A multicenter, randomized phase III maintenance study of thalidomide (arm A) versus observation (arm B) in patients with malignant pleural mesothelioma (MPM) after induction chemotherapy.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 7006-7006 ◽  
Author(s):  
P. Baas ◽  
W. Buikhuisen ◽  
O. Dalesio ◽  
A. Vincent ◽  
N. Pavlakis ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Malignant Pleural Mesothelioma ◽  
Phase Iii ◽  
Pleural Mesothelioma ◽  
Maintenance Study

scholarly journals Induction Chemotherapy Followed by Pleurectomy Decortication and Hyperthermic Intraoperative Chemotherapy (HITHOC) for Early-Stage Epitheliod Malignant Pleural Mesothelioma—A Prospective Report

2021 ◽  
Vol 10 (23) ◽  
pp. 5542
Author(s):  
Stefano Bongiolatti ◽  
Francesca Mazzoni ◽  
Ottavia Salimbene ◽  
Enrico Caliman ◽  
Carlo Ammatuna ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Malignant Pleural Mesothelioma ◽  
Early Stage ◽  
Disease Free Survival ◽  
Stage I ◽  
Long Term Results ◽  
Pleural Mesothelioma ◽  
Free Survival ◽  
Therapy Regimen ◽  
Platinum Based Chemotherapy

Malignant pleural mesothelioma (MPM) is an aggressive disease with poor prognosis and the current treatment for early-stage MPM is based on a multimodality therapy regimen involving platinum-based chemotherapy preceding or following surgery. To enhance the cytoreductive role of surgery, some peri- or intra-operative intracavitary treatments have been developed, such as hyperthermic chemotherapy, but long-term results are weak. The aim of this study was to report the post-operative results and mid-term outcomes of our multimodal intention-to-treat pathway, including induction chemotherapy, followed by surgery and Hyperthermic Intraoperative THOracic Chemotherapy (HITHOC) in the treatment of early-stage epithelioid MPM. Since 2017, stage I or II epithelioid MPM patients have been inserted in a surgery-based multimodal approach comprising platinum-based induction chemotherapy, followed by pleurectomy and decortication (P/D) and HITHOC with cisplatin. The Kaplan–Meier method was used to estimate overall survival (OS), disease-free survival (DFS) and progression-free survival (PFS). During the study period, n = 65 patients affected by MPM were evaluated by our institutional Multidisciplinary Tumour Board; n = 12 patients with stage I-II who had no progression after induction chemotherapy underwent P/D and HITHOC. Post-operative mortality was 0, and complications developed in n = 7 (58.3%) patients. The median estimated OS was 31 months with a 1-year and 3-year OS of 100% and 55%, respectively. The median PFS was 26 months with 92% of a 1-year PFS, whereas DFS was 19 months with a 1-year DFS rate of 83%. The multimodal treatment of early-stage epithelioid MPM, including induction chemotherapy followed by P/D and HITHOC, was well tolerated and feasible with promising mid-term oncological results.

A randomized phase III trial of active symptom control (ASC) with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma: First results of the Medical Research Council (MRC) / British Thoracic Society (BTS) MS01 trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. LBA7525-LBA7525 ◽  
Author(s):  
M. Muers ◽  
P. Fisher ◽  
M. Snee ◽  
E. Lowry ◽  
M. O'Brien ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Median Survival ◽  
Malignant Pleural Mesothelioma ◽  
Survival Benefit ◽  
Phase Iii ◽  
Pleural Mesothelioma ◽  
Significant Survival Benefit ◽  
Significant Survival ◽  
Symptom Palliation ◽  
Weekly Cycles

