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https://www.readbyqxmd.com/read/28213365/fda-approval-summary-tas-102
#1
Leigh Marcus, Steven J Lemery, Sachia Khasar, Emily Wearne, Whitney S Helms, Weishi Yuan, Kun He, Xianhua Cao, Jingyu Yu, Hong Zhao, Yaning Wang, Olen Stephens, Erika Englund, Rajiv Agarwal, Patricia Keegan, Richard Pazdur
FDA approved TAS-102 (Lonsurf, Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In an international, multicenter, double-blinded, placebo-controlled trial (TPU-TAS-102-301, herein referred to as RECOURSE), 800 patients with previously treated mCRC were randomly allocated (2:1) to receive either TAS-102 35mg/m2 orally twice daily after meals on Days 1-5 and 8-12 of each 28-day cycle (n=534) or matching placebo (n=266)...
February 17, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28197787/dermatux-phase-iv-trial-of-cetuximab-plus-folfiri-in-first-line-metastatic-colorectal-cancer-receiving-a-pre-defined-skin-care
#2
Carl Christoph Schimanski, Frank Staib, Thomas Göhler, Holger Hebart, Michael Heike, Michael Neise, Jochen Rudi, Thomas Geer, Gerrit Dingeldein, Claudia Lang, Peter Ehscheidt, Thomas Flohr, Klaus Maria Josten, Meinolf Karthaus, Alexander Schmittel, Jan Wierecky, Emil Boller, Martin Indorf, Marcus-Alexander Wörns, Peter R Galle, Markus Moehler
PURPOSE: Cetuximab-induced skin rash Gd3+ occurs in ≥16% patients (pts) (Heinemann et al., Lancet Oncol 15(10):1065-1075, 2014; Van Cutsem et al. J Clin Oncol 27(19):3117-25; 2009b). Survival, response, and toxicity parameters were re-evaluated under a pre-defined skin prophylaxis consistent of vitamin K1 ointment and oral doxycycline. METHODS: This is a national, multicenter, phase 4, first-line mCRC (K-RAS wt) trial. Pts received irinotecan 180 mg/m² (d1), FA 400 mg/m² (d1), 5-FU 400 mg/m² (d1), 5-FU 2400 mg/m² (d1-2), and cetuximab [400 mg/m² (d1), and then 250 mg/m² qw], prophylactic 0...
February 14, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28174488/a-pilot-phase-ii-study-of-neoadjuvant-triplet-chemotherapy-regimen-in-patients-with-locally-advanced-resectable-colon-cancer
#3
Haitao Zhou, Yan Song, Jun Jiang, Haitao Niu, Hong Zhao, Jianwei Liang, Hao Su, Zheng Wang, Zhixiang Zhou, Jing Huang
OBJECTIVE: This study aims to investigate the feasibility, safety and efficacy of triplet regimen of neoadjuvant chemotherapy in patients with locally advanced resectable colon cancer. METHODS: Patients with clinical stage IIIb colon cancer received a perioperative triple chemotherapy regimen (oxaliplatin 85 mg/m(2) and irinotecan 150 mg/m(2), combined with folinic acid 200 mg, 5-fluorouracil 500 mg bolus and then 2,400 mg/m(2) by 44 h infusion or capecitabine 1 g/m(2) or S-1 40-60 mg b...
