Chinese largest cohort data from NCT03120846: Efficacy and safety of VEGFR2 inhibitor apatinib for metastatic soft tissue sarcomas.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e22532-e22532
Author(s):  
Jilong Yang ◽  
Zhichao Liao ◽  
Xinyue Liu
Keyword(s):  
Soft Tissue ◽  
Skin Reaction ◽  
Soft Tissue Tumor ◽  
Soft Tissue Sarcomas ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Tissue Tumor ◽  
Hand Foot Skin Reaction

e22532 Background: There is no standard treatment for stage IV soft tissue tumor (STS) after the failure of Adriamycin-based chemotherapy. This opening, single-arm, multi-center phase II study (NCT03120846) assessed the efficacy and safety of Apatinib (YN968D1), a new tyrosine kinase inhibitor that targets VEGFR-2, for patients with stage IV soft tissue tumor after the failure of chemotherapy. Methods: Between September 2015 and February 2018, we recruited 42 patients with stage IV STS who had failed chemotherapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were progression-free survival rate (PFR), objective response rate (ORR), and disease control rate (DCR) at week 12. Secondary endpoint was overall survival (OS). Treatment-related adverse effects (AEs) were evaluated. Results: Patients (19 men, 23 women; 14-83 years, average age: 47.67years) received 500 mg apatinib on Days 1–28 of 4-week cycles (median 5.7 cycles; range: 0–23 cycles). Median follow-up was 9 months (range: 1–28 months). We assessed 42 patients for AEs and 38 for efficacy. At 12 weeks, PFR was 70% and the ORR was 26.32% (10/38) and DCR was 86.84% (33/38). For the overall responses, the ORR was 23.68% (9/38) and DCR was 57.89% (22/38). The median PFS was 7.87 months and median OS was 17.55 months. The top AEs included hypertension ( n= 18, 42.86%), hand-foot-skin reaction ( n= 15, 35.71%), Apositia (13, 30.95%), and proteinuria ( n= 11, 26.19%). No patients had grade-4 AEs. 11 (26.19%) had grade-3 AEs. 2 patients (4.76%) quit because the AE. Notably, the 26 patients (61.90%) who suffered hypertension, hand-foot-skin reaction or proteinuria had significantly longer OS than those without these AEs (20.94 vs. 8.93 months; Log Rank (Mantel-Cox) = 12.94, P= 0.0003). Conclusions: Apatinib is effective and well tolerated in patients with advanced soft tissue sarcomas. The adverse events hypertension, hand-foot-skin reaction, or proteinuria may indicate a favorable prognosis, representing a novel finding in STS patients. Clinical trial information: NCT03120846.

scholarly journals Preoperative Radiation Therapy Followed by Reexcision May Improve Local Control and Progression-Free Survival in Unplanned Excisions of Soft Tissue Sarcomas of the Extremity and Chest-Wall

2016 ◽  
Vol 2016 ◽  
pp. 1-8
Author(s):  
Hina Saeed ◽  
David M. King ◽  
Candice A. Johnstone ◽  
John A. Charlson ◽  
Donald A. Hackbarth ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Proportional Hazards Model ◽  
Performance Status ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Preoperative Radiation ◽  
Free Survival ◽  
Unplanned Excision

Background. The management for unplanned excision (UE) of soft tissue sarcomas (STS) has not been established. In this study, we compare outcomes of UE versus planned excision (PE) and determine an optimal treatment for UE in STS.Methods. From 2000 to 2014 a review was performed on all patients treated with localized STS. Clinical outcomes including local recurrence-free survival (LRFS), progression-free survival (PFS), and overall survival (OS) were evaluated using the Kaplan-Meier estimate. Univariate (UVA) and multivariate (MVA) analyses were performed to determine prognostic variables. For MVA, Cox proportional hazards model was used.Results. 245 patients were included in the analysis. 14% underwent UE. Median follow-up was 2.8 years. The LR rate was 8.6%. The LR rate in UE was 35% versus 4.2% in PE patients (p<0.0001). 2-year PFS in UE versus PE patients was 4.2 years and 9.3 years, respectively (p=0.08). Preoperative radiation (RT) (p=0.01) and use of any RT for UE (p=0.003) led to improved PFS. On MVA, preoperative RT (p=0.04) and performance status (p=0.01) led to improved PFS.Conclusions. UEs led to decreased LC and PFS versus PE in patients with STS. The use of preoperative RT followed by reexcision improved LC and PFS in patients who had UE of their STS.

