Randomized phase 2 trial of pemetrexed, pemetrexed/bevacizumab, and pemetrexed/carboplatin/bevacizumab in patients with stage IIIB/IV non–small cell lung cancer and an Eastern Cooperative Oncology Group performance status of 2. Issue 9 (16th February 2018)

• Record Type: Journal Article
• Authors: Spigel, David R.; Hainsworth, John D.; Joseph, Mathew J.; Shipley, Dianna L.; Hagan, M. Kelly; Thompson, Dana S.; Burris, Howard A.; Greco, F. Anthony
• Is Part Of: Cancer. Volume 124:Issue 9(2018)
• Page Start: 1982
• Page End: 1991
• Publication Date: 2018-02-16
• Subjects: bevacizumab -- carboplatin -- non–small cell lung cancer (NSCLC) -- pemetrexed -- randomized phase 2; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.30986
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract : BACKGROUND: The best treatment for patients with advanced non–small cell lung cancer (NSCLC) and a poor performance status is not well defined. In this phase 2 trial, patients were randomized to receive treatment with either single‐agent pemetrexed or 1 of 2 combination regimens. METHODS: Patients with newly diagnosed, histologically confirmed nonsquamous NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 were stratified by age and serum albumin level and were randomized (1:1:1) to 1 of 3 regimens: pemetrexed (arm 1), pemetrexed and bevacizumab (arm 2), or pemetrexed, carboplatin, and bevacizumab (arm 3). The response to treatment was assessed every 2 cycles; responding and stable patients continued treatment until progression or unacceptable toxicity. RESULTS: One hundred seventy‐two patients were randomized, 162 patients began the study treatment, and 146 patients completed 2 cycles and were evaluated for their response. The median progression‐free survival (PFS) was 2.8 months in arm 1, 4.0 months in arm 2, and 4.8 months in arm 3. The overall response rates were 15% in arm 1, 31% in arm 2, and 44% in arm 3. The overall survival was similar in the 3 treatment arms. All 3 regimens were relatively well tolerated. Patients receiving bevacizumab had an increased incidence of hypertension, proteinuria, and bleeding episodes, but most events were mild or moderate. CONCLUSIONS: All 3 regimens were feasible for patients with advanced NSCLC and an ECOG performance status of 2. The addition of bevacizumab to pemetrexed increased the overall response rate. The efficacy of pemetrexed/carboplatin/bevacizumab (median PFS, 4.8 months) approached the prespecified study PFS goal of 5 months. Larger studies will be necessary to define the role of bevacizumab in addition to standard pemetrexed and carboplatin in this population. Cancer 2018;124:1982‐91 . © 2018 American Cancer Society . Abstract : A comparison of 3 treatment regimens for patients with nonsquamous non–small cell lung cancer and an Eastern Cooperative Oncology Group performance status of 2 (pemetrexed; pemetrexed and bevacizumab; and pemetrexed, carboplatin, and bevacizumab) shows that all 3 regimens are feasible in this population. The addition of bevacizumab to pemetrexed increases the overall response rate, and the combination of pemetrexed, carboplatin, and bevacizumab improves the response rate and progression‐free survival in comparison with pemetrexed.