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Higher dose PCI added no benefit to limited-stage SCLC
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The standard dose of 25 Gy of prophylactic cranial irradiation should remain the standard of care for limited-stage small cell cancer, according to recent data presented at the 2008 ASCO Annual Meeting.
The results of a trial comparing 25 Gy prophylactic cranial irradiation (PCI) to 36 Gy were presented by Cecile Le Pechoux, MD, of the Institut Gustave-Roussy, Villejuif, France.
“[The data from] this study showed that there was no significant difference in the incidence of brain metastases when a higher dose of PCI was administered,” Le Pechoux said. “Survival was unexpectedly worse in the high-dose arm due to more thoracic relapses and deaths from disease progression.”
The researchers enrolled 720 patients with histologically proven small cell lung cancer and a complete response to induction therapy. Patients were enrolled between September 1999 and December 2005 at 157 centers in 22 countries. The primary endpoint was brain metastases incidence at two years median follow-up.
The incidence of brain metastases was not statistically different between the standard dose (30%) and the high dose (24%). The HR for brain metastasis in the 36 Gy group vs. 25 Gy was 0.77 (95% CI, 0.55-1.08).
Overall survival was significantly worse in the high-dose PCI arm (HR=1.22; 95% CI, 1.02-1.47). Two years after randomization 42% of the patients in standard arm were alive vs. 37% in the PCI high-dose arm. The causes of death were not significantly different between the two arms.
Incidence of non-brain metastases was not statistically significant between the two arms (HR=1.19), but chest relapse incidence was significantly worse in the high-dose arm (HR=1.32).
The most common toxicities were headache, fatigue, insomnia and nausea. Adverse events were similar for the two treatment arms. – by Leah Lawrence
For more information:
- Le Pechoux C. Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): Primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). #LBA7514. Presented at: the 2008 ASCO Annual Meeting; May 30-June 3, 2008; Chicago.