Soft tissue sarcoma (STS) is rare malignancy of mesodermal origin, representing less than 1%
of all malignant neoplasms. They are a group of diseases encompassing diverse histological
subtypes with very different biomorphologies, prognoses, and responses to treatments. At
advanced stages of STS, anticancer treatments are less effective and the prognosis is poor
with a median survival of 8 to 18 months. Doxorubicin and ifosfamide given each alone or in
their combination have represented the mainstream of anticancer treatments in metastatic STS.
However, salvage treatments for patients with progression after doxorubicin/ifosfamide-based
treatment are limited and anticancer agents such as gemcitabine/docetaxel, pazopanib,
eribulin and trabectedin are currently used as a standard of care (SOC).
For metastatic sarcoma, a study of pemetrexed alone in patients with refractory STS who have
progressed after doxorubicin and/or ifosfamide-based anticancer treatment was conducted. In
this study including 48 patients, most of whom had relatively poor course of disease with
disease progression after the 2nd- and/or 3rd-line treatment, pemetrexed was well tolerated
and associated with 5% of response rate and 33% of 3-month progression-free rates suggesting
potential antitumor efficacy with good tolerability profile with refractory STS.
However, as conventional agents have showed different efficacy depending on various subtypes
of STS, a confirmatory study to see clinical utilities of a given regimen by subtype is
required also for pemetrexed/cisplatin. Therefore, the investigators intend to proceed this
phase 2 clinical trial to evaluate the efficacy and safety of pemetrexed/cisplatin
combination therapy in patients with advanced/metastatic STS who received up to two-lines of
prior palliative anticancer treatments with histological subtype-specific cohorts
(leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, and others) in
order to provide a basis for a subsequent phase 3 study by selecting histological subtype(s)
in which the efficacy of study regimen is to be proven.