NCI sarcoma(135)
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adriamycin...... 50 [If WBC ok increase by 10 per cycle to 70]
mg/sqm IV day 1.
cytoxan......... 500 [If well tolerated and WBC ok increase by
100 per cycle to 700] mg/sqm IV day 1.
radiation....... 180 to 200 rad per fraction to 4,500 to 5,000
rad, started three days after the initiation of
chemotherapy. The tumor bed may be irradiated
to a maximum of 6,000 to 7,000 rads over the
next two weeks.
methotrexate.... When adriamycin cummulative dose reaches 550
mg/sqm, susbtitute with methotrexate at 50 [If
well tolerated, increase by 50 per cycle to
250] mg/kg IV over 6 h on day 1.
leucovorin...... 15 mg/sqm IV, 2 h after completion of
methotrexate, then repeated every 6 h times 8.
FREQUENCY....... Repeat cycle every 28 days.
reference...
Rosenberg SA. Tepper J. Glatstein E. Costa J. Young R.
Baker A. Brennan MF. Demoss EV. Seipp C. Sindelar WF.
Sugarbaker P. Wesley R. Prospective randomized evaluation of
adjuvant chemotherapy in adults with soft tissue sarcomas of
the extremities. Cancer. 52(3):424-34, 1983 Aug 1.
abstract...
Sixty-five patients with high-grade soft tissue sarcomas of
the extremities were treated in a prospective randomized trial
evaluating the efficacy of adjuvant chemotherapy with
doxorubicin, cyclophosphamide, and high-dose methotrexate.
Local therapy was administered using either amputation or wide
local resection plus radiation therapy and the chemotherapy
was begun in the immediate postoperative period. Actuarial
analysis with median follow-up of 653 days revealed an
advantage in continuous disease-free and overall survival in
the patient group receiving chemotherapy (P = 0.0008 and P =
0.04, respectively, one-sided Mantel-Haenszel test). The
continuous disease-free survival at three years is 92% in the
chemotherapy group compared to 60% in the no chemotherapy
group. Overall survival is 95% and 74% in these two patient
groups. Fifty-eight percent of patients had limb-sparing
surgery plus radiation therapy and 42% underwent amputation.
In both treatment subgroups analyzed separately, chemotherapy
resulted in an improvement in disease-free survival compared
to randomized controls not receiving chemotherapy (P = 0.006
and P = 0.04 for groups receiving amputation and limb sparing,
respectively). There were no local failures in the patients
receiving chemotherapy and two local failures in the no
chemotherapy group. The results of this trial confirm the
historically controlled pilot trial performed in 26 patients
between 1975 and 1977. A current update of the patients in the
pilot trial, with a minimum four-year follow-up, reveals an
improvement in disease-free and overall survival due to
chemotherapy (P less than 0.002). Analysis of the previous
pilot trial indicates that only few recurrences are seen
beyond three years. Thus, it appears that adjuvant
chemotherapy should be a part of the treatment adult patients
with soft tissue sarcomas of the extremities.
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