Initial versus recent outcomes with a non–risk adapted surveillance policy in stage I non-seminomatous germ cell tumors (NSGCT)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5021-5021 ◽  
Author(s):  
I. Duran ◽  
J. F. Sturgeon ◽  
M. A. Jewett ◽  
L. Anson-Cartwright ◽  
D. R. Berthold ◽  
...  
Keyword(s):  
High Risk ◽  
Relapse Rate ◽  
Germ Cell Tumors ◽  
Low Risk ◽  
Stage I ◽  
Testis Cancer ◽  
Stage Migration ◽  
Time To Relapse ◽  
Disease Specific ◽  
Over Time

5021 Background: Since 1981 the Princess Margaret Hospital testicular cancer group has used surveillance as the preferred management option for all patients (pts) with clinical stage I NSGCT. In a report of the first 105 pts [Sturgeon et al. J Clin Oncol, 1992] the relapse rate was 35% and the disease specific 5-year survival 99%. Improvements in imaging technique over time could cause stage migration with an overall lower relapse rate in this patient population. We compare our experience with surveillance over different time points. Methods: Three-hundred and five pts with stage I NS-GCT were placed on an active surveillance protocol between 1981–2004. They were not stratified by risk and only received treatment on the event of a relapse. Recurrence rates, time to relapse, risk factors predictive for recurrence, disease specific and overall survival were determined. For the analysis by time period, pts were divided in two groups based on diagnosis date. (Initial=1981–1992 [N=141] and Recent=1993–2004 [N=164]). Results: With a median follow-up of 6.3 years, 77/305 pts (25%) relapsed; 46/141 pts (32.6%) in the initial group and 31/164 (18.9%) in the recent. All but 3 (4%) relapses occurred within 2 years after orchiectomy with a median time to relapse of 7 months. A multivariate analysis established lympho-vascular invasion (p<0.01) and pure embryonal carcinoma (p= 0.03) as independent predictors of recurrence. Overall 104/305 (34.1%) pts were designated as ‘high- risk’ based on the presence of at least one of these factors. In the initial group 60/141 (42.6%) pts were high risk and 32/60 (53%) relapsed versus 14/81 (17.3%) low-risk (p=0.047). In the recent group 44/164 (26.8%) pts were high-risk and 17/44 (38.6%) recurred, versus 14/120 (11.7%) low-risk (p<0.001). There were 2 (0.7%) deaths due to testis cancer. The estimated 5-year disease specific survival was 98.9% in the initial group and 100% in the recent one. Conclusions: Surveillance is an effective strategy for the management of all stage I NSGCT. A risk-adapted policy would result in more than 50% of the patients being unnecessarily treated. The relapse rate has reduced over time, likely due to improvements in imaging causing stage migration. No significant financial relationships to disclose.

scholarly journals Chemotherapy burden of risk-adapted treatment verse surveillance for clinical stage I pediatric testicular cancer: A decision tree model analysis

2020 ◽  
Author(s):  
yunlin ye ◽  
Zhuang-fei Chen ◽  
Jun Bian ◽  
Hai-tao Liang ◽  
Zi-ke Qin
Keyword(s):  
High Risk ◽  
Testicular Cancer ◽  
Decision Analysis ◽  
Relapse Rate ◽  
Risk Group ◽  
Clinical Stage ◽  
Low Risk ◽  
Stage I ◽  
Decision Analysis Model ◽  
Risk Patients

Abstract Background Different from adult clinical stage I (CS1) testicular cancer, surveillance was recommended for CS1 pediatric testicular cancer. For high-risk children, greater than 50% of them suffered relapse and progress during surveillance and adjuvant chemotherapy was administrated. Risk-adapted treatment might reduce chemotherapy burden for those children.Methods Using decision analysis model, we collected clinical utilities from literature and survey and compared chemotherapy exposure between risk-adapted treatment and surveillance.Results In base case decision analysis of CS1 pediatric testicular cancer, risk-adapted treatment preferred lower exposure of chemotherapy than surveillance (average: 0.7965 cycle verse 1.3419 cycles). The sensitivity analysis demonstrated that when relapse rate after primary chemotherapy ≤ 0.10 and the relapse rate of high-risk group ≥ 0.40, risk-adapted treatment would expose lower chemotherapy, without association of the proportion of low-risk patients, the relapse rate of low-risk group, relapse rate after salvage chemotherapy and toxicity utility of second-line chemotherapy compared to salvage chemotherapy.Conclusions Risk-adapted treatment might decrease chemotherapy-related toxicity for these high-risk patients and further clinical study was needed.

scholarly journals Chemotherapy burden of risk-adapted treatment verse surveillance for clinical stage I pediatric testicular cancer: A decision tree model analysis

