Benefit of fluorouracil and folinic acid adjuvant in colon cancer elderly patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13564-13564 ◽  
Author(s):  
S. Lonardi ◽  
M. Stefani ◽  
A. Jirillo ◽  
C. Ghiotto ◽  
L. M. Pasetto ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Recurrence ◽  
Progression Free Survival ◽  
Tnm Stage ◽  
Stage Ii ◽  
Rank Test ◽  
Log Rank Test ◽  
Significant Difference ◽  
Unselected Population

13564 Background: Retrospective analyses on elderly people enrolled in clinical trials of adjuvant chemotherapy for colon cancer indicated the maintenance of the efficacy in that subset of patients (pts). However, data on the benefit of the routinely used adjuvant treatment in an unselected population of pts aged more than 65 years are few. Methods: All the charts of pts radically operated for colon cancer from 1996–2001 at Medical Oncology, Padua Hospital, were retrospectively analysed. 147 out of 330 pts consecutively treated with fluorouracil (FU)-based chemotherapy was aged 65 years or more at the time of diagnosis. Kaplan-Meyer progression-free-survival (PFS) and overall survival (OS) of stage II and III pts were calculated. Results: Pts characteristics were: males/females: 87/60, median age 71 (range 65–87), ECOG PS 0/1: 124/23, right/left colon primary tumor: 62/85, TNM stage: 24/63/60. 86 out of 147 pts were treated with the following regimen of adjuvant chemotherapy: FU 370 mg/mq + leucovorin (LV) 20 mg/mq day 1–5 q 28 for 6 cycles (Machover regimen, n=69), or FU 500 mg/mq + LV 250 mg/mq weekly × 6 q 56 for 4 cycles (Roswell Park regimen, n=17). Treated pts were staged as follows: TNM stage I/II/III: 1/38/47. No toxic death were observed and only nine of 86 pts (10.4%) stopped the treatment due to acute grade III gastrointestinal toxicity. At a median follow-up of 73.2 months, 19 out of 86 pts (22%) developed cancer recurrence (3-y PFS: 82.2%, 5-y PFS: 80.3%). Seventeen pts (19.7%) died, 13 (15.1%) due to tumor progression, 3 (3.4%) due to acute heart failure, and 1 (1.1%) due to chronic pulmonary disease (3-y OS: 88.8%, 5-y OS: 82.4%). No statistically significant difference in survival was observed comparing pts aged 65–70 (n=41) with pts more than 70 years old (n=45): 5-y OS 84.1% vs 77.8%, respectively (p=2.23, log rank test). A separate survival analysis on stage II pts was performed (n=63). 5 of 38 (13.1) treated pts dead, compared to 9 of 25 (36%) non treated pts; 5-y survival in the two groups were 86.6% and 60.8%, respectively (p= 0.03, log-rank test). Conclusions: The efficacy of adjuvant chemotherapy appears maintained in an unselected population of elderly pts. Surprisingly, our retrospective analysis suggest that even stage II pts may benefit of a fluorouracil-based well tolerated chemotherapy. No significant financial relationships to disclose.

A prospective randomized phase III trial of adjuvant chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) in patients with stage II colon cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4052-4052
Author(s):  
W. Schippinger ◽  
H. Samonigg ◽  
R. Greil ◽  
J. Tschmelitsch ◽  
G. Steger ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Lower Risk ◽  
Stage Ii ◽  
Phase Iii ◽  
Disease Relapse ◽  
Chi Square ◽  
Significant Difference ◽  
Stage Ii Colon Cancer

