Pooled analysis of individual patient data from capecitabine monotherapy clinical trials in locally advanced or metastatic breast cancer

Breast Cancer Research and Treatment

Volumn 136, Issue 3, 2012, Pages 777-788

  Blum, Joanne L ^a   Barrios, Carlos H ^b   Feldman, Nancy ^c   Verma, Sunil ^d   McKenna, Edward F ^e   Lee, Luen F ^e   Scotto, Nana ^f   Gralow, Julie ^g  

^a BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^b PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^c OLIVE VIEW UCLA MEDICAL CENTER   (United States)

^d UNIVERSITY OF TORONTO   (Canada)

^e GENENTECH INC   (United States)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

^g UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Capecitabine; Hormone receptor positive; Metastatic breast cancer; Pretreated; Treatment line

Indexed keywords

CAPECITABINE; ESTROGEN RECEPTOR; PROGESTERONE RECEPTOR; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOODY DIARRHEA; BREAST METASTASIS; CANCER LOCALIZATION; CANCER SURVIVAL; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHEMA; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL SYMPTOM; HAND FOOT SYNDROME; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA AND VOMITING; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PALMAR ERYTHEMA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLANTAR ERYTHEMA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEPSIS; SKIN DISEASE; STOMATITIS; BREAST TUMOR; DISEASE FREE SURVIVAL; META ANALYSIS; METABOLISM; MIDDLE AGED; MORTALITY; MULTIVARIATE ANALYSIS; PATHOLOGY; PROPORTIONAL HAZARDS MODEL; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; BREAST NEOPLASMS; BREAST NEOPLASMS, MALE; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HAND-FOOT SYNDROME; HUMANS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; PROPORTIONAL HAZARDS MODELS; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84878765775     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-012-2288-x     Document Type: Article

References (35)

1. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T (1996) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17:485-493
2. Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, Osterwalder B (2001) Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 92:1759-1768
3. ® ) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 14:1227-1233
4. Fumoleau P, Largillier R, Clippe C, Dièras V, Orfeuvre H, Lesimple T, Culine S, Audhuy B, Serin D, Curé H, Vuillemin E, Morère JF, Montestruc F, Mouri Z, Namer M (2004) Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline-and taxane-pretreated metastatic breast cancer. Eur J Cancer 40:536-542
5. Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS (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
6. Largillier R, Fumoleau P, Clippe C, et al. (2006) Capecitabine monotherapy after anthracycline and taxane failure in metastatic breast cancer (MBC): long-term survival data. Ann Oncol 17(Abstract 161P)
7. Kusama M, Nomizu T, Aogi K, Yoshimoto M, Horikoshi N, Tabei T, Noguchi S, Miura S, Yoshimura N, Kimura M, Toyama K, Shin E (2010) Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer. Breast Cancer 17:233-240
8. Mikhail SE, Sun JF, Marshall JL (2010) Safety of capecitabine: a review. Expert Opin Drug Saf 9:831-841
9. Zielinski C, Gralow J, Martin M (2010) Optimising the dose of capecitabine in metastatic breast cancer: confused, clarified or confirmed? Ann Oncol 21:2145-2152
10. Leonard R, Hennessy BT, Blum JL, O'Shaughnessy J (2011) Dose-adjusting capecitabine minimizes adverse effects while maintaining efficacy: a retrospective review of capecitabine for metastatic breast cancer. Clin Breast Cancer 11:349-356
11. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D (2006) Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355:2733-2743
12. Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu CG, Chan S, Jagiello-Gruszfeld A, Kaufman B, Crown J, Chan A, Campone M, Viens P, Davidson N, Gorbounova V, Raats JI, Skarlos D, Newstat B, Roychowdhury D, Paoletti P, Oliva C, Rubin S, Stein S, Geyer CE (2008) A phase III randomized comparison of lapatinib plus capecitabine vs 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
13. von Minckwitz G, du Bois A, Schmidt M, Maass N, Cufer T, de Jongh FE, Maartense E, Zielinski C, Kaufmann M, Bauer W, Baumann KH, Clemens MR, Duerr R, Uleer C, Andersson M, Stein RC, Nekljudova V, Loibl S (2009) Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German breast group 26/breast international group 03-05 study. J Clin Oncol 27:1999-2006
14. Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roché HH (2007) Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 25:5210-5217
15. Hortobagyi GN, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Lerzo GL, Pivot XB, Hurtado de Mendoza F, Xu B, Vahdat LT, Peck RA, Mukhopadhyay P, Roché HH (2010) Analysis of overall survival from a phase III study of ixabepilone plus capecitabine vs capecitabine in patients with MBC resistant to anthracyclines and taxanes. Breast Cancer Res Treat 122:409-418
16. 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. ASCO 2008 Breast Cancer Symposium; September 5-7, 2008; Washington, DC. (Abstract 186)
17. Brufsky AM, Hurvitz S, Perez E, Swamy R, Valero V, O'Neill V, Rugo HS (2011) RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 29:4286-4293
18. Barrios CH, Liu MC, Lee SC, Vanlemmens L, Ferrero JM, Tabei T, Pivot X, Iwata H, Aogi K, Lugo-Quintana R, Harbeck N, Brickman MJ, Zhang K, Kern KA, Martin M (2010) Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Res Treat 121:121-131
19. Crown J, Dieras V, Staroslawska E, Yardley DA, Davidson N, Bachelot TD, Tassell VR, Huang X, Kern KA, Romieu G (2010) Phase III trial of sunitinib (SU) in combination with capecitabine (C) versus C in previously treated advanced breast cancer (ABC). J Clin Oncol 28(Abstract LBA 1011)
20. Robert NJ, Diéras V, Glaspy J, Brufsky AM, Bondarenko I, Lipatov ON, Perez EA, Yardley DA, Chan SY, Zhou X, Phan SC, O'Shaughnessy J (2011) RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol 29:1252-1260
21. ®) 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
22. Talbot DC, Moiseyenko V, Van Belle S, O'Reilly SM, Alba Conejo E, Ackland S, Eisenberg P, Melnychuk D, Pienkowski T, Burger HU, Laws S, Osterwalder B (2002) Randomised, phase II trial comparing oral capecitabine (Xeloda) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines. Br J Cancer 86:1367-1372
23. Sparano JA, Vrdoljak E, Rixe O, Xu B, Manikhas A, Medina C, Da Costa SC, Ro J, Rubio G, Rondinon M, Perez Manga G, Peck R, Poulart V, Conte P (2010) Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 28:3256-3263
24. Kaufmann M, Maass N, Costa SD, Schneeweiss A, Loibl S, Sütterlin MW, Schrader I, Gerber B, Bauer W, Wiest W, Tomé O, Distelrath A, Hagen V, Kleine-Tebbe A, Ruckhaeberle E, Mehta K, von Minckwitz G, GBG-39 Trialists (2010) First-line therapy with moderate dose capecitabine in metastatic breast cancer is safe and active: results of the MONICA trial. Eur J Cancer 46:3184-3191
25. Stockler MR, Harvey VJ, Francis PA, Byrne MJ, Ackland SP, Fitzharris B, Van Hazel G, Wilcken NR, Grimison PS, Nowak AK, Gainford MC, Fong A, Paksec L, Sourjina T, Zannino D, Gebski V, Simes RJ, Forbes JF, Coates AS (2011) Capecitabine versus classical cyclophosphamide, methotrexate, and fluorouracil as first-line chemotherapy for advanced breast cancer. J Clin Oncol 29:4498-4504
26. Jäger E, Al-Batran S, Saupe S, Schmidt M, Kreienberg R, Müller L, Otremba BJ, Warm M, Waldenmaier D, Harbeck N (2010) A randomized phase III study evaluating pegylated liposomal doxorubicin (PLD) vs capecitabine (CAP) as first-line therapy for metastatic breast cancer (MBC): results of the PELICAN study. J Clin Oncol 28(Abstract 1022)
27. Vahdat L, Fein LE, Karwal MW, Campone M, Peck R, Mukhopadhyay P, Jassem J (2009) Ixabepilone plus capecitabine vs capecitabine in patients with metastatic breast cancer receiving ixabepilone in the first line setting: a pooled analysis from two phase III studies. Cancer Res 69(Abstract 6117)
28. Baselga J, Segalla JG, Roché H, Del Giglio A, Pinczowski H, Ciruelos EM, Filho SC, Gómez P, Van Eyll B, Bermejo B, Llombart A, Garicochea B, Durán MÁ, Hoff PM, Espié M, de Moraes AA, Ribeiro RA, Mathias C, Gil Gil M, Ojeda B, Morales J, Kwon Ro S, Li S, Costa F (2012) Sorafenib in combination with capecitabine: an oral regimen for patients with HER2-negative locally advanced or metastatic breast cancer. J Clin Oncol 30:1484-1491
29. Glück S, Russell C, O'Shaughnessy J, Yuan G, Odom D, Sherrill B, Blum J (2009) Relationship between survival and estrogen receptor (ER) status in pts with metastatic breast cancer (MBC) treated with capecitabine (C) and docetaxel (D): an exploratory data analysis. J Clin Oncol 27(Abstract 1024)
30. Gilabert M, Bertucci F, Esterni B, Madroszyk A, Tarpin C, Jacquemier J, Extra JM, Viens P, Gonçalves A (2011) Capecitabine after anthracycline and taxane exposure in HER2-negative metastatic breast cancer patients: response, survival and prognostic factors. Anticancer Res 31:1079-1086
31. Pippen JE, Paul D, Stokoe CT, Blum JL, Krekow L, Holmes FA, Lindquist DL, Sedlacek SM, Rivera RR, Brooks RJ, Vukelja SJ, McIntyre K, Lopez-Diaz C, O'Shaughnessy J (2011) Randomized, phase III study of adjuvant doxorubicin plus cyclophosphamide (AC) followed by docetaxel (T) with or without capecitabine (X) in high-risk early breast cancer: Exploratory Ki-67 analyses. J Clin Oncol;29(Abstract 500)
32. Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Kokko R, Ahlgren J, Auvinen P, Paija O, Helle L, Villman K, Nyandoto P, Nilsson G, Pajunen M, Asola R, Poikonen P, Leinonen M, Kataja V, Bono P, Lindman H (2012) Adjuvant capecitabine, docetaxel, cyclophosphamide, and epirubicin for early breast cancer: final analysis of the randomized FinXX trial. J Clin Oncol 30:11-18
33. Blum JL, Kohles J, McKenna E, Scotto N, Hu S, Odom D, Kaye JA, Glück S (2011) Association of age and overall survival in capecitabine-treated patients with metastatic breast cancer in clinical trials. Breast Cancer Res Treat 125:431-439
34. Twelves C, Scheithauer W, McKendrick J, Nowacki M, Seitz J, Van Hazel G, Wong A, Diaz-Rubio E, Gilberg F, Cassidy J (2008) Capecitabine versus 5-FU/LV in stage III colon cancer: updated 5-year efficacy data from X-ACT trial and preliminary analysis of relationship between hand-foot syndrome (HFS) and efficacy. ASCO 2008 Gastrointestinal Cancers Symposium (Abstract 274)
35. Diab SG, Elledge RM, Clark GM (2000) Tumor characteristics and clinical outcome of elderly women with breast cancer. J Natl Cancer Inst 92:550-556