Pattern of recurrence after partial and total nephrectomy in non-metastatic renal cell carcinoma (RCC) of low, intermediate and high risk: Implications for follow-up.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 601-601
Author(s):  
Axel Bex ◽  
Yvette Kuijpers ◽  
Allard Noe ◽  
Ruud Bosch ◽  
Simon Horenblas ◽  
...  
Keyword(s):  
High Risk ◽  
Partial Nephrectomy ◽  
Clear Cell ◽  
Local Therapy ◽  
Risk Groups ◽  
Cross Sectional ◽  
Risk Patients ◽  
The Impact ◽  
Metastatic Rcc

601 Background: Guidelines recommend risk-adapted follow-up (FUP) after (partial) nephrectomy in non-metastatic RCC. VEGF-targeted therapy does not cure multiple metastatic RCC. FUP should therefore focus on local recurrences or single-/-oligometastases that may potentially be cured by local therapy. The rate of potentially curable recurrences per risk group is unknown and their pattern and management were analyzed in this study. Methods: From an IRB approved database non-metastatic RCC patients who underwent (partial) nephrectomy from 2004 to 2011 with a minimum FUP of ≥4 years and regular cross-sectional imaging were identified. Risk stratification was assigned to Leibovich- (clear-cell ) or UICC-stage- (non-clear cell) risk groups . Local recurrence, solitary and oligometastases defined as < 3 lesions at a single site were considered potentially curable by local therapy modalities. Recurrences were recorded as was the time to detection of recurrence (TDR) and their management. Results: From 230 patients identified, 191 (clear-cell) and 39 (non-clear cell) were assigned to the Leibovich- or UICC-risk groups respectively. Together, 69 developed recurrences (30 %), of whom 29 (42 %) were potentially curable. Of low-risk patients (32.6 %), only 9 (12 %) had recurrences of which 5 (55.6 %) were potentially curable. In high-risk (19.1 %), of 26 (59.1%) recurrences, the majority were multiple and rapid at a median TDR of 8.4 months (IQR 13.7) with only 6 (23.1 %) potentially curable at a median TDR of 17.6 (IQR 53.8) months. Of 24 recurrences (33.8 %) in intermediate risk, 12 (50 %) potentially curable lesions were detected after a median TDR of 26 (IQR 36.2) months. Together, of 29 potentially curable lesions 15 (51.7 %) were not treated because of comorbidity, poor performance or prognosis and irresectability. Conclusions: High-risk patients predominantly develop multiple metastases early during FUP. A benefit of FUP might derive from identifying potentially curable lesions which develop with latency especially in intermediate and high risk. With only 48 % of potentially curable lesions treated locally the impact of FUP on OS remains controversial.

Survival in Patients with Newly Diagnosed Myeloma Undergoing Therapy with Lenalidomide and Dexamethasone: Impact of High-Risk Cytogenetic Risk Status on Outcome

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 95-95 ◽  
Author(s):  
Prashant Kapoor ◽  
Shaji Kumar ◽  
Rafael Fonseca ◽  
Martha Q. Lacy ◽  
Thomas E Witzig ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Stratification ◽  
Plasma Cell ◽  
Risk Groups ◽  
Newly Diagnosed ◽  
High Risk Patients ◽  
Risk Patients ◽  
The Impact ◽  
Standard Risk

