Effect of Oncotype DX colon cancer test results on treatment recommendations in patients with stage II colon cancer: Preliminary results.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 398-398
Author(s):  
Thomas H. Cartwright ◽  
Calvin Chao ◽  
Margarita Lopatin ◽  
Tanya GK Bentley ◽  
Michael Samuel Broder ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Adjuvant Treatment ◽  
Recurrence Score ◽  
Treatment Recommendations ◽  
Oncotype Dx ◽  
Stage Ii ◽  
Medical Oncologists ◽  
Stage Ii Colon Cancer ◽  
The Impact

398 Background: The Oncotype DX Colon Cancer Recurrence Score (RS) has been clinically validated as an independent predictor of individual recurrence risk in stage II colon cancer patients following surgery. As a result, physicians have been ordering the Oncotype DX assay for stage II colon cancer patients since January 2010, yet no data exist on the assay’s impact on adjuvant treatment planning in practice. We performed a survey to characterize the impact of the assay on adjuvant treatment recommendations in stage II colon cancer. Methods: U.S. medical oncologists (N=277) who ordered Oncotype DX for ≥3 patients with stage II colon cancer were contacted and asked to complete a web-based survey regarding the single most recent stage II colon cancer patient for whom the assay was ordered. The survey was developed through cognitive interviews with four medical oncologists, and the protocol was institutional review board approved. Results: As a planned preliminary analysis, we analyzed surveys from 92 eligible physicians. Physicians were more often in community (85%) than academic or other practices, and had a median of 14.5 years (range, 2-40) of practice experience. The median patient age was 62 years (range, 34–81). 84% of patients had T3 disease. Patients had ≤8, 9-11 and ≥12 nodes examined 2%, 14% and 84% of the time and 36% had comorbidities. Of the 60 patients tested for MMR/MSI, 9 (15%) were MMR-D or MSI-high and 37 (62%) were MMR-P or MSI-low; 14 (23%) unknown. Median RS was 20 (range, 1-77). Before obtaining the RS, chemotherapy was planned in 38 (41%) patients, observation in 35 (38%), and there was no recommendation in 19 (21%). For the 73 patients with pre-assay recommendations, recommended treatment changed after obtaining the RS for 23 patients (32%), including changes from chemotherapy to observation and vice-versa. Conclusions: These preliminary findings indicate that for stage II colon cancer patients, treatment recommendations were changed by RS results approximately one-third of the time. Final results will be reported to include accrual through December 2011.

Effect of the 12-gene colon cancer assay results on treatment recommendations in patients with stage II colon cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3626-3626
Author(s):  
Thomas H. Cartwright ◽  
Calvin Chao ◽  
Margarita Lopatin ◽  
Tanya G. Bentley ◽  
Michael S. Broder ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Adjuvant Treatment ◽  
Treatment Recommendations ◽  
Oncotype Dx ◽  
Stage Ii ◽  
Treatment Intensity ◽  
Medical Oncologists ◽  
Stage Ii Colon Cancer ◽  
The Impact

