الفهرس 
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Abstract
Breast cancer is the second most common cause of death
in all cancer female patients. The American Cancer Society
estimated that 235,030 new cases of invasive breast cancer were
diagnosed in the United States during 2014, of which
approximately 40,430 women were expected to die from it
(Siegel et al., 2014).
In Egypt, breast cancer is the most common cancer in
females, it represents 26.8% of all cancer cases in Minia female
registry 2009 & 32.9% of all cancer female cases in Damietta
cancer registry 2009 (NCI, 2010).
Radiotherapy reduces the risk of local relapse and breast
cancer mortality and is offered to nearly all patients after
conservative surgery (Clarke et al., 2005).
The high number of women with breast cancer, receiving
postoperative RT, led to think that a shorter course of irradiation
would result in improved quality of life for patients, in
potentially better integration with systemic treatments and in
reduced costs. Therefore, alternative schedules based on a lower
total dose delivered in fewer, larger fractions (hypofractionation) were firstly introduced in Canada and the United
Kingdom (Owen et al., 2006).
Our study is a phase III prospective open labeled
randomized clinical trial conducted in Clinical Oncology and
Nuclear Medicine Department, Ain Shams University Hospitals,
during the period between January 2013 to April 2014.
The study included Fifty Four eligible patients with early
breast cancer who were classified into two groups; twenty seven
patients in each group.
Summary
174
Group I received Hypo-fractionated postoperative
radiotherapy; they were treated with whole breast irradiation of
45 Gy in 20 fractions, 2.25 Gy/fraction followed by 9 Gy in 3
fractions as a boost dose to the tumor bed, while Group II
received Conventional postoperative radiotherapy; they were
treated with conventional fractionation of 2 Gy to a total dose of
50 Gy in 25 fractions followed by a boost dose of 10-16 Gy in 5-8 fractions to the tumor bed.
Pre-radiotherapy assessment included history taking and
clinical examination, assessment of performance status, Bilateral
sonomamograph, Pathology confirmed invasive ductal or lobular
breast cancer with Immunohistochemistry ER, PR, Her 2 neu and
Ki 67, Investigations including chest x-ray, bone scan, pelvic and
abdominal U/S or CT, Full blood count, Kidney and Liver
function tests, echocardiograph. Then after receiving adjuvant
chemotherapy, if indicated, patients underwent a baseline high
resolution CT Chest, and then submitted to one of the two arms.
The aim of the present study is to assess hypo-fractionated
radiotherapy after conservative breast surgery in early breast
carcinoma (p T1-2 N0-1 M0) in terms of Local control, Acute
and late toxicities, Breast cosmesis at 1 year as primary end
points. The median follow up of our study was 12 months.
CT simulation was performed in the supine position with
immobilization that ensured the arm in abduction position with
hands over the head, using breast wedge .The CT data was
transferred to treatment planning system where all required
structures were contoured. All CT scans were planned and
treated with 6 MV and 15 MV photon beam on a linear
accelerator. 3 DCRT (3-Dimensional Conformal Radiotherapy)
plans were carried out using medial & lateral wedged tangential
photon fields and anterior supraclavicular field (if indicated).
Isodose distributions and Dose Volume Histograms (DVHs) for
conventional and hypo-fractionated techniques were generated.
Summary
175
Patients were followed up weekly during treatment to
monitor acute toxicities; it was done according to RTOG scoring
system, then 4-6 weeks after radiation therapy to monitor Local
control, late toxicities according to the RTOG/EORTC
recommendations and Breast cosmesis at 1 year was assessed
using the Harvard scale, where results were ranked according to
comparisons between the operated breast and the untreated
breast.
The following results were obtained from this study:
The age of patients included in this study ranged between
28 to 73 years with mean age 50.5± 12.2 years, about 57.4% of
the cases were Post menopausal and about 57.4% of cases had PS
zero. 33 patients (61.1%) of all the study cases had left sided
breast cancer, while 21 patients (38.9%) had right sided breast
cancer.
In most of our patients, the most common site of the
affected breasts was upper outer quadrant (44.4%) and most of
their tumors (79.6%) were classified as grade II tumors, In our
study, we found that most of all the patients (55.6 %) were lymph
node negative and only 44.4% of all the patients were node
positive (48.1 % in Group I and 40.7 % in Group II)
Most of the patients included in our study, were stage IIA
and IIB, 57.4% were Luminal A , 81.5 % had estrogen-receptor–
positive disease; 63% received adjuvant tamoxifen, and 90.7%
had received adjuvant systemic therapy.
In the present study, no patients of those who received
hypo-fractionated radiotherapy got local recurrence, while only
one patient of those who received conventional radiotherapy got
local recurrence. It was statistically non-significant (p-value = 1).
Also in the present study only one patient of those who
received Hypo-fractionated radiotherapy developed distant bone & lung metastasis and also only one patient of those who
received Conventional radiotherapy developed distant bone
metastasis, they both died during their follow up. It was
statistically non-significant (p-value = 1).
The toxicities of treatment were generally within an
acceptable level and comparable with other studies. No patients
died from treatment related toxicity. 17 patients (63%) of Group I
had positive acute skin toxicity, while19 patients (70.4%) of
Group II were positive. It was not statistically significant (p =
0.564). Grade I was the most common type in both groups
(88.2% in Group I &73.7% in Group II). One patient only had
Grade III acute skin toxicity in each arm. At one year median
follow up, 18 patients (66.7%) of Group I had positive late skin
and subcutaneous toxicity, while 21 patients (80.8 %) of Group II
were positive. Grade I was the most common type in both groups
(88.9% in Group I &85.7% in Group II). It was not statistically
significant (p =0.244).
Also at one year median follow up, 8 patients (29.6%)
of Group I developed Grade I-II late Arm Lymphedema, while
11 patients (42.3%) of Group II developed Grade I-II Arm
Lymphedema. It was not statistically significant (p =0.336).
The present study showed that no patients developed
acute pneumonitis in Group I, while only one case in Group II
developed acute pneumonitis. It was not statistically significant
(p = 1).
At one year median follow up, 9 patients (33.3%) of
Group I had Grade I lung fibrosis, while 8 patients (30.8%) of
Group II had Grade I lung fibrosis. It was not statistically
significant (p = 0.84). Also there was no significant difference
( p = 0.126 ) between the two study groups as regards affection
in cardiac function monitored by Echo cardiography which
calculate the ejection fraction at baseline then every 3 months
till 12 months after radiotherapy in the two study groups.
Recommendations
Summary