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TPS11580 Background: Soft tissue sarcomas (STS) are a rare type of malignancy, which comprises of a variety of histologies. Chemotherapy is the standard treatment for patients with advanced STS. Doxorubicin alone or in combination with ifosfamide is widely accepted as the first-line chemotherapy for advanced STS. While a combination with gemcitabine and docetaxel is regarded as a standard regimen of the second-line chemotherapy after failure of doxorubicin-based first-line regimen, the efficacy is not sufficient. Trabectedin, eribulin, and pazopanib are the candidates of the second-line chemotherapy for advanced STS, although there is no clear evidence showing which is better among those agents. The purpose of this clinical trial conducted by Bone and Soft Tissue Tumor Study Group of Japan Clinical Oncology Group (JCOG) is to determine the most promising regimen among trabectedin, eribulin and pazopanib as the test arm regimen in the future phase III trial of the second-line treatment for patients with advanced STS. Methods: The study, JCOG1802, is a multicenter, selection design, randomized phase II trial comparing trabectedin (1.2 mg/m2 IV, every 3 weeks), eribulin (1.4 mg/m2 IV, days 1 and 8, every 3 weeks) and pazopanib (800 mg PO, everyday) for patients with unresectable or metastatic STS refractory to doxorubicin-based first-line chemotherapy. Eligibility criteria include 16 year-old or older, unresectable and/or metastatic STS, an exacerbation within 6 months prior to registration, histological diagnosis of STS other than Ewing sarcoma, well-differentiated liposarcoma and myxoid liposarcoma, a history of chemotherapy for STS other than doxorubicin-based regimen, ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2, and sufficient organ function. Primary endpoint is progression-free survival (PFS), and secondary endpoints include overall survival, disease-control rate, response rate, and adverse events. To select the most promising regimen in median PFS (3 months in the worst regimen and 4 months in the best regimen) with a probability of at least 80%, a total of 120 patients will be enrolled from 37 institutions in Japan. After JCOG1802, a subsequent phase III trial comparing the winner of this study and a combination of gemcitabine and docetaxel will be planned. The study was activated at December 5, 2019 and 22 of planned 120 patients have been enrolled as of February 15, 2021. Clinical trial information: jRCTs031190152.

11504 Background: Our previous phase II study for high-grade soft tissue sarcomas (STS), JCOG0304, suggested long-term favorable effects of perioperative adriamycin plus ifosfamide (AI) on survival of STS patients. We have also reported in 2015 ASCO Annual Meeting that a phase II/III trial to confirm the non-inferiority of perioperative gemcitabine plus docetaxel (GD) to AI for high-grade STS (JCOG1306) had been started. We herein report the results of JCOG1306 at the early termination by the preplanned second interim analysis. Methods: Patients with operable, FNCLCC grade 2/3 STS primary tumor (T2bN0M0 or anyTN1M0, AJCC 7th edition) or first local recurrent tumor in the extremities or trunk were randomized to AI or GD. Chemotherapy consisted of adriamycin 60 mg/m2 plus ifosfamide 10 g/m2 for AI or gemcitabine 1,800 mg/m2 plus docetaxel 70 mg/m2 for GD. The treatments were repeated for 3 courses preoperatively and 2 courses postoperatively in a 3-week interval. The primary endpoint in phase III part was overall survival (OS). Planned sample size was 140 with a one-sided alpha of 0.1, power of 0.7 and a non-inferiority margin of 8% at 3-year OS, assuming 3-year OS of AI to be 85% and that of GD as 87%. The patient accrual has started in February 2014 and finished in September 2018. Results: A total of 143 patients were enrolled and included in the efficacy analysis. Seventy and 73 patients were assigned to AI and GD, respectively. At the second interim-analysis on December 2019, the estimated 2-year OS was 94.3 % (95% confidence interval (CI) 83.4–98.1) in AI and 91.6 % (80.9–96.4) in GD (hazard ratio (HR) 2.55, 95% CI 0.67–9.78). The estimated 2-year progression-free survival was 81.9 % (95% CI: 69.5–89.7) in AI and 64.0 % (51.1–74.4) in GD (HR 2.32, 95% CI 1.22–4.39). There were no treatment-related deaths in both groups. The most common Grade 3 or higher adverse events in AI were neutropenia (88.4%), anemia (49.3%), and febrile neutropenia (36.2%), whereas those in GD were neutropenia (79.5%), febrile neutropenia (17.8%), and alanine aminotransferase (9.6%). Based on the result of this analysis, the Data Monitoring and Safety Committee of JCOG recommended terminating the study since the point estimate of HR was above the pre-specified allowable HR of 1.61. Conclusions: Although the toxicities were modest in GD, non-inferiority of GD to AI could not be confirmed. In the perioperative chemotherapy for high-grade STS in the extremities and trunk, AI remains the standard regimen. Clinical trial information: UMIN000013175 .

e22505Background: Leiomyosarcoma of bone (LMSoB) is a rare malignant bone tumor. Its clinical outcome has not been deeply assessed in the literature. This multicenter retrospective study was conduc...

10578Background: High dose Methotrexate (HDMTX) has been a key element of standard therapies for lymphatic malignancy (ML), osteosarcoma (OS), etc. Despite optimal supportive care, delayed MTX excr...

TPS10575 Background: Based on the results of JCOG0304, which showed sufficient efficacy of perioperative chemotherapy with adriamycin plus ifosfamide (AI) for operable high-grade soft tissue sarcom...

10524 Background: T binds to the minor groove of DNA and blocks DNA repair machinery following the inhibition of cell cycle and proliferation. In addition, T inhibits interactions of transcription ...