3626 Background: The Oncotype DX Colon Cancer Recurrence Score (RS) has been clinically validated as an independent predictor of individual recurrence risk in stage II colon cancer patients following surgery. As a result, physicians have been ordering the Oncotype DX assay for stage II colon cancer patients since January 2010, yet no data exist on the assay’s impact on adjuvant treatment planning in clinical practice. We performed a survey to characterize the impact of the assay on adjuvant treatment recommendations in stage II colon cancer. Methods: U.S. medical oncologists (n=346) who ordered Oncotype DX for ≥3 patients with stage II colon cancer were contacted and asked to complete a web-based survey regarding the single most recent stage II colon cancer patient for whom the assay was ordered. The survey was developed through cognitive interviews with four medical oncologists, and the protocol was institutional review board approved. Results: We analyzed survey results from 116 eligible physicians. Physicians were more often in community (86%) than academic or other practices, and had a median of 14.5 years (range, 2-40) of practice experience. The median patient age was 62 years (range, 32–85). Most patients (81%) had T3 disease. Patients had ≤8, 9-11 and ≥12 nodes examined 3%, 13% and 84% of the time and 38% had comorbidities. Of the 76 patients tested for MMR/MSI, 13 (17%) were MMR-D or MSI-H and 46 (61%) were MMR-P or MSI-L; 17 (22%) unknown. Median RS was 20 (range, 1-77). Before obtaining the RS, chemotherapy was planned in 52 (45%) patients, observation in 40 (34%), and there was no recommendation in 24 (21%). For the 92 patients with pre-assay recommendations, recommended treatment changed after obtaining the RS for 27 patients (29%). Treatment intensity decreased for 18 (67%) and increased for 9 (33%) of 27 changed recommendations. A significant trend of decreasing treatment intensity with lower RS values was observed (p=.0035). Conclusions: These findings indicate that for stage II colon cancer patients, treatment recommendations were changed by RS results in 29% of patients. Use of the Oncotype DX assay may lead to reductions in treatment intensity, contributing to the assay’s cost effectiveness.

scholarly journals Prospective Multicenter Study of the Impact of Oncotype DX Colon Cancer Assay Results on Treatment Recommendations in Stage II Colon Cancer Patients

2014 ◽  
Vol 19 (5) ◽  
pp. 492-497 ◽  
Author(s):  
Geetika Srivastava ◽  
Lindsay A. Renfro ◽  
Robert J. Behrens ◽  
Margarita Lopatin ◽  
Calvin Chao ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Multicenter Study ◽  
Treatment Recommendations ◽  
Oncotype Dx ◽  
Stage Ii ◽  
Prospective Multicenter Study ◽  
Stage Ii Colon Cancer ◽  
The Impact

Mismatch repair status predicts survival after adjuvant treatment in stage II colon cancer patients

2019 ◽  
Vol 121 (2) ◽  
pp. 392-401 ◽  
Author(s):  
I. Gkekas ◽  
J. Novotny ◽  
P. Fabian ◽  
R. Nemecek ◽  
R. Palmqvist ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Mismatch Repair ◽  
Adjuvant Treatment ◽  
Stage Ii ◽  
Mismatch Repair Status ◽  
Stage Ii Colon Cancer

Association of the colon cancer recurrence score with treatments received in patients with stage II colon cancer: The Clalit Health Services experience.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e22111-e22111
Author(s):  
Baruch Brenner ◽  
Ravit Geva ◽  
Alexander Beny ◽  
Ygael Dror ◽  
Mariana Steiner ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Health Services ◽  
Cancer Recurrence ◽  
Recurrence Score ◽  
Treatment Decisions ◽  
Oncotype Dx ◽  
Stage Ii ◽  
Technical Failure ◽  
Stage Ii Colon Cancer ◽  
Colon Cancer Recurrence

e22111 Background: The Oncotype DX Colon Cancer Recurrence Score (RS) is a validated prognosticator in stage II colon cancer following surgery. However, the impact of the RS on daily practice is still unclear. Clalit Health Services(CHS) has reimbursed Oncotype DX colon testing since 1/2011. This prospective study examined the use of the RS and its association with treatment decisions in this setting in Israel. Methods: Eligible patients had stage II colon cancer and testing reimbursed by CHS from 1/2011 to 5/2012. Patient/tumor data and treatment information were gathered prospectively. Data were analyzed using the Chi-squared test. Results: The study included 341 patients of whom 314 had confirmed stage II, T3N0 disease, and were included in the analysis. Median age was 68 years (range: 29-89); 18.2%, 68.5%, and 9.9% had grade 1, 2, and 3 tumors, respectively; 15.3% had colonic obstruction and 5.7% had lymphovascular invasion. Thirty-nine patients (12.4%) had mismatch repair (MMR)-deficient tumors and their samples were not tested further. Of the 275 tested patients, 160 (58.2%), 87 (31.6%), and 27 (9.8%) had low (<30), intermediate (30-40), and high (>40) RS, respectively (1 patient [0.4%] had no RS due to technical failure of the assay). The grade 3 group had a higher proportion of MMR-deficient tumors than the grade 2 and grade 1 groups (35.5%, 7.9% and 10.5%, respectively, P<.0001). In the MMR-proficient tumors, the proportions of low RS tumors according to grade were 60.8%, 58.1% and 70.0% for grades 1, 2 and 3, respectively (P=0.57). Chemotherapy was administered to 86/314 (27.4%) patients, including 3/39 (7.7%) in the MMR-deficient, 27/160 (16.9%) in the low, 39/87 (44.8%) in the intermediate, and 17/27 (63.0%) in the high RS groups. The most commonly used regimen was capecitabine monotherapy (61/86 treated patients, 70.9%). The differences in the proportions of patients receiving chemotherapy between the MMR-deficient, low, intermediate, and high RS groups were significant (P<.0001). Conclusions: Our findings suggest that the RS results and MMR-deficient status are significantly associated with treatment decisions in stage II colon cancer patients in Israel.

