Eribulin alongwith capecitabine in relapsed carcinoma breast- a retrospective single-Institutional study.
Eribulin with capecitabine in carcinoma breast.
-
Soumita Poddar
,
Amitabha Chakrabarti
,
Bodhisattwa Dutta
,
Santu Mondal
,
SK. MD. Rejakul Islam
,
Azizul Purkait
Abstract
Background: Carcinoma breast is most commonly diagnosed cancer at present. Due to systemic nature of disease, chemotherapy plays an important role in treatment of carcinoma breast. Relapse (loco-regional or metastatic) is not uncommon in this disease. Both eribulin and capecitabine are effective as single agent in relapsed disease. In this single-institutional retrospective study, eribulin and capecitabine have been used as combination chemotherapy regimen in patients with relapsed carcinoma breast. Marerials and methods: Patients diagnosed to have relapsed carcinoma of breast, who were ER and/or PR positive, Her-2/neu negative or triple negative and received eribulin alongwith capecitabine, were included in our study. Primary objective of this study was to assess response, progression-free survival (PFS) and overall survival (OS). Secondary objective was toxicity assessment. Results: 48 patients were included in our study. Median age of patients was 56 years. Thirty six (75%) patients had ER and/or PR positive status and twelve (25%) patients had ER/PR negative status. Five (10.4%) patients achieved complete response (CR). Thirty two (66.7%) patients achieved partial response (PR). Disease was stable (SD) in nine (18.8%) patients. Two (4.2%) patients suffered from progressive disease (PD). Median Progression-free survival (PFS) was 10.15 months. Mean of PFS of patients was 10.72 (95% CI- 9.72-11.72) months. Median overall survival (OS) was 18.15 months. Mean of overall survival of patients was 19.56 (95% CI- 17.9-21.22) months. Nineteen (39.6%) and three (6.2%) patients experienced grade 2 and grade 3 anemia respectively. Eighteen (37.5%) and two (4.2%) patients suffered from grade 2 and grade 3 neutropenia respectively. One patients experienced grade 2 thrombocytopenia. Nineteen (39.6%) patients experienced grade 2 diarrhoea. One patients suffered from grade 3 diarrhoea. Palmo-plantor erythrodysesthesia was seen in eight (16.7%) patients. Six (12.5%) patients suffered from grade 2 neuropathy. Two (4.2%) patients experienced grade 3 neuropathy. Fatigue was seen in 19 (39.6%) patients. Conclusion: Eribulin alongwith capectabine can be used in patients with relapsed carcinoma breast, in whom anthracycline and taxane have previously been used; with response rate and survival better than either single agent chemotherapy. This regimen is important particularly for TNBC, where option for chemotherapy is limited.
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13] Rebbeck TR, Mitra N, Wan F, Sinilnikova OM, Healey S, McGuffog L, et al. Association of type and location of BRCA1 and BRCA2 mutations with risk of breast and ovarian cancer. JAMA. 2015; 313, 1347–1361.
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15] Antoniou A, Pharoah PD, Narod S, Risch HA, Eyfjord JE, Hopper JL, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case series unselected for family history: A combined analysis of 22 studies. Am J Hum Genet. 2003; 72(5):1117–1130.
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20] Cardoso F, Spence D, Mertz S, Corneliussen-James D, Sabelko K, Gralow J, et al: Global analysis of advanced/metastatic breast cancer: Decade report (2005–2015). Breast.2018; 39: 131–138.
21] Dawood S, Broglio K, Gonzalez-Angulo AM, Buzdar AU, Hortobagyi GN and Giordano SH: Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol. 2008; 26: 4891–4898.
22] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 ; 365(9472): 1687-717.
23] Lin Y, Yin W, Yan T, Zhou L, Di G, Wu J,et al. Site-specific relapse pattern of the triple negative tumors in Chinese breast cancer patients. BMC Cancer 2009; 9: 342.
