Delayed start of adjuvant 5-FU/leucovorin based chemotherapy in colon cancer is safe up to 12 weeks postoperatively

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4056-4056 ◽  
Author(s):  
G. Carlsson ◽  
P. Albertsson ◽  
B. Gustavsson

4056 Background: Postoperatively adjuvant chemotherapy with 5-Fluorouracil modulated by leucovorin alone or in combination with Oxaliplatin significantly reduce the risk of recurrence and prolong the disease free survival (DFS) in patients with a radical resection for colonic carcinoma. In all reported studies the chemotherapy has started within 6–8 weeks after surgery. Due to complications following surgery it is not always possible to start adjuvant chemotherapy within this time frame. The aim of the present retrospective study was to investigate the effect on risk of recurrence and effect on DFS in patients treated in clinical routine practice in one single institution. Methods: Between 1992 and 2004, 234 patients (121 females, 113 males) with a median age of 66 years (range 25–84 years) received weekly bolus 5-FU/leucovorin postoperatively for 6 months. 211 (90.2%) had a Dukes′ C tumour and 23 (9.8%) high risk Dukes′ B tumour. The median time from surgery and start of adjuvant therapy was 71 days (range 30–190 days). Patients were divided in three groups, where chemotherapy started within 6 weeks, 8 weeks and 12 weeks after surgery and the frequency of recurrent disease and DFS were compared between these groups. Results: Medium follow-up was 35.6 months (range 2,7- 140.6 months). Five patients (21.7%) with Dukes′ B tumours and 76 patients (36.0%) with Dukes′ C tumours recurred during the follow-up period. There were no differences in the proportion of Dukes′ B and C tumours between the three groups. Recurrent disease was more frequent but no significant difference in patients that started within 6 weeks (52.6%) compared with patients that started within 8 weeks (45.5%) and 12 weeks (35.5%). In all three groups there was a tendency to better DFS in patients that started later than 6 or 8 weeks, but these differences were not significant. Conclusions: Starting adjuvant 5-Fluorouracil/leucovorin alone later than 6–8 weeks do not negatively effect the risk of recurrent disease or DFS. No significant financial relationships to disclose.

2019 ◽  
Vol 37 (16) ◽  
pp. 1436-1447 ◽  
Author(s):  
Christopher Lieu ◽  
Erin B. Kennedy ◽  
Emily Bergsland ◽  
Jordan Berlin ◽  
Thomas J. George ◽  
...  

PURPOSE To develop recommendations for duration of adjuvant chemotherapy with a fluoropyrimidine and oxaliplatin for patients with completely resected stage III colon cancer based on the results of trials of 3 months compared with 6 months of treatment. METHODS ASCO convened an Expert Panel and conducted a systematic review of relevant studies. The guideline recommendations were based on the review of evidence by the Expert Panel. RESULTS Pooled data from the six International Duration Evaluation of Adjuvant Chemotherapy (IDEA) Collaboration randomized controlled trials comprise the evidence base for these guideline recommendations. RECOMMENDATIONS The recommendations for therapy duration apply to patients with completely resected stage III colon cancer who are being offered adjuvant chemotherapy with oxaliplatin and a fluoropyrimidine. Recommendations are informed by the findings of a recent pooled analysis of clinical trials that compared 6 months versus 3 months of oxaliplatin-based chemotherapy. For patients at a high risk of recurrence (T4 and/or N2), adjuvant chemotherapy should be offered for a duration of 6 months. For patients at a low risk of recurrence (T1, T2, or T3 and N1), either 6 months of adjuvant chemotherapy or a shorter duration of 3 months may be offered on the basis of a potential reduction in adverse events and no significant difference in disease-free survival with the 3-month regimen. In determining duration of therapy, the Expert Panel recommends a shared decision-making approach, taking into account patient characteristics, values and preferences, and other factors and including a discussion of the potential for benefit and risks of harm associated with treatment duration. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10610-10610
Author(s):  
J. Ahn ◽  
S. Kim ◽  
B. Son ◽  
S. Ahn ◽  
W. Kim

