Multicenter Randomized Trial of Adjuvant Fluorouracil and Folinic Acid Compared With Surgery Alone After Resection of Colorectal Liver Metastases: FFCD ACHBTH AURC 9002 Trial

2006 ◽  
Vol 24 (31) ◽  
pp. 4976-4982 ◽  
Author(s):  
Guillaume Portier ◽  
Dominique Elias ◽  
Olivier Bouche ◽  
Philippe Rougier ◽  
Jean-François Bosset ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Liver Metastases ◽  
Odds Ratio ◽  
Systemic Chemotherapy ◽  
Disease Free Survival ◽  
Secondary Outcome ◽  
Control Group ◽  
Free Survival ◽  
Disease Free

Purpose Complete resection of liver metastases of colorectal origin is the only potentially curative treatment. In order to decrease recurrences, the use of adjuvant systemic chemotherapy after liver resection is controversial because no randomized study demonstrated its benefit. Patients and Methods In a multicenter trial, we randomly assigned 173 patients with completely resected (R0) hepatic metastases from colorectal cancer to surgery alone and observation (87 patients) or to surgery followed by 6 months of systemic adjuvant chemotherapy with a fluorouracil and folinic acid monthly regimen (86 patients). The main outcome criterion was disease-free survival. Secondary outcome measures were overall survival and treatment-related toxicity. Results The intention-to-treat analysis was based on 171 patients, after a median follow-up of 87 months (SE = 5.8). The 5-year disease-free survival rate, after adjustment for major prognostic factors, was 33.5% for patients in the chemotherapy group and 26.7% for patients in the control group (Cox multivariate analysis: odds ratio for recurrence or death = 0.66; 95% CI, 0.46 to 0.96; P = .028). With regard to secondary outcome measures, a trend towards increased overall survival was observed but did not reach statistical significance (5-year overall survival: chemotherapy group, 51.1% v control group, 41.1%; odds ratio for death, 0.73; 95% CI, 0.48 to 1.10; P = .13). Conclusion Despite a suboptimal regimen, which was the standard at the beginning of the study, adjuvant intravenous systemic chemotherapy provided a significant disease-free survival benefit for patients with resected liver metastases from colorectal cancer.

Validation of MAF biomarker for response prediction to adjuvant bisphosphonates in 2 clinical trials: AZURE and NSABP-B34.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 513-513
Author(s):  
Alexander H. G. Paterson ◽  
Stewart J. Anderson ◽  
Roger Gomis ◽  
Joel [email protected] ◽  
Juan-Carlos Tercero ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Disease Free Survival ◽  
Collaborative Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Free Survival ◽  
Disease Free

513 Background: An Early Breast Cancer Trialists' Collaborative Group (EBCTCG) meta-analysis indicates that adjuvant bisphosphonates increase time to bone recurrence and survival in postmenopausal breast cancer patients, but results of individual trials have been inconclusive. Retrospective analyses of AZURE, a trial of adjuvant zoledronic acid, showed MAF (a transcription factor of the AP-1 family) amplification status predicted bisphosphonate benefit independently of menopause for invasive disease-free survival (IDFS) and overall survival (OS). Validation of MAF amplification status as a potential companion diagnostic for adjuvant bisphosphonates was confirmed using NSABP-B34 specimens. Methods: The randomized, placebo-controlled NSABP B-34 study of women with stage 1-3 breast cancer were assigned to adjuvant systemic therapy plus oral clodronate 1600 mg daily or placebo for 3 years. The primary endpoint was disease-free survival (DFS) with overall survival (OS) as a secondary outcome. MAF amplification was assessed by fluorescence in-situ hybridization on anonymized sections of breast tumor tissue in all patients with tumor samples and performed in a laboratory blind to treatment assignment. Protocol and analysis plans were pre-specified. Disease outcomes were analysed using intention to treat principles. Results: 2496 B-34 patients contributed tumor samples (from 2001-2004), of whom 1883 (75%) were evaluable (947 placebo and 936 clodronate). 1515 (80%) tumors were MAF negative (766 placebo and 749 clodronate) and 368 were MAF positive. At median follow-up of 108 months, MAF was prognostic for DFS, OS and bone-metastasis-free survival in the control group (MAF-positive vs MAF-negative: HRDFS=1·39, 95%CI 1·01-1·92; p=0.045; HROS=1·59, 95%CI 1·08-2·33; p=0.018; HRBM=2·03, 95%CI 1·13-3·68; p=0.016). In patients with MAF-negative tumors, clodronate gave higher DFS and OS than controls at 60 months (HRDFS=0·70, 95%CI 0·51-0·94; p=0.020 and HROS=0·59, 95%CI 0·37-0·93; p=0.024), the latter maintained through follow-up (HROS=0·74, 95%CI 0·54-1.00; p=0.047), but not in patients with MAF-positive tumors - consistent with previous AZURE results. Conclusions: MAF benefit prediction from adjuvant bisphosphonates was confirmed using specimens from 2 randomized clinical trials (AZURE and NSABP-B-34) conducted and analyzed in similar manner using the same validated tests and clinical endpoints. These results are evidence towards introducing MAF testing into clinical practice.