Abstract Background: Multiple myeloma (MM) is a heterogeneous disease with very divergent outcomes that are dictated in a large part by specific cytogenetic abnormalities, as well as other prognostic factors such as the proliferative rate of marrow plasma cells. Prognostic systems incorporating these factors have shown clinical utility in identifying high-risk patients, and are increasingly being utilized for treatment decision-making. However, the prognostic relevance of these factors may change with the application of novel therapies. The objective of this study was to determine the impact of risk-stratification (incorporating plasma cell metaphase cytogenetics, interphase fluorescent in-situ hybridization (FISH) and the slide-based plasma cell labeling index (PCLI)) in a cohort of patients with newly diagnosed MM treated initially with lenalidomide + dexamethasone (Rev-Dex). Methods: From March 2004 to November 2007, 100 consecutive patients treated with Rev (25mg/day) on days 1 through 21 of a 4-week cycle in combination with dexamethasone as initial therapy for newly diagnosed myeloma, were identified. High-risk MM was defined as presence of any one or more of the following: hypodiploidy, monoallelic loss of chromosome 13 or its long arm (by metaphase cytogenetics only), deletion of p53 (locus 17p13) or PCLI ≥ 3% or immunoglobulin heavy chain (IgH) translocations, t(4;14) (p16.3;q32) or t(14;16)(q32;q23) on FISH. PFS and OS survival estimates were created using the Kaplan Meier method, and compared by log-rank tests. Results: The median estimated follow-up of the entire cohort (N=100) was 36 months. The median PFS was 31 months; the median OS has not been reached. The 2- and 3-year OS estimates were 93% and 83%, respectively. 16% patients were deemed high-risk by at least one of the 3 tests (cytogenetics, FISH or PCLI). Response rates (PR or better) were 81% versus 89% in the high-risk and standard risk groups, respectively, P=NS; corresponding values for CR plus VGPR rates were 38% and 45% respectively. The median PFS was 18.5 months in high-risk patients compared to 37 months in the standard-risk patients (n=84), P<0.001(Figure). Corresponding values for TTP were 18.5 months and 36.5 months, respectively, P=<0.001. OS was not statistically significant between the two groups; 92% 2-year OS was noted in both the groups. Overall, 95 patients had at least one of the 3 tests to determine risk, while 55 patients could be adequately stratified based on the availability of all the 3 tests, or at least one test result that led to their inclusion in the high-risk category. The significant difference in PFS persisted even when the analysis was restricted to the 55 patients classified using this stringent criterion; 18.5 months vs. 36.5 months in the high-risk and standard- risk groups respectively; P<0.001. In a separate analysis, patients who underwent SCT before the disease progression were censored on the date of SCT to negate its effect, and PFS was still inferior in the high-risk group (p=0.002). Conclusion: The TTP and PFS of high-risk MM patients are inferior to that of the standard-risk patients treated with Rev-Dex, indicating that the current genetic and proliferation-based risk-stratification model remains prognostic with novel therapy. However, the TTP, PFS, and OS obtained in high-risk patients treated with Rev-Dex in this study is comparable to overall results in all myeloma patients reported in recent phase III trials. In addition, no significant impact of high-risk features on OS is apparent so far. Longer follow-up is needed to determine the impact of risk stratification on the OS of patients treated with Rev-Dex. Figure Figure

scholarly journals Malaria in pregnancy in rural Gabon: a cross-sectional survey on the impact of seasonality in high-risk groups

2013 ◽  
Vol 12 (1) ◽  
pp. 412 ◽  
Author(s):  
Mario J Jäckle ◽  
Christian G Blumentrath ◽  
Rella M Zoleko ◽  
Daisy Akerey-Diop ◽  
Jean-Rodolphe Mackanga ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Groups ◽  
Malaria In Pregnancy ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
The Impact ◽  
In Pregnancy

A multicenter quality improvement initiative on the impact of pharmacists’ postdischarge follow-up to reduce medication-related acute care episodes

2020 ◽  
Vol 77 (12) ◽  
pp. 938-942
Author(s):  
Lydia Noh ◽  
Kristina Heimerl ◽  
Rita Shane
Keyword(s):  
Quality Improvement ◽  
High Risk ◽  
Acute Care ◽  
Academic Medical Centers ◽  
Quality Improvement Initiative ◽  
Medical Centers ◽  
Academic Medical ◽  
Risk Patients ◽  
The Impact

Abstract Purpose This multicenter quality improvement initiative aims to measure and quantify pharmacists’ impact on reducing medication-related acute care episodes (MACEs) for high-risk patients at an increased risk for readmission due to drug-related problems (DRPs). Methods This was a prospective, multicenter quality improvement initiative conducted at 9 academic medical centers. Each participant implemented a standardized methodology for evaluating MACE likelihood to demonstrate the impact of pharmacist postdischarge follow-up (PDFU). The primary outcome was MACEs prevented, and the secondary outcome was DRPs identified and resolved by pharmacists. During PDFU, pharmacists were responsible for identification and resolution of DRPs, and cases were reviewed by physicians to confirm whether potential MACEs were prevented. Results A total of 840 patients were contacted by 9 participating academic medical centers during a 6-week data collection period. Of these, 328 cases were identified as MACEs prevented during PDFU by pharmacists, and physician reviewers confirmed that pharmacist identification of DRPs during PDFU prevented 27.9% of readmissions. Pharmacist identified 959 DRPs, 2.8% (27) of which were identified as potentially life threatening. Potentially serious or significant DRPs made up 56.6% (543) of the DRPs, and 40.6% (389) were identified as having a low capacity for harm. Conclusion The results demonstrate that PDFU of high-risk patients reduces DRPs and prevents MACEs based on physician confirmation. Implementation of MACE methodology provides health-system pharmacy departments the ability to demonstrate pharmacists’ value in transitions of care and assist in expanding pharmacist services.

