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Phase III Randomized Trial Comparing Docetaxel in Combination with Doxorubicin and Cyclophosphamide (TAC) Versus
Doxorubicin and Cyclophosphamide Followed by Docetaxel (AC
T) in Her-2/neu Negative Early Breast Cancer Patients
1069 with Positive Axillary Lymph Nodes: Interim Analysis of the BCIRG 005 Study
Eiermann W,1 Pienkowski T,2 Crown J,3 Chap L,4 Pawlicki M,5 Martin M,6 Chan A,7 Saleh M,8 Sehdev S,9 Provencher L,10 Von Minckwitz G,1 Semiglazov V,11 Slamon D,4 Tabah-Fisch I,12 Buyse M,13 Riva A,14 Taupin H,14 Sauter G,15 Mackey J,16 on behalf of the BCIRG 005 investigators
1GBG, München, Germany; 2Maria Sklodowska-Curie (MSC) Centre, Warsaw, Poland; 3ICORG, Dublin, Ireland; 4UCLA, Los Angeles, CA; 5MSC Institute, Krakow, Poland; 6GEICAM, Madrid, Spain; 7Mount Hospital, Perth, Australia; 8Georgia Cancer Specialists, Atlanta, GA; 9William Osler Health Centre, Brampton, Canada;
10Hôpital Du Saint Sacrement du CHA, Quebec, Canada; 11NN Petrov Research Institute, St Petersburg, Russian Federation; 12sanofi-aventis, Paris, France; 13IDDI, Brussels, Belgium; 14CIRG, Paris, France; 15University Medical Center, Hamburg, Germany; 16Cross Cancer Institute, Edmonton, Canada
■ The first prophylactic G-CSF administration was at Cycle 1 in 16% of patients in the TAC arm Table 4. Grade 3–4 nonhematologic toxicities (NCI-CTC version 2.0) occurring in >1% of patients ABSTRACT*
SAFETY RESULTS
and 3% of patients in the AC→T arm (Figure 2); a total of 44% and 28% patients, PATIENTS (%)
respectively, received G-CSF during the study period.
TOXICITY
Background: The relative benefits of adjuvant breast cancer chemotherapy with docetaxel in combination with
Study design and treatment
■ At the protocol-mandated event-driven interim analysis, the median follow-up was 30 months Safety profile
anthracycline, or given sequentially after an anthracycline-based regimen, are unknown.
Vomiting
Eligible patients were randomized to 6 cycles of TAC or 4 cycles of AC followed by 4 cycles Materials and Methods: We randomized patients (pts) with axillary lymph node positive, HER-2 negative breast
The safety profile was generally comparable between the two treatment arms, although: Diarrhea
The Independent Data Monitoring Committee (IDMC) met to review the efficacy and safety cancer to either TAC (75/50/500 mg/m2 q3wk x 6 cycles) or AC (60/600 mg/m2 q3wk x 4 cycles) followed by results on September 9, 2005. The IDMC chose to release only the safety data to the — febrile neutropenia was more common among patients treated with TAC (17.9%) than with Stomatitis
T (100 mg/m2 q3wk x 4 cycles). Pts were prospectively stratified by number of positive nodes (1–3 vs 4+) and Asthenia/fatigue
hormone receptor status. Pts with ER and/or PR positive (HR+) tumors received hormonal therapy for 5 yrs after chemotherapy. The primary endpoint was disease-free survival (DFS) with 80% power (0.05 significance level) Allergic reaction
to detect an absolute difference of 5%. Secondary endpoints included overall survival and safety. Patient characteristics
— neurotoxicities and myalgia were more common among patients treated with AC→T than Arthralgia
Results:
Patients
TAC (75/50/500 mg/m2)
A total of 3298 pts (1649 per arm) were recruited between Aug 2000 and Feb 2003. Baseline Eligibility criteria
■ A total of 3298 patients (1649 per arm) were recruited between August 2000 and February 2003 Sensory neuropathy
characteristics were well balanced: age <50 yrs 47%, 1–3 nodes 61%, HR+ 82%, T >2 cm 58%. The planned • Histologically proven breast cancer; ■ Absolute neutrophil count was <1000/L in 60% and 58% of patients in the TAC and AC→T Fluid retention/peripheral edema
6 cycles of TAC were given to 93.5% of pts and 8 cycles of AC→T to 90.5%. Febrile neutropenia (17.9% vs 8.5%) ■ Baseline characteristics were well balanced between the two arms (Table 1).
was more frequent with TAC, while grade 3/4 neutropenic infections were equivalent (8.7% with TAC vs 8.0%).
Hand–foot reaction
Primary prophylaxis with G-CSF was given beginning Cycle 1 in 16.4% of pts receiving TAC and 3.5% of pts on Table 1. Selected patient and tumor characteristics ■ One patient in the TAC arm died from sepsis.
AC→T. One septic death occurred in the TAC arm. Grade 3/4 nonhematologic toxicity rates were fatigue (5.2% vs Headache
6.3%), nausea (4.5% vs 4.1%), vomiting (4.2% vs 4.1%), diarrhea (2.9% vs 3.1%), stomatitis (2.6% vs 3.0%), Hyperglycemia
peripheral edema (1.3% vs 2.6%), sensory neuropathy (0.6% vs 2.0%), and CHF (0.1% vs 0.4%) in the TAC and CHARACTERISTIC
Hypertension
Stratification
AC→T arms, respectively. Other grade 3/4 docetaxel-specific toxicities (nail and skin) were observed in less than Patients randomized, n
0.5% in both arms. At the protocol-specified event-driven interim analysis, median follow-up was 30 months and Median age, years [range]
PATIENTS (%)
392 DFS events were observed. However, the IDMC has chosen not to release efficacy data at this time. • Negative Her-2/neu overexpression AC (60/600 mg/m2)
Median Karnofsky performance status, % [range]
Discussion: The safety profile of the two common docetaxel-based adjuvant chemotherapy regimens is
Thrombosis/embolism
Mastectomy, %
comparable with the exception of a higher incidence of febrile neutropenia with TAC. Additional follow-up is TOXICITY
(N=1635)
(N=1634)
NCI-CTC, National Cancer Institute Common Toxicity Criteria.
