title: Phase II study of pemetrexed and carboplatin plus bevacizumab, followed by maintenance pemetrexed and bevacizumab in Japanese patients with non-squamous non-small cell lung cancer.
abstract: The present study evaluated the efficacy and safety of pemetrexed, carboplatin and bevacizumab, followed by maintenance pemetrexed and bevacizumab, in chemotherapy-naïve patients with stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC). The patients were administered pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve, 6.0 mg/ml × min) and bevacizumab (15 mg/kg) intravenously every three weeks for up to six cycles. Patients who did not experience tumor progression remained on maintenance pemetrexed and bevacizumab until disease progression or unacceptable toxicity occurred. The primary endpoint was the overall response rate. Of the 26 patients enrolled between March 2010 and April 2011, three were excluded due to brain metastases, therefore the intention-to-treat (ITT) population consisted of 23 patients. The median age was 64 years (range, 40-74 years) and 15 patients were male. In total, six patients had a performance status of 0, and 20 had stage IV tumors. The response rate was 69.6% [95% confidence interval (CI), 47.1-86.8], the disease control rate was 100% and the time to response was 1.2 months (95% CI, 0.72-1.93). The median progression-free survival time was 8.6 months (95% CI, 5.9-10.9) and the median overall survival time was 18.6 months (95% CI, 12.9-24.8). There were no grade 3 or worse hemorrhagic events and the feasibility was modest. Overall, pemetrexed and carboplatin plus bevacizumab, followed by maintenance pemetrexed and bevacizumab, was effective and tolerable in the patients with non-squamous NSCLC, and the time to response was relatively short.
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yokoi
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Yoshitaro
authors.initials: Y
authors.lastname: Torii
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Katashiba
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Sugimoto
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tanijiri
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Ogata
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Noriko
authors.initials: N
authors.lastname: Inagaki
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Kayoko
authors.initials: K
authors.lastname: Kibata
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Mina
authors.initials: M
authors.lastname: Hayashi
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Maiko
authors.initials: M
authors.lastname: Niki
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Toshiki
authors.initials: T
authors.lastname: Shimizu
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Miyara
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Takayasu
authors.initials: T
authors.lastname: Kurata
authors.affiliation: First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka 573-1010, Japan.
authors.forename: Shosaku
authors.initials: S
authors.lastname: Nomura
keywords: Japanese; bevacizumab; chemotherapy; non-squamous non-small cell lung cancer; pemetrexed