Ramucirumab Plus Docetaxel for Patients with Non-small cell Lung Cancer with Brain Metastases: A Multicenter, Open-Label Single-Arm Phase II Trial.

Abstract

BACKGROUND:

Ramucirumab plus docetaxel combination therapy (DOC/RAM) for advanced non-small cell lung cancer (NSCLC) achieves favorable outcomes; however, efficacy and safety for patients with brain metastases are still unclear.

METHODS:

Eligible patients included those with advanced NSCLC with measurable asymptomatic brain metastases that progressed after chemotherapy. Patients were intravenously administered ramucirumab (10 mg/kg) and docetaxel (60 mg/m2) every 21-day cycle.

RESULTS:

Due to difficulties in accumulating the planned 65 participants, enrollment was terminated early when 25 patients were enrolled. Primary endpoint: Median progression-free survival (PFS) was 3.9 months (95% CI, 1.8-5.3). Secondary endpoints: Median intracranial progression-free survival was 4.6 months (95% CI, 2.5-5.9); median overall survival was 20.9 months (95% CI, 6.6-not possible to estimate); objective response rate was 20% (95% CI, 6.8-40.7); disease control rate was 68% (95% CI, 46.5-85.1). The most common grade 3 or higher toxicities were neutropenia in 10 patients (40%). Neither intracranial hemorrhage nor grade 5 adverse events were observed. Patients with higher serum soluble vascular endothelial growth factor receptor 2 concentrations at the start of treatment had slightly longer PFS.

CONCLUSION:

No clinical concerns were identified with DOC/RAM for NSCLC with brain metastases in this study. Further investigation with a larger sample size is needed to determine the tolerability and safety of these populations (Trial Identifiers: University Hospital Medical Information Network in Japan [UMIN000024551] and Japan Registry of Clinical Trials [jRCTs071180048]).

• Authors: Keiko Tanimura, Junji Uchino, Hideharu Kimura, Osamu Hiranuma, Yusuke Chihara, Shigeru Tanzawa, Chieko Takumi, Toshiyuki Kita, Koji Inoue, Koichi Minato, Shinnosuke Takemoto, Akira Nakao, Kenichi Yoshimura, Koichi Takayama
• Journal: The oncologist (Oncologist) Vol. 28 Issue 6 Pg. 551-e454 (06 02 2023) ISSN: 1549-490X [Electronic] England
• PMID: 37053467 (Publication Type: Clinical Trial, Phase II, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2023. Published by Oxford University Press.

Chemical References

• Docetaxel
• Vascular Endothelial Growth Factor A

Topics

• Humans
• Carcinoma, Non-Small-Cell Lung (pathology)
• Docetaxel
• Lung Neoplasms (pathology)
• Vascular Endothelial Growth Factor A
• Brain Neoplasms (drug therapy, secondary)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Ramucirumab