Skip to main content

Advertisement

SpringerLink
Log in

Association of age and overall survival in capecitabine-treated patients with metastatic breast cancer in clinical trials

  • Clinical trial
  • Published:
Breast Cancer Research and Treatment Aims and scope Submit manuscript

Abstract

We sought to determine if an association exists between age and capecitabine efficacy among patients with metastatic breast cancer (MBC). Pooled analysis of five phase II or III registration trials of capecitabine 2,500–2,510 mg/m2/day for 2 weeks and 1 week off, or combination therapy was performed. Four trials enrolled patients previously exposed to other chemotherapy, generally a taxane. Of 570 patients, 193 (34%) were 18–49 years old, 246 (43%) were 50–64, and 131 (23%) were ≥65. Median average daily dose was 2,067 mg/m2 in the 18- to 49-year-old group and 2,105 mg/m2 in the 50–64 and ≥65 year groups. Overall survival (OS) in all groups was similar by log-rank test for the individual trials (P = 0.71–0.95) and Cox regression of the pooled trials. Univariate analysis demonstrated no difference in clinical benefit or objective response between groups. Treatment failure analysis showed 283 (50%) patients experienced progressive disease, while 114 (20%) withdrew for safety. Serious adverse events (AEs) occurred in 71 (36.8%), 85 (34.6%), and 59 (45.0%) patients in the 18–49, 50–64, and ≥65 years groups, respectively. There was no statistically significant association between age and OS, clinical benefit, or objective response in patients with MBC treated with capecitabine. Frequency of AEs and serious AEs was not related to age at treatment, although women ≥65 years were more likely to withdraw from treatment because of an AE than younger women.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. U.S. Centers for Disease Control and Prevention: Breast cancer rates by age. http://www.cdc.gov/cancer/breast/statistics/age.htm

  2. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ (2009) Cancer statistics, 2009. CA Cancer J Clin 598:225–249

    Article  Google Scholar 

  3. Anderson WF, Jatoi I, Sherman ME (2009) Qualitative age interactions in breast cancer studies: mind the gap. J Clin Oncol 27:5308–5311

    Article  PubMed  Google Scholar 

  4. Christman K, Muss HB, Case LD, Stanley V (1992) Chemotherapy of metastatic breast cancer in the elderly. The Piedmont Oncology Association experience [see comment]. JAMA 268:57–62

    Article  CAS  PubMed  Google Scholar 

  5. Pentheroudakis G, Fountzilas G, Kalofonos HP, Hellenic Cooperative Oncology Group et al (2008) Palliative chemotherapy in elderly patients with common metastatic malignancies: a Hellenic Cooperative Oncology Group registry analysis of management, outcome and clinical benefit predictors. Crit Rev Oncol Hematol 66:237–247

    Article  PubMed  Google Scholar 

  6. Muss HB, Berry DA, Cirrincione C et al (2007) Toxicity of older and younger patients treated with adjuvant chemotherapy for node-positive breast cancer: the Cancer and Leukemia Group B experience. J Clin Oncol 25:3699–3704

    Article  CAS  PubMed  Google Scholar 

  7. Sledge GW, Robert N, Sparano JA et al (1995) Eastern Cooperative Oncology Group studies of paclitaxel and doxorubicin in advanced breast cancer. Semin Oncol 22(3 Suppl 6):105–108

    PubMed  Google Scholar 

  8. Xeloda® (capecitabine) [prescribing information]: Genentech, Inc. South San Francisco, CA; 2009

  9. Sledge GW, Neuberg D, Bernardo P, Ingle JN, Martino S, Rowinsky EK, Wood WC (2003) 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 21:588–592

    Article  PubMed  Google Scholar 

  10. Stockler M, Sourjina T, Grimison P et al (2007) A randomized trial of capecitabine (C) given intermittently (IC) rather than continuously (CC) compared to classical CMF as first-line chemotherapy for advanced breast cancer (ABC). J Clin Oncol 25:39s (18S; abstr 1031)