Metronomic continuous oral cyclophosphamide as second and further line in soft-tissue sarcomas (STS) of the adult.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 10572-10572
Author(s):  
Alessandro Comandone ◽  
Antonella Boglione ◽  
Elena Giubellino ◽  
Paola Bergnolo ◽  
Giancarlo Gino ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Locally Advanced ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Oral Cyclophosphamide ◽  
Second Line ◽  
Good Tolerability ◽  
Free Survival ◽  
Heavily Pretreated ◽  
Third Line

10572 Background: In STS third line treatment is poorly defined. However many patients (pts), after aggressive therapy as first and second line progress in their disease ask to be treated. Oral cyclophosphamide (CPM) was already used in breast cancer, prostate cancer and in elderly pts with STS with favourable results. Aim of our study was to define the feasibility, tolerability and activity of oral CPM as third line and further line chemotherapy Methods: 45 pts (19 M; 26 F) with advanced or metastatic STS heavily pretreated were included. Oral CPM was given daily at total dose of 50 mg/day without interruption excepted for toxicity or progressive disease Results: Median age was 60 (32-81), histological subtypes were: leiomyosarcoma 12, liposarcoma 10, condrosarcoma 5, sinovialsarcoma 4, sarcoma NOS 4, other 10. Primary sites were: extremities 21, retroperitoneum 19, trunk 5. 41 pts were metastatic, 4 locally advanced. 41 pts were pretreated with chemotheraphy (15 were in II line, 17 in III line, 7 in IV line, 2 in V line). Median PS (ECOG) was 2 . Median duration of theraphy was 4 months (1-38). Progression free survival (PFS) ranged from 0 to 42+ months (median 4 months). Treatment was well tolerated, we registred only one episode of leucopenia G2 and one of asthenia G2. No complete responses were seen. Only 3 minimal responses and 18 stable disease were seen. Conclusions: Oral CPM showed a mild activity and good tolerability in advanced soft tissue and metastatic STS. It could be an appropriate solution as second line and further therapy and in unfit or elderly pts.

Pazopanib for metastatic soft-tissue sarcoma: A multicenter retrospective study

2020 ◽  
pp. 107815522092407
Author(s):  
Sinan Koca ◽  
Mehmet Beşiroğlu ◽  
Melike Özçelik ◽  
Mustafa Karaca ◽  
Mehmet Bilici ◽  
...  
Keyword(s):  
Overall Survival ◽  
Weight Loss ◽  
Retrospective Study ◽  
Soft Tissue ◽  
Kinase Inhibitor ◽  
Single Agent ◽  
Real Life ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Free Survival

Purpose Soft tissue sarcomas are associated with a poor prognosis and low chemotherapeutic efficiency. Pazopanib is an orally available multi-tyrosine kinase inhibitor that was explored in patients with non-adipocytic advanced soft tissue sarcomas. The aim of this retrospective study was to evaluate the real life data of single-agent pazopanib efficacy and safety for soft tissue sarcomas in the Turkish population. Materials and methods We evaluated a total of 103 patients (41 males, 62 females) who received pazopanib for advanced non-adipocytic soft tissue sarcomas diagnosis in eight centers of Turkey, retrospectively. The pazopanib dose was 800 mg once daily. Progression-free survival, overall survival, and adverse events were analyzed. Results The median age was 50 years (range, 38–58). Majority of the patients had leimyosarcoma (41%). Median progression-free survival was 4.3 months, and the median overall survival was 10.1 months. The main common toxicities were fatigue, anorexia, weight loss, nausea, hypertension, and grade ≥3 toxicities were fatigue, anorexia, weight loss, and liver disorder. Conclusion Pazopanib is an efficient and tolerable agent and is well tolerated in good performance status patients with relapsed, advanced non-adipocytic soft tissue sarcomas.

scholarly journals Efficacy and Safety of Trabectedin in Patients with Soft Tissue Sarcoma: A Bicentric Retrospective Analysis.

2021 ◽  
Author(s):  
Chaigneau Loïc ◽  
Jary Marine ◽  
Nerich Virginie ◽  
Hervieu Alice ◽  
Aubry Sébastien ◽  
...  
Keyword(s):  
Overall Survival ◽  
Soft Tissue ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Myxoid Liposarcoma ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Heterogenous Group ◽  
End Of Treatment ◽  
Low Toxicity

Abstract Background: Soft tissue sarcomas (STS) are a rare and heterogenous group of tumors, with poor prognostic, judging from their frequency to relapse. Few drugs are available. Since 2007, trabectedin got approval after failure of anthracyclines and ifosfamide, for advanced or metastatic STS.Patients and Methods: This retrospective study describes effects of trabectedin on survival, response, and toxicity, in STS patients. One hundred twenty-nine patients treated between 2002 and 2019 were analysed, from two French centers. All patients were tested for toxicities, and efficacy was assessed in patients exposed to at least 2 cycles of trabectedin.Results: Three median cycles were administered per patient (1-79). Among the 115 patients analysed for efficacy, the median progression free survival was 3.0 months [CI95%: 2.3 – 4.7], with an overall survival of 11.9 months [CI95%: 10.2 – 16.6]. The rate of disease control was 45.2% at the end of treatment. Myxoid liposarcoma (n = 11) was the histology subtype that benefited most from this chemotherapy with median progression free survival and an overall survival of 13.3 months [CI95%: 2.3 – 18.7] and 27.8 months [CI95%: 3.2 – 64.7], respectively. Adverse events were manageable. Conclusion: Efficacy of trabectedin is confirmed in terms of clinical benefit and low toxicity, especially for myxoid liposarcoma.

