Characterization of pneumonitis in patients with advanced non-small cell lung cancer treated with everolimus (RAD001) Journal Article
| Authors: | White, D. A.; Schwartz, L. H.; Dimitrijevic, S.; Scala, L. D.; Hayes, W.; Gross, S. H. |
| Article Title: | Characterization of pneumonitis in patients with advanced non-small cell lung cancer treated with everolimus (RAD001) |
| Abstract: | Purpose: To assess the incidence and radiographic and clinical presentation of pneumonitis associated with the mammalian target of rapamycin inhibitor everolimus in patients with advanced non-small cell lung cancer. PATIENTS AND Methods: A retrospective, centralized review of serial computed tomography scans and corresponding clinical data from patients with advanced non-small cell lung cancer treated with 10-mg oral once daily everolimus monotherapy in a phase II clinical study was conducted. Serial chest CT scans underwent a consensus read by two radiologists for presence of pneumonitis. These cases were then reviewed with corresponding clinical data by a pulmonologist to assess the suspected causality to everolimus and outcome. Results: Twenty-four of 64 patients reviewed were found to have radiographic evidence of pneumonitis. In 16 of these 24 patients, pneumonitis was suspected as either possibly (12) or probably (4) related to everolimus. The most common radiographic manifestations were focal areas of consolidation at the lung bases or ground-glass opacities. Pneumonitis evaluated with Common Terminology Criteria for Adverse Events (version 3) was grade 1 or 2 in 12 of 16 suspected cases, with 4 patients experiencing higher grades. In most of the patients, pneumonitis remained at the same or lower grade without discontinuation of therapy. Patients with evidence of interstitial lung disease at baseline had an increased risk of Common Terminology Criteria for Adverse Events grade more than or equal to 3 pneumonitis. Conclusion: Within the limitation of this retrospective study, Results suggest that a mostly low-grade pneumonitis with a possible or probable relationship to everolimus was relatively frequent, occurring in 25% of evaluated patients. These Results suggest a need for monitoring of pulmonary adverse events and the development of guidelines for managing pneumonitis in future studies with everolimus. © 2009 by the International Association for the Study of Lung Cancer. |
| Keywords: | adult; cancer chemotherapy; controlled study; aged; middle aged; retrospective studies; young adult; major clinical study; clinical trial; erlotinib; advanced cancer; cancer risk; drug dose reduction; monotherapy; united states; outcome assessment; follow-up studies; cancer incidence; cancer grading; consensus; phase 2 clinical trial; lung non small cell cancer; carcinoma, non-small-cell lung; lung neoplasms; incidence; tomography, x-ray computed; patient monitoring; dose-response relationship, drug; diagnostic imaging; pneumonia; radiography, thoracic; adverse outcome; radiologist; gefitinib; single drug dose; interstitial lung disease; thorax radiography; administration, oral; everolimus; non-small cell lung cancer; sirolimus; immunosuppressive agents; mtor inhibitor; pneumonitis; rad001 |
| Journal Title: | Journal of Thoracic Oncology |
| Volume: | 4 |
| Issue: | 11 |
| ISSN: | 1556-0864 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2009-11-01 |
| Start Page: | 1357 |
| End Page: | 1363 |
| Language: | English |
| DOI: | 10.1097/JTO.0b013e3181ba20b1 |
| PUBMED: | 19745764 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 3" - "Export Date: 30 November 2010" - "Source: Scopus" |
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