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<strong>Review</strong> cin, and cyclophosphamide (FEC) with four cycles of FEC followed by eight cycles of weekly paclitaxel. 9 The authors concluded that patients treated with weekly paclitaxel had improved outcomes regardless of hormone receptor status. Conclusion The randomized trial conducted by ECOG is one of the first trials to compare standard every-3-week paclitaxel with weekly paclitaxel and docetaxel either weekly or every 3 weeks in the adjuvant setting. A 32% reduction in the hazard ratio for death in the weekly paclitaxel group compared with standard therapy was seen. The benefit of disease-free survival for weekly paclitaxel was seen in women with HER2-negative disease irrespective of hormone receptor status. ✦ References 1. Sparano JA, Wang M, Martino S, et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008;358: 1663-1671. 2. Early Breast Cancer Trialist’ Collaborative <strong>Group</strong> (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet. 2005;365:1687-1717. 3. Mamounas EP, Bryant J, Lembersky B, et al. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from the NSABP B- 28. J Clin Oncol. 2005;23:3686-3696. 4. Henderson IC, Berry DA, Demetri GD, et al. Improved outcomes from adding sequential paclitaxel but not from escalat- 14 The American Journal of Hematology/Oncology ing doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol. 2003;21:976-983. 5. Martin M, Pienkowski T, Mackey J, et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005;352: 2302-2313. 6. Seidman AD, Berry D, Cirrincione C, et al. CALGB 9840: phase III study of weekly (W) paclitaxel (P) via 1-hour (h) infusion versus standard (S) 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. J Clin Oncol. 2004;22(July 15 suppl):6s. Abstract 512. 7. Jones SE, Erban J, Overmeyer B, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol. 2005;23:5542-5551. 8. Hayes DF, Thor AD, Dressler LG, et al. HER 2 and response to paclitaxel in node-positive breast cancer. N Engl J Med. 2007; 357:1496-1506. 9. Rodriguez-Lescure A, Martin M, Ruiz A, et al. Subgroup analysis of GEICAM 9906 trial comparing six cycles of FE 90 C (FEC) to four cycles of FE 90 C followed by 8 weekly paclitaxel administrations (FECP): relevance of HER2 and hormonal status (HR). J Clin Oncol. 2007;25(June 20 suppl):589s. Abstract 10598. Supported by grants from the Department of Health and Human Services and the National Institutes of Health. Author disclosures: Dr Sparano: speaker and consultant: Sanofi- Aventis. Correspondence address: Rachel E. Raab, MD, East Carolina University Brody School of Medicine, Department of Hematology/Oncology, 600 Moye Blvd, Brody 3E 127, Greenville, NC 27834; phone: (252) 744-3326; fax: (252) 744- 3418; e-mail: raabr@ecu.edu. Committed to bringing you the latest and most relevant information in cancer management. Look in an upcoming issue for a review by Dr Henry L. Gomez of his recent article: INVITED PRESENTATIONS OF PEER-REVIEWED CLINICAL RESEARCH ® Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J Clin Oncol. 2008;26:2999-3005. Commentary by Drs Heather L. McArthur and Maura N. Dickler. ®
Commentary Optimizing Taxane Therapy for Patients With Primary Breast Cancer: What Are the Lessons Learned? Lawrence N. Shulman, MD Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Boston, Massachusetts The article by Sparano and colleagues comparing different taxanes and different dose schedules represents an important step forward in the treatment of primary breast cancer and also highlights some important lessons for drug development in our field. 1 Since the introduction of paclitaxel nearly 20 years ago, physicians have struggled to determine the ideal dosing and schedule. Through much of the 1980s and 1990s, our philosophy on chemotherapy administration was based on delivering the maximum dose possible, with the interval of therapy determined by the time needed for normal organ recovery. However, a series of dose escalation studies with paclitaxel in metastatic breast cancer suggested that higher doses were not necessarily associated with better outcomes. 2 Prolonged paclitaxel infusions were also tried based on preclinical data but failed to show a benefit. In both of these circumstances, toxicity was considerably worse. Since the introduction of docetaxel, the younger sibling of paclitaxel, there has been debate as to whether one taxane is better than the other for the treatment of breast cancer (as well as other diseases). 3-5 The North American Breast Intergroup study reported by Sparano and colleagues enrolled approximately 5000 patients with node-positive or high-risk node-negative primary breast cancer comparing the two taxanes and two schedules following standard cyclophosphamide and doxorubicin therapy. Paclitaxel or docetaxel was administered either weekly or every 3 weeks. Differences in disease-free and overall survival were small, with a small numerical advantage favoring weekly paclitaxel. One could argue that the results with weekly paclitaxel were no different than those for every-3-week docetaxel, and either would be acceptable therapy. An important consideration, however, is toxicity. When cancer outcomes are similar, toxicity and quality of life should be of paramount importance. Docetaxel administered every 3 weeks had a 46% incidence of grade Since the introduction of docetaxel, . . . there has been debate as to whether one taxane is better than the other. 3/4 neutropenia and a 16% likelihood of febrile neutropenia, whereas weekly paclitaxel had a 2% and 1% incidence of these toxicities, respectively. Grade 3/4 neuropathy was slightly more likely in the patients receiving weekly paclitaxel versus every-3week docetaxel, 8% versus 4%. Finally, grade 3/4 fatigue was more likely to occur with every-3-week docetaxel compared with weekly paclitaxel, 9% versus 3%. Although fatigue is not a life-threatening toxicity, for these patients it was significant, and the combination of toxicities caused by docetaxel result- Dr Lawrence N. Shulman was invited to provide commentary on the following article: Sparano JA, Wang M, Martino S, et al. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008;358:1663-1671. November 2008 • Vol 7 • Supplement 5 15
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