Neoadjuvant chemotherapy to improve colon cancer survival in resectable metastatic colon cancer: A real world NCDB data analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3567-3567
Author(s):  
Saurabh Parasramka ◽  
Aasems Jacob ◽  
Quan Chen ◽  
Bin Huang ◽  
Zhonglin Hao
Keyword(s):  
Colon Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Metastatic Disease ◽  
Real World ◽  
Cox Regression ◽  
Survival Advantage ◽  
Metastatic Colon Cancer ◽  
Factors Associated ◽  
Additional Surgery ◽  
Single Organ

3567 Background: According to the SEER database, approximately 21% of colon cancer patients have synchronous metastatic disease at presentation with a five-year survival of only 14%. Liver is by far the most common site of metastasis. For resectable and borderline resectable metastatic lesions after conversion to surgical resection, five-year survival ranges between 40-70% in different series. Survival advantage of neoadjuvant chemotherapy is not clear. We present here an updated analysis of effect of different variables on survival of 3,247 patients from the National Cancer Database (NCDB) treated from 2010-2015. Methods: Adults 20 years or older with primary colon cancer and single organ metastatic disease either in the liver and/or lung at diagnosis were identified. All patients had received surgery to the primary site, resection of the distant site and chemotherapy within 1 year of diagnosis. Patients were categorized into 2 cohorts based on whether they received chemotherapy in the pre-operative/peri-operative setting (neoadjuvant chemotherapy –NAC) or post-operative setting (adjuvant chemotherapy AC). Descriptive analysis, Kaplan-Meier plots, Log-Rank tests and Cox regression models for multivariate survival analyses were performed. To assess uncertainty of estimates, a sensitive analysis was also performed based on the intention to treat principle by including additional surgery only and chemotherapy only cases. Results: A total of 3,247 patients with colon cancer with liver or lung metastases were identified. A large majority 2,527 patients (77.8%) received AC. 54.5% were males and 45.5% females. On multivariate analysis, patients who received NAC had overall survival (OS) advantage with hazard ratio (HR) 0.86 (0.75-0.98). Clinical factors associated with worse survival included age > 75 HR 1.31; positive margin status with R1 HR 1.49 or R2 HR 2.33; Comorbidity index ≥ 2 HR 1.68; positive KRAS status HR 1.20; N2 disease HR1.95; ; having liver metastasis compared to lung HR 1.65 ;. Factors associated with improved survival were CEA less than 30 ng/ml at diagnosis and left sided tumor with HR of 0.64 (0.56-0.72) and 0.75(0.67-0.84) respectively. Conclusions: Metastatic colon cancer with single organ liver or lung lesions benefit from neoadjuvant chemotherapy based on our analysis of the real-world data. The survival advantage in this setting has not been shown before.

Sequencing of treatment matters in synchronous liver or lung only metastatic colon cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4049-4049
Author(s):  
Saurabh Parasramka ◽  
Aasems Jacob ◽  
Quan Chen ◽  
Bin Huang ◽  
Zhonglin Hao
Keyword(s):  
Colon Cancer ◽  
Multivariate Analysis ◽  
Metastatic Disease ◽  
Proportional Hazards ◽  
Private Insurance ◽  
Univariate Analysis ◽  
Academic Research ◽  
Metastatic Colon Cancer ◽  
Sensitive Analysis ◽  
Additional Surgery

4049 Background: Per SEER database, approximately 21% of patients have synchronous metastatic disease at presentation with a median 5 year survival of 14%. Liver is by far the most common site of metastatic disease followed by lung. Metastatectomy of appropriate lesions have achieved a 5 year survival ranged between 40%-70% depending on the extent of the metastasis. For liver or lung only metastatic disease, practice varies from surgery followed by adjuvant chemotherapy to perioperative chemotherapy. Benefit of one approach versus the other has not been demonstrated. We decided to study this using the National Cancer Database (NCDB) database available from the 2010-2015 period. Methods: Adults > 20 years with primary colon cancer (excluding rectal and recto sigmoid junction) with single organ metastatic disease to liver and/or lung at diagnosis were identified. All patients had received surgery to the primary site, resection of the distant site and chemotherapy in the neoadjuvant setting (NAC) or adjuvant setting (AC) within 1 year of diagnosis. Histology except for adenocarcinoma and variants were excluded. Patients who died within 90 days of surgery were excluded. Descriptive analysis, Kaplan-Meier plots, Log-Rank tests for univariate and proportional hazards models for multivariate survival analyses were performed. To reduce biases, a sensitive analysis was also performed based on the intention to treat principle by including additional surgery only and chemotherapy only cases. Results: A total of 3175 colon cancer patients with liver or lung only metastatic disease were identified. 2487 (78%) had AC and 688 (22%) had NAC. Approximately 54% were males with 90% less than 75 years of age. More patients had private insurance and were treated in academic centers in the NC group (62 Vs 51%) and (58 Vs 42%) respectively. Both groups had similar Charlson comorbidity index. NC approach had better OS with HR of 0.75 (CI 0.65-0.85; p < 0.0001) on univariate analysis and 0.86 (0.74-0.98; P < 0.0281) on multivariate analysis. On multivariate analysis, age group > 75 years, black race, treatment outside academic research program had worse survival (p < 0.0001, 0.0139, 0.0001) respectively. The sensitive analysis showed the similar effects. Conclusions: Within the limitations of database review, our analysis suggests survival advantage of neoadjuvant chemotherapy approach over surgery first.

