Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program

Breast Cancer Research and Treatment

Volumn 88, Issue 2, 2004, Pages 117-129

  Pierga, J Y ^a   Fumoleau, P ^b   Brewer, Y ^c   Zelek, L ^d   Martin, D ^e   Turpin, F L ^f   Goudier, M J ^g   Gil Delgado, M ^h   Baticle, J L ⁱ   Namer, M ^j   Chollet, P ^k   Sutherland, W ^l   Barats, J C ^m  

^a INSTITUT CURIE   (France)

^b CENTRE RENÉ GAUDUCHEAU   (France)

^c INSTITUT SAINTE CATHERINE   (France)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e Laval   (France)

^f CENTRE RENÉ HUGUENIN   (France)

^g Centre Hospitalier de Lorient   (France)

^h PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

ⁱ IVF Laboratory   (France)

^j CENTRE ANTOINE LACASSAGNE   (France)

^k CENTRE JEAN PERRIN   (France)

^l 18 20 R Pasteur Le Kremlin B ^*  (United States)

^m HÔPITAL CIVIL   (France)

more..

Author keywords

capecitabine; compassionate use; metastatic breast cancer

Indexed keywords

CAPECITABINE;

ADULT; AGE DISTRIBUTION; AGED; ALLERGY; ANEMIA; ASTHENIA; BREAST CARCINOMA; CARDIOTOXICITY; CLINICAL TRIAL; CONFERENCE PAPER; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HUMAN; INFECTION; LEUKOPENIA; LIVER FUNCTION TEST; LIVER TOXICITY; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTIVARIATE ANALYSIS; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; PAIN; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; VISUAL DISORDER; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; BREAST NEOPLASMS; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; FRANCE; HUMANS; MIDDLE AGED; NEUTROPENIA; OUTPATIENTS; RETROSPECTIVE STUDIES; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 9744278998     PISSN: 01676806     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10549-004-1282-3     Document Type: Conference Paper

References (30)