24] Mayer EL, Burstein HJ, Chemotherapy for metastatic breast cancer. Hematol Oncol Clin North Am. 2007 Apr; 21(2): 257-72.
25] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016; 66: 7-30.
26] American Cancer Society. Cancer Facts & Figures 2016.
27] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer. Version 3. 2015: 187.
28] Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev 2003; 2003(2): CD002747.
29] Carmo-Pereira J, Costa FO, Henriques E, Godinho F, Cantinho-Lopes MG, Sales-Luis A, et al. A comparison of two doses of adriamycin in the primary chemotherapy of disseminated breast carcinoma. Br J Cancer 1987; 56: 471-3.
30] Cowan JD, Neidhart J, McClure S, Coltman CA Jr, Gumbart C, Martino S, et al. Randomized trial of doxorubicin, bisantrene, and mitoxantrone in advanced breast cancer: a Southwest Oncology Group study. J Natl Cancer Inst 1991; 83: 1077-84.
31] Henderson IC, Allegra JC, Woodcock T, Wolff S, Bryan S, Cartwright K, et al. Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989; 7: 560-71.
32] Ingle JN, Pfeifle DM, Green SJ, Kvols LK, Brunk SF, Reuter NF, et al. Randomized clinical trial of doxorubicin alone or combined with mitolactol in women with advanced breast cancer and prior chemotherapy exposure. Am J Clin Oncol 1985; 8: 275-82.
33] Cyclophosphamide. USP DI. Volume 1. Drug information for the health care professional. 20th ed. Englewood, Colorado: Micromedex, Inc.; 2002.
34] Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995; 13(10): 2575-81.
35] Reichman BS, Seidman AD, Crown JP, Heelan R, Hakes TB, Lebwohl DE, et al. Paclitaxel and recombinant human granulocyte colony-stimulating factor as initial chemotherapy for metastatic breast cancer. J Clin Oncol. 1993; 11(10): 1943-51.
36] CURRERI AR, ANSFIELD FJ, McIVER FA, WAISMAN HA, HEIDELBERGER C. Clinical studies with 5-fluorouracil. Cancer Res. 1958 May;18(4):478-84.
37] Carter SK. Integration of chemotherapy into combined modality treatment of solid tumors VII. Adenocarcinoma of the breast. Cancer Treat Rev. 1976 Sep;3(3):141-74.
38] Pinedo HM, Peters GF. Fluorouracil: biochemistry and pharmacology. J Clin Oncol. 1988 Oct; 6(10): 1653-64.
39] Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, et al. 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. 1998 Jul; 34(8): 1274-81.
40] Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999 Feb; 17(2): 485-93.
41] Smorenburg CH, Bontenbal M, Verweij J. Capecitabine in breast cancer: current status. Clin Breast Cancer. 2001 Jan;1(4):288-93.
42] Kuznetsov G, Towle MJ, Cheng H, Kawamura T, TenDyke K, Liu D, et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res. 2004; 64(16): 5760-6.
43] Wozniak KM, Nomoto K, Lapidus RG, Wu Y, Carozzi V, Cavaletti G, et al. Comparison of neuropathy-inducing effects of eribulin mesylate, paclitaxel, and ixabepilone in mice. Cancer Res. 2011; 71(11): 3952-62.
44] Thadani-Mulero M, Nanus DM, Giannakakou P. Androgen receptor on the move: boarding the microtubule expressway to the nucleus. Cancer Res. 2012; 72(18): 4611-4615.
45] Towle MJ, Salvato KA, Wels BF, Aalfs KK, Zheng W, Seletsky BM, et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71: 496-505.
46] Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011; 377(9769): 914-23.
47] Hattori M, Ishiguro H, Masuda N, Yoshimura A, Ohtani S, Yasojima H, et al. Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study. Breast Cancer. 2018; 25(1): 108-117.
48] Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009; 45(2): 228-47.
49] Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Published: May 28, 2009 (v4.03: June 14, 2010). U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES. National Institutes of Health. National Cancer Institute.
50] Quintero, Dino; et al. "Workload Optimized Systems: Tuning POWER7 for Analytics". Abstract.
51] Lee, SH, Lee, J, Park J, Park SH, Lee KE, Lee SI, et al. Capecitabine monotherapy in patients with anthracycline-and taxane-pretreated metastatic breast cancer. Med Oncol. 2004; 21: 223–231.
52] Fumoleau P, Largillier R, Clippe C, Dièras V, Orfeuvre H, Lesimple T et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004; 40(4): 536-42.
53] Saeki T, Kimura T, Toi M, Taguchi T. A pilot phase II study of capecitabine in advanced or recurrent breast cancer. Breast Cancer. 2006; 13(1): 49-57.
54] Sari M, Saip P. Eribulin monotherapy in heavily pretreated metastatic breast cancer patients in real life. Indian J Cancer. 2020; 57(1): 55-61.
55]. Twelves C, Anthoney A, Savulsky CI, et al. A phase 1b/2, open-label, dose-escalation, and dose-confirmation study of eribulin mesilate in combination with capecitabine. Br J Cancer. 2019; 120(6): 579-586.
2] World Health Organization (WHO). Global Health Estimates 2020: Deaths by Cause, Age, Sex, by Country and by Region, 2000-2019. WHO; 2020. Accessed December 11, 2020.
3] Omran AR. The epidemiologic transition. A theory of the epidemiology of population change. Milbank Mem Fund Q. 1971;49:509-538.
4] Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Piñeros M. et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer. 2019 Apr 15; 144(8): 1941-1953.
5] Freddie Bray, Jacques Ferlay, Rebecca L. Siegel, Lindsey A. Torre MSPH, Ahmedin Jemal.
Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries CA: A Cancer Journal for Clinicians.Volume 68, Issue 6 p. 394-424.
6] Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019;11:151-164.
7] Thun M, Linet MS, Cerhan JR, Haiman CA, Schottenfeld D, eds. Cancer Epidemiology and Prevention. 4th ed. Oxford University Press; 2018: 861-888.
8] Roy, R., Chun, J. & Powell, S. N. BRCA1 and BRCA2: different roles in a common pathway of genome protection. Nat. Rev. Cancer. 2012;68–78.
9] Brose MS, Rebbeck TR, Calzone KA, Stopfer JE, Nathanson KL, Weber BL. Cancer risk estimates for BRCA1 mutation carriers identified in a risk evaluation program. J Natl Cancer Inst. 2002;94(18):1365-72.
10] Tai YC, Domchek S, Parmigiani G, Chen S. Breast cancer risk among male BRCA1 and BRCA2 mutation carriers. J Natl Cancer Inst. 2007 Dec 5;99(23):1811-4.
11] Levy-Lahad E, Friedman E. Cancer risks among BRCA1 and BRCA2 mutation carriers. Br J Cancer. 2007 Jan 15;96(1):11-5.
12] Ferrone CR, Levine DA, Tang LH, Allen PJ, Jarnagin W, Brennan MF, Offit K, Robson ME. BRCA germline mutations in Jewish patients with pancreatic adenocarcinoma. J Clin Oncol. 2009 Jan 20;27(3):433-8.
13] Rebbeck TR, Mitra N, Wan F, Sinilnikova OM, Healey S, McGuffog L, et al. Association of type and location of BRCA1 and BRCA2 mutations with risk of breast and ovarian cancer. JAMA. 2015; 313, 1347–1361.
14] Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ et al. Risks of breast, ovarian, and contralateral breast cancer for BRCA1 and BRCA2 mutation carriers. JAMA 2017; 317(23):2402–2416.
15] Antoniou A, Pharoah PD, Narod S, Risch HA, Eyfjord JE, Hopper JL, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case series unselected for family history: A combined analysis of 22 studies. Am J Hum Genet. 2003; 72(5):1117–1130.
