Phase III Study of Fluorouracil, Leucovorin, and Levamisole in High-Risk Stage II and III Colon Cancer: Final Report of Intergroup 0089

Haller, Daniel G.; Catalano, Paul J.; Macdonald, John S.; O’Rourke, Mark Allen; Frontiera, Michael; Jackson, Don V.; Mayer, Robert J.

doi:10.1200/jco.2004.00.5686

Cited by 338 publications

(189 citation statements)

References 31 publications

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“…No difference was observed in the efficacies of 6-and 12-month chemotherapy durations in a 5-fluorouracil (5-FU)/ levamisole adjuvant chemotherapy study [13]. In addition, no difference was found between 6-and 9-month chemotherapy durations in the GERCOR C96.1 trial [14].…”

Section: Introductionmentioning

confidence: 88%

“…Moertel et al reported that 12 months of adjuvant chemotherapy with 5-FU plus levamisole yielded excellent outcomes [29]. Thereafter, the Intergroup trial 0089 (INT-0089) and the Groupe Cooperateur Multidisciplinaire en Oncologie trial found no difference in efficacy among 6, 9, and 12 months of 5-FU/LV [13,14]. The ideal duration for adjuvant chemotherapy in patients with colon cancer is 6 months, which is 12 cycles of FOLFOX and 6 of FL.…”

Section: Discussionmentioning

confidence: 99%

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Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy

et al. 2015

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Adjuvant chemotherapy is benefit for high-risk stage II and stage III colon cancer after curative resection. But, the optimal time between surgical and initiation of adjuvant chemotherapy remains unclear. Moreover, no study of efficacy with different lengths of adjuvant chemotherapy has appeared. This study was aimed to identify association between time (initiation and length) and oncological outcomes of adjuvant chemotherapy on the stages II and III colon cancer patients. A total of 406 high-risk stages II and III colon cancer patients were retrospectively enrolled in prospectively collected data. They were categorized into three groups representing chemotherapy initiation time: less than 4 weeks (group 1), 4 to 6 weeks (group 2), and more than 6 weeks (group 3). They were categorized into two groups representing chemotherapy length time : less than 200 days (group 1a) and more than 200 days (group 2a). The 5-year disease-free survival (DFS) rates were 74.97 % in group 1, 76.94 % in group 2, and 63.97 % in group 3 (p>0.05). The 5-year DFS rates were 75.49 % in the group that received adjuvant chemotherapy within 6 weeks and 63.97 % in the group that received adjuvant chemotherapy >6 weeks (p=0.0539). The 5-year DFS rates were 77.21 % in group 1a and 81.82 % in group 2a (p>0.05). Adjuvant chemotherapy should be safely offered within 6 weeks after surgical excision in patients with colon cancer after considering the patient's general physical condition and hematological factors, even if the chemotherapy length is prolonged.

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Section: Introductionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy

et al. 2015

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“…17 FU and LV administration has since become standard adjuvant chemotherapy for stage III and high-risk stage II CRC. 18,19 Adjuvant chemotherapy is promising for CRC that is highly suspicious for metastasis after curative surgical resection. Furthermore, new active agents such as irinotecan, oxaliplatin, cetuximab, and bevacizumab, have been reported in use for distant-metastatic CRC.…”

Section: Discussionmentioning

confidence: 99%

Prognostic Prediction Models for Colorectal Cancer Patients After Curative Resection