    Google Scholar 

  11. O’Shaughnessy J, Miles D, Vukelja S et al (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20:2812–2823

    Article  PubMed  Google Scholar 

  12. 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

    CAS  PubMed  Google Scholar 

  13. 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

    Article  CAS  PubMed  Google Scholar 

  14. Talbot DC, Moiseyenko V, Van Belle S et al (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

    Article  CAS  PubMed  Google Scholar 

  15. O’Shaughnessy 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

    Article  Google Scholar 

  16. Balducci L (2001) The geriatric cancer patient: equal benefit from equal treatment. Cancer Control 8(Suppl 2):1–25

    CAS  PubMed  Google Scholar 

  17. Ibrahim NK, Frye DK, Buzdar AU, Walters RS, Hortobagyi GN (1996) Doxorubicin-based chemotherapy in elderly patients with metastatic breast cancer: tolerance and outcome. Arch Intern Med 156:882–888

    Article  CAS  PubMed  Google Scholar 

  18. Muss HB, Berry DA, Cirrincione CT et al (2009) Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 360:2055–2065

    Article  CAS  PubMed  Google Scholar 

  19. Rimawi MF, Shetty PB, Weiss HL, Schiff R, Osborne CK, Chamness GC, Elledge RM (2010) Epidermal growth factor receptor expression in breast cancer association with biologic phenotype and clinical outcomes. Cancer 116:1234–1242

    Article  PubMed  Google Scholar 

  20. Heitz F, Harter P, Lueck HJ, Fissler-Eckhoff A, Lorenz-Salehi F, Scheil-Bertram S, Traut A, du Bois A (2009) Triple-negative and HER2-overexpressing breast cancers exhibit an elevated risk and an earlier occurrence of cerebral metastases. Eur J Cancer 45:2792–2798

    Article  CAS  PubMed  Google Scholar 

  21. Chang J, Clark GM, Allred DC, Mohsin S, Chamness G, Elledge RM (2003) Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor. Cancer 97:545–553

    Article  PubMed  Google Scholar 

Download references

Acknowledgments

The five studies, individually and pooled, were sponsored by Roche, manufacturer of Xeloda® (capecitabine). Editorial support was provided by Insight Medical Communications, NY, funded by Roche.

Conflict of interest

Dr. Joanne Blum serves as a consultant or advisor to Roche, manufacturer of capecitabine [Xeloda®]. Dr. Joseph Kohles was an employee of Roche Laboratories, Inc. at the time this study and manuscript were developed. Dr. Edward McKenna is an employee of Roche Laboratories, Inc. Dr. Nana Scotto is an employee of F. Hoffmann-La Roche. Dr. Sylvia Hu is an employee of Genentech-Roche and has stock ownership in F. Hoffman-La Roche. Roche sponsored the research summarized in this manuscript through funding to RTI Health Solutions, which employs Dawn Odom and Dr. James Kaye. Dr. Stefan Glück serves as a consultant or advisor for and has received honoraria and research support from Roche.

Author information

Authors and Affiliations

  1. Baylor-Sammons Cancer Center, Texas Oncology, US Oncology, 3535 Worth St, Suite 600, Dallas, TX, 75246, USA

    Joanne L. Blum

  2. Roche Laboratories, Inc, Nutley, NJ, USA

    Joseph Kohles, Edward McKenna & Sylvia Hu

  3. F. Hoffman-LaRoche, Basel, Switzerland

    Nana Scotto

  4. RTI Health Solutions, Research Triangle Park, NC, USA

    Dawn Odom & James A. Kaye

  5. Sylvester Comprehensive Cancer Center, University of Miami School of Medicine, Miami, FL, USA

    Stefan Glück

Authors
  1. Joanne L. Blum
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Joseph Kohles
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Edward McKenna
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Nana Scotto
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sylvia Hu
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Dawn Odom
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. James A. Kaye
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Stefan Glück
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Joanne L. Blum.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Blum, J.L., Kohles, J., McKenna, E. et al. Association of age and overall survival in capecitabine-treated patients with metastatic breast cancer in clinical trials. Breast Cancer Res Treat 125, 431–439 (2011). https://doi.org/10.1007/s10549-010-1222-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10549-010-1222-3

Keywords

Search

Navigation