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Journal of Clinical Oncology, Vol 17, Issue 2 (February), 1999: 485
© 1999 American Society for Clinical Oncology

Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast Cancer

Joanne L. Blum, Stephen E. Jones, Aman U. Buzdar, Patricia Mucci LoRusso, Irene Kuter, Charles Vogel, Bruno Osterwalder, Hans-Ulrich Burger, Cheryl Stoner Brown, Tom Griffin

From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ.

Address reprint requests to Joanne L. Blum, MD, PhD, Physician Reliance Network Research, 3535 Worth St, Suite 230, Dallas, TX 75246.

PURPOSE: Capecitabine is a novel, oral, selectively tumor-activated fluoropyrimidine carbamate. This large multicenter phase II trial tested the efficacy and safety of twice-daily oral capecitabine at 2,510 mg/m2/d given for 2 weeks followed by a 1-week rest period and repeated in 3-week cycles, in patients with paclitaxel-refractory metastatic breast cancer.

PATIENTS AND METHODS: Patients were to have received at least two but not more than three prior chemotherapeutic regimens, one of which had to have contained paclitaxel given for metastatic disease. One hundred sixty-three patients were entered onto the study at 25 centers, and 162 patients received capecitabine. One hundred thirty-five patients had bidimensionally measurable disease, and 27 patients had assessable disease.

RESULTS: The overall response rate was 20% (95% confidence interval, 14% to 28%). All responding patients were resistant to or had failed paclitaxel, and all had received an anthracycline. Three complete responses were seen, with complete response durations of 106, 109, and 194+ days. Median duration of response was 8.1 months, median survival time was 12.8 months, and the median time to disease progression was 93 days. The most common treatment-related adverse events were hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. Diarrhea (14%) and hand-foot syndrome (10%) were the only treatment-related adverse events that occurred with grade 3 or 4 intensity in more than 10% of patients.

CONCLUSION: Capecitabine is an active drug in the treatment of paclitaxel-refractory metastatic breast cancer. It has a favorable toxicity profile with the added advantage of being an oral drug administered at home.


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S. Morita, M. Toi, T. Kobayashi, Y. Ito, Y. Hozumi, S. Ohno, H. Iwata, and J. Sakamoto
Application of a Continual Reassessment Method to a Phase I Clinical Trial of Capecitabine in Combination with Cyclophosphamide and Epirubicin (CEX) for Inoperable or Recurrent Breast Cancer
Jpn. J. Clin. Oncol., February 1, 2004; 34(2): 104 - 106.
[Abstract] [Full Text] [PDF]

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P. Gilbar
Palmar-plantar erythrodysesthesia
Journal of Oncology Pharmacy Practice, December 1, 2003; 9(4): 137 - 150.
[Abstract] [PDF]

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J. E Mortimer, M. K. Lauman, B. Tan, C. L Dempsey, A. C Shillington, and K. S Hutchins
Pyridoxine treatment and prevention of hand-and-foot syndrome in patients receiving capecitabine
Journal of Oncology Pharmacy Practice, December 1, 2003; 9(4): 161 - 166.
[Abstract] [PDF]

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 Ann OncolHome page
W. Scheithauer, J. McKendrick, S. Begbie, M. Borner, W. I. Burns, H. A. Burris, J. Cassidy, D. Jodrell, P. Koralewski, E. L. Levine, et al.
Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial
Ann. Onc., December 1, 2003; 14(12): 1735 - 1743.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. C. Wolff, D. K. Armstrong, J. H. Fetting, M. K. Carducci, C. D. Riley, J. F. Bender, R. A. Casero Jr., and N. E. Davidson
A Phase II Study of the Polyamine Analog N1,N11-Diethylnorspermine (DENSpm) Daily for Five Days Every 21 Days in Patients with Previously Treated Metastatic Breast Cancer
Clin. Cancer Res., December 1, 2003; 9(16): 5922 - 5928.
[Abstract] [Full Text] [PDF]

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J. Zhou, Z.-Y. Tang, J. Fan, Z.-Q. Wu, Y. Ji, Y.-S. Xiao, Y.-H. Shi, X.-M. Li, Q.-M. Sun, Y.-K. Liu, et al.
Capecitabine Inhibits Postoperative Recurrence and Metastasis after Liver Cancer Resection in Nude Mice with Relation to the Expression of Platelet-Derived Endothelial Cell Growth Factor
Clin. Cancer Res., December 1, 2003; 9(16): 6030 - 6037.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
Y. H. Park, B.-Y. Ryoo, H. J. Lee, S. A. Kim, and J.-H. Chung
High incidence of severe hand-foot syndrome during capecitabine-docetaxel combination chemotherapy
Ann. Onc., November 1, 2003; 14(11): 1691 - 1692.
[Full Text] [PDF]

