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Randomized phase II study of pemetrexed or pemetrexed plus bevacizumab for elderly patients with previously untreated non-squamous non-small cell lung cancer: Results of the Lung Oncology Group in Kyushu (LOGIK1201)


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Title: Randomized phase II study of pemetrexed or pemetrexed plus bevacizumab for elderly patients with previously untreated non-squamous non-small cell lung cancer: Results of the Lung Oncology Group in Kyushu (LOGIK1201)
Authors: Fukuda, Minoru / Kitazaki, Takeshi / Ogawara, Daiki / Ichiki, Masao / Mukae, Hiroshi / Maruyama, Riichiroh / Nakagaki, Noriaki / Shimada, Midori / Ikeda, Takaya / Kishimoto, Junji / Harada, Taishi / Seto, Takashi / Ebi, Noriyuki / Takayama, Koichi / Okamoto, Isamu / Ichinose, Yukito / Sugio, Kenji
Issue Date: Jun-2019
Publisher: Elsevier B.V.
Citation: Lung Cancer, 132, pp.1-8; 2019
Abstract: Objectives: To evaluate the efficacy and safety, we conducted a randomized phase II study of pemetrexed (Pem) versus Pem + bevacizumab (Bev) for elderly patients with non-squamous non-small cell lung cancer (NSqNSCLC). Patients and methods: The eligibility criteria were as follows: NSqNSCLC, no prior therapy,stage IIIB/IV disease or postoperative recurrence, age: ≥75 years, performance status (PS): 0–1, and adequate bone marrow function. The patients were randomly assigned (1:1 ratio)to receive Pem or Pem + Bev. The primary endpoint was progression-free survival (PFS).The secondary endpoints were the response rate, OS, toxicities, and cost-effectiveness. Results: Forty-one patients were enrolled and 40 (20 from each group) were assessable. Their characteristics were as follows: male/female = 23/17; median age (range) = 78 (75–83); stage IIIB/IV/postoperative recurrence = 1/30/9; PS 0/1 = 11/29. All cases involved adenocarcinoma.There was no significant intergroup difference in PFS and the median PFS (95% confidence interval) values of the Pem and Pem + Bev groups were 5.4 (3.0–7.4) and 5.5 (3.6–9.9) months, respectively (p = 0.66). The response rate was significantly higher in the Pem + Bev group(15% vs. 55%, p = 0.0146), and there was no significant difference in OS (median: 16.0 vs. 16.4 months, p = 0.58). Grade 3 and 4 leukopenia, neutropenia,and thrombocytopenia were seen in 10 and 30, 20 and 55, and 5 and 5 cases, respectively. Drug costs were higher in the Pem + Bev group (median: 1,522,008 vs. 3,368,428 JPY, p = 0.01). No treatment-related deaths occurred. Conclusions: Adding Bev to Pem did not result in improved survival in the elderly NSqNSCLC patients. Compared with Pem + Bev, Pem monotherapy had similar effects on survival, a more favorable toxicity profile, and was more cost-effective in elderly NSqNSCLC patients. Pem monotherapy might be one of the optional regimen for NSqNSCLC patients aged ≥75 years.
Keywords: pemetrexed / bevacizumab / lung cancer / elderly / NSqNSCLC
URI: http://hdl.handle.net/10069/39064
ISSN: 01695002
DOI: 10.1016/j.lungcan.2019.01.008
Rights: © 2019 Elsevier B.V. This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/
Type: Journal Article
Text Version: author
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/39064

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