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Curated Journal Articles on Mesothelioma

A Phase I Trial of Surgical Resection and Intraoperative Hyperthermic Cisplatin and Gemcitabine for Pleural Mesothelioma

Journal of Thoracic Oncology 2018 May 3 [Link]

Burt BM, Richards WG, Lee HS, Bartel S, Dasilva MC, Gill RR, Jaklitsch MT, Johnson BE, Swanson SJ, Bueno R, Sugarbaker DJ

Abstract

INTRODUCTION:
The primary objective of this single-institution Phase I clinical trial was to establish the maximum tolerated dose (MTD) of gemcitabine added to cisplatin delivered as heated intraoperative chemotherapy (HIOC) following resection of malignant pleural mesothelioma (MPM).

METHODS:
Extrapleural pneumonectomy (EPP) and pleurectomy/decortication (P/D) treatment arms were based on investigators’ assessment of patient fitness and potential for macroscopic complete resection. Previously established intracavitary dosing of cisplatin (175-225 mg/m2) with systemic cytoprotection was used in combination with escalating doses of gemcitabine, following a 3+3 design from 100 mg/m2 in 100 mg increments.

RESULTS:
From 2007 to 2011, 141 patients were enrolled and 104 completed treatment. Of those completing treatment the median was age 65 (43-85) and 22 (21%) were females. EPP arm (n=59): epithelioid histology 31 (53%), median radiographic tumor volume 236cc (16-4285cc); P/D arm (n=41): epithelioid 29 (71%), tumor volume 79cc (6-1107cc). Operative mortality was 2%. Thirty-five and 22 serious adverse events were encountered among 27 (46%) and 16 (39%) patients on the EPP and P/D arms, respectively. Dose-limiting toxicity (Grade 3 leukopenia) was observed in two patients at 1100 mg/m2 gemcitabine, establishing the MTD at 1000 mg/m2, in combination with 175 mg/m2 cisplatin. Median overall and recurrence-free survival in treated patients was 20.3 and 10.7 months, respectively.

CONCLUSIONS:
Combination cisplatin and gemcitabine HIOC can be administered safely and feasibly in the context of complete surgical resection of MPM by EPP or P/D.

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