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Clinical Trial
. 2011 Sep 1;81(1):77-84.
doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26.

Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer

Aaron H Wolfson  1 , Kyounghwa Bae, Ritsuko Komaki, Christina Meyers, Benjamin Movsas, Cecile Le Pechoux, Maria Werner-Wasik, Gregory M M Videtic, Yolanda I Garces, Hak Choy
Affiliations
Clinical Trial

Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer

Aaron H Wolfson et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: To determine the effect of dose and fractionation schedule of prophylactic cranial irradiation (PCI) on the incidence of chronic neurotoxicity (CNt) and changes in quality of life for selected patients with limited-disease small-cell lung cancer (LD SCLC).

Methods and materials: Patients with LD SCLC who achieved a complete response after chemotherapy and thoracic irradiation were eligible for randomization to undergo PCI to a total dose of 25 Gy in 10 daily fractions (Arm 1) vs. the experimental cohort of 36 Gy. Those receiving 36 Gy underwent a secondary randomization between daily 18 fractions (Arm 2) and twice-daily 24 fractions (Arm 3). Enrolled patients participated in baseline and follow-up neuropsychological test batteries along with quality-of-life assessments.

Results: A total of 265 patients were accrued, with 131 in Arm 1, 67 in Arm 2, and 66 in Arm 3 being eligible. There are 112 patients (42.2%) alive with 25.3 months of median follow-up. There were no significant baseline differences among groups regarding quality-of-life measures and one of the neuropsychological tests, namely the Hopkins Verbal Learning Test. However, at 12 months after PCI there was a significant increase in the occurrence of CNt in the 36-Gy cohort (p=0.02). Logistic regression analysis revealed increasing age to be the most significant predictor of CNt (p=0.005).

Conclusions: Because of the increased risk of developing CNt in study patients with 36 Gy, a total PCI dose of 25 Gy remains the standard of care for patients with LD SCLC attaining a complete response to initial chemoradiation.

Trial registration: ClinicalTrials.gov NCT00057746.

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Conflict of interest statement

“Conflicts of Interest Notification”

No conflicts of interest exist for any of the authors.

Figures

Figure 1
Figure 1
Cumulative incidence of brain metastasis at one year. There is 1 patient for which there has been no followup-information submitted to RTOG Head Quarters.
See this image and copyright information in PMC

References

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    1. Le Pechoux C, Dunant A, Suresh S, et al. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): A randomized clinical trial. Lancet Oncol. 2009;10:467–474. - PubMed
    1. Benedict RHB, Schretlen D, Groinger L, et al. Hopkins Verbal Learning Test-Revised: Normative data and abalysis of Inter-form and test-retest reliability. Clin Neuropsychol. 1998;12:43–55.

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