AUA and NCCN surveillance guidelines for RCC: Do they effectively capture recurrences following nephrectomy?

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 402-402
Author(s):  
Suzanne B. Stewart ◽  
Christine M. Lohse ◽  
Sarah P. Psutka ◽  
John C. Cheville ◽  
Stephen A. Boorjian ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Surgical Treatment ◽  
Partial Nephrectomy ◽  
Radical Nephrectomy ◽  
Clear Cell ◽  
Risk Groups ◽  
Site Specific ◽  
American Urological Association ◽  
Cancer Network

402 Background: The American Urological Association (AUA) and the National Comprehensive Cancer Network (NCCN) are highly utilized sources for surveillance strategies following surgical treatment for renal cell carcinoma (RCC). However, the duration of follow-up may be inadequate to capture the majority of recurrences. Herein, we assess the ability of these guidelines to effectively capture recurrences of RCC following primary surgical resection. Methods: We reviewed our institutional database of 3,725 patients treated with radical or partial nephrectomy for M0 sporadic RCC between 1970-2008. For comparison to the AUA guidelines, patients were stratified into low risk following partial nephrectomy (LRp) or radical nephrectomy (LRr) = pT1N0, and moderate/high risk (M/HR) = pT2-4 N0-1. Guideline effectiveness was assessed by calculating the percentage of recurrences detected within the prescribed follow-up periods given for site-specific recurrence: AUA—LRp: 3yrs for all sites; LRr: 1yr for abdominal and 3yrs for chest/bone/other sites; M/HR: 5yrs for all sites; NCCN—6 months for abdominal/chest sites and 5yrs for bone/other sites. Results: Of the 3,725 patients, 2721 (73.1%) underwent radical nephrectomy, 2,210 (59.3%) were classified as pT1 NX-0 and 2,910 (78.1%) as clear cell RCC. Median postoperative follow-up was 8.9yrs (IQR 5.5-14.2) during which 1,114 (29.9%) patients developed recurrence. Of these recurrences, 760 (68.2%) would have been detected using the AUA guidelines and 432 (38.8%) by NCCN recommendations. Within AUA risk groups, 37.2% recurrences were captured in LRp, 31.4% in LRr and 80.2% in M/HR. Capture of 90% of recurrences in the abdomen and chest would require surveillance for 9yrs and 8 yrs, respectively in LRp, 15yrs and 12yrs in LRr and 11yrs and 10yrs in M/HR. Conclusions: Duration of follow-up recommended by current surveillance algorithms by the AUA and NCCN do not adequately capture many recurrences in RCC following radical or partial nephrectomy. Guidelines using risk stratification and site-specific recurrence parameters to assign length of surveillance may allow providers to better individualize surveillance regimens.

Efficacy of daratumumab + SOC versus SOC in myeloma induction regimens, by risk-stratification: Meta-analysis of phase III randomized control trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20512-e20512
Author(s):  
Nisha Joseph ◽  
Craig C. Hofmeister ◽  
Madhav V. Dhodapkar ◽  
Lawrence Boise ◽  
Sagar Lonial ◽  
...  
Keyword(s):  
High Risk ◽  
Meta Analysis ◽  
Phase 3 ◽  
High Risk Patients ◽  
Hazard Ratios ◽  
Risk Patients ◽  
Q Statistic ◽  
The Impact ◽  
Standard Risk

