Effect of postoperative complications on adjuvant chemotherapy use in stage III colon cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 551-551
Author(s):  
Ryan P. Merkow ◽  
David J Bentrem ◽  
Warren B. Chow ◽  
Mark E Cohen ◽  
Clifford Y. Ko ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Renal Failure ◽  
Adjuvant Chemotherapy ◽  
Postoperative Complications ◽  
Adjuvant Therapy ◽  
Stage Iii ◽  
Treatment Gap ◽  
Stage Iii Colon Cancer ◽  
Space Infection ◽  
Organ Space Infection

551 Background: The National Quality Forum has endorsed the use of adjuvant chemotherapy in stage III colon cancer yet a substantial treatment gap exists in the United States. Our objective was to evaluate the contribution of postoperative complications on the use of adjuvant therapy after colectomy for cancer. Methods: Patients from the ACS NSQIP and the NCDB who underwent colon resection for cancer were linked (2006-2008) to create a novel dataset containing robust information on comorbidities, complications, and oncologic variables. The association of complications on adjuvant chemotherapy use was assessed using multivariable regression models. Results: From 140 hospitals, 2414 patients underwent resection for stage III colon adenocarcinoma (open colectomy: 64%, laparoscopic colectomy: 36%). Overall, 896 (37.1%) patients were not treated with adjuvant therapy, of which 116 (12.9%) had documented severe comorbidities or advanced age as the reason for no adjuvant therapy receipt. Of the remaining 780 patients, 202 (25.9%) had a potential complication that could account for not receiving adjuvant therapy: 33 perioperative deaths and 169 patients with ≥1 serious complications including organ space infection (n=32), wound dehiscence (n=12), respiratory failure (n=48), pneumonia (n=45), renal failure (n=22) and septic shock (n=38). The remaining 611 patients did not have a documented reason for not receiving adjuvant chemotherapy. Complications independently associated with decreased adjuvant therapy use were renal failure (OR 0.17, 95% CI 0.0-0.59), respiratory failure (OR 0.23, 95% CI 0.11-0.51) and pneumonia (OR 0.36, 95% CI 0.18-0.75). Organ space infection was not associated with decreased use of adjuvant therapy, but significantly increased time to treatment (69 vs. 45 days, P<0.05). Superficial SSI did not decrease adjuvant therapy use or delay treatment. Conclusions: Serious postoperative complications explained one quarter of the adjuvant chemotherapy treatment gap among stage III colon cancer patients and should be considered in quality assessment of colon cancer care. Judging provider performance on quality metrics is challenging without clinical data.

Effect of postoperative complications on adjuvant chemotherapy use in stage III colon cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3608-3608
Author(s):  
Ryan P Merkow ◽  
David J Bentrem ◽  
Mary Frances Mulcahy ◽  
Clifford Y. Ko ◽  
Karl Y. Bilimoria
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Postoperative Complications ◽  
Adjuvant Therapy ◽  
Anastomotic Leak ◽  
The United States ◽  
Stage Iii ◽  
Treatment Gap ◽  
Stage Iii Colon Cancer ◽  
National Quality

3608 Background: The National Quality Forum has endorsed the use of adjuvant chemotherapy in stage III colon cancer, yet a substantial treatment gap exists in the United States. Our objective was to evaluate the contribution of postoperative complications on the use of adjuvant therapy after colectomy for cancer. Methods: Patients from the National Surgical Quality Improvement Program and the National Cancer Data Base who underwent colon resection for cancer were linked (2006-2008). The association of complications on adjuvant chemotherapy use was assessed using multivariable regression models. Results: From 140 hospitals, 2368 patients underwent resection for stage III colon adenocarcinoma. Overall, 36.8% (871/2,368) patients were not treated with adjuvant therapy, of which 47.8% (416/871) had documented severe comorbidities or advanced age (≥80) as the reason for no adjuvant therapy receipt. Of the remaining 455 patients, 21.3% (97/455) had ≥1 serious complication that could account for adjuvant therapy omission. The remaining 41.1% (358/871) patients did not have a documented reason for not recieving adjuvant therapy. Complications associated with adjuvant therapy omission were abscess/anastomotic leak (OR 1.91, 95% CI 1.02-3.59), renal failure (OR 7.16, 95% CI 1.92-26.79), prolonged ventilation (OR 7.92, 95% CI 2.97-21.13), re-intubation (OR 5.69, 95% CI 2.13-15.18), and pneumonia (OR 4.05, 95% CI 2.07-7.90). Abscess/anastomotic leak was associated with a 28-day delay in time to adjuvant chemotherapy (73 vs. 45 days, p<0.05). Superficial surgical site infection did not decrease adjuvant therapy receipt but delayed the time to its use (57 vs. 44 days, p<0.05). The occurrence of postoperative sepsis was associated with a 15-day delay to adjuvant chemotherapy (60 vs. 45 days, p<0.05). Conclusions: Serious postoperative complications explained nearly one quarter of the adjuvant chemotherapy treatment gap among stage III colon cancer patients. Postoperative complications affect treatment utilization and should be considered when calculating adherence with the Stage III adjuvant therapy for colon cancer measure. Judging provider performance using quality metrics is challenging without clinical data.

