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Study protocol of the Asian XELIRI ProjecT(AXEPT):a multinational,randomized,non-inferiority,phase Ⅲ trial of second-line chemotherapy for metastatic colorectal cancer, comparing the eicacy and safety of XELIRI with or without bevacizumab versus FOLFIRI w

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Chinese Journal of Cancer 2016年第12期35卷 735-742页

作者： Masahito Kotaka Ruihua Xu Kei Muro Young Suk Park Satoshi Morita Satoru Iwasa Hiroyuki Uetake Tomohiro Nishina Hiroaki Nozawa Hiroshi Matsumoto Kentaro Yamazaki Sae-Won Han Wei Wang Joong Bae Ahn Yanhong Deng Sang-Hee Cho Yi Ba Keun-Wook Lee Tao Zhang Taroh Satoh Marc E.Buyse Baek-Yeol Ryoo Lin Shen Junichi Sakamoto Tae Won Kim Gastrointestinal Cancer Center Sano HospitalHyogo 655-0031Japan. State Key Laboratory of Oncology in South China Department of Medical OncologyCollaborative Innovation Center for Cancer MedicineSun Yat-sen Univer-sity Cancer CenterGuangzhouGuangdong 510060P.R.China. Depart-ment of Clinical Oncology Aichi Cancer Center HospitalNagoya 464-8681Japan. Department of Medicine Samsung Medical CenterSungkyunkwan University School of MedicineSeoul 135-710South Korea. Department of Biomedical Statistics and Bioinformatics Graduate School of MedicineKyoto UniversityKyoto 606-8501Japan. Gastrointestinal Medical Oncology Division National Cancer Center HospitalTokyo 104-0045Japan. Depart-ment of Surgical Specialties Graduate SchoolTokyo Medical and Dental UniversityTokyo 113-8519Japan. Department of Gastrointestinal Medical Oncology National Hospital Organization Shikoku Cancer CenterMatsuy-ama 791-0280Japan. Department of Surgical Oncology The University of TokyoTokyo 113-0033Japan. Department of Surgery Tokyo Metropoli-tan Komagome HospitalTokyo 113-8677Japan. Division of Gastrointestinal Oncology Shizuoka Cancer CenterShizuoka 411-8777Japan. Department of Internal Medicine Seoul National University HospitalSeoul 110-744South Korea. Department of Gastrointestinal Oncology The First People's Hospital of FoshanFoshanGuangdong 528000P.R.China. Department of Inter-nal Medicine Yonsei University College of MedicineSeoul 120-752South Korea. Department of Medical Oncology The Sixth Ailiated HospitalSun Yat-sen UniversityGuangzhouGuangdong 510655P.R.China. Depart-ment of Hematology-Oncology Chonnam National University Medical SchoolGwangju 519-809South Korea. Department of Digestive Oncology Tianjin Medical University Cancer Institute and HospitalTianjin 300060P.R.China. Department of Internal Medicine Seoul National University Bundang Hos-pitalSeoul National University College of MedicineSeongnam 463-707South Korea. Department of Medical Oncology Union Hospital of Tongji Medical College

Background: Capecitabine and irinotecan combination therapy(XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer(m CRC). Recently, in the Association of Medical Oncology of the German Cancer Society(AIO) 0604 trial, tri?weekly XELIRI plus bevacizumab, with reduced doses of irinotecan(200 mg/m^2 on day 1) and capecitabine(1600 mg/m^2 on days 1–14), repeated every 3 weeks, has shown favorable tolerability and eicacy which were comparable to those of capecitabine and oxaliplatin(XELOX) plus bevacizumab. The doses of capecit?abine and irinotecan in the AIO trial are considered optimal. In a phase I/II study, XELIRI plus bevacizumab(BIX) as second?line chemotherapy was well tolerated and had promising eicacy in Japanese ***: The Asian XELIRI Projec T(AXEPT) is an East Asian collaborative, open?labelled, randomized, phase Ⅲ clinical trial which was designed to demonstrate the non?inferiority of XELIRI with or without bevacizumab versus standard FOLFIRI(5?fluorouracil, leucovorin, and irinotecan combination) with or without bevacizumab as second?line chemo?therapy for patients with m CRC. Patients with 20 years of age or older, histologically conirmed m CRC, Eastern Coop?erative Oncology Group performance status 0–2, adequate organ function, and disease progression or intolerance of the irst?line regimen will be eligible. Patients will be randomized(1:1) to receive standard FOLFIRI with or with?out bevacizumab(5 mg/kg on day 1), repeated every 2 weeks(FOLIRI arm) or XELIRI with or without bevacizumab(7.5 mg/kg on day 1), repeated every 3 weeks(XELIRI arm). A total of 464 events were estimated as necessary to show non?inferiority with a power of 80% at a one?sided α of 0.025, requiring a target sample size of 600 patients. The 95% conidence interval(CI) upper limit of the hazard ratio was pre?speciied as less than ***: The Asian XELIRI Projec T is a multinational phase III trial being conducted to provide evidence fo

关键词： Metastatic colorectal cancer Randomized phase Ⅲ clinical trial XELIRI Bevacizumab second-line therapy

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Helicobacter pylori:Management in 2013

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World Journal of Gastroenterology 2014年第18期20卷 5302-5307页

作者： Yesim Ozen Alahdab Cem Kalayci Department of Gastroenterology and Hepatology Fatih Sultan Mehmet Education and Research Hospital34752 IstanbulTurkey Department of Gastroenterology and Hepatology Feneryolu Mh Kadikoy34724 IstanbulTurkey