scholarly journals NCDB Analysis of Melanoma 2004–2015: Epidemiology and Outcomes by Subtype, Sociodemographic Factors Impacting Clinical Presentation, and Real-World Survival Benefit of Immunotherapy Approval

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1455
Author(s):  
Sunny R. K. Singh ◽  
Sindhu J. Malapati ◽  
Rohit Kumar ◽  
Christopher Willner ◽  
Ding Wang
Keyword(s):  
Metastatic Melanoma ◽  
Metastatic Disease ◽  
Real World ◽  
Care Delivery ◽  
Sociodemographic Factors ◽  
P Value ◽  
Real World Data ◽  
Factors Associated ◽  
Improvement In Survival ◽  
The Impact

Background: The incidence of invasive melanoma is rising, and approval for the first immune checkpoint inhibitor (ICI) to treat metastatic melanoma occurred in 2011. We aim to describe the epidemiology and outcomes in recent years, sociodemographic factors associated with the presence of metastasis at diagnosis, and the real‐world impact of ICI approval on survival based on melanoma subtype and race. Methods: This is a retrospective analysis of the National Cancer Database (NCDB) from the years 2004–2015. The primary outcome was the overall survival of metastatic melanoma by subtype. Secondary outcomes included sociodemographic factors associated with the presence of metastasis at diagnosis and the impact of treatment facility type and ICI approval on the survival of metastatic melanoma. Results: Of the 419,773 invasive melanoma cases, 93.80% were cutaneous, and 4.92% were metastatic at presentation. The odds of presenting with metastatic disease were higher in African Americans (AA) compared to Caucasians (OR 2.37; 95% CI 2.11–2.66, p < 0.001). Treatment of metastatic melanoma at an academic/research facility was associated with lower mortality versus community cancer programs (OR 0.75, 95 % CI 0.69–0.81, p-value<0.001). Improvement in survival of metastatic melanoma was noted for Caucasians after the introduction of ICI (adjusted HR 0.80, 95% CI 0.78–0.83, p < 0.001); however, this was not statistically significant for AA (adjusted HR 0.80, 95% CI 0.62–1.02, p‐value = 0.073) or ocular cases (HR 1.03, 95% CI 0.81–1.31, p‐value 0.797). Conclusion: Real‐world data suggest a 20% improvement in survival of metastatic melanoma since the introduction of ICI. The disproportionately high odds of metastatic disease at presentation in AA patients with melanoma suggest the need for a better understanding of the disease and improvement in care delivery.

Association of immune-regulatory (FoxP3+)-T-cell tumor infiltration status with benefit from chemoimmunotherapy with gemcitabine, oxaliplatin, 5-FU/FA plus GM-CSF and aldesleukine (GOLFIG) in metastatic colon cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 3045-3045
Author(s):  
P. Correale ◽  
P. Tagliaferri ◽  
M. T. Del Vecchio ◽  
C. Remondo ◽  
C. Migali ◽  
...  
Keyword(s):  
Colon Cancer ◽  
T Cells ◽  
Cancer Patients ◽  
Cox Regression ◽  
Treg Cells ◽  
Phase Iii ◽  
Metastatic Colon Cancer ◽  
Tumor Infiltration ◽  
Gm Csf ◽  
Independent Variable

