469P - Comparison of combined chemoradiotherapy regimens; Paclitaxel plus carboplatin and cisplatin plus etoposide for locally advanced non-small cell lung cancer: A randomised phase III trial

Background

The optimal chemotherapy regimen to use with radiotherapy in stage III non–small cell lung cancer (NSCLC) is still unknown. This phase III comparative randomized trial was conducted to determine the optimal chemotherapy regimen with standard daily concurrent thoracic radiation therapy (CTRT), in patients with locally advanced unresected stage III NSCLC.

Methods

We recruited 188 patients aged 18–81 years with stage III, histologically confirmed NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, an estimated life expectancy of greater than 3 months, and adequate organ function from January 2011 to December 2018. Patients were randomised (1:1) to paclitaxel plus carboplatin and cisplatin plus etoposide arms.

Results

Patients with unresected stages IIIA and IIIB NSCLC received carboplatin (AUC=2) and paclitaxel (45 mg/m2) given weekly with CTRT (63 Gy) followed by two cycles of consolidation therapy (carboplatin AUC=6, paclitaxel 200 mg/m2) (arm CP) and cisplatin (50 mg/m2 on days 1, 8, 29, and 36) plus etoposide (50 mg/m2 daily on days 1 to 5, and 29 to 33) with CTRT followed by consolidation cisplatin plus etoposide (arm EP) were included. On hundred eighty eligible patients were evaluated. With median follow-up time of 41.7 months, median overall survival was 19.8 and 18.1 months for arms CP and EP, respectively (P = 0.279). But patients in arm EP, compared with patients in arm CP, had more grade 4 neutropenia (18.5% vs 11,1%, p < 0.001), grade 4 naussea/vomiting (18,5% vs 15.3 %, p < 0.001) grade 3-4 mucositis/esophagitis (23,4% vs 15,3%, p < 0.001) and acute kidney disease (27.1% vs 15,1%, p < 0.001).

Conclusions

In patients with stage III NSCLC treated with cisplatin plus etoposide and carboplatin plus paclitaxel had similar overall survival, but cisplatin plus etoposide arm was associated with increased toxicity.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

East Mediterranean Oncology Initiation.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.