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Reviewer: Dr. Randeep Sangha Date posted: June 21, 2007

Phase III trial of cisplatin (P) plus etoposide (E) plus concurrent chest radiation (XRT) with or without consolidation docetaxel (D) in patients with inoperable stage III non-small cell lung cancer (NSCLC): HOG LUN 01-24/USO-023 Authors: Hanna et al. Abstract # 7512.

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Reviewer: Dr. Randeep Sangha Date posted: June 21, 2007

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  1. Phase III trial of cisplatin (P) plus etoposide (E) plus concurrent chest radiation (XRT) with or without consolidation docetaxel (D) in patients with inoperable stage III non-small cell lung cancer (NSCLC): HOG LUN 01-24/USO-023Authors: Hanna et al. Abstract # 7512 Reviewer: Dr. Randeep Sangha Date posted: June 21, 2007

  2. Background • Stage III inoperable NSCLC • SWOG 9019 • Phase II study enrolling 50 Stage IIIB pts • Platinum (P)/Etoposide (E) + XRT → consolidation EP x 2 • 5 yr overall survival (OS) of 15% and median survival time (MST) of 15 months Albain et. al. JCO 2002, 20:3454-60 Less effective More effective

  3. Background • SWOG 9504 • Phase II single arm study • Consolidation Docetaxel (D) following PE/XRT further improved survival • MST 26 months Gandara et. al., JCO 2003;21:2004-10

  4. Study Design Study Question • In a randomized, prospective, Phase III study comparing EP/XRT with or without consolidation D for Stage III NSCLC patients, will D offer a significant survival advantage? Endpoints • Primary Endpoint • Overall survival (OS) • Secondary Endpoints • Progression free survival (PFS) • Toxicity Study Population • Data Safety Monitoring Board recommended early termination after analysis of 203 patients (147 randomized) • Based upon evidence of futility (predefined as p>0.7271)

  5. Study Design D 75 mg/m2 q21d x 3 cycles • P 50 mg/m2 d1,8,29,36 • E 50 mg/m2 d1-5, 29-33 • XRT to 59.4 Gy R • Inoperable Stage IIIA/B NSCLC • PS 0-2 • FEV1 ≥ 1 • <5% weight loss Observation

  6. Results *OS for all pts: 21.1 months

  7. Study Commentary • Docetaxel consolidation does not improve survival when compared with observation following PE/XRT • Increased toxicities with Docetaxel consolidation • Higher rate of hospitalization • Increased grade 3/4 toxicities • Increased treatment related death • PE/XRT should be the reference regimen for stage III inoperable NSCLC

  8. Bottom Line for Canadian Medical Oncologists • Previous studies show that concurrent chemoradiation is more effective than sequential chemoradiation or radiation alone for Stage III inoperable NSCLC • Three cycle of consolidation Docetaxel after concurrent chemoradiation does not significantly add to survival • Associated with significant Grade 3/4 toxicities and an increased hospitalization rate • There is a lack of Phase III evidence demonstrating a survival benefit for consolidative therapies in Stage III NSCLC • Concurrent chemoradiation alone could be considered standard treatment for Stage III inoperable NSCLC

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