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Malignant Mesothelioma

Malignant Mesothelioma. Mesothelioma is an insidious neoplasm arising from the mesothelial surfaces of the pleural and peritoneal cavities, the tunica vaginalis, or the pericardium . Mesothelioma Causes. The vast majority of mesothelioma cases are attributed to asbestos exposure.

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Malignant Mesothelioma

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  1. Malignant Mesothelioma Mesothelioma is an insidious neoplasm arising from the mesothelial surfaces of the pleural and peritoneal cavities, the tunica vaginalis, or the pericardium.

  2. Mesothelioma Causes • The vast majority of mesothelioma cases are attributed to asbestos exposure. • Less common causes of mesothelioma include: • Radiation therapy • Erionite fibers (genetic susceptibility) • Collapsotherapy (the induction of artificial pneumothorax or pneumoperitoneum for treatment of tuberculosis) • The DNA tumor virus SV40

  3. Mesothelioma Industries with High Incidence of Mesothelioma • Construction (carpenters, plumbers, electricians, insulators) • Ship and boat building • Manufacture of cement products • Manufacture of non-metallic mineral products (including asbestos) • Glass products manufacturing • Generation of electricity • Brick and ceramic products manufacturing • McDonald etal,2001

  4. Observed (to 1989) and predicted (1990-2029) annual no. of pleural cancer deaths in men in Western Europe. From: J. Peto et al. Br. J. Cancer 79: 666-672 (1999)

  5. Absolute frequency of MM, recorded at NCI, Cairo and Abbassia chest hospital Relative frequency of MPM, NCI hospital-based registry Alyeldin etal,MOG ,Alex,2004

  6. Lancet vol 366, July 30 ,2005Robinson etalMalignant mesotheliomaNo chemotherapy regimen for mesothelioma has proven curative , but several regimes are valuable for palliation. These treatments not only decrease tumor burden but also improve symptoms such as pain, breathlessness and chest wall masses.Untill 5 years ago, comprehensive reviews of chemotherapy and mesothelioma were unable to recommend any particular therapy as a standard of care because of the low RR. Two therapeutic regimens have since proven to be of value.

  7. In patients with good PS, we consider the standard of care for 1st line palliative chemotherapy to be Pemetrexed + Cisplatin. There is no 2ndline chemotherapy that could be considered as standard of care at present but the most commonly used regimen is Gemcitabine and cisplatin.Robinson etal,2005

  8. ALIMTA Reduced polyglutamates Folate Carrier Mechanism of Action of ALIMTA TS DHFR FPGS ALIMTA GARFT AICARFT Outer Membrane Cell Membrane Inner Membrane C-1 THF Synthetase

  9. Cisplatin+/- PemetrexedVogelzang etal,JCO 21: 2636, 2003 D1 Q 21 days: • Cisplatin 75 mg/m2 +/- • Pemetrexed 500mg/m2 Dexametazone 4mg POBID Eligibility: measurable pleural mesothelioma, PS ≥70, adequate organ function, Creat. Clear. ≥45ml/mn, no prior chemo therapy. Total number of cases= 456 Number for final analysis = 448 Phase III trial

  10. Conclusion

  11. Conclusion

  12. Protocol Overview H3E-US-JMFE Open-Label Study of ALIMTA (pemetrexed) alone or in Combination with Cisplatin for Patients with Malignant Mesothelioma NCI, CAIRO

  13. Primary Objective • To provide for the treatment of patients with malignant mesothelioma. Patient access to ALIMTA will be provided under this protocol prior to and during its review by Regulatory Agencies for commercial release. • Collection of further basic safety data • Determination of the best overall tumor response Secondary Objectives

  14. Baseline Patient Characteristics (N=34)

  15. Baseline Disease Characteristics (N=34)

  16. Efficacy Results (N=32)

  17. NCI-CTC Toxicities (N=34) Can list Grade 1 - 4 if known or list as 3/4

  18. FDA Approves Alimta-Cisplatin Combination for Treatment of Asbestos-Related Cancer February 05, 2004

  19. Conclusions Pemetrexed with or without cisplatin proved to be safe and effective in the treatment of advanced malignant mesothelioma. Pemetrexed/Cisplatinum is now the standard therapy in malignant mesothelioma against which other doublets will be compared Trials are now investigating the role of Pemetrexed/Cisplatinum prior to surgical resection

  20. A phase II feasibility trial of induction chemotherapy followed by extrapleural pneumonectomy and postoperative radiotherapy in patients with malignant pleural mesothelioma EORTC Protocol 08031 Study coordinator: Paul E. Van Schil

  21. Serum mesothelin-related protein (SMRP) formesothelioma diagnosisUntil recently, no reliable serum marker of mesothelioma had been identified. SMRP is the circulating product of mesothelin, a surface protein thought to be important in mesothelial cell adhesion and possibly signalling; it is possibly the protein product of an alternatively spliced variant of mesothelin mRNA. In astudy of 44 mesothelioma patients, 84% had elevated concentrations of SMRP compared with fewer than 2% of patients with other pleural or pulmonary inflammatory or malignant diseases . Thus SMRP had a sensitivity of 84% and specificity approaching 100% compared with other lung tumours or pleural diseases, and a specificity over 80% compared with other people who had been exposed to asbestos. SMRP concentrations parallel disease progression and regression, and, importantly, are elevated in more than 60% of mesothelioma patients at diagnosis. SMRP will probably be used as an adjunct for mesothelioma diagnosis. Robinson etal,2005

  22. Thank you

  23. A M M + + Pretreatment After 4 cycles

  24. A M M Pretreatment After 4 cycles

  25. AMM Pretreatment

  26. AMM After 4 cycles

  27. F M E + + Pretreatment After 2 cycles

  28. F M E + + After 2 cycles Pretreatment

  29. M A + Pretreatment

  30. M A After 4 cycles

  31. M N + + Pretreatment

  32. M N After 2 cycles

  33. M N After 1 year

  34. M N Prettt After 2 cycles + + After 1 year

  35. Pemetrexed-Cisplatin :A New Standard Therapy for Advanced Malignant Mesothelioma Rabab Gaafar,MD Professor Medical OncologyNational Cancer Institute, Cairo University Damascus, June 1-3, 2005

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