Prospective evaluation of a 12-gene assay on treatment recommendations in patients with stage II colon cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 453-453 ◽  
Author(s):  
Geetika Srivastava ◽  
Lindsay Anne Renfro ◽  
Robert J. Behrens ◽  
Margarita Lopatin ◽  
Calvin Chao ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Score Test ◽  
Recurrence Score ◽  
Recurrence Risk ◽  
Treatment Recommendation ◽  
Medical Oncologists ◽  
Gene Assay ◽  
Stage Ii Colon Cancer

453 Background: A 12-gene assay (Oncotype DX Colon Cancer) has been clinically validated as a predictor of recurrence risk in stage 2 colon cancer patients following surgery. We conducted the first prospective study to characterize the impact of Recurrence Score results on medical oncologists’ recommendations regarding adjuvant chemotherapy in T3, Mismatch Repair-proficient (MMR-P) stage 2 colon cancer patients. Methods: Consecutive patients with resected stage 2A colon cancer who were candidates for adjuvant chemotherapy were consented and enrolled by 105 medical oncologists from 17 sites in the Mayo Clinic Cancer Research Consortium. Each patient’s tumor specimen was assessed by the Recurrence Score test (quantitative RT-PCR) and MMR (IHC). Prior to and after receiving these results, physicians completed surveys indicating their planned treatments given hypothetical or known MMR results, recorded as Observation (Obs), 5FU-based chemotherapy (5FU), or 5FU + Oxaliplatin (Oxal). Change in treatment recommendation intensity from baseline to follow-up was defined as: increased if change from Obs to 5FU +/- Oxal or from 5FU to 5FU+Oxal, decreased if change from 5FU + Oxal to 5FU or Obs, or from 5FU to Obs, or no change. Results: 187 of 221 patients enrolled were evaluable including 141 who were MMR-P (avg age 63, 65% ECOG PS 0, med tumor size 5 cm, 11% high grade, 91% with 12+ nodes examined). In the primary analysis treatment recommendations changed for 63 (45%) of 141 MMR-P patients, with intensity decreasing for 47 (33%) and increasing for 16 (11%). Recommendations for chemotherapy (5-FU +/- Oxal) decreased from 73 (52%) patients pre-assay to 42 (30%) post-assay. Increased treatment intensity was more likely at higher Recurrence Score values and decreased intensity at lower Recurrence Score values (p=0.011), and any change was more likely when MMR status was unknown at baseline (p = 0.041). Conclusions: In this prospective study, quantitative recurrence risk information provided by the Recurrence Score test was associated with treatment recommendation changes for 45% of T3 MMR-P stage II colon cancer patients. Use of the 12-gene assay may lead to overall reductions in chemotherapy.

scholarly journals The Impact of Delayed Chemotherapy on Its Completion and Survival Outcomes in Stage II Colon Cancer Patients

PLoS ONE ◽  
2014 ◽  
Vol 9 (9) ◽  
pp. e107993 ◽  
Author(s):  
Fang Xu ◽  
Alfred A. Rimm ◽  
Pingfu Fu ◽  
Smitha S. Krishnamurthi ◽  
Gregory S. Cooper
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Stage Ii ◽  
Survival Outcomes ◽  
Stage Ii Colon Cancer ◽  
The Impact

