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Weekly paclitaxel (Ta) and capecitabine (Xel) in HER2 negative metastatic breast cancer (MBC):
a multicentre GINECO randomised phase II study comparing two TaXel schedules
A.Lortholary 1, A.C. Hardy-Bessard 2, T. Bachelot 3, P. Dalivoust 4, G. de Rauglaudre 5, J. Alexandre 6, H. Bourgeois 7, D. Jaubert 8, D. Paraiso 9, R. Largillier 10; GINECO Group, Paris, France (1)Centre Catherine de Sienne, Nantes, (2)Clinique Armoricaine, Saint Brieuc, (3)Centre Léon Bérard, Lyon, (4)Hôpital Saint-Joseph, Marseille, (5)Clinique Sainte Catherine, Avignon, (6)Hôpital Hôtel Dieu, Paris, (7)Centre Jean Bernard, Le Mans (8)Clinique Tivoli, Bordeaux, (9)Centre Hospitalier de l’Agglomération Montargoise, Amilly, (10)Centre Antoine Lacassagne, Nice. ABSTRACT - N°1114
BaCkGROuNd: Ta and Xel are synergistic in vitro. Compa-
sTudY dEsIGN
sTaTIsTICal aNalYsIs
red to a continuous weekly Tax combined with a classical 14 days (d)/21 Xel administration (Elza-Brown et al ASCO 2000), This is a phase II, open label, multicentre, Median dose-intensity of Taxol (mg/m²/week) was identical in both arms
Main objective
Secondary objectives
The primary endpoint of this study was to determine the propor- we have explored the combination of Xel 5d/week (wk) and prospective, randomised study. All patients tion of patients who needed a dose reduction in the first 6 months Arm A (n=66)
weekly Ta 3 wk out of 4 with the objective of increasing the of the treatment or a delay more than 1 week in one cycle related Patients
(standard schedule - every 21 days)
efficacy/toxicity ratio of the TaXel combination.
to a grade 3-4 toxicity according to CTCAE.
with Good Clinical Practice Guidelines.
The sample size of this study was based on estimates of dose treated with anthracycline ± docetaxel were randomised Arm B (n=64)
reduction rate of about 75%. On the basis of a predicted attrition either to A: Ta (60 mg/m²/w) + Xel (2000 mg/m²/d x 14 d/21) (experimental schedule - every 28 days)
rate of 15%, α risk = 0.05 (type I error) and β = 0.20 (type II error), or to B: Ta (80 mg/m²/w) + Xel (2000 mg/m²/d x 5 d/wk) 3wk Number of patients: n=130
a total of 130 patients were needed (65 per arm) for the study. REsulTs: From 01/2006 to 01/2008, 130 pts were accrued
(A 66, B 64). Pt characteristics were well balanced between
the two arms including median age (58 yrs), histologic type
and grade, hormone receptor-positive tumour (80%), previous treatment, visceral disease (72%), number of sites (>1; 63%), PaTIENT dEMOGRaPHICs
ECOG PS (0; 42%, 1; 58%). Pts received a median of 6 cycles (1-23) with a received/planned mean dose of 89.3% for Ta in From 01/2006 to 01/2008, 130 patients were accrued (66 in Arm A Objective response rate was not significantly different between both arms and of 74 and 76% for Xel respectively in arm A and 64 in Arm B). Patient (Pt) characteristics were well balanced The PRiMARy oBjEcTivE of the study was met:
the two arms (44% in arm A vs 52% in arm B, p=0.524). and B. Haematological toxicity (Tox) was low in both arms with There is significantly less dose reduction throughout the first neutropenia Gr 3 in only 8% of cycles, G-CSF support in 2% 6 cycles in patients treated in arm B (67%) compared A progression-free survival advantage was seen in arm B over A of cycles and infection G3 in 5 pts. Alopecia G2 was less Patient and disease characteristics
(12 vs 9 months, p=0.172), including in the triple negative patient frequent in arm A (29 vs 60%). Other Tox were similar in both subset (n=26 patients) (6.5 vs 4.9 months, p=0.07) (Figures 1 & 2). Dose reductions
arms: [G2/3 (%) cutaneous (35/17), pain (36/9), fatigue (26/13), Fig.1: Progression free survival of the whole population
neuropathy (20/3), diarrhoea (15/6), mucositis (8/2), vomiting (Kaplan-Meier)
(9/1)] but treatment interruption due to Tox was more frequent in A (A 19, B 7 pts) (p=0.02). Response rate was 52% (B) vs 44% (A). A progression-free survival advantage was seen CONClusION
for B over A (366 vs 272 days, p=0.15) including in the triple 7.5-10.7
negative pt subset (n = 26 pts) (197 vs 150 days, p=0.07).
The intermittent TaXel schedule
CONClusION: The intermittent schedule (3 wk out of 4)
Delayed cycles rates were similarly reported in arm A (58%) compared (weekly taxol 3/4 weeks and Xeloda
of weekly paclitaxel and capecitabine 5d/week is a well 5d/wk concomitant with Taxol admi-
a- censored
accepted, safe and effective TaXel regimen and might be nistration) was found to have a more
B- censored
a chemotherapy regimen of choice in MBC including triple ropor
favorable benefit/risk ratio than the
standard TaXel schedule (continuous
Treatment discontinuations due to toxicity were significantly more weekly Taxol and d1-14 Xeloda):
frequent in arm A (29%) than in arm B (8%) (p=0.02). The difference between the 2 arms is mainly due to non-haematological toxicity A better tolerance (less dose re-
(A=26% of the pts, B = 8%), including hand-foot syndrome (A = 12%, duction & early treatment stopping)
And a trend for better efficacy in
Hospitalisation for toxicity was required for 14% and 3% of the patients term of progression-free survival
The combination of a Taxane and Capecitabine has These encouraging results in favor
demonstrated a synergic effect and significant antitumour Fig.2: Progression free survival of the triple negative subset
of the intermittent TaXel schedule
activity in patients with advanced breast cancer.1,2 Treatment-related grade 3/4 - Adverse Events and supportive treatments
population (Kaplan-Meier)
were also found in the triple nega-
Paclitaxel (175 mg/m² q3w) combined with a classical tive population warranting further
14 days/21 Xel administration (standard schedule) showed studies in this subset of MBC
excellent efficacy (Objective Response Rate: 52%; Time To patients.
Progression: 8.1 months) in a phase II study in metastatic However, this schedule of Ta in combination with Xel was a- censored
associated with significant toxicities (particularly hand-foot Abbreviations: ER, oestrogen receptor, PR, progesterone receptor, RH, receptor hormone the patients in arm A and B, respectively.
B- censored
1- O’Shaughnessy J et al, JCO. 2002 Jun TREaTMENT EXPOsuRE
excellent efficacy/safety ratio in phase I.3 A total of 414 and 402 cycles of paclitaxel and capecitabine were The purpose of this study was to explore the efficacy/ administered to 66 patients in arm A and 64 in arm B, respectively. toxicity safety of the combination of Xel 5d/week (wk) Patients received a median of 6 cycles (range 1 to 23 cycles) with and weekly Ta 3 wk out of 4 compared to a continuous a received/planned mean dose of 89% for Ta in both arms and 75% weekly Tax combined with a classical 14 days (d)/21 Xel for Xel in both arms in patients who were on treatment.
18.00 Months
administration (standard schedule) in patients with MBC.
Supported by Roche France


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