Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 7058
© 2005 American Society of Clinical Oncology

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Abstract

Low incidence of pneumonitis on SWOG 0023: A preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and gefitinib/placebo maintenance in patients with inoperable stage III non-small cell lung cancer

Univ of Colorado Health Sciences Ctr, Aurora, CO; Cancer Research and Biostatistics, Seattle, WA; Loyola Univ Medcl Ctr, Chicago, IL; Univ of CA Davis Cancer Ctr, Sacramento, CA

7058

Background: Significant pneumonitis ( grade 3) is reported in up to 19% of patients (pts) with stage III non-small cell lung cancer treated with concurrent chemoradiotherapy (Werner-Wasik Proc ASCO: 2002). Among known risk factors for radiation (RT)-related pneumonitis is % total lung volume irradiated exceeding 20 Gy (TLV-20). SWOG 0023 is an ongoing randomized phase III trial incorporating three distinct treatment phases: concurrent cisplatin/etoposide (PE) plus thoracic RT, docetaxel consolidation and gefitineb (Iressa)/placebo maintenance. Each phase alone or in combination could contribute to pneumonitis, including interstitial pneumonitis (ILD) from Iressa. A preliminary analysis was conducted to determine the incidence, timing and severity of pneumonitis. Methods: Pneumonitis was defined by NCI CTC Version 2.0. Results: As of 12/02/2004, 516 eligible pts have been accrued. 406 pts are evaluable for concurrent chemoRT, 277 pts for consolidation, 82 pts for Iressa maintenance and 85 pts for placebo maintenance. The incidence of pneumonitis during each treatment phase is reported in the table below. Overall 20/406 pts (5%) discontinued treatment due to pneumonitis. Comparative data from relevant recent trials including SWOG 9504 (PE/TRT followed by docetaxel), RTOG 9410 (sequential versus concurrent versus experimental chemotherapy and TRT) and CALGB 39801 (concurrent paclitaxel and carboplatin (PC) plus TRT versus induction PC followed by PC/TRT) reported grade 3 pneumonitis rates of 5%, 2–6% (acute) and 11–13% (late) and 2–5% respectively. Conclusions: The incidence of significant pneumonitis currently observed in SWOG 0023 is low and compares favorably to prior reports in the literature. A detailed analysis to identify risk factors such as required RT to TLV-20 <35% is underway.

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Abstract presentation from the 2005 ASCO Annual Meeting