Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03)

Publication

Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03)

Journal Paper/Review - Nov 15, 2011

Pesce Gianfranco A, Bernhard Jürg, Kotrubczik Nina M, D'Addario Giannicola, Pilop Christiane, Weber Damien C, Bodis Stephan, Pless Miklos, Mayer Michael, Cathomas Richard, Peters Solange, Klingbiel Dirk, Ribi Karin, Zouhair Abderahim, von Moos Roger, Schlaeppi Marc, Caspar Clemens B, Fischer Natalie, Anchisi Sandro, Stupp Roger

Citation

Pesce G, Bernhard J, Kotrubczik N, D'Addario G, Pilop C, Weber D, Bodis S, Pless M, Mayer M, Cathomas R, Peters S, Klingbiel D, Ribi K, Zouhair A, von Moos R, Schlaeppi M, Caspar C, Fischer N, Anchisi S, Stupp R. Outcome, quality of life and cognitive function of patients with brain metastases from non-small cell lung cancer treated with whole brain radiotherapy combined with gefitinib or temozolomide. A randomised phase II trial of the Swiss Group for Clinical Cancer Research (SAKK 70/03). Eur J Cancer 2011; 48:377-84.

Type

Journal Paper/Review (English)

Journal

Eur J Cancer 2011; 48

Publication Date

Nov 15, 2011

Issn Electronic

1879-0852

Pages

377-84

Brief description/objective

PURPOSE
Patients with brain metastases (BM) rarely survive longer than 6months and are commonly excluded from clinical trials. We explored two combined modality regimens with novel agents with single agent activity and radiosensitizing properties.

PATIENTS AND METHODS
In this randomised phase II trial patients with BM from NSCLC were randomly assigned to 30Gy WBRT with either concomitant gefitinib (GFT) 250mg/day continuously or temozolomide (TMZ) 75mg/m(2) for 21/28days. The primary end-point was overall survival, with quality of life and cognitive function as secondary end-points.

RESULTS
We enrolled 59 patients (GFT 16, TMZ 43), and 56 patients have died, mainly (80%) from disease progression. Four patients succumbed complications of the disease or corticosteroids (intestinal perforation (2), CNS haemorrhage and pulmonary emboli). Median overall survival in the gefitinib arm was 6.3months (95% CI 2.1-14.6), and 4.9months (95% CI 2.3-5.6) in TMZ treated patients. Fatigue was the main complaint.

CONCLUSIONS
No relevant toxicity with those therapeutic regimens was observed. Fatal outcome in three patients may have been related to corticosteroids. Cognitive function improved during treatment. However, median overall survival for all patients was only 4.9months (95% CI 2.3-5.7) and 1-year survival 25.4% (95% CI 15.4-37.0%).