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Metronomic continuous oral cyclophosphamide (CPM) as second and further line in metastatic soft tissue sarcomas (STS) of the adult (presented as Poster at the ASCO meeting)

ABSTRACT
In metastatic soft tissue sarcomas (mSTS) second and further line of therapy are poorly defined. However many patients (pts), after first line therapy including Antracyclines progress in their disease and ask to be treated. Oral cyclophosphamide (CPM) was already used in breast cancer, prostate cancer and
in one study in mSTS with contrasting results. Aim of our study was to define the feasibility, tolerability and activity of oral CPM as second and further line chemotherapy in mSTS patients: 45 pts (19 M; 26 F) median age 60 (32-81), with pretreated mSTS were included. Oral CPM was given daily at total dose of 50 mg/day without interruption excepted for toxicity or progressive disease. Results: leiomyosarcoma 12, liposarcoma 10, MPNST 5, synovialsarcoma 4, indifferentiated sarcoma 4, other rarer subtypes 10.
Sites of the primary tumor were: extremities 21, retroperitoneum 19, trunk 5.41 pts were metastatic, 4 locally relapsed. All 45 pts were pretreated with chemotherapy (17 were in II line, 18 in III line, 8 in IV line, 2 in V line). Median PS (ECOG) was 2. Median duration of therapy was 4.4 months (from 1 to 38 months). The 6-month PFS rate was 46%.
Treatment was well tolerated: neutropenia grade 2 in 1 case, fatigue grade 2 in 7 patients, nausea grade 1-2 in 22 cases. No grade 3-4 side effects were recorded.
Twenty two stable disease were recorded. No partial or complete responses were seen. The median OS was 10.2 months [95% CI: 6.4; 13.2]. The 6-month OS rate was 64% and 32% at one year.
Oral CPM showed a mild activity and good tolerability in pretreated mSTS. It could be an appropriate solution as second and further line therapy and in unfit or elderly patients.

IMPACT STATEMENT
This phase II monoinstitutional study evaluates the activity as second and further line of therapy of metronomic cyclophosphamide in metastatic soft tissue sarcomas. The results obtained showed a stabilization of the disease in most cases and a good profile of toxicity.

Table of Content: Vol. 1 (No. 2) 2021 June

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