Prognostic characteristics of patients with benign mesenteric lymph node enlargement after surgical resection for colorectal cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4027-4027
Author(s):  
Fei Tian ◽  
Gong Chen
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Mesenteric Lymph Node ◽  
Disease Free Survival ◽  
Control Group ◽  
Free Survival ◽  
Mesenteric Lymph ◽  
Lymph Node Enlargement ◽  
Disease Free

4027 Background: Patients with lymph node metastasis of colorectal cancer (CRC) have a greater risk of recurrence. However, the characteristics of benign mesenteric lymph node enlargement (BLNE) are not well documented. The aim of this study is to assess clinical and prognostic significance of BLNE in patients with CRC. Methods: 601 patients who underwent surgery for stage 0, I, II CRC from January 2010 to April 2014 were included and separated into two groups by presence of BLNE. Univariate and multivariate analyses were constructed to demonstrate prognostic factors between BLNE group (n = 275) and control group (n = 326). Results: The risk of recurrence in BLNE group after curative resection was significantly lower than control group, with the 1-, 3-, and 5-year disease-free survival rates being 98.2, 91.6, and 86.9 %, in BLNE group and 95.7, 86.2, and 78.2 %, in control group respectively (p = 0.004). The mortality in BLNE group was lower compared with non BLNE group (mean overall survival: 95.7±1.2 vs. 89.5±1.4 months, p = 0.001). Patients of BLNE group also had a higher percentage of younger age, family tumor history, left sided tumors and tumor size ≥4cm. Adjusted Cox regression showed BLNE was an independent prognostic factor for both disease free survival and overall survival ( P= 0.003 and 0.001). Conclusions: The study indicates that BLNE can be a useful positive factor in predicting recurrence and long-term survival concerning CRC patients. This conclusion offers a new viewpoint about CRC genesis and progression.

Preoperative hepatic and regional arterial chemotherapy in the prevention of liver metastasis after colorectal cancer surgery

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4090-4090
Author(s):  
J. Xu ◽  
Y. Zhong ◽  
W. Niu ◽  
X. Qin ◽  
Y. Wei ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Liver Metastasis ◽  
Disease Free Survival ◽  
Stage Ii ◽  
Stage Iii ◽  
Control Group ◽  
Free Survival ◽  
Significant Difference ◽  
Disease Free

4090 Background: To investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving curative colorectal cancer resection. Methods: Patients with Stage II or Stage III colorectal cancer (CRC) were randomly assigned to receive preoperative hepatic and regional arterial chemotherapy (PHRAC group, n=256) or surgery alone (control group, n=253). The primary endpoint was disease-free survival, whereas the secondary endpoints included liver metastasis-free survival and overall survival. Results: There were no significant differences in overall morbidity between PHRAC and Control groups. During the follow-up period (median, 42 months), the median liver metastasis time for patients with stage III CRC was significantly longer in the PHRAC group (16±3 months v.s. 8±1 months, P=0.01). In stage III patients, there was also significant difference between the two groups with regard to the incidence of liver metastasis (18.9% vs 27.3%, P=0.01), 5-year disease-free survival (70.2% vs 52.0%, P=0.0076), 5-year overall survival (80.3% vs 69.5%, P=0.020) and the median survival time (40.1± 4.6 months vs 36.3 ± 3.2 months, P=0.03). In the PHRAC arm, the risk ratio of recurrence was 0.63 (95% CI, 0.51–0.79, P=0.0001), of death was 0.50(95% CI, 0.32–0.67; P=0.005), and of liver metastasis was 0.70 (95% CI, 0.52–0.86; p=0.01). In contrast, PHRAC seemed to be no benefit for stage II patients. Toxicities, such as hepatic toxicity and leucocyte decreasing, were mild and could be cured with medicine. Conclusions: Preoperative hepatic and regional arterial chemotherapy, in combination with surgical resection, could be able to reduce and delay the occurrence of liver metastasis and therefore improve survival rate in patients with stage III colorectal cancer. No significant financial relationships to disclose.