December 2016: Chinese Journal of Cancer Research, Chung-kuo Yen Cheng Yen Chiu
https://www.readbyqxmd.com/read/28156640/efficacy-of-rolapitant-for-prevention-of-chemotherapy-induced-nausea-and-vomiting-cinv-in-patients-with-gastrointestinal-and-colorectal-cancers
#4
Karin Jordan, Bernardo Leon Rapoport, Ian D Schnadig, Martin Chasen, Sujata Arora, Daniel Powers, Lee Steven Schwartzberg
: 222 Background: Rolapitant (VARUBI) is a selective, long-acting neurokinin-1 receptor antagonist (RA) for the prevention of CINV. Rolapitant effectively prevented CINV in phase 3 trials of patients (pts) receiving highly or moderately emetogenic chemotherapy (HEC, MEC). While MEC and HEC regimens are commonly used to treat pts with gastrointestinal and colorectal cancers (GI/CRC), very few studies have evaluated the effectiveness of a neurokinin-1 RA regimen in these pts. We assessed the incidence of CINV and efficacy of rolapitant in a subset of pts with GI/CRC...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28133357/-a-case-of-unresectable-advanced-rectal-cancer-with-a-pancreatic-tumor-that-was-successfully-treated-with-folfirinox
#5
Nobushige Yabe, Shinji Murai, Hiroki Ozawa, Takahiro Yokose, Ippei Oto, Takahisa Yoshikawa, Kenjiro Kitasato, Hirotomo Shimizu, Kenji Kojima, Hirotoshi Hasegawa, Yuko Kitagawa
A 72-year-old man was admitted to our hospital department in September 2014 because of a positive fecal occult blood test.Colonoscopy showed a type 2 tumor in half of the AV 15 cm rectosigmoid colon.Histology of the biopsy indicated a moderately differentiated adenocarcinoma, and the RAS gene test found wild type.On CT examination, there were multiple liver lung metastases and a 30mm diameter tumor with pancreatic duct extension to the pancreatic body.A PET-CT examination had a high SUVmax at the same site...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28128439/second-line-systemic-therapy-for-metastatic-colorectal-cancer
#6
REVIEW
Simone Mocellin, Zora Baretta, Marta Roqué I Figuls, Ivan Solà, Marta Martin-Richard, Sara Hallum, Xavier Bonfill Cosp
BACKGROUND: The therapeutic management of people with metastatic colorectal cancer (CRC) who did not respond to first-line treatment represents a formidable challenge. OBJECTIVES: To determine the efficacy and toxicity of second-line systemic therapy in people with metastatic CRC. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 4), Ovid MEDLINE (1950 to May 2016), Ovid MEDLINE In-process & Other Non-Indexed Citations (1946 to May 2016) and Ovid Embase (1974 to May 2016)...
January 27, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28123730/pseudocirrhosis-caused-by-regorafenib-in-an-advanced-rectal-cancer-patient-with-multiple-liver-metastases
#7
Kensuke Kumamoto, Shungo Endo, Noriyuki Isohata, Azuma Nirei, Daiki Nemoto, Kenichi Utano, Takuro Saito, Kazutomo Togashi
A 70-year-old man who was diagnosed with unresectable advanced rectal cancer with multiple liver metastases, received oxaliplatin-based treatment with bevacizumab as first-line chemotherapy and irinotecan-based treatment with bevacizumab as second-line chemotherapy for a total of 17 months. The patient was treated with regorafenib (160 mg/day for 3 weeks) as third-line chemotherapy. Following completion of one course of regorafenib treatment, the patient complained of abdominal distension. Computed tomography (CT) examination identified liver atrophy and massive ascites, while no such symptoms were observed prior to the regorafenib treatment...
January 2017: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/28111925/combination-of-bevacizumab-irinotecan-and-temozolomide-for-refractory-or-relapsed-neuroblastoma-results-of-a-phase-ii-study
#8
Shakeel Modak, Brian H Kushner, Ellen Basu, Stephen S Roberts, Nai-Kong V Cheung
BACKGROUND: The rationale for studying the combination of bevacizumab, irinotecan, and temozolomide (BIT) in neuroblastoma (NB) is based on the following: (i) vascular endothelial growth factor (VEGF) expression is associated with an aggressive phenotype, (ii) anti-VEGF antibody bevacizumab enhances irinotecan-mediated suppression of NB xenografts, (iii) bevacizumab safety has been established in pediatric phase I studies, and (iv) irinotecan + temozolomide (IT) is a standard salvage chemotherapy...