16] Chen S, Parmigiani G. Meta-analysis of BRCA1 and BRCA2 penetrance. J Clin Oncol. 2007; 25(11):1329–1333.
15] Metcalfe KA, Poll A, Royer R, Llacuachaqui M, Tulman A, Sun P, et al. Screening for founder mutations in BRCA1 and BRCA2 in unselected Jewish women. J Clin Oncol. 2010; 28: 387-391.
17] Mavaddat N, Barrowdale D, Andrulis IL, Domchek SM, Eccles D, Nevanlinna H, et al.Pathology of breast and ovarian cancers among BRCA1 and BRCA2 mutation carriers: results from the Consortium of Investigators of Modifiers of BRCA1/2 (CIMBA). Cancer Epidemiol Biomarkers Prev. 2012 ; 21(1): 134-47.
18] Merino T, Ip T, Domínguez F, et al. Risk factors for loco-regional recurrence in breast cancer patients: a retrospective study. Oncotarget. 2018;9(54):30355-30362.
19] Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, et al. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: An open-label randomised controlled trial. Lancet Oncol. 2015; 16: 1380–1388.
20] Cardoso F, Spence D, Mertz S, Corneliussen-James D, Sabelko K, Gralow J, et al: Global analysis of advanced/metastatic breast cancer: Decade report (2005–2015). Breast.2018; 39: 131–138.
21] Dawood S, Broglio K, Gonzalez-Angulo AM, Buzdar AU, Hortobagyi GN and Giordano SH: Trends in survival over the past two decades among white and black patients with newly diagnosed stage IV breast cancer. J Clin Oncol. 2008; 26: 4891–4898.
22] Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 ; 365(9472): 1687-717.
23] Lin Y, Yin W, Yan T, Zhou L, Di G, Wu J,et al. Site-specific relapse pattern of the triple negative tumors in Chinese breast cancer patients. BMC Cancer 2009; 9: 342.
24] Mayer EL, Burstein HJ, Chemotherapy for metastatic breast cancer. Hematol Oncol Clin North Am. 2007 Apr; 21(2): 257-72.
25] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin 2016; 66: 7-30.
26] American Cancer Society. Cancer Facts & Figures 2016.
27] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer. Version 3. 2015: 187.
28] Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev 2003; 2003(2): CD002747.
29] Carmo-Pereira J, Costa FO, Henriques E, Godinho F, Cantinho-Lopes MG, Sales-Luis A, et al. A comparison of two doses of adriamycin in the primary chemotherapy of disseminated breast carcinoma. Br J Cancer 1987; 56: 471-3.
30] Cowan JD, Neidhart J, McClure S, Coltman CA Jr, Gumbart C, Martino S, et al. Randomized trial of doxorubicin, bisantrene, and mitoxantrone in advanced breast cancer: a Southwest Oncology Group study. J Natl Cancer Inst 1991; 83: 1077-84.
31] Henderson IC, Allegra JC, Woodcock T, Wolff S, Bryan S, Cartwright K, et al. Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer. J Clin Oncol 1989; 7: 560-71.
32] Ingle JN, Pfeifle DM, Green SJ, Kvols LK, Brunk SF, Reuter NF, et al. Randomized clinical trial of doxorubicin alone or combined with mitolactol in women with advanced breast cancer and prior chemotherapy exposure. Am J Clin Oncol 1985; 8: 275-82.
33] Cyclophosphamide. USP DI. Volume 1. Drug information for the health care professional. 20th ed. Englewood, Colorado: Micromedex, Inc.; 2002.
34] Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 1995; 13(10): 2575-81.
35] Reichman BS, Seidman AD, Crown JP, Heelan R, Hakes TB, Lebwohl DE, et al. Paclitaxel and recombinant human granulocyte colony-stimulating factor as initial chemotherapy for metastatic breast cancer. J Clin Oncol. 1993; 11(10): 1943-51.
