Abstract 510P
Background
Maintenance therapy is one strategy that has been investigated as a way of improving outcomes in patients with non-small cell lung cancer. This study was conducted to evaluate the effect of weekly paclitaxel as a continuation maintenance therapy in advanced NSCLC patients.
Methods
This prospective study included patients with advanced non-small cell lung cancer (NSCLC) patients with stage IIIB (T4 N2 or any T N3 disease) and Stage IV disease (T any N M1) with performance status (P.S) ≤ 2 who presented to Clinical Oncology Department in Menoufia University. All patients received carboplatin – paclitaxel for 4 cycles. the patients with initial good response, or stable disease were randomized into 2 arms, the first arm, received weekly paclitaxel (70 mg/m2) as continuation maintenance therapy for 3 weeks of 4 weeks cycle, and evaluated every 12 weeks, continued till disease progression or unacceptable toxicity (maintenance arm), and the second arm was kept under observation (observation arm). The Primary end-point was time to progression, and the Secondary end-point was toxicity of the drug, and the quality of life of the patients, and overall survival.
Results
Total 92 patients were included, 46 patients were in the maintenance arm, and 46 patients were in the observation arm. only 14 patients continued maintenance paclitaxel till end of the study (30.4%). Most patients who completed paclitaxel maintenance therapy till the end of follow up period was 0 PS (85.7%), stage IIIB (57.1%), grade II (42.9%), and all of them was adenocarcinoma. Treatment related toxicities were significantly higher in the maintenance arm compared to observation arm p value: (0.017, 0.001 and <0.001) respectively. lung cancer symptoms scale was bettre in maintenance arm. PFS for maintenance arm was 10 months, while 8 months for observation arm (P value =0.16). OS in maintenance arm was 29 months versus 12.5 months for observation arm with significant P value (0.047).
Conclusions
continuation Maintenance with paclitaxel can be a reasonable treatment option in patients with NSCLC with performance status 0, stage IIIB, grade II tumors of adenocarcinoma histology who experienced complete or partial response after initial paclitaxel carboplatin combination.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
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