scholarly journals Prophylactic Irradiation of Tracts in Patients With Malignant Pleural Mesothelioma: An Open-Label, Multicenter, Phase III Randomized Trial

2019 ◽  
Vol 37 (14) ◽  
pp. 1200-1208 ◽  
Author(s):  
Neil Bayman ◽  
Wiebke Appel ◽  
Linda Ashcroft ◽  
David R. Baldwin ◽  
Andrew Bates ◽  
...  

PURPOSE Prophylactic irradiation to the chest wall after diagnostic or therapeutic procedures in patients with malignant pleural mesothelioma (MPM) has been a widespread practice across Europe, although the efficacy of this treatment is uncertain. In this study, we aimed to determine the efficacy of prophylactic radiotherapy in reducing the incidence of chest wall metastases (CWM) after a procedure in MPM. METHODS After undergoing a chest wall procedure, patients with MPM were randomly assigned to receive prophylactic radiotherapy (within 42 days of the procedure) or no radiotherapy. Open thoracotomies, needle biopsies, and indwelling pleural catheters were excluded. Prophylactic radiotherapy was delivered at a dose of 21 Gy in three fractions over three consecutive working days, using a single electron field adapted to maximize coverage of the tract from skin surface to pleura. The primary outcome was the incidence of CWM within 6 months from random assignment, assessed in the intention-to-treat population. Stratification factors included epithelioid histology and intention to give chemotherapy. RESULTS Between July 30, 2012, and December 12, 2015, 375 patients were recruited from 54 centers and randomly assigned to receive prophylactic radiotherapy (n = 186) or no prophylactic radiotherapy (n = 189). Participants were well matched at baseline. No significant difference was seen in the incidence of CWM at 6 months between the prophylactic radiotherapy and no radiotherapy groups (no. [%]: 6 [3.2] v 10 [5.3], respectively; odds ratio, 0.60; 95% CI, 0.17 to 1.86; P = .44). Skin toxicity was the most common radiotherapy-related adverse event in the prophylactic radiotherapy group, with 96 patients (51.6%) receiving grade 1; 19 (10.2%), grade 2; and 1 (0.5%) grade 3 radiation dermatitis (Common Terminology Criteria for Adverse Events, version 4.0). CONCLUSION There is no role for the routine use of prophylactic irradiation to chest wall procedure sites in patients with MPM.

2014 ◽  
Vol 5 (1) ◽  
pp. 29-36
Author(s):  
R Gaafar ◽  
H Khaled ◽  
Y.A. Sallam ◽  
H Shafik ◽  
F.A. Aboulkassem ◽  
...  

Abstract Purpose: Patients with malignant pleural mesothelioma (MPM) are well known to have poor response to chemotherapy. The aim of this work was to evaluate the efficacy and safety of new chemotherapeutic agents for the treatment of Egyptian MPM patients. Patients and methods: The first study was a non-randomised, open-label trial. It included 34 eligible patients who were assigned to receive either cisplatin–pemetrexed or pemetrexed alone if cisplatin was contraindicated for a maximum of eight cycles. In the second trial, 21 chemo-naive patients with histologically proven advanced MPM were included. They received cisplatin and raltitrexed for a maximum of six cycles. Results: In the first trial, the median age was 43.5 years (range 25–69), partial response (PR) was achieved in 37.5%, stable disease (SD) in 50%. Median time to progression (TTP) and overall survival (OS) were 7 and 14 months, respectively. Survival at 1 year was 64.7%. No toxicity was observed in 17.6% of patients and grade 3–4 toxicity was evident in 11.8% (neutropenia), 8.8% (anaemia) and 2.9% (vomiting and diarrhoea) of patients. In the second trial, median age was 46 years (range 19–71), PR was achieved in 23.2% and one CR was reported. SD was noticed in 61.9% of patients. Median TTP and OS were 6 and 12 months, respectively. Survival at 1 year was 51.6%. Conclusion: Both cisplatin–pemetrexed and cisplatin–raltitrexed are effective and safe regimens in the treatment of MPM.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e18560-e18560
Author(s):  
Emin Tamer Elkiran ◽  
Alper Sevinc ◽  
Hakan Harputluoglu

e18560 Background: Malignant pleural mesothelioma (MPM) is a relatively rare, but aggressive tumor that causes high mortality. The major risk factor involved in the etiology is environmental and occupational exposure to asbestos. The optimal modality of therapy is controversial. Methods: The present study retrospectively evaluated the 141 patients from the database. Results: There were 80 males and 61 females with a mean age of 56 ± 1.07 years. The median survival in patients who were administered front-line chemotherapy was 17 months (95% CI: 13.19-20.81). 106 patients were administered pemetrexed-platinum combination and 35 patients were administered gemcitabine-platinum combination as front-line chemotherapy. For the patients who received pemetrexed-platinum regimen, a median of 6 cycles of chemotherapy was administered and 50 patients (47.2%) were able to receive all 6 cycles as planned. For the patients who received gemcitabine-platinum regimen, a median of 6 cycles of chemotherapy was administered and 19 patients (54.3%) were able to receive all 6 cycles. Median survival was found 16 months in the pemetrexed-platinum regimen and 26 months in the gemcitabine- platinum regimen. There was no statistically significant difference between the patients who received pemetrexed-platinum and gemcitabine-platinum regimens in terms of the median overall survival (p = 0.15). Conclusions: Results of our study suggest that chemotherapy prolongs overall survival. Survival rates in patients who received combining platinum analogues with pemetrexed or gemcitabine as front-line chemotherapy were found to be similar.


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