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Capecitabine

Manufactured by Roche
Sourced in China, Switzerland

Capecitabine is an orally administered chemotherapy medication developed by Roche. It is designed to be converted into the active anti-cancer drug 5-fluorouracil (5-FU) within the tumor. Capecitabine is primarily used to treat certain types of cancer, including colorectal, breast, and stomach cancers.

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10 protocols using capecitabine

1

Metastatic Colorectal Cancer Treatment

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As recommended by the guidelines of the National Comprehensive Cancer Network, patients were allocated to FU-based treatment. FOLFIRI, irinotecan (Camptosar; Pfizer) 180 mg/m2 intravenous (IV) infusion over 30–90 minutes, day 1; leucovorin 400 mg/m2 IV infusion to match the duration of irinotecan infusion, day 1; 5-FU 400 mg/m2 IV bolus, day 1; then 1200 mg/m2/day × 2 days (total 2400 mg/m2 over 46–48 hours) continuous infusion; repeat every 14 days or mCapeIRI35 (link) regimen (irinotecan 125 mg/m2, days 1 and 8; capecitabine (Xeloda; Roche)825–1000 mg/m2, twice daily on days 1–14; repeat every 21 days) or FOLFOX (oxaliplatin 80 mg/m2 IV infusion over 2 hours, day 1; leucovorin 400 mg/m2 IV over 2 hours, day 1; 5-FU 400 mg/m2 IV bolus, day 1; then 1200 mg/m2/day × 2 days continuous infusion; repeat every 14 days) or CapeOX (Oxaliplatin 130 mg/m2 day 1, capecitabine 825–1000 mg/m2, twice daily on days 1–14; repeat every 21 days) or single-agent chemotherapy of capecitabine (1250 mg/m2 twice daily on days 1–14; repeat every 21 days). All patients accepted 5-hydroxytryptamine receptor antagonist (5 mg once a day) 30–60 minutes before irinotecan or oxaliplatin. The chemotherapy continued until disease progressed or intolerable toxicities came out or patients asked to withdrew due to any reason.
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2

Utidelone plus Capecitabine in Metastatic Breast Cancer

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Eligible patients were randomized (computer-generated by an independent randomization statistician and loaded into the Interactive Website Response System) 2:1 to utidelone (30 mg/m2 intravenously once per day on days 1–5 every 3 weeks, Beijing Biostar Technologies, Ltd. Beijing, China) plus capecitabine (1,000 mg/m2 twice per day orally on days 1–14 every 3 weeks, Hoffmann-La Roche AG, Basel, Switzerland) or capecitabine (1,250 mg/m2 twice per day orally on days 1–14 every 3 weeks, Hoffmann-La Roche AG, Basel, Switzerland). This trial was open label, and eligible patients, physicians, and individuals assessing outcomes and analyzing data were not masked to treatment allocation. Utidelone and capecitabine were given until disease progression or unacceptable toxicity. Dose reductions were permitted for utidelone or capecitabine to manage adverse effects. Protocol-specific guidance for utidelone or capecitabine dose reduction and discontinuation is provided in the Appendix (Supplementary Table 1).
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3

Colorectal Cancer XELOX Chemotherapy

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The control group was treated with XELOX chemotherapy: On the first day, oxaliplatin (Qilu Pharmaceutical Hainan Co., LTD.) 130 mg/m2 was given by intravenous infusion. Capecitabine (Shanghai Roche Pharmaceuticals Co., LTD.) 1,000 mg/m2 was administered orally twice daily for 14 consecutive days. Three weeks is one cycle. On the basis of the control group, bevacizumab was additionally used in the observation group: bevacizumab (Roche Diagnostics GmbH) was given by intravenous infusion at 7.5 mg/kg. The treatment was repeated every 3 weeks and the curative effect was observed after 2 cycles.
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4

Oxaliplatin and Capecitabine Combination

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On the first day, oxaliplatin (130 mg/m2) was administered by intravenous infusion in 500 mL of 5% glucose over a period of 2 h. From the 1st day to the 14th day, capecitabine (Shanghai Roche Pharmaceuticals Ltd., Shanghai, China) 1500 mg (twice daily) was administered po. A cycle of the two regimens was repeated every 3 weeks.
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5

Doublet Chemotherapy and Radiotherapy for LARC

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It was a dose-finding study evaluating safety, activity and efficacy of doublet chemotherapy association, consisting of capecitabine and oxaliplatin, combined with radiotherapy, as preoperative treatment in LARC patients. Doublet chemotherapy association was administered according to the following schedule: capecitabine (Xeloda, Roche, Welwyn Garden City, United Kingdom), per os, at the dose of 825 mg/m2/ twice daily 5 days/week; oxaliplatin (Eloxatin; Sanofi-Aventis, Milan, Italy), over 2-hours as a 250 ml intravenous infusion of a solution containing 5% glucose, at the dose of 35-40 mg/m2/week. The concentration of the capecitabine used is already enstabilished in neoadjuvant setting trials, 825 mg / m2 twice daily for 5 days as radiosensitizing agent.
Radiation therapy in 25 daily fractions, 5 days a week: 50 Gy of 2 Gy on rectal tumor and 45 Gy of 1.8 Gy on locoregional lymph nodes, in the former 5 patients; 45 Gy of 1.8 Gy on rectal tumour and locoregional lymph nodes and boost of 9 Gy in 25 daily fractions of 0.36 Gy on rectal tumor, in the latter 12 patients.
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6

