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
; 132: 1-8, 2019 06.
Article
em En
| MEDLINE
| ID: mdl-31097081
ABSTRACT
OBJECTIVES:
To evaluate the efficacy and safety, we conducted a randomized phase II study of pemetrexed (Pem) versus Pemâ¯+â¯bevacizumab (Bev) for elderly patients with non-squamous non-small cell lung cancer (NSqNSCLC). PATIENTS ANDMETHODS:
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 (11 ratio) to receive Pem or Pemâ¯+â¯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/femaleâ¯=â¯23/17; median age (range)â¯=â¯78 (75-83); stage IIIB/IV/postoperative recurrenceâ¯=â¯1/30/9; PS 0/1â¯=â¯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 Pemâ¯+â¯Bev groups were 5.4 (3.0-7.4) and 5.5 (3.6-9.9) months, respectively (pâ¯=â¯0.66). The response rate was significantly higher in the Pemâ¯+â¯Bev group (15% vs. 55%, pâ¯=â¯0.0146), and there was no significant difference in OS (median 16.0 vs. 16.4 months, pâ¯=â¯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 Pemâ¯+â¯Bev group (median 1,522,008 vs. 3,368,428 JPY, pâ¯=â¯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 Pemâ¯+â¯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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma Pulmonar de Células não Pequenas
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Pemetrexede
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Bevacizumab
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Neoplasias Pulmonares
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article