Results of a phase II study of pemetrexed as first-line chemotherapy in patients with advanced or metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 126, Issue 1, 2011, Pages 101-108

  Robert, Nicholas J ^a,b   Conkling, Paul R ^a,c   O'Rourke, Mark A ^a,d   Kuefler, Paul R ^a,e   McIntyre, Kristi J ^a,g   Zhan, Feng ^a   Asmar, Lina ^a   Wang, Yanping ^h   Shonukan, Oluwatoyin O ^h   O'Shaughnessy, Joyce A ^a,f  

^a US Oncology   (United States)

^b Virginia Cancer Specialists   (United States)

^c Virginia Oncology Associates   (United States)

^d Cancer Centers of the Carolinas   (United States)

^e Northern Arizona Hematology Oncology   (United States)

^f TEXAS ONCOLOGY   (United States)

^g Presbyterian Medical Center of Dallas   (United States)

^h ELI LILLY AND COMPANY   (United States)

Author keywords

Chemotherapy; Dose dense; First line; Metastatic breast cancer; Multicenter; Pemetrexed

Indexed keywords

CYANOCOBALAMIN; DEXAMETHASONE; ERYTHROPOIETIN; ESTROGEN RECEPTOR; FOLIC ACID; GRANULOCYTE COLONY STIMULATING FACTOR; PEMETREXED; PROGESTERONE RECEPTOR;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASTHENIA; BREAST CANCER; CENTRAL NERVOUS SYSTEM METASTASIS; CLINICAL ARTICLE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; EDEMA; FATIGUE; FEMALE; HUMAN; LEUKOPENIA; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; THROMBOCYTE COUNT; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BONE NEOPLASMS; BREAST NEOPLASMS; FEMALE; GLUTAMATES; GUANINE; HUMANS; LIVER NEOPLASMS; LUNG NEOPLASMS; LYMPHATIC METASTASIS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; RECEPTOR, ERBB-2; SKIN NEOPLASMS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 79151473460     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-010-1286-0     Document Type: Article

References (30)