1. Archer CD, Lowdell C, Sinnett HD, English J, Khan S, Coombes R: Docetaxel: response in patients who have received at least two prior chemotherapy regimens for metastatic breast cancer. Eur J Cancer 34: 816-819, 1998
2. Valero V, Jones SE, von Hoff DD, Booser D, Mennel RG, Ravdin P, Holmes F, Rahman Z, Schottstaedt M, Erban J, Esparza-Guerra L, Earhart R, Hortobagyi G, Burris H: A phase II study of docetaxel in patients with paclitaxel-resistant metastatic breast cancer. J Clin Oncol 16: 3362-3368, 1998
3. Carlson R: Quality of life issues in the treatment of metastatic breast cancer. Oncology (Huntingt) 12: 27-31, 1998
4. Livingston R, Ellis G, Gralow J, Williams MA, White R, McGuirt C, Adamkiewicz BB, Long CA: Dose-intensive vinorelbine with current granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 15: 1395-1400, 1997
5. Seidman A, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, Lepore J, Gilewski T, Currie V, Crown J, Hakes T, Baselga J, Sklarin N, Moynihan ME, Tong W, Egorin M, Kearns C, Spriggs D, Norton L: Phase II Trial of Paclitaxel by 3-Hour Infusion as Initial and Salvage Chemotherapy for Metastatic Breast Cancer. J Clin Oncol 13: 2575-2581, 1995
6. Bishop J, Dewar J, Toner GC, Tattersall M, Olver I, Ackland S, Kennedy I, Goldstein D, Gurney H, Walpole E, Levi J, Stephenson J: Paclitaxel as first-line treatment for metastatic breast cancer. The Taxol Investigational Trials Group, Australia and New Zealand. Oncology (Huntingt) 11: 19-23, 1997
7. D'Andrea G, Seidman A: Docetaxel and paclitaxel in breast cancer therapy: present status and future prospects. Semin Oncol 24: S13 (Suppl.13), 1997
8. Winer E, Morrow M, Osborne CK, Harris JR: Malignant tumors of the breast. In: DeVita VT, Hellman S, Rosenberg S (eds) CANCER Principles and Practice of Oncology. Philadelphia, Lippincott Williams & Wilkins, 2001, pp 1651-1717
9. Nabholtz JM, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Vogel C, Weaver C, Walley BMMCLTE-JEGR, Howell A, Hainsworth J, Fornander T, Blitz S, Gazel S, Loret C, Riva A: Phase III trial comparing TAC (docetaxel, doxorubicin, cyclophosphamide) with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) in the adjuvant treatment of node positive breast cancer (BC) patients: interim analysis of the BCIRG 001 study. Proc Am Soc Clin Oncol 21: 36a, 2002 (abstr)
10. Degardin M, Bonneterre J, Hecquet B, Pion J, Adenis A, Horner D, Demaille A: Vinorelbine (Navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 5: 423-426, 1994
11. Fumoleau P, Delgado FM, Delozier T, Monnier A, Gil Delgado M, Kerbrat P, Garcia-Giralt E, Keiling R, Namer M, Closon M: Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 11: 1245-1252, 1993
12. Romero A, Rabinovich M, Vallejo C, Perez J, Rodriquez R, Cuevas M, Machiavclli M, Lacava J, Langhi M, Romero AL: Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 12: 336-341, 1994
13. Weber B, Vogel C, Jones S, Harvey H, Hutchins L, Bigley J, Hohneker J: Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 13: 2722-2730, 1995
14. Roche H, Fumoleau P, Tresca P, Pinon G, Serin D, Marie FN, Delgado M, Bellepomme D: Vinorelbine, a new active drug in breast carcinoma: results of an ARTAC phase II trial. Ann Oncol 1: 36 (Suppl. to Vol. 1), 1990, (abstr)
15. Fazeny B, Zifko U, Meryn S, Huber H, Grisold W, Dittrich C: Vinorelbine-induced neurotoxicity in patients with advanced breast cancer pretreated with paclitaxel - a phase II study. Cancer Chemother Pharmacol 39: 150-156, 1996
16. Seidman A, Hochhauser D, Gollub M, Edelman B, Yao TJ, Hudis C, Francis P, Fennelly D, Gilewski T, Moynihan ME, Currie V, Badselga J, Tong W, O'Donaghue M, Salvaggio R, Auguste L, Spriggs D, Norton L: Ninety-Six Hour Paclitaxel Infusion After Progression During Short Taxane Exposure : A Phase II Pharmacokinetics and Pharmacodynamic Study in Metastatic Breast Cancer. J Clin Oncol 14: 1877-1884, 1996
17. Perez E, Vogel C, Irwin DH, Kirshner J, Patel R: Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol 19: 4216-4223, 2001
18. Hansen R, Quebbeman E, Beatty P, Ritch P, Anderson T, Jenkins D, Frick J, Ausman R: continuous 5-fluorouracil infusion in refractory carcinoma of the breast. Breast Cancer Res Treat 10: 145-149, 1987
19. Izzo J, Fandi A, Villalobos W, Azli N, Bachouchi M, Levin FM, Benahmed M, Armand J, Rougier P, Cvitkovic E: Low-dose protracted continuous 5-fluorouracil infusion in solid tumors. J Infus Chemother 4: 135-139, 1994
20. Jabboury K, Holmes F, Hortobagyi G: 5-Fluorouracil rechallenge by protracted continuous infusion in refractory breast cancer. Cancer : 793-797, 1989
21. Huan S, Pazdur R, Singhakowinta A, Samal B, Vaitkevicius VK: Low-dose continuous infusion 5-fluorouracil. Evaluation in advanced breast carcinoma. Cancer 63: 419-422, 1989
22. Ishikawa T, Utoh M, Sawada N, Nishida M, Fukase Y, Sekiguchi F, Ishitsuka H: Tumor selective delivery of 5-fluorouracil by capecitabine, a new oral fluoropyrimidine carbamate, in human cancer xenografts. Biochem Pharmacol 55: 1091-1097, 1998
23. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda I, Ishitsuka H: Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34: 1274-1281, 1998
24. Mackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J: A Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol 16: 2977-2985, 1998
25. Schuller J, Cassidy J, Dumont E, Roos B, Durston S, Banken L, Utoh M, Mori K, Weidekamm E, Reigner B: Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 45: 291-297, 2000
26. Blum JL, Jones SE, Buzdar AU, LoRusso P, Kuter I, Vogel C, Osterwalder B, Burger H, Brown C, Griffin T: Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17: 485-493, 1999
27. O'Shaughnessy J, Moiseyenko V, Bell D, Nabholtz JM, Miles D, Gorbunova V, Laws S, Griffin T: A randomized phase II study of Xeloda™ (Capecitabine) vs CMF as first line chemotherapy of breast cancer in women aged > = 55 years. Proc Am Soc Clin Oncol 17: 103a, 1998 (abstr)
28. Miller AB, Hoogstraten B, Staquet M, Winkler A: reporting results of cancer treatment. Cancer 47: 207-214, 1981
29. Anderson JR, Cain KC, Gelber RD: analysis of survival by tumor response. J Clin Oncol 1: 710-719, 1983
30. Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B: multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 92: 1759-1768, 2001