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L. Pusztai, J. H. Zhen, B. Arun, E. Rivera, C. Whitehead, W. J. Thompson, K. M. Nealy, A. Gibbs, W. F. Symmans, F. J. Esteva, et al.
Phase I and II Study of Exisulind in Combination With Capecitabine in Patients With Metastatic Breast Cancer
J. Clin. Oncol., September 15, 2003; 21(18): 3454 - 3461.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
P. Reichardt, G. von Minckwitz, P. C. Thuss-Patience, W. Jonat, H. Kolbl, F. Janicke, D. G. Kieback, W. Kuhn, A. E Schindler, S. Mohrmann, et al.
Multicenter phase II study of oral capecitabine (Xeloda") in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy
Ann. Onc., August 1, 2003; 14(8): 1227 - 1233.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
M. Martin, M. Spielmann, M. Namer, A. duBois, C. Unger, D. Dodwell, P. Vodvarka, M. Lind, H. Calvert, A. Casado, et al.
Phase II study of pemetrexed in breast cancer patients pretreated with anthracyclines
Ann. Onc., August 1, 2003; 14(8): 1246 - 1252.
[Abstract] [Full Text] [PDF]

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V. Valero and G. N. Hortobagyi
Are Anthracycline-Taxane Regimens the New Standard of Care in the Treatment of Metastatic Breast Cancer?
J. Clin. Oncol., March 15, 2003; 21(6): 959 - 962.
[Full Text] [PDF]

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T. Tominaga, H. Koyama, T. Toge, S. Miura, K. Sugimachi, S. Yamaguchi, K. Hirata, Y. Monden, Y. Nomura, M. Toi, et al.
Randomized Controlled Trial Comparing Oral Doxifluridine Plus Oral Cyclophosphamide With Doxifluridine Alone in Women With Node-Positive Breast Cancer After Primary Surgery
J. Clin. Oncol., March 15, 2003; 21(6): 991 - 998.
[Abstract] [Full Text] [PDF]

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A. Salesiotis, R. Soong, R. B. Diasio, A. Frost, and K. J. Cullen
Capecitabine Induces Rapid, Sustained Response in Two Patients with Extensive Oral Verrucous Carcinoma
Clin. Cancer Res., February 1, 2003; 9(2): 580 - 585.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
J. O'Shaughnessy, C. Twelves, and M. Aapro
Treatment for Anthracycline-Pretreated Metastatic Breast Cancer
Oncologist, December 1, 2002; 7(90006): 4 - 12.
[Abstract] [Full Text] [PDF]

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A. D. Seidman, J. O'Shaughnessy, and J.-L. Misset
Single-Agent Capecitabine: A Reference Treatment for Taxane-Pretreated Metastatic Breast Cancer?
Oncologist, December 1, 2002; 7(90006): 20 - 28.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
L. Biganzoli, M. Martin, and C. Twelves
Moving Forward with Capecitabine: a Glimpse of the Future
Oncologist, December 1, 2002; 7(90006): 29 - 35.
[Abstract] [Full Text] [PDF]

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J. Dunst, T. Reese, T. Sutter, H. Zuhlke, A. Hinke, K. Kolling-Schlebusch, and S. Frings
Phase I Trial Evaluating the Concurrent Combination of Radiotherapy and Capecitabine in Rectal Cancer
J. Clin. Oncol., October 1, 2002; 20(19): 3983 - 3991.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
T. R. J. Evans, G. Pentheroudakis, J. Paul, A. McInnes, R. Blackie, N. Raby, R. Morrison, G. M. Fullarton, M. Soukop, and A. C. McDonald
A phase I and pharmacokinetic study of capecitabine in combination with epirubicin and cisplatin in patients with inoperable oesophago-gastric adenocarcinoma
Ann. Onc., September 1, 2002; 13(9): 1469 - 1478.
[Abstract] [Full Text] [PDF]

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E. K. Rowinsky
Taxane Analogues: Distinguishing Royal Robes from the "Emperor's New Clothes"
Clin. Cancer Res., September 1, 2002; 8(9): 2759 - 2763.
[Full Text] [PDF]

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M. Malet-Martino and R. Martino
Clinical Studies of Three Oral Prodrugs of 5-Fluorouracil (Capecitabine, UFT, S-1): A Review
Oncologist, August 1, 2002; 7(4): 288 - 323.
[Abstract] [Full Text] [PDF]

