Early survival outcomes in stage I-III operated colon cancer patients from a low prevalence, lower-middle income country: The Indian experience.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 857-857
Author(s):  
Rushabh Kiran Kothari ◽  
Vikas S. Ostwal ◽  
Anant Ramaswamy ◽  
Tara Chand Gupta ◽  
Sandeep Kumar Bairwa ◽  
...  

857 Background: Data regarding survival and outcomes in operated colon cancer patients from a lower-middle income and low prevalence nation like India is scarce. Methods: Patients who underwent curative resection for non-metastatic, non-rectal colon cancer from January 2013 to December 2016 were retrospectively analyzed from a prospectively maintained database for baseline demographics, disease characteristics, adjuvant chemotherapy, recurrence free survival (RFS) and overall survival (OS). RFS and OS were calculated by Kaplan Meier method. Results: 505 patients underwent resection in the pre-defined time-period. Median age of the patients was 53 years (range: 17 – 87) and 339 patients (67.3%) were male. Patients with stage I, stage II and stage III disease were 43(8.6%), 233(46.1%) and 217(42.9%), respectively, while 12 patients(2.4%) were not adequately staged, though non-metastatic. Right sided colon cancers were more prevalent as compared to left sided (56% vs. 44%) and 41 patients (8%) had signet ring adenocarcinoma on cytomorphology. Median number of nodes retrieved during surgery was 22 nodes(range:1-96 ). Adjuvant chemotherapy was planned for 406 patients (80.4%), with the common regimens used being capecitabine-oxaliplatin, capecitabine , 5-fluorouracil – oxaliplatin and 5-fluorouracil in 280 (55.2%), 80 (16%), 34 (7%) and 6 patients (1.2%), respectively. Planned adjuvant chemotherapy was completed in 334 patients(82.3%; n = 406) with 27 patients (6%) required dose reduction. 35 patients (7%) required permanent cessation of adjuvant treatment due to chemotherapy related toxicity. With a median follow up of 21.8 months (range: 0-56),estimated 3 year RFS for the entire cohort was 86.2% and estimated median OS was 95.2%. Estimated RFS in stage I, Stage II, stage III patients were 90.3%, 89.5% and 78% respectively (p-0.006). Conclusions: Early survival outcomes with Stage I-III colon cancers in a low prevalence country like India appears to be comparable or potentially superior to outcomes published from high prevalence countries. Adjuvant chemotherapy in Stage II and Stage III colon cancers in a real world scenario in India appears to be well tolerated.

2019 ◽  
Vol 08 (03) ◽  
pp. 160-165
Author(s):  
Anant Ramaswamy ◽  
Rushabh Kothari ◽  
Ashwin Desouza ◽  
Tarachand Gupta ◽  
Sandeep Bairwa ◽  
...  

Abstract Background: Data regarding the practice of adjuvant chemotherapy, specifically with modified CAPOX, and survival outcomes in operated colon cancer patients from a nontrial cohort in a lower-middle income and low prevalence nation like India is scarce. Materials and Methods: Patients who underwent upfront curative resection for colon cancer from January 2013 to December 2016 were analyzed for baseline variables and outcomes. Results: A total of 491 patients underwent curative resection in the predefined time period. The median age of the patients was 53 years (range: 17–87). Patients with Stage I, Stage II, and Stage III disease comprised 7.9%, 44.8%, and 45.4% of the entire cohort, respectively. Patients with Stage I cancer were observed. Adjuvant chemotherapy was planned for 384 patients (78.2%), with the doublet regimens (capecitabine-oxaliplatin, or 5-fluorouracil-oxaliplatin) being used commonly (77.6%). Common toxicities were Hand-foot syndrome (Grade 2/3 - 21.4%) and peripheral neuropathy (Grade 2/3 - 20.1%). About 85% of patients receiving monotherapy (capecitabine or 5 fluorouracil) and 81.2% of patients receiving doublet chemotherapy (mCAPOX or modified FOLFOX-7) completed their planned adjuvant treatment. With a median follow-up of 22 months, estimated 3 years event-free survival was 86%, and overall survival (OS) was 93.6%. Stage, younger age (<50 years), underlying cardiovascular abnormalities, need for dose reductions and noncompletion of planned chemotherapy predicted for inferior estimated 3-year OS on multivariate analysis. Conclusions: Adjuvant chemotherapy especially with modified CAPOX appears well tolerated in the Indian population and early survival outcomes appear to be comparable to published literature.


