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.

• Authors: 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
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 132 Pg. 1-8 (06 2019) ISSN: 1872-8332 [Electronic] Ireland
• PMID: 31097081 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2019 Elsevier B.V. All rights reserved.

Chemical References

• Pemetrexed
• Bevacizumab

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bevacizumab (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, genetics, mortality)
• Cost-Benefit Analysis
• Female
• Humans
• Lung Neoplasms (drug therapy, genetics, mortality)
• Male
• Neoplasm Staging
• Pemetrexed (therapeutic use)
• Prospective Studies
• Survival Analysis
• Treatment Outcome