2019 ◽  
Author(s):  
Yunlin Ye ◽  
Hong-chao Li ◽  
Ji Zhang ◽  
Hai-tao Liang ◽  
Zike Qin ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
High Risk ◽  
Testicular Cancer ◽  
Decision Analysis ◽  
Relapse Rate ◽  
Risk Group ◽  
Clinical Stage ◽  
Low Risk ◽  
Stage I ◽  
Risk Patients

Abstract Background Different from adult clinical stage I (CS1) testicular cancer, surveillance was recommended for CS1 pediatric testicular cancer. This study was to compare chemotherapy exposure between risk-adapted treatment and surveillance in CS1 pediatric testicular cancer.Methods We collected clinical utilities from literature and survey. Using decision analysis model, we compared chemotherapy exposure between risk-adapted treatment and surveillance and sensitivity analysis was performed.Results In base case decision analysis of CS1 pediatric testicular cancer, risk-adapted treatment preferred lower exposure of chemotherapy than surveillance (average: 0.7965 cycle verse 1.3419 cycles). The sensitivity analysis demonstrated that when relapse rate after primary chemotherapy ≤0.10 and the relapse rate of high-risk group ≥0.40, risk-adapted treatment would expose lower chemotherapy, without association of the proportion of low-risk patients, the relapse rate of low-risk group, relapse rate after salvage chemotherapy and toxicity utility of second-line chemotherapy compared to salvage chemotherapy.Conclusion Decision analysis demonstrated that risk-adapted treatment was associated with lower exposure of chemotherapy for patients with CS1 pediatric testicular cancer. This might decrease chemotherapy-related toxicity for these high-risk patients and further clinical study was needed.

scholarly journals A highly expressed mRNA signature for predicting survival in patients with stage I/II non-small-cell lung cancer after operation

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Nan Ma ◽  
Lu Si ◽  
Meiling Yang ◽  
Meihua Li ◽  
Zhiyi He
Keyword(s):  
High Risk ◽  
Roc Curve ◽  
Expression Profiles ◽  
Low Risk ◽  
Stage I ◽  
Risk Scores ◽  
Training Set ◽  
Cox Regression Analysis ◽  
Nsclc Patients ◽  
Rna Signature

AbstractThere is an urgent need to identify novel biomarkers that predict the prognosis of patients with NSCLC. In this study,we aim to find out mRNA signature closely related to the prognosis of NSCLC by new algorithm of bioinformatics. Identification of highly expressed mRNA in stage I/II patients with NSCLC was performed with the “Limma” package of R software. Survival analysis of patients with different mRNA expression levels was subsequently calculated by Cox regression analysis, and a multi-RNA signature was obtained by using the training set. Kaplan–Meier estimator, log-rank test and receiver operating characteristic (ROC) curves were used to analyse the predictive ability of the multi-RNA signature. RT-PCR used to verify the expression of the multi-RNA signature, and Westernblot used to verify the expression of proteins related to the multi-RNA signature. We identified fifteen survival-related mRNAs in the training set and classified the patients as high risk or low risk. NSCLC patients with low risk scores had longer disease-free survival than patients with high risk scores. The fifteen-mRNA signature was an independent prognostic factor, as shown by the ROC curve. ROC curve also showed that the combined model of the fifteen-mRNA signature and tumour stage had higher precision than stage alone. The expression of fifteen mRNAs and related proteins were higher in stage II NSCLC than in stage I NSCLC. Multi-gene expression profiles provide a moderate prognostic tool for NSCLC patients with stage I/II disease.

Short-course adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis: a Medical Research Council report.

1996 ◽  
Vol 14 (4) ◽  
pp. 1106-1113 ◽  
Author(s):  
M H Cullen ◽  
S P Stenning ◽  
M C Parkinson ◽  
S D Fossa ◽  
S B Kaye ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Germ Cell ◽  
Medical Research ◽  
Research Council ◽  
Medical Research Council ◽  
Germ Cell Tumors ◽  
Stage I ◽  
Nonseminomatous Germ Cell Tumors

