Electrochemotherapy Treatment of Locally Advanced and Metastatic Soft Tissue Sarcomas: Results of a Non-Comparative Phase II Study View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2013-10-30

AUTHORS

Luca G. Campana, Giuseppe Bianchi, Simone Mocellin, Sara Valpione, Laura Campanacci, Antonella Brunello, Davide Donati, Elisabetta Sieni, Carlo R. Rossi

ABSTRACT

AimsOur aim was to evaluate the activity, toxicity, and feasibility of electrochemotherapy (ECT) in patients with soft-tissue sarcomas (STS).MethodsA two-stage phase II trial was conducted between October 2006 and March 2012. Patients (N = 34) with locally advanced or metastatic STS, unsuitable for standard oncological treatments and with maximum 3-cm deep tumors, received an intravenous bolus of bleomycin (15,000 IU/m2), followed by tumor electroporation according to the European Standard Operating Procedures of ECT. Outcome measures included local response according to response evaluation criteria in solid tumors (RECIST), toxicity and tumor control. Feasibility measures included the accuracy of electrode placement and the intensity of electric current flowing in tumor tissue.ResultsMedian tumor size was 4.0 cm (range 2–12). Objective response, assessed on 71 target lesions, was 92.2 % (complete 32.3, 95 % CI 28–64). A total of 15 patients received up to four cycles due to incomplete response, but re-treatment did not significantly improve outcome (p = 0.205). After a median follow-up of 19.3 months, 2-year local control rate was 72.5 %. Median time to local failure (N = 11 patients) was 5.1 months. Tumor response (p = 0.041) and control (p = 0.047) correlated with histological grading. Relevant toxicity consisted of G3 skin ulceration and soft tissue necrosis (35 and 23 % of patients, respectively), although this was manageable on an outpatient basis. The accuracy of electrode placement was 47.1 %, and the adequacy of electroporative current 85.3 %.ConclusionsECT may represent an active and safe treatment to achieve local control in advanced STS patients with symptomatic disease. Future research challenges include the improvement of electrode placement and voltage delivery together with the containment of soft tissue toxicity. More... »

PAGES

813-822

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00268-013-2321-1

DOI

http://dx.doi.org/10.1007/s00268-013-2321-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1038490036

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24170155


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35 schema:description AimsOur aim was to evaluate the activity, toxicity, and feasibility of electrochemotherapy (ECT) in patients with soft-tissue sarcomas (STS).MethodsA two-stage phase II trial was conducted between October 2006 and March 2012. Patients (N = 34) with locally advanced or metastatic STS, unsuitable for standard oncological treatments and with maximum 3-cm deep tumors, received an intravenous bolus of bleomycin (15,000 IU/m2), followed by tumor electroporation according to the European Standard Operating Procedures of ECT. Outcome measures included local response according to response evaluation criteria in solid tumors (RECIST), toxicity and tumor control. Feasibility measures included the accuracy of electrode placement and the intensity of electric current flowing in tumor tissue.ResultsMedian tumor size was 4.0 cm (range 2–12). Objective response, assessed on 71 target lesions, was 92.2 % (complete 32.3, 95 % CI 28–64). A total of 15 patients received up to four cycles due to incomplete response, but re-treatment did not significantly improve outcome (p = 0.205). After a median follow-up of 19.3 months, 2-year local control rate was 72.5 %. Median time to local failure (N = 11 patients) was 5.1 months. Tumor response (p = 0.041) and control (p = 0.047) correlated with histological grading. Relevant toxicity consisted of G3 skin ulceration and soft tissue necrosis (35 and 23 % of patients, respectively), although this was manageable on an outpatient basis. The accuracy of electrode placement was 47.1 %, and the adequacy of electroporative current 85.3 %.ConclusionsECT may represent an active and safe treatment to achieve local control in advanced STS patients with symptomatic disease. Future research challenges include the improvement of electrode placement and voltage delivery together with the containment of soft tissue toxicity.
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41 schema:keywords AimsOur aim
42 ConclusionsECT
43 European Standard Operating Procedures
44 II study
45 II trial
46 Response Evaluation Criteria
47 ResultsMedian tumor size
48 STS patients
49 accuracy
50 activity
51 adequacy
52 advanced STS patients
53 aim
54 basis
55 bleomycin
56 bolus
57 challenges
58 containment
59 control
60 control rate
61 criteria
62 cycle
63 deep tumors
64 delivery
65 disease
66 electrochemotherapy
67 electrochemotherapy treatment
68 electrode placement
69 electroporation
70 evaluation criteria
71 failure
72 feasibility
73 feasibility measures
74 feasibility of electrochemotherapy
75 future research challenges
76 grading
77 histological grading
78 improvement
79 incomplete response
80 intensity
81 intravenous bolus
82 lesions
83 local control
84 local control rate
85 local failure
86 local response
87 measures
88 median time
89 metastatic soft tissue sarcoma
90 months
91 necrosis
92 non-comparative phase II study
93 objective response
94 oncological treatment
95 operating procedures
96 outcome measures
97 outcomes
98 outpatient basis
99 patients
100 phase II study
101 phase II trial
102 placement
103 procedure
104 rate
105 relevant toxicity
106 research challenges
107 response
108 results
109 safe treatment
110 sarcoma
111 size
112 skin ulceration
113 soft tissue necrosis
114 soft tissue sarcomas
115 soft tissue toxicity
116 solid tumors
117 standard oncological treatment
118 standard operating procedures
119 study
120 symptomatic disease
121 target lesions
122 time
123 tissue
124 tissue necrosis
125 tissue sarcomas
126 tissue toxicity
127 total
128 toxicity
129 treatment
130 trials
131 tumor control
132 tumor electroporation
133 tumor response
134 tumor size
135 tumor tissue
136 tumors
137 two-stage phase II trial
138 ulceration
139 voltage delivery
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