e20512 Background: Addition of daratumumab, a CD38 monoclonal antibody, to standard of care (SOC) myeloma induction regimens resulted in deeper responses. Phase 3 trials comparing daratumumab + SOC vs SOC consistently favored the daratumumab combinations. The objective of this analysis is to test the hypothesis that high-risk patients benefit from the addition of daratumumab to SOC induction regimens. Methods: We identified four phase 3 clinical trials (RCT) that randomized newly diagnosed myeloma patients to receive daratumumab +SOC vs. SOC. The GRIFFIN trial did not have PFS events and was excluded. A meta-analysis of 3 RCTs with updated data from ASH 2019 (ALCYONE, MAIA, CASSIOPEIA) was performed using the fixed (Mantel-Haenszel) model to calculate the impact of daratumumab + SOC versus SOC. The consistency of results (effect sizes) among studies was investigated by means of two heterogeneity tests, the χ 2-based Cochran's Q test, and the I2 Statistic. We considered that heterogeneity was present when the P value of the Cochran's Q test was < 0.1 and I2 statistic was > 50%. Results: The pooled hazard ratios (HR) for standard risk patients for PFS was HR 0.589 (95% CI 0.502-0.691; P < 0.001) in favor of daratumumab. Q-statistic for PFS ( P= 3.462; df= 2; I2 = 42.23) suggests homogeneity across studies. The pooled hazard ratios (HR) for high risk patients for PFS was HR 0.799 (95% CI 0.609-1.047; P= 0.104) in favor of daratumumab. Q-statistic for PFS ( P= 1.306; df= 2; I2 = 0.00) suggests homogeneity across studies. Conclusions: Our meta-analysis demonstrates that addition of daratumumab to SOC myeloma induction regimens prevented progression in both standard and high-risk patients, though the impact was more pronounced in the standard-risk patients. This benefit seems to improve with longer follow up, as seen both in ALCYONE (Mateos et al ASH 2019) and MAIA trial (Bahlis et al ASH 2019). Focused accrual of high-risk patients in larger daratumumab induction trials and longer follow up of the existing trials are further needed.

Recurrence risk stratification by Dutch clinical risk criteria for early-stage luminal breast cancer patients in Taiwan: A population-based analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12509-e12509
Author(s):  
Lei Lei ◽  
Han-Ching Chan ◽  
Wang Xiao Jia ◽  
Tzu-Pin Lu ◽  
Skye Hung-Chun Cheng
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Early Stage ◽  
Risk Groups ◽  
Low Risk ◽  
Luminal Breast Cancer ◽  
Breast Cancer Patients ◽  
Risk Patients

e12509 Background: Dutch clinical risk criteria (low-risk definition: age > 35 years and (grade 1 with tumor ≤3cm, grade 2 with tumor ≤2cm, or grade 3 with tumor ≤1cm) have been used to stratify the benefit of MammaPrint and Oncotype DX for the decision-making regarding adjuvant chemotherapy for early-stage luminal breast cancer. We propose that the criteria could help to identify low-risk patients who could barely benefit from multi-gene testing. Methods: Breast cancer patients from Taiwan Cancer Database initially treated with primary surgeries between 2008 and 2012 who met the following criteria: (1) pathologic node-negative, (2) hormone receptor-positive, (3) HER2-negative, (4) undergone hormonal therapy, and (5) a minimum follow-up time of 5-year if free from any event, were enrolled in this study. Out of the total 2679 eligible patients, 1074 (40.1%) patients received adjuvant chemotherapy in addition to endocrine therapy. The study endpoints included breast cancer-specific survival (BCSS) and overall survival (OS). Kaplan-Meier statistics estimated the difference between clinical outcomes in low- and high-risk groups. Results: The median follow-up time of BSCC and OS was 5.9 years (range, 0-7 years) and 5.8 years (range, 0-7 years), respectively. There were statistical significances of 5-year BCSS (n = 2679) and 5-year OS (n = 2636) between low-risk and high-risk groups (in both endpoints, P < 0.0001). According to the Dutch criteria, low-risk patients with and without adjuvant chemotherapy had a 5-year BCSS of 99.0% vs. 99.2% and a 5-year OS of 98.4% vs. 97.4%, respectively. High-risk patients with and without adjuvant chemotherapy had a 5-year BCSS of 97.7% vs. 98.1% and a 5-year OS of 96.4% vs. 95.3%, respectively. Conclusions: The benefit of chemotherapy in low-risk patients classified by Dutch criteria might be very small since the breast cancer mortality was less than 1% with a minimum of 5-year follow-up. Dutch criteria cannot identify high-risk patients who would benefit from chemotherapy. We assumed that multi-gene testing in low-risk patients would not be cost-effective.

