Adjuvant Taxotere and Cytoxan (TC) for breast cancer with or without Herceptin – pro

Lay Summary: Non-antracyline containing adjuvant regimens are beginning to replace AC for adjuvant breast cancer chemotherapy. The TC regimen is reviewed.

Adriamycin/Cytoxan (AC) has long been considered a standard adjuvant chemotherapy combination for the treatment of breast cancer. Thirty years ago, results were published that established AC as the standard adjuvant treatment for breast cancer.

The next improvement on AC was to add paclitaxel or docetaxel in various schedules. Since then, however, it has been noted that the anthracycline is associated with risks of cardiotoxicity, particularly in patients with underlying cardiac issues or the elderly. Furthermore, Taxotere has demonstrated greater anti-tumor activity than Adriamycin in women with advanced breast cancer. This prompted a trial by researchers affiliated with the U.S. Oncology Research, Inc. in Houston to directly compare AC to Taxotere/Cytoxan (TC) as adjuvant treatment in breast cancer. This recent trial showed that TC improves disease-free survival compared with AC for the treatment of adjuvant breast cancer. Although cardiac side effects were not presented, the researcher noted that TC does not appear to have the cardiotoxicity issues associated with AC, which is a very important issue for some patients. NCCN considers TC an appropriate regimen for adjuvant treatment for breast cancer.

What about adding weekly Herceptin to the TC regimen? There is strong evidence that adding Herceptin to the Taxotere alone or Taxotere and Carboplatin adjuvant regimens greatly increases effectiveness as it does when added to anthracycline containing regimens. However there is still an ongoing trial: Adj TC + Herceptin Early Stage Breast Cancer, NCT00493649. It used the every 3 weeks Herceptin schedule.  However, the trial si no longer recruiting and I suspect that widespread adopation of TC regimen makes recruitment difficult.

Most recently, a trial reported in NEJM showed that the addition of 1 year of adjuvant trastuzumab significantly improved disease-free and overall survival among women with HER2-positive breast cancer. The risk–benefit ratio favored the nonanthracycline TCH regimen over AC-T plus trastuzumab, given its similar efficacy, fewer acute toxic effects, and lower risks of cardiotoxicity and leukemia.

NCCN 2012 lists this regimen on p. BINV-K.

Dennis Slamon, M.D., Ph.D., Wolfgang Eiermann, M.D., Nicholas Robert, M.D., Tadeusz Pienkowski, M.D., Miguel Martin, M.D., Michael Press, M.D., Ph.D., John Mackey, M.D., John Glaspy, M.D., Arlene Chan, M.D., Marek Pawlicki, M.D., Tamas Pinter, M.D., Vicente Valero, M.D., Mei-Ching Liu, M.D., Guido Sauter, M.D., Gunter von Minckwitz, M.D., Frances Visco, J.D., Valerie Bee, M.Sc., Marc Buyse, Sc.D., Belguendouz Bendahmane, M.D., Isabelle Tabah-Fisch, M.D., Mary-Ann Lindsay, Pharm.D., Alessandro Riva, M.D., and John Crown, M.D. for the Breast Cancer International Research Group Adjuvant Trastuzumab in HER2-Positive Breast Cancer  N Engl J Med 2011; 365:1273-1283 October 6, 2011

Jones, Stephen E., Savin, Michael A., Holmes, Frankie Ann, O’Shaughnessy, Joyce A., Blum, Joanne L., Vukelja, Svetislava, McIntyre, Kristi J., Pippen, John E., Bordelon, James H., Kirby, Robert, Sandbach, John, Hyman, William J., Khandelwal, Pankaj, Negron, Angel G., Richards, Donald A., Anthony, Stephen P., Mennel, Robert G., Boehm, Kristi A., Meyer, Walter G., Asmar, Lina Phase III Trial Comparing Doxorubicin Plus Cyclophosphamide With Docetaxel Plus Cyclophosphamide As Adjuvant Therapy for Operable Breast Cancer
J Clin Oncol 2006 24: 5381-5387

Pegram MD, Pienkowski T, Nothfelt D, et al. Results of two open-label multicenter phase II studies of docetaxel, platinum salts, and trastuzumab in HER2-positive advanced breast cancer. J Natl Cancer Inst 2004;96:759–769.

Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al.; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672.

Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684.
Hortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med. 2005;353(16):1734-1736.

Joensuu H, Kellokumpu-Lehtinen P-L, Bono P, et al. Trastuzumab in combination with docetaxel or vinorelbine as adjuvant treatment of breast cancer: the FinHer trial. Proceedings from the 28th Annual San Antonio Breast Cancer Symposium. San Antonio, Texas. December 2005. Abstract #2.

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