A multicenter, single-arm phase II study of pemetrexed plus doxorubicin administered every 21 days in patients with advanced breast cancer

Clinical Breast Cancer

Volumn 9, Issue 3, 2009, Pages 155-160

  Martin, Miguel ^a   Blasinska Morawiec, Maria ^b   Salas, J Fernando ^c   Falcon, Silvia ^d   Rolski, Janusz ^e   Ferrari, Bruno L ^f   Gulyas, Stephen ^g   Liu, Yushan ^h   Benhadji, Karim A ^g  

^a HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^b N Copernicus Hospital   (Poland)

^c HOSPITAL NACIONAL GUILLERMO ALMENARA IRIGOYEN   (Peru)

^d HOSPITAL NACIONAL EDGARDO REBAGLIATI MARTINS   (Peru)

^e INSTITUTE OF ONCOLOGY   (Poland)

^f Hospital Luxemburgo   (Brazil)

^g ELI LILLY AND COMPANY   (United States)

^h I3 Statprobe   (United States)

Author keywords

Anthracycline; Antifolate metabolite; Combination therapy; Neutropenia

Indexed keywords

DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PEMETREXED; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIBIOTIC; DRUG DERIVATIVE; ENZYME INHIBITOR; GLUTAMIC ACID DERIVATIVE; GUANINE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BONE MARROW TOXICITY; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER DIAGNOSIS; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LETHARGY; LEUKOPENIA; MAJOR CLINICAL STUDY; MALAISE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; SCORING SYSTEM; SIDE EFFECT; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT RESPONSE; VITAMIN SUPPLEMENTATION; BREAST TUMOR; DRUG ADMINISTRATION; MIDDLE AGED; PATHOLOGY; TIME; TREATMENT OUTCOME;

ADULT; AGED; ANTIBIOTICS, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; ENZYME INHIBITORS; FEMALE; GLUTAMATES; GUANINE; HUMANS; MIDDLE AGED; TIME FACTORS; TREATMENT OUTCOME;

EID: 70350761918     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2009.n.025     Document Type: Article

References (35)