4052 Background: Whereas several studies showed adjuvant chemotherapy to improve survival of patients with stage III colon cancer, survival benefit from adjuvant treatment in patients with stage II disease is a matter of controversy. Methods: Patients with curatively resected stage II colon cancer (T3–4, N0, M0) according to UICC were randomized to either adjuvant chemotherapy with 5-FU/LV (100 mg/m2 LV + 450 mg/m2 5-FU weekly, w 1–6, in 8 w cycles x 7) or surveillance only. Primary endpoint was overall survival (OS) with 636 patients originally planned to demonstrate a difference in OS of 10% with 85% power and alfa =0.05 in a final analysis 7 years after study initiation. After accrual of 535 patients between 11/1993 and 6/2003, recruitment was stopped ahead of schedule for low accrual rates. Results: 505 patients were eligible and evaluable for analyses. After a median follow-up of 96 months, 56 (21.8%) patients have died in the 5-FU/LV arm and 58 (23.4%) in the surveillance arm. There was no statistically significant difference in OS between the two treatment arms (HR 1.137, 95% CI 0.787–1.641, p=0.4947, chi square), thus the primary endpoint of the study was not met. Disease relapse was documented in 35 (13.6%) patients of the chemotherapy arm and in 48 (19.4%) patients of the control arm. The relative risk for disease relapse was higher for patients in the surveillance arm compared to patients in the 5-FU/LV arm, however, this difference was statistically not significant (HR 1.506, 95% CI 0.974–2.328, p=0.0657, chi square). Subgroup analysis including in the chemotherapy arm only patients who received at least one cycle of 5-FU/LV (n=250), showed a statistically significantly lower risk for relapse in patients treated with 5- FU/LV (HR 1.559, 95% CI 1.001–2.429, p=0.0477, chi square). Conclusions: Results of this trial demonstrate a trend to a lower risk for relapse in patients treated with adjuvant 5-FU/LV for stage II colon cancer. However, adjuvant chemotherapy did not significantly improve DFS and OS. No significant financial relationships to disclose.

Development and validation of a robust prognostic and predictive signature for colorectal cancer (CRC) patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4036-4036
Author(s):  
A. M. Glas ◽  
P. Roepman ◽  
R. Salazar ◽  
G. Capella ◽  
V. Moreno ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Gene Signature ◽  
Low Risk ◽  
Stage Ii ◽  
Significant Difference ◽  
Independent Cohort

4036 Background: Between 25 and 35% of stage II CRC patients will experience a recurrence of their disease and may benefit from adjuvant chemotherapy. Official guidelines give suggestions but no clear recommendation for best risk stratification. Here we describe the development a robust signature that predicts disease relapse and can assist in treatment decisions. Methods: Fresh frozen tumor tissues from 180 patients with stage I, II and III colorectal cancer undergoing surgery were analyzed using high density Agilent 44K oligonucleotide arrays. Median FU was 70.2 months; 85% of patients did not receive adjuvant chemotherapy. Unsupervised hierarchical clustering based on full-genome gene expression measurement indicated the existence of 3 main colon molecular subclasses. Survival analysis of the 3 classes showed that subtype C (n= 27) had a poor outcome and subtype A (n= 48) good outcome. Only the intermediate group B (n=104) was used to develop a signature by using a cross validation procedure to score all genes for their association with 5-yr distant metastasis free survival (DMFS) and subsequently applied to all samples (n=180). The obtained gene signature was further validated on an independent cohort of 178 stage II + III colon samples. Results: A set of 38 prognosis related gene probes showed robust DMFS association in over 50% of all iterations in the Training Set of 180 samples. The gene signature was validated on an independent cohort of 178 samples from stage II + III colon cancer patients. The profile classified 61% of the validation samples as low-risk and 39% as high-risk. The low- and high-risk samples showed a significant difference in DMFS with a HR of 3.19 (P= 8.5e-4). Five-year DMFS rates were 89% (95%CI 83–95) for low-risk and 62% (95%CI 50–77) for high-risk samples. Moreover, the profile showed a significant performance within stage II (P=0.0058) and III (P=0.036) only samples. The performance of the profile was significant for both untreated (P=0.0082) and treated patients (P=0.016) suggesting that its power is independent of treatment benefits. Conclusions: ColoPrint is able to predict the prognosis of stage II and III colon cancer patients and facilitates the identification of patients who would benefit from adjuvant chemotherapy. [Table: see text]

