NEW YORK (Reuters Health) Feb 21 - Three cycles of full-dose adjuvant chemotherapy is not inferior to five in treatment of high-risk adult soft tissue sarcomas, European researchers report.
"Many randomized trials in soft tissue sarcoma have shown that chemotherapy improves disease-free survival and, to a lesser extent, overall survival," lead author Dr. Alessandro Gronchi, of Fondazione IRCCS Istituto Nazionale Tumori in Milan, Italy, told Reuters Health by email.
"Given this relatively small impact on survival, chemotherapy with an anthracycline and ifosfamide can be justified in high risk patients (affected by large, deep and high grade tumors)."
However, the optimal treatment course is still unclear, note Dr. Gronchi and his colleagues in their report, published online February 6 in the Journal of Clinical Oncology.
The team studied 321 patients who received three preoperative cycles of epirubicin and ifosfamide with granulocyte colony-stimulating factor. Half of the patients were then randomly assigned to receive two extra cycles postoperatively.
After a median of 63 months of follow-up, 49 patients in the three-cycle group had died compared to 51 in the five-cycle group.
The five-year survival rate was 0.68 in the three-cycle group versus 0.71 in the five-cycle group, resulting in a Cox-model hazard ratio of 1.00.
"This trial has shown that three cycles of full-dose anthracycline and ifosfamide has equivalent outcomes to 5 cycles," Dr. Gronchi concluded. "Therefore a more-prolonged neoadjuvant chemotherapy treatment does not improve outcome while it is associated with increased toxicity."
"When indicated," he added, "this treatment can be safely combined with radiation therapy, even in the preoperative phase."
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