A feasibility study of induction pemetrexed plus cisplatin followed by pleurectomy/decortication aimed at macroscopic complete resection for malignant pleural mesothelioma

Our plain-English summary of A feasibility study of induction pemetrexed plus cisplatin followed by pleurectomy/decortication aimed at macroscopic complete resection for malignant pleural mesothelioma, by M. Shimokawa, S. Hasegawa, K. Fukuoka, et al (Japanese Journal of Clinical Oncology, 2013).

The study

• Authors: M. Shimokawa, S. Hasegawa, K. Fukuoka, M. Okada, K. Yokoi, F. Tanaka, T. Yamanaka, T. Daimon, T. Nakano
• Journal: Japanese Journal of Clinical Oncology
• Published: 2013;43(5):575-8
• Cited by: 7 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

A prospective multi-institutional study has been initiated in Japan to evaluate the feasibility of induction chemotherapy using pemetrexed plus cisplatin, followed by pleurectomy/decortication aimed at macroscopic complete resection in patients with resectable malignant pleural mesothelioma. The study was initiated on September 2012, for which 24 patients will be recruited over a period of 2 years. The primary endpoint is the macroscopic complete resection rate, regardless of the surgical technique employed (i.e. pleurectomy/decortication or extrapleural pneumonectomy). The secondary endpoints are the pleurectomy/decortication rate, macroscopic complete resection rate by pleurectomy/decortication, pulmonary function at 3 months after surgery, adverse events, treatment-related mortality, response rate to chemotherapy and 3-year overall survival rate.

In plain English

This clinical trial note described a planned study and reported no patient results. It set out a prospective, multi-institutional, single-arm study to test whether a treatment plan for resectable malignant pleural mesothelioma was feasible. Patients were to receive three cycles of induction chemotherapy, pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 every 21 days. This was to be followed by pleurectomy/decortication, surgery removing the pleura, aimed at removing all visible tumor (macroscopic complete resection). Extrapleural pneumonectomy also removes the lung, diaphragm and pericardium. It could be used where operators judged that only it could achieve complete resection. The plan was to enroll 24 patients aged 20 to 75 over 2 years at 24 Japanese institutions, with 3 years of follow-up. The main measure was the rate of complete resection by either operation. The treatment would count as feasible if the lower 95% confidence limit for that rate exceeded 0.5. Other measures included lung function 3 months after surgery, adverse events, treatment-related deaths and chemotherapy response. Another measure was 3-year overall survival among eligible patients with complete resection. Asbestos exposure was not studied.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Protocol description (clinical trial note) of a prospective, multi-institutional, single-arm feasibility study; no results reported
• Who was studied: Planned: 24 patients with histologically confirmed, resectable malignant pleural mesothelioma (clinical T1–3, N0–2, M0), aged 20 to 75, with no prior treatment, recruited over 2 years from September 2012 at 24 institutions in Japan
• Exposure: Not an asbestos exposure study. The intervention was three cycles of induction pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) every 21 days, followed by pleurectomy/decortication (or extrapleural pneumonectomy) aimed at macroscopic complete resection

Topics

The National Library of Medicine indexes this study under subjects our site covers: Mesothelioma.

Medical terms in this study, explained in our Lexicon: Pemetrexed (Alimta), Cisplatin, Pleurectomy/Decortication (P/D), Pleural Mesothelioma, Chemotherapy, Extrapleural Pneumonectomy (EPP), Overall Survival.

Related studies

• Trimodality strategy for treating malignant pleural mesothelioma: results of a feasibility study of induction pemetrexed plus cisplatin followed by extrapleural pneumonectomy and postoperative hemithoracic radiation (Japan Mesothelioma Interest Group 0601 Trial) — S. Hasegawa, M. Okada, et al. (2016)
• Survival after trimodality therapy for malignant pleural mesothelioma: Radical Pleurectomy, chemotherapy with Cisplatin/Pemetrexed and radiotherapy — S. Bölükbas, C. Manegold, et al. (2011)
• Comparison of cisplatin plus pemetrexed and cisplatin plus gemcitabine for the treatment of malignant pleural mesothelioma in Japanese patients — T. Shukuya, T. Takahashi, et al. (2014)
• LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients With Unresectable Malignant Pleural Mesothelioma — G.V. Scagliotti, R. Gaafar, et al. (2017)
• Complete pathological response to neoadjuvant pemetrexed/cisplatin in combination with regional hyperthermia in a patient with sarcomatoid peritoneal mesothelioma — S. Kruger, M.K. Angele, et al. (2014)
• Raltitrexed plus cisplatin is cost-effective compared with pemetrexed plus cisplatin in patients with malignant pleural mesothelioma — B. Woods, N. Paracha, et al. (2012)

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