scholarly journals Combination of CDX2 expression and T stage improves prognostic prediction of colorectal cancer

2019 ◽  
Vol 47 (5) ◽  
pp. 1829-1842 ◽  
Author(s):  
Weimin Xu ◽  
Yilian Zhu ◽  
Wei Shen ◽  
Wenjun Ding ◽  
Tingyu Wu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Hazard Ratio ◽  
Free Survival ◽  
T Stage ◽  
Cdx2 Expression ◽  
Prognostic Prediction ◽  
Disease Free

Objective Prognostic prediction of colorectal cancer (CRC) remains challenging because of its heterogeneity. Aberrant expression of caudal-type homeobox transcription factor 2 (CDX2) is strongly correlated with the prognosis of CRC. Methods Tissue samples of patients with CRC who underwent surgery in Xinhua Hospital (Shanghai, China) from January 2010 to January 2013 were collected. CDX2 expression was semiquantitatively evaluated via immunohistochemistry. Results In total, 138 patients were enrolled in this study from a prospectively maintained institutional cancer database. The median follow-up duration was 57.5 months (interquartile range, 17.0–71.0 months). In the Cox proportional hazards model, low CDX2 expression combined with stage T4 CRC was significantly the worst prognostic factor for disease-free survival (hazard ratio = 7.020, 95% confidence interval = 3.922–12.564) and overall survival (hazard ratio = 5.176, 95% CI = 3.237–10.091). In the Kaplan–Meier survival analysis, patients with low CDX2 expression and stage T4 CRC showed significantly worse disease-free survival and overall survival than those with low CDX2 expression alone. Conclusion CDX2 expression combined with the T stage was more accurate for predicting the prognosis of CRC. Determining the prognosis of CRC using more than one variable is valuable in developing appropriate treatment and follow-up strategies.

Efficacy and tolerability of adjuvant therapy in ≥70-year-old patients with T3N0M0 colorectal cancer: An observational study

2019 ◽  
Vol 26 (3) ◽  
pp. 619-631
Author(s):  
Abdullah Sakin ◽  
Nurgul Yasar ◽  
Suleyman Sahin ◽  
Serdar Arici ◽  
Saban Secmeler ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Risk Group ◽  
Disease Free Survival ◽  
Old Patients ◽  
Free Survival ◽  
Disease Free

Background This study aimed to retrospectively investigate the efficacy and tolerability of adjuvant chemotherapy in ≥70-year-old patients with stage IIA (T3N0M0) colorectal cancer. Methods Lymphovascular invasion, perineural invasion, margin positivity, dissected lymph node count of <12, and presence of perforation/obstruction were accepted as risk factors. Those patients with at least one risk factor were regarded as having high risk. Results The study included 168 patients, among which 95 (56.5%) were male and 73 (43.5%) were female. The median age of patients was 73 years (range: 70–94). One hundred one (60.1%) patients were identified to have high risk. Eighty-one (87%) patients received 5-flourouracil+leucovorin and 12 (13%) patients received capecitabine regimens as adjuvant chemotherapy. The patients receiving capecitabine regimen had significantly higher rates of dose reduction at initiation and during the treatment. Among low-risk group, there was no statistically significant difference between patients with and without adjuvant chemotherapy in terms of disease-free survival or overall survival (p = 0.528 and p = 0.217, respectively). In high-risk group, patients receiving adjuvant chemotherapy significantly differed from those not receiving adjuvant chemotherapy in terms of median disease-free survival and overall survival (p = 0.009 and p < 0.001, respectively). While the grade, lymph node status, and adjuvant chemotherapy were identified as the most significant independent factors for disease-free survival, the most significant factors for overall survival were the age, Eastern Cooperative Oncology Group performance status, adjuvant chemotherapy, and recurrence. Conclusion The findings of our study showed improved disease-free survival and overall survival in high-risk ≥70-year-old patients who received adjuvant chemotherapy due to T3N0M0 colorectal cancer. We believe that 5-flourouracil+leucovorin or capecitabine regimens should be recommended for these older high-risk patients who could receive adjuvant chemotherapy regardless of age.