PURPOSE This United Kingdom Medical Research Council (UK-MRC) study prospectively evaluated efficacy and long-term toxicity of adjuvant chemotherapy in high-risk stage I nonseminomatous germ cell tumors of the testis (NSGCTT). PATIENTS AND METHODS Eligible patients were those identified by the local histopathologist as having features confirmed in MRC surveillance studies to indicate an approximate 50% risk of relapse. Central histopathology review was undertaken. Chemotherapy consisted of two courses of cisplatin 100 mg/m2, bleomycin 30 mg weekly x 3, and etoposide 120 mg/m2 x 3, every 21 days (BEP). RESULTS One hundred fourteen eligible cases were enrolled. Median time of follow-up was 4 years, with 93 patients followed-up for at least 2 years. There have been two relapses, including one patient who did not have a germ cell tumor (GCT), according to the reference histopathologist. This patient is alive with active disease, the other has died. There was one death after a cerebrovascular accident during treatment. Assessment of fertility, lung function, and audiometry pretreatment and more than 9 months posttreatment indicated no clinically significant changes. A mean decrease in transfer factor coefficient (KCO) of 15% of the predicted value was noted, but no patient had symptomatic respiratory dysfunction. CONCLUSION There have been only two relapses among 114 cases of high-risk stage I NSGCTT treated with two courses of adjuvant BEP chemotherapy. The 95% confidence interval (CI) excludes a true relapse rate of more than 5%. Of 104 patients confirmed on histopathology review to have GCT, there has been only one relapse. Adjuvant chemotherapy is free from significant long-term toxicity, offering an effective alternative to surveillance or retroperitoneal lymph node dissection (RPLND) followed by surveillance, and may be preferred by some patients.

Do Unexpected and Cryptic FISH Lesions Of Chromosomally Normal MDS Patients Have Any Prognostic Relevance?

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1549-1549
Author(s):  
Paolo Bernasconi ◽  
Irene Dambruoso ◽  
Marina Boni ◽  
Paola Maria Cavigliano ◽  
Ilaria Giardini ◽  
...  
Keyword(s):  
High Risk ◽  
Disease Progression ◽  
Low Risk ◽  
Disease Stage ◽  
Intermediate Risk ◽  
Disease Evolution ◽  
Prognostic Relevance ◽  
Increased Risk ◽  
Very High ◽  
Disease Specific

Abstract Conventional cytogenetic (CC) still remains a mandatory step in the routine diagnostic work-up of every MDS patient (pt), is one of the major determinant of disease outcome and guides potential treatment decisions. However, CC is not informative in about 50% of chromosomally normal (CN) pts and provides limited information in those with very rare defects even if the revised IPSS cytogenetic categories have tried to overcome this drawback. More sensitive techniques (aCGH, SNP-a and NGS), still used in the research setting only, suggest that CN pts may instead contain novel unexpected chromosomal lesions which prognosis is still undefined. Thus, the principal goal of our study was to establish whether FISH with disease specific probes (i.e. for chromosomal regions most commonly affected in MDS) along with non-disease specific probes (i.e. for regions which alteration in MDS has been demonstrated by aCGH only) may effectively unmask clonal cryptic defects. Other aims were to establish the nature of these defects, to identify the potentially targeted genes and to estimate their possible prognostic relevance. The one-hundred twenty-seven consecutive CN MDS pts of the present study came to our observation in the period January 2003-December 2012. They were forty-nine females and seventy-eight males, median age 66 years (range 24-88). Twenty-one pts were diagnosed as RARS, 29 as RA, one as CRMDS, one as U-MDS, 25 as RCMD, 26 as RAEB-1 and 24 as RAEB-2. On CC 122 pts presented a normal karyotype and five no mitotic figures. Considering the revised IPSS score, 62 pts were considered very low-risk, 32 low-risk, 23 intermediate risk, 8 high-risk and 2 very high-risk. Median follow-up was 22 months (range 1-90). At the time of the study nine pts have died. FISH probes were chosen based on the frequency of their involvement in MDS and their Mb position determined using UCSC genome browser on Human Mar. 2003 assembly. They were obtained from BACPAC Resources Center at C.H.O.R.I. (Oakland, USA), labelled and applied as previously described. These probes were: RP11-912D8 (19q13.2); RP11-196P12 (17q11.2); RP11-269C4 (14q12); RP11-351O1 (10q21.3); RP11-144G6 (10q11.2); RP11-122A11 (7q34); RP11-951K18 (5q13.1); RP11-101K5 (4p14); RP11-544H14 (2q33). i-FISH cut-off values were fixed at 10%. Thirty-one pts (24.4%) presented at least a single defect, always represented by deletions or gains of chromosomal material. Among them 8 pts (25.8%) presented at least two defects. Bands most commonly targeted by deletions/amplifications were 19q13.2 (61.3%), 14q12 (32.2%), 17q11.2 (16.1%), 5q13.1 (12.9%), 7q34 (12.9%), 4p14 (9.6%). Deletions of bands 10q11.2, 10q21.3 and 2p33 were more rare. As the RMD-1 gene, involved in DNA double strand breaks and homologous recombination, maps at band 19q13.2, the most commonly deleted chromosomal area, additional molecular tests are being developed to analyse this gene. An abnormal FISH pattern was observed in 2/21 (9.5%) RARS, in 7/29 (24.1%) RA, in 5/25 (20.0%) RCMD, in 8/26 (30.6%) RAEB-1 and in 9/24 (37.5%) RAEB-2. Considering IPSS, an abnormal FISH pattern was revealed in 7/62 (11.3%) very low-risk, in 8/32 (25%) low-risk, in 10/23 (43.4%) intermediate risk, in 5/8 (62.5%) high-risk and in 1/2 very high-risk patients. Disease evolution occurred in a total of 34 pts (3 RARS, 7 RA, 5 CRMD, 11 RAEB-1 and 8 RAEB-2), 16 (one RARS, 3 RA, 2 CRMD, 6 RAEB-1 and 4 RAEB-2) with an abnormal FISH pattern. All the 8 patients with at least two chromosomal deletions experienced disease progression. In conclusion, i) FISH reveals novel unexpected karyotype defects, most commonly deletions pinpointing genes involved in DNA repair, in about 24.4% of CN MDS; ii) band 19q13.2 deletion is the most common defect, frequently associated with disease evolution; ii) an abnormal FISH pattern is correlated with an advanced disease stage and an intermediate/high revised IPSS score; iii) >two lesions are associated with an increased risk of disease progression. Disclosures: No relevant conflicts of interest to declare.

