A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy

Yoshimatsu, Kazuhiko; Ishibashi, Keiichiro; Koda, Keiji; Yokomizo, Hajime; Oda, Noritaka; Oshiro, Mitsuru; Kato, Hiroyuki; Oya, Mototsugu; Nakajima, Hideo; Ooki, Shinji; Maekawa, Hiroshi; Matsunami, Toshio; Tsubaki, Masahiro; Yamada, Takeshi; Kobayashi, Mariko; Tanakaya, Kohji; Yokoyama, Masaru; Ishida, Hideyuki

doi:10.1007/s00595-019-1771-y

Cited by 8 publications

(7 citation statements)

References 21 publications

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“…The study was a phase II clinical study to investigate the efficacy and safety of FOLFOX and XELOX therapy as postoperative adjuvant chemotherapy for Japanese patients with stage III CC. Among the 132 CC patients enrolled (7,8), gene expression analyses using a microarray was conducted in 51 patients. The regimens of mFOLFOX6 and XELOX are described in our previous report (7,8): Briefly, the mFOLFOX6 regimen comprises intravenous infusions of oxaliplatin (85 mg/m 2 ) and LV (200 mg/m 2 ) for 2 h, followed by rapid intravenous bolus infusion of 5-FU (400 mg/m 2 ) for 5 min, and continuous intravenous infusion of 5-FU (2,400 mg/m 2 ) for 46 h. This regimen is repeated every 2 weeks for 12 cycles.…”

Section: Methodsmentioning

confidence: 99%

“…Among the 132 CC patients enrolled (7,8), gene expression analyses using a microarray was conducted in 51 patients. The regimens of mFOLFOX6 and XELOX are described in our previous report (7,8): Briefly, the mFOLFOX6 regimen comprises intravenous infusions of oxaliplatin (85 mg/m 2 ) and LV (200 mg/m 2 ) for 2 h, followed by rapid intravenous bolus infusion of 5-FU (400 mg/m 2 ) for 5 min, and continuous intravenous infusion of 5-FU (2,400 mg/m 2 ) for 46 h. This regimen is repeated every 2 weeks for 12 cycles. The XELOX regimen comprises intravenous infusion of oxaliplatin (130 mg/m 2 over 2 h) on day 1 and oral administration of capecitabine (1,000 mg/m 2 twice daily) from the evening of day 1 to the morning of day 15.…”

Section: Methodsmentioning

confidence: 99%

“…In Japan, oral 5-FU regimens have been used for stage III CRC patients after curative resection (6). We conducted the FACOS study to verify the efficacy and safety of Ox+5-FU/LV (FOLFOX therapy) and Ox+capecitabine (XELOX therapy) as postoperative adjuvant chemotherapy for Japanese patients with stage III colon cancer (CC) (7,8). Even in stage III CC patients in whom Ox-based adjuvant chemotherapy was successfully completed, a subset of patients still developed tumor recurrence, regardless of clinicopathological factors.…”

Section: Introductionmentioning

confidence: 99%

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Expressions of 10 genes as candidate predictors of recurrence in stage�III colon cancer patients receiving adjuvant oxaliplatin‑based chemotherapy

et al. 2019

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Approximately 30% patients with stage III colon cancer (CC) develop local recurrence and/or distant metastasis, even if postoperative adjuvant chemotherapy with oxaliplatin plus 5-fluorouracil and leucovorin (5-FU/LV) has been completed. In the present study, molecular analysis was performed to identify molecular markers of tumor recurrence in patients with stage III CC receiving oxaliplatin-based adjuvant chemotherapy. The FACOS study was conducted as a phase II study to evaluate the safety and efficacy of oxaliplatin-based treatment for stage III CC patients. Of the 132 CC patients enrolled in the present study, gene expression analysis using a microarray was conducted in 51 patients. Of these 51 patients, 6 developed recurrence within 5 years. The topmost 5% genes that showed differential expressions between cases that developed/did not develop recurrence were selected, and a set of predictive molecular markers for recurrence was identified. Of the 34,694 genes in the microarray, 1,734 genes were extracted as topmost 5% genes showing differential expressions between cases with and without recurrence. Among these, 10 genes, including ADH1A, ADH1C, CA12, CHP2, HMGCS2, SNAR-A1, TPI1, MS4A12, PLA2G10 and PTPRO , were identified as markers that could clearly divide patients with and without recurrence. Although several prediction models of tumor recurrence have been reported for CC, the set of 10 genes that the present study identified may be useful to predict the risk of recurrence in stage III CC patients receiving oxaliplatin-based adjuvant chemotherapy. Based on these results, high-risk patients with CC should be carefully observed to detect tumor recurrence during the follow-up period.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Expressions of 10 genes as candidate predictors of recurrence in stage�III colon cancer patients receiving adjuvant oxaliplatin‑based chemotherapy

et al. 2019

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“…In addition to treatment-related adverse events, non-medical factors might cause individuals to be reluctant to complete chemotherapy or prolong the completion time, such as treatment costs and access. For patients who had not completed adjuvant chemotherapy, the DFS was significantly lower (21), so it was difficult to evaluate the effect of chemotherapy completion time on prognosis. Therefore, only patients who had completed all chemotherapy plans (XELOX regimen for 8 cycles, and FOLFOX regimen for 12 cycles) were included in the present study.…”

