652 Charged Particle and Photon Interactions with Matter
and the low-risk group was treated with carbon-ion radiotherapy alone (Akakura etal., 2004; Tsuji
etal., 2005; Ishikawa etal., 2006). Patients considered to not require long-term hormone therapy
were separated from the high-risk group as a medium-risk group, and the period of their hormone
therapy
was reduced to 6 months for the last couple of years.
The
incidence of adverse reactions of Grade 3 or more in the rectum or lower urinary tract (blad-
der/urethra) in all patients was 1.5%, but no reactions of Grade 3 or more were observed in any
patients after the optimal irradiation dose was established. The incidence of adverse reactions of
Grade 2 with the current technique was as low as 1.5% in the rectum and 5.7% in the lower urinary
tract, and it has recently tended to decrease after the total dose was reduced to 63GyE. Treatment
with 57.6GyE in 16 fractions has produced no reactions of Grade 2 during observation for 6 months
or more, and this regimen is considered to be safer than that of 63GyE in 20 fractions. According to
the recent survival analysis in these patients, the 5-year survival rate was 91.6%, the cause-specic
survival rate was 98.5%, the 5-year local control rate was 99.1%, and the biochemical nonrecurrence
rate was 88.5%. A comparison of the biochemical nonrecurrence rate in patients with a PSA level of
20ng/mL or higher before treatment and in those receiving other radiotherapies showed a remark-
ably higher nonrecurrence rate in those receiving carbon-ion radiotherapy. The high nonrecurrence
rate should also be associated with the effects of our sound use of combination hormone therapy, but
a comparison with clinical studies in Europe and North America combining hormone therapy and
x-ray radiotherapy showed that the survival rate in our results was 10%–15% higher, conrming that
the
high local effect of carbon-ion radiotherapy led to good treatment results.
Treatment
with 57.6GyE in 16 fractions, the present standard regimen for prostate cancer at
NIRS, is expected to produce results better than those produced with an irradiation of 20 fractions
over 5 weeks in terms of the antitumor effect with a lower risk of adverse reactions, and shows great
promise
for future long-term results.
24.2.2.6
bone
and s
oft
t
issue
t
umors
In bone and soft tissue tumors, a phase I/II dose escalation study was followed by a phase II xed-
dose
study, and it is now being performed as a clinical practice.
The
total dose started at 52.8GyE in 16 fractions over 4 weeks, and was increased to 73.6GyE
in the initial study. The local control rate improved as the dose increased, but some patients in the
group who were given the largest dose developed severe skin and soft tissue reactions (Kamada
etal.,
2002).
In
the phase II xed-dose study, the 3- and 5-year local control rates were both 84% and the 3- and
5-year survival rates were 68% and 49%, respectively. Skin and soft tissue toxicities, as severe side
effects, developed at an incidence of about 3%, but recently, as a result of decreased skin doses, almost
no side effects have been observed. In patients with osteosarcomas in the pelvis or spine, whose resection
was difcult, the 5-year survival rate was 25%. In patients with chordomas other than those developing
in the skull base, the 5-year local control rate was 96% and the 5-year survival rate was 81%. Chordomas
of the sacral bone were reported in Clinical Cancer Research, 2004, and appeared in the Year Book of
Oncology, 2006 (Imai etal., 2006; Leoehrer etal., 2006).
Bone and soft tissue tumors are considered one of the best indications for carbon-ion radio-
therapy. Although long-term observation should be continued, carbon-ion radiotherapy may replace
surgical resection in elderly patients and in patients whose function would be greatly reduced with
resection,
as well as provide a treatment for patients for whom resection is not indicated.
More
than 4500 patients have already received carbon-ion radiotherapy at NIRS. The results
have been revolutionary for cancer treatment. It has proven effective for cancers in the head and
neck, lung, liver, prostate, sarcomas, etc. Many of the diseases targeted in these clinical trials were
considered unlikely to be effectively treatable with other therapies. Although it is difcult to carry
out direct comparative studies with other therapeutics, it has become increasingly evident that
carbon-ion radiotherapy is capable of curing cancers that are incurable by other treatments, as well
as
in a shorter time and more safely than when treated by other modalities.