A prospective study of 18FDG PET in the prediction of relapse in patients with high risk clinical stage I (CS1) non-seminomatous germ cell cancer (NSGCT): MRC study TE22

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4520-4520 ◽  
Author(s):  
R. Huddart ◽  
M. O’Doherty ◽  
A. Padhani ◽  
G. Rustin ◽  
G. Mead ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Relapse Rate ◽  
Fdg Pet ◽  
Cell Cancer ◽  
Pet Scan ◽  
Stage I ◽  
Pet Scanning ◽  
Study Results ◽  
Free Rate

4520 Background: High risk stage I NSGCT is characterised by vascular or lymphatic invasion within the primary tumour. This group comprises ∼50% of stage I pts with, (untreated) a relapse rate of 35–40%. Options for the management of such pts include adjuvant chemotherapy, retroperitoneal lymph node dissection (± adjuvant chemotherapy) and surveillance, each achieving similarly high cure rates. An FDG PET scan may be able to aid discrimination between pts without occult metastatic disease, for whom surveillance is an attractive option, and those requiring immediate therapy. Methods: High risk (vascular invasion +ve) CS1 NSGCT pts underwent FDG PET scanning within ∼8 weeks of orchidectomy. PET+ve pts went off study, PET -ve pts were followed on surveillance. The primary outcome measure was the -ve predictive value of PET, defined as the 2-year relapse-free rate (RFR) in pts with a negative PET scan. Assuming a RFR of ∼90%, to exclude a RFR < 80% with 80% power (5% significance), ∼100 PET negative pts were required from ∼135 scanned pts. All baseline CT scans were subject to central review blinded to PET result and relapse status and, in relapsed pts, a retrospective comparison of the CT and PET scan results. Results: Pts were registered between 5/02 and 1/05, when the trial was stopped early by the independent Data Monitoring Committee due to an unacceptably high relapse rate in the PET-ve pts. 116 pts were registered of whom 111 underwent PET scans. 88 pts (79%) were PET-ve; 87 proceeded to surveillance and one requested adjuvant chemotherapy. With median follow-up of 11 months, 33 of the 87 pts on surveillance relapsed for a one-year relapse-free rate of 63% 90% CI (54%, 72%). The PET +ve/relapse rate was 69% in patients with normal markers pre-orchidectomy (n = 36) and 41% in those with raised markers (n = 66). There has been one death (suicide) amongst the PET -ve pts. The radiology and PET scan review will be completed by May 2006. Conclusions: Though PET identified a proportion of pts with disease not detected by CT scan the relapse rate amongst PET -ve pts remains high. The study results therefore suggest that 18FDG PET scanning is not able to identify pts at sufficiently low risk of relapse to replace other treatment options in this setting. No significant financial relationships to disclose.

scholarly journals MIB-1 immunohistochemistry in clinical Stage I nonseminomatous testicular germ cell tumors predicts patients at low risk for metastasis

Cancer ◽  
1997 ◽  
Vol 79 (9) ◽  
pp. 1710-1716 ◽  
Author(s):  
Peter Albers ◽  
Erhard Bierhoff ◽  
Daniela Neu ◽  
Rolf Fimmers ◽  
Nicolas Wernert ◽  
...  
Keyword(s):  
Germ Cell ◽  
Clinical Stage ◽  
Germ Cell Tumors ◽  
Low Risk ◽  
Stage I ◽  
Testicular Germ Cell Tumors ◽  
Testicular Germ Cell ◽  
Mib 1
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