Study in Lancet Oncology sheds light on YONDELIS prolonged therapy in soft-tissue sarcoma . El Tratamiento con Yondelis puede prolongarse más alla de los 6 ciclos .. como Terapia de Mantenimiento .

Study in Lancet Oncology sheds light on YONDELIS prolonged therapy in soft-tissue sarcoma .

Madrid, February 2015 .

*.- The results suggest not including a drug holiday in patients with advanced soft-tissue sarcoma (STS) who benefit from trabectedin in terms of tumor control after six cycles of treatment .

*.- The safety profile was the same in both groups and as expected for patients treated with trabectedin .

PharmaMar announced that The Lancet Oncology published online the results from a final analysis of a randomized phase 2 trial study which found that treatment continuation with trabectedin in advanced STS patients who have not progressed after six cycles of treatment increases PFS (NCT01303096 clinical trials.gov) . The data indicate that continued treatment may be recommended for these patients, who received doxorubicin-based chemotherapy and are eligible for trabectedin, until treatment intolerance or disease given the acceptable and manageable safety profile and lack of cumulative toxicity of trabectedin .

"In the clinic, whether trabectedin should be given after six cycles in patients with advanced soft-tissue sarcoma who have not progressed during treatment was not clear, and the results of our study supports the maintenance of this therapy to achieve longer progression-free survival", points outt lead investigator of the clinical study Nicolas Penel, MD, PhD, Department of Medical Oncology, Centre Oscar Lambret, France.

The study carried out at 14 centers of the French Sarcoma Group included 178 patients with advanced STS who were treated with six cycles of trabectedin (given at a dose of 1.5 mg/m2 for 24 hours every 3 weeks). Of the 91 patients who were free of progression at the end of the treatment, 53 were then randomly assigned to continuously receive trabectedin or to drug interruption (although patients allocated to this group were allowed to restart trabectedin in case of progressive disease). The first clinical endpoint of the study was PFS after 6 months of the randomization, which was achieved by 51.9% of the patients in the continuation group versus 23.1% in the interruption group. When the PFS was measured at 12 months after randomization, a greater portion of patients in the continuation group were also progression-free compared to those who were not receiving trabectedin (33.3% versus 15.4%). This improvement in survival without progression was also supported by an increased in the median PFS, which was 7.2 months (95% CI 4.0-12.7) in the continuation group and 4.0 months (95% CI 2.5-5.5) in the interruption group.

The study also showed how continuation of treatment with trabectedin in these patients was not associated with an increase in toxicity, suggesting that the safety profile of trabectedin is maintained after more than six cycles of treatment, and that this is accompanied by an improved PFS. Patients in the continuation group received a median of 11 cycles of trabectedin in total at the cutoff date, and two patients are still on treatment.

Although the study has its limitations as it was a non-comparative phase 2 trial, the investigators underscore that more than half of the patients in this setting treated with trabectedin were free of progression after six cycles of treatment and that early interruption of the drug results in worse PFS. This study adds to the results obtained in two randomized phase 2 trials in patients with several different subtypes of STS , indicating the value of trabectedin treatment in terms of progression-free survival, and sheds light on the role of maintenance therapy in patients who benefit from trabectedin after six cycles of treatment.

U.S. Food and Drug Administration . New and Generic Drug Approvals . Cisplatin ( Post by Celtia ) .

February 26, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type

* Binosto alendronate sodium Tablet, Effervescent;Oral Mission Pharma Labeling Revision
* Cisplatin cisplatin Injectable;Injection Hq Spclt Pharma Labeling Revision
* Firmagon degarelix acetate Powder;Subcutaneous Ferring Labeling Revision
* Kynamro mipomersen sodium Solution;Subcutaneous Genzyme Corp Labeling Revision
*.Neupro rotigotine Film, Extended Release;Transdermal Ucb Inc Labeling Revision
* Pediatric Advil ibuprofen Suspension/Drops;Oral Pfizer Manufacturing Change or Addition
* Platinol cisplatin Injectable;Injection Hq Spclt Pharma Labeling Revision
* Platinol-Aq cisplatin Injectable;Injection Hq Spclt Pharma Labeling Revision
* Prolia denosumab Injectable; Subcutaneous Amgen Labeling Revision
* Reyataz atazanavir sulfate Capsule;Oral Bristol Myers Squibb Labeling Revision
* Suprane desflurane Liquid;Inhalation Baxter Hlthcare Labeling Revision
* Torisel temsirolimus Solution;Intravenous Pf Prism Cv Labeling Revision
* Xgeva denosumab Injectable; Subcutaneous Amgen Labeling Revision

El consumo de Estatinas podría reducir el riesgo de sufrir Cáncer de Hígado .

PUBLICADO EN 'JNCI' /// En enfermos hepáticos o con diabetes, el efecto sería más potente.

CF | 28/02/2015 .