Analysis of overall survival from a phase III study of ixabepilone plus capecitabine versus capecitabine in patients with MBC resistant to anthracyclines and taxanes

Breast Cancer Research and Treatment

Volumn 122, Issue 2, 2010, Pages 409-418

  Hortobagyi, Gabriel N ⁿ   Gomez, Henry L ^a   Li, Rubi K ^b   Chung, Hyun Cheol ^c   Fein, Luis E ^d   Chan, Valorie F ^e   Jassem, Jacek ^f   Lerzo, Guillermo L ^g   Pivot, Xavier B ^h   De Mendoza, Fernando Hurtado ⁱ   Xu, Binghe ^j   Vahdat, Linda T ^k   Peck, Ronald A ^l   Mukhopadhyay, Pralay ^l   Roché, Henri H ^m  

^a INSTITUTO NACIONAL DE ENFERMEDADES NEOPLÁSICAS   (Peru)

^b ST LUKE S MEDICAL CENTER   (Philippines)

^c Yonsei University College of Medicine   (South Korea)

^d Centro de Oncologia Rosario   (Argentina)

^e Veterans Memorial Medical Center   (Philippines)

^f MEDICAL UNIVERSITY OF GDANSK   (Poland)

^g Hospital Maria Curie   (Argentina)

^h UNIVERSITY HOSPITAL OF BESANÇON   (France)

ⁱ HOSPITAL NACIONAL EDGARDO REBAGLIATI MARTINS   (Peru)

^j CANCER HOSPITAL   (China)

^k WEILL CORNELL MEDICAL COLLEGE   (United States)

^l BRISTOL MYERS SQUIBB   (United States)

^m INSTITUT CLAUDIUS REGAUD   (France)

ⁿ NONE

more..

Author keywords

Epothilone; Ixabepilone; Metastatic breast cancer; Overall survival

Indexed keywords

ANTHRACYCLINE; CAPECITABINE; DOXORUBICIN; EPIRUBICIN; IXABEPILONE; TAXANE DERIVATIVE; TRASTUZUMAB; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIBIOTIC; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; EPOTHILONE DERIVATIVE; FLUOROURACIL; TAXOID; TUBULIN MODULATOR;

ADULT; ANEMIA; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; BURNING SENSATION; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSESTHESIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERESTHESIA; HYPESTHESIA; LEUKOPENIA; MAJOR CLINICAL STUDY; MONOTHERAPY; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MYALGIA; NAUSEA; NEURALGIA; NEURITIS; NEUROPATHY; NEUROTOXICITY; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PALLANESTHESIA; PARESTHESIA; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; POLYNEUROPATHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING; AGED; ANALOGS AND DERIVATIVES; ASIA; BREAST NEOPLASMS; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; DRUG RESISTANCE; EUROPE; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; PROPORTIONAL HAZARDS MODEL; RISK ASSESSMENT; RISK FACTOR; SECONDARY; SOUTH AMERICA; TIME; TREATMENT OUTCOME; UNITED STATES;

ADULT; AGED; ANTHRACYCLINES; ANTIBIOTICS, ANTINEOPLASTIC; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIA; BREAST NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG RESISTANCE, NEOPLASM; EPOTHILONES; EUROPE; FEMALE; FLUOROURACIL; HUMANS; KAPLAN-MEIERS ESTIMATE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; RISK ASSESSMENT; RISK FACTORS; SOUTH AMERICA; TAXOIDS; TIME FACTORS; TREATMENT OUTCOME; TUBULIN MODULATORS; UNITED STATES; KAPLAN-MEIER ESTIMATE;

EID: 77955448465     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-010-0901-4     Document Type: Article

References (43)

