Japanese Phase III Trial Shows No Survival Benefit of First-Line Weekly Cisplatin/Docetaxel vs Docetaxel in Elderly Patients With Advanced NSCLC
In a Japanese phase III trial (Intergroup Trial JCOG0803/WJOG4307L) reported in the Journal of Clinical Oncology, Abe et al found no overall survival benefit of weekly cisplatin/docetaxel vs standard docetaxel in the first-line treatment of elderly patients with advanced non–small cell lung cancer (NSCLC). The trial was terminated early.
Study Details
In the trial, 276 patients with stage III or IV or recurrent disease aged ≥ 70 years with Eastern Cooperative Oncology Group performance status 0 or 1 who were considered unsuitable for bolus cisplatin treatment were randomly assigned between October 2008 and September 2010 to receive docetaxel 20 mg/m2 plus cisplatin 25 mg/m2 on days 1, 8, and 15 every 4 weeks (n = 139) or docetaxel 60 mg/m2 on day 1 every 3 weeks (n = 137). The primary endpoint was overall survival.
For the combination and monotherapy groups, the median age was 76 years in both, 73% and 69% of patients were male, 26% and 28% were never-smokers, 65% and 64% had a performance status of 1, 69% in both groups had stage IV or recurrent disease, and 63% and 67% had adenocarcinoma histology, respectively.
Early Termination
In the first interim analysis, including data from 221 patients, overall survival was poorer in the combination group (hazard ratio [HR] = 1.56, 95% confidence interval [CI] = 0.98–2.49); the probability of a statistically superior difference favoring combination treatment on final analysis was 0.996%, with the study thus being terminated early. In an updated analysis including all patients, median overall survival was 13.3 months in the combination group vs 14.8 months in the monotherapy group (HR = 1.18, 95% CI = 0.83–1.69).
Toxicity
Grade 3 or 4 leukopenia (63% vs 5%) and neutropenia (89% vs 10%) and grade 3 febrile neutropenia (15% vs 0%) were more common in the monotherapy group, and grade 3 or 4 anorexia (11% vs 1.5%) and hyponatremia (15% vs 5%) were more common with the combination.
The investigators concluded: “This study failed to demonstrate any survival advantage of weekly docetaxel plus cisplatin over docetaxel monotherapy as first-line chemotherapy for advanced NSCLC in elderly patients.”
Tetsuya Abe, MD, PhD, of Niigata Cancer Center Hospital, is the corresponding author for the Journal of Clinical Oncology article.
The study was supported by grants from the Ministry of Health, Labour, and Welfare of Japan. For full disclosures of the study authors, visit jco.ascopubs.org.
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