Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer

Isamu Okamoto, Keisuke Aoe, Terufumi Kato, Yukio Hosomi, Akira Yokoyama, Fumio Imamura, Katsuyuki Kiura, Tomonori Hirashima, Makoto Nishio, Naoyuki Nogami, Hiroaki Okamoto, Hideo Saka, Nobuyuki Yamamoto, Naoto Yoshizuka, Risa Sekiguchi, Kazuhiro Kiyosawa, Kazuhiko Nakagawa, Tomohide Tamura

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Introduction This study prospectively evaluated the efficacy and safety of pemetrexed and carboplatin followed by maintenance pemetrexed in chemo-naïve patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Methods A total of 109 patients received pemetrexed (500 mg/m 2) and carboplatin (area under the curve = 6 mg/mL·min) every 21 days. For patients without disease progression after 4 cycles, pemetrexed was continued until disease progression or unacceptable toxicity. Pre-planned subgroup analysis results based on the presence of epidermal growth factor receptor (EGFR) mutations are also presented. Results The median number of treatment cycles was 5 (range: 1-30) in the entire study period. Most of the grade ≥3 toxicities observed were hematologic in nature, with no increase in the relative incidence associated with continuation maintenance therapy with pemetrexed. Among the 106 total patients assessable for efficacy, the objective response rate was 35.8 %, median progression free survival (PFS) 5.7 months, and median overall survival (OS) 20.2 months. Sixty patients received maintenance pemetrexed (median: 4 cycles, range: 1-26 cycles); median PFS from the beginning of induction treatment was 7.5 months. From the subgroup analysis for EGFR mutation status, the median OS of EGFR wild-type patients (n = 61) was 20.2 months. Conclusions Pemetrexed/carboplatin followed by pemetrexed was well tolerated and active for front-line treatment of advanced nonsquamous NSCLC. Encouraging survival outcomes were observed even in EGFR-wild type patients.

Original languageEnglish
Pages (from-to)1275-1282
Number of pages8
JournalInvestigational New Drugs
Volume31
Issue number5
DOIs
Publication statusPublished - Oct 2013

Fingerprint

Pemetrexed
Carboplatin
Non-Small Cell Lung Carcinoma
Epidermal Growth Factor Receptor
Therapeutics
Disease-Free Survival
Survival
Disease Progression
Maintenance
Mutation
Area Under Curve

Keywords

  • Carboplatin
  • Continuation maintenance
  • EGFR mutation status
  • Nonsquamous NSCLC
  • Pemetrexed

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer. / Okamoto, Isamu; Aoe, Keisuke; Kato, Terufumi; Hosomi, Yukio; Yokoyama, Akira; Imamura, Fumio; Kiura, Katsuyuki; Hirashima, Tomonori; Nishio, Makoto; Nogami, Naoyuki; Okamoto, Hiroaki; Saka, Hideo; Yamamoto, Nobuyuki; Yoshizuka, Naoto; Sekiguchi, Risa; Kiyosawa, Kazuhiro; Nakagawa, Kazuhiko; Tamura, Tomohide.

In: Investigational New Drugs, Vol. 31, No. 5, 10.2013, p. 1275-1282.

Research output: Contribution to journalArticle

Okamoto, I, Aoe, K, Kato, T, Hosomi, Y, Yokoyama, A, Imamura, F, Kiura, K, Hirashima, T, Nishio, M, Nogami, N, Okamoto, H, Saka, H, Yamamoto, N, Yoshizuka, N, Sekiguchi, R, Kiyosawa, K, Nakagawa, K & Tamura, T 2013, 'Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer', Investigational New Drugs, vol. 31, no. 5, pp. 1275-1282. https://doi.org/10.1007/s10637-013-9941-z
Okamoto, Isamu ; Aoe, Keisuke ; Kato, Terufumi ; Hosomi, Yukio ; Yokoyama, Akira ; Imamura, Fumio ; Kiura, Katsuyuki ; Hirashima, Tomonori ; Nishio, Makoto ; Nogami, Naoyuki ; Okamoto, Hiroaki ; Saka, Hideo ; Yamamoto, Nobuyuki ; Yoshizuka, Naoto ; Sekiguchi, Risa ; Kiyosawa, Kazuhiro ; Nakagawa, Kazuhiko ; Tamura, Tomohide. / Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer. In: Investigational New Drugs. 2013 ; Vol. 31, No. 5. pp. 1275-1282.
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T1 - Pemetrexed and carboplatin followed by pemetrexed maintenance therapy in chemo-naïve patients with advanced nonsquamous non-small-cell lung cancer