A novel interaction of genotype, gender, and adjuvant treatment in survival after resection of stage III colon cancer: Results of CALGB 89803.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 452-452
Author(s):  
Chloe Evelyn Atreya ◽  
Robert S. Warren ◽  
Donna Niedzwiecki ◽  
Robert J. Mayer ◽  
Richard M. Goldberg ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Phase Iii ◽  
Zinc Binding ◽  
Stage Iii ◽  
P53 Mutations ◽  
Stage Iii Colon Cancer ◽  
Mutational Status ◽  
The Impact

452 Background: The p53 tumor suppressor gene is frequently mutated in colorectal cancer, but reports on the effect of p53 mutations on response to adjuvant chemotherapy and survival are inconclusive. This study investigates whether p53 mutational status (wild-type, zinc or non-zinc binding mutations) impacts survival following adjuvant therapy containing fluorouracil/leucovorin with or without irinotecan (5FU/LV or IFL) in women and men with stage III colon cancer. Methods: As part of a retrospective analysis of prospectively accrued data, p53 mutational status was determined for 609 patients with stage III colon cancer who were randomized on CALGB 89803, a phase III adjuvant chemotherapy trial. p53 exons 5-8 were analyzed by direct sequencing or sequencing by hybridization. p53 mutations were identified in 276 tumors (45%), of which 134 were in the zinc binding and 142 were in the non-zinc binding regions of the core domain. Cox regression was used to study the impact of p53 mutational status, sex, and adjuvant chemotherapy on disease-free (DFS) and overall survival (OS). Results: p53 mutational status did not predict differential survival or response to adjuvant therapy among the 609 patients assessed. However, a significant sex by treatment interaction was observed for both DFS (Pinteraction=0.008) and OS (Pinteraction=0.002). Significant differences in DFS by p53 mutational status were observed among women (logrank P = 0.009). No such differences were observed among men (logrank P = 0.33). Similar results were observed for OS. There was marginal evidence of a treatment-related impact on the interaction between sex and p53 mutational status for both DFS and OS (DFS Pinteraction = 0.07; OS Pinteraction = 0.11). There was a trend toward improved OS when women with zinc binding mutations received IFL versus 5FU/LV (P = 0.08) and toward worse DFS when women with non-zinc binding mutations were treated with IFL versus 5FU/LV (P =0.08). Conclusions: This exploratory subset analysis suggests that p53 mutational status may be used to predict prognosis in a sex- and potentially chemotherapeutic regimen-specific manner.

Noninferiority of S-1 to UFT/LV as adjuvant chemotherapy for stage III colon cancer: A randomized phase III trial (ACTS-CC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3518-3518 ◽  
Author(s):  
Yoshihiko Nakamoto ◽  
Megumi Ishiguro ◽  
Motoki Yoshida ◽  
Koji Ikejiri ◽  
Izumi Mochizuki ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Completion Rate ◽  
Phase Iii ◽  
Stage Iii ◽  
Curative Surgery ◽  
Aged Patients ◽  
Phase Iii Trial ◽  
Stage Iii Colon Cancer

