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 Management of stage I and II nonsmall cell lung cancer

2016 ◽  
Vol 49 (1) ◽  
pp. 1600764 ◽  
Author(s):  
Fiona McDonald ◽  
Michèle De Waele ◽  
Lizza E. L. Hendriks ◽  
Corinne Faivre-Finn ◽  
Anne-Marie C. Dingemans ◽  
...  
Keyword(s):  
Lung Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cell Lung Cancer ◽  
Targeted Therapies ◽  
Nonsmall Cell Lung Cancer ◽  
Stage I ◽  
Ageing Population ◽  
Randomised Trials ◽  
Long Term Outcome

The incidence of stage I and II nonsmall cell lung cancer is likely to increase with the ageing population and introduction of screening for high-risk individuals. Optimal management requires multidisciplinary collaboration. Local treatments include surgery and radiotherapy and these are currently combined with (neo)adjuvant chemotherapy in specific cases to improve long-term outcome. Targeted therapies and immunotherapy may also become important therapeutic modalities in this patient group. For resectable disease in patients with low cardiopulmonary risk, complete surgical resection with lobectomy remains the gold standard. Minimally invasive techniques, conservative and sublobar resections are suitable for a subset of patients. Data are emerging that radiotherapy, especially stereotactic body radiation therapy, is a valid alternative in compromised patients who are high-risk candidates for surgery. Whether this is also true for good surgical candidates remains to be evaluated in randomised trials. In specific subgroups adjuvant chemotherapy has been shown to prolong survival; however, patient selection remains important. Neoadjuvant chemotherapy may yield similar results as adjuvant chemotherapy. The role of targeted therapies and immunotherapy in early stage nonsmall cell lung cancer has not yet been determined and results of randomised trials are awaited.

ENGOT-en11/GOG-3053/KEYNOTE-B21: Phase 3 study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with newly diagnosed high-risk endometrial cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5608-TPS5608
Author(s):  
Toon Van Gorp ◽  
Mansoor Raza Mirza ◽  
Alain Lortholary ◽  
David Cibula ◽  
Axel Walther ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Combination Therapy ◽  
Stage I ◽  
Newly Diagnosed ◽  
Phase 3 ◽  
Eortc Qlq

TPS5608 Background: Pembrolizumab, a selective humanized anti–PD-1 monoclonal antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% ORR as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer (EC). ENGOT-en11/GOG-3053/KEYNOTE-B21 is a phase 3, randomized, double-blind study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with EC. Methods: Eligible patients are ≥18 years old with newly diagnosed, histologically confirmed high-risk (stage I/II non-endometrioid, stage III/IVa, p53 abnormality) EC (carcinoma or carcinosarcoma) following surgery with curative intent with no evidence of disease post-operatively or on imaging, and without prior systemic therapy/radiotherapy. In total, ̃990 patients are randomized to receive pembrolizumab 200 mg or placebo Q3W for 6 cycles + chemotherapy (carboplatin area under the curve [AUC] 5 or 6 + paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2 or 2.7 + paclitaxel 60 mg/m2 QW) in stage 1. Patients receive pembrolizumab 400 mg or placebo Q6W for 6 cycles in stage 2 per their treatment assignment. At the investigator’s discretion, radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m2 (days 1 and 29) may be administered after completion of chemotherapy. Randomization is stratified by MMR status (pMMR vs dMMR) and, within pMMR, by planned radiation therapy (cisplatin-EBRT vs EBRT vs no EBRT), histology (endometrioid vs non-endometrioid), and International Federation of Gynecology and Obstetrics (FIGO) surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and overall survival (OS), both estimated by the Kaplan-Meier method, with a stratified log-rank test to assess treatment differences and a Cox proportional hazard model with Efron’s method of tie handling to assess the magnitude of treatment differences. Secondary endpoints include DFS (per blinded independent central review), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety (per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0) and quality of life (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and Endometrial Cancer Module [EORTC QLQ-EN24]). The study began enrollment in December 2020. Clinical trial information: NCT04634877.

scholarly journals Clinical Outcome of Patients With High-Risk Endometrial Carcinoma After Treatment With Chemotherapy Only

