316P - Phase II study of ramucirumab and docetaxel for platinum-resistance NSCLC patients with malignant pleural effusion: Analysis of pleural effusion control rate

Background

The prognosis of non-small cell lung cancer (NSCLC) patients with malignant pleural effusion (MPE) due to pleural carcinomatosis is reported to be poor. Several studies suggested that anti-angiogenic treatments had the effect of decreasing vascular permeability and reducing pleural effusion. Ramucirumab (RAM), a vascular endothelial growth factor receptor-2 antibody that inhibits tumor angiogenesis, is widely used with docetaxel (DTX) after platinum doublet therapy failure. Presently, there is no data concerning the safety profile and efficacy of administering RAM+DTX to NSCLC patients with MPE.

Methods

This was a single-arm, multicenter phase II study to examine the effect and safety of administering DTX + RAM in a combined treatment for platinum-resistance NSCLC patients with MPE. RAM 10 mg/kg + DTX 60 mg/m² every 3 weeks until the patient until progression or unacceptable toxicity. The primary objective of this study was to evaluate the pleural effusion control rate at 8 weeks after the start of treatment. Pleural effusion control was defined as the percentage of patients not requiring drainage within 8 weeks after RAM+DTX. An expected pleural effusion control rate was 50%, a threshold was 20%, α of 0.05, β of 0.20.The secondary objectives of the study were: objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.

Results

From Sep 2019 to Mar 2022, 15 patients were enrolled. Prior MPE management (none/ Thoracentesis/ Chest tube drainage): 7/2/6. One patient discontinued the protocol treatment on day 29 because of refusal of treatment and excluded from the analysis. The pleural effusion control rate at 8 weeks was 100 % (14 out of 14 evaluable cases, 95%CI: 76.8-100). 28.6% (95%CI: 8.4-58.1) of patients had decreased pleural effusion determined by Chest X-ray or CT. ORR was 7.2% (95% CI 0.2-36.0). Median PFS was 191 days (95% CI 57-292; 10 events) and median OS was 309 days (95%CI 98-NA; 6 events). Severe AEs; Grade 3 febrile neutropenia (n=2, 15.3%), Grade 3 pneumonitis (n=1, 7.6%), Grade 3 edema limbs (n=1, 7.6%) and Grade 4 neutropenia (n=2, 15.3%) were occurred.

Conclusions

RAM+DTX seemed to be a safe and effective for platinum-resistance NSCLC patients with MPE.

Clinical trial identification

jRCTs071190013.

Editorial acknowledgement

Legal entity responsible for the study

Nagasaki University Hospital.

Funding

Eli Lilly.

Disclosure

All authors have declared no conflicts of interest.