AU - Okamoto, Isamu

AU - Aoe, Keisuke

AU - Kato, Terufumi

AU - Hosomi, Yukio

AU - Yokoyama, Akira

AU - Imamura, Fumio

AU - Kiura, Katsuyuki

AU - Hirashima, Tomonori

AU - Nishio, Makoto

AU - Nogami, Naoyuki

AU - Okamoto, Hiroaki

AU - Saka, Hideo

AU - Yamamoto, Nobuyuki

AU - Yoshizuka, Naoto

AU - Sekiguchi, Risa

AU - Kiyosawa, Kazuhiro

AU - Nakagawa, Kazuhiko

AU - Tamura, Tomohide

PY - 2013/10

Y1 - 2013/10

N2 - Introduction This study prospectively evaluated the efficacy and safety of pemetrexed and carboplatin followed by maintenance pemetrexed in chemo-naïve patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Methods A total of 109 patients received pemetrexed (500 mg/m 2) and carboplatin (area under the curve = 6 mg/mL·min) every 21 days. For patients without disease progression after 4 cycles, pemetrexed was continued until disease progression or unacceptable toxicity. Pre-planned subgroup analysis results based on the presence of epidermal growth factor receptor (EGFR) mutations are also presented. Results The median number of treatment cycles was 5 (range: 1-30) in the entire study period. Most of the grade ≥3 toxicities observed were hematologic in nature, with no increase in the relative incidence associated with continuation maintenance therapy with pemetrexed. Among the 106 total patients assessable for efficacy, the objective response rate was 35.8 %, median progression free survival (PFS) 5.7 months, and median overall survival (OS) 20.2 months. Sixty patients received maintenance pemetrexed (median: 4 cycles, range: 1-26 cycles); median PFS from the beginning of induction treatment was 7.5 months. From the subgroup analysis for EGFR mutation status, the median OS of EGFR wild-type patients (n = 61) was 20.2 months. Conclusions Pemetrexed/carboplatin followed by pemetrexed was well tolerated and active for front-line treatment of advanced nonsquamous NSCLC. Encouraging survival outcomes were observed even in EGFR-wild type patients.

AB - Introduction This study prospectively evaluated the efficacy and safety of pemetrexed and carboplatin followed by maintenance pemetrexed in chemo-naïve patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Methods A total of 109 patients received pemetrexed (500 mg/m 2) and carboplatin (area under the curve = 6 mg/mL·min) every 21 days. For patients without disease progression after 4 cycles, pemetrexed was continued until disease progression or unacceptable toxicity. Pre-planned subgroup analysis results based on the presence of epidermal growth factor receptor (EGFR) mutations are also presented. Results The median number of treatment cycles was 5 (range: 1-30) in the entire study period. Most of the grade ≥3 toxicities observed were hematologic in nature, with no increase in the relative incidence associated with continuation maintenance therapy with pemetrexed. Among the 106 total patients assessable for efficacy, the objective response rate was 35.8 %, median progression free survival (PFS) 5.7 months, and median overall survival (OS) 20.2 months. Sixty patients received maintenance pemetrexed (median: 4 cycles, range: 1-26 cycles); median PFS from the beginning of induction treatment was 7.5 months. From the subgroup analysis for EGFR mutation status, the median OS of EGFR wild-type patients (n = 61) was 20.2 months. Conclusions Pemetrexed/carboplatin followed by pemetrexed was well tolerated and active for front-line treatment of advanced nonsquamous NSCLC. Encouraging survival outcomes were observed even in EGFR-wild type patients.

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