3518 Background: The ACTS-CC trial is a phase III trial designed to validate non-inferiority of S-1 to UFT/LV, a standard treatment in Japan as adjuvant chemotherapy for stage III colon cancer. This is the first report which evaluated the efficacy of S-1 as adjuvant therapy for colon cancer. Methods: 20-80 aged patients with stage III colon cancer who underwent curative surgery were randomly assigned to receive S-1 (80, 100, or 120 mg/day according to BSA on days 1 to 28, followed by 14 days rest, 4 courses) or UFT/LV (UFT: 300 to 600 mg/day according to BSA and, LV: 75 mg/day on days 1 to 28, followed by 7 days rest, 5 courses). Primary endpoint was DFS. Sample size was 1,480 determined with one-sided alpha of 0.05, power of 0.80, and non-inferiority margin of hazard ratio (HR) of 1.29. Results: Among 1535 enrolled patients between Apr. 2009 and Jun. 2010, 1518 patients (758 in S-1 group, 760 in UFT/LV group) were included in the efficacy analysis. Median follow-up was 41.3 months, the mean age at enrollment was 64.5 years, wide lymph node dissection (D3) was done in 79.8%, the median number of dissected lymph nodes was 17, and stage IIIA/IIIB/IIIC were 15%/71%/14%. The 3-year DFS rate was 75.5% in S-1 group and 72.5% in UFT/LV group. The HR of DFS was 0.85 (95%CI: 0.70-1.03) and non-inferiority of S-1 was demonstrated (p<0.0001). The completion rate of the protocol treatment was 76.5% in S-1 group and 72.5% in UFT/LV group. The overall incidence of grade ≥3 adverse events (AEs) in S-1 group and UFT/LV group were 16.0% and 14.4%: 4.4% and 5.5% for diarrhea, 4.9% and 3.5% for anorexia, 0.7% and 0.4% for leucopenia, 0.9% and 0.1% for anemia, 0.1% and 0.4% for thrombocytopenia, 1.2% and 1.5% for hyperbilirubinemia, 0.8% and 2.1% for AST elevation, and 1.1% and 3.3% for ALT elevation, respectively. Conclusions: Adjuvant therapy of S-1 for stage III colon cancer was demonstrated to be non-inferior in DFS to that of UFT/LV. Although AE profiles differed between S-1 group and UFT/LV group in this trial, incidence and degree of AEs were acceptable, and the completion rate of the protocol treatment was high. Adjuvant chemotherapy using S-1 will be a treatment option for stage III colon cancer. Clinical trial information: NCT00660894.

Surgeon and hospital variation in adjuvant chemotherapy delivery to patients with stage III colon cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3596-3596
Author(s):  
Zhaomin Xu ◽  
Carla Francesca Justiniano ◽  
Adan Z Becerra ◽  
Christopher Thomas Aquina ◽  
Francis P. Boscoe ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Cancer Patients ◽  
New York State ◽  
High Volume ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
Hospital Variation ◽  
Comorbidity Burden

3596 Background: It is well established that age and comorbidities have significant impact on adjuvant chemotherapy delivery to stage III colon cancer patients. This study examines differences in the hospital and surgeon-specific probabilities of adjuvant therapy delivery to stage III colon cancer patients by comorbidity burden and age. Methods: Patients who underwent surgery for stage III colon cancer from 2004-2013 were included from the New York State Cancer Registry and the Statewide Planning and Research Cooperative System. Comorbidity burden was defined with the Charlson Comorbidity Index (CCI). Multilevel logistic regressions characterized variation in adjuvant chemotherapy delivery among individual hospitals and surgeons by CCI and age. Results: 11575 patients met inclusion criteria, of which 59% received adjuvant therapy. Younger age, lower CCI, and high volume surgeons/hospitals were associated with delivery of adjuvant therapy (p < 0.01). Median time to chemotherapy was 43 days among CCI = 0 vs 48 among CCI≥2. The risk adjusted hospital and surgeon-specific probabilities of adjuvant delivery decreased with increasing CCI and age. The proportion of variation attributable to surgeons, vs hospitals, increased with CCI and age. Hospital variation between the highest and lowest hospitals increased from a 6-fold difference among CCI = 0 to an 11 fold difference among CCI≥2. Surgeon variation increased from a 14-fold difference among CCI = 0 to a 40 fold difference among CCI≥2. Conclusions: Variation in adjuvant chemotherapy delivery to stage III colon cancer patients increased with higher comorbidity burden and age. While a larger proportion of variation is attributable to surgeons among patients with the highest CCI and the most elderly, the vast majority of the variation is related to hospital factors. Even taking into account that some patients may be unfit for adjuvant therapy, this variation in treatment is alarmingly high. [Table: see text]

Socioeconomic and clinical factors associated with delayed initiation of adjuvant chemotherapy for stage III colon cancer.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 173-173 ◽  
Author(s):  
Alex Bernard Haynes ◽  
Y. Sabrina Chiang ◽  
Genevieve Marie Boland ◽  
Yan Xing ◽  
Nader N. Massarweh ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Surgical Resection ◽  
Stage Iii ◽  
Unplanned Readmission ◽  
Coordinated Care ◽  
Cancer Data ◽  
Stage Iii Colon Cancer ◽  
Increased Risk