2018 ◽  
Vol 28 (9) ◽  
pp. 1789-1795 ◽  
Author(s):  
Elisabeth Smogeli ◽  
Milada Cvancarova ◽  
Yun Wang ◽  
Ben Davidson ◽  
Gunnar Kristensen ◽  
...  
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Recurrence Rate ◽  
Total Population ◽  
Standard Treatment ◽  
International Federation ◽  
Stage I ◽  
Stage Ii ◽  
Stage Iiic ◽  
Gynecology And Obstetrics

ObjectivesAdjuvant treatment of high-risk endometrial cancer (EC) is still controversial. Several studies have tried to clarify the best treatment strategy, and guidelines have been made, but no study to date has shown a survival benefit for radiation over chemotherapy. We aimed to evaluate the outcome of high-risk EC patients treated with adjuvant chemotherapy only in a population where the routine administration of adjuvant radiotherapy was omitted.MethodsThis is a retrospective study including 230 EC patients with International Federation of Gynecology and Obstetrics stage I type II, stage Ib type I/G3, stage II, and IIIc treated at Oslo University Hospital between 2005 and 2012. Standard treatment was hysterectomy, bilateral salpingo-oophorectomy and at least pelvic lymphadenectomy followed by adjuvant chemotherapy.ResultsOf the 230 high-risk patients, standard treatment was given to 146 patients (63.5%): 60 patients in stage I, 10 patients in stage II, and 76 patients in stage IIIc. Only 10% of patients with stage I disease relapsed, with 3.3% locoregional relapses and 6.7% distant relapses. Recurrence rate in stage IIIc was 39.5%, with 7.9% isolated vaginal and 31.6% distant relapses. The 3-year disease-free survival was 92% for stage I, 80% for stage II, and 60% for stage IIIc disease. In the total population, 55 patients had International Federation of Gynecology and Obstetrics stage Ia, 43 Ib, 42 stage II, and 90 stage IIIc disease. Recurrence rate in the total population was 29.6%, with 9.6% isolated vaginal recurrences, 1.7% recurrences located in the pelvis, and 18.3% distant recurrences.ConclusionsPatients with high-risk EC have acceptable vaginal/pelvic control rates after adjuvant chemotherapy. However, prognosis remains poor for patients with stage IIIc disease, also after chemotherapy.

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.

Risk-Adapted Treatment in Clinical Stage I Testicular Seminoma: The Third Spanish Germ Cell Cancer Group Study

2011 ◽  
Vol 29 (35) ◽  
pp. 4677-4681 ◽  
Author(s):  
Jorge Aparicio ◽  
Pablo Maroto ◽  
Xavier García del Muro ◽  
Josep Gumà ◽  
Alfonso Sánchez-Muñoz ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adjuvant Chemotherapy ◽  
Clinical Stage ◽  
Cell Cancer ◽  
Stage I ◽  
Adequate Treatment ◽  
Local Risk ◽  
Stage I Seminoma ◽  
Disease Free

Purpose To confirm the efficacy of a risk-adapted treatment approach for patients with clinical stage I seminoma. The aim was to reduce both the risk of relapse and the proportion of patients receiving adjuvant chemotherapy while maintaining a high cure rate. Patients and Methods From 2004 to 2008, 227 patients were included after orchiectomy in a multicenter study. Eighty-four patients (37%) presented no local risk factors, 44 patients (19%) had tumors larger than 4 cm, 25 patients (11%) had rete testis involvement, and 74 patients (33%) had both criteria. Only the latter group received two courses of adjuvant carboplatin, whereas the rest were managed by surveillance. Results After a median follow-up time of 34 months, 16 relapses (7%) have been documented (15 [9.8%] among patients on surveillance and one [1.4%] among those treated with carboplatin). All relapses occurred in retroperitoneal lymph nodes, except for one case in pelvic nodes. Median node size was 25 mm, and median time to recurrence was 14 months. All patients were rendered disease-free with chemotherapy. The actuarial 3-year disease-free survival rate was 88.1% (95% CI, 82.3% to 93.9%) for patients on surveillance and 98.0% (95% CI, 94.0% to 100%) for those treated with adjuvant chemotherapy. Overall 3-year survival was 100%. Conclusion With the limitations of the short follow-up duration, we confirm that a risk-adapted approach is effective for stage I seminoma. Adjuvant carboplatin seems adequate treatment for patients with 2 risk criteria, as is active surveillance for those with 0 to one risk factors. More reliable predictive factors are needed to improve the applicability of this model.

