Multitargeted a ntifolate L Y231514 as first-line chemotherapy for patients w ith advanced non(cid:173)
`smal l-cell lung cancer: A phase II study. National Cancer Institute of Canada Clin ica l Trials
`Group.
`
`By: Rusthoven, J J ; Eisenhauer, E; Butts, C; Gregg, R; Dancey , J: F isher B; Iglesias
`
`Journal ofclinicnl oncology : official jo urna l of the Am eri can Society of Cli nical Oncolog y
`Volu me: 17 1ssue: .f Pages: 11 94
`Published: 1999-Apr
`
`Abstract
`
`PURP OS E: To eva luate the effic acy and safety of the mul ti targeted anti folata LY231 514 (MTA) in patients rec ei v in g ini tial chem otherapy for unresec table,
`adv anced non-small -cell lung cancer (NSCLC).
`
`PATIENTS AND METHODS: Patients with measurable, advanced NSCLC vth o had not recei ved previous chemotherapy for advanced di sease w ere
`considered for thi s stu dy. Eligible pat ients who ga ve 'Mitten inf ormed consent ini1ially received MTA 600 mglm (2) intrav enous ly (IV ) for 10 minutes every 3
`weeks. After th ree patients recei ved treatment at this dose, the dos e was reduced to 500 mglm(2) IV at the same infus ion time and frequency becaus e of
`tox icity seen in this study and anoth er Canadian MTA trial in co lorectal cancer. Patients recei v ed up to four cy cles after complete or pa rtial remission or six
`cyc les after stable cis ea se w as documented
`
`RE SULTS: Th irty -i hree patien.ts were acc rued onto the st udy Al l were ass es sable for toxicity , an d 30 pat ients w ere a.sses sable for res ponse. A ll but one
`patient had an Eas tern Cooperative Onc ology Group performan ce status sc ore of 0 or 1, 16 patient s {55%) had adenocarcinoma, and ni ne patients (27% ) had
`squam ous cell carcinoma. Tw enty -fiv e patients (76%) had stage IV disease, and t he remain der had st age I li B disease at trial entry . Seven patients
`experienced a confirmed partial response and no com plete responses were seen: thus . the ov erall response rate was 23.3% (95% confi den ce int erv al, 9.9%
`to 42 . 3%~ Th e media n duration of response was 3. 1 months (ran ge. 2. 3 to 13.5 m onths ) aft er a median foll ow-up peri od of 7.9 months. Four (67% ) of six
`patient s with stage I li B disea se and three (12.5%) of 24 wi th sta ge IV disease responded to treat ment. Four patient s {13.3%) ex perienced febrile neutropenia
`an d 13 (39%.) eKperienced gra de 3 or 4 neutropenia, wherea s only one patient (3%) developed gra de 4 thromboc y topenia. Nonhematologic toxicity w as
`generally mil d or moderat e, but 39% of patients dev eloped a gra de 3 skin rash. Most other tox icities compri sed grade 1 or 2 .slomal itis, diarrhea, lethargy. an d
`an orexia. Ten patients stopped protocol therapy because of tox icity _
`
`CONCLUSION: MTA seems to hav e clinicall y meaningful activity as a single agent against advanced NSCLC. T ox icity is generally mil d an d tolerable. Further
`stu dy of t hi s agent in combination with cis platin and other activ e drugs is warranted in this dis eas e
`
`Author Information
`
`Address: Hamil ton Regional Canc er Centre, Hamilton , Onta ri o, Canada.
`
`Categ ories I Classi fica ti o n
`
`Research A reas : Geriatrics & Geront ology : Phamlacolomr & Pharmacy: Respiratory Sys tem : Bi ochemis try & Molecular Biology (prov ided by Thom son
`Reuters)
`
`Citation Network
`
`146 Tim es Cited
`
`24 Cited Ref erences
`View Related Rec ords
`
`~ V iew Citati on Map
`... Create Citati o n A I en.
`
`(data .fro m 'Y t>b of Sc~na: ru Co re Co lkchon)
`
`View PubMed Related Articles
`
`A ll Times Cited Co unt s
`156 in A ll Databases
`146 in Web of Science Core Collection
`70 in BIOSIS Citation Index
`10 in Chinese Science Citation
`Databas e
`0 in Data Citali on Index
`0 in Sci E LO a tation Index
`
`Usage Co unt
`
`Last 180 Days:
`Since 20 13: 0
`
`Learn more
`
`Most Recent Citatio n
`
`lzz edine, Hassan. Pemetrexed
`nephrotmdcity . BULLETIN DU
`CANCER, FEB 20 15.
`
`View All
`
`T hi s record i s fro m:
`ME DLI NE ®
`
`suggest a correction
`If y ou would like to improve the quality
`of the data in this rec ord, please
`suggest a correction
`
`MeSH Tem1s:
`
`Heading
`
`Quali fi er
`
`Adu~
`
`Aged
`
`Antineoplastic Agents
`
`adverse effects
`
`"therapeutic use
`
`Carcinoma, Small Cell
`
`.. drug th era py
`
`Female
`
`Glutamates
`
`Guanine
`
`adverse effects
`
`''therapeutic use
`
`advers e effects
`
`.. anal ogs & deriv ativ es
`
`th era peuti c us e
`
`Humans
`
`Infus ions . Intravenous
`
`Lung Neoplasms
`
`"dru g therapy
`
`Male
`
`Middle Aged
`
`Survival Analysis
`
`I Treatment Outcome
`
`Chem ical:
`
`I Registry Number
`
`Substance
`
`NEPTUNE GENERICS 1034- 00001
`
`APOTEX 1034-0001
`
`

`
`Ant ineoplastic Agents
`
`Glutamates
`
`pemetrexed
`
`Guanine
`
`0409AIZ7NO
`
`5Z9JL87A1R
`
`DocLJment lnfonnation
`Document Type: Cl inical Trial; Cli nica l Trial , Phase II; Journal A rti cle; Research Support, Non-U.S. Gov't
`
`Language: English
`
`PubMed ID: 1056 11 78
`
`NLM Unique ID: 8309333
`
`Date Created: 07 Jan 2000
`
`Date Completed: 07 Jan 2000 Date Revised: 21 Nov 2013
`
`Country: UNITED STATE S
`
`IS SN: 0732-183X
`
`Journal Information
`
`Table of Co ntents: Current Contents Connect®
`Impact Facto r: Journal Citation Reports®
`
`Oth er Information
`Citation Subset: Index Medicus
`
`Status: MEDLI NE
`
`© 2015 NUl.
`® 2015 THOMSON REUTERS
`
`TERMS OF USE
`
`PR IVACY POLICY
`
`FEEDBAC K
`
`~ 4of 4 ~
`
`NEPTUNE GENERICS 1034- 00002
`
`APOTEX 1 034 - 0002