scholarly journals Two-fraction high-dose-rate brachytherapy within a single day combined with external beam radiotherapy for prostate cancer: single institution experience and outcomes

2016 ◽  
Vol 57 (3) ◽  
pp. 280-287 ◽  
Author(s):  
Junyang Liu ◽  
Motoki Kaidu ◽  
Ryuta Sasamoto ◽  
Fumio Ayukawa ◽  
Nobuko Yamana ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Groups ◽  
High Dose Rate ◽  
High Dose ◽  
Single Institution ◽  
Risk Patients ◽  
Prescription Dose ◽  
Grade 3 ◽  
3D Crt

Abstract We investigated the outcomes of treatment for patients with localized prostate cancer (PCa) treated with 3D conformal radiation therapy (3D-CRT) followed by two-fraction high-dose-rate brachytherapy within a single day (2-fr.-HDR-BT/day) at a single institution. A total of 156 consecutive Asian males (median age, 67 years) were enrolled. To compare our findings with those of other studies, we analyzed our results using the D'Amico classification, assigning the patients to low- ( n = 5; 3.2%), intermediate- ( n = 36; 23.1%) and high-risk ( n = 115; 73.7%) groups (Stage T3 PCa patients were classified as high-risk). One patient in the D'Amico low-risk group (20%), 13 intermediate-risk patients (36.1%) and 99 high-risk patients (86.1%) underwent androgen deprivation therapy. We administered a prescription dose of 39 Gy in 13 fractions of 3D-CRT combined with 18 Gy of HDR-BT in two 9-Gy fractions delivered within a single day. We did not distinguish between risk groups in determining the prescription dose. The median follow-up period was 38 months. Of the 156 patients, one died from primary disease and five died from other diseases. The 3-year overall survival (OS) rates were 100%, 100% and 93.7%, and the 3-year ‘biochemical no evidence of disease (bNED)’ rates were 100%, 100% and 96.9% for the D'Amico low-, intermediate- and high-risk groups, respectively. No patient developed ≥ Grade 3 early toxicity. The Grade 3 late genitourinary toxicity rate was 2.6%, and no ≥ Grade 3 late gastrointestinal toxicity occurred. The efficacy and safety of this study were satisfactory, and longer-term follow-up is necessary.

The impact of C1/D1 treatment follow-up calls on emergency room visits for chemotherapy patients.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 289-289
Author(s):  
Kimberly Davidson
Keyword(s):  
High Risk ◽  
Emergency Room ◽  
Hospital Readmissions ◽  
Care Coordinator ◽  
Risk Patients ◽  
Oncology Care ◽  
New Treatment ◽  
Chemotherapy Patients ◽  
The Impact

289 Background: One of the more challenging aspects of managing patients receiving chemotherapy is to reduce Emergency Room (ER) visits and ultimately hospital readmissions. Patients may not understand who or when to call with issues and may be concerned about reaching their physician or receiving a call back in a reasonable amount of time. Methods: C1/D1 calls were initiated with the Medical Oncology Care Coordinator (CC) staff in August 2017. All patients receiving a C1/D1 dose of a new treatment and change in regimen were called by the CC. During this call, the patient is asked several questions including how they are currently feeling, if they are having any issues as well as reviewing contact information and direction regarding if they have a fever. Re-education was provided to the staff in January 2018 regarding the importance of the calls. Also at this time, the CC were asked to do Nadir calls (repeat call 7-10 days after D1) for those patients who were determined to be high risk (percentage calculated using a toxicity formula). Results: Initially the % of ER visits were reduced after the C1/D1 calls were initiated but then began trending upward again. After re-education and the initiation of the Nadir calls, ER visits again trended down. Conclusions: Increased touch points with patients, including C1/D1 follow up calls, Nadir calls and toxicity checks for high risk patients contributed to a downward trend of treatment patients visiting the ER.[Table: see text]

scholarly journals Preoperative Troponin Levels and Outcomes of Coronary Surgery Following Myocardial Infarction