scholarly journals Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial

2020 ◽  
Vol 8 (2) ◽  
pp. e001561
Author(s):  
Javier Martin-Broto ◽  
Nadia Hindi ◽  
Giovanni Grignani ◽  
Javier Martinez-Trufero ◽  
Andres Redondo ◽  
...  
Keyword(s):  
Survival Rate ◽  
Soft Tissue ◽  
Phase Ii ◽  
Evaluation Criteria ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Recommended Dose ◽  
Free Survival ◽  
Phase Ib ◽  
Inhibition Of Angiogenesis

BackgroundSarcomas exhibit low expression of factors related to immune response, which could explain the modest activity of PD-1 inhibitors. A potential strategy to convert a cold into an inflamed microenvironment lies on a combination therapy. As tumor angiogenesis promotes immunosuppression, we designed a phase Ib/II trial to test the double inhibition of angiogenesis (sunitinib) and PD-1/PD-L1 axis (nivolumab).MethodsThis single-arm, phase Ib/II trial enrolled adult patients with selected subtypes of sarcoma. Phase Ib established two dose levels: level 0 with sunitinib 37.5 mg daily from day 1, plus nivolumab 3 mg/kg intravenously on day 15, and then every 2 weeks; and level −1 with sunitinib 37.5 mg on the first 14 days (induction) and then 25 mg per day plus nivolumab on the same schedule. The primary endpoint was to determine the recommended dose for phase II (phase I) and the 6-month progression-free survival rate, according to Response Evaluation Criteria in Solid Tumors 1.1 (phase II).ResultsFrom May 2017 to April 2019, 68 patients were enrolled: 16 in phase Ib and 52 in phase II. The recommended dose of sunitinib for phase II was 37.5 mg as induction and then 25 mg in combination with nivolumab. After a median follow-up of 17 months (4–26), the 6-month progression-free survival rate was 48% (95% CI 41% to 55%). The most common grade 3–4 adverse events included transaminitis (17.3%) and neutropenia (11.5%).ConclusionsSunitinib plus nivolumab is an active scheme with manageable toxicity in the treatment of selected patients with advanced soft tissue sarcoma, with almost half of patients free of progression at 6 months.Trial registration numberNCT03277924.

Efficacy and safety of regorafenib in Korean patients with advanced gastrointestinal stromal tumor after failure of imatinib and sunitinib: A multicenter study based on the management access program.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 175-175
Author(s):  
Myoung Kyun Son ◽  
Min-Hee Ryu ◽  
Joon Oh Park ◽  
Seock-Ah Im ◽  
Baek-Yeol Ryoo ◽  
...  
Keyword(s):  
Skin Reaction ◽  
Rest Period ◽  
Progression Free Survival ◽  
Abdominal Distension ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Hand Foot Skin Reaction ◽  
Grade 3 ◽  
Clinical Records ◽  
Advanced Gist

175 Background: GRID phase III trial showed that regorafenib improves progression free survival (PFS) in patients (pts) with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib. This study aims to confirm the efficacy and safety of regorafenib for advanced GIST in Korean pts. Methods: Clinical records were reviewed from 57 Korean pts with advanced GIST who failed both imatinib and sunitinib and were treated with regorafenib under MAP between December 2012 and November 2013. Pts received regorafenib 160mg p.o. once daily in a 3 weeks on/1 week off schedule, every 4 weeks until intolerable toxicities or disease progression with no benefit by physician’s discretion. Results: Out of total 57 pts, none achieved a complete or a partial response whereas 25 pts (44%) showed stable disease for ≥ 12 weeks. With a median follow-up of 8.6 months (range, 0.2-15.3), median PFS and overall survival (OS) were 4.5 months (95% CI, 3.8-5.3) and 12.2 months (95% CI, 10.1-14.3), respectively. Interestingly, 15 patients (26%) experienced an exacerbation of cancer-related symptoms (abdominal pain in 8 and abdominal distension in 5) during the rest period of regorafenib, which were reduced with resumption of regorafenib. The most common grade 3 or 4 adverse events were hand-foot skin reaction (25%), hypertension (7%), and skin rash (7%). The dose of regorafenib was reduced in 44 patients (77%) because of toxicities, mainly due to hand-foot skin reaction (n=31). There was no treatment-related death. Conclusions: We could confirm the efficacy and safety ofregorafenib for advanced GIST after failure of imatinib and sunitinib reported in GRID trial in Korean pts. Considering exacerbation of cancer-related symptoms during rest periods, continuous dosing schedule of regorafenib needs to be explored in future clinical trials.

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