Toledano A, Garaud P, Serin D, Fourquet A, Bosset JF, Breteau N, Body G, Azria D, Le Floch O, Calais G, et al.
International journal of radiation oncology, biology, physics. Date of publication 2006 Jun 1;volume 65(2):324-32.
1. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):324-32. Epub 2006 Mar 20.
Concurrent administration of adjuvant chemotherapy and radiotherapy after
breast-conserving surgery enhances late toxicities: long-term results of the
ARCOSEIN multicenter randomized study.
Toledano A(1), Garaud P, Serin D, Fourquet A, Bosset JF, Breteau N, Body G, Azria
D, Le Floch O, Calais G.
Author information:
(1)Department of Radiotherapy, Hospital Tenon AP-HP, Paris, France.
alain.toledano@gmail.com
Comment in
Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):314; author reply 314-5.
PURPOSE: In 1996, a multicenter randomized study was initiated that compared
sequential vs. concurrent adjuvant chemotherapy (CT) with radiation therapy (RT)
after breast-conserving surgery (ARCOSEIN study). After a median follow-up of 6.7
years (range, 4.3-9 years), we decided to prospectively evaluate the late effects
of these 2 strategies.
METHODS AND MATERIALS: A total of 297 patients from the 5 larger participating
institutions were asked to report for a follow-up examination. Seventy-two
percent (214 patients) were eligible for evaluation of late toxicity. After
breast-conserving surgery, patients were treated either with sequential treatment
with CT first followed by RT (Arm A) or CT administered concurrently with RT (Arm
B). In all patients, CT regimen consisted of mitoxantrone (12 mg/m2), 5-FU (500
mg/m2), and cyclophosphamide (500 mg/m2), 6 cycles (Day 1 to Day 21).
Conventional RT was delivered to the whole breast by administration of a 2 Gy per
fraction protocol to a total dose of 50 Gy (+/- boost to the primary tumor bed).
The assessment of toxicity was blinded to treatment and was graded by the
radiation oncologist, according to the LENT/SOMA scale. Skin pigmentation was
also evaluated according to a personal 5-points scoring system (excellent, good,
moderate, poor, very poor).
RESULTS: Among the 214 evaluable patients, 107 were treated in each arm. The 2
populations were homogeneous for patient, tumor, and treatment characteristics.
Subcutaneous fibrosis (SF), telangectasia (T), skin pigmentation (SP), and breast
atrophy (BA) were significantly increased in Arm B. No statistical difference was
observed between the 2 arms of the study concerning Grade 2 or higher pain,
breast edema, or lymphedema. No deaths were caused by late toxicity.
CONCLUSION: After breast-conserving surgery, the concurrent use of CT with RT is
significantly associated with an increase incidence of Grade 2 or greater late
side effects.
DOI: 10.1016/j.ijrobp.2005.12.020
PMID: 16542788 [Indexed for MEDLINE]
