Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial.
INTRODUCTION
This study aimed to compare the efficacy of first-line nedaplatin (80 mg/m2) plus docetaxel (75 mg/m2) (ND) versus cisplatin (75 mg/m2) plus docetaxel (75 mg/m2) (CD) in patients with advanced squamous cell lung carcinoma.


METHODS
This open-label randomized controlled phase III trial was performed at 12 hospitals in China. Patients with squamous cell lung carcinoma were randomized to four cycles of ND or CD. The primary endpoint was progression-free survival (PFS). Secondary endpoints included time to progression, best overall response, and adverse events.


RESULTS
In the intent-to-treat analysis set (ND: n = 141; CD: n = 139), median PFS was 4.63 months (95% confidence interval: 4.43-5.10) for the ND and 4.23 months (95% confidence interval: 3.37-4.53) for CD groups (p = 0.056). No significant difference in time to progression was observed between the two groups. Best overall responses and disease control rate were better with ND 51.5%, than with CD 38.1% (p = 0.033 and p = 0.0004, respectively). Grade III or IV adverse events and grade 3-4 nausea and fatigue were more frequent in the CD group compared with the ND group (all p < 0.05).


CONCLUSIONS
There is no improvement in PFS with the nedaplatin and docetaxel combination in the intent-to-treat analysis. More hematologic toxicities were observed in the ND group (compared with CD), whereas more nonhematologic toxicities were observed in the CD group. ND could be a new treatment option for advanced or relapsed squamous cell lung cancer (NCT02088515 at ClinicalTrials.gov).
['Lu|Shun|S|', 'Chen|Zhiwei|Z|', 'Hu|Chengping|C|', 'Zhang|Jian|J|', 'Chen|Yuan|Y|', 'Song|Yong|Y|', 'Zhao|Qiong|Q|', 'Fan|Yun|Y|', 'Wu|Gang|G|', 'Ma|Zhiyong|Z|', 'Fang|Jian|J|', 'Yu|Qitao|Q|', 'Liu|Zhe|Z|']
D000368:Aged D000971:Antineoplastic Combined Chemotherapy Protocols D002294:Carcinoma, Squamous Cell D002945:Cisplatin D000077143:Docetaxel D005260:Female D006801:Humans D008175:Lung Neoplasms D008297:Male D008875:Middle Aged D009944:Organoplatinum Compounds
Nedaplatin Docetaxel Cisplatin Phase III Squamous cell lung carcinoma Randomized controlled trial