There is no advantage to weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for elderly patients with advanced non–small cell lung cancer, according to phase III study results published online Jan. 12 in the Journal of Clinical Oncology.
For the study, 276 chemotherapy-naive patients aged 70 years or older with stage III, stage IV, or recurrent non–small cell lung cancer (NSCLC) who were considered unsuitable for bolus cisplatin administration were randomly assigned to receive docetaxel 60 mg/m2 on day 1, every 3 weeks, or docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks.
At the interim analysis, overall survival was inferior among patients who received docetaxel plus cisplatin, compared with those who received docetaxel only (hazard ratio, 1.56; 95% confidence interval, 0.98 to 2.49), Dr. Tetsuya Abe of Niigata (Japan) Cancer Center Hospital and his associates reported (J. Clin. Onc. 2015 Jan. 12. [doi:10.1200/JCO.2014.55.8627]).
The investigators terminated the study early after finding the predictive probability that the treatment arm would be statistically superior to the monotherapy arm on final analysis was less than 1%. The median survival time as 14.8 months for the monotherapy arm and 13.3 months for the docetaxel plus cisplatin arm (HR, 1.18; 95% CI, 0.83 to 1.69).
Toxicity varied between arms. The rates of neutropenia were higher with docetaxel alone, while rates of grade 3 or greater anemia, anorexia, and hyponatremia were higher in the combination arm, they said.
Docetaxel every 3 weeks remains the standard treatment for elderly patients with advanced NSCLC, Dr. Abe and associates concluded.
Dr. Abe reported having no financial disclosures. Other authors reported honoraria from sanofi-aventis and Bristol-Myers Squibb.
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