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The results will be presented at the 2008 annual meeting of the AmericanSociety of Clinical Oncology, ASCO, in Chicago (Monday June 2, 2008, 2-6 pm,poster number 1D, abstract 542).
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In Europe and North America, most breast cancer patients are diagnosed atan early stage, before the tumor has spread to the lymph nodes. However, fewclinical trials in the past were dedicated exclusively to this population ofpatients. GEICAM 9805/Target-0 is the first taxane-based study to exclusivelyenroll women with node-negative early stage breast cancer considered to be athigh risk for recurrence. High risk patients were defined as having at leastone of the following St Gallen 1998 criteria: patient's age <35 years, tumorhistological grade II/III, tumor size >2 cm, or hormone-receptor (estrogenand/or progesterone receptor) negative tumor.
The 1059 women enrolled in this multicenter, phase III study wererandomized to receive either TAC (n=539) or FAC (n=520) after surgicalresection of their tumor. Therapy was given every three weeks for a total of 6cycles. The primary end point was Disease Free Survival (DFS) and secondaryend points included overall survival (OS), safety, and quality of life.
Analysis of efficacy, determined by DFS, was performed after a minimum of5-years of follow up. The study showed a significant improvement in 5-yearDFS that was demonstrated in the TAC arm over the FAC arm, with 91% and 86%patients, respectively, alive and disease free (HR 0.66, 95% CI 0.46-0.94,p=0.0202). The OS data are immature; estimated 5-year OS is 97% for TAC and95% for FAC (HR 0.72, 95% CI 0.40-1.30, p=0.2677). The safety results havebeen already published (Martin et al (2006), Ann Oncol 17: 1205-12) TACproduced significantly more hematological adverse reactions than FAC. Primaryprophylaxis with G-CSF reduced the rate of neutropenic fever. No toxic deathswere reported.
"First of all, I would like to congratulate the patients and my fellowinvestigators for having the courage to participate in this innovative trialin a purely node-negative patient population. This study showed that the TACregimen improves Disease Free Survival in women with high risk node-negativebreast cancer," said GEICAM Chair and principal investigator of the 9805study, Prof. Miguel Martin.
About the Study
The GEICAM 9805/Target-0 trial was initiated as a complementary study toBCIRG 001/TAX 316, a study that enrolled women with node-positive early stagebreast cancer.
From December 2001 to March 2003, 1059 patients aged 18-71, with T1-T3,N0, M0 operable breast cancer and at least one high-risk St Gallen 1998criterion (patient age <35 years, tumor grade II/III, tumor size >2 cm, orhormone-receptor negative tumor) were enrolled in the study; 1047 patientswere eligible. Patients from Spain as well as Germany and Poland werestratified by institution and menopausal status and randomized after surgeryto receive either TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2,cyclophosphamide 500 mg/m2) or FAC (5-fluorouracil 500 mg/m2, doxorubicin 50mg/m2, cyclophosphamide 500 mg/m2) every 3 weeks for 6 cycles. Radiotherapywas mandatory after conservative surgery and recommended for patients withtumors > 5 cm; tamoxifen was given for 5 years to all patients with endocrineresponsive tumors. A study amendment initiated during enrollment mandated the