2019 ◽  
Vol 17 (3.5) ◽  
pp. QIM19-124
Author(s):  
Dayna Crawford ◽  
Brook Blackmore ◽  
Jeremy Ortega ◽  
Erica Williams

Background: Colon cancer is the 3rd most common cancer in men and women combined, with an occurrence rate of 4.49% for men and 4.15% for women. The 2018 expectation is 50,630 deaths related to colon cancer in the United States (American Cancer Society Facts and Figures 2018). Early detection is increasing with nearly 45% of colon cancers diagnosed as stage I/II (Sarah Cannon Cancer Registry 2015). Treatment for early stage I/II colon cancer patients usually involves surgery then surveillance. On-site navigators perform their duties by patient need and barriers to care. Late stage III/IV colon cancer patients require more assistance and face more barriers, which often leaves early stage I/II patients without an advocate. This disparity can lead to lower rates of follow-up care for early stage I/II patients. Sarah Cannon created a program for virtual colon navigation (VCN) to determine if early stage I/II patients benefit from a virtual navigator who offers support by phone throughout their disease process. Objectives: The goal was to increase early stage I/II patients’ knowledge of their cancer and convey the importance of compliance with follow-up care, such as repeat colonoscopy as recommended by their physician and NCCN Guidelines. Methods: By developing software that utilizes artificial intelligence, Sarah Cannon created an automated process to identify colon cancer patients at the time of diagnosis. This technology then routes positive pathology reports to a VCN who contacts the early stage I/II patients by telephone, ensuring patient connection to the suitable physician for treatment. The VCN helps patients understand their diagnosis, provides education, assesses barriers to care, connects to resources, provides emotional support, and offers assistance with follow-up for physician visits, imaging and procedures such as colonoscopies, based upon NCCN Guidelines and physician guidelines. The VCN also connects stage III/IV patients with an on-site navigator in their region for more hands-on navigation. Results: Through September 2018, Sarah Cannon navigated 734 colon cancers, 332 stage I/II and 402 stage III/IV. With our increased capacity, Sarah Cannon/HCA maintained a 98% rate of follow-up care with new diagnoses of all stages of colon cancer. Conclusions: The VCN program allowed Sarah Cannon/HCA to improve care continuity and compliance based upon NCCN Guidelines for early stage I/II colon cancer patients throughout 5 regions and 37 facilities.


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 647-647
Author(s):  
Yuji Toiyama ◽  
Hiroyuki Fujikawa ◽  
Yasuhiro Inoue ◽  
Hiroki Imaoka ◽  
Masato Okigami ◽  
...  

647 Background: Albumin to globulin ratio (AGR) has been reported to predict long term mortality in patients with several cancers. However, prognostic impact of preoperative AGR in colon cancer patients with curative intent has not yet been fully addressed. Therefore, we, for the first time, investigated the association between AGR and clinico-pathological findings including overall survival (OS) and disease free survival (DFS) in stage I-III colon cancer patients. Methods: Clinicopathological findings including preoperative laboratory data (carcinoembryonic antigen [CEA] and AGR) from 251 curative colon cancer patients were assessed as indicators of early recurrence and poor prognosis in this retrospective study. AGR was calculated as [AGR = albumin/ (total protein - albumin)]. The cut-off value of AGR was 1.32 in current study. Results: Several clinicopathological categories related with tumor progression such as lymph node metastasis, T4 tumor, large tumor size, undifferentiated tumor, venous and lymphatic invasion, and high CEA were significantly associated with low AGR level. The patients with low AGR were significantly poorer OS (P = 0.001) and DFS (P = 0.003) than those with high AGR, respectively. In addition, multivariate analyses demonstrated that low AGR was independently associated with early recurrence (HR = 2.87, P = 0.007) and poor prognosis (HR = 2.56, P = 0.008), respectively. On the other hand, sub analysis of survival curves revealed that stage III colon cancer patients with low AGR were significantly poorer OS (P = 0.007) and DFS (P = 0.02) than those with high AGR, respectively. Furthermore, significantly poorer OS and DFS were also shown in stage I-II colon cancer patients with low AGR, respectively (OS: P = 0.02, DFS: P = 0.01). Conclusions: Preoperative AGR was an independent predictor of early recurrence and poor prognosis in curative colon cancer patients. AGR may represent a simple, potentially useful predictive biomarker for selecting stage I-II colon cancer patients who might need adjuvant chemotherapy. Furthermore, AGR may select candidates who are better to introduce more intensive adjuvant chemotherapy after curative operation in stage III colon cancer patients.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 306-306
Author(s):  
Jennifer Leigh Lund ◽  
Michael Webster-Clark ◽  
Emily W. Bratton

