Four Versus Six Cycles of Pemetrexed/Platinum for MPM
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The prognosis of mesothelioma is generally poor. The median survival of patients with
unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is
poor because there is no curative treatment.
Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality
treatment regimens have been reported to prolong survival. Other new therapeutic approaches
include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and
photodynamic therapy, but the results have not yet been completely validated. Even with the
introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean
survival of 12 months. The current standard of care for unresectable malignant pleural
mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a study
including 448 patients from 19 countries which was the largest trial to date among patients
suffering from malignant mesothelioma. Results showed statistically significant increase in
overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for
cisplatin alone. In addition, there was an improvement in lung function (forced vital
capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.
Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in
malignant mesothelioma and there are no approved predictive markers for response.
Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable
toxicity and so we need to rationalize its use in our Egyptian patients.
Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of
pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for
response.