10610 Background: Recently, adjuvant AC followed by paclitaxel has improved disease-free survival (DFS) or overall survival (OS) of node-positive breast cancer. Although adjuvant TAC, as compared with FAC, significantly improves DFS and OS rate in node-positive breast cancer, AC→T has not been yet compared with FAC. Since 2001, we discussed the options of adjuvant CAF versus AC→T with patients who had 4 or more positive axillary nodes. We evaluated the efficacies of adjuvant CAF and AC→T, retrospectively. Methods: Between September 2001 and July 2004, a total of 1,394 patients underwent surgery and received adjuvant chemotherapy. Among them, 253 (18.1%) patients had 4 or more than axillary nodes and received either six cycles of CAF (n = 116) or 4 cycles of AC→T) (n = 137). The medical records and pathologic data of these patients were reviewed, retrospectively. Results: Median age of all patients was 46 years (range, 22∼76 years). The two groups were well balanced in terms of demographic and tumor characteristics. With a median follow-up period of 24 months (range, 6∼90 months), 49 (19.4%) patients had disease recurrence including 27 (23.3%) in CAF group and 22 (16.1%) in AC→T group (p = 0.155). The 3 year-DFS rate was 68.3% in CAF group and 71.1% in AC→T group (p = 0.9366), and the estimated 3-year OS rate was 90.3% and 92.3%, respectively (p = 0.8237). There was no significant difference in 3-year DFS rate according to hormone-receptor status. Febrile neutropenia occurred in 11 (9.6%) patients in CAF group and 7 (5.1%) patients in AC→T group (p = 0.222). Conclusion: Our data suggest that there is no significant difference in DFS or OS rates between six cycles of CAF and 4 cycles of AC followed by 4 cycles of paclitaxel as adjuvant chemotherapy in patients with 4 or more than involved axillary nodes. However, long-term follow-up period and prospective studies are needed to define better regimen. No significant financial relationships to disclose.


2002 ◽  
Vol 49 (2) ◽  
pp. 19-22 ◽  
Author(s):  
Zoran Krivokapic ◽  
Goran Barisic ◽  
V. Markovic ◽  
Milos Popovic ◽  
Sladjan Antic ◽  
...  

In the period 01.01.1991 - 12.31.1996, 523 operations due to rectal carcinoma were performed on the First Surgical Clinic, the Third Department for Colorectal Surgery. Most common localization of tumor was in the distal third of the rectum 65,2%. In the middle third, there were 28,9% and in the upper, intraperitoneal third 5,9%. We performed 286 low anterior stapled resections, 93 anterior resections with hand-sewn anastomosis and 144 Abdominoperineal excisions of rectum (Miles procedure). Pathohistological examination revealed adenocarcinoma in all cases. In this study we analyzed local recurrence and five-year survival after long-term follow-up in the group where Miles procedure was carried out as a potentially curative procedure (except 4,9% cased with Dukes D stage). There were 74,3% males and 23,7% females median age 59,2 years. According to Dukes classification there were 4,9% in stage A, 47,2% in stage B, 43,1% stage C, and 4,9% stage D. There were 4 (2,7%) postoperative deaths. Recurrence of the disease was registered in 44 (30,5%) patients. Local recurrence alone was found in 14 (9,7%) patients, while distant spread was registered in 30 (20,8%) patients. At present, the median follow-up is at 72,9 months. Analysis by the Kaplan-Meier's test shows cumulative survival of 61%, and disease free survival of 63,4% at 60 months of the follow-up. Dukes C is associated with a very poor prognosis; sur-M\al after 60 months of follow up shows cumulative Survival of 0,35 while Dukes B has far better prognosis (0,86). Analysis of disease free survival by Dukes stage shows that Dukes C has the worst prognosis (disease free survival 0,36 after 60 months), while stage B has much better prognosis (0,84). Local recurrence analysis by the Kaplan-Meier's test shows disease free survival of 84,9% at 60 months of follow-up. Analysis of local recurrence by Dukes stage shows 1,00% disease free survival for cases in stage A, 0,94 for Dukes B and 0,66 for Dukes C, while overall comparison between groups regarding local recurrence using the Wilcoxon (Gehan) statistic shows statistically significant difference (p=0,005). There is no statistical difference between Dukes A and Dukes B cases in distribution of local recurrence.


