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Randomized Prospective Comparison of Adjuvant Mediastinal Radiation (RT) with or without Concurrent Chemotherapy with Cisplatin and Etoposide (PE) for Patients with Completely Resected T1-3N1-2M0 Non-Small Cell Lung Cancer (NSCLC): US

Todd Doyle, MD
OncoLink Assistant Editor
Last Modified: November 1, 1999

Presenter: Keller SM et al
Affiliation: Beth Israel Medical Center

Summary:
Multiple retrospective reviews as well as the prospective study from the Lung Cancer Study Group have demonstrated a local control advantage to adjuvant radiation therapy for NSCLC. However, the overwhelming pattern of failure remains distant. This trial was initiated in order to address this problem and to possibly allow local control with radiation therapy to have a more dramatic impact on the survival of patients with resected non small cell lung cancer.

Methods:
Four hundred and eighty-eight patients with non small cell lung cancer and involved hilar or mediastinal lymph nodes were stratified for pre-treatment prognostic factors and randomized to post operative radiation therapy (RT) or post operative radiation in addition to four cycles of concurrent cisplatin and etoposide (RTC).

Results:

• There was no significant difference in median survival between the two groups (41.9 months for RT and 38.6 months for RTC).
• Similarly, the intrathoracic failure rates were not significantly different for the two groups (28% RT and 31% RTC).
• The rates of distant metastases were not significantly different.
• Grade 3 or higher leukopenia occurred in 1% of the RT group and 65% of the RTC group.
• Grade 3 or higher esophagitis occurred in 9% of the RT group and 23% of the RTC group.

Clinical/Scientific Implications:

• This trial demonstrates no advantage to concurrent adjuvant chemotherapy in addition to adjuvant radiation therapy for node positive non small cell lung cancer. This is underscored by the increase in grade 3 or higher toxicity.
• The goal of using this strategy to improve the rate of distant metastases should not necessarily be abandoned. Possibilities for future investigations could include alternative and possibly more active agents such as taxanes. In the meantime further work will continue on defining which patients are most likely to benefit from adjuvant radiation as well as adjuvant combined modality treatment.

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