitution, actuarial DFS, and relapse rate of patients transplanted in first complete remission (CR) of AML with those in second or subsequent CR, and to evaluate transplant related mortality. Fifty-two patients with AML, 22 in first CR (low risk) and 30 in second or subsequent CR (high risk), underwent total body irradiation (12.1 to 16.7 Gy) and cyclophosphamide (CY) treatment (200 mg/kg) followed by ABMT. The autograft was incubated with the active CY derivative Mafosfamide (ASTA Werke, Bielefeld, Federal Republic of Germany) to reduce the number of possibly contaminating clonogenic tumor cells. All patients showed three lineage engraftments with platelet recovery observed as being the slowest. The transplant related death rate was low at 5.8%. There was no significant difference in the kinetics of polymorphonuclear (PMN) cell or platelet reconstitution between the low and high risk patient subgroups. The estimated probability of DFS (relapse) after ABMT in first CR was 61% (36%) compared with 34% (65%) in second or subsequent CR, the longest follow-up being 55 months and 57 months, respectively (median follow-up 31 months and 19 months, respectively). ABMT offers a stable long-term DFS when performed in first CR with no relapses occurring in over a year after transplantation. Six later relapses, however, were seen after ABMT in second or subsequent CR, although DFS was not statistically different from that of first remission patients (P = .72).

Adjuvant Treatment of High-risk Adult Soft Tissue Sarcomas: A Survey by the Italian Sarcoma Group

2006 ◽  
Vol 92 (2) ◽  
pp. 92-97 ◽  
Author(s):  
Sergio Frustaci ◽  
Massimiliano Berretta ◽  
Alessandro Comandone ◽  
Ettore Bidoli ◽  
Antonino De Paoli ◽  
...  
Keyword(s):  
Overall Survival ◽  
High Risk ◽  
Soft Tissue ◽  
Survival Rates ◽  
Soft Tissue Sarcomas ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free ◽  
Overall Survival Rates

Aims and Background After the first adjuvant study on adult soft tissue sarcomas was concluded, the participating institutions continued to select and treat patients according to that protocol. The aim of this study was to test the protocol reproducibility when applied as a standard practice. Methods A call for retrospective data was launched in June 1999 (self-referral of consecutive unregistered patients); thereafter, a prospective follow-up was performed. The treatment regimen consisted of epirubicin (60 mg/m2 days 1 and 2), ifosfamide (3 g/m2/die for 3 days) and equimolar doses of 6-mercapto-ethansulfonate (MESNA), with 300 μg G-CSF administered subcutaneously from day +8 until recovery, every 3 weeks for a total of 5 cycles. Results From November 1996 to June 1999, 55 high-risk, adult patients were treated. The average median dose intensity was 89% of the planned program. Grade 3-4 toxicities were leukopenia (49%), thrombocytopenia (14%), transfusion requiring anemia in 7 patients (16%), and alopecia in all patients (100%). After a median follow-up of 70 months, 23 patients (41.8%) relapsed and 19 died. Median disease-free, local disease-free and overall survival rates have not yet been reached. The disease-free survival rates at 2 and 4 years were 73% and 57%, respectively; the corresponding overall survival rates were 91% and 70%, respectively. Conclusions The feasibility and reproducibility of the original protocol were confirmed, since disease-specific overall survival and disease-free survival rates at the same period of observation and with the same prolonged follow-up did not differ.

scholarly journals 3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT

2019 ◽  
Vol 23 (64) ◽  
pp. 1-88 ◽  
Author(s):  
Timothy Iveson ◽  
Kathleen A Boyd ◽  
Rachel S Kerr ◽  
Jose Robles-Zurita ◽  
Mark P Saunders ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Treatment Group ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free

Background Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy. Objectives To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations. Design An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial. Setting A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand. Participants Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum. Interventions The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months. Main outcome measures The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient. Results Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n = 3035; 6-month analysis, n = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p-value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand–foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years (p < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4–6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. Conclusions The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019–20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease. Trial registration Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre – Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).

Disease-free survival after autologous bone marrow transplantation in patients with acute myelogenous leukemia

Blood ◽  
1989 ◽  
Vol 74 (6) ◽  
pp. 1898-1904 ◽  
Author(s):  
M Korbling ◽  
W Hunstein ◽  
TM Fliedner ◽  
S Cayeux ◽  
B Dorken ◽  
...  
Keyword(s):  
High Risk ◽  
Autologous Bone Marrow Transplantation ◽  
Disease Free Survival ◽  
Autologous Bone Marrow ◽  
Myelogenous Leukemia ◽  
Free Survival ◽  
Acute Myelogenous ◽  
Autologous Bone ◽  
Disease Free