Phase II trial of adjuvant immunotherapy with autologous tumor-derived Gp96 vaccination in patients with gastric cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 117-117
Author(s):  
Lin Chen ◽  
Kecheng Zhang ◽  
Zheng Peng ◽  
Bo Wei ◽  
Hongqing Xi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Immune Responses ◽  
Phase Ii Trial ◽  
Disease Free Survival ◽  
Control Group ◽  
Autologous Tumor ◽  
Free Survival ◽  
Experimental Group ◽  
Disease Free

117 Background: Autologous, tumor-derived heat shock protein Gp96 peptides complexes have shown antitumor potential in various cancers. We conducted the first Phase II trial to evaluate the safety and efficacy of Gp96 vaccination in adjuvant settings for patients with gastric cancer. Methods: Consecutive patients from November 2012 to December 2015 were enrolled. Participants were allocated to the experimental group or control group, receiving Gp96 vaccination plus chemotherapy or chemotherapy alone respectively. The primary endpoints were disease-free survival and toxicity. The secondary outcomes were overall survival and tumor-specific immune responses. Results: Thirty-nine and forty patients received Gp96 vaccination plus chemotherapy and chemotherapy alone in the adjuvant settings respectively. Significant increased tumor-specific immune responses were observed after Gp96 vaccination. There were comparable disease-free survival ( p = 0.413; HR: 0.75; 95% CI: 0.37−1.48) and overall survival ( p = 0.485; HR: 0.68; 95% CI: 0.24−1.96) between experimental group and control group. In subgroup of patients with stage II and stage III gastric cancer, patients who have received Gp96 vaccination had improved disease-free survival compared those who have not ( p = 0.044; HR: 0.45; 95% CI: 0.22−0.96). Gp96 vaccination plus chemotherapy was well tolerated and no Gp96-related serious adverse event has been observed. Conclusions: Gp96 vaccination could elicit tumor-specific immune responses and could be safely used in adjuvant settings combined with chemotherapy. Patients with less aggressive diseases might benefit from Gp96 therapy.

scholarly journals Anastomotic Leakage Following Colorectal Cancer Surgery: Comparison Between Conservative and Surgical Treatment

2020 ◽  
Author(s):  
Yasuhiro Ishiyama ◽  
Masaki Oneyama ◽  
Yuki Tomizawa ◽  
Manabu Amiki ◽  
Shingo Ito ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Surgical Treatment ◽  
Conservative Treatment ◽  
Anastomotic Leakage ◽  
Disease Free Survival ◽  
Colorectal Cancer Surgery ◽  
Free Survival ◽  
Conservative And Surgical Treatment ◽  
Disease Free

Abstract Backgrounds Anastomotic leakage following colorectal cancer is associated with significant morbidity and mortality. However, whether the choice of the treatment for anastomotic leakage may affect the oncological outcomes is under debate. We evaluated the oncological outcomes after colorectal cancer surgery for anastomotic leakage between conservative and surgical treatment. Methods We retrospectively analyzed data for patients with colorectal cancer who underwent curative colectomy from April 2010 to January 2020. Results A total 1039 patients underwent surgery colorectal cancer in our hospital. After exclusion, a total of 915 patients underwent a low anastomosis with diverting stoma for colorectal cancer of which 92 (10.0%) anastomotic leakage occurred. After stage Ⅳ and emergency surgery case were excluded, a total of 75 patients were included for the analysis. The surgical treatment group was 25 cases. The conservative treatment group was 50 cases. Early anastomotic leakage was more than in surgical treatment compared to conservative treatment (84% vs 54%, P =0.008). The 5-year overall survival rates and the 5-year disease free survival did not differ significantly between the two groups. The recurrence location of liver metastasis was more than in surgical treatment compared to conservative treatment (20% vs 2 %, P=0.02). On a multivariable analysis, anastomotic leak did not impact overall survival and disease free survival. Conclusion We found that the treatment for anastomotic leakage was not depended on increased local, distance recurrence, overall survival, and disease free survival. Our findings may help surgeons determine which AL treatment is most appropriate, when the decision is unclear.

scholarly journals Prognostic value of the C-reactive protein to albumin ratio in colorectal cancer: an updated systematic review and meta-analysis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Chun-Kai Liao ◽  
Yen-Lin Yu ◽  
Yueh-Chen Lin ◽  
Yu-Jen Hsu ◽  
Yih-Jong Chern ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Prognostic Value ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Progression Free Survival ◽  
Poor Overall Survival ◽  
Free Survival ◽  
Pre Treatment ◽  
Disease Free

