Monthly Archives: January 2016

Particle beam radiotherapy is to be used under national insurance from April 2016 for pediatric cancer and bone soft tissue tumor patients

Central Social Insurance Medical Council, an advisory body for Ministry of Health, Labour and Welfare decided on January 20 to apply particle beam radiotherapy under national insurance coverage to the following patient therapies: ion bean radiotherapy for pediatric cancer and for bone soft tissue tumors in bones and muscles that are difficult to be operated by surgery. A therapy called “blood patch” for headaches caused by losing cerebrospinal fluid after automobile and other accidents is also to get national insurance coverage. Both procedures will begin from April 2016.

Particle beam radiotherapy is a treatment to attack cancer cells by using beams of energetic protons, neutrons, or positive ions for cancer treatment. It used to be assigned as an advance medical care and only the necessary medical examination and hospitalization costs were covered by national insurance. It costs three million yen if patients have to pay by themselves. The monetary burden for the patients will be significantly reduced by this insurance application.

Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma

The following is an article appeared on the Journal of Clinical Oncology:

 Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial

 George D. Demetri, Margaret von Mehren, Robin L. Jones, Martee L. Hensley, Scott M. Schuetze, Arthur Staddon, Mohammed Milhem, Anthony Elias, Kristen Ganjoo, Hussein Tawbi, Brian A. Van Tine, Alexander Spira, Andrew Dean, Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, Trilok V. Parekh, Robert G. Maki and  Shreyaskumar R. Patel

Abstract

Purpose This multicenter study, to our knowledge, is the first phase III trial to compare trabectedin versus dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior therapy with an anthracycline and at least one additional systemic regimen.

Patients and Methods Patients were randomly assigned in a 2:1 ratio to receive trabectedin or dacarbazine intravenously every 3 weeks. The primary end point was overall survival (OS), secondary end points were disease control—progression-free survival (PFS), time to progression, objective response rate, and duration of response—as well as safety and patient-reported symptom scoring.

Results A total of 518 patients were enrolled and randomly assigned to either trabectedin (n = 345) or dacarbazine (n = 173). In the final analysis of PFS, trabectedin administration resulted in a 45% reduction in the risk of disease progression or death compared with dacarbazine (median PFS for trabectedin v dacarbazine, 4.2 v 1.5 months; hazard ratio, 0.55; P < .001); benefits were observed across all preplanned subgroup analyses. The interim analysis of OS (64% censored) demonstrated a 13% reduction in risk of death in the trabectedin arm compared with dacarbazine (median OS for trabectedin v dacarbazine, 12.4 v 12.9 months; hazard ratio, 0.87; P = .37). The safety profiles were consistent with the well-characterized toxicities of both agents, and the most common grade 3 to 4 adverse effects were myelosuppression and transient elevation of transaminases in the trabectedin arm.

Conclusion Trabectedin demonstrates superior disease control versus conventional dacarbazine in patients who have advanced liposarcoma and leiomyosarcoma after they experience failure of prior chemotherapy. Because disease control in advanced sarcomas is a clinically relevant end point, this study supports the activity of trabectedin for patients with these malignancies.