M Patricia Rivera1, Frank C Detterbeck2, Mark A Socinski3, Dominic T Moore3, Martin J Edelman4, Thierry M Jahan5, Rafat H Ansari6, James D Luketich7, Guangbin Peng8, Matthew Monberg8, Coleman K Obasaju8, Richard J Gralla9. 1. Multidisciplinary Thoracic Oncology Group, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: mprivera@med.unc.edu. 2. Yale Comprehensive Cancer Center, Yale University, New Haven, CT. 3. Multidisciplinary Thoracic Oncology Group, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC. 4. University of Maryland Greenebaum Cancer Center, Baltimore, MD. 5. University of California San Francisco, San Francisco, CA. 6. Michiana Hematology/Oncology, South Bend, IN. 7. University of Pittsburgh Physicians, Pittsburgh, PA. 8. Eli Lilly and Company, Indianapolis, IN. 9. North Shore-Long Island Jewish Health System, Lake Success, NY.
Abstract
BACKGROUND: Several chemotherapy agents, including gemcitabine and paclitaxel, have been reported to cause interstitial pneumonitis. The incidence of pulmonary toxicity from the combination of gemcitabine and paclitaxel is reported to be approximately 5%. In this report, pulmonary function test (PFT) results were analyzed from two similar randomized phase 2 trials that tested platinum and nonplatinum regimens preoperatively in patients with stage I or II non-small cell lung cancer (NSCLC). METHODS: The regimens included gemcitabine plus carboplatin, paclitaxel, or cisplatin. PFT and dyspnea scores were obtained at baseline and postchemotherapy, and were compared to one of several secondary end points, including ability to undergo surgical resection. RESULTS:Baseline PFT scores varied with smoking status. Mean levels of diffusing capacity of the lung for carbon monoxide (Dlco) adjusted for hemoglobin declined 8% from pre- to postinduction (Wilcoxon signed rank test, p < 0.0001). Changes in FVC, FEV(1), and total lung capacity were not statistically significant after chemotherapy. Although 27% of patients in the study had some reduction in PFT results, only 2 of the 85 eligible patients did not undergo surgery due to PFT reduction following chemotherapy. One patient in the study experienced a clinically significant respiratory toxicity (grade 3 dyspnea). Pulmonary toxicity was only statistically associated with male gender. CONCLUSION: In the preoperative setting, gemcitabine-based chemotherapy was well tolerated. The most commonly affected PFT parameter postchemotherapy was the Dlco. Although 15% of patients had a significant reduction in the Dlco postchemotherapy, it did not correlate with clinical symptoms or affect the ability to undergo surgical resection.
RCT Entities:
BACKGROUND: Several chemotherapy agents, including gemcitabine and paclitaxel, have been reported to cause interstitial pneumonitis. The incidence of pulmonary toxicity from the combination of gemcitabine and paclitaxel is reported to be approximately 5%. In this report, pulmonary function test (PFT) results were analyzed from two similar randomized phase 2 trials that tested platinum and nonplatinum regimens preoperatively in patients with stage I or II non-small cell lung cancer (NSCLC). METHODS: The regimens included gemcitabine plus carboplatin, paclitaxel, or cisplatin. PFT and dyspnea scores were obtained at baseline and postchemotherapy, and were compared to one of several secondary end points, including ability to undergo surgical resection. RESULTS: Baseline PFT scores varied with smoking status. Mean levels of diffusing capacity of the lung for carbon monoxide (Dlco) adjusted for hemoglobin declined 8% from pre- to postinduction (Wilcoxon signed rank test, p < 0.0001). Changes in FVC, FEV(1), and total lung capacity were not statistically significant after chemotherapy. Although 27% of patients in the study had some reduction in PFT results, only 2 of the 85 eligible patients did not undergo surgery due to PFT reduction following chemotherapy. One patient in the study experienced a clinically significant respiratory toxicity (grade 3 dyspnea). Pulmonary toxicity was only statistically associated with male gender. CONCLUSION: In the preoperative setting, gemcitabine-based chemotherapy was well tolerated. The most commonly affected PFT parameter postchemotherapy was the Dlco. Although 15% of patients had a significant reduction in the Dlco postchemotherapy, it did not correlate with clinical symptoms or affect the ability to undergo surgical resection.
Authors: James G Connolly; Megan Fiasconaro; Kay See Tan; Michael A Cirelli; Gregory D Jones; Raul Caso; Daniel E Mansour; Joseph Dycoco; Jae Seong No; Daniela Molena; James M Isbell; Bernard J Park; Matthew J Bott; David R Jones; Gaetano Rocco Journal: J Thorac Cardiovasc Surg Date: 2021-12-23 Impact factor: 6.439