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01-07-2018 | Original Article

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

Authors: Taro Koba, Seigo Minami, Yu Nishijima-Futami, Kentaro Masuhiro, Hiromi Kimura, Shinji Futami, Moto Yaga, Masahide Mori, Hiroyuki Kagawa, Takeshi Uenami, Satoshi Kohmo, Tomoyuki Otsuka, Suguru Yamamoto, Kiyoshi Komuta, Takashi Kijima

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2018

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.

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Title: 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
Authors: Taro Koba
Seigo Minami
Yu Nishijima-Futami
Kentaro Masuhiro
Hiromi Kimura
Shinji Futami
Moto Yaga
Masahide Mori
Hiroyuki Kagawa
Takeshi Uenami
Satoshi Kohmo
Tomoyuki Otsuka
Suguru Yamamoto
Kiyoshi Komuta
Takashi Kijima
Publication date: 01-07-2018
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 1/2018
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-018-3598-4

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