LBA7525 Background: Although chemotherapy is widely used in the treatment of mesothelioma it has never been compared in a randomized trial with ASC alone. Two chemotherapy regimens that had shown good symptom palliation in phase II studies were chosen for investigation. Methods: Patients with malignant pleural mesothelioma were randomized to ASC alone (regular follow-up in a specialist clinic, and treatment could include steroids, analgesics, bronchodilators, palliative radiotherapy, etc), ASC+MVP (4 × 3-weekly cycles of mitomycin 6g/m2, vinblastine 6mg/m2, and cisplatin 50mg/m2), or ASC+N (12 weekly injections of vinorelbine 30mg/m2). 420 patients were required to detect a 3-month improvement in median survival with ASC+CT (both chemotherapy arms combined). Quality of Life (QL) was assessed using the EORTC QLQ-C30. Results: 409 patients were accrued (136 ASC, 137 ASC+MVP, 136 ASC+N). Median age: 65 years, male: 91%, Performance status 0: 23%, Epithelial histology: 73%, Stage III: 33%, Stage IV: 48%. In the ASC+MVP group 61% received all 4 cycles, and in the ASC+N group 49% received at least 10 weekly cycles. Good symptom palliation (defined as prevention, control or improvement) was achieved in all 3 groups, and no between-group differences were observed in 4 pre-defined QL subscales (physical functioning, dyspnoea, pain and global QL). A small (not conventionally significant) survival benefit was seen for ASC+CT (349 deaths, HR 0.89, 95%CI 0.72, 1.12, p=0.32). Median survival: ASC: 7.6 months, ASC+CT: 8.5 months. Exploratory analyses suggested a survival advantage for vinorelbine compared to ASC alone (HR 0.81, 95%CI 0.63, 1.05, p=0.11), with a median survival of 9.4 months, but no evidence of a benefit with MVP (HR 0.98, 95%CI 0.76, 1.28), p=0.91). Conclusions: This is the 2nd largest ever randomized trial in mesothelioma and the first to compare ASC with or without chemotherapy. Although the addition of chemotherapy to ASC did not result in a conventionally significant survival benefit, there was an indication that vinorelbine should be investigated further, and that MVP probably has no role in this disease. [Table: see text]

A feasibility study of induction pemetrexed plus cisplatin followed by pleurectomy/decortication for malignant pleural mesothelioma (Japan Mesothelioma Interest Group 1101 Trial).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8518-8518
Author(s):  
Seiki Hasegawa ◽  
Kohei Yokoi ◽  
Morihito Okada ◽  
Fumihiro Tanaka ◽  
Mototsugu Shimokawa ◽  
...  
Keyword(s):  
Surgical Technique ◽  
Pulmonary Function ◽  
Induction Chemotherapy ◽  
Malignant Pleural Mesothelioma ◽  
Primary Endpoint ◽  
Pulmonary Function Tests ◽  
Survival Rates ◽  
Extrapleural Pneumonectomy ◽  
Pleural Mesothelioma ◽  
Acceptable Risks

8518 Background: Although pleurectomy/decortication (P/D) has become a preferred surgical technique for malignant pleural mesothelioma (MPM), only a few prospective, multi-center clinical trials have been conducted. Here we present final results of a nationwide, prospective, multi-institutional study to evaluate the feasibility of induction chemotherapy followed by P/D. Methods: Eligibility criteria: a histologically confirmed diagnosis of MPM; clinical T1–3, N0–2, M0 disease; no prior treatment for the disease; age between 20 and 75 years; ECOG performance status of 0 or 1; and written informed consent. Treatment methods: Induction chemotherapy of pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 for 3 cycles, followed by P/D. Intraoperative conversion from P/D to extrapleural pneumonectomy (EPP) was permitted. Pulmonary function tests were performed at 3, 6, 12, 24, and 36 months after surgery. Primary endpoint was macroscopic complete resection (MCR) rate regardless of the surgical technique. Results: Of 24 patients enrolled, 20 patients were eligible: median age 66 (48–74); M/F: 17/3, Clinical stage I/II/III: 8/9/3; Histology epi/sar/bi: 19/1/0. Two discontinued protocol before surgery due to deteriorated FEV1 or adverse effect (AE) of chemotherapy, and the remaining 18 patients completed surgery with MCR: P/D in 15 patients and EPP in 3. The trial met the primary endpoint with MCR rate of 90% (18/20). There was no treatment-related 30- and 90-day mortality. There were two cases of chemotherapy-related grade 4 AEs, but no surgery-related grade 4 AE occurred. The overall survival rates at 1 and 2 years and median survival time (MST) after registration were 95.0% (95% CI, 69.5 to 99.3), 70.0% (45.1 to 85.3), and 41.4 months (19.7 to NA), respectively. The progression-free survival rates at 1 and 2 years and MST after registration were 84.7% (60.0 to 94.8), 42.4% (20.5 to 62.7), and 22.9 months (12.7 to 28.4), respectively. Recurrence occurred in 17 patients, and initial relapse sites were local in 17 (100%) and distal in 6 (35.3%). The best values of FVC and FEV1 during postoperative period were 78.0% and 82.5% of preoperative values, respectively. Conclusions: Induction chemotherapy plus P/D yielded a MST over 40 months with acceptable risks. Postoperative pulmonary function was approximately 80% of preoperative value. Clinical trial information: UMIN000009092.

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