1. CT Chung RW Carlson 2003 Goals and objectives in the management of metastatic breast cancer Oncologist 8 514 520 10.1634/theoncologist.8-6-514 14657529 (Pubitemid 37467366)
2. M Colozza E deAzambuja N Personeni, et al. 2007 Achievements in systemic therapies in the pregenomic era in metastatic breast cancer The Oncologist 12 253 270 1:CAS:528:DC%2BD2sXlsVSqtbw%3D 10.1634/theoncologist.12-3-253 17405890 (Pubitemid 46556792)
3. American Cancer Society. Breast cancer-facts and figures http://www.cancer.org/downloads/STT/BCFF-Final.pdf
4. American Cancer Society: Cancer Facts and Figures (2009) http://www.cancer.org/downloads/STT/500809web.pdf
5. EA Perez DW Hillman JA Mailliard, et al. 2004 Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both J Clin Oncol 22 2849 2855 1:CAS:528:DC%2BD2cXpsVWkt7c%3D 10.1200/JCO.2004.10.047 15254052 (Pubitemid 41079903)
6. C Shih VJ Chen LS Gossett, et al. 1997 LY231514, a pyrrolo[2,3-d] pyrimidine-based antifolate that inhibits multiple folate-requiring enzymes Cancer Res 57 1116 1123 1:CAS:528:DyaK2sXhvFOisLc%3D 9067281
7. Alimta (pemetrexed) (2009) Package insert: Indianapolis. Eli Lilly and Company, IN. http://pi.lilly.com/us/alimta-pi.pdf
8. JA O'Shaughnessy 2002 Pemetrexed: an active new agent for breast cancer Semin Oncol 29 6 Suppl 18 57 62 10.1053/sonc.2002.37474 12571813 (Pubitemid 36176677)
9. Cripps MC, Burnell M, Jolivet J, et al (1997 ) Phase II study of a multi-targeted antifolate (LY231514)(MTA) as first line therapy in patients with locally advanced or metastatic colorectal cancer (MCC). Eur J Cancer 33:(suppl 8, abstr 768) ECCo9
10. JJ Rusthoven E Eisenhauer C Butts, et al. 1999 Multitargeted antifolate LY231514 as first line chemotherapy for patients with advanced non-small cell lung cancer: a phase II study J Clin Oncol 17 1194 1199 1:CAS:528: DyaK1MXisFenur4%3D 10561178 (Pubitemid 29162943)
11. KD Miller PJ Loehrer J Picus, et al. 2000 Phase II study of the multitargeted antifolate LY231514 (ALIMTA, MTA, pemetrexed disodium) in patients with advance pancreatic cancer Ann Oncol 11 101 103 1:STN:280: DC%2BD3c7lsV2rtA%3D%3D 10.1023/A:1008305205159 10690396 (Pubitemid 30084588)
12. FV Fossella U Gatzemeier 2002 Phase I trials of pemetrexed Semin Oncol 29 2 suppl 5 8 16 1:CAS:528:DC%2BD38Xks1WksLY%3D 10.1053/sonc.2002.30764 12023787 (Pubitemid 34564408)
13. AR Hanauske V Chen P Paoletti, et al. 2001 Pemetrexed disodium: a novel antifolate clinically active against multiple solid tumors Oncologist 6 363 373 1:CAS:528:DC%2BD3MXmvFKrs7c%3D 10.1634/theoncologist.6-4-363 11524555 (Pubitemid 32816541)
14. JA O'Shaughnessy A Gennari P Conte 2002 Pemetrexed: a promising new treatment for breast cancer Semin Oncol 29 2 suppl 5 36 41 10.1053/sonc.2002. 30766 12023791 (Pubitemid 34564412)
15. DW Miles IE Smith RE Coleman, et al. 2001 A phase II study of pemetrexed disodium (LY231514) in patients with locally recurrent or metastatic breast cancer Eur J Cancer 37 1366 1371 1:CAS:528:DC%2BD3MXkvVeisbs%3D 10.1016/S0959-8049(01)00117-4 11435066 (Pubitemid 32588747)
16. ®, Multitargeted Antifolate, LY231514) in metastatic breast cancer patients previously treated with an anthracycline and a taxane: an interim analysis Clin Breast Cancer 2 1 47 51 1:CAS:528: DC%2BD38XosFGlsbw%3D 10.3816/CBC.2001.n.010 11899382 (Pubitemid 32440423)
17. JA O'Shaughnessy RS Clark JL Blum, et al. 2005 Phase II study of pemetrexed in patients pretreated with an anthracycline, a taxane, and capecitabine for advanced breast cancer Clin Breast Cancer 6 143 149 10.3816/CBC.2005.n.016 16001992 (Pubitemid 40975610)
18. A Llombart-Cussac M Theodoulou K Rowland RS Clark T Nakamura E Carrasco G Cruciani 2006 Pemetrexed in patients with locally advanced or metastatic breast cancer who had received previous anthracycline and taxane treatment: phase II study Clin Breast Cancer 7 5 380 385 1:CAS:528:DC%2BD2sXhs1Wht7c%3D 10.3816/CBC.2006.n.054 17239262 (Pubitemid 46157558)
19. A Goldhirsch AS Coates M Coleoni, et al. 1998 Adjuvant chemoendocrine therapy in postmenopausal breast cancer cyclophosphamide, methotrexate, and fluorouracil dose and schedule may make a difference J Clin Oncol 16 4 1358 1362 1:CAS:528:DyaK1cXis1GhsLY%3D 9552037 (Pubitemid 28175751)
20. AZ Dudek T Larson MJ McCleod DJ Schneider JE Dowell TK Banerjee KJ Pandya JL Bromund R Chen MJ Monberg CK Obasaju 2008 Phase 1/2 dose escalating study of twice-monthly pemetrexed and gemcitabine in patients with advanced cancer and non-small cell lung cancer J Thorac Oncol 3 4 394 399 10.1097/JTO. 0b013e318169cdc4 18379358 (Pubitemid 351489480)
21. P Therasse SG Arbuck EA Eisenhauer, et al. 2000 New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada J Natl Cancer Inst 92 205 216 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10.1093/jnci/92.3.205 10655437
22. EL Kaplan P Meier 1958 Nonparametric estimation from incomplete observations JASA 53 457 481
23. KM Li LP Rivory SJ Clarke 2009 Pemetrexed pharmacokinetics and pharmacodynamics in a phase 1/2 study of doublet chemotherapy with vinorelbine: implications for further optimization of pemetrexed schedules Br J Cancer 97 1071 1076 10.1038/sj.bjc.6603995
24. Emmanouilides CE, Sapountzi E, Diamandidis D (2008) Feasibility of treatment of relapsed NSLCLC with accelerated pemetrexed given every 2 weeks. J Clin Oncol 26 (suppl: abstr 19106)
25. A Llombart-Cussac M Martin N Harbeck, et al. 2007 A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer Clin Cancer Res 13 12 3652 3689 1:CAS:528:DC%2BD2sXmsFCqurY%3D 10.1158/1078-0432.CCR-06-2377 17575230 (Pubitemid 46955129)
26. M Martin M Spielmann M Namer, et al. 2003 Phase II study of pemetrexed in breast cancer patients pretreated with anthracyclines Ann Oncol 14 1246 1252 1:STN:280:DC%2BD3szkvVaqsA%3D%3D 10.1093/annonc/mdg339 12881387 (Pubitemid 37039051)
27. CX Ma P Steen KM Rowland, et al. 2006 A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: an NCCTG study Ann Oncol 17 226 231 1:STN:280:DC%2BD28%2FjvVGluw%3D%3D 10.1093/annonc/mdj054 16303865 (Pubitemid 43160110)
28. R Paridaens L Dirix H Dumez, et al. 2007 Phase I/II pharmacokinetic study of pemetrexed and epirubicin in patients with locally advanced or metastatic breast cancer Clin Breast Cancer 7 861 866 1:CAS:528:DC%2BD1cXhtlyntL4%3D 10.3816/CBC.2007.n.051 18269776
29. A Garin A Manikhas M Biakhov, et al. 2008 A phase II study of pemetrexed and carboplatin in patients with locally advanced or metastatic breast cancer Breast Cancer Res Treat 110 309 315 1:CAS:528:DC%2BD1cXmslygsr0%3D 10.1007/s10549-007-9722-5 17851759 (Pubitemid 351793878)
30. T Traina M Theodoulou K Feigin, et al. 2008 Phase I study of a novel capecitabine schedule based on the Norton-Simon mathematical model in patients with metastatic breast cancer J Clin Oncol 26 1797 1802 1:CAS:528: DC%2BD1cXmsFemsLc%3D 10.1200/JCO.2007.13.8388 18398145