306 Background: Randomized controlled trials are the gold standard for assessing the efficacy of new cancer therapies and are required for marketing approval. However, participants enrolled into trials are often not representative of the more diverse populations in whom treatment will ultimately be delivered. Real-world data can be used to potentially bridge this gap by evaluating the effectiveness and safety of therapies in more generalizable populations. In this study, we describe differences in demographic and clinical characteristics between participants enrolled in a phase III trial of adjuvant chemotherapy for colon cancer and a contemporary comparator cohort using structured oncology electronic medical records (EMR) data. Methods: We drew upon publications from the Multicenter International Study of Oxaliplatin/5 Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) recruiting patients primarily from Western Europe with stage II or III colon cancer from October 1998-January 2001. This trial established FOLFOX (oxaliplatin + 5-FU) as the standard of care over 5FU alone in treating stage III colon cancer and led to US marketing approval. For comparison, we identified patients diagnosed with stage II or III colon cancer (September 2014-2020) who received FOLFOX in the IQVIA US Oncology EMR database via E360, IQVIA’s Real World Discovery and Analytics platform. In the two populations, we described distributions of prognostic factors including age, sex, stage of disease, body mass index (BMI), and Eastern Cooperative Group (ECOG) performance status. Results: The MOSAIC trial included 2,246 participants; we identified 4,566 patients starting FOLFOX in the EMR comparator. Median age was similar: 61 versus 62 years, but the range differed (19-75 years versus 18-85 years) in the trial and EMR comparator, respectively. Female sex was similar at 44% and 48%, while the proportion of patients with stage III disease differed considerably at 60% and 84% for trial and EMR comparator, respectively. Half (51%) of all EMR patients were missing ECOG status; among those with a reported ECOG status, 96% had a score of 0-1, while 87% of trial participants had an ECOG of 0-1. BMI was missing in 34% of patients in the EMR comparator; among those with a reported BMI, 28% had a BMI < 25, while 54% of trial participants had a BMI < 25. Conclusions: Colon cancer patients receiving FOLFOX in an EMR comparator had a similar age and sex distribution as MOSAIC trial participants, but were more likely to have stage III disease. Missing ECOG and BMI data were common in the EMR comparator, which limited comparisons. Structured oncology EMR data represent an important resource for generating real-world evidence; future data enrichment efforts focused on critical patient-level variables via unstructured EMR extraction may improve data completeness and quality.


Oncotarget ◽  
2016 ◽  
Vol 7 (45) ◽  
pp. 73876-73887 ◽  
Author(s):  
Evert van den Broek ◽  
Oscar Krijgsman ◽  
Daoud Sie ◽  
Marianne Tijssen ◽  
Sandra Mongera ◽  
...  

