HEALTH PROFESSIONAL · SOURCE READING
Neoadjuvant chemotherapy
Source: Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 21, 2025 · Captured 2026-09-09.
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Context: Treatment Option Overview for Soft Tissue Sarcoma / Chemotherapy
In prospective studies, neoadjuvant chemotherapy with or without radiation therapy has shown response rates of 17% to 32%, 10-year RFS rates of up to 58%, and 10-year OS rates of up to 64%.[46,52-56]
In retrospective studies, neoadjuvant chemotherapy with or without radiation therapy has resulted in DFS rates of 80% to 90% compared with about 60% in historical controls.[57-59]
A combined analysis of the RTOG-9514 study (NCT00002791) of neoadjuvant chemoradiation and the RTOG-0630 study (NCT00589121) of neoadjuvant radiation therapy showed rates of pathological complete response of 27.5% in patients on neoadjuvant chemoradiation and 19.4% in patients on neoadjuvant radiation therapy in 123 evaluable patients. At a median follow-up of more than 5 years, the OS rate was 100% in patients with pathological complete responses; 5-year survival rates were 76.5% (RTOG-9514) and 56.4% (RTOG-0630) for patients who did not achieve pathological complete responses.[60]
Evidence (neoadjuvant histotype-tailored chemotherapy vs. standard chemotherapy):
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported:
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The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported:
Standard chemotherapy (every 21 days):
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported: › Standard chemotherapy (every 21 days):
Epirubicin, 60 mg/m2, on days 1 and 2 plus ifosfamide, 3 g/m2, on days 1, 2, and 3.
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported:
Histotype-tailored chemotherapy:
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported: › Histotype-tailored chemotherapy:
Undifferentiated pleomorphic sarcoma: docetaxel, 75 mg/m2, on day 8 plus gemcitabine, 900 mg/m2, on days 1 and 8 (every 21 days).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported: › Histotype-tailored chemotherapy:
Myxoid liposarcoma: trabectedin, 1.3 mg/m2, continuous infusion (every 21 days).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported: › Histotype-tailored chemotherapy:
Synovial sarcoma: ifosfamide, 14 g/m2, 14 days of continuous infusion (every 28 days).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported: › Histotype-tailored chemotherapy:
Malignant peripheral nerve sheath tumor: ifosfamide, 3 g/m2, on days 1, 2, and 3 plus etoposide, 150 mg/m2, on days 1, 2, and 3 (every 21 days).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported: › Histotype-tailored chemotherapy:
Leiomyosarcoma: gemcitabine, 1,800 mg/m2, on day 1 plus dacarbazine, 500 mg/m2, on day 1 (every 14 days).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported:
With a median follow-up of 12.3 months, the projected RFS rate at 46 months was 62% (95% CI, 48%–77%) for patients who received standard chemotherapy versus 38% (95% CI, 22%–P = .004).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported:
The OS rate was 89% (95% CI, 78%–99%) in the standard chemotherapy group versus 64% (95% CI, 27%–100%) in the histotype-tailored chemotherapy group (P = .034).
The phase III ISG-STS1001 study (NCT01710176) enrolled 164 patients with high-risk features (grade 3 tumor or grade 2 tumor with more than 50% necrosis, size ≥5 cm, deep location).[56] Patients were randomly assigned to receive either standard chemotherapy or histotype-tailored chemotherapy for three cycles as listed below:The following results were reported:
Trabectedin for myxoid liposarcoma had outcomes similar to those for the standard chemotherapy group.[56]
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