Adjuvant chemotherapy for pathological stage I non-small cell lung cancer with high-risk factors for recurrence: A multicenter study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8500-8500 ◽  
Author(s):  
Yasuhiro Tsutani ◽  
Kentaro Imai ◽  
Hiroyuki Ito ◽  
Takahiro Mimae ◽  
Yoshihiro Miyata ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Stage I ◽  
Pathological Stage ◽  
Component Size ◽  
High Risk Factors ◽  
Invasive Component ◽  
Risk Factors For Recurrence ◽  
Lymphatic Permeation

8500 Background: The role of adjuvant chemotherapy for pathological stage I non-small cell lung cancer (NSCLC) is controversial. The purpose of this study was to investigate the effect of adjuvant chemotherapy for pathological stage I NSCLC with high-risk factors for recurrence. Methods: Prospectively collected data from 1,278 patients with pathological stage I (8th edition) NSCLC undergoing lobectomy were retrospectively analyzed. High-risk factors for recurrence were determined by multivariable Cox proportional hazards model for recurrence-free survival (RFS). RFS, overall survival (OS), and cancer-specific survival (CSS) were compared between patients who received adjuvant chemotherapy and those who did not. Results: In multivariable analysis, age (≥70 y; hazard ratio [HR], 2.14), invasive component size ( > 2 cm; HR, 1.60), visceral pleural invasion (HR, 1.81), lymphatic permeation (HR, 1.67), and vascular invasion (HR, 2.78) were identified as independent factors for RFS. In patients with high-risk factors for recurrence such as invasive component size of > 2 cm, visceral pleural invasion, lymphatic permeation, or vascular invasion (high-risk group; n = 641), RFS was significantly different between patients who received adjuvant chemotherapy (n = 222; 5-y RFS, 81.4%) and those who did not (n = 418; 5-y RFS, 73.8%; P = 0.023). OS and CSS were also significantly better in patients who received adjuvant chemotherapy (5-y OS, 92.7%; 5-y CSS, 95.0%) than in those who did not (5-y OS, 81.7%; P < 0.0001; 5-y CSS, 89.5%; P = 0.012). In patients without any high-risk factors for recurrence (low-risk group; n = 637), RFS was not significantly different between patients who received adjuvant chemotherapy (n = 83; 5-y RFS, 98.1%) and those who did not (n = 554; 5-y RFS, 95.7%; P = 0.30). OS and CSS were also not significantly different between patients who received adjuvant chemotherapy (5-y OS, 98.0%; 5-y CSS, 100%) and those who did not (5-y OS, 95.6%; P = 0.35; 5-y CSS, 99.4%; P = 0.52). Conclusions: Adjuvant chemotherapy may improve survival in patients with pathological stage I NSCLC who have high-risk factors for recurrence such as invasive component size of > 2 cm, visceral pleural invasion, lymphatic permeation, or vascular invasion.

scholarly journals Development of a Gene-Based Prediction Model for Recurrence of Colorectal Cancer Using an Ensemble Learning Algorithm

2021 ◽  
Vol 11 ◽  
Author(s):  
Han-Ching Chan ◽  
Amrita Chattopadhyay ◽  
Eric Y. Chuang ◽  
Tzu-Pin Lu
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Prediction Models ◽  
Stage I ◽  
Training Data ◽  
Differentially Expressed ◽  
Support Vector ◽  
Data Set ◽  
Risk Of Recurrence

It is difficult to determine which patients with stage I and II colorectal cancer are at high risk of recurrence, qualifying them to undergo adjuvant chemotherapy. In this study, we aimed to determine a gene signature using gene expression data that could successfully identify high risk of recurrence among stage I and II colorectal cancer patients. First, a synthetic minority oversampling technique was used to address the problem of imbalanced data due to rare recurrence events. We then applied a sequential workflow of three methods (significance analysis of microarrays, logistic regression, and recursive feature elimination) to identify genes differentially expressed between patients with and without recurrence. To stabilize the prediction algorithm, we repeated the above processes on 10 subsets by bagging the training data set and then used support vector machine methods to construct the prediction models. The final predictions were determined by majority voting. The 10 models, using 51 differentially expressed genes, successfully predicted a high risk of recurrence within 3 years in the training data set, with a sensitivity of 91.18%. For the validation data sets, the sensitivity of the prediction with samples from two other countries was 80.00% and 91.67%. These prediction models can potentially function as a tool to decide if adjuvant chemotherapy should be administered after surgery for patients with stage I and II colorectal cancer.

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