Interim analysis of a phase II trial evaluating the safety and efficacy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer

Danno, Katsuki; Hata, Taishi; Tamai, Koki; Fujie, Yujiro; Ide, Yoshihito; Kim, Ho Min; Ohnishi, Tadashi; Morita, Shunji; Yoshioka, Shinichi; Kudo, Toshihiro; Nishimura, Junichi; Matsuda, Chu; Akamatsu, Hiroki; Mizushima, Tsunekazu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki

doi:10.1007/s00280-017-3419-1

Cited by 11 publications

(7 citation statements)

References 22 publications

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“…The completion rate of ACT was relatively lower than that reported in the literature for colorectal cancer. In our study, the completion in vivo 34: 3399-3406 (2020) rates of UFT/LV, Capecitabine and CAPOX were 10 out of 16 patients, 1 out of 3 patients and 2 out of 14 patients respectively, although previous studies in Japanese patients with colorectal cancer have reported 73-77%, 66% and 73.7%, respectively (5,(13)(14)(15). In addition, previous studies have shown that low completion rate and low relative dose intensity of ACT had negative impact on overall survival rate (16,17).…”

Section: Discussioncontrasting

confidence: 61%

“…One patient experienced grade 3 acute kidney disease and needed rehospitalization. The incidence of the chemotherapy-induced diarrhea was not higher than in previous studies, whereas the percentage of grade 3 was higher (13,15,23). These results indicated that once diarrhea is induced by ACT, presence of ileostomy might be a prognostic factor for severe adverse events.…”

Section: Discussionmentioning

confidence: 46%

“…The completion rate of CAPOX was only 2 out of 14 patients, and 2 patients completed the treatment after switching to Capecitabine alone. A previous study with a larger number of Japanese patients regarding safety and efficacy of CAPOX as adjuvant chemotherapy (MCSCO-1024) reported a completion rate of 73.7%, which included switching to capecitabine alone (13). In that study, reasons for discontinuation of ACT were patient refusal of 16.8%, disease recurrence of 5.8%, and adverse event of 3.7%.…”

Section: Discussionmentioning

confidence: 98%

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Tolerability and Adverse Events of Adjuvant Chemotherapy for Rectal Cancer in Patients With Diverting Ileostomy

Takahashi

Tsujinaka

Maemoto

et al. 2020

In Vivo

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Background/Aim: The impact of diverting ileostomy on the feasibility of adjuvant chemotherapy (ACT) remains unclear. We retrospectively investigated the tolerability and adverse events of ACT for rectal cancer in patients with diverting ileostomy. Patients and Methods: Thirty-three patients who received ACT after curative resection with ileostomy construction for rectal cancer were analyzed. We assessed completion rate, the mean relative dose intensities, and the factors affecting the tolerability of ACT. Results: The completion rate of each chemotherapy regimen was 10 out of 16 patients in oral uracil-tegafur plus leucovorin (UFT/LV), 1 out of 3 patients in oral capecitabine (Capecitabine) and 2 out of 14 patients in capecitabine plus oxaliplatin (CAPOX). The mean relative dose intensities were 77% in UFT/LV, 48% in Capecitabine, and 57% of capecitabine and 42% of oxaliplatin in CAPOX. In multivariate analysis, laparoscopic surgery (Odds ratio=11.6, p=0.021) and receiving preoperative chemoradiotherapy (Odds ratio=32.4, p=0.021) were associated with treatment completion. Conclusion: Completion rate of ACT in patients with diverting ileostomy was lower than that of colorectal cancer patients in the previous studies. UFT/LV may be a more tolerable regimen than Capecitabine or CAPOX in colorectal cancer patients with diverting ileostomy.Anastomotic leakage is one of the severe complications of the surgical treatment for rectal cancer, causing morbidity and mortality. Diverting ileostomy is constructed in lower rectal surgery with high risk of anastomotic leakage. Previous reports have demonstrated that constructing a diverting stoma reduces clinically relevant anastomotic leakage (1-3).Several studies have proven that adjuvant chemotherapy (ACT) improves postoperative survival in patients with stage III colorectal cancer (4-6). In case of advanced lower rectal cancer, ACT is indicated in patients with ileostomy. However, there is scarce data regarding the tolerability of ACT for rectal cancer in patients with diverting ileostomy.This retrospective cohort study aimed to investigate the tolerability and adverse events of ACT for rectal cancer in patients with diverting ileostomy.

