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 4 elderly NSqNSCLC patients. Pem monotherapy might be one of the optional regimen for NSqNSCLC patients aged ≥75 years.

The Safety and Effectiveness of Bevacizumab in the Treatment of Nonsquamous Non-Small-Cell Lung Cancer: A Meta-Analysis of Randomized Controlled Trials

“…Two hundred and thirty-three studies were considered potentially eligible for further assessment after duplicates were removed. Finally, 10 RCTs [17][18][19][20][21][22][23][24][25][26] that involved a total of 3134 patients published between 2006 and 2020 met the inclusion criteria and were included in this meta-analysis after a full-text review. Figure 1 shows the literature selection process.…”

RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability

“…This is possibly due to chance because of the small sample size of the subgroup aged ≥ 70 years, which might increase the magnitude of variability in incidence rates in this group. Similarly, a higher incidence of grade ≥ 3 AEs was reported in elderly (≥ 75 years) patients with advanced NSCLC who received other antiangiogenic agents such as bevacizumab plus chemotherapy [ 23 , 24 ].…”

Real-World Incidence of Febrile Neutropenia among Patients Treated with Single-Agent Amrubicin: Necessity of the Primary Prophylactic Administration of Granulocyte Colony-Stimulating Factor

“…It is interesting to note that single-agent amrubicin treatment in elderly patients was not a risk factor in the present study, whether they were 65 years or older or 75 years or older. Although chemotherapy in elderly patients is known to have different results than in younger patients [ 32 , 33 , 34 ], it is presumed that chemotherapy can safely be administered to even elderly patients with good PS and an appropriate dose setting. An amrubicin dose of 45 mg/m 2 was a factor for longer OS, and decrease in dose before treatment was a risk factor.…”