Cisplatin and Capecitabine Combination Therapy

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Patients in group A were treated with cisplatin alone: cisplatin (SFDA Approval No. H20056422, Fenghuang Pharmaceutical Co., Ltd., Shandong, China), 20 mg/m2, intravenous drip, for 5 days. Those in group B were given oral capecitabine (SFDA Approval No. H20073024, Roche Pharmaceutical Co., Ltd., Shanghai, China) on the basis of group A, 1000 mg/m2, twice a day, and they took a rest for 1 week after 2 weeks, and 3 weeks were regarded as a course of treatment. In both groups, 3 weeks were taken as one cycle, 3 cycles in total. In order to prevent hand-foot syndrome, vitamin B6 was given orally at the same time, and the maximum daily dose could reach 200 mg.
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7

Postoperative Colorectal Cancer Surveillance

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All patients were followed for 5 years with measurement of serum carcinoembryonic antigen every 3 months, computed tomography (CT) every 6 months and colonoscopy every 12 months. When we suspected any recurrence, CT and positron emission tomography were carried out at that time.
For 6 months after surgery, patients with stage III disease received oral S‐1 (Taiho Pharmaceuticals Co. Ltd, Tokyo, Japan) or capecitabine (Xeloda; Hoffmann‐La Roche, Basel, Switzerland), whereas patients with stage II disease received no adjuvant chemotherapy.
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8

Fluoropyrimidine-Based Regimens for Gastric Cancer

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All eligible patients received fluoropyrimidine-based regimen every 21 days for 4–6 cycles after recovery from surgery within 8 weeks. Single-drug regimen refers to oral drug of FU, comprising of 40–60 mg of tegafur/gimeracil/oteracil potassium capsules (S-1®, Taiho Pharmaceutical Co. Ltd., Tokyo, Japan; or Tegafur Capsules, Hengrui Medicine Co. Ltd., Jiangsu, P.R. China), twice daily, or 625–825 mg/m2 of oral capecitabine (Xeloda®, Roche Pharmaceutical Co. Ltd., Basel, Switzerland) twice daily. The doublet regimen refers to the combination of two kinds of chemotherapeutic drugs, comprising of 85–130 mg/m2 of oxaliplatin (Aiheng®, Hengrui Medicine Co. Ltd.) or 75–100 mg/m2 of cisplatin (Qilu Pharmaceutical Co. Ltd., Shandong, P.R. China) or 70–85 mg/m2 of docetaxel (Aisu®, Hengrui Medicine Co. Ltd.) plus bolus 1,600–2,000 mg/m2 of FU and 200–400 mg/m2 of leucovorin (Xudong Hepu Pharmaceutical Co., Ltd., Shanghai, P.R. China) or oral drugs of FU. The triplet regimen refers to three combinations of chemotherapeutic drugs (ie, ECF: epirubicin [50 mg/m2, Haizheng Pharmaceutical Co. Ltd., Zhejiang, P.R. China], platinum plus FU; mDCF: docetaxel [40–75 mg/m2], platinum plus FU).
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9

Metastatic Colorectal Cancer Treatment

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SOX regimen: oxaliplatin (Jiangsu Hengrui Medicine Co., Ltd., Lianyungang, China) at 130 mg/m2 (intravenous infusion administered in 500 mL of 5% glucose over a period of 2 h) and S-1 (Taiho Pharmaceutical Co., Ltd., Tokyo, Japan) of 60 mg (orally administered twice a day on days 1–14). XELOX regimen: oxaliplatin at 130 mg/m2 (intravenous infusion administered in 500 mL of 5% glucose over a period of 2 h) and capecitabine (Shanghai Roche Pharmaceuticals Ltd., Shanghai, China) of 1,500 mg (orally administered twice a day on days 1–14). A cycle of the two regimens were repeated every 3 weeks.
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10

Bevacizumab and Capecitabine Combination Treatment

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Bevacizumab and capecitabine were provided by F. Hoffmann-La Roche (Basel, Switzerland) as a liquid and fine powder, respectively. Human immunoglobulin G (HuIgG) was purchased from MP Biomedicals (Solon, OH, USA). capecitabine was dissolved in 40 mM citrate buffer (pH 6.0) containing 5% gum arabic (capecitabine vehicle).
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