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).

Abstract

PURPOSE:

We conducted a prospective multi-institutional study to determine the feasibility of trimodality therapy (TMT) comprising induction chemotherapy followed by extrapleural pneumonectomy (EPP) and radiation therapy in Japanese patients with malignant pleural mesothelioma (MPM).

METHODS:

Major eligibility criteria were histologically confirmed diagnosis of MPM, including clinical subtypes T0-3, N0-2, M0 disease; no prior treatment for the disease; age 20-75 years; Eastern Cooperative Oncology Group performance status 0 or 1; predicted postoperative forced expiratory volume >1000 ml in 1 s; written informed consent. Treatment methods comprised induction chemotherapy using pemetrexed (500 mg/m(2)) plus cisplatin (60 mg/m(2)) for three cycles, followed by EPP and postoperative hemithoracic radiation therapy (54 Gy). Primary endpoints were macroscopic complete resection (MCR) rate for EPP and treatment-related mortality for TMT.

RESULTS:

Forty-two eligible patients were enrolled: median age 64.5 (range 43-74) years; M:F = 39:3, clinical stage I:II:III = 14:13:15; histological type epithelioid were sarcomatoid; biphasic; others = 28:1:9:4. Of 42 patients, 30 completed EPP with MCR and 17 completed TMT. The trial met the primary endpoints, with an MCR rate of 71 % (30/42) and treatment-related mortality of 9.5 % (4/42). Overall median survival time and 2-year survival rate for 42 registered patients were 19.9 months and 42.9 %, respectively. Two-year relapse-free survival rate of 30 patients who completed EPP with MCR was 37.0 %.

CONCLUSION:

This phase II study met the predefined primary endpoints, but its risk/benefit ratio was not satisfactory.

• Authors: Seiki Hasegawa, Morihito Okada, Fumihiro Tanaka, Takeharu Yamanaka, Toshinori Soejima, Norihiko Kamikonya, Tohru Tsujimura, Kazuya Fukuoka, Kohei Yokoi, Takashi Nakano
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 21 Issue 3 Pg. 523-30 (Jun 2016) ISSN: 1437-7772 [Electronic] Japan
• PMID: 26577445 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Antineoplastic Agents
• Pemetrexed
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemotherapy, Adjuvant
• Cisplatin (administration & dosage)
• Feasibility Studies
• Female
• Humans
• Induction Chemotherapy (methods)
• Japan
• Male
• Mesothelioma (pathology, therapy)
• Middle Aged
• Neoadjuvant Therapy
• Neoplasm Recurrence, Local (surgery)
• Pemetrexed (administration & dosage)
• Pleural Neoplasms (pathology, therapy)
• Pneumonectomy
• Prospective Studies
• Radiotherapy, Adjuvant
• Survival Rate