2000 ◽  
Vol 15 (1) ◽  
pp. 51-55 ◽  
Author(s):  
A.I. Behbehani ◽  
H. Al-Sayer ◽  
M. Farghaly ◽  
N. Kanawati ◽  
A. Mathew ◽  
...  

Preoperative CEA and CA 19–9 levels have been used in the past as prognostic indicators in colorectal cancer, but Dukes’ stage is still considered to be the most important prognostic factor. Recent survival estimates may have been influenced by the fact that in the last decade adjuvant chemotherapy and postoperative irradiation have been included in the routine management of advanced-stage disease. In a heterogeneous Kuwaiti population higher reference levels (95th percentile) of CEA and CA 19–9 have been found than those usually employed. In the present study 62 patients with Dukes’ stage B + C could be analyzed for two-year disease-free survival (DFS). Relapse was observed in 19 patients, 28 patients were disease free and 15 patients with censored observations were included. No significant difference in DFS was observed in Dukes’ B (69%) versus Dukes’ C (48%) patients (p=0.09). On the other hand, Dukes’ stage B+C patients with elevated preoperative levels of CEA or CA 19–9 had a significantly poorer DFS than patients with normal levels. For CEA levels below or above the cutoff the DFS was 74% versus 23% (p=0.003); for CA 19–9 levels below or above the cutoff the DFS was 71% versus 33% (p=0.004). In 54 patients with Dukes’ stage B+C for whom preoperative levels of both CEA and CA 19–9 were available multivariate analysis revealed a decreasing risk of relapse in the following order: CEA and/or CA 19–9 elevated (chi-square 7.09; p=0.008), CA 19–9 elevated (chi-square 6.27; p=0.01), CEA elevated (chi-square 5.47; p=0.02), and Dukes’ C (chi-square 2.08; p=0.15 n.s.). Hence, novel treatment protocols may have improved the disease-free survival, but the use of adjuvant chemotherapy and/or radiotherapy is of questionable benefit in patients who have elevated levels of CEA and/or CA 19–9 prior to treatment.


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 609-609
Author(s):  
C. R. Oxner ◽  
S. Choi ◽  
M. J. Hein ◽  
D. Lim ◽  
S. Shibata ◽  
...  

609 Background: Adjuvant chemotherapy is recommended after rectal cancer surgery. Yet the success and complication rates of this adjuvant treatment are poorly studied. The purpose of this study is to determine the success rate and define the toxicity profile of adjuvant chemotherapy in rectal cancer patients previously treated with neoadjuvant chemotherapy. Methods: Study design is a retrospective review of patients from December 2002-December 2007 from the City of Hope database. Data is available with 66 patients diagnosed with locally advanced rectal cancer treated with neoadjuvant chemo radiation and resection. Data points analyzed included demographics, chemotherapy-related toxicity and survival. Results: Adjuvant chemotherapy was started in 35/66 (53%) of patients. In 31 cases chemotherapy was not given because of patient refusal or physician preference. 9 patients were lost to follow-up. Follow-up ranged from 9-59 months with median follow-up of 27 months. In the 26 patients with adequate follow up there were a total of 165 episodes of toxic events 3a grade 1. Most of the events were mild to moderate grade 1-2. In 10 patients (28%) 22 major toxicities 3a grade 3 episodes were observed. The median Karnofsky performance scale (KPS) showed no significant difference in patients before and after adjuvant chemotherapy (p = 0.071). The rates of 1-year, 3-year and 5-year survival were 100%, 90%, and 60%, respectively; corresponding disease-free survival was 88%, 83%, and 69% respectively. Conclusions: These preliminary data suggest that only a fraction of rectal cancer patients previously treated with neoadjuvant CRT complete a full course of adjuvant chemotherapy. Future studies will help confirm these preliminary findings and generate an outcome comparison between patients receiving and not receiving adjuvant therapy. No significant financial relationships to disclose.