January 23, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28081543/randomised-phase-ii-trial-of-irinotecan-plus-s-1-in-patients-with-gemcitabine-refractory-pancreatic-cancer
#9
T Ioka, Y Komatsu, N Mizuno, A Tsuji, S Ohkawa, M Tanaka, H Iguchi, A Ishiguro, M Kitano, T Satoh, T Yamaguchi, K Takeda, M Kida, K Eguchi, T Ito, M Munakata, T Itoi, J Furuse, C Hamada, Y Sakata
BACKGROUND: We aimed to compare the efficacy and safety of irinotecan/S-1 (IRIS) therapy with S-1 monotherapy in patients with gemcitabine-refractory pancreatic cancer. METHODS: Patients were treated with oral S-1 (80-120 mg for 14 days every 4 weeks) plus intravenous irinotecan (100 mg m(-2) on days 1 and 15 every 4 weeks; IRIS group) or oral S-1 group (80-120 mg daily for 28 days every 6 weeks). The primary endpoint was progression-free survival (PFS)...
February 14, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28011980/potential-safety-concerns-of-tlr4-antagonism-with-irinotecan-a-preclinical-observational-report
#10
Janet K Coller, Joanne M Bowen, Imogen A Ball, Hannah R Wardill, Ysabella Z A van Sebille, Romany L Stansborough, Zenab Lightwala, Anthony Wignall, Joseph Shirren, Kate Secombe, Rachel J Gibson
PURPOSE: Irinotecan-induced gut toxicity is mediated in part by Toll-Like receptor 4 (TLR4) signalling. The primary purpose of this preclinical study was to determine whether blocking TLR4 signalling by administering (-)-naloxone, a TLR4 antagonist, would improve irinotecan-induced gut toxicity. Our secondary aim was to determine the impact of (-)-naloxone on tumour growth. METHODS: Female Dark Agouti (DA) tumour-bearing rats were randomly assigned to four treatments (n = 6 in each); control, (-)-naloxone (100 mg/kg oral gavage at -2, 24, 48, and 72 h), irinotecan (175 mg/kg intraperitoneal at 0 h), and (-)-naloxone and irinotecan...
December 23, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27938508/regorafenib-plus-folfiri-with-irinotecan-dose-escalated-according-to-uridine-diphosphate-glucuronosyltransferase-1a1-genotyping-in-patients-with-metastatic-colorectal-cancer
#11
Cheng-Jen Ma, Ching-Wen Huang, Yung-Sung Yeh, Hsiang-Lin Tsai, Huang-Ming Hu, I-Chen Wu, Tian-Lu Cheng, Jaw-Yuan Wang
We analyzed the results of previously treated patients with metastatic colorectal cancer (mCRC) who received regorafenib plus FOLFIRI with the irinotecan dose escalation on the basis of uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotyping. Thirteen patients with previously treated mCRC were subjected to UGT1A1 genotyping between Oct 2013 and June 2015 and were administered regorafenib plus FOLFIRI with irinotecan dose escalation. Patients with UGT1A1*1/*1 and *1/*28 genotypes were administered 180 mg/m(2) 48 of irinotecan, whereas those with the UGT1A1*28/*28 genotype were administered 120 mg/m(2) 49 of irinotecan...
17, 2016: Oncology Research
https://www.readbyqxmd.com/read/27909037/safety-and-efficacy-of-stereotactic-body-radiation-therapy-combined-with-s-1-simultaneously-followed-by-sequential-s-1-as-an-initial-treatment-for-locally-advanced-pancreatic-cancer-silapanc-trial-study-design-and-rationale-of-a-phase-ii-clinical-trial
#12
Xiaofei Zhu, Xiaoping Ju, Fei Cao, Fang Fang, Shuiwang Qing, Yuxin Shen, Zhen Jia, Yangsen Cao, Huojun Zhang
INTRODUCTION: Upfront surgeries are not beneficial to most patients with pancreatic cancer. Therefore, more emphasis has been placed chemoradiotherapy in locally advanced pancreatic cancer recently. Gemcitabine-based regimens or FOLFIRINOX (a chemotherapy regimen including leucovorin, 5-FU, irinotecan, oxaliplatin) has been proven as a standard chemotherapy in pancreatic cancer. However, severe toxicities may prevent the completion of chemotherapy. S-1 has showed better objective response rates, similar overall survival rates and progression-free survival rates compared with gemcitabine, revealing that S-1 may be a potential candidate in treating pancreatic cancer, especially for patients refractory to gemcitabine...
