Progression-free survival (PFS) was found to be prolonged with docetaxel maintenance therapy after first-line treatment for advanced non-small cell lung cancer (NSCLC), according to the results of a phase 3 trial published in the Annals of Translational Medicine.
A previous study demonstrated that docetaxel maintenance therapy improved survival among a White population with NSCLC. This study aimed to determine if docetaxel plus cisplatin maintenance therapy was effective among an Asian population and characterize the optimal dose.
The multicenter, open-label, phase 3 trial (TFINE; ClinicalTrials.gov Identifier: NCT01038661) randomly assigned 375 patients with stage IIIB or IV NSCLC to first-line therapy with docetaxel at 75 mg/m2 or 60 mg/m2 plus cisplatin at 75 mg/m2 for up to 4 cycles. Patients who achieved disease control were then randomly assigned to maintenance therapy of best standard of care (BSC) or docetaxel at 60 mg/m2 for up to 6 cycles. The primary endpoint was PFS, and the secondary endpoints included best response rate, disease control rate, objective response rate, and overall survival (OS).
During a median follow-up of 22.8 months, the median PFS was 5.8 months with docetaxel maintenance compared with 3.0 months with BSC (hazard ratio, 0.57; 95% CI, 0.40-0.80; P =.0001). This translated to 1-year PFS of 21.9% and 6.9% in the docetaxel maintenance and BSC groups, respectively.
The median PFS from first-line therapy was similar between the groups at 4.9 and 4.7 months in the groups who received 75 mg/m2 or 60 mg/m2 of docetaxel, respectively (P =.99).
The study found OS to be similar regardless of maintenance therapy, with a median of 12.3 months with docetaxel maintenance and 13.7 months in the BSC group (P =.77). The median OS was also similar in the groups administered different docetaxel doses as first-line therapy, at 11.8 months with 75 mg/m2 and 13.0 months with 60 mg/m2.
The different docetaxel doses as first-line therapy resulted in similar objective response rates of 23.9% in the 60 mg/m2 arm and 30.7% in the 75 mg/m2 arm.
Adverse events were reported among 47.8% and 45.7% of patients treated with 75 mg/m2 or 60 mg/m2 of docetaxel, respectively. Adverse events were more common with docetaxel maintenance therapy at 73.7% compared with 11.5% with BSC.
The authors concluded that “continuation maintenance therapy with a lower dose of docetaxel following 4 cycles of platinum-based chemotherapy containing docetaxel significantly improved PFS in patients with advanced NSCLC.” They added that due to the lower frequency of adverse events, the 60 mg/m2 dose of docetaxel as first-line therapy may be preferred among East Asian populations.
Zhang L, Lu S, Cheng Y, et al. Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial. Ann Transl Med. 2021;9:338. doi:10.21037/atm-20-8078