Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study

Autor: Marsha A. Ketcham, Alissa S. Marr, Anne Kessinger, Mary M. Huerter, Addison Tolentino, Karin Swenson, Holly DeSpiegelaere, Jane L. Meza, M. Sitki Copur, Apar Kishor Ganti, Susan Kruse, Mary E. Kos, Sarah E. Radniecki
Rok vydání: 2017
Předmět:
Male
0301 basic medicine
Oncology
Lung Neoplasms
medicine.medical_treatment
Phases of clinical research
Brain Ischemia
0302 clinical medicine
Quality of life
Carcinoma
Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
Chemotherapy-Induced Febrile Neutropenia
Hypoxia
Aged
80 and over
Anemia
Vinorelbine
Survival Rate
030220 oncology & carcinogenesis
Early Termination of Clinical Trials
Carcinoma
Squamous Cell
Female
Respiratory Insufficiency
medicine.drug
medicine.medical_specialty
Neutropenia
Paclitaxel
Adenocarcinoma
Vinblastine
Disease-Free Survival
03 medical and health sciences
Lymphopenia
Internal medicine
medicine
Humans
Lung cancer
Aged
Chemotherapy
business.industry
Cancer
Pneumonia
Interim analysis
medicine.disease
Heart Arrest
Surgery
Clinical trial
030104 developmental biology
Quality of Life
Geriatrics and Gerontology
Tomography
X-Ray Computed
business
Zdroj: Journal of Geriatric Oncology. 8:18-22
ISSN: 1879-4068
DOI: 10.1016/j.jgo.2016.07.006
Popis: Objective Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70 years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients > 70 years with advanced NSCLC. Materials and Methods Patients with treatment naive metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL). Results The study closed at second interim analysis as 6/19 patients had ≥ grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response + stable disease) was 47% (n = 9); 37% (n = 7) progressed. No complete responses were seen. Median PFS was 3.5 months (95% CI: 1.4, 5.5) and OS 7.8 months (95% CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17. Conclusions Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.
Databáze: OpenAIRE
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