Helicobacter pylori (H. pylori) is a prevalent, worldwide, chronic infection. Choice of treatment can be modified according to antibiotic-resistance rates of H. pylori. The ideal therapeutic regimen for H. pylori infection should achieve an eradication rate of ≥ 80%. In some countries, triple therapy with a proton-pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole is still the best option. Bismuth-containing quadruple therapy consisting of bismuth salts, tetracycline, metronidazole and PPI, may be the preferred option in countries with clarithromycin resistance > 20%. Sequential therapy including a PPI and amoxicillin given for the first 5 d, followed by triple therapy including a PPI, clarithromycin, and nitroimidazole antimicrobial (all twice daily) for the remaining 5 d, can be another option for the first-line treatment of H. pylori. Recent data suggest that treatment with PPI, levofloxacin, and amoxicillin for 10 d is a good choice for second-line therapy. Concomitant therapy consisting of PPI, amoxicillin, clarithromycin and metronidazole is another option for second-line treatment. If second-line treatment also fails, it is recommended to culture H. pylori from biopsy specimens and perform antimicrobial susceptibility testing. Rescue treatment should be based on antimicrobial susceptibility.

关键词： Helicobacter pylori First-line therapy second-line therapy Rescue therapy

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Does maintenance of Bevacizumab after treatment failure have a role in metastatic colon cancer?

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The Chinese-German Journal of Clinical Oncology 2009年第1期8卷 24-32页

作者： Khaled M. Galal Khaled Zaghlol Ehab Esmat Fawzy Saleh Mansour Mahmoud Abdul Salam Ehab Mostafa Mohamed Radiotherapy and Oncology Center (NEMROCK) Cairo University Oncology Center Saudi German Hospital Department of Internal Medicine Tanta University King Abdul Aziz University Hospital Department of Radiotherapy & Clinical Oncology Mansoura University King Faisal Specialized Hospital Department of Radiotherapy & Clinical Oncology Ain Shams University

Objective： To study the timing of Bevacizumab （BVC） in the overall treatment strategy of advanced metastatic colorectal cancer - early use （first-line） or later use. Methods： 41 patients with progressive metastatic colorectal carcinoma were included. Patients were randomized to receive chemotherapy with or without BVC. Primary end point was objective response. secondary end points were median survival, time to tumor progression, and toxicity. Results： Partial response with second-line BVC group constituted 25% and 18.8% in patients with first-line chemotherapy and BVC-based regimen respectively, compared to 11.8% and 5.9% with second-line chemotherapy. Median time to progression was 3.1 vs. 2.3 months for cases with first-line chemotherapy and BVC-based regimens respectively. Median survival was 8.2 vs. 4 months in both groups respectively （P = 0.019）. Conclusion： second-line chemotherapy combined BVC had higher disease control rate （partial response and stable disease）, median time to progression and median survival in BVC-naive patients compared to patients with first-line BVC-based therapy. BVC should be maintained in the second- and third-line settings, as cases with BVC discontinuation had significantly lower median time to disease progression and median survival. Selection of patients for use of BVC was recommended with taking into consideration the cost-benefit value and that the discontinuation of BVC would increase tumor progression.

关键词： second-line therapy Bevacizumab (BVC) metastatic colorectal carcinoma

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Phase I trial of dose escalation of capecitabine combined with fixed docetaxel in previously treated patients with non-small cell lung cancer

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The Chinese-German Journal of Clinical Oncology 2012年第1期11卷 6-10页

作者： Qiang Lin Yue'e Liu Chuilin Chang Na Wang Jingmei Fu Xiaocang Ren Xueji Chen Jing Hu Yansheng Tian Zhijun Guo Yannan Zhao Department of Oncology Hebei Medical University Affiliated North China Petroleum Bureau General HospitalRenqiu 062552China

Objective： Capecitabine combined with docetaxel have demonstrated antitumor synergy for non-small cell lung cancer （NSCLC）. Due to absence of phase I trial in China, we conducted this study to define the maximum-tolerated dose （MTD） of capecitabine with fixed docetaxel for Chinese patients with previously treated NSCLC. Methods： Previously treated patients with NSCLC were entered into this study. Escalating doses of capecitabine with fixed docetaxel were administered in a modified Fibonacci sequence. The initial doses were capecitabine 625 mg/m2, bid, on days d5-d 18, and docetaxe130 mg/m2 on days 1 and 8, respectively. The regimen was repeated every 21 days. If no dose-limiting toxicity （DLT） was observed, the next dose level was applied. The procedures were repeated until DLT appeared. The MTD was declared to be one dose level below the level at which DLT appeared. Results： Eighteen patients received 67 cycles at capecitabine of level I （1250 mg/m2, divided into 625 mg/m2, bid） and level II （1500 mg/m2, 750 mg/m2, bid）. The most common toxicities were neutropenia, hand and feet syndrome, fatigue and nausea. Eight DLTs occurred in 5 patients in the whole group, including 1 DLT in dose level I and 7 DLTs in dose level 2. Since 4 of 6 patients in level II experienced DLTs, we declared thus level I was MTD. Cunclusion： MTD of our phase I trial was capecitabine of 1250 mg/m2/d combined with docetaxel of 30 mg/m2/wk. This combination regimen was well tolerated for previously treated patients with NSCLC. The efficacy of this schedule is currently being further evaluated in a prospective phase II trial.

关键词： dose escalation second-line therapy chemotherapy capecitabine docetaxel

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