3045 Background: GOLFIG is a novel chemoimmunotherapy regimen, combining gemcitabine, oxaliplatin, 5-FU/FA with immunoadjuvant GM-CSF and aldesleukine, which resulted safe and very active in colon cancer patients. Antitumor activity and immunity feedback to the treatment resulted strictly correlated. The best outcome was observed in patients showing autoimmunity signs, rise in central-memory-T cells, and decline in peripheral and tumor infiltrating immuno-regulatory T (Treg) cells. On these bases, we investigated a possible correlation between Treg tumor infiltration at diagnosis and clinical outcome of these patients. Methods: An immunohistochemistry study was carried out to quantify the infiltration of Treg (FoxP3+) lymphocytes in tumor samples of 41 colon cancer patients who received FOLFOX-4 chemotherapy or GOLFIG chemo-immunotherapy as enrolled in the ongoing phase III GOLFIG-2 trial. Treg tumor infiltration score (range 0 to 5) was then correlated with survival (OS) and time to progression (TTP). Results: A higher Treg tumor infiltration score (score 3–5) was associated to a longer OS and TTP in the whole patient population (high vs low score; TTP=18 vs 9.4 months; p=0.002; OS=55.7 vs 28.9 months; p=0.001); however, those patients with high tumor infiltration of FoxP3+-T cells who received GOLFIG regimen showed the most favorable outcome (high vs low score; TTP=20.8 vs 11.6 months; p=0.04; OS=68.1 vs 41 months; p=0.04). A Cox regression model demonstrated in these patients that a high Treg tumor infiltration score is an independent variable of long survival and prolonged TTP. Conclusions: Our results suggest that GOLFIG chemoimmunotherapy is highly effective in colon carcinoma patients with high FoxP3+ infiltration score and that Treg-tumor infiltration score may be a favorable prognostic marker in colon cancer patients. No significant financial relationships to disclose.

Algorithm for identifying various second- and third-line chemotherapy regimens in elderly U.S. Medicare patients with metastatic colon cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 553-553
Author(s):  
Kaloyan A Bikov ◽  
C. Daniel Mullins ◽  
Ebere Onukwugha ◽  
Brian S. Seal ◽  
Nader Hanna
Keyword(s):  
Colon Cancer ◽  
Sensitivity Analysis ◽  
Real World ◽  
Face Validity ◽  
Metastatic Colon Cancer ◽  
The Face ◽  
Medicare Patients ◽  
Utilization Patterns ◽  
Third Line ◽  
Clinical Rules

553 Background: Patients with metastatic colon cancer (mCC) often receive multiple lines of chemotherapy treatment (TX) in response to disease progression or toxicities. A claims-based algorithm that identifies TX lines can provide information on “real world” clinical practice patterns that may not be captured by clinical trials. Methods: Our claims-based algorithm was applied to SEER-Medicare data of elderly mCC patients diagnosed in ‘03-‘07 and followed through ‘09. The algorithm included 17 clinical rules for identifying the beginning and end TX lines. The face validity of the algorithm was assessed by 1) examining the output against a TX map for a random sample of patients; 2) evaluating the overall results; and 3) conducting a sensitivity analysis, which evaluated the variability in the number of detected TX lines as a function of key algorithm parameters. Results: Of 7,951 mCC patients, 3,266 (41%) received TX; 1,440 (18% of all, 44% of TX) and 274 (3% of all, 8% of TX) received 2nd and 3rd line TX, respectively. Fewer than 1% of treated patients had a 4th TX line. The utilization patterns in terms of number and type of TX lines were robust to changes in the algorithm parameters. OX±BEV (45%), 5FU/LV±BEV (33%) and IRI±BEV (16%) were the three most common initial TXs. 2nd line TX most commonly consisted of IRI±BIOLOGIC (62%) and OX±BIOLOGIC (26%), but 6% of patients received only BIOLOGICS. CETUX (19%), PANIT (15%), IRI alone (17%) and OX alone (12%) were the most common 3rd line TXs. OX to IRI (49%), IRI to OX (14%), 5FU/LV to OX (12%), and 5FU/LV to IRI (12%) were the most frequent TX progressions for those with 2nd line TX. 5FU/LV to OX to IRI (26%), OX to IRI to BIOLOGICS alone (25%), 5FU/LV to IRI to OX (14%) and IRI to OX to BIOLOGICS alone (6%) were the most frequent TX progressions for those with 3rd line TX. Conclusions: Our claims-based algorithm suggests that during 2003-2009 relatively few elderly mCC patients received 2nd and 3rd line TX. Sensitivity analysis confirmed the robustness of the algorithm. Future observational studies should address the “real world” benefits and risks of 2nd and 3rd line TX among elderly mCC patients.

