PMID- 29728800 OWN - NLM STAT- MEDLINE DCOM- 20190625 LR - 20190625 IS - 1432-0843 (Electronic) IS - 0344-5704 (Linking) VI - 82 IP - 1 DP - 2018 Jul TI - Phase II trial of induction chemotherapy of pemetrexed plus split-dose cisplatin followed by pemetrexed maintenance for untreated non-squamous non-small-cell lung cancer. PG - 111-117 LID - 10.1007/s00280-018-3598-4 [doi] AB - 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/m(2), days 1 and 8) plus pemetrexed (500 mg/m(2), 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. FAU - Koba, Taro AU - Koba T AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. AD - Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. FAU - Minami, Seigo AU - Minami S AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. FAU - Nishijima-Futami, Yu AU - Nishijima-Futami Y AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. AD - Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. FAU - Masuhiro, Kentaro AU - Masuhiro K AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. AD - Department of Thoracic Malignancy, Osaka Habikino Medical Center, 3-7-1 Habikino, Habikino, 583-8588, Japan. FAU - Kimura, Hiromi AU - Kimura H AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. AD - Department of Internal Medicine, Osaka Hospital Anti-Tuberculosis Association, 2276-1 Neyagawa-kouen, Neyagawa, Osaka, 572-0854, Japan. FAU - Futami, Shinji AU - Futami S AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. AD - Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. FAU - Yaga, Moto AU - Yaga M AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. AD - Department of Respiratory Medicine, NTT West Osaka Hospital, 2-6-40 Karasugatsuji, Tennoji-ku, Osaka, Osaka, 543-8922, Japan. FAU - Mori, Masahide AU - Mori M AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. FAU - Kagawa, Hiroyuki AU - Kagawa H AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. FAU - Uenami, Takeshi AU - Uenami T AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. FAU - Kohmo, Satoshi AU - Kohmo S AD - Department of General Internal Medicine, Nissay Hospital, 6-3-8 Itachibori, Nishi-ku, Osaka, Osaka, 550-0012, Japan. FAU - Otsuka, Tomoyuki AU - Otsuka T AD - Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan. AD - Department of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan. AD - Department of Medical Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Oska, Osaka, 541-8567, Japan. FAU - Yamamoto, Suguru AU - Yamamoto S AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. FAU - Komuta, Kiyoshi AU - Komuta K AD - Department of Respiratory Medicine, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, Osaka, 543-0035, Japan. FAU - Kijima, Takashi AU - Kijima T AD - 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. AD - 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. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20180504 PL - Germany TA - Cancer Chemother Pharmacol JT - Cancer chemotherapy and pharmacology JID - 7806519 RN - 04Q9AIZ7NO (Pemetrexed) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Cisplatin/administration & dosage/adverse effects MH - Drug Administration Schedule MH - Female MH - Humans MH - Induction Chemotherapy MH - Kaplan-Meier Estimate MH - Lung Neoplasms/*drug therapy MH - Maintenance Chemotherapy MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local/*drug therapy MH - Pemetrexed/administration & dosage/adverse effects MH - Progression-Free Survival OTO - NOTNLM OT - Maintenance therapy OT - Multi-centered OT - Non-squamous non-small-cell lung cancer OT - Pemetrexed OT - Phase 2 trial OT - Split-dose cisplatin EDAT- 2018/05/08 06:00 MHDA- 2019/06/27 06:00 CRDT- 2018/05/06 06:00 PHST- 2017/12/19 00:00 [received] PHST- 2018/05/01 00:00 [accepted] PHST- 2018/05/08 06:00 [pubmed] PHST- 2019/06/27 06:00 [medline] PHST- 2018/05/06 06:00 [entrez] AID - 10.1007/s00280-018-3598-4 [pii] AID - 10.1007/s00280-018-3598-4 [doi] PST - ppublish SO - Cancer Chemother Pharmacol. 2018 Jul;82(1):111-117. doi: 10.1007/s00280-018-3598-4. Epub 2018 May 4.