1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Ann Oncol 2005;16:482-8.
2. Kataja V, Castiglione M, on behalf of the ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2008;18:ii9-11.
3. Parkin DM, Bray F, Ferlay J, et al. Global cancer statistics, 2002. Cancer J Clin 2005;55:74-108.
4. Fornari FA, Randolph JK, Yalowich JC, et al. Interference by doxorubicin with DNA unwinding in MCF-7 breast tumor cells. Mol Pharmacol 1994;45:649-56.
5. Bonadonna G, Beretta G, Tancini G, et al. Adriamycin (NSC-123127) studies at the Istituto Nazionale Tumor, Milan. Cancer Chemother Rep 1975;6:231-45.
6. Tormey DC. Adriamycin (NSC-123127) in breast cancer: an overview of studies. Cancer Chemother Rep 1975;6:319-27.
7. Hoogstraten B. Adriamycin (NSC-123127) in the treatment of advanced breast cancer; Studies by the Southwest Oncology Group. Cancer Chemother Rep 1975;6:329-34.
8. Sledge GW, Neuberg D, Bernardo P, et al. Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an Intergroup Trial (E1193). J Clin Oncol 2003;21:588-92.
9. Shih C, Chen VJ, Gossett LS, et al. Oy231514, a pyrrolo [2, 3-d] pyrimidinebased antifolate that inhibits multiple folate-requiring enzymes. Cancer Res 1997;57:1116-23.
10. Adjei AA. Pemetrexed (Alimta) : a novel multitargeted antifolate agent. [review] Expert Rev Anticancer Ther 2003;3:145-56.
11. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003;21:2636-44.
12. Hanna N, Shepherd FA, Fossella F V, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004;22:1589-97.
13. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008;26:3543-51.
14. Martin M. Clinical experience with pemetrexed in breast cancer. Semin Oncol 2006;33(suppl 2):S15-8.
15. Gomez HL, Santillana SL, Vallejos CS, et al. A phase II trial of pemetrexed in advanced breast cancer: Clinical response and association with molecular target expression. Clin Cancer Res 2006;12:832-8.
16. O'Shaughnessy JA, Clark RS, Blum JL, et al. Phase II study of pemetrexed in patients pretreated with an anthracycline, a taxane, and capecitabine for advanced breast cancer. Clin Breast Cancer 2005;6:143-149.
17. Llombart-Cussac A, Martin M, Harbeck N, et al. A randomized, double-blind, phase II study of two doses of pemetrexed as first-line chemotherapy for advanced breast cancer. Clin Cancer Res 2007;13:3652-9.
18. Dittrich C, Petruzelka L, Vodvarka P, et al. A Phase I study of pemetrexed (Alimta) and cyclophosphamide in patients with locally advanced or metastatic breast cancer. Can Ther: Clin 2006;12:7071-8.
19. Garin A, Manikhas A, Biakhov M, et al. A phase II study of pemetrexed and carboplatin in patients with locally advanced or metastatic breast cancer. Breast Cancer Res Treat 2008;110:309-15.
20. Dempsey JA, Schultz RM. Interaction between the multitargeted antifolate (MTA, LY231514) and doxorubicin in ZR-75-1 human breast carcinoma cells. Proc Amer Assoc Cancer 1999;40:590 (Abstract 2894).
21. Forler PA, Phares VG, Amsrud T, et al. Antifolates in combination therapy regimens using human tumor zenografts. Proc Am Assoc Cancer Res 1999;40:289-90 (Abstract 1922).
22. Hughes AN, Lind M, Azzabi A, et al. A phase I dose escalation study of doxorubicin in combination with pemetrexed. Breast Cancer Res Treat 2001;69:286 (Abstract 438).
23. Therasse P, Arbuck SG, Eisenhauer EA, et al. 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 2000;92:205-16.
24. National Cancer Institute (NCI). 2003. Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events, Version 3.0. Available at: http://ctep. cancer.gov/forms/CTCAEv3.pdf. Accessed: March 25, 2008.
25. 2 from contingency tables, and the calculation of P. J R Stat Soc [Ser A] 1922;85:87-94.
26. Kaplan EL, Meier P. Nonparametric estimation of incomplete observations. J Am Stat Assoc 1958;53:457-81.
27. Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 1982;38:29-41.
28. Chan S, Friedrichs K, Noel D, et al. (303 Study Group). Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999;17:2341-54.
29. Biganzoli L, Cufer T, Bruning P, et al. Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: the European Organization of Research and Treatment of Cancer 10961 Multicenter Phase III trial. J Clin Oncol 2002;20:3114-21.
30. Nabholtz J-M, Falkson C, Campos D, et al. (TAX 206 Study Group). Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, Phase III trial. J Clin Oncol 2003;21:968-75.
31. Blajman C, Balbiani L, Block J, et al. A prospective, randomized Phase III trial comparing combination chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil with vinorelbine plus doxorubicin in the treatment of advanced breast carcinoma. Cancer 1999;85:1091-7.
32. Bontenbal M, Creemers G-J, Braun HJ, et al. Phase II to III study comparing doxorubicin and docetaxel with fluorouracil, doxorubicin, and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: results of a Dutch community setting trial for the clinical trial group of the Comprehensive Cancer Centre. J Clin Oncol 2005;23:7081-8.
33. Henderson IC, Frei E, III. Adriamycin cardiotoxicity. Am Heart J 1980;99:671-4.
34. Univerferth DV, Magorien RD, Leier CV, et al. Doxorubicin cardiotoxicity. Cancer Treat Rev 1982;9:149-64.
35. Slamon D, Eiermann W, Robert W, et al. BCIRG 006: Second interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumak (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER-2/neu positive early breast cancer patients. Breast Cancer Res Treat 2007;101(suppl 1):3.