Comparative effectiveness of primary tumor resection in metastatic colon cancer: An instrumental variable analysis.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 674-674 ◽  
Author(s):  
Zeinab Alawadi ◽  
Uma Phatak ◽  
Chung-Yuan Hu ◽  
Christina Edwards Bailey ◽  
Lillian Kao ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Regression Analysis ◽  
Primary Tumor ◽  
Instrumental Variable ◽  
Survival Benefit ◽  
Cox Regression ◽  
Tumor Resection ◽  
Metastatic Colon Cancer ◽  
Landmark Analysis ◽  
Treatment Bias

674 Background: Although the safety of chemotherapy without primary tumor resection (PTR) has been established, questions remain regarding potential survival benefit with PTR. The purpose of this study was to compare mortality with and without PTR among patients with unresectable metastatic colon cancer using nationwide hospital based cancer registry data. Methods: An observational study was conducted of patients with stage 4 colon cancer identified from the National Cancer Data Base (2003-2005). Patients who underwent metastectomy were excluded. Patient, treatment, and hospital data were analyzed. Multivariate Cox regression stratified by receipt of chemotherapy was performed to compare survival with and without PTR. To account for treatment selection bias, Propensity Score Weighting (PSW) and Instrumental Variable (IV) analyses, using hospital-level PTR rate as the instrument, were performed. In order to account for the potential bias associated with early comorbidity or disease burden associated deaths (survivor treatment bias), 1 year landmark analysis was performed. Results: A total of 14,399 patients met inclusion criteria and 6,735 patients were eligible for landmark analysis. PTR was performed in 38.2% of the total cohort and 73.8% of those at landmark. Using multivariate Cox regression analysis, PTR was associated with a significant reduction in mortality (HR 0.39; 95% CI, 0.38-0.41). This effect persisted with PSW (HR 0.4; 95% CI, 0.38-0.43). However, IV analysis showed a much smaller effect, (RR 0.88; 95% CI, 0.83-0.93). While a smaller benefit was seen on landmark analysis using multivariate Cox regression (HR 0.6; 95% CI, 0.55-0.64) and PSW (HR 0.59; 95% CI, 0.54-0.64), IV analysis showed no improvement in survival with PTR (RR 0.97; 95% CI, 0.87-1.06). Stratification by chemotherapy did not alter the results. Conclusions: Among patients with stage IV colon cancer, PTR offered no survival benefit over systemic chemotherapy alone when the IV method was applied at the 1 year landmark. Subject to selection and survivor treatment bias, standard regression analysis may overestimate the benefit of PTR. Future study should focus on identifying patients most likely to benefit from PTR.

Mutation profile of colon cancer in hispanic population of central California.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16067-e16067
Author(s):  
Sanjay Hinduja ◽  
Mir Ali ◽  
Mohammed SANI Bukari ◽  
Uzair Bashir Chaudhary ◽  
Tanner Mortenson ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Microsatellite Instability ◽  
Metastatic Disease ◽  
Pik3ca Mutation ◽  
Population Based ◽  
Metastatic Colon Cancer ◽  
Hispanic Population ◽  
Central California ◽  
Mutation Profile ◽  
Hispanic Patients

e16067 Background: The clinical and mutational profile of Hispanic patients with metastatic colon cancer is not well documented. In this retrospective study, we aim to describe the clinical and mutational profile of Hispanic patients with metastatic colon cancer in central California. Methods: We retrospectively evaluated the clinical and mutational profile of colon cancer at a single institution in Fresno, California from 2010-2019. We selected 136 patients out of which 70 patients self-identified as Hispanic and 66 self-identified as non-Hispanic. We studied clinical parameters and next-generation sequencing via Foundation one testing for these patients. Results: Among Hispanics, there were 43(61%) males and 27(38%) females. The median age at diagnosis was similar in both groups at 57. Right sided colon cancer accounted for 52% of Hispanic patients versus 40% in non-Hispanics. Fifty two percent of Hispanic patients presented with metastatic disease versus 45% in non-Hispanics. The frequency of commonly mutated genes in colon cancer in Hispanics versus non-Hispanics are as follows. KRAS (35.7% vs 37%), NRAS (11% vs 4%) BRAF (8% vs 7%), Her2/neu 0% in both groups. The frequency of other mutations such as TP53, APC, ATM, PTEN, CDKN2A, Myc amplification were also noted to be similar in both groups. PIK3CA mutation was seen in 18.6% of Hispanic patients versus 34% in non-Hispanic population which was statistically significant with a p value = 0.032. Microsatellite instability (MSI) was seen at 3.3% in Hispanics versus 10.6% in non-Hispanics. Tumor mutational burden was similar in both groups. Conclusions: The frequency of actionable mutations was similar in both Hispanic and non-Hispanic patients. Hispanics were noted to have lower PIK3CA and microsatellite instability. Metastatic disease and right sided colon cancer were seen at higher frequency in Hispanic population. Our results were similar to another population-based study which analyzed KRAS mutation with colon cancer patients in Puerto Rico[1]. Larger population based studies would be needed to further assess the differences in this patient population. Ruiz-Candelaria, Y., C. Miranda-Diaz, and R.F. Hunter-Mellado, K-RAS mutation profile in Puerto Rican patients with colorectal cancer: trends from April 2009 to January 2011. Int J Biol Markers, 2013. 28(4): p. e393-7.