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Section: Discussioncontrasting

confidence: 61%

Section: Discussionmentioning

confidence: 46%

Section: Discussionmentioning

confidence: 98%

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Tolerability and Adverse Events of Adjuvant Chemotherapy for Rectal Cancer in Patients With Diverting Ileostomy

Takahashi

Tsujinaka

Maemoto

et al. 2020

In Vivo

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“…Treatment was postponed for a maximum of 42 days if any of the following criteria were not met within 24 h of the start of each course: neutrophil count ≥1500/mm 3 , platelet count ≥75,000/mm 3 , persistent grade ≤ 1 peripheral sensory neuropathy, grade ≤ 1 hand-foot syndrome, and any other parameter as decided by the attending physician. Dose modifications were based on the most severe adverse events observed during the previous treatment cycle, and were performed according to previously reported criteria [12].…”

Section: Methodsmentioning

confidence: 99%

Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study

et al. 2019

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Background Preoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency. Adjuvant oxaliplatin plus capecitabine (XELOX) is a recommended regimen for patients with curatively resected colon cancer. However, the efficacy of postoperative adjuvant therapy for rectal cancer patients who have not undergone preoperative chemoradiation remains unknown. We aimed to evaluate the efficacy of surgery and postoperative XELOX without preoperative chemoradiation for treating rectal cancer. Methods We performed a prospective, multicenter, open-label, single arm phase II study. Patients with curatively resected high-risk stage II and stage III rectal cancer who had not undergone preoperative therapy were treated with a 120 min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and capecitabine (2000 mg/m2/day) in 2 divided doses for 14 days of a 3-week cycle, for a total of 8 cycles (24 weeks). The primary endpoint was 3-year disease-free survival (DFS). Results Between August 2012 and June 2015, 60 men and 47 women with a median age was 63 years (range: 29–77 years) were enrolled. Ninety-three patients had Eastern Cooperative Oncology Group performance status scores of ‘0’ and 14 had scores of ‘1’. Tumors were located in the upper and lower rectums in 54 and 48 patients, respectively; 8 patients had stage II disease and 99 had stage III. The 3-year DFS was 70.1% (95% confidence interval, 60.8–78.0%) and 33 patients (31%) experienced recurrence, most commonly in the lung (16 patients) followed by local recurrence (9) and hepatic recurrence (7). Conclusions Postoperative XELOX without preoperative chemoradiation is effective for rectal cancer and provides adequate 3-year DFS prospects. Trial registration This clinical trial was registered in the University Hospital Medical Information Network registry system as UMIN000008634 at Aug 06, 2012.

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“…Độc tính về tiêu hóa là một trong những độc tính thường gặp khi sử dụng hóa trị phác đồ XELOX do tác dụng của thuốc hóa trị lên niêm mạc đường tiêu hóa. Kết quả NC của chúng tôi cao hơn so với NC của Võ Văn Kha có tỷ lệ buồn nôn, nôn là 20.6%, đau thượng vị là 11% nhưng phù hợp với nhiều NC khác trong và ngoài nước [5], [6], [7].…”

Section: Bàn Luậnunclassified

Tác Dụng Không Mong Muốn Của Hóa Trị Bổ Trợ Phác Đồ Xelox Trong Điều Trị Ung Thư Đại Tràng Giai Đoạn Ii, Iii Tại Bệnh Viện Đà Nẵng

Sơn¹,

Tuấn²,

Hiếu³

2022

VMJ

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Mục tiêu: Mô tả một số đặc điểm lâm sàng, cận lâm sàng bệnh nhân ung thư đại tràng giai đoạn II, III tại bệnh viện Đà Nẵng và đánh giá tác dụng không mong muốn của hóa trị bổ trợ phác đồ XELOX trong nhóm bệnh nhân nghiên cứu. Đối tượng và phương pháp: Nghiên cứu mô tả lâm sàng có theo dõi dọc trên 66 bệnh nhân được chẩn đoán ung thư đại tràng giai đoạn II nguy cơ cao và giai đoạn III điều trị tại Bệnh viện Đà Nẵng từ tháng 6/2017 – 6/2020. Kết quả: Tuổi trung bình của bệnh nhân là 59.98 ± 10.33, nhóm tuổi từ 50-59 và 60-69 chiếm tỷ lệ cao nhất là 34.8%. Vị trí u hay gặp nhất là đại tràng góc gan 22.7%, đại tràng sigma 37.9%, khối u biệt hóa vừa chiếm tỷ lệ 74.2%. Đa phần độc tính của điều trị đều ở độ 1-2, tỷ lệ độc tính độ 3-4 về huyết học, tăng men gan, hội chứng bàn tay bàn chân, độc tính thần kinh ngoại biên chiếm tỷ lệ 3%-4.5%. Kết luận: Phác đồ XELOX an toàn trong điều trị bổ trợ ở nhóm bệnh nhân nghiên cứu với các tác dụng không mong muốn ở mức độ nhẹ.

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Interim analysis of a phase II trial evaluating the safety and efficacy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer

Abstract: Adjuvant XELOX is tolerable for Japanese patients with Stage III colon cancer.

Cited by 11 publications

References 22 publications

Tolerability and Adverse Events of Adjuvant Chemotherapy for Rectal Cancer in Patients With Diverting Ileostomy

Tolerability and Adverse Events of Adjuvant Chemotherapy for Rectal Cancer in Patients With Diverting Ileostomy

Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: a prospective, multicenter, open-label, single-arm phase II study

Tác Dụng Không Mong Muốn Của Hóa Trị Bổ Trợ Phác Đồ Xelox Trong Điều Trị Ung Thư Đại Tràng Giai Đoạn Ii, Iii Tại Bệnh Viện Đà Nẵng

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