Miyoshi

Ohue

Noura

et al. 2016

International Surgery

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To develop a prediction tool for recurrence and survival in colorectal cancer (CRC) patients following surgically curative resections. We developed a reliable prediction model for CRC patients after surgically curative resections. Using clinicopathologic factors, novel prediction models were constructed with the area under the curve (AUC) of 0.841 and 0.876 for DFS and CSS, respectively. Between January 2004 and December 2007, 376 CRC patients were investigated at the Osaka Medical Center for Cancer and Cardiovascular Diseases. Patients with at least 1 of the following criteria were excluded: preoperative treatment, synchronous distant metastasis, noncurative resection, and incomplete follow-up after operation. All patients were retrospectively analyzed. A Cox proportional hazards model was used to develop a prediction model for disease-free survival (DFS) and cancer-specific survival (CSS). In univariate and multivariate analyses of clinicopathologic factors, the following factors had significant correlation with DFS and CSS: tumor location, preoperative serum carcinoembryonic antigen (CEA), pathologically defined tumor invasion, and lymph node metastasis. Using these variables, novel prediction models were constructed by the logistic regression model with AUC of 0.840 and 0.876 for DFS and CSS, respectively. The prediction models were validated by external datasets in an independent patient group. This study showed novel and reliable personalized prognostic models, integrating not only TNM factors but also tumor location and preoperative serum CEA to predict patient prognosis. These individualized prediction models could help clinicians in the treatment of postoperative CRC patients. Key words: Prediction tool -Colorectal cancer -Metastasis -SurvivalCorresponding author: Norikatsu Miyoshi, MD, PhD, Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1À3À3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan.Tel.: þ81 6 6972 1181, Fax: þ81 6 6981 8055, E-mail: miyosi-no@mc.pref.osaka.jp 406Int Surg 2016;101 I n developed countries with an ever-increasing aging population, cancer is one of the most prominent illnesses in terms of both public welfare and health measures. Colorectal cancer (CRC) is a frequent malignancy and one of the leading causes of cancer-related deaths.1 The metastatic dissemination of the primary tumors directly relates to patient survival, and distant metastases are a major cause of death in CRC. Systemic chemotherapy is the standard approach to treat metastatic CRC, and the last decade showed remarkable progress in therapies for CRC. Many new drugs are currently in use for metastatic CRC, and the average median survival duration has increased in recent years largely due to the availability of new active agents, such as irinotecan, oxaliplatin, cetuximab, and bevacizumab.2-4 Although many patients with metastatic CRC are hard to be cured, a subset of patients with liver-or lung-isolated disease have been reported to be potentially curable with surgery. 5,6 Develo...

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“…Post-operative adjuvant chemotherapy for colon cancer is one of the most important clinical advances in oncology to have been introduced in recent years (21)(22)(23). Prior to 2000, 5-FU was the only useful cytotoxic agent in the adjuvant setting for patients with stage III colon cancer (24).…”

Section: Introductionmentioning

confidence: 99%

“…Haller et al (23) assessed the three chemotherapy regimens: Low-dose leucovorin plus 5-FU regimen; high-dose LV plus 5-FU regimen; and low-dose LV plus levamisole plus 5-FU regimen, each administered for 30-32 weeks. The control arm was levamisole plus 5-FU for 1 year.…”

Section: Introductionmentioning

confidence: 99%

Comparison of adjuvant FOLFOX4 chemotherapy and oral UFUR/LV following adjuvant FOLFOX4 chemotherapy in?patients with stage?III colon cancer subsequent to radical resection

et al. 2017

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Abstract. The present study aimed to demonstrate the potential advantage of oral uracil-tegafur (UFUR)/leucovorin (LV) as the subsequent therapy in patients with stage III colon cancer following adjuvant LV, 5-fluorouracil and oxaliplatin (FOLFOX4) chemotherapy. Of a total 143 patients, 62 patients received only FOLFOX adjuvant chemotherapy (FOLFOX4 biweekly x 12 cycles for 6 months), and 81 patients received FOLFOXU adjuvant treatment (which consisted of FOLFOX4 biweekly x 12 cycles for 6 months followed by oral UFUR/LV for an additional 6 months). The 3-year disease-free survival (DFS) rate of the FOLFOXU group was 74.3%; which was superior to that of the FOLFOX4 group (59.9%). The average DFS time of the FOLFOXU group was superior to that of the FOLFOX4 group (P=0.003). The 5-year overall survival (OS) rate of the FOLFOXU group was 76.9%, which was also superior to that of the FOLFOX4 group (63.8%). The average OS time of patients in the FOLFOXU group was longer than that of the patients in the FOLFOX4 group (hazard ratio, 0.155; 95% confidence interval, 0.054-0.450; P=0.001). In comparison to the FOLFOX regimen, the FOLFOXU regimen achieved a more favorable response and survival time without a significant increase of toxicities in patients with stage III colon cancer as the adjuvant chemotherapy.

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Phase III Study of Fluorouracil, Leucovorin, and Levamisole in High-Risk Stage II and III Colon Cancer: Final Report of Intergroup 0089

Cited by 338 publications

References 31 publications

Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy

Association Between Time (Initiation and Length) and Oncological Outcomes for the Patients with Colon Cancer Treated with Adjuvant Chemotherapy

Prognostic Prediction Models for Colorectal Cancer Patients After Curative Resection

Comparison of adjuvant FOLFOX4 chemotherapy and oral UFUR/LV following adjuvant FOLFOX4 chemotherapy in?patients with stage?III colon cancer subsequent to radical resection

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