Abstract Backgrounds The inflammatory biomarker “C-reactive protein to albumin ratio (CAR)” has been reported to significantly correlate to a variety of human cancers. However, there are conflicting results regarding the prognostic value of CAR in colorectal cancer. Previous studies mainly assessed patients in Eastern countries, so their findings may not be applicable to the Western population. Therefore, this updated meta-analysis aimed to investigate the prognostic value of pre-treatment CAR and outcomes of patients with colorectal cancer. Methods We conducted a systematic search for eligible literature until October 31, 2020, using PubMed and Embase databases. Studies assessing pre-treatment CAR and outcomes of colorectal cancer were included. Outcome measures included overall survival, disease-free survival, progression-free survival, and clinicopathological features. The pooled hazard ratios (HR) with 95% confidence intervals (CI) were used as effective values. Results A total of 15 studies involving 6329 patients were included in this study. The pooled results indicated that a high pre-treatment CAR was associated with poor overall survival (HR 2.028, 95% CI 1.808−2.275, p < 0.001) and poor disease-free survival/progression-free survival (HR 1.768, 95% CI 1.321–2.365, p < 0.001). Subgroup analysis revealed a constant prognostic value of the pre-treatment CAR despite different study regions, sample size, cancer stage, treatment methods, or the cut-off value used. We also noted a correlation between high pre-treatment CAR and old age, male sex, colon cancer, advanced stage (III/IV), large tumor size, poor differentiation, elevated carcinoembryonic antigen levels, neutrophil-to-lymphocyte ratio, and the modified Glasgow prognostic score. Conclusions High pre-treatment CAR was associated with poor overall survival, disease-free survival, and progression-free survival in colorectal cancer. It can serve as a prognostic marker for colorectal cancer in clinical practice.

scholarly journals COMBINED MODALITY TREATMENT FOR PATIENTS WITH INOPERABLE COLORECRAL LIVER METASTASES

2018 ◽  
Vol 17 (3) ◽  
pp. 34-40
Author(s):  
A. V. Shabunin ◽  
M. M. Tavobilov ◽  
D. N. Grekov ◽  
P. A. Drozdov
Keyword(s):  
Radiofrequency Ablation ◽  
Liver Metastases ◽  
Treatment Outcomes ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Regional Chemotherapy ◽  
Control Group ◽  
Free Survival ◽  
Group I ◽  
Disease Free

The purpose of the study was to improve treatment outcomes for patients with inoperable colorectal liver metastases using the  combination of chemoembilization of the hepatic artery and radiofrequency ablation.Material and methods. Treatment outcomes of 60 patients with methachronic unresectable liver metastases from colorectal cancer  were analyzed. Eligibility criteria were as follows: absence of  extrahepatic metastases, size of metastases from 3 to 5 cm, and  inability to perform resection. All patients were divided into two groups. Group I included 30 patients who received combination  of regional chemotherapy and radiofrequency ablation. Group II (the control group) consisted of 30 patients who received radiofrequency ablation only.Results. Post-embolization and post-ablation syndromes were observed in both groups of patients. Rightsided hydrothorax  (Clavien-Dindo grade II) was found in 4 out of 60 patients (2  patients in Group I and 2 patients in Group II). One-, two- and  three-year disease-free survival rates in Group I patients were 96.6  %, 76.6 % and 53.3 %, respectively. The corresponding rates in the  control group patients were 90.0 %, 53.6 % and 30.0 %,  respectively (p=0.049). The overall one-, two-and three-year  survival rates in Group I patients were 100 %, 90 % and 63.3 %,  respectively. The corresponding rates in the control group patients  were 100 %, 70 % and 50.0 %, respectively (p=0.202).Conclusion. The combination of regional chemotherapy and radiofrequency ablation led to the improvement in overall and disease-free survival rates.

scholarly journals Prognostic Impact of Tumor-Associated Macrophages on Long-Term Oncologic Outcomes in Colorectal Cancer

Life ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 1240
Author(s):  
Hyeong Chan Shin ◽  
Incheol Seo ◽  
Hasong Jeong ◽  
Sang Jun Byun ◽  
Shin Kim ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Oncologic Outcomes ◽  
Prognostic Impact ◽  
Tumor Associated Macrophages ◽  
Free Survival ◽  
Disease Free ◽  
Term Data

This study evaluated the correlation between tumor-associated macrophages (TAMs) and long-term oncologic outcomes in colorectal cancer (CRC). We evaluated TAMs based on the expression of CD68, CD11c, and CD163 as optimal markers via immunohistochemistry in 148 patients with CRC who underwent surgical resection between September 1999 and August 2004. A high proportion of CD68-positive macrophages were associated with the occurrence of distant metastasis. A low proportion of CD11c-positive macrophages were associated with unfavorable overall survival (OS) and disease-free survival. CD11c-positive macrophages were found to act as independent prognostic factors for OS. An analysis of our long-term data indicated that TAMs are significantly associated with OS and prognosis in CRC.

Sign in / Sign up

Export Citation Format

Share Document