639 / 1082
S623
ESTRO 36 2017
_______________________________________________________________________________________________
Conclusion
Patients older than 80 treated by Stage I-III breast cancer
have long survival after treatment. OS and BCSS is high at
five years. Patients with locally advanced preoperatory
disease, pathologic tumor size and locorregional
irradiation contributed negatively to survival.
EP-1156 A clinical trial on hypofractionated whole-
breast irradiation after breast-conserving surgery
M. Nozaki
1
, Y. Kagami
2
, T. Shibata
3
, K. Nakamura
4
, Y.
Ito
5
, Y. Nishimura
6
, Y. Kawaguchi
7
, Y. Saito
8
, Y. Nagata
9
,
Y. Matsumoto
10
, T. Akimoto
11
, T. Nishimura
12
, T. Uno
13
, K.
Tsujino
14
, M. Kataoka
15
, T. Kodaira
16
, K. Shiraishi
17
, K.
Inoue
18
, F. Isohashi
19
, M. Hiraoka
20
, K. Karasawa
21
, S.
Izumi
22
, H. Sakurai
23
1
Dokkyo Medical University Koshigaya Hospital,
Radiology, Koshigaya, Japan
2
Showa University School of Medicine, Radiation
Oncology, Shinagawa, Japan
3
National Cancer Center, Statistical Section- The Japan
Clinical Oncology Group Data Center, Chuo, Japan
4
National Cancer Center, Study Coordination Section,
Chuo, Japan
5
National Cancer Center Hospital, Radiation Oncology,
Chuo, Japan
6
Kindai University Faculty of Medicine, Radiation
Oncology, Osakasayama, Japan
7
Osaka Medical Center for Cancer and Cardiovascular
Diseases, Radiation Oncology, Osaka, Japan
8
Saitama Cancer Center, Radiation Oncology, Kitaadachi,
Japan
9
Hiroshima University Graduate School of Biomedical
Science, Radiation Oncology, Hiroshima, Japan
10
Niigata Cancer Center Hospital, Radiation Oncology,
Niigata, Japan
11
National Cancer Center Hospital East, Radiation
Oncology and Particle Therapy, Kashiwa, Japan
12
Shizuoka Cancer Center, Radiation and Proton Therapy
Center, Sunto, Japan
13
Graduate School of Medicine- Chiba University,
Diagnostic Radiology and Radiation Oncology, Chiba,
Japan
14
Hyogo Cancer Center, Radiation Oncology, Akashi,
Japan
15
Shikoku Cancer Center Hospital, Radiotherapy,
Matsuyama, Japan
16
Aichi Cancer Center Hospital, Radiation Oncology,
Nagoya, Japan
17
The University of Tokyo Hospital, Radiology, Bunkyo,
Japan
18
Tochigi Cancer Center, Radiotherapy, Utsunomiya,
Japan
19
Osaka University Graduate School of Medicine,
Radiation Oncology, Suita, Japan
20
Graduate School of Medicine- Kyoto University,
Radiation Oncology and Image-applied Therapy, Kyoto,
Japan
21
Tokyo Metropolitan Cancer and Infectious diseases
Center- Komagome Hospital, Radiology, Bunkyo, Japan
22
Tokyo Women’s Medical University, Radiation
Oncology, Shinjuku, Japan
23
University of Tsukuba, Radiation Oncology, Tsukiba,
Japan
Purpose or Objective
To evaluate the safety and efficacy of short-course
hypofractionated whole-breast irradiation (HWBI) on
Japanese women after breast-conserving surgery (BCS), a
prospective single-arm confirmatory trial (JCOG0906,
UMIN000003200) has been conducted in 25 hospitals.
Material and Methods
Japanese women who had invasive breast cancer with
clinical tumor size of 3 cm or less, no or one to three
pathologically positive lymph nodes and pathologically
negative inked margin were prospectively registered after
BCS with or without adjuvant chemotherapy. The HWBI of
42.56Gy/16fr was delivered to the whole-breast without
regional nodal irradiation, and a boost irradiation (BI) of
10.64Gy/4fr to the original tumor bed was added when the
surgical margin was 5 mm or less. The recommended
treatment period was within 29 days for HWBI and 33 days
for HWBI and BI. The primary endpoint was the proportion
of pre-specified eight items of grade 2 or higher late
adverse reactions (ARs) including telangiectasia,
ulceration, fibrosis-deep connective tissue, fracture,
pneumonitis, cardiac ischemia/infarction, pericardial
effusion and pain-breast occurring between 91 days and
three years from the start of HWBI. The sample size was
set as 310 patients with one-side alpha of 5%, power of
90%, threshold value of 8%, and expected value of 4%,
estimated from the proportion of the late ARs on the
historical control including 703 patients followed up for
three years or more after conventional fractionated
whole-breast irradiation (CWBI) in our pilot survey prior to
the present trial. Secondary endpoints included the
proportion of treatment completion within the
recommended period, early adverse events (AEs)