MSKCC Phase II Mesothelioma

Background

Phase 2 prospective single-arm trial. N=88 MPM patients evaluated for surgical resection 1995–1998 at Memorial Sloan-Kettering. Resected patients received adjuvant high-dose hemithoracic RT (54 Gy) to the entire hemithorax including pleural folds and incision sites.

Interventions and follow up

Treatment: Surgical resection (EPP) followed by adjuvant hemithoracic RT 54 Gy to the entire hemithorax
Primary endpoint: Local control and overall survival
mFollow up: NR

Results

Postoperative mortality: 7.9% (7/88 patients)
Median OS (stage I–II): 33.8 months
Median OS (stage III–IV): 10 months, P=.04
54 Gy RT tolerability: Well tolerated (grade 0–2 fatigue, esophagitis); 1 late esophageal fistula
Sites of recurrence (EPP patients): Locoregional only 2, locoregional + distant 5, distant only 30

Adverse events

RT toxicity: 54 Gy well tolerated — grade 0–2 fatigue and esophagitis predominated
Late: 1 esophageal fistula
Postoperative mortality: 7.9% (institutional learning curve)
Pattern of failure: Distant failure dominant (30/37 recurrences)

Conclusions

High-dose hemithoracic RT (54 Gy) after complete resection reduced local recurrence in MPM while being well tolerated. Median OS 33.8 months for stage I–II exceeded historical results; distant failure remained the predominant pattern, highlighting need for systemic therapy.

Key Limitations

Single-arm, single-institution; no randomized comparator; selected resectable patients; survival benefit confounded by patient selection.

Clinical Context

Landmark series establishing 54 Gy adjuvant hemithoracic RT after EPP; technique later described by Yajnik (2003). EPP-based approaches now largely supplanted by lung-sparing P/D + IMRT.

References