Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (The FACOS study)

Kosugi, Chihiro; Koda, Keiji; Ishibashi, Keiichiro; Yoshimatsu, Kazuhiko; Tanaka, Soichi; Kato, Ryouji; Kato, Hiroyuki; Oya, Mototsugu; Narushima, Kazuo; Mori, Mikito; Shuto, Kiyohiko; Ishida, Hideyuki

doi:10.1007/s00384-018-2979-9

Cited by 10 publications

(9 citation statements)

References 22 publications

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“…In the present study, conducting using the database of the FACOS study, we found novel predictive molecular markers for recurrence in stage III CC patients receiving postoperative adjuvant oxaliplatin-based chemotherapy (8). The recurrence group could be definitively identified according to the expression levels of 10 genes, including ADH1A, ADH1C, CA12, CHP2, HMGCS2, SNAR-A1, TPI1, MS4A12, PLA2G10 , and PTPRO ; high expression levels of 7 genes ( ADH1A, ADH1C, CA12, CHP2, HMGCS2, MS4A12 , and PLA2G10 ) and low expression levels of 3 genes ( SNAR-A1, TPI1 , and PTPRO ) were associated with tumor recurrence.…”

Section: Discussionmentioning

confidence: 83%

“…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: Discussionmentioning

confidence: 83%

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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“…This proportion is contrary to the recent publication of Kosugi et al, which showed that the proportion of elevated SGOT and SGPT is about 3%. 14…”

Section: Discussionmentioning

confidence: 99%

Modified Folfox6 as Adjuvant Chemotherapy in Vietnamese Patients With Colorectal Cancer

et al. 2019

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Colorectal cancer is the third most common cancer and the second leading cause of death from cancer worldwide. In Vietnam, the disease is the fifth leading cancer (8.9%), with 14 733 new cases in 2018. In recent years, the mFolfox6 regimen has been indicated commonly as the adjuvant chemotherapy after curative resection for patients with colorectal cancer. However, the efficacy of the regimen in Vietnamese patients has not been assessed and reported. In this retrospective study, we reviewed medical records of 83 patients with stage II or stage III colorectal cancer who received mFOLFOX6 regimen in order to investigate simultaneously survival and safety of this chemotherapy regimen. Three-year overall and disease-free survival were 84.3% and 79.5%, respectively. Our data revealed that postoperative Carcinoma Embryonic Antigen (CEA) level was a significant prognostic factor for survival, with hazard ratio of 3.83 and 3.67, respectively ( P < .05), for overall survival and disease-free survival in the elevated CEA level group when compared to the normal CEA level group. The regimen also demonstrated to be well tolerated and can be used in routine practice as an adjuvant chemotherapy.

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Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy in patients with metastatic colorectal cancer (VOICE trial)

Kosugi

Koda

Denda

et al. 2021

Int J Colorectal Dis

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Background: In the rst-line treatment of metastatic colorectal cancer (mCRC) patients with CAPOX plus bevacizumab, the optimal duration of maintenance treatment without oxaliplatin to avoid discontinuation of therapy due to peripheral sensory neuropathy (PSN) remains unknown. The aim of this phase II study was to evaluate the e cacy and safety of combination therapy with ve-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by ve-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for ve cycles, with a preplanned oxaliplatin intermittent strategy in mCRC.Methods: Patients with untreated mCRC were administered CAPOX [oxaliplatin 130 mg/m 2 and capecitabine (2000 mg/m 2 daily) as intermittent treatment for 14 days, followed by a 7-day treatment-free interval, every 3 weeks] + bevacizumab (7.5 mg/kg) every 3 weeks for ve cycles, maintenance treatment without oxaliplatin for ve cycles, and CAPOX + bevacizumab reintroduction for ve cycles or upon tumor progression. The primary endpoint was progressionfree survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety.Results: Forty-seven patients who ful lled the inclusion criteria were enrolled in the evaluation of e cacy and safety. The relative dose intensity and the cumulative dose of oxaliplatin during the overall treatment period were 649.1 mg/m 2 and 1132.5 mg, respectively. Median PFS was 14.1 months (95% con dence interval [CI], 8.6-19.5), and median TTF was 12.3 months (95% CI, 10.3-14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, PSN, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%. Conclusion: CAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief vecycle induction therapy, ve-cycle maintenance therapy with capecitabine plus bevacizumab, and ve-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients.

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Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (The FACOS study)

Abstract: As adjuvant chemotherapy for stage III colon cancer, mFOLFOX6/XELOX regimens are acceptable.

Cited by 10 publications

References 22 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

Modified Folfox6 as Adjuvant Chemotherapy in Vietnamese Patients With Colorectal Cancer

Multicenter phase II clinical study of the efficiency and safety of capecitabine plus intermittent oxaliplatin with bevacizumab as first-line therapy in patients with metastatic colorectal cancer (VOICE trial)

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