Pleural Mesothelioma: clinical records on 11 patients
M.D. Mauro Madarena - Pleural Mesothelioma: clinical records on 11 patients treated with Di Bella's Method - Hospital S.Camillo-Forlanini, Rome
Summary
The purpose of this investigation was to assess the therapeutic efficacy of the oncologic-bio-immune method (Di Bella Method), encoded by Prof. Luigi Di Bella, in patients with Malignant Pleural Mesothelioma in relation to the parameter Median survival and to make a comparison:
- With homogeneous patients treated with standard chemotherapy approach: Cisplatin (Trade/Brand names Platinol, Platinol-AQ and Platin - Side effects) + Epirubicin (Trade name Ellence, Pharmorubicin or Epirubicin Ebewe - Side effects);
- With the results obtained with Pemetrexed (Brand name Alimta - SIde effects) active agent, now considered the treatment of choice in mesothelioma.
Our investigation revealed an average survival of 18,4 months with DBM (Di Bella Method), compared to 9 months with "CDPD + EPI" (Cisplatin + Epirubicin) and 12,1 months with Pemetrexed (see Slide 1 below).
The result is of such interest, to recommend a multicenter trial with numerically significant enrollment in order to check data, which, if confirmed, indicates the MDB as first-line therapy in the treatment of Malignant Pleural Mesothelioma.
In the study were enrolled 27 patients, with confirmed diagnosis histologically and instrumentally of widespread Malignant Pleural Mesothelioma.
The starting treatment MDB group was of 11 patients, the starting treatment group with "CDDP + EPI" was of 16 patients.
Patients treated with MDB have made regular and daily use of prescribed therapy not showing any toxicity, having only and in some cases modest side effects (nausea 35% - meteorism 70% - asthenia 9%) that did not result in discontinuation of treatment. All patients in this group have carried out chemical blood tests every 20-30 days and radiographic checks every 8-12 weeks. There has been recorded one voluntary suspension of the therapy.
The second group performed standard treatment with Cisplatin (50 mg/m^2) and Epirubicin (60 mg/m^2) on day 1 with support for 5-HT3 antagonists, Mannitol and KCl (Potassium chloride); the cycle has been repeated every 28 days until tolerance or progression (900 mg/m^2 as maximum dose of Epirubicin). Out of the 16 patients, 2 discontinued treatment after the second cycle for acute hematologic toxicity grade 3 of the W.H.O. scale (World Health Organization scale, see below), 10 patients discontinued after the third cycle because of progression. 60% have had nausea and/or vomiting during treatment, 35% neuropathy. All patients had blood chemistry checks every 7-10 days and radiographic ones after the third and sixth cycle or in any case after treatment discontinuation.
The Phase III study carried out, although based on a limited sample, seems to indicate a considerable increase of the median survival in patients treated with DBM, accompanied by a better survival at 1 and 2 years, together with a better survival at 1 and 2 years and a lower toxicity.
The framework of these results require data confirmation with a Phase III randomized trial on a larger sample.
It is however noted that the data shows, within the useful therapies for widespread Pleural Mesothelioma, DBM as the first-line therapy in the Survival/tolerance relationship of the treatment.
Translated by: Giovanni Bellotti