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 684-684
Author(s):  
Caitlin C. Murphy ◽  
Linda C Harlan ◽  
Jennifer Leigh Lund ◽  
Charles Lynch ◽  
Ann M. Geiger

684 Background: Colorectal cancer (CRC) incidence and mortality have declined in the U.S. over the past two decades. Much of the decline can be attributed to screening and advances in treatment. Few studies have evaluated the extent to which recommended therapies have been adopted in community settings and temporal changes in patterns of care. Methods: Patients diagnosed with stages II and III CRC were randomly sampled from the population-based Surveillance, Epidemiology, and End Results (SEER) program in 1990-91, 1995, 2000, 2005, and 2010 (n=7,056). Treatment data were obtained through medical record review and physician verification. We described the receipt of adjuvant chemotherapy among colon cancer patients and preoperative or postoperative radiation therapy among rectal cancer patients. Log-binomial regression was used to examine factors associated with receipt of therapy. Results: Receipt of adjuvant chemotherapy increased among stages II and III colon cancer patients from 1990 (stage II: 22%, stage III: 55%) to 2005 (stage II: 32%, stage III: 72%) and decreased in 2010 (stage II: 29%, stage III: 65%). Chemotherapy regimens changed over time; there was an increase in the use of capecitabine (3% in 2000 to 24% in 2010) and oxaliplatin (6% in 2000 to 79% in 2010). Stage III colon cancer patients who were older (75-79 years: RR 0.82, 95% CI 0.72, 0.94; ≥80 years: RR 0.36, 95% CI 0.27, 0.49) or had a comorbidity score ≥ 2 (RR 0.54, 95% CI 0.34, 0.86) were less likely to receive adjuvant chemotherapy. Receipt of radiation therapy among stages II and III rectal cancer patients increased across all study years from 46% to 66%, with a shift toward preoperative therapy in 2005. From 2005 to 2010, receipt of neoadjuvant chemoradiation followed by surgery and postoperative chemotherapy nearly doubled (11% in 2005 to 21% in 2010). Increasing age (75-79 years: RR 0.60, 95% CI 0.48, 0.75; ≥80 years: RR 0.34, 95% CI 0.25, 0.45) was associated with lower chemoradiation use in rectal cancer. Conclusions: Our findings demonstrate increased adoption of adjuvant therapies for both colon and rectal cancer patients and differences in therapy receipt by age, comorbidity, and diagnosis year. Improved receipt of adjuvant therapies in the community may further reduce CRC mortality.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14529-e14529
Author(s):  
Walter Tsang ◽  
Argyrios Ziogas ◽  
Chaitali Singh Nangia ◽  
Jason A. Zell

e14529 Background: High-grade (HG; poorly differentiated and undifferentiated) colon carcinoma has an increased risk of recurrence after surgical resection compared to low-grade tumors. However, the benefits of adjuvant chemotherapy (AC) in this patient population remain unclear. Using a large population-based database, we examined survival outcomes of HG stage II/III colon cancer patients treated with or without AC. Methods: Stage II/III adult colon cancer patients with HG tumors who have undergone resection were identified in the California Cancer Registry from 1989 to 2006, with follow-up through 2009. Estimates of Colorectal Cancer Specific Survival (CRC-SS) were generated using Kaplan-Meier methods. CRC-SS multivariate analyses were performed using Cox proportional-hazard regression models adjusted for age, gender, race/ethnicity, histology, tumor site, chemotherapy, time period of diagnosis (1989-1994, 1995-2000, 2001-2006) and socioeconomic status. Results: Significant CRC-SS improvements were observed in stage III patients treated with AC (n=3,793) versus no AC (n=2,582) in univariate (Table) and multivariate analyses (HR=0.89, 95% CI 0.82-0.96). In contrast, among stage II patients treated with AC (n=1,232) vs. no AC (n=3,470), no differences were observed in univariate analyses (Table); furthermore, an increased risk of CRC-specific mortality was observed in multivariate analyses (HR=1.23, 95% CI 1.06-1.44). Conclusions: In high-grade colon cancer, despite significant survival benefits of adjuvant chemotherapy to stage III patients, adjuvant chemotherapy was independently associated with increased mortality in stage II patients. These findings invoke new questions about the utility of adjuvant chemotherapy among patients with high-grade stage II colon cancer. [Table: see text]


2016 ◽  
Vol 61 ◽  
pp. 1-10 ◽  
Author(s):  
F.N. van Erning ◽  
L.G.E.M. Razenberg ◽  
V.E.P.P. Lemmens ◽  
G.J. Creemers ◽  
J.F.M. Pruijt ◽  
...  

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