36] CURRERI AR, ANSFIELD FJ, McIVER FA, WAISMAN HA, HEIDELBERGER C. Clinical studies with 5-fluorouracil. Cancer Res. 1958 May;18(4):478-84.
37] Carter SK. Integration of chemotherapy into combined modality treatment of solid tumors VII. Adenocarcinoma of the breast. Cancer Treat Rev. 1976 Sep;3(3):141-74.
38] Pinedo HM, Peters GF. Fluorouracil: biochemistry and pharmacology. J Clin Oncol. 1988 Oct; 6(10): 1653-64.
39] Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, et al. 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. 1998 Jul; 34(8): 1274-81.
40] Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999 Feb; 17(2): 485-93.
41] Smorenburg CH, Bontenbal M, Verweij J. Capecitabine in breast cancer: current status. Clin Breast Cancer. 2001 Jan;1(4):288-93.
42] Kuznetsov G, Towle MJ, Cheng H, Kawamura T, TenDyke K, Liu D, et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Res. 2004; 64(16): 5760-6.
43] Wozniak KM, Nomoto K, Lapidus RG, Wu Y, Carozzi V, Cavaletti G, et al. Comparison of neuropathy-inducing effects of eribulin mesylate, paclitaxel, and ixabepilone in mice. Cancer Res. 2011; 71(11): 3952-62.
44] Thadani-Mulero M, Nanus DM, Giannakakou P. Androgen receptor on the move: boarding the microtubule expressway to the nucleus. Cancer Res. 2012; 72(18): 4611-4615.
45] Towle MJ, Salvato KA, Wels BF, Aalfs KK, Zheng W, Seletsky BM, et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res 2011; 71: 496-505.
46] Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011; 377(9769): 914-23.
47] Hattori M, Ishiguro H, Masuda N, Yoshimura A, Ohtani S, Yasojima H, et al. Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study. Breast Cancer. 2018; 25(1): 108-117.
48] Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009; 45(2): 228-47.
49] Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Published: May 28, 2009 (v4.03: June 14, 2010). U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES. National Institutes of Health. National Cancer Institute.
50] Quintero, Dino; et al. "Workload Optimized Systems: Tuning POWER7 for Analytics". Abstract.
51] Lee, SH, Lee, J, Park J, Park SH, Lee KE, Lee SI, et al. Capecitabine monotherapy in patients with anthracycline-and taxane-pretreated metastatic breast cancer. Med Oncol. 2004; 21: 223–231.
52] Fumoleau P, Largillier R, Clippe C, Dièras V, Orfeuvre H, Lesimple T et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004; 40(4): 536-42.
53] Saeki T, Kimura T, Toi M, Taguchi T. A pilot phase II study of capecitabine in advanced or recurrent breast cancer. Breast Cancer. 2006; 13(1): 49-57.
54] Sari M, Saip P. Eribulin monotherapy in heavily pretreated metastatic breast cancer patients in real life. Indian J Cancer. 2020; 57(1): 55-61.
55]. Twelves C, Anthoney A, Savulsky CI, et al. A phase 1b/2, open-label, dose-escalation, and dose-confirmation study of eribulin mesilate in combination with capecitabine. Br J Cancer. 2019; 120(6): 579-586.
| Files | ||
| Issue | Vol 14 No 2 (2022) | |
| Section | Original Articles | |
| DOI | https://doi.org/10.18502/bccr.v14i2.14379 | |
| Keywords | ||
| Eribulin capecitabine relapsed carcinoma breast. | ||
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How to Cite
1.
Poddar S, Chakrabarti A, Dutta B, Mondal S, Islam SMR, Purkait A. Eribulin alongwith capecitabine in relapsed carcinoma breast- a retrospective single-Institutional study. Basic Clin Cancer Res. 2023;14(2):113-122.
