Stellar Trial Mesothelioma, Novel Mesothelioma Treatment Closer To Fda Approval

In vitro human mesothelioma cells were highly susceptible to ttfields.

Lol dolls pictures to colour in. We read with great interest the paper by giovanni ceresoli and colleagues on the stellar study 1 a single arm phase 2 study investigating tumour treating fields ttfields in addition to standard first line chemotherapy platinumpemetrexed in malignant pleural mesothelioma. This new and innovative approach in malignant pleural mesothelioma has received us food and drug administration. Stellar was a prospective multicenter single arm phase 2 study designed to study the safety and efficacy of optune lua and pemetrexed cisplatin or carboplatin first line in patients with unresectable locally advanced or metastatic malignant pleural mesothelioma mpm.

The trial accrued 80 patients with unresectable previously untreated mesothelioma. All 80 study participants had mesothelioma that was unresectable meaning they were not candidates for surgery. Patients were treated with continuous 150 khz ttfields 18hday in combination with pemetrexed and cisplatin or carboplatin.

The device administers ttfields to patients concomitantly to the best. 53 patients had epithelioid mesothelioma and 21 patients had non epithelioid cell types. Ma1206 stellar final results of a phase 2 trial of ttfields with chemotherapy for first line treatment of malignant pleural mesothelioma.

It is designed to test the efficacy and safety of a medical device the novottf 100l system in patients with malignant pleural mesothelioma when the device is combined with chemotherapy for mesothelioma. The stellar trial also known as the ef 23 trial is a pilot analogous to drug phase ii single arm trial. The primary endpoint was overall survival os.

Stellar was a phase 2 prospective pivotal single arm study 15. 45 not written in the stars yet the stellar trial reported a median os primary endpoint of 182 months 95 ci 121 258. Ttfields have been shown to extend survival of patients with glioblastoma when added to chemotherapy.

Tumor treating fields is not approved by the fda for use in patients with malignant pleural mesothelioma. Response rates were similar to the ones reported for the current standard of care treatment but lasted longer with the addition of ttfields. Stellar was a prospective single arm phase 2 trial done at 12 european academic and non academic sites five in italy three in poland one in france one in belgium one in spain and one in the netherlands for treatment naive patients with histologically confirmed unresectable malignant pleural mesothelioma.

Inclusion criteria included ecog ps of 0 1 and pathologically proven mesothelioma. The stellar study met its primary endpoint of significant survival extension for previously untreated mesothelioma patients. The stellar trial was used to test the effectiveness of novottf 100l in treating patients with malignant pleural mesothelioma in particular.