December 1, 2016: BMJ Open
https://www.readbyqxmd.com/read/27906628/role-of-genomic-factors-beyond-thymidylate-synthase-in-the-prediction-of-response-to-5-fluorouracil
#13
Godefridus J Peters, K Smid, E Meijer, C J van Groeningen, L G Leon
5-Fluorouracil (5FU) is still a major drug in combinations regimens for the treatment of colorectal cancer (CRC) both in the adjuvant and palliative setting. 5FU or its oral prodrug capecitabine is usually combined with irinotecan/oxaliplatin and the novel agents bevacizumab/cetuximab. Although this improved the outcome, the overall prognosis in patients with metastasized disease is still relatively poor. Although the target for 5FU, thymidylate synthase was shown to have a predictive value, this could only predict response in a subset of patients...
December 2016: Nucleosides, Nucleotides & Nucleic Acids
https://www.readbyqxmd.com/read/27858180/irinotecan-monotherapy-as-third-line-treatment-for-advanced-gastric-cancer-refractory-to-fluoropyrimidines-platinum-and-taxanes
#14
Takashi Nishimura, Satoru Iwasa, Kengo Nagashima, Natsuko Okita, Atsuo Takashima, Yoshitaka Honma, Ken Kato, Tetsuya Hamaguchi, Yasuhide Yamada, Yasuhiro Shimada, Narikazu Boku
BACKGROUND: Because standard chemotherapy for advanced gastric cancer consists of oral fluoropyrimidines plus platinum as first-line therapy, with paclitaxel plus ramucirumab as the second line, irinotecan is usually positioned as third-line chemotherapy in clinical practice in Japan. METHODS: A retrospective evaluation was conducted to determine the efficacy and safety of irinotecan as third-line chemotherapy for advanced gastric cancer in patients refractory or intolerant to fluoropyrimidines, platinum, and taxanes...
November 17, 2016: Gastric Cancer
https://www.readbyqxmd.com/read/27803477/pharmaceutical-investigation-for-individualized-and-optimal-cancer-pharmacotherapy
#15
Tomohiro Terada
 After the year 2000, the treatment of cancer remarkably changed, including the development of outpatient cancer chemotherapy. Meanwhile, we have encountered many clinical problems related to cancer patient pharmacy services. To resolve these problems, I have tried to establish the individualized and optimal cancer pharmacotherapy utilizing the findings of basic research. In this review, three topics of my research will be introduced. 1) In 2005, information regarding the genetic polymorphism of UGT1A1*28 was described in the package insert of the drug irinotecan in the United States...
2016: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/27643650/phase-i-clinical-study-of-irinotecan-plus-s-1-in-patients-with-advanced-or-recurrent-cervical-cancer-previously-treated-with-platinum-based-chemotherapy
#16
Seiji Mabuchi, Eriko Yokoi, Takao Owa, Katsumi Kozasa, Michiko Yamashita, Eiji Kobayashi, Takuji Tomimatsu, Takeshi Yoki, Tateki Tsutui, Tadashi Kimura
OBJECTIVES: This study aimed to determine the maximum tolerated dose and acute dose-limiting toxicities (DLTs) of intravenous irinotecan plus oral S-1 in patients with advanced or recurrent uterine cervical cancer. METHODS: Irinotecan was administered intravenously over the course of 90 minutes on day 1, and S-1 was given orally in 2 divided doses from days 1 to 14 of a 21-day cycle. The dose of S-1 was escalated in a stepwise fashion from 40 (level 1) to 60 mg/m (level 2) and then 80 mg/m (level 3), whereas the dosage of irinotecan remained the same (150 mg/m)...