173 Background: We have previously described an association between a greater than 8-week interval to initiation of adjuvant chemotherapy after resection of stage III adenocarcinoma of the colon and an approximately 20% increased risk of mortality. We sought to understand the factors that lead to delay in chemotherapy initiation. Methods: Patients who received adjuvant chemotherapy after resection of stage III colon cancer between 2003 and 2007 were identified from the National Cancer Data Base. Delayed chemotherapy was defined as the first date of chemotherapy administration being eight weeks or more after surgical resection. Comorbidity was categorized using the Charlson/Deyo index. Prolonged length of stay and unplanned readmission were used as surrogates for surgical complications. Multivariate logistic regression was performed to examine the associations between various clinical and socioeconomic variables and delay in the receipt of adjuvant chemotherapy. Results: 33,011 stage III colon cancer patients who received chemotherapy after surgery were identified. 8,036 (24.3%) initiated chemotherapy more than eight weeks after surgical resection. Unplanned readmission (OR 1.76, 95% CI 1.58-1.95), prolonged postoperative stay (OR 1.56, 95% CI 1.48-1.65), and comorbidity (OR 1.18, 95% CI 1.12-1.25) were all independent predictors of delay. Nonclinical factors, including African-American race (OR 1.34, 95% CI 1.24-1.45), lack of insurance (OR 1.63, 95% CI 1.43-1.87), and residence more than 100 miles from treating center (OR 1.23, 95% CI 1.01-1.51) were also independently associated with delayed chemotherapy. Conclusions: Delay in the initiation of adjuvant therapy for colon cancer beyond 8 weeks has previously been found to be an independent predictor of increased mortality. While some delays may result from patient frailty or postoperative complications, these data suggest that nonclinical factors may also contribute to delays. Increased focus on overcoming barriers to coordinated care should be prioritized to ensure that those patients who may benefit from adjuvant therapy receive it in a timely fashion to optimize survival advantages.

Reasons for and outcomes of adjuvant chemotherapy choices in elderly patients with resected stage III colon cancer.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 571-571 ◽  
Author(s):  
Jenny Ko ◽  
Hagen F. Kennecke ◽  
Howard John Lim ◽  
Sharlene Gill ◽  
Ryan Woods ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Elderly Patients ◽  
Cancer Patients ◽  
Treatment Effect ◽  
Advanced Age ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
To Receive

571 Background: Research suggests that elderly cancer patients are commonly undertreated, but the precise reasons for this are unclear. Robust clinical data on the optimal adjuvant chemotherapy regimen for elderly colon cancer patients are also lacking. Our aims were to: 1) evaluate the impact of advanced age on choice of adjuvant chemotherapy (none vs. capecitabine vs. FOLFOX) for curatively resected colon cancer; b) determine the reasons for selecting a particular regimen; and 3) examine whether treatment effect on outcomes is modified by age. Methods: All patients diagnosed with stage III colon cancer between 2006 and 2008, and referred to any 1 of 5 regional cancer centers in British Columbia, Canada were identified. Descriptive statistics were used to summarize treatment patterns among young patients (YPs) aged <70 years vs. elderly patients (EPs) aged >/=70 years. Multivariate logistic regression models were constructed to evaluate the association between adjuvant chemotherapy and cancer-specific survival (CSS) in YPs and EPs. Results: In total, 810 patients were identified: 51% were male, 52% YPs and 48% EPs, and 74% received adjuvant chemotherapy. When compared to YPs, EPs had worse ECOG and more comorbidities (both p<0.001). EPs were less likely than YPs to receive adjuvant chemotherapy (57% vs. 91%, p<0.001). Frequent reasons for no treatment included age, comorbidities, and small perceived benefit from adjuvant therapy. Among treated pts, EPs were less likely to receive FOLFOX (32% vs. 74%, p<0.0001) in favor of capecitabine due to patient preference, age, and comorbidities. In multivariate analyses, receipt of either FOLFOX or capecitabine was correlated with improved CSS compared to surgery alone. The effect of adjuvant chemotherapy on CSS was not modified by age (interaction p for capecitabine and age = 0.26; interaction p for FOLFOX and age = 0.40). Conclusions: EPs with stage III colon cancer frequently received either no adjuvant treatment or capecitabine monotherapy due to advanced age and co-morbidities. The treatment effect of adjuvant therapy on CSS is similar among EPs and YPs. Adjuvant chemotherapy should not be withheld from colon cancer patients based on advanced age alone.

