Eastern Cooperative Oncology Group: a comparison of adjuvant doxorubicin and observation for patients with localized soft tissue sarcoma.

Abstract

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.

Adjuvant chemotherapy for soft-tissue sarcoma: review and meta-analysis of the published results of randomised clinical trials

“…The OR calculated using the total number of observed deaths in the ten trials that reported it (Antman et al, 1984;Glenn et al, 1985a,b;Omura et al, 1985;Lerner et al, 1987;Baker et al, 1988;Picci et al, 1988;Piver et al, 1988;Ravaud et al, 1990;Bramwell et al, 1994) is 0.61 (95% CI = 0.46-0.82, P = 0.003), which is very similar to that calculated at 5 years. This analysis suggests that the overall odds of dying are reduced by 39% (95% CI = 18-54%) for those patients who are treated with chemotherapy.…”

“…Two trials included patients with all histological grades (Edmonson et al, 1985;Lerner et al, 1987) and one entered patients with all but very low-grade sarcomas (Bramwell et al, 1994). Most of the remaining trials concentrated on patients with intermediate and high-grade sarcomas (Antman et al, 1984;Glenn et al, 1985a,b;Benjamin et al, 1987;Baker, 1988;Chang et al, 1988;Kinsella et al, 1988;Ravaud et al, 1990) or high-grade sarcomas only (Picci et al, 1988;Alvegard et al, 1989).…”

Adjuvant Chemotherapy Following Complete Resection of Soft Tissue Sarcoma in Adults: A Clinical Practice Guideline

“…20 Reporting of adverse effects in the other trials was not standardized. Some trials reported mostly qualitative assessments of toxicity, [11][12][13]15,21,28 while others reported quantitative data according to standard toxicity grading scales. 14,17,[23][24][25][26][27] Adverse effects frequently consisted of alopecia, fatigue, anorexia, nausea and vomiting, leucopenia or neutropenia, thrombocytopenia, infections, mucositis and cardiotoxicity.…”

“…Potential heterogeneity of results was explored and no significant (p < 0.10) values were observed. One study 13 recorded recurrence, but did not distinguish between local and distant recurrence and, therefore, was not included in the analyses of these outcome measures 9 .…”

“…14,17,[23][24][25][26][27] Adverse effects frequently consisted of alopecia, fatigue, anorexia, nausea and vomiting, leucopenia or neutropenia, thrombocytopenia, infections, mucositis and cardiotoxicity. Alopecia was considered significant in 50% 27 to 90% 13,21,25 of patients. Nausea and vomiting was mild to moderate in some trials; it was considered severe in 22-50% of patients in other trials.…”