2003 ◽  
Vol 13 (4) ◽  
pp. 395-404 ◽  
Author(s):  
B. Winter-Roach ◽  
L. Hooper ◽  
H. Kitchener

A systematic review and meta analysis has been undertaken in order to evaluate the effectiveness of adjuvant therapy following surgery for early ovarian cancer. Trials reported since 1990 have been of a higher quality enabling a meta analysis of adjuvant chemotherapy vs adjuvant radiotherapy and a meta analysis of adjuvant chemotherapy vs observation. There was no significant difference between radiotherapy and chemotherapy, though these comprised studies which demonstrated considerable heterogeneity. Chemotherapy did confer significant benefit over observation in terms of both overall and disease free survival. Except for women in whom adequate surgical staging has revealed well differentiated disease confined to one or both ovaries with intact capsule, platinum chemotherapy should be offered to reduce risk of recurrence.


2011 ◽  
Vol 29 (34) ◽  
pp. 4491-4497 ◽  
Author(s):  
Edith A. Perez ◽  
Vera J. Suman ◽  
Nancy E. Davidson ◽  
Julie R. Gralow ◽  
Peter A. Kaufman ◽  
...  

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen.


BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e021341
Author(s):  
Cheng-I Hsieh ◽  
Raymond Nien-Chen Kuo ◽  
Chun-Chieh Liang ◽  
Hsin-Yun Tsai ◽  
Kuo-Piao Chung

ObjectivesOne feature unique to the Taiwanese healthcare system is the ability of physicians other than oncologists to prescribe systemic chemotherapy. This study investigated whether the care paths implemented by oncologists and non-oncologists differ with regard to patient outcomes.SettingData from the Taiwan Cancer Registry and National Health Insurance Database were linked to identify patients with colon cancer who underwent colectomy as first treatment within 3 months of diagnosis and adjuvant chemotherapy between 2005 and 2009.Participants and methodsPostoperative patients who underwent adjuvant chemotherapy were included in this study. The exclusion criteria included patients with stage IV disease, a positive surgical margin and early disease recurrence. Among the patients presenting with multiple primary cancers, we also excluded patients who were diagnosed with colon cancer but for whom this was not the first primary cancer. The variables included sex, age, comorbidities, disease stage, chemotherapy cycle and changes in treatment regimen as well as the specialty of treatment providers and their case volume. Cox regression models and Kaplan-Meier analysis were used to examine differences in outcomes in the matched cohorts.ResultsWe examined 3534 patients who were prescribed adjuvant chemotherapy by physicians from different disciplines. In terms of 5-year disease-free survival, no significant difference was observed between the groups of oncologists or surgeons among patients with stage II (90.02%vs88.99%) or stage III (77.64%vs79.99%) diseases. Patients who were subjected to changes in their chemotherapy regimens presented recurrence rates higher than those who were not.ConclusionsThe discipline of practitioners is seldom taken into account in most series. This is the first study to provide empirical evidence demonstrating that the outcomes of patients with colon cancer do not depend on the treatment path, as long as the selection criteria for adjuvant chemotherapy is appropriate. Further study will be required before making any further conclusions.


2019 ◽  
Vol 49 (8) ◽  
pp. 714-718
Author(s):  
Hao Yu ◽  
Linlin Zhang ◽  
Dapeng Li ◽  
Naifu Liu ◽  
Yueju Yin ◽  
...  