Subset of patients with unfavorable T1N2-3M0 gastric cancer for whom surgery alone is the standard treatment.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 105-105
Author(s):  
Yukio Maezawa ◽  
Tsutomu Sato ◽  
Toru Aoyama ◽  
Kazuki Kano ◽  
Kenki Segami ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Standard Treatment ◽  
Stage Ii ◽  
Rank Test ◽  
Cancer Center ◽  
Tumor Diameter ◽  
Significant Difference ◽  
Macroscopic Tumor

105 Background: ACTS-GC trial demonstrated that S-1 is effective as adjuvant chemotherapy for Japanese patients who have undergone curative D2 gastrectomy for gastric cancer and were diagnosed with pathological stage II disease. However, stages T1N2M0 and T1N3M0, which are classified as part of Stage II, were excluded from the ACTS-GC trial. The aim of the present study was to identify the unfavorable subset of patients with T1N2M0 and T1N3M0 gastric cancer for whom surgery alone is the standard treatment. Methods: The present study examined 59 patients who were diagnosed with T1N2M0 or T1N3M0 gastric cancer at Kanagawa Cancer Center and Yokohama City University Hospital between January 2000 and June 2010. Univariate and multivariate analyses were performed to identify risk factors for overall survival using a Cox proportional hazards model. Results: When overall survival was compared by the log-rank test, a significant difference was observed with regard to macroscopic tumor diameter. A macroscopic tumor diameter greater than 30mm was regarded as a critical point of classification considering the survival. Mulitivariate Cox’s proportional hazard analyses demonstrated that macroscopic tumor diameter was the only significant independent prognosticator. The five-year survival was 60.0% in patients with a macroscopic tumor diameter < 30mm, and 84.6% in those with a macroscopic tumor diameter > 30mm (P = 0.027). Conclusions: Among T1N2M0 and T1N3M0 gastric cancer patients for whom surgery alone is the standard treatment, having a small T1N2-3 tumor of less than 30 mm in diameter was the sole risk factor for gastric cancer survival. These tumors might be another target for adjuvant chemotherapy.

Association of early tumor shrinkage with progression-free survival in patients with metastatic colorectal cancer treated with bevacizumab-based chemotherapy: HGCSG0802.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 749-749
Author(s):  
Hiroshi Nakatsumi ◽  
Satoshi Yuki ◽  
Tetsuhito Muranaka ◽  
Hiraku Fukushima ◽  
Takashi Kato ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Progression Free Survival ◽  
Rank Test ◽  
Tumor Shrinkage ◽  
First Line ◽  
Free Survival ◽  
Log Rank Test ◽  
Early Tumor Shrinkage ◽  
Significant Difference ◽  
Early Tumor

749 Background: It was reported that early tumor shrinkage (ETS) was associated with better overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC) receiving cetuximab. We investigated association of ETS with progression free survival (PFS) in pts with unresectable colorectal liver metastases (CLM) from HGCSG0802 observational cohort study in pts with mCRC treated with first-line bevacizumab (BV)-based chemotherapy. Methods: The objective of HGCSG0802 was to evaluate PFS, OS, time to treatment failure (TTF), response rate (RR), safety and so on. The key eligibility criteria were evaluable lesions, older than 20 years old, ECOG PS 0-2. In this analysis, association of ETS at 8 weeks from the start of chemotherapy with pts characteristics, PFS and TTF was evaluated. Pts characteristics were compared using Student-t test, chi-square test and Fisher’s exact test. PFS and TTF were analyzed with Kaplan-Meier method and compared using log-rank test. Univariate analysis for the association of pts characteristics with PFS and TTF was performed using log-rank test, and multivariate analysis was performed using Cox proportional hazards model. Results: Of 108 pts (the full analysis set), 74 pts with CLM were evaluable for ETS. Forty-nine pts (66.2%) had ETS ≥20%. The pts characteristics between ETS ≥20% and <20% were well balanced. The median PFS was 7.3 months in ETS <20% versus 10.0 months in ETS ≥20% (HR 0.55; p=0.025). In multivariate analysis for PFS, there was no significant difference between ETS ≥20% and <20% (HR 0.585; p=0.066). The median TTF (ETS <20% v ≥20%) was 5,1 months vs. 7.7 months (HR 0.46; p=0.003). In multivariate analysis for TTF, there was significant difference between ETS ≥20% and <20% (HR 0.509; p=0.017). Conclusions: In this analysis, ETS ≥20% might be positive predictive marker for PFS and TTF in pts with CLM receiving first-line BV-based chemotherapy.

