Athanasios Karampeazis1, Lambros Vamvakas2, Nikolaos Kentepozidis3, Aris Polyzos4, Vassilis Chandrinos5, Georgios Rigas6, Charalambos Christofyllakis7, Athanasios Kotsakis8, Dora Hatzidaki9, Athanasios G Pallis9, Vassilis Georgoulias10. 1. 401 Army General Hospital, Athens, Greece; Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece. 2. Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece. 3. Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Medical Oncology Department, 251 General Air Force Hospital, Athens, Greece. 4. Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; 1st Department of Medicine, Medical School, University of Athens, Laikon General Hospital, Athens, Greece. 5. Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; 1st Department of Pulmonary Disease, Sismanoglion Hospital, Athens, Greece. 6. Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Unit of Medical Technology and Intelligent Information Systems, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece. 7. 401 Army General Hospital, Athens, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece. 8. Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece; Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Crete, Greece. 9. Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece. 10. Laboratory of Tumor Cell Biology, School of Medicine, University of Crete, Heraklion, Crete, Greece; Lung Cancer Working Group of the Hellenic Oncology Research Group (HORG), Athens, Greece. Electronic address: georgoul@med.uoc.gr.
Abstract
BACKGROUND: The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities of the biweekly carboplatin/gemcitabine combination and evaluate its safety and efficacy in patients aged ≥ 70 years with advanced squamous non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients aged ≥ 70 years with advanced or metastatic squamous NSCLC received escalated doses of carboplatin (area under the curve [AUC] 2-2.5 intravenously) and gemcitabine (800-1100 mg/m2 intravenously) every 2 weeks (phase I). In the phase II, the drugs were administered at their previously defined MTDs (carboplatin, AUC 2.5; gemcitabine, 1100 mg/m2). The primary endpoint was the overall response rate. RESULTS: A total of 69 patients were enrolled (phase I, n = 15). The median age was 76 years (range, 70-84 years); 52 patients had stage IV disease, and 61 and 8 patients had Eastern Cooperative Oncology Group performance status of 0 to 1 and 2, respectively. The MTDs could not be reached at the predefined last dose levels. The dose-limiting toxicities were grade 5 renal toxicity and grade 3 thrombocytopenia. In the phase II study, the overall response rate was 35.8% (95% confidence interval [CI], 23.0%-48.8%). In the intention-to-treat analysis, the median progression-free survival was 6.7 months (95% CI, 4.2-8.8 months), and the median overall survival was 13.3 months (95% CI, 7.1-19.6 months). Grade 3 or 4 neutropenia was observed in 7 patients (12.3%), grade 3 or 4 thrombocytopenia in 4 patients (7.1%), and grade 2 or 3 fatigue in 10 patients (17.5%). One toxic death occurred in the phase I of the study. CONCLUSION: The biweekly regimen of gemcitabine and carboplatin showed satisfactory efficacy and a favorable toxicity profile in elderly patients with advanced or metastatic squamous cell NSCLC.
BACKGROUND: The present study was a phase I/II study to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities of the biweekly carboplatin/gemcitabine combination and evaluate its safety and efficacy in patients aged ≥ 70 years with advanced squamous non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients aged ≥ 70 years with advanced or metastatic squamous NSCLC received escalated doses of carboplatin (area under the curve [AUC] 2-2.5 intravenously) and gemcitabine (800-1100 mg/m2 intravenously) every 2 weeks (phase I). In the phase II, the drugs were administered at their previously defined MTDs (carboplatin, AUC 2.5; gemcitabine, 1100 mg/m2). The primary endpoint was the overall response rate. RESULTS: A total of 69 patients were enrolled (phase I, n = 15). The median age was 76 years (range, 70-84 years); 52 patients had stage IV disease, and 61 and 8 patients had Eastern Cooperative Oncology Group performance status of 0 to 1 and 2, respectively. The MTDs could not be reached at the predefined last dose levels. The dose-limiting toxicities were grade 5 renal toxicity and grade 3 thrombocytopenia. In the phase II study, the overall response rate was 35.8% (95% confidence interval [CI], 23.0%-48.8%). In the intention-to-treat analysis, the median progression-free survival was 6.7 months (95% CI, 4.2-8.8 months), and the median overall survival was 13.3 months (95% CI, 7.1-19.6 months). Grade 3 or 4 neutropenia was observed in 7 patients (12.3%), grade 3 or 4 thrombocytopenia in 4 patients (7.1%), and grade 2 or 3 fatigue in 10 patients (17.5%). One toxic death occurred in the phase I of the study. CONCLUSION: The biweekly regimen of gemcitabine and carboplatin showed satisfactory efficacy and a favorable toxicity profile in elderly patients with advanced or metastatic squamous cell NSCLC.
Authors: Alastair Greystoke; Nicola Steele; Hendrik-Tobias Arkenau; Fiona Blackhall; Noor Md Haris; Colin R Lindsay; Raffaele Califano; Mark Voskoboynik; Yvonne Summers; Karen So; Dana Ghiorghiu; Angela W Dymond; Stuart Hossack; Ruth Plummer; Emma Dean Journal: Br J Cancer Date: 2017-08-24 Impact factor: 7.640
Authors: Cesare Gridelli; Tianlei Chen; Amy Ko; Mary E O'Brien; Teng Jin Ong; Mark A Socinski; Pieter E Postmus Journal: Drug Des Devel Ther Date: 2018-05-24 Impact factor: 4.162