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Multicenter, randomized phase III study of adjuvant chemotherapy for axillary positive breast cancer (APBC) comparing 6 cycles (cy) of FEC vs 4 cy of FEC followed by 8 weekly paclitaxel (T) administrations: Safety analysis of GEICAM 9906 trial
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2004
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Surgical OncologyBreast OncologyCancer ManagementAdjuvant ChemotherapyPharmacotherapyArm BRadiation MedicineOncologyMetronomic TherapyClinical TrialsRadiation OncologyCancer ResearchHealth SciencesWeekly TCancer TreatmentPharmacologyCancer EpidemiologyBreast CancerSafety AnalysisMedicinePhase Iii StudyArm A
596 Background: Role of weekly T in adjuvant treatment of breast cancer is presently under evaluation in several studies like GEICAM 9906. Objective: This study compared differences in toxicity profile between arms. Methods: Patients (pt) with operable APBC, age: 18–70, Karnofsky ≥ 90, adequate bone marrow, renal and hepatic function, were randomized to receive 6 FEC cy (Fluorouracil 600 mg/m2 [F], Epirubicin 90 mg/m2 [E], Cyclophosphamide 600 mg/m2 [C]) day 1 every 3 weeks (Arm A) or 4 cy of the same schedule followed by 8 weekly doses of T 100 mg/m2 (Arm B). 1.249 pt were recruited in 30 months. 633 pt in arm A and 610 pt in arm B were analyzed for toxicity. Study was conducted as per GCP/ICH with 100% source data verification. Results: Median age was 50.4 years (Arm A) vs 50.2 (Arm B). Median number of FEC cy (A vs B) and T doses were 6 (range 1–6) vs 4 (range 1–4) and 8 (range 1–8), respectively. No statistical differences were found between relative dose-intensities (RDI) of E (98.8 vs 98.8%) and C (99.1 vs 99.1%). Median RDI of T was 99.5%. FEC administration: febrile neutropenia (FN) rate was statistically higher in arm A (9.3 vs 5.1% pt; p=0.004). Statistical differences were observed in (% pt): G3/4 neutropenia (30 vs 20.5%), G3 leukopenia (10.6 vs 7.4%) and G3 mucositis (5.4 vs 3%). No statistical differences were observed in (% pt): G3 nausea (5.8 vs 5.4%) and G3 vomiting (9.6 vs 7.4%). T administration: 0.5% of pt had FN. G3/4 neutropenia/ leukopenia occurred in 12.1% of pt. G2 neuropathy (sensory) and asthenia were present in 21.3 and 23.4% of pt, respectively. One sudden death (0.2%) occurred in Am A and 4 (0.7%) in arm B (2 of them late events) (p=0.294). Conclusions: Analysis of 1243 pt suggests treatment with FEC x 4 followed by T is associated with less severe neutropenia and FN events, but induces more peripheral neuropathy and asthenia. No significant financial relationships to disclose.