Journal of Clinical Oncology, Vol 5, 613-617, Copyright © 1987 by American Society of Clinical Oncology
Eastern Cooperative Oncology Group: a comparison of adjuvant doxorubicin and observation for patients with localized soft tissue sarcoma
HJ Lerner, DA Amato, ED Savlov, WD DeWys, A Mittleman, RC Urtasun, S Sobel and M Shiraki
Forty-seven patients with stage I, II, or III soft tissue sarcoma were
entered into a prospective randomized Eastern Cooperative Oncology Group
(ECOG) adjuvant protocol. Eligibility included conservative or radical
primary treatment for local cure. Patients were then randomized to control
or Adriamycin (Adria Laboratories, Columbus, OH). Adriamycin was
administered at 70 mg/m2 (slow push, every 3 weeks for seven courses for a
maximum of 550 mg/m2). To date, 32 patients, 17 males and 15 females, with
an age range of 17 to 75 years (median, 44 years) have been followed
sufficiently long to be included in this analysis. Nine patients have died.
The median follow-up of the remaining 23 patients is 30 months (range, 2 to
50 months). Survival was not significantly different between Adriamycin or
control. However, the disease-free interval was slightly different in favor
of observation. This preliminary report does not support the hypothesis
that Adriamycin is an effective adjuvant therapy for soft tissue sarcoma.
Due to the small numbers, these results must be interpreted in relation to
our ability to detect a difference, if in fact one existed. These
preliminary data suggest that adjuvant Adriamycin not be used outside the
confines of a clinical trial such as the current intergroup adjuvant
sarcoma study.
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