Taro Koba1,2, Seigo Minami1, Yu Nishijima-Futami1,2, Kentaro Masuhiro1,3, Hiromi Kimura4,5, Shinji Futami1,2, Moto Yaga1,6, Masahide Mori4, Hiroyuki Kagawa4, Takeshi Uenami4, Satoshi Kohmo7, Tomoyuki Otsuka2,4,8, Suguru Yamamoto1, Kiyoshi Komuta1, Takashi Kijima9,10. 1. Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. 2. Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. 3. Department of Thoracic Malignancy, Osaka Habikino Medical Center, 3-7-1 Habikino, Habikino, 583-8588, Japan. 4. Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. 5. Department of Internal Medicine, Osaka Hospital Anti-Tuberculosis Association, 2276-1 Neyagawa-kouen, Neyagawa, Osaka, 572-0854, Japan. 6. Department of Respiratory Medicine, NTT West Osaka Hospital, 2-6-40 Karasugatsuji, Tennoji-ku, Osaka, Osaka, 543-8922, Japan. 7. Department of General Internal Medicine, Nissay Hospital, 6-3-8 Itachibori, Nishi-ku, Osaka, Osaka, 550-0012, Japan. 8. Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Oska, Osaka, 541-8567, Japan. 9. Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. tkijima@hyo-med.ac.jp. 10. Division of Respiratory Medicine, Department of Internal Medicine, Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan. tkijima@hyo-med.ac.jp.
Abstract
PURPOSE: We conducted a phase II trial to evaluate the efficacy and safety of induction chemotherapy of pemetrexed plus split-dose cisplatin followed by pemetrexed maintenance for advanced non-squamous non-small-cell lung cancer (NSCLC). METHODS: Patients with advanced or recurrent untreated non-squamous NSCLC received split-dose cisplatin (40 mg/m2, days 1 and 8) plus pemetrexed (500 mg/m2, day 1) tri-weekly. After four cycles of induction, patients without disease progression received pemetrexed maintenance until disease progression or unacceptable toxicity. The primary endpoint was the 1-year survival rate. The secondary endpoints were progression-free survival (PFS), overall survival (OS), response in induction phase, and safety. RESULTS: From February 2012 to September 2014, 53 assessable patients were enrolled in this study. Thirty-eight (71.7%) patients completed induction therapy, while 35 (66.0%) received maintenance therapy. The 1-year survival rate was 67.7%. The median PFS and OS were 5.3 and 18.6 months, respectively. The response rate and disease control rate (DCR) during the induction phase were 37.7 and 86.8%, respectively. Eight patients (15.1%) discontinued the therapy due to adverse events (AEs) during the induction phase, but both hematological and non-hematological AEs were infrequent. CONCLUSIONS: Treatment with induction chemotherapy of pemetrexed plus split-dose cisplatin showed a promising 1-year survival rate, DCR, and transition rate into maintenance phase. This regimen is feasible and well-tolerated. A phase III study comparing this regimen with conventional tri-weekly regimen is warranted.
PURPOSE: We conducted a phase II trial to evaluate the efficacy and safety of induction chemotherapy of pemetrexed plus split-dose cisplatin followed by pemetrexed maintenance for advanced non-squamous non-small-cell lung cancer (NSCLC). METHODS:Patients with advanced or recurrent untreated non-squamous NSCLC received split-dose cisplatin (40 mg/m2, days 1 and 8) plus pemetrexed (500 mg/m2, day 1) tri-weekly. After four cycles of induction, patients without disease progression received pemetrexed maintenance until disease progression or unacceptable toxicity. The primary endpoint was the 1-year survival rate. The secondary endpoints were progression-free survival (PFS), overall survival (OS), response in induction phase, and safety. RESULTS: From February 2012 to September 2014, 53 assessable patients were enrolled in this study. Thirty-eight (71.7%) patients completed induction therapy, while 35 (66.0%) received maintenance therapy. The 1-year survival rate was 67.7%. The median PFS and OS were 5.3 and 18.6 months, respectively. The response rate and disease control rate (DCR) during the induction phase were 37.7 and 86.8%, respectively. Eight patients (15.1%) discontinued the therapy due to adverse events (AEs) during the induction phase, but both hematological and non-hematological AEs were infrequent. CONCLUSIONS: Treatment with induction chemotherapy of pemetrexed plus split-dose cisplatin showed a promising 1-year survival rate, DCR, and transition rate into maintenance phase. This regimen is feasible and well-tolerated. A phase III study comparing this regimen with conventional tri-weekly regimen is warranted.
Authors: Martin Metzenmacher; Hans-Georg Kopp; Frank Griesinger; Niels Reinmuth; Martin Sebastian; Monika Serke; Cornelius Florian Waller; Michael Thomas; Jochen Eggert; Gerald Schmid-Bindert; Mathias Hoiczyk; Daniel Christian Christoph; Martin Kimmich; Burkhard Deuß; Stephanie Seifert; Swantje Held; Martin Schuler; Thomas Herold; Frank Breitenbuecher; Wilfried Ernst Erich Eberhardt Journal: Ther Adv Med Oncol Date: 2021-03-09 Impact factor: 8.168