Purpose: The North Central Cancer Treatment Group performed a phase III trial to determine whether chemotherapy plus either bid radiation therapy (RT) or daily (qd) RT resulted in a better outcome for patients with stage III nonsmall-cell lung cancer (NSCLC). No difference in survival was identified between the two arms. This secondary analysis was performed to examine the relationship between patient age and outcome.Patients and Methods: Two hundred forty-six patients were randomized to receive etoposide plus cisplatin and either RT qd or split-course RT bid. This retrospective study compared the outcomes of patients aged >70 years ("elderly patients") with those of younger individuals. Of the 244 assessable patients, 63 (26%) were elderly, and 181 (74%) were younger individuals.Results: The 2-year and 5-year survival rates were 39% and 18%, respectively, in patients younger than 70 years, compared with 36% and 13%, respectively, in elderly patients (P ؍ .4). Grade 4؉ toxicity occurred in 62% of patients younger than 70 years compared with 81% of elderly patients (P ؍ .007). Grade 4؉ hematologic toxicity occurred in 56% of patients younger than 70 years, compared with 78% of elderly patients (P ؍ .003). Grade 4؉ pneumonitis occurred in 1% of those younger than 70 years, compared with 6% of elderly patients (P ؍ .02).Conclusion: Toxicity, especially myelosuppression and pneumonitis, was more pronounced in the elderly patients receiving combined-modality therapy for locally advanced NSCLC. Despite increased toxicity, elderly patients have survival rates equivalent to younger individuals. Therefore, fit, elderly patients with locally advanced NSCLC should be encouraged to receive combined-modality therapy, preferably on clinical trials with cautious, judicious monitoring. Future studies should explore ways to decrease toxicity of therapy in elderly patients.
BACKGROUND The current study was conducted to determine whether the addition of interferon‐α (IFN‐α) to treatment with radiation therapy and carmustine (BCNU) improves time to disease progression or overall survival in patients with high‐grade glioma. METHODS Patients with anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma multiforme, or gliosarcoma received radiation therapy plus BCNU as initial therapy. Subsequently, patients without tumor progression at the completion of radiation therapy were stratified by age, extent of surgery, tumor grade and histology, Eastern Cooperative Oncology Group performance status, and treating institution, and then were randomly assigned to receive either BCNU alone (200 mg/m2 on Day 1) or BCNU (150 mg/m2 on Day 3) plus IFN—α (12 million U/m2 on Days 1–3, Weeks 1, 3, and 5) every 7 weeks for a maximum of 6 cycles. RESULTS Of the 383 patients enrolled in the study, 275 eligible patients were randomized. There was no significant difference with regard to time to disease progression or overall survival between the two groups. Patients receiving IFN‐α experienced more fever, chills, myalgias, and neurocortical symptoms including somnolence, confusion, and exacerbation of neurologic deficits. Cox multivariate regression models confirmed known favorable prognostic variables including younger age, Grade 3 tumor (according to World Health Organization criteria), and greater extent of surgery. Cox and classification and regression tree analysis models also demonstrated that a normal baseline Folstein mini‐mental status examination (MMSE) score was associated with better prognosis. CONCLUSIONS IFN‐α does not appear to improve time to disease progression or overall survival in patients with high‐grade glioma and appears to add significantly to toxicity. The baseline MMSE score may serve as an independent prognostic factor and warrants further investigation. Cancer 2001;92:420–33. © 2001 American Cancer Society.
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