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`lzzedine, Hassan. Pemetrexed
`nephrotoxicity . BULLETIN DU
`CANCER, FEB 2015.
`View All
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`This record is from:
`MEDLINE 3
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`‘‘ LY231514 as first-line chemotherapy for patients with advanced non-
`small-cell lung cancer: A phase II study. National Cancer Institute of Canada Clinical Trials
`Group.
`By:
`
`J J; Eisenhauer_ E; Butts, C; Gregg. R; Dancey_ J; Fisher. B; lglesias. J
`
`Journal of clinical oncology : official journal of the American Society of Clinical Oncology
`Volume: 17 Issue: 4 Pages: 1194
`Published: 1999—Apr
`
`Abstract
`PURPOSE: To evaluate the efficacy and satety ot the-‘ LY231514 {MTAJ in patients receiving initial chemotherapy for unresectable,
`advanced non-small-cell lung cancer [NSCLC].
`
`PATIENTS AND METHODS: Patients with measurable, advanced NSCLC who had not received previous chemotherapy for advanced disease were
`considered for this study, Eligible patients who gave written intormed consent initially received MTA 600 mgfm(2] intravenorsly (IV) for 10 minutes every 3
`weeks. After three patients received treatment at this dose, the dose was reduced to 5UU mgfm(2] IV at the same infusion time and frequency because of
`toxicity seen in this study and another Canadian MTA trial in colorectal cancer. Patients received up to four cycles after complete or partial remission or six
`cycla after stable disease was documented,
`
`RESULTS: Thiny-three patients were accrued onto the study, All were assessable for toxicity, and 30 patients were assessable for mporse, All but one
`patient had an Eastern Cooperative Oncology Group performance status score of U or 1, 18 patients (55%) had adenocarcinoma, and nine patients (27%) had
`squamous cell carcinoma. Twenty-five patients (76%) had stage IV disease, and the remainder had stage IIIB disease at trial entry. Seven patients
`experienced a confirmed partial rwporse and no complete rmporsm were seen; thts, the overall rmponse rate was 23.3% (95% confidence interval, 9.9%
`to 42.3%]. The median duration ot response was 3.1 months (range, 2. 3 to 13.5 montts] after a median follow-up period ot 7.9 months. Four (67%) ot six
`patients with stage IIIB disease and three (12.5%) of 24 with stage IV disease raponded to treatment. Four patients (13.3%) experienced febrile neutropenia
`and 13 (39%) experienced grade 3 or 4 neutropenia, whereas only one patient (3%) developed grade 4 thrombocytopenia. Nonhematologic toxicity was
`generally mild or moderate, but 39% of patients developed a grade 3 skin rash. Most other toxicities comprised grade 1 or2 stomatitis, diarrhea, lethargy, and
`anorexia, Ten patients stopped protocol therapy became of toxicity,
`
`CONCLUSION: MTA seems to have clinically meaningful activity as a single agent against advanced NSCLC. Toxicity is generally mild and tolerable. Further
`study of this agent in combination with cisplatin and other active dmgs is warranted in this disease,
`
`Author Information
`Address: Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada.
`
`categories I Classilication
`Research Areas: Geriatrics & Gerontology; Pharmacology & Phamracy; Rwpiratory System; Biochemistry & Molecular Biology (provided by Thomson
`Reuters]
`MeSH Tenrrs:
`
`adverse effects
`"therapeutic use
`"drug therapy
`
`adverse effects
`
`"therapeutic use
`adverse effects
`
`‘analogs & derivativa
`therapeutic Lse
`
`Heading
`Adult
`
`Aged
`Antineoplastic Agents
`
`Carcinoma. Small Cell
`Female
`Glutamates
`
`Humans
`
`Infusions, Intravenous
`
`Lung Neoplasms
`Male
`
`Middle Aged
`Survival Analysis
`Treatment Outcome
`
`Chemical:
`
`Registry Number
`
`Teva – Fresenius
`Exhibit 1034-00001
`
`
`
`0
`0
`
`Antineuplastic Agents
`Glutam ates
`
`IMQQAIZTNO
`5Z93L87A1 R
`
`pemetrexed
`Guanine
`
`Document Information
`Document Type: Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non—U.S. Gov-"t
`Language: English
`PubMed ID: 10561178
`NLM Unique ID: 8309333
`
`Date Created:‘ Date Completed: 07 Jan 2000
`Country: UNITED STATES
`ISSII: 0T32—183X
`
`Date Revised: 21 Nov 2013
`
`Journal Information
`Table of Contents: Current Contents Connects
`Impact Factor: Journal Citation Reponsm
`
`Other Information
`Citation Subset: Index Medicus
`Status: MEDLINE
`
`@2015 IILII.
`® 2015 THOMSON REUTERS
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`Teva — Fresenius
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`Exhibit 1034-00002
`
`Teva – Fresenius
`Exhibit 1034-00002