Phase III Study Comparing a Semimonthly With a Monthly Regimen of Fluorouracil and Leucovorin As Adjuvant Treatment for Stage II and III Colon Cancer Patients: Final Results of GERCOR C96.1

2007 ◽  
Vol 25 (24) ◽  
pp. 3732-3738 ◽  
Author(s):  
Thierry André ◽  
Emmanuel Quinaux ◽  
Christophe Louvet ◽  
Philippe Colin ◽  
Erik Gamelin ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Treatment ◽  
Disease Free Survival ◽  
International Study ◽  
Stage Ii ◽  
Phase Iii ◽  
Rank Test ◽  
Treatment Groups ◽  
Metastatic Relapse ◽  
Significant Difference

PurposeThis randomized, 2 × 2 factorial study compared a semimonthly regimen (fluorouracil [FU] and leucovorin [LV] semi-monthly is LV5FU2) with a monthly regimen of FU and LV (mFU/LV) as well as 24 weeks versus 36 weeks of each regimen as adjuvant treatment of stage II and III colon cancer.Patients and MethodsLV5FU2 was administered semimonthly for 2 days as racemate (dl) or levogyre (l-; 200 or 100 mg/m2) as a 2-hour infusion, followed by 400 mg/m2FU bolus and a 600-mg/m2FU 22-hour continuous infusion. FU and LV were administered monthly (mFU/LV) for 5 days as dl- or l-LV 15-minute infusion, followed by a 400 mg/m2FU 15-minute infusion. The primary end point was disease-free survival (DFS).ResultsBetween September 1996 and November 1999, 905 patients with stage II (43%) and III (57%) colon cancer were enrolled. The median follow-up was 6 years. There was no statistically significant difference between mFU/LV and LV5FU2 in terms of DFS (150 v 148 events; hazard ratio [HR],1.01; 95% CI, 0.806 to 1.269; P = .94) and overall survival (OS; 104 v 103 events; HR,1.02; 95% CI, 0.77 to 1.34; P = .91). No statistical difference was observed between 24 or 36 weeks of chemotherapy. Median survival from metastatic relapse was 24 months. The survival of patients with metastatic relapse (n = 243) was significantly longer for patients with a longer time from random assignment to relapse (< 1, 1 to 2, ≥ 2 years; log-rank test for trend P, .0497).ConclusionDFS and OS were not statistically different between treatment groups and treatment durations. These data confirm the value of LV5FU2 as control arm in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer and Pan-European Trials in Adjuvant Colon Cancer studies.

Predictive factors for the underutilization of adjuvant chemotherapy in colon cancer in Southwestern Sydney

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6070-6070
Author(s):  
W. L. Ng ◽  
G. Gabriel ◽  
E. Moylan
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Predictive Factors ◽  
Predictive Factor ◽  
Treatment Guidelines ◽  
Stage Ii ◽  
Stage Iii ◽  
Utilization Rate ◽  
Co Morbidity ◽  
Significant Difference