Recurrence score distributions in stage II colon cancers of African American (AA) and Caucasian (CA) patients.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 613-613 ◽  
Author(s):  
Rangaswamy Govindarajan ◽  
James Posey ◽  
Calvin Y. Chao ◽  
Ruixiao Lu ◽  
Trafina Jadhav ◽  
...  
Keyword(s):  
Gene Expression ◽  
Colon Cancer ◽  
Cancer Patients ◽  
Medical Center ◽  
Expression Profiles ◽  
Gene Expression Profiles ◽  
Recurrence Score ◽  
Stage Ii ◽  
Racial Groups ◽  
Stage Ii Colon Cancer

613 Background: The 12-gene colon cancer assay (Oncotype DX) can identify groups of stage II colon cancer patients with lower or higher recurrence risk, but distribution of scores based on race/ethnicity has not been assessed. This study compared the distribution of Recurrence Score results and gene expression profiles between African American (AA) and Caucasian (CA) stage II colon cancer patients. Methods: Stage II colon cancer patients were identified from tumor registry data from four institutions: University of Arkansas for Medical Sciences, Little Rock; Veterans Administration Medical Center, Little Rock; Baptist Medical Center, Memphis, and University of Alabama at Birmingham. The 12-gene assay and mismatch repair (MMR) status were performed on formalin-fixed paraffin-embedded tissues by Genomic Health (Redwood City, CA). T-test and Wilcoxon test were used to compare data from the two groups (SAS Enterprise Guide 5.1). Results: Of the 244 subjects, there were 118 women (63 AA, 55 CA) and 126 men (59 AA, 67 CA). Median ages (years) were 66 for AAs and 68 for CAs. Age, gender, surgery year, pathologic T-Stage, tumor location, number of nodes examined, lympho-vascular invasion, and MMR status were not significantly different between groups (p>0.05). Recurrence Score results between AAs (mean 27.9; SD 12.8) and CAs (mean 28.1; SD 11.8) were not statistically different (p>0.05). The proportion of patients with high Recurrence Score values (≥41) was similar between the groups (17/122 AA; 15/122 CA). None of the gene expression variables, either single genes or gene groups, (cell cycle group, stromal group, BGN1, FAP, INHBA1, Ki67, MYBL2, cMYC3 and GADD45B) was significantly different between the racial groups (p>0.05). After controlling for clinical and pathologic covariates, means and distributions of Recurrence Score and gene expression profiles still showed no statistical significance between racial groups (p>0.05). Conclusions: In a cohort of AA and CA stage II colon cancer patients with similar clinical characteristics, the distribution of Recurrence Score results and gene expression data were similar between AA and CA patients.

Polymorphisms of genes encoding for regulatory proteins in the coagulation cascade to predict outcome for stage II and III colon cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 227-227
Author(s):  
Martin D. Berger ◽  
Inti Zlobec ◽  
Shu Cao ◽  
Yuji Miyamoto ◽  
Mitsukuni Suenaga ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Recurrence Rate ◽  
Multivariate Analyses ◽  
Stage Ii ◽  
Regulatory Proteins ◽  
Coagulation Cascade ◽  
Genes Encoding ◽  
Stage Ii Colon Cancer ◽  
The Impact

