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)

Minoru Fukuda, Takeshi Kitazaki, Daiki Ogawara, Masao Ichiki, Hiroshi Mukae, Riichiroh Maruyama, Noriaki Nakagaki, Midori Shimada, Takaya Ikeda, Junji Kishimoto, Taishi Harada, Takashi Seto, Noriyuki Ebi, Koichi Takayama, Isamu Okamoto, Yukito Ichinose, Kenji Sugio

研究成果: ジャーナルへの寄稿記事

抄録

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.

元の言語英語
ページ(範囲)1-8
ページ数8
ジャーナルLung Cancer
132
DOI
出版物ステータス出版済み - 6 1 2019

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Pemetrexed
Non-Small Cell Lung Carcinoma
Lung Neoplasms
Disease-Free Survival
Bevacizumab
Recurrence
Drug Costs
Survival
Leukopenia

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

これを引用

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). / 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.

:: Lung Cancer, 巻 132, 01.06.2019, p. 1-8.

研究成果: ジャーナルへの寄稿記事

Fukuda, M, Kitazaki, T, Ogawara, D, Ichiki, M, Mukae, H, Maruyama, R, Nakagaki, N, Shimada, M, Ikeda, T, Kishimoto, J, Harada, T, Seto, T, Ebi, N, Takayama, K, Okamoto, I, Ichinose, Y & Sugio, K 2019, '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)', Lung Cancer, 巻. 132, pp. 1-8. https://doi.org/10.1016/j.lungcan.2019.01.008
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. / 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). :: Lung Cancer. 2019 ; 巻 132. pp. 1-8.
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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)",
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.",
author = "Minoru Fukuda and Takeshi Kitazaki and Daiki Ogawara and Masao Ichiki and Hiroshi Mukae and Riichiroh Maruyama and Noriaki Nakagaki and Midori Shimada and Takaya Ikeda and Junji Kishimoto and Taishi Harada and Takashi Seto and Noriyuki Ebi and Koichi Takayama and Isamu Okamoto and Yukito Ichinose and Kenji Sugio",
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month = "6",
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language = "English",
volume = "132",
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TY - JOUR

T1 - Randomized phase II study of pemetrexed or pemetrexed plus bevacizumab for elderly patients with previously untreated non-squamous non-small cell lung cancer

T2 - Results of the Lung Oncology Group in Kyushu (LOGIK1201)

AU - Fukuda, Minoru

AU - Kitazaki, Takeshi

AU - Ogawara, Daiki

AU - Ichiki, Masao

AU - Mukae, Hiroshi

AU - Maruyama, Riichiroh

AU - Nakagaki, Noriaki

AU - Shimada, Midori

AU - Ikeda, Takaya

AU - Kishimoto, Junji

AU - Harada, Taishi

AU - Seto, Takashi

AU - Ebi, Noriyuki

AU - Takayama, Koichi

AU - Okamoto, Isamu

AU - Ichinose, Yukito

AU - Sugio, Kenji

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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.

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DO - 10.1016/j.lungcan.2019.01.008

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JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

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