6070 Background: Adjuvant chemotherapy improves survival in stage III and high risk stage II colon cancers and is therefore recommended in current treatment guidelines. Despite this, retrospective studies demonstrate that utilization rates remain suboptimal in Australia and other countries. In this study we aimed to identify predictive factors for adjuvant chemotherapy underutilization in the Southwestern Sydney Area Health Service (SWSAHS). Methods: We examined data collected on all patients with a diagnosis of stage II or III colon and rectosigmoid cancers from SWSAHS colorectal database between 1997 and 2003. Follow-up and survival were calculated until October 2005. SPSS was used for statistical analysis and Kaplan-Meier for survival analysis. Results: 704 patients were identified. The overall adjuvant chemotherapy utilization rate was 48% (68% for stage III and 26% for stage II). Overall 5 year survival was 69% for patients who received adjuvant chemotherapy compared with 39% for those who did not receive chemotherapy (p<0.001). The main predictive factor identified for not receiving chemotherapy in both stages was increasing age. Rates of utilization of adjuvant chemotherapy for stage III colon cancer were 90% (<50 yrs), 81% (50–69 yrs) and 50% (70+ yrs). The trend was similar for stage II patients with corresponding utilization rates of 69%, 37% and 10%, respectively. The difference in chemotherapy utilization by age groups is highly significant (p<0.001). Other factors including sex, health insurance status, site of primary colon cancer and index of relative socioeconomic disadvantage did not show significant difference in chemotherapy usage. We were unable to evaluate the effect of co-morbidity on chemotherapy use from our database. Conclusions: Increasing age is the single most important predictive factor in the underutilization of adjuvant chemotherapy in colon cancer despite evidence that the elderly can accrue the same benefit from adjuvant chemotherapy as their younger counterparts. No significant financial relationships to disclose.

Transient increase in serum CEA while on adjuvant chemotherapy for colon cancer: Is this of prognostic importance?

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 654-654
Author(s):  
Nicola Jane Mitchell ◽  
Victoria Hinder ◽  
Melissa Murray ◽  
Jerome Macapagal ◽  
Paul Ivan Thompson ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Cox Regression ◽  
Transient Increase ◽  
Stage Ii ◽  
Response To Treatment ◽  
Metastatic Colon Cancer ◽  
Continuous Increase ◽  
Significant Difference ◽  
Serum Carcinoembryonic Antigen

654 Background: Serum Carcinoembryonic Antigen (CEA) is used to monitor response to treatment in metastatic colon cancer. Transient surges in CEA can occur after initiation of chemotherapy and are not associated with worse outcome. There is little data on transient CEA surge in the adjuvant setting. We aimed to review patterns of change in CEA levels with adjuvant chemotherapy and investigate associations between transient rises and patient survival. Methods: A retrospective review of patients in Auckland with a new diagnosis of colon cancer in 2001 or 2005 was reported previously [Murray, NZMJ, 2011]. CEA results immediately pre-chemotherapy, during and up to 9 months post chemotherapy were collected and death data was updated. Increase in CEA during chemotherapy was measured as the maximum change from baseline; values more than 2 (within-person) standard deviations above baseline [Erden, Scand, J Clin Lab Inv, 2008] were classified as increased. An increase was transient if the last recorded CEA post chemotherapy was within 2 sd of baseline. Three patient groups were defined: NI (no increase in CEA); TI (transient increase in CEA); and CI (continuous increase in CEA). Kaplan-Meier methods were used to estimate 5-year survival; Cox regression and log-rank p-values were used to compare survival. Results: Of the 77 patients identified with stage II or III disease who had received adjuvant chemotherapy, 61 had sufficient CEA data to be included. The TI group were younger (median [quartiles]: TI 59 [54, 64]; NI 65 [53, 74]; CI 68 [62, 74]) but a greater proportion were stage II (TI 32%; NI 23%; CI 17%). Patients were followed up for a minimum of 7.3 years (or death). Number of deaths per group were: TI 3/19; NI 9/30; CI 7/12. The 5 year overall survival was: TI 95%; NI 83%; CI 42%. There was no significant difference between TI and NI (p = 0.1), but the confidence interval was wide (HR 0.3; 95% CI (0.07 to 1.5). For CI compared to NI, the HR was 2.8 (95% CI (1.0 to 7.6), p = 0.04). Conclusions: The observation that CEA surge does not signal poorer prognosis will be further examined as part of a separate population-based New Zealand-wide study of colorectal cancer diagnosis, treatment and outcome. Part funded by a Genesis Oncology Trust grant.

