Phase II study of bevacizumab, cisplatin, and docetaxel plus maintenance bevacizumab as first-line treatment for patients with advanced non-squamous non-small-cell lung cancer combined with exploratory analysis of circulating endothelial cells: Thoracic Oncology Research Group (TORG)1016.
Abstract | BACKGROUND: METHODS: Eligible patients were chemotherapy-naive and had advanced/recurrent non-squamous NSCLC. The patients received 4 cycles of docetaxel (60 mg/m2), cisplatin (80 mg/m2), and bevacizumab (15 mg/kg) once every 3 weeks, followed by bevacizumab as maintenance therapy, every 3 weeks until disease progression or attainment of unacceptable toxicity level. The primary endpoint was objective response rate (ORR). The numbers of circulating endothelial cells (CEC) were also estimated on days 1 and 8 of the first cycle for the exploratory analysis of efficacy prediction. RESULTS: A total of 47 patients were enrolled from October 2010 to April 2012. Bevacizumab as maintenance therapy was administered to 41 patients (87.2%), and the median number of total treatment cycles was 9 (range: 1-36). ORR, median progression-free survival (PFS), and median overall survival of the patients were 74.5%, 9.0 months, and 27.5 months, respectively. The most common grade 3/4 adverse event was neutropenia (95.7%), followed by leukopenia (59.6%) and hypertension (46.8%). PFS was longer in patients with ≥10 count increase in CECs than that in patients with < 10 count increase in CECs (respective median PFS of 11.0 months versus 6.90 months) although the difference was not statistically significant (p = 0.074). CONCLUSIONS: TRIAL REGISTRATION: UMIN Clinical Trial Registry; UMIN000004368 . Registered date; October 11, 2010 (Retrospectively registered).
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Authors | Satoshi Ikeda, Terufumi Kato, Takashi Ogura, Akimasa Sekine, Tsuneyuki Oda, Noriyuki Masuda, Satoshi Igawa, Ken Katono, Sakiko Otani, Kouzo Yamada, Haruhiro Saito, Tetsuro Kondo, Yukio Hosomi, Yoshiro Nakahara, Masanori Nishikawa, Keiko Utumi, Yuki Misumi, Takeharu Yamanaka, Kentaro Sakamaki, Hiroaki Okamoto |
Journal | BMC cancer
(BMC Cancer)
Vol. 18
Issue 1
Pg. 241
(03 02 2018)
ISSN: 1471-2407 [Electronic] England |
PMID | 29499653
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Taxoids
- Docetaxel
- Bevacizumab
- Cisplatin
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Topics |
- Adenocarcinoma
(blood, drug therapy, pathology)
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Bevacizumab
(administration & dosage)
- Carcinoma, Non-Small-Cell Lung
(blood, drug therapy, pathology)
- Cisplatin
(administration & dosage)
- Docetaxel
- Endothelial Cells
(pathology)
- Female
- Follow-Up Studies
- Humans
- Lung Neoplasms
(blood, drug therapy, pathology)
- Male
- Middle Aged
- Neoplastic Cells, Circulating
(pathology)
- Prognosis
- Retrospective Studies
- Survival Rate
- Taxoids
(administration & dosage)
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