Neoadjuvant Chemotherapy for Metastatic Colon Cancer: A Cautionary Note

2005 ◽  
Vol 23 (36) ◽  
pp. 9073-9078 ◽  
Author(s):  
Anton J. Bilchik ◽  
Graeme Poston ◽  
Steven A. Curley ◽  
Steven Strasberg ◽  
Leonard Saltz ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Metastatic Colon Cancer ◽  
Cautionary Note

scholarly journals Factors associated with efficacy of FOLFIRI/aflibercept in patients with metastatic colon cancer

2019 ◽  
Vol 9 (2) ◽  
pp. 29-37
Author(s):  
M. Yu. Fedyanin ◽  
L. Yu. Vladimirova ◽  
V. A. Chubenko ◽  
L. A. Zagorskaya ◽  
A. V. Belyaeva ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Metastatic Colon Cancer ◽  
Factors Associated

Real-world treatment patterns and the uptake of biologics in elderly medicare patients with metastatic colon cancer.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 540-540
Author(s):  
C. Daniel Mullins ◽  
Kaloyan A. Bikov ◽  
Brian S. Seal ◽  
Anna Hung ◽  
Nader Hanna
Keyword(s):  
Colon Cancer ◽  
Clinical Practice ◽  
Real World ◽  
Practice Patterns ◽  
Population Based ◽  
Metastatic Colon Cancer ◽  
Clinical Practice Patterns ◽  
Medicare Patients ◽  
Number Of Treatment ◽  
Cancer Network

540 Background: Metastatic colon cancer (mCC) patients may receive multiple lines of treatment (Tx1, Tx2, etc.) consisting of one or more cytotoxic (CYT: 5FU/LV, oxaliplatin [OX], irinotecan [IRI]) and biologic (BIO: bevacizumab [BEV], cetuximab [CET], panitumumab [PAN]) drugs. The National Comprehensive Cancer Network (NCCN) provides evidence-based Tx recommendations for each line. The objective of this study was to examine real-world clinical practice patterns between 2002 and 2010. In particular, we compared the most common regimens across Tx lines and how Tx patterns changed over time. We also documented the uptake and use of new BIOs. Methods: We used population-based SEER-Medicare data to determine Tx1, Tx2, and Tx3 regimens of 4,616 mCC patients (the median age at diagnosis was 78) diagnosed in 2003-2009 and followed through 2010. We will use an algorithm previously developed by us to identify regimens. Results: The most common CYT backbone in Tx1 was OX (51% of patients) followed by 5FU/LV (30%). In comparison, IRI was a preferred choice in Tx2 (65%) and Tx3 (31%). In 2003, the most common Tx1 regimens were 5FU/LV- (56%) and IRI-based (35%). 5FU/LV and IRI use decreased to 22% and 9% respectively in 2009, while OX use increased from 7% in 2003 to 63% in 2009. In 2004, the FDA approved BEV for Tx1. BEV’s share increased from 9% in 2004 to 53% in 2005. BEV was used in 9% of Tx2 regimens in 2004 and 46% in 2005. CET was approved in 2004. CET was used in less than 5% of Tx1 regimens in any year up to 2010. CET use in Tx2 increased from 19% to 27% between 2005 and 2007, and declined to 23% in 2010. The FDA approved PAN in September 2006 for treatment after failure of CYT-based regimens, i.e., primarily in Tx3 and beyond. Only 350 (8%) of patients received Tx3, and of these 59 (17%) received PAN without a CYT backbone. One in three Tx3 regimens consisted of biologics only (54% CET, 43% PAN). Conclusions: This study used SEER-Medicare registry data to examine and document real-world clinical practice patterns in treatment of elderly mCC patients between 2003 and 2010. We observed that as new biologic agents were introduced to the market, variations in the combinations and the number of treatment have significantly and rapidly changed.

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