Optune

Property	Information
Drug Name	Optune (Optune Gio® for newer version)
FDA Approval	Approved for newly diagnosed glioblastoma in October 2015; ongoing trials for broader applications
Used for	Newly diagnosed glioblastoma, with trials for other cancers ongoing
Clinical Trial Phase	Phase 3 (EF-14 Trial); Phase 3 TRIDENT trial ongoing
Clinical Trial Explanation	Not specified
Common Side Effects	Mild to moderate skin irritation beneath transducer arrays, thrombocytopenia, nausea, constipation, vomiting, fatigue, headache, convulsions, depression
OS without	16 months (control group in EF-14 Trial)
OS with	20.9 months (Optune plus temozolomide, final EF-14 analysis)
PFS without	4 months (control group in EF-14 Trial)
PFS with	7.1 months (Optune arm in EF-14 Trial); 6.7 months from diagnosis in updated analysis
Usefulness Rating	5
Usefulness Explanation	Not specified
Toxicity Level	2
Toxicity Explanation	Most common adverse reaction is skin irritation at the device contact points; no increase in systemic adverse events

Notes: Optune's significance is underscored by its addition to standard care for glioblastoma, showing remarkable survival benefits. It exemplifies the potential for non-invasive therapies in treating aggressive cancers, suggesting a paradigm shift in oncological treatments.

From Ben Williams Book: Optune, now including Optune Gio® as its latest version, has shown significant survival benefits for newly diagnosed glioblastoma patients, especially when used in combination with temozolomide. It has been a part of a landmark phase 3 trial (EF-14) that demonstrated a considerable extension in both overall survival and progression-free survival. An ongoing TRIDENT trial is further investigating its efficacy in conjunction with radiation therapy and temozolomide from the onset of treatment. Optune represents a shift towards non-invasive cancer treatment modalities with reduced systemic toxicity and improved quality of life for patients.Property "Has original text" (as page type) with input value "Optune, now including Optune Gio® as its latest version, has shown significant survival benefits for newly diagnosed glioblastoma patients, especially when used in combination with temozolomide. It has been a part of a landmark phase 3 trial (EF-14) that demonstrated a considerable extension in both overall survival and progression-free survival. An ongoing TRIDENT trial is further investigating its efficacy in conjunction with radiation therapy and temozolomide from the onset of treatment. Optune represents a shift towards non-invasive cancer treatment modalities with reduced systemic toxicity and improved quality of life for patients." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.

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