Abstract Autologous bone marrow transplantation (ABMT) makes it possible to escalate the dose of cytotoxic treatment to a lethal range. Disease- free survival (DFS) following myeloablative therapy and ABMT has been shown to be superior to conventional treatment in high risk patients with acute myelogenous leukemia (AML). It was the purpose of the present study to compare hematopoietic reconstitution, actuarial DFS, and relapse rate of patients transplanted in first complete remission (CR) of AML with those in second or subsequent CR, and to evaluate transplant related mortality. Fifty-two patients with AML, 22 in first CR (low risk) and 30 in second or subsequent CR (high risk), underwent total body irradiation (12.1 to 16.7 Gy) and cyclophosphamide (CY) treatment (200 mg/kg) followed by ABMT. The autograft was incubated with the active CY derivative Mafosfamide (ASTA Werke, Bielefeld, Federal Republic of Germany) to reduce the number of possibly contaminating clonogenic tumor cells. All patients showed three lineage engraftments with platelet recovery observed as being the slowest. The transplant related death rate was low at 5.8%. There was no significant difference in the kinetics of polymorphonuclear (PMN) cell or platelet reconstitution between the low and high risk patient subgroups. The estimated probability of DFS (relapse) after ABMT in first CR was 61% (36%) compared with 34% (65%) in second or subsequent CR, the longest follow-up being 55 months and 57 months, respectively (median follow-up 31 months and 19 months, respectively). ABMT offers a stable long-term DFS when performed in first CR with no relapses occurring in over a year after transplantation. Six later relapses, however, were seen after ABMT in second or subsequent CR, although DFS was not statistically different from that of first remission patients (P = .72).

scholarly journals HE4 is superior to CA125 in the detection of recurrent disease in high-risk endometrial cancer patients

Tumor Biology ◽  
2018 ◽  
Vol 40 (2) ◽  
pp. 101042831875710 ◽  
Author(s):  
Karin Abbink ◽  
Petra LM Zusterzeel ◽  
Anneke J Geurts-Moespot ◽  
Antonius E van Herwaarden ◽  
Johanna MA Pijnenborg ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
High Risk ◽  
Confidence Interval ◽  
Cancer Patients ◽  
Recurrent Disease ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free

Objective: To date, biomarkers are not routinely used in endometrial cancer diagnosis, prognosis, and follow-up. The purpose of this study was to evaluate whether serum HE4 was related to clinicopathological risk factors and outcome. Second, the role of serum HE4 and CA125 was assessed as indicator for recurrent disease during follow-up. Methods: A total of 174 patients with endometrial cancer between 1999 and 2009 were selected for this retrospective study. Serum HE4 and CA125 were analyzed at primary diagnosis, during follow-up, and at the time of recurrence. Correlations with clinicopathological factors were studied by univariate and multivariate survival analyses. Lead time was calculated in order to determine which serum marker was elevated prior to clinical detection of recurrent disease. Results: Serum levels of HE4 and CA125 were significantly associated with high tumor grade, myometrial invasion, lymph node involvement, and advanced stage (p < 0.01). HE4 was an independent prognostic factor for reduced disease-free survival and overall survival with hazard ratios of 2.96 (95% confidence interval: 1.18–7.99) and 3.27 (95% confidence interval: 1.18–9.02), respectively. At recurrence, 75% of the patients had an elevated HE4 compared to 54% with an elevated CA125. HE4 levels were more frequently elevated in patients with distant metastasis compared to local recurrences, 67% and 37%, respectively. Serum HE4 detected a recurrence with a median of 126 days earlier than clinical confirmation. Conclusion: Elevated serum HE4 is an independent risk factor for reduced disease-free survival and overall survival. HE4 seems to be superior to CA125 in the detection of recurrent disease during follow-up, mainly in high-risk endometrial cancer patients who are more prone to distant metastasis.

A phase II trial of radiation therapy with concurrent paclitaxel chemotherapy in high-risk endometrial cancer patients after staging operation: An interim analysis of a prospective multicenter trial (KGOG2001)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16069-16069
Author(s):  
J. Kim ◽  
J. Jeong ◽  
B. Nam ◽  
S. Kim ◽  
C. Cho ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Survival Rate ◽  
High Risk ◽  
Concurrent Chemoradiotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free Survival Rate ◽  
Disease Free ◽  
Staging Operation

16069 Background: This is an interim report of a prospective multicenter phase II trial to evaluate 2-year disease free survival rate, toxicity, overall survival rate and recurrence rate in high-risk endometrial cancer patients who received concurrent chemoradiotherapy after staging operation. Methods: Thirty four patients with endometrial cancer from 17 medical centers in Korea have enrolled the study. The cell types were all endometrioid type and they had no prior chemotherapy. They were in either stage III or IV and all received staging operation including total hysterectomy, bilateral salpingo-oophorectomy, pelvic and paraaortic lymph node dissection and washing cytology. Concurrent chemoradiotherapy was performed with paclitaxel (60 mg/m2/weekly, 6 cycles) and external field irradiation (5 fractions/week, total 4,500–5,040 cGy). Primary end point was 2-year disease free survival rate. Overall survival rate and recurrence rate were secondary end points. Toxicity of the treatment was also evaluated. Results: The expected number of subjects to complete the trial is 56. The trial was activated on 5th June 2005 and median follow up period is 5.8 (0–11) months until December 2006. 19 patients (55.8%) have completed treatment regimen and 14 patients (41.1%) are still receiving treatment. 1 patient (2.9%) died during treatment of the disease and 1 patient (2.9%) was lost during the follow up period. Disease free survival is 94.1% (32/34) and no recurrence has occurred so far. Toxicities have occurred in 52.9% (18/34) with gastrointestinal symptoms (13/34, 38.2%) such as diarrhea and constipation being the most common ones. Conclusions: This interim report suggest a possibility that a concurrent chemoradiotherapy for high-risk endometrial cancer may be an optimal treatment option to improve disease free survival rate. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document