Author of

• 10743

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  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10796

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    P1.10-053 - Sodiumselenite as a treatment against cancer. A phase I study. (ID 3233)

    09:30 - 09:30  |  Author(s): M. Björnstedt
    • Abstract

    Background
    Selenite is a trace element, necessary in doses of 40 – 200 microg/day. In these doses it has a reducing, detoxifying effect. However, in human cell-lines in much higher doses, it becomes toxic resulting in apoptosis. Most malignant cell-lines are significantly more sensitive than benignant ones. This indicates that there might be a therapeutic index, so we have started a clinical study.

    Methods
    This phase I study, the SECAR study has the purpose to find the maximal tolerable dose (MTD) of sodiumselenite. Patients with progressing malignant disease, mainly lung cancer, already treated with established drugs, were included. Treatment was given iv once daily 10 times during 2 weeks. According to a fixed schedule doses were escalated for each new cohort of 3 patients. If a serious adverse event (SAE) was observed 3 more patients were included. If 3/6 patients had an SAE, this dose level was considered too high and MTD was defined as the nearest lower dose.

    Results
    After 34 patients MTD has been defined to 10.2 mg/m2. Half life is 10 – 16 hours. The most common toxicity was sickness, vomiting and fatigue. However, at higher doses confusion and hallucinations were observed, and the most alarming toxicity was signs of heart ischemia and dyspnea with chock. One patient had a complete remission, but in the rest stable disease and very limited tumour shrinkage was observed at best. Tumour reevaluation is ongoing.

    Conclusion
    We now have defined the MTD for sodiumselenite. However, we also have got pharmacokinetic data indicating that treatment might probably be optimized. Antitumoural effect has been observed, so the SECAR study will go on at first with an altered treatment schedule.