T (100 mg/m2)
required to evaluate the relative efficacy of combination vs sequential docetaxel-containing chemotherapy in the Infection
adjuvant treatment of women with node positive, HER-2 negative breast cancer.
Table 5. Treatment-specific nonhematologic toxicities Premenopausal, %
*Updated results are presented in the poster.
Hormone therapy %
PATIENTS (%)
Febrile neutropenia
INTRODUCTION
Radiotherapy, %
Neutropenia (grade 3/4)
TOXICITY
ALL GRADES
GRADE 3/4
ALL GRADES
GRADE 3/4
Number of positive lymph nodes, %
Sensory neuropathy
Anemia (grade 3/4)
Motor neuropathy
Docetaxel-based chemotherapy has significant benefits, particularly in terms of survival, in the Thrombocytopenia (grade 3/4)
Nail changes
adjuvant breast cancer setting. Six cycles of docetaxel (T) in combination with doxorubicin (A) Leukemia/myelodysplastic syndrome
Prophylactic antibiotics
and cyclophosphamide (C) (TAC) has shown superior efficacy when compared with Tumor size, %
Stomatitis
6 cycles of 5-fluorouracil (F), doxorubicin, and cyclophosphamide (FAC) as adjuvant treatment for ■ Prophylactic antibiotic therapy was given to patients in the TAC arm: Cardiac left ventricular function
node-positive breast cancer (BCIRG 001).1 The sequence of AC followed by a taxane is also a — ciprofloxacin 500 mg orally twice a day for 10 days starting on Day 5 of each cycle.
Figure 2. Cumulative incidence of febrile neutropenia and prophylactic G-CSF administration, feasible treatment option for patients with operable breast cancer.2–5 ER- and/or PR-positive, %
CONCLUSIONS
However, the relative benefits of sequential and combination docetaxel-based regimens remain G-CSF support
ER, estrogen receptor; PR, progesterone receptor.
undetermined, and Phase III studies are currently underway to compare the two strategies. While ■ Granulocyte colony-stimulating factor (G-CSF) was administered as: Treatment administered
The safety profiles of TAC and ACT are similar, although the
the NSABP B-30 study is investigating a 4-cycle TAC regimen versus sequential AC→T, our study — curative treatment for febrile neutropenia or infection ■ Of 1649 randomized patients in each arm, 1635 (99%) and 1634 (99%) were treated in incidence of febrile neutropenia is higher with TAC and the
employed the same TAC regimen that showed superiority in the BCIRG 001 study.1 BCIRG — prophylactic treatment following an episode of febrile neutropenia in an earlier cycle the TAC and AC→T arms, respectively. Of these, 94% and 91%, respectively, completed the incidences of neurotoxicities and myalgia are higher with ACT.
directly compared 6 cycles of TAC with 4 cycles of AC followed by 4 cycles of T (AC→T) in planned number of chemotherapy cycles (TAC, 6; AC→T, 8) (Table 2).
Toxicities were acceptable and manageable in both arms.
patients with Her-2/neu negative, axillary lymph node positive breast cancer in this multicenter, — treatment for delayed recovery of absolute neutrophil count at Day 21.
international, randomized Phase III study.
Additional follow-up is required to assess the relative efficacy of
Primary prophylaxis (ie from the first cycle onwards) was permitted at the investigator’s combination (TAC) versus sequential (ACT) docetaxel-based
discretion for either arm but was not mandatory.
OBJECTIVES
chemotherapy as adjuvant therapy for Her-2/neu negative, node-
Approved G-CSF regimens were rHuG-CSF 150 µg/m2/day or r-metHuG-CSF 5 µg/kg/day PARAMETER
(N=1635)
(N=1634)
positive breast cancer.
Median number of cycles received [range]
subcutaneously, Days 4–10. If the Day 11 absolute neutrophil count was <1.0 x 109/L, Relative dose intensity
injections were continued to Day 13.
References
1. Martin M, Pienkowski T, Mackey J, et al. N Engl J Med 2005;352:2302–2313.
Postchemotherapy treatment
Secondary
2. von Minckwitz G, Raab G, Schuette M, et al. Proc Am Soc Clin Oncol 2002;21:43a.
Median cumulative dose, mg/m2
3. Bear HD, Anderson S, Brown A, et al. J Clin Oncol 2003;21:4165–4174.
■ Tamoxifen 20 mg/day was given to patients with estrogen- and/or progesterone receptor- 4. Henderson IC, Berry DA, Demetri GD, et al. J Clin Oncol 2003;21:976–983.
5. Mamounas EP, Bryant J, Lembersky B, et al. J Clin Oncol 2005;23:3686–3696.
Toxicity (the focus of this presentation) positive (HR+) tumors. Switching to aromatase inhibitors was allowed.
■ Quality of life and socioeconomic analyses Acknowledgment
Radiation therapy was administered to all patients who underwent breast-conserving surgery Patients completing planned number of
The authors thank all the BCIRG 005 investigators for their contribution. Pathologic and molecular marker analysis for predicting efficacy.
and according to center guidelines following mastectomy.
chemotherapy cycles, %
This study is supported by the sanofi-aventis Group.
Presented at the 28th Annual San Antonio Breast Cancer Symposium, December 8–11, 2005, San Antonio, TX, USA

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