Section: Discussionmentioning

confidence: 99%

Optimal adjuvant chemotherapy completion time for stage III colon cancer: a cohort study

Ren¹,

Zhang²,

Zhang³

et al. 2021

J Gastrointest Oncol

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Background: Adjuvant chemotherapy for 6 months following surgery is the standard treatment plan for stage III colon cancer. The aim of the present study was to determine whether the adjuvant chemotherapy completion time for stage III colon cancer had an effect on prognosis and cut-off time that affected the prognosis. Methods: This was a retrospective study of stage III colon cancer patients who completed adjuvant chemotherapy at Guangzhou Red Cross Hospital from January 2010 to December 2017. Univariate and multivariate analyses were used to determine the association between adjuvant chemotherapy completion time and the 3-year disease-free survival (DFS). The restricted cubic spline model was used to analyze the cut-off time that affected the 3-year DFS. Results: A total of 431 patients were included in the study. The 3-year DFS was associated with a combination of obstruction or perforation, preoperative serum carcino-embryonic antigen (CEA) concentration, T stage, N stage, pathological stage, and adjuvant chemotherapy completion time in the univariate analysis (P<0.05). A combination of obstruction or perforation, preoperative serum CEA concentration, N stage, and adjuvant chemotherapy completion time were independent prognostic factors in the multivariate analysis (P<0.05). The cut-off time was 28 weeks for adjuvant chemotherapy completion time in the restricted cubic spline model analysis. For those whose adjuvant chemotherapy completion time was >28 weeks, the risk of 3-year recurrence was 1.428 times higher compared with those whose adjuvant chemotherapy completion time was ≤28 weeks. [P=0.032, 95% confidence interval (CI): 1.034-2.055]. Conclusions:The 3-year DFS of stage III colon cancer was related to the adjuvant chemotherapy completion time. For those who completed adjuvant chemotherapy >28 weeks, the risk of 3-year recurrence increased.

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“…), medication compliance was improved by twice‐daily administrations. In the phase III Adjuvant Chemotherapy for Gastric Cancer trial [8] that examined the utility of S‐1 for the surgery only group, the outcomes of postoperative adjuvant chemotherapy were affected by drug compliance in stage II and III gastric cancer patients receiving postoperative adjuvant chemotherapy. In that study, the convenience of administration in group B (test group) was improved relative to that in group A.…”

Section: Trial Informationmentioning

confidence: 99%

Administration Method of Adjuvant Tegafur-Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study

Hata

Hagihara²,

Tsutsui

et al. 2021

The Oncologist

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Lessons Learned The 3‐year disease‐free survival rate of the twice‐daily regimen was not inferior to that of the conventional three‐times‐daily regimen, and the twice‐daily regimen did not lead to an increase in adverse events. The effectiveness of the twice‐daily regimen highlights an increased number of treatment options for patients. This will facilitate personalized medicine, particularly for elderly or frail patients who may experience more severe side effects from the combination therapy. Background Tegafur‐uracil (UFT)/leucovorin calcium (LV) is an adjuvant chemotherapy treatment for colorectal cancer. We conducted a multicenter randomized trial to assess the noninferiority of a twice‐daily compared with a three‐times‐daily UFT/LV regimen for stage II/III colorectal cancer in an adjuvant setting. Methods Patients were randomly assigned to group A (three doses of UFT [300 mg/m2 per day]/LV [75 mg per day]) or B (two doses of UFT [300 mg/m2 per day]/LV [50 mg per day]). The primary endpoint was 3‐year disease‐free survival. Results In total, 386 patients were enrolled between July 28, 2011, and September 27, 2013. The 3‐year disease‐free survival rates of group A (n = 194) and B (n = 192) were 79.4% and 81.4% (95% confidence interval, 72.6–84.4–74.5–85.9), respectively. The most common grade 3/4 adverse events in group A and B were diarrhea (3.9% vs. 7.3%), neutropenia (2.9% vs. 1.6%), increase in aspartate aminotransferase (4.0% vs. 3.9%), increase in alanine aminotransferase (6.2% vs. 6.8%), nausea (1.7% vs. 3.4%), and fatigue (1.1% vs. 2.3%). Conclusion Group B outcomes were not inferior to group A outcomes, and adverse events did not increase.

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A Japanese multicenter phase II study of adjuvant chemotherapy with mFOLFOX6/CAPOX for stage III colon cancer treatment after D2/D3 lymphadenectomy

Cited by 8 publications

References 21 publications

Expressions of 10 genes as candidate predictors of recurrence in stage�III colon cancer patients receiving adjuvant oxaliplatin‑based chemotherapy

Expressions of 10 genes as candidate predictors of recurrence in stage�III colon cancer patients receiving adjuvant oxaliplatin‑based chemotherapy

Optimal adjuvant chemotherapy completion time for stage III colon cancer: a cohort study

Administration Method of Adjuvant Tegafur-Uracil and Leucovorin Calcium in Patients with Resected Colorectal Cancer: A Phase III Study

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