scholarly journals Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer

ESMO Open ◽  
2018 ◽  
Vol 3 (6) ◽  
pp. e000428 ◽  
Author(s):  
Tetsuya Kusumoto ◽  
Megumi Ishiguro ◽  
Eiji Nakatani ◽  
Motoki Yoshida ◽  
Tsukasa Inoue ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Controlled Trial ◽  
Disease Free Survival ◽  
Stage Iiib ◽  
Phase Iii ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

ObjectiveAdjuvant Chemotherapy Trial of TS-1 for Colon Cancer (ACTS-CC), a randomised phase III trial, demonstrated that adjuvant therapy with S-1 for stage III colon cancer was non-inferior in 3-year disease-free survival (DFS) to that of tegafur-uracil plus leucovorin (UFT/LV). We updated DFS and overall survival (OS) and performed T x N subset analysisMethodsA total of 1518 patients with curatively resected stage III colon cancer were randomly assigned to receive S-1 (80–120  mg/day on days 1–28 every 42 days, four courses) or UFT/LV (UFT: 300–600  mg/day and LV: 75  mg/day on days 1–28 every 35 days, five courses)ResultsThe 5-year DFS rates of the S-1 and UFT/LV group were 70.2 % and 66.9 %, respectively (HR 0.88; 95%  CI 0.74 to 1.06; p=0.177), and non-inferiority of DFS was reconfirmed with a median of 63.5-month follow-up. The similarity of OS was also confirmed (HR 0.92; 95%  CI 0.72 to 1.17; p=0.488); 5-year OS rates of the S-1 and UFT/LV group were 86.0 % and 84.4 %, respectively. No significant interactions were identified between the major baseline characteristics and DFS of the S-1 and UFT/LV groups, except for histological type; S-1 was more favourable in patients with poorly differentiated adenocarcinoma. Patient outcomes were well separated by TNM-substages (IIIA/IIIB/IIIC). With the patients divided into 20 subsets by T and N factors, the DFS and OS rates of T3 and N1 subset, which accounted for 62 % of stage IIIB patients and 44 % of all studied subjects, were significantly better than those of the other subsets in stage IIIB and similar to those of stage IIIA.ConclusionsAdjuvant therapy of S-1 for stage III colon cancer was reconfirmed to be non-inferior in DFS to those of UFT/LV after long follow-up. No difference in OS was also demonstrated. T3N1 patients might be considered separately from other patients included in stage IIIB because of its favourable outcome.Trial registration numberNCT00660894.

Association between delays in adjuvant chemotherapy for stage III colon cancer and increased mortality.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 541-541 ◽  
Author(s):  
Alex Bernard Haynes ◽  
Yj Chiang ◽  
Barry W. Feig ◽  
Yan Xing ◽  
George J. Chang ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Relative Survival ◽  
Standard Of Care ◽  
Tumor Grade ◽  
Stage Iii ◽  
Time Interval ◽  
Risk Of Death ◽  
Stage Iii Colon Cancer

541 Background: Administration of adjuvant chemotherapy is the standard of care for stage III adenocarcinoma of the colon. There are conflicting data regarding the optimum interval for the initiation of adjuvant therapy and whether this affects survival. Methods: Patients were identified from the National Cancer Database (1998-2002) who received adjuvant chemotherapy after resection of stage III colon cancer. Multivariate analyses were performed to examine the associations between time interval from surgery to chemotherapy initiation and overall and relative survival. Relative survival was used as a surrogate for disease-specific survival. Results: 32,327 stage III colon cancer patients who received chemotherapy after surgery were identified. The relationship between timing of adjuvant chemotherapy and survival is reported in Table 1. Delay of chemotherapy beyond 8 weeks postoperatively was associated with an increased likelihood of death in a relative survival model, with a hazard ratio for death of 1.19 (95% CI: 1.11, 1.28) in the 8 to 12 week interval. Longer delays were associated with worse outcomes, with a 7.6% absolute decrease in relative survival. Other independent factors associated with reduced survival included gender, race, type of insurance, margin status, and tumor grade. Conclusions: Delay in the initiation of adjuvant therapy beyond eight weeks is an independent predictor of increased mortality. While other factors contribute to the risk of death from disease, chemotherapy delays may be preventable. Policy interventions should be developed to encourage the administration of chemotherapy within eight weeks of resection when indicated. Further effort should be expended to understand the etiology of and mitigate these delays. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document