Assessment of treatment
tumor, Tumor, SD, Tumors, Toxicity
ADVERSE EVENT, TUMOR, METASTASIS, TUMOR, TUMORS, ADVERSE EVENT
Before commencement of therapy, a complete medical history, physical examination, and resting 12‐lead electrocardiogram were performed. Tumor staging was determined by physical examination, routine chest radiography, computed tomography (CT) of the chest and abdomen, bone scintigraphy, or positron emission tomography (PET), and magnetic resonance imaging (MRI) of the head. Staging was performed according to the 7th edition of the tumor, node, metastasis (TNM) system. A complete blood count including differential leukocyte count, urinalysis, and biochemical analyses were performed two or three times per month during induction therapy and once per course during maintenance therapy. Physical examinations and adverse event assessments according to the Common Toxicity Criteria of Adverse Events, version 4.0 were evaluated for each course of therapy. Tumor efficacy was evaluated radiologically using the Response Evaluation Criteria In Solid Tumors version 1.1. Chest X‐rays were performed at least twice per course during induction therapy and once per course during maintenance therapy.After the second cycle of induction chemotherapy with cisplatin, pemetrexed, and bevacizumab, CT of the chest and abdomen was performed. After the fourth cycle of induction chemotherapy, CT of the chest and abdomen and MRI of the head were performed between Day 15 and Day 29 after the fourth cycle of induction chemotherapy. In induction therapy, tumor response of CR and PR was needed to confirm the four‐week response duration in this study. After the tumor response evaluation of induction therapies, patients with CR, PR, and SD following induction therapy were randomized (1:1) to receive maintenance therapy with pemetrexed plus bevacizumab or pemetrexed alone. The maintenance therapy started between 3 weeks and 8 weeks after the fourth cycle of induction therapy. During maintenance therapy, CT of the chest and abdomen was performed every 6 weeks, and tumor efficacy was evaluated. All CT and MRI examinations were diagnosed by independent radiologists.