September 2016: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/27628195/a-dose-finding-study-for-oxaliplatin-irinotecan-and-s-1-ois-in-patients-with-metastatic-or-recurrent-gastrointestinal-cancer
#17
Boram Han, Joo Young Jung, Hyeong Su Kim, Ji Woong Cho, Kab Choong Kim, Hyun Lim, Ho Suk Kang, Hong Il Ha, Min-Jeong Kim, Jung Hoon Kim, Dae Ro Choi, Geundoo Jang, Jung Han Kim, Hunho Song, Dae Young Zang
PURPOSES: To determine the maximum tolerated dose (MTD), recommended dose (RD), and activity of combined oxaliplatin, irinotecan, and S-1 chemotherapy for metastatic or recurrent gastrointestinal (GI) cancer. METHODS: Oxaliplatin and irinotecan were administered intravenously on day 1, and S-1 was administered orally on days 1-7, every 2 weeks. This phase I study used the following dose levels for oxaliplatin/irinotecan/S-1: level 1, 85/120/60 mg/m(2); level 2, 85/120/80 mg/m(2); level 3, 85/120/100 mg/m(2); level 4, 85/150/100 mg/m(2); and level 5, 85/180/100 mg/m(2)...
September 15, 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27590707/intestinal-permeability-to-iohexol-as-an-in-vivo-marker-of-chemotherapy-induced-gastrointestinal-toxicity-in-sprague-dawley-rats
#18
Richard A Forsgård, Riitta Korpela, Reetta Holma, Jere Lindén, Rafael Frias, Thomas Spillmann, Pia Österlund
PURPOSE: Gastrointestinal toxicity is the most common adverse effect of chemotherapy. Chemotherapeutic drugs damage the intestinal mucosa and increase intestinal permeability. Intestinal permeability is one of the key markers of gastrointestinal function and measuring intestinal permeability could serve as a useful tool for assessing the severity of chemotherapy-induced gastrointestinal toxicity. METHODS: Male Sprague-Dawley rats were injected intraperitoneally either with 5-fluorouracil (150 mg/kg), oxaliplatin (15 mg/kg) or irinotecan (200 mg/kg)...
October 2016: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/27510985/effect-of-hesperidin-on-the-pharmacokinetics-of-cpt-11-and-its-active-metabolite-sn-38-by-regulating-hepatic-mrp2-in-rats
#19
Xingdong Wang, Zhi Rao, Hongyan Qin, Guoqiang Zhang, Yanrong Ma, Yongwen Jin, Miao Han, Axi Shi, Yanping Wang, Xinan Wu
The usage of irinotecan hydrochloride (CPT-11) chemotherapy is hindered by its dose-limiting diarrhea which appears to be associated with the intestinal exposure to SN-38, the active metabolite of CPT-11. Hesperidin, a safe and natural food ingredient flavonoid, exhibits various biological properties. Accumulated evidence showed that the regulatory effect of hesperidin on the expression of Mrp2 in the liver may be one of the critical factors controlling the biliary excretion of SN-38. This study examined the effect of hesperidin on the pharmacokinetics of CPT-11 and SN-38 as well as the regulatory effect on the hepatic expression of Mrp2...
October 2016: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/27468920/multicenter-phase-ii-study-of-combination-therapy-with-cetuximab-and-s-1-in-patients-with-kras-exon-2-wild-type-unresectable-colorectal-cancer-previously-treated-with-irinotecan-oxaliplatin-and-fluoropyrimidines-kscc-0901-study
#20
Takao Takahashi, Yasunori Emi, Eiji Oki, Kazuma Kobayashi, Akihito Tsuji, Mototsugu Shimokawa, Takaho Tanaka, Yoshito Akagi, Yutaka Ogata, Hideo Baba, Kazuhiro Yoshida, Shoji Natsugoe, Yoshihiko Maehara
PURPOSE: Anti-epidermal growth factor receptor antibody therapy alone or in combination with irinotecan is recognized as a standard third-line treatment for KRAS wild-type unresectable metastatic colorectal cancer. However, in some cases, it is difficult to administer irinotecan after third-line treatment. Therefore, we examined the efficacy and safety of the combination of cetuximab and S-1 in patients with KRAS wild-type unresectable metastatic colorectal cancer who were previously treated with irinotecan, oxaliplatin, and fluoropyrimidines...
September 2016: Cancer Chemotherapy and Pharmacology
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