Back to Search
Start Over
A single arm Phase I/II trial on the combination of carboplatin, nab-paclitaxel and avastin as first-line treatment for advanced non-squamous non-small cell lung cancer (TORG1424/OLCSG1402: CARNAVAL).
- Source :
-
Japanese journal of clinical oncology [Jpn J Clin Oncol] 2024 Jul 07; Vol. 54 (7), pp. 805-812. - Publication Year :
- 2024
-
Abstract
- Background: Bevacizumab with platinum doublet therapy including paclitaxel + carboplatin improves the survival of patients with non-squamous non-small cell lung cancer. However, in a previous trial (CA031), paclitaxel + carboplatin led to Grade > 3 neutropenia in a Japanese population. Nanoparticle albumin-bound paclitaxel exhibits an improved toxicity profile. We evaluated the safety, dosage and response rate of the nanoparticle albumin-bound paclitaxel + carboplatin + bevacizumab combination in a Japanese population.<br />Methods: Chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer were included. The dosage schedule was established in the Phase I trial as follows: 4-6 cycles of carboplatin (area under the concentration-time curve = 6 on Day 1) + nanoparticle albumin-bound paclitaxel (100 mg/m2 on Days 1, 8 and 15) + bevacizumab (15 mg/kg on Day 1), followed by maintenance therapy (nanoparticle albumin-bound paclitaxel + bevacizumab). The response rate and presence of adverse effects were evaluated in the Phase II trial.<br />Results: The overall response rate was 56.5% (90% confidence interval: 44.5-68.5), and 93% of patients (43/46) showed tumor shrinkage or maintained a stable disease course. The primary endpoint was achieved. At the median follow-up duration of 42 months, the median overall survival was 18.9 (range: 10.5-32.4) months. The most frequently observed Grade ≥ 3 adverse effects were neutropenia (72%), leukopenia (50%) and anemia (30%).<br />Conclusions: All adverse effects were manageable and none resulted in patient death. In conclusion, the nanoparticle albumin-bound paclitaxel + carboplatin + bevacizumab combination is favorable and well tolerated in Japanese patients as first-line treatment for advanced non-squamous non-small cell lung cancer.<br /> (© The Author(s) 2024. Published by Oxford University Press.)
- Subjects :
- Humans
Male
Female
Aged
Middle Aged
Adult
Japan
Carcinoma, Non-Small-Cell Lung drug therapy
Carcinoma, Non-Small-Cell Lung pathology
Carboplatin administration & dosage
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols adverse effects
Lung Neoplasms drug therapy
Lung Neoplasms pathology
Bevacizumab administration & dosage
Bevacizumab adverse effects
Paclitaxel administration & dosage
Albumins administration & dosage
Albumins adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1465-3621
- Volume :
- 54
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Japanese journal of clinical oncology
- Publication Type :
- Academic Journal
- Accession number :
- 38594880
- Full Text :
- https://doi.org/10.1093/jjco/hyae044