2021 ◽  
Author(s):  
Nicholas Hess ◽  
Ibrahim Sultan ◽  
Yisi Wang ◽  
Floyd Thoma ◽  
Arman Kilic
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Artery Bypass ◽  
Multivariable Analysis ◽  
Risk Groups ◽  
Continuous Variable ◽  
High Risk Group ◽  
Lengths Of Stay ◽  
Risk Patients ◽  
The Impact

Background: This study evaluates the impact of peak preoperative troponin level on outcomes of coronary artery bypass grafting (CABG) for non-ST-elevation myocardial infarction (NSTEMI). Methods: This was a retrospective review of patients undergoing isolated CABG from 2011-2018 with presentation of NSTEMI. Patients were stratified into low- and high-risk groups based on median preoperative peak troponin (1.95ng/dL). Major cardiac and cerebrovascular events (MACCE) and mortality were compared. Multivariable analysis was performed to model risk factors for MACCE and mortality. Results: This study included 1,211 patients, 607 low- (≤1.95ng/dL) and 604 high-risk (>1.95ng/dL). Patients were well-matched with respect to age and comorbidity. High-risk patients had lower median preoperative ejection fraction (46.5% [IQR 35.0%-55.0%] vs 53.0% [IQR 40.0%-58.0%]) and higher incidence of preoperative intra-aortic balloon pump (15.9% vs 8.73%). Intensive care unit (47 hours [IQR 26-82] vs 43 hours [IQR 25-69]) and hospital lengths of stay (10 days [IQR 8-13] vs 9 days [IQR 8-12]) were longer in the high-risk group (each P<0.05). Postoperative complications and thirty-day, one- and five-year rates of both MACCE and survival were similar between groups. Peak troponin >1.95ng/dL was not associated with increased hazards for MACCE, mortality, or readmission in multivariable modeling. In sub-analyses, neither increasing troponin as a continuous variable nor peak troponin >10.00ng/mL were associated with increased hazards for these outcomes. Conclusions: Higher preoperative troponin levels are associated with longer lengths of stay but not MACCE or mortality following CABG. Dictating timing of CABG for NSTEMI based on peak troponin does not appear to be warranted.

Cohort Analysis of Patients With Localized, High-Risk, Extremity Soft Tissue Sarcoma Treated at Two Cancer Centers: Chemotherapy-Associated Outcomes

2004 ◽  
Vol 22 (22) ◽  
pp. 4567-4574 ◽  
Author(s):  
Janice N. Cormier ◽  
Xuelin Huang ◽  
Yan Xing ◽  
Peter F. Thall ◽  
Xuemei Wang ◽  
...  
Keyword(s):  
High Risk ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Local Therapy ◽  
Distant Recurrence ◽  
Hazard Ratio ◽  
Stage Iii ◽  
Clinical Benefits ◽  
The Impact

Purpose Patients with American Joint Committee on Cancer stage III soft tissue sarcoma (STS) have high risks of distant recurrence and death. The role of chemotherapy for these patients remains controversial despite several randomized trials and a meta-analysis. Methods We reviewed the treatments and outcomes of 674 consecutive adult patients presenting with primary stage III extremity STS between 1984 and 1999. Pre- or postoperative doxorubicin-based chemotherapy was used in a nonrandomized fashion in approximately half of this high-risk population. The objective of this review was to evaluate the impact of chemotherapy while accounting for known prognostic variables. Results Among 674 patients, 338 (50%) were treated with local therapy only, and 336 (50%) were treated with local therapy plus chemotherapy. The median follow-up for survivors was 6.1 years. Five-year local and distant recurrence-free interval probabilities were 83% and 56%, respectively, for the two groups combined. The 5-year disease-specific survival (DSS) rate was 61%. Cox regression analyses showed a time-varying effect associated with chemotherapy. During the first year, the hazard ratio associated with DSS for patients treated with chemotherapy versus no chemotherapy was 0.37 (95% CI, 0.20 to 0.69; P = .002). Thereafter, this hazard ratio was 1.36 (95% CI, 1.02 to 1.81; P = .04). Conclusion It seems that the clinical benefits associated with doxorubicin-based chemotherapy in patients with high-risk extremity STS are not sustained beyond 1 year. These results suggest that caution should be used in the interpretation of randomized clinical trials of adjuvant chemotherapy that seem to demonstrate clinical benefits with relatively short-term follow-up.

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