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Authors: Dr. Sunil Verma Date posted: June 22 nd , 2009

Efficacy of BSI-201, a PARP-Inhibitor in combination with Gemcitabine/Carboplatin in Triple Negative Breast Cancer: Randomized Phase II trial Presented by Dr. Joyce O’Shaughnessey. Authors: Dr. Sunil Verma Date posted: June 22 nd , 2009. Background.

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Authors: Dr. Sunil Verma Date posted: June 22 nd , 2009

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  1. Efficacy of BSI-201, a PARP-Inhibitor in combination with Gemcitabine/Carboplatin in Triple Negative Breast Cancer: Randomized Phase II trialPresented by Dr. Joyce O’Shaughnessey Authors: Dr. Sunil Verma Date posted: June 22nd, 2009

  2. Background • Triple Negative (TN) disease represents the next frontier in Breast Cancer • TN disease shares key features with Basal-like and BRCA associated cancer • BRCA dysfunction • Susceptibility to DNA damaging agents • In the setting of BRCA dysfunction, the cancer cell increasingly relies on PARP for DNA repair process • This may represent an important therapeutic target

  3. Treatment A: Gemcitabine +Carboplatin R Treatment B: Gemcitabine + Carboplatin + BSI-201 (a PARP – inhibitor) Triple Negative MBC

  4. RESULTS

  5. STUDY COMMENTARY • This is an important study as it shows that the addition of PARP-inhibitors to chemotherapy improves the outcome for TN MBC • This is the first Phase II trial evaluating this class of drugs in MBC • There is a planned Phase III trial designed to evaluate BSI-201 in combination with carboplatin+gemcitabine • There are some unanswered questions related to this class of drugs: • - Do PARP-Inhibitors need DNA damaging stimulus? • -Will they be effective in a broader subgroup of patients? • TN • Non-TN • - What are the long-term toxicities associated with these agents? • ? Increase risk of tumorogenesis • - Oral vs. IV

  6. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Triple Negative Breast Cancer is associated with poor prognosis and represents an aggressive phenotype of breast cancer. • Majority of TN disease is associated with basal-like profile. Furthermore, basal-like breast cancer shares a number of features associated with BRCA related cancers • TN breast cancer may particularly be sensitive to DNA damaging agents including Cisplatin and PARP inhibitors • This study suggests that PARP inhibitors are efficacious for TN MBC • While the results from this Phase II trial are impressive, there are still a number of unanswered questions and future trials evaluating PARP-inhibitors will help establish the magnitude of benefit and their role for early stage and advanced TN breast cancer

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