Abstract Objectives The current study was aimed to evaluate the efficacy and toxicity of postoperative adjuvant chemotherapy (CT) combined with intracavitary brachytherapy (ICRT) in cervical cancer patients with intermediate-risk. Methods We analyzed the medical records of 558 patients who were submitted to radical surgery for Stage IB-IIA cervical cancer. A total of 172 of those 558 patients were considered intermediate-risk according to the GOG criteria. Among those 172 patients, 102 were subjected to CT combined with ICRT (CT+ICRT) and the remaining 70 patients were treated with concurrent chemoradiation (CCRT). The 3-year disease free survival (DFS), overall survival (OS), and complications of each group were evaluated and analyzed. Results No significant difference was observed in 3-year DFS or OS of the patients submitted to CT+ICRT and CCRT. Importantly, the frequencies of grade III to IV acute complications were significantly higher in patients submitted to CCRT than in those treated with CT+ICRT (Hematologic, P = 0.016; Gastrointestinal, P = 0.041; Genitourinary, P = 0.019). Moreover, the frequencies of grade III–IV late complications in patients treated with CCRT were significantly higher compared with CT+ICRT-treated patients (Gastrointestinal, P = 0.026; Genitourinary, P = 0.026; Lower extremity edema, P = 0.008). Conclusions Postoperative adjuvant CT+ICRT treatment achieved equivalent 3-year DFS and OS but low complication rate compared to CCRT treatment in early stage cervical cancer patients with intermediate-risk.


2004 ◽  
Vol 51 (2) ◽  
pp. 133-137 ◽  
Author(s):  
Zoran Krivokapic ◽  
Goran Barisic ◽  
V. Markovic ◽  
Milos Popovic ◽  
Sladjan Antic ◽  
...  

In the period 1990 - 2002, 1674 patients with colorectal carcinoma were operated in the First Surgical Clinic, Third Department for Colorectal Surgery. In 1264 cases (75,5%) rectal carcinoma was the indication for surgical treatment. Sphincter saving procedures (SSP) were performed in 824 (65,2%), abdominoperineal resections (APR) in 340 (26,9%) and resections of rectum with definitive stoma (Hartmann procedure) in 100 (7,9%) patients. We analyzed 1095 cases where curative SSP or APR were performed. All cases where curative resection was not possible because of liver metastases or inability to excise all macroscopic disease were excluded. In the group of patients where SSP was performed (767 cases), there were 26,6% high colorectal anastomoses (8cm from anal verge), 65,4% with low (4-8cm from anal verge) and 8,0% with intersphincteric coloanal anastomosis (cm from anal verge). Patohistological exam showed 5,3% Dukes A, 53,1% Dukes B, 36,5% Dukes C and 4,9% Dukes D. In the APR group (328 cases) there were 1,5% Dukes A, 32,4% Dukes B, 62,1% Dukes C and 3,5% Dukes D. In this study we analyzed local recurrence and five-year survival in both groups. Recurrence of the disease was registered in 325 (29,6%) out of 1095 patients. Local recurrence was found in 81 (7,4%) patients. In the SSP group recurrence occured in 215 (28,0%) out of 767 curative resections. Local recurrence alone was found in 53 patients (6,9%). SSP group was also divided into two subgroups; in the first group TME was performed and in second transection of mesorectum was carried out. Analyzing local recurrence in these two groups, in the TME group it was 7,6% and in the transection group 5,6%. In the APR group recurrence was registered in 110 (33,5%) out of 328 patients while local recurrence alone was found in 28 (8,5%) cases. Analyzing mortality we found that 234 (21,4%) out of 1095 patients died during follow-up. In the SSP group 154 out of 767 patients (20,1%) died. In the TME group mortality was 21,7% and in the transection group 16,9%. Mortality in the APR group showed that 80 out of 328 (24,4%) patients died during follow-up. Analysis by the Kaplan-Meier?s test shows cumulative survival of 0,69 for all cases. In the SSP group cumulative survival is 0,72 and in the APR group 0,64 with statistically significant difference (p,001). In the TME group cumulative survival is 0,75 and in the transection group 0,72 with statistically significant difference (p,05). We believe that performing SSP should be encouraged whenever it is possible because there is no difference in local recurrence rates and survival compared to APR. Transection of mesorectum can safely be performed in most cases with tumors located more than 8 cm form anal verge. We believe that exact preoperative staging and preoperative radiotherapy could improve results.


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