227 Background: In cancer patients, an activated coagulation cascade might promote tumor cell dissemination. There are preliminary data suggesting that fibrinogen in combination with platelets can build a meshwork that entraps cancer cells enabling them to escape from immunosurveillance. We therefore hypothesize that variations in genes encoding for regulatory proteins within the coagulation pathway may predict outcome in patients with stage II and III colon cancer. Methods: The impact of three functional single nucleotide polymorphisms (SNPs) within the FGB, SERPINC1 and ITGA2B genes on time to recurrence and overall survival was evaluated in 209 patients with stage II and III colon cancer. Genomic DNA was isolated from formalin-fixed paraffin embedded tissue and the SNPs were analyzed by PCR-based direct sequencing. Results: Baseline characteristics were as follows: median age = 70y (19-91); female/male ratio = 42.8% / 57.2%; 111 patients had stage II, and 98 stage III colon cancer. The FGB rs4220 SNP showed significant association with recurrence rate in the overall population. Patients harboring any A allele had a higher 3-years recurrence rate compared to those with a G/G genotype (28% vs 17%) in both univariate (HR 1.83, 95% confidence interval (CI) 0.99-3.36, p = 0.048) and multivariate analyses (HR 1.94, 95% CI 1.05-3.57, p = 0.034). This trend was most evident among pts with stage II and especially the subgroup of high-risk stage II colon cancer. Again, A allele carriers had a higher 3-years recurrence rate compared to those having a G/G genotype (24% vs 10% and 44% vs 15% respectively) in both univariate (HR 3.32, 95% CI 1.26-8.74, p = 0.010 and HR 5.34, 95% CI 1.38-20.68, p = 0.006) and multivariate analyses (HR 3.34, 95% CI 1.27-8.78, p = 0.015 and HR 5.44, 95% CI 1.40-21.15, p = 0.015). Conclusions: Here, we demonstrate that the FGB polymorphism rs4220 might serve as a prognostic biomarker in stage II colon cancer. Assessment of FGB rs4220 might help us to identify those stage II colon cancer patients who will derive the most benefit from adjuvant chemotherapy.

Prospective multicenter study of the impact of the 12-gene assay recurrence score on adjuvant chemotherapy treatment recommendations for stage II/III colon cancer in the post-IDEA era: SUNRISE-Decision Impact study.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. TPS868-TPS868
Author(s):  
Takeharu Yamanaka ◽  
Takeo Sato ◽  
Sayoko Nakashima ◽  
Takayuki Yoshino
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Recurrence Score ◽  
Recurrence Risk ◽  
Treatment Recommendations ◽  
Stage Ii ◽  
Stage Iii ◽  
Treatment Recommendation ◽  
Gene Assay ◽  
The Impact

TPS868 Background: The results of IDEA collaboration study in ASCO 2017 suggested that adjusting the duration of adjuvant chemotherapy (CTx) for stage III colon cancer may be possible according to patient’s risk (T and N factors) and treatment regimen (FOLFOX and CAPOX) in order to balance the benefit and neurotoxicity of oxaliplatin-based CTx. The 12-Gene Assay Recurrence Score (12-gene RS), known as Oncotype DX, has been validated to predict the recurrence risk of stage II/III colon cancer patients through several studies, including our SUNRISE study (J Clin Oncol, 2016), and thus to personalize adjuvant CTx taking account of individual recurrence risk. The objective of this SUNRISE-DI study is to determine the impact of the 12-gene RS on adjuvant CTx treatment recommendations, including the decision for the duration of oxaliplatin-based CTx in stage III patients as well as that for oxaliplatin-based CTx versus 5FU-based monotherapy in stage II/III patients. This study enables us to evaluate how physicians employ the IDEA collaboration results combined with the 12-gene RS to determine the regimen. Methods: Patients who have a curatively resected Stage II/IIIA/IIIB colon cancer, an age of more than 20, and an ECOG PS of 0-1 are eligible. Treating physicians will formulate a treatment recommendation and complete a pre-assay questionnaire, and the 12-gene assay will be performed. Following receipt of the RS result, the treatment recommendation will be revised and a post-assay questionnaire completed. The primary endpoint is the proportion of changes in treatment recommendations between pre- and post-assay across all patients. Secondary endpoints include the proportion of changes by stage; the proportion of changes in the duration of oxaliplatin-based CTx (3 months vs 6 months); the proportion switched to observation only, 5-FU mono, or 5-FU plus oxaliplatin; and changes in expressed physician confidence level. The enrollment target is 200 patients with stage IIIA/IIIB and 100 patients with stage II from 15 centers in Japan. Clinical trial registry number: UMIN000028784

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