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J. O'Shaughnessy, D. Miles, S. Vukelja, V. Moiseyenko, J.-P. Ayoub, G. Cervantes, P. Fumoleau, S. Jones, W.-Y. Lui, L. Mauriac, et al.
Superior Survival With Capecitabine Plus Docetaxel Combination Therapy in Anthracycline-Pretreated Patients With Advanced Breast Cancer: Phase III Trial Results
J. Clin. Oncol., June 15, 2002; 20(12): 2812 - 2823.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
R. H. De Boer, T. G. Eisen, P. A. Ellis, S. R. D. Johnston, G. Walsh, S. Ashley, and I. E. Smith
A randomised phase II study of conventional versus accelerated infusional chemotherapy with granulocyte colony-stimulating factor support in advanced breast cancer
Ann. Onc., June 1, 2002; 13(6): 889 - 894.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J. A. O'Shaughnessy
Potential of capecitabine as first-line therapy for metastatic breast cancer: dosing recommendations in patients with diminished renal function
Ann. Onc., June 1, 2002; 13(6): 983 - 983.
[Full Text] [PDF]

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 Ann OncolHome page
M. Venturini, L. Del Mastro, O. Garrone, C. Angiolini, M. Merlano, M. Bergaglio, G. Tolino, A. Lambiase, A. Baldini, G. Canavese, et al.
Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer
Ann. Onc., April 1, 2002; 13(4): 546 - 552.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
E. Diaz-Rubio, T. R. J. Evans, J. Tabernero, J. Cassidy, J. Sastre, M. Eatock, D. Bisset, P. Regueiro, and J. Baselga
Capecitabine (Xeloda(R)) in combination with oxaliplatin: a phase I, dose-escalation study in patients with advanced or metastatic solid tumors
Ann. Onc., April 1, 2002; 13(4): 558 - 565.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J. Cassidy, C. Twelves, E. Van Cutsem, P. Hoff, E. Bajetta, M. Boyer, R. Bugat, U. Burger, A. Garin, U. Graeven, et al.
First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin
Ann. Onc., April 1, 2002; 13(4): 566 - 575.
[Abstract] [Full Text] [PDF]

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M. Summerhayes
Capecitabine: a novel, orally administered, tumour-activated treatment for breast cancer
Journal of Oncology Pharmacy Practice, March 1, 2002; 8(1): 1 - 17.
[Abstract] [PDF]

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 Ann OncolHome page
E. Van Cutsem, P. M. Hoff, J. L. Blum, M. Abt, and B. Osterwalder
Incidence of cardiotoxicity with the oral fluoropyrimidine capecitabine is typical of that reported with 5-fluorouracil
Ann. Onc., March 1, 2002; 13(3): 484 - 485.
[Full Text] [PDF]

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D. Toppmeyer, A. D. Seidman, M. Pollak, C. Russell, K. Tkaczuk, S. Verma, B. Overmoyer, V. Garg, E. Ette, M. W. Harding, et al.
Safety and Efficacy of the Multidrug Resistance Inhibitor Incel (Biricodar; VX-710) in Combination with Paclitaxel for Advanced Breast Cancer Refractory to Paclitaxel
Clin. Cancer Res., March 1, 2002; 8(3): 670 - 678.
[Abstract] [Full Text] [PDF]

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R. B. Diasio
An Evolving Role for Oral Fluoropyrimidine Drugs
J. Clin. Oncol., February 15, 2002; 20(4): 894 - 896.
[Full Text] [PDF]

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E. Rivera, L. Sutton, B. Colwell, M. Graham, D. Frye, M. Somerville, H. S. Conklin, C. McGuirt, J. Levin, and G. N. Hortobagyi
Multicenter Phase II Study of a 28-Day Regimen of Orally Administered Eniluracil and Fluorouracil in the Treatment of Patients With Anthracycline- and Taxane-Resistant Advanced Breast Cancer
J. Clin. Oncol., February 15, 2002; 20(4): 987 - 993.
[Abstract] [Full Text] [PDF]

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L. B. Michaud and K. L. Jones
Recent Advances in the Systemic Management of Metastatic Breast Cancer
Journal of Pharmacy Practice, February 1, 2002; 15(1): 52 - 61.
[Abstract] [PDF]

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R. L. Schilsky, D. Bertucci, N. J. Vogelzang, H. L. Kindler, and M. J. Ratain
Dose-Escalating Study of Capecitabine Plus Gemcitabine Combination Therapy in Patients With Advanced Cancer
J. Clin. Oncol., January 15, 2002; 20(2): 582 - 587.
[Abstract] [Full Text] [PDF]

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T. H. Cartwright, A. Cohn, J. A. Varkey, Y.-M. Chen, T. P. Szatrowski, J. V. Cox, and J. J. Schulz
Phase II Study of Oral Capecitabine in Patients With Advanced or Metastatic Pancreatic Cancer
J. Clin. Oncol., January 1, 2002; 20(1): 160 - 164.
[Abstract] [Full Text] [PDF]


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