1. Ries LAG, Melbert D, Krapcho M et al (2008) Surveillance epidemiology and end results. Available at http://seer.cancer.gov/csr/1975-2005/results-single/ sect-01-table.01.pdf. Posted on SEERS website 2008.
2. Henderson IC, Berry DA, Demetri GD et al (2003) Improved outcomes from adding sequential Paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 21:976-983.
3. Mamounas EP, Bryant J, Lembersky B et al (2005) Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B- 28. J Clin Oncol 23:3686-3696.
4. Martin M, Pienkowski T, Mackey J et al (2005) Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352:2302-2313.
5. Bonneterre J, Dieras V, Tubiana-Hulin M et al (2004) Phase II multicentre randomised study of docetaxel plus epirubicin vs 5-fluorouracil plus epirubicin and cyclophosphamide in metastatic breast cancer. Br J Cancer 91:1466-1471.
6. Bontenbal M, Creemers GJ, Braun HJ et al (2005) 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 23:7081-7088.
7. Jassem J, Pienkowski T, Pluzanska A et al (2001) Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: final results of a randomized phase III multicenter trial. J Clin Oncol 19:1707-1715.
8. Nabholtz JM, Falkson C, Campos D (2003) 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 21:968-975.
9. Longley DB, Johnston PG (2005) Molecular mechanisms of drug resistance. J Pathol 205:275-292.
10. Valero V, Hortobagyi GN (2003) Are anthracycline-taxane regimens the new standard of care in the treatment of metastatic breast cancer? J Clin Oncol 21:959-962.
11. Cardoso F, Di LA, Lohrisch C et al (2002) Second and subsequent lines of chemotherapy for metastatic breast cancer: what did we learn in the last two decades? Ann Oncol 13:197-207.
12. Bernard-Marty C, Cardoso F, Piccart MJ (2004) Facts and controversies in systemic treatment of metastatic breast cancer. Oncologist 9:617-632.
13. Lee JJ, Swain SM (2005) Development of novel chemotherapeutic agents to evade the mechanisms of multidrug resistance (MDR). Semin Oncol 32:S22-S26.
14. Lee FY, Shen H, Lee H et al (2008) Ixabepilone overcomes multiple mechanisms of drug resistance including overexpression of class III ß tubulin and breast cancer resistance protein. Eur J Cancer 6:219 (abstr).
15. Lee FYF, Camuso A, Castenada S et al (2006) Preclinical studies of ixabepilone (BMS-247550) demonstrate optimal anti-tumor activity against both chemotherapy sensitive and resistant tumor types. Proc Am Assoc Cancer Res 47 (abstr).
16. Baselga J, Zambetti M, Llombart-Cussac A et al (2009) Phase II genomics study of ixabepilone as neoadjuvant treatment for breast cancer. J Clin Oncol 27:526-534.
17. Bunnell C, Vahdat L, Schwartzberg L et al (2008) Phase I/II study of ixabepilone plus capecitabine in anthracycline-pretreated/resistant and taxane-resistant metastatic breast cancer. Clin Breast Cancer 8:234-241.
18. Low JA, Wedam SB, Lee JJ et al (2005) Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer. J Clin Oncol 23:2726-2734.
19. Perez EA, Lerzo G, Pivot X et al (2007) Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol 25:3407-3414.
20. Roche H, Yelle L, Cognetti F et al (2007) Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy. J Clin Oncol 25:3415-3420.
21. Thomas E, Tabernero J, Fornier M et al (2007) Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol 25:3399-3406.
22. Thomas ES, Gomez HL, Li RK et al (2007) Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 25:5210-5217.
23. Thomas ES (2008) Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline, taxane treatment. J Clin Oncol 26:2223.
24. Blum JL, Jones SE, Buzdar AU et al (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17:485-493.
25. Oshaughnessy JA, Blum J, Moiseyenko V et al (2001) Randomized, open-label, phase II trial of oral capecitabine (Xeloda) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 12:1247-1254.
26. Hortobagyi GN, Perez E, Vrdoljak E, Medina C, Xu B, Conte P, Roche H, Peck R, Poulart V, Sparano JA (2008) Analysis of overall survival (OS) among patients (pts) with metastatic breast cancer (MBC) receiving either Ixabepilone (I) plus capecitabine (C) or C alone: results from two randomized phase III trials. In: The 2008 Breast Cancer Symposium-integrating emerging science into clinical practice, September 5-7, 2008, Washington, D.C., p 178 (abst 186), (Poster presentation).
27. Cameron D, Casey M, Press M et al (2008) A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 112:533-543.
28. Geyer CE, Forster J, Lindquist D et al (2006) Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355:2733-2743.
29. Martin M, Ruiz A, Munoz M et al (2007) Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol 8:219-225.
30. Miller KD, Chap LI, Holmes FA et al (2005) Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 23:792-799.
31. Sargent DJ, Hayes DF (2008) Assessing the measure of a new drug: is survival the only thing that matters? J Clin Oncol 26:1922-1923.
32. Petrelli F, Cabiddu M, Cazzaniga ME et al (2008) Targeted therapies for the treatment of breast cancer in the post-trastuzumab era. Oncologist 13:373-381.
33. Piccart-Gebhart MJ, Burzykowski T, Buyse M (2008) Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol 26:1980-1986.
34. Giordano SH, Buzdar AU, Smith TL et al (2004) Is breast cancer survival improving? Cancer 100:44-52.
35. Jemal A, Siegel R, Ward E et al (2008) Cancer statistics, 2008. CA Cancer J Clin 58:71-96.
36. Lekberg TG, Rutqvist LE et al (2003) Markedly improved survival in patients with systemic metastatic breast cancer during a twenty year period-population based registry data from the Stockholm health care region. Breast Cancer Res Treat 82 (Suppl 1) (abstr).
37. Amar S, Roy V, Perez EA (2008) Treatment of metastatic breast cancer: looking towards the future. Breast Cancer Res Treat.
38. Carrick S, Parker S, Thornton CE et al (2009) Single agent versus combination chemotherapy for metastatic breast cancer. Cochrane Database Syst Rev CD003372.
39. Muss HB, Case LD, Richards F et al (1991) Interrupted versus continuous chemotherapy in patients with metastatic breast cancer. The Piedmont Oncology Association. N Engl J Med 325:1342-1348.
40. Coates A, Gebski V, Bishop JF et al (1987) Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Engl J Med 317:1490-1495.
41. Pazdur R (2008) Endpoints for assessing drug activity in clinical trials. Oncologist 13(Suppl 2):19-21.
42. Chia SK, Speers CH, D'yachkova Y et al (2007) The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer 110:973-979.
43. Miller K, Wang M, Gralow J et al (2007) Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357:2666-2676.