1 Choosing a Clinical Trial for Advanced Mesothelioma RN Taub (Onc) J Chabot (Surg) A Borczuk (Path) J Sonnet (Surg) M Kluger (Surg) R Fawwaz (Nuc. Med) E Hare (Onc) Columbia University Mesothelioma Center
2 Many mesothelioma patients are helped by drugs but not all
3 Empowering the patient INFORMATION: Internet, books, Journals MARF Other patients BIOLOGY: Histology Stage Imaging Biomarkers PERSONAL: Past medical Hx, Current illnesses Biological Age Partnership with YOUR DOCTOR PSYCHSOCIAL SUPPORT: Family Peers Friends Professionals AVAILABLE TREATMENTS: Conventional: Surgery Pemetrexed/Cisplatin CLINIAL TRIALS Phase I, Phase II, Phase III
4 What Kind of Mesothelioma Do I Have? Epithelioid Biphasic/Sarcomatoid
5 What other Illnesses Do I Have? Prior Heart disease makes Surgery Risky. Prior Smoking or Lung Disease makes it difficult to tolerate lung surgery.. Prior Diabetes or Kidney disease makes it difficult to tolerate Platinum and other chemotherapy drugs..
6 Mesothelioma confined to pleural surfaces of right lung. Chest wall Diseased Lung Normal Left Lung, Pleura Mesothelioma CT Scan - Mesothelioma
7 Extrapleural Pneumonectomy 1. Incision 2. Pleurectomy 3. Pericardium 4. Diaphragm 5. Reconstruction 6. Postop Cavity 7. Removed Specimen Lung
8 Laparotomy, Omentectomy, Cytoreduction, Intraperitoneal Catheters for Abdominal Mesothelioma Omentum Laparotomy Omentum removed, Margin sutured Bilateral Mediport-attached Intraperitoneal catheters
9 Which shall I choose? Conventional: Pemetrexed/ Platinum: ~40% Gemcitabine/ Platinum: ~25% Navelbine, Mitomycin, others: <15% Experimental: Phase III: SAHA Phase II: Bortezomib,/platinum Targeted agents Others Phase I: frequent arrival of new drugs.
10 CONTROLLED CLINICAL TRIAL PHASES Phase I Finding the dose of drug that can be given safely to patients. (Increasing doses to 3 pts at a time).
11 CONTROLLED CLINICAL TRIAL PHASES Phase II Testing a given drug for its safety and effectiveness against a given cancer, (in 20% or more of patients).
12 CONTROLLED CLINICAL TRIAL PHASES Phase III- Assessing drug effectiveness against standard treatment. (Strongest evidence, fewest number of trials)
13 RECOMMENDATIONS FOR NEWLY DIAGNOSED PATIENTS CHOOSING A CLINICAL TRIAL Phase III trials are best but are rare in Mesothelioma. The Initial choice should be a Phase II trial with solid preliminary data. Pharmaceutical companies prefer to try drugs in previously untreated patients. Best not to believe everything you are told about the promise of a drug. Most Phase II drugs are eventually discarded. Don t believe everything you are told
14 RECOMMENDATIONS FOR NEWLY DIAGNOSED PATIENTS CHOOSING A CLINICAL TRIAL If a Phase II drug is not available go with conventional FDA-approved drugs that have been shown to work. If those drugs are exhausted, the options include no further treatment, or volunteering (sic) for a Phase I clinical trial. OR OR
15 Multimodal team treatment is key
16 Fear-driven urges impede decision-making
17 Old vs young patients have different medical needs
18 Doctors treating mesothelioma must keep our patients fully informed so that they may function as normally as possible, and we can together await the development and arrival of the definitive pill that will make the disease go away forever