scholarly journals Overall Survival Benefit in Rectal Cancer After Neoadjuvant Radiotherapy and Adjuvant Chemotherapy: A Propensity-Matched Population-Based Study

2020 ◽  
Vol 10 ◽  
Author(s):  
Zhiju Chen ◽  
Shaowei Li ◽  
Yehong Wang ◽  
Zhiming Fu ◽  
Ning Liu ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Surgical Resection ◽  
Survival Benefit ◽  
Stage I ◽  
Stage Ii ◽  
Rank Test ◽  
Neoadjuvant Radiotherapy ◽  
Log Rank Test

BackgroundIt is well known that neoadjuvant radiotherapy could reduce local recurrence followed by surgical resection. However, evidence about oncologic efficacy of radiotherapy and survival benefit of adjuvant chemotherapy after neoadjuvant radiotherapy is still lacking.MethodsThis retrospective propensity score-matched cohort study identified patients with pathologically confirmed rectal cancer and receiving surgery with curative intent from the Surveillance, Epidemiology, and End Results database from 2004 through 2014. Overall survival was compared using the stratified log-rank test. Multivariate Cox regression analysis was used for identifying risk factor and developing prediction nomogram.ResultsA total of 22,008 (11,004 for each group) propensity-matched patients were identified. In the context of receiving adjuvant chemotherapy after surgical resection, there was no significant difference in terms of overall survival between surgery alone group and neoadjuvant radiotherapy and surgery group, whether for stage I (log-rank test p = 0.467), stage II (log-rank test p = 0.310), or stage III (p = 0.994). In case of receiving a prior combination therapy of neoadjuvant radiotherapy and surgery, the following adjuvant chemotherapy could significantly improve overall survival for patients with stage I (log-rank test p &lt;0.001), stage II (log-rank test p = 0.038), and stage III (log-rank test p = 0.014). Nomogram integrating clinicopathologic factors was developed to predict survival benefit associated with neoadjuvant radiotherapy. Calibration and ROC curves validated promising performance for the nomogram.ConclusionPatients with rectal cancer underwent neoadjuvant radiotherapy yield acceptable outcomes and are more likely to benefit from adjuvant chemotherapy in terms of overall survival. These data would be evidential for advocating consistency in guideline adherence to the use of adjuvant chemotherapy after neoadjuvant radiotherapy.

Association of genetic variants in plastin family genes with tumor recurrence in stage II/III colon cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14031-e14031
Author(s):  
Yan Ning ◽  
Thomas Winder ◽  
Wu Zhang ◽  
Dongyun Yang ◽  
Fotios Loupakis ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Tumor Recurrence ◽  
Cox Regression ◽  
Stage Ii ◽  
In Vivo Studies ◽  
Actin Binding ◽  
Comprehensive Cancer Center ◽  
Rank Test ◽  
Cancer Center ◽  
Log Rank Test

