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Farmas USA

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#50482

Re: Farmas USA

culpa Mia ......
thld

#50484

Re: Farmas USA

recordatorio

©American Society of Clinical Oncology
Phase II Study of the Safety and Antitumor Activity of the Hypoxia-Activated Prodrug TH-302 in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma
Sant P. Chawla⇑, Lee D. Cranmer, Brian A. Van Tine, Damon R. Reed, Scott H. Okuno, James E. Butrynski, Douglas R. Adkins, Andrew E. Hendifar, Stew Kroll and Kristen N. Ganjoo
+ Author Affiliations

Sant P. Chawla, Sarcoma Oncology Center, Santa Monica; Andrew E. Hendifar, Cedars Sinai Medical Center, Los Angeles; Stew Kroll, Threshold Pharmaceuticals, South San Francisco; Kristen N. Ganjoo, Stanford University Medical Center, Stanford, CA; Lee D. Cranmer, University of Arizona Cancer Center, Tucson, AZ; Brian A. Van Tine and Douglas R. Adkins, Washington University in St Louis, St Louis, MO; Damon R. Reed, Moffitt Cancer Center and Research Institute, Tampa, FL; Scott H. Okuno, Mayo Clinic, Rochester, MN; and James E. Butrynski, Dana-Farber Cancer Institute, Boston, MA.
Corresponding author: Sant P. Chawla, MD, FRACP, Sarcoma Oncology Center, 2811 Wilshire Blvd, Suite 414, Santa Monica, CA 90403; e-mail: [email protected].
Abstract

Purpose TH-302, a prodrug of the cytotoxic alkylating agent bromo-isophosphoramide mustard, is preferentially activated in hypoxic conditions. This phase II study investigated TH-302 in combination with doxorubicin, followed by single-agent TH-302 maintenance therapy in patients with first-line advanced soft tissue sarcoma (STS) to assess progression-free survival (PFS), response rate, overall survival, safety, and tolerability.

Patients and Methods In this open-label phase II study, TH-302 300 mg/m2 was administered intravenously on days 1 and 8 with doxorubicin 75 mg/m2 on day 1 of each 21-day cycle. After six cycles, patients with stable and/or responding disease could receive maintenance monotherapy with TH-302.

Results Ninety-one patients initiated TH-302 plus doxorubicin induction treatment. The PFS rate at 6 months (primary efficacy measure) was 58% (95% CI, 46% to 68%). Median PFS was 6.5 months (95% CI, 5.8 to 7.7 months); median overall survival was 21.5 months (95% CI, 16.0 to 26.2 months). Best tumor responses were complete response (n = 2 [2%]) and partial response (n = 30 [34%]). During TH-302 maintenance (n = 48), five patients improved from stable disease to partial response, and one patient improved from partial to complete response. The most common adverse events during induction were fatigue, nausea, and skin and/or mucosal toxicities as well as anemia, thrombocytopenia, and neutropenia. These were less severe and less frequent during maintenance. There was no evidence of TH-302–related hepatic, renal, or cardiac toxicity.

Conclusion PFS, overall survival, and tumor response compared favorably with historical outcomes achieved with other first-line chemotherapies for advanced STS. A phase III study of TH-302 is ongoing (NCT01440088).

#50485

Re: Farmas USA

Pero cuantas acciones tiene este tío???

#50486

Re: Farmas USA

Que va, te debo una por ayudarme ha analizarla ;-))

ACHN

#50487

Re: Farmas USA

ACTC
Ana pero este Lanza lleva lanzando papel al mercado hace ya varias sesiones, sera que se va a comprar un yate.? Ese dato q nos das confirma mi teoria conspiranoide, joooerr el bajon que le van a meter, al final parece que corto es ahora por estos niveles una probable buena opcion. -Bendita volatilidad SEA BIENVENIDA, para hacer pasta

#50488

Re: Farmas USA

Me alegra que estemos en las dos, que por cierto están a un precio similar. Por poner un precio, cual de ellas llegará antes a 8? :))

THLD++NVAX