PMID- 32729237 OWN - NLM STAT- MEDLINE DCOM- 20211115 LR - 20211115 IS - 1759-7714 (Electronic) IS - 1759-7706 (Print) IS - 1759-7706 (Linking) VI - 11 IP - 9 DP - 2020 Sep TI - Phase II study of adjuvant chemotherapy with pemetrexed and cisplatin with a short hydration method for completely resected nonsquamous non-small cell lung cancer. PG - 2536-2541 LID - 10.1111/1759-7714.13567 [doi] AB - BACKGROUND: Cisplatin (CDDP) and vinorelbine as an adjuvant chemotherapy improve the overall survival of patients with completely resected non-small cell lung cancer (NSCLC). However, the treatment completion rate is low due to severe adverse events (AEs). Pemetrexed (PEM) has been used in advanced NSCLC due to its high safety and efficacy. Additionally, the safety of a short hydration method for CDDP administration has been previously reported. Here, we investigated the feasibility of CDDP plus PEM with a short hydration method as adjuvant chemotherapy. METHODS: A total of 21 completely resected nonsquamous NSCLC patients with pathological stage IIA to IIIA disease were enrolled into the study. Adjuvant chemotherapy consisted of four cycles of CDDP (75 mg/m(2) ) plus PEM (500 mg/m(2) ) every three weeks with a short hydration method. The primary endpoint was the treatment completion rate, and the secondary endpoints included toxicity, the two-year relapse-free survival (RFS) rate, and the outpatient treatment rate. RESULTS: A total of 21 patients (median age: 66 years; 12 males) were enrolled in two centers. All cases were adenocarcinoma with PS0 (71.4%) or PS1 (28.6%). A total of 81.0% of the patients received four cycles of therapy as scheduled and the primary endpoint was met. The rate of outpatient chemotherapy completion after the second cycle was 90.5%. The grade 3 or higher toxicities were anorexia (n = 2) and pulmonary thromboembolism (n = 1). No grade 3/4 hematological toxicities or creatinine level elevations were observed. The two-year RFS rate was 57.3%. CONCLUSIONS: CDDP and PEM with a short hydration is well tolerated in the outpatient setting with limited toxicity. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: CDDP plus PEM adjuvant therapy with a short hydration method is well tolerated in the outpatient setting with limited toxicity. WHAT THIS STUDY ADDS: CDDP plus PEM with a short hydration method has the potential to be one of the options of adjuvant therapy in the future. CI - (c) 2020 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd. FAU - Tachihara, Motoko AU - Tachihara M AUID- ORCID: 0000-0002-4598-220X AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Dokuni, Ryota AU - Dokuni R AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Okuno, Keiko AU - Okuno K AD - Department of Respiratory Medicine, Aijinkai Takatsuki General Hospital, Takatsuki, Japan. FAU - Tokunaga, Shuntaro AU - Tokunaga S AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Nakata, Kyosuke AU - Nakata K AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Katsurada, Naoko AU - Katsurada N AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Yamamoto, Masatsugu AU - Yamamoto M AUID- ORCID: 0000-0003-0596-555X AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Nagano, Tatsuya AU - Nagano T AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Kobayashi, Kazuyuki AU - Kobayashi K AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Tanaka, Yugo AU - Tanaka Y AUID- ORCID: 0000-0002-6541-1754 AD - Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Funada, Yasuhiro AU - Funada Y AD - Department of Respiratory Medicine, Aijinkai Takatsuki General Hospital, Takatsuki, Japan. FAU - Maniwa, Yoshimasa AU - Maniwa Y AD - Division of Thoracic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan. FAU - Nishimura, Yoshihiro AU - Nishimura Y AD - Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20200730 PL - Singapore TA - Thorac Cancer JT - Thoracic cancer JID - 101531441 RN - 04Q9AIZ7NO (Pemetrexed) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/pharmacology/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology MH - Cisplatin/pharmacology/*therapeutic use MH - Female MH - Humans MH - Lung Neoplasms/*drug therapy/pathology MH - Male MH - Pemetrexed/pharmacology/*therapeutic use PMC - PMC7471012 OTO - NOTNLM OT - Adjuvant chemotherapy OT - cisplatin OT - non-small cell carcinoma OT - pemetrexed OT - short hydration EDAT- 2020/07/31 06:00 MHDA- 2021/11/16 06:00 PMCR- 2020/09/01 CRDT- 2020/07/31 06:00 PHST- 2020/05/22 00:00 [received] PHST- 2020/06/12 00:00 [revised] PHST- 2020/06/17 00:00 [accepted] PHST- 2020/07/31 06:00 [pubmed] PHST- 2021/11/16 06:00 [medline] PHST- 2020/07/31 06:00 [entrez] PHST- 2020/09/01 00:00 [pmc-release] AID - TCA13567 [pii] AID - 10.1111/1759-7714.13567 [doi] PST - ppublish SO - Thorac Cancer. 2020 Sep;11(9):2536-2541. doi: 10.1111/1759-7714.13567. Epub 2020 Jul 30.