e14031 Background: Plastins belong to a subclass of actin-binding proteins known as actin bundling proteins. Plastins family constitute of two isoforms in human as T-plastin (PLS3) and L-plastin (LCP1). Recent in vitro and in vivo studies found plastin genes are overexpressed in colon cancer cells and can lead to increased proliferation, invasion and metastasis. Here we tested the hypothesis whether potential functional tagging polymorphisms in PLS3 (rs6643869, rs5987947, rs2522188) and LCP1 (rs4941543, rs1409429, rs11342) may predict tumor recurrence in adjuvant colon cancer patients. Methods: Either blood or FFPE tissue specimens were obtained from 234 patients (107 females and 127 males; median age 59 years (range 22–78 years)) with stage II (105 patients) or III (129 patients) colon cancer at the University of Southern California/Norris Comprehensive Cancer Center. The median follow-up was 4.4 years. PLS3 and LCP1 SNPs were determined by PCR-RFLP or PCR-based direct sequence. The primary endpoint of the study was time to tumor recurrence (TTR). Results: In univariable analysis, PLS3 rs6643869 and LCP1 rs4941543 were significantly associated with time to tumor recurrence (TTR). Patients with PLS3 AA genotype had shortest median TTR 3.2 years (95% C.I: 1.5-10.7) compared to those with AG or GG genotype, which had median TTR 9.4 years (95% C.I: 5.7-12.2) (p=0.012, log-rank test). Patients with LCP1 CC genotype had longer median TTR 10.7 years (95% C.I: 5.7-16.8+) compared to those with CT and TT genotypes, which had shorter median TTR 4.9 years (95% C.I: 1.4-9.0+)(p=0.040, log-rank test). PLS3 rs6643869 remained significant in the multivariate Cox regression model adjusted by stage and type of adjuvant therapy and stratified by race (p=0.021). Conclusions: Our preliminary results demonstrated that polymorphisms in plastin family genes PLS3 and LCP1 might be potential molecular markers to predict TTR in adjuvant colon cancer. Further large and biomarker embedded trial needed to confirm our findings.

A randomized phase II trial of adjuvant chemotherapy with S-1 versus S-1 and gemcitabine (GS) versus gemcitabine alone (GEM) in patients with resected pancreatic cancer (CAP-002 study).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4056-4056 ◽  
Author(s):  
Hideyuki Yoshitomi ◽  
Hiroaki Shimizu ◽  
Hiroyuki Yoshidome ◽  
Masayuki Ohtsuka ◽  
Atsushi Kato ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Progression Free Survival ◽  
Residual Tumor ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Rank Test ◽  
Free Survival ◽  
Significant Difference

4056 Background: Although the adjuvant therapy using GEM is now the standard therapy for patients with resected pancreatic cancer (PC), the prognosis still remains poor. Resent study demonstrated the non-inferiority of S-1 and superiority of GS to GEM with respect to progression free survival in patients with unresectable pancreatic cancer. Methods: Patients with invasive ductal PC who underwent radical surgery were enrolled. After stratification for R0/1, stage and institution, patients were randomized to receive GEM (GEM 1g/ m2, iv, d1, 8, and 15, q4w X12), S-1 (80/100/120mg/day based on BSA, po, d1-14, q3w X 16) or GS (S-1 60/80/100mg/day based on BSA po, d1-14 plus GEM 1g/ m2, iv, d8, 15, q3w X 16) within 8weeks after operation. Eligibility included histological residual tumor (R) 0 or 1, and no previous chemo- or/and radiation therapy. Primary endpoint was 2y disease free survival (DFS) rate and secondary endpoints included overall survival (OS), and safety. Results: Between January 2007 and October 2010, 96 patients were randomized into the three arms of the trial (32 pts to each group). Patients’ characteristics were well balanced (GEM/S-1/GS) with regard to age (66/67/66y), tumor location (head 66/69/75%), tumor status (T3+4 88/78/91%), and nodal status (positive 75/69/75%). Until November 2012, 74 events (77%) have occurred for DFS. Two year DFS rate was 24.2%, 28.1% and 34.4% in GEM, S-1 and GS, respectively and there was no significant difference between groups. The median OS was 21m in GEM, 26m in S-1 and 27.9m in GS (Log rank test: N.S.). Grade 3/4 toxicities in GEM/S-1/GS were hematological 63/10/74% and non-hematological 17/10/23%, respectively. No treatment related death was observed during the study. Conclusions: S-1 and GS provided similar efficacy to GEM as the adjuvant chemotherapy for resected PC. According to the results, S-1 and GS is the adequate combination for phase III trial to examine the efficacy of adjuvant chemotherapy for PC. Clinical trial information: UMIN000002000.

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