Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial

Toshiyuki Sawa, Takashi Yana, Minoru Takada, Takahiko Sugiura, Shinzoh Kudoh, Tadashi Kamei, Takeshi Isobe, Hidehiko Yamamoto, Soichiro Yokota, Nobuyuki Katakami, Yuji Tohda, Akira Kawakami, Yoichi Nakanishi, Yutaka Ariyoshi

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Purpose: Amrubicin is a novel 9-aminoanthracycline. This multicenter phase II study was conducted to evaluate the efficacy and safety of amrubicin in patients with non-small-cell lung cancer (NSCLC). Patients and methods: Sixty-one previously untreated patients with stage III or IV NSCLC were entered this study. The patients were required to have cytologically or histologically proven measurable NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Amrubicin was administered by daily intravenous injection at 45 mg/m2/day for 3 consecutive days every 3 weeks. At least 3 cycles of treatment were administered to each patient. Results: All 61 patients registered in this trial were eligible and assessable for efficacy and toxicity. Of them, 17 patients achieved objective responses, consisting of one complete response and 16 partial responses, and the overall response rate was 27.9% (95% confidence interval [CI], 17.1% to 40.8%). The median survival time was 9.8 months (95% CI, 7.7 months to 14.9 months). The major toxicity was myelosuppression. The incidences of grade 3 or 4 toxicity were 72.1% for neutropenia, 52.5% for leukopenia, 23.0% for anemia, and 14.8% for thrombocytopenia. As noticeable toxic events, grade 3 hypotention and alkaline phosphatase elevation were transiently observed in one patient each. In addition, three patients who had had asymptomatic interstitial pneumonitis, identified by diagnostic imaging before treatment, aggravated after amrubicin treatment; two of them died. Other non-hematologic toxicities were relatively mild. Conclusion: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.

Original languageEnglish
Pages (from-to)151-158
Number of pages8
JournalInvestigational New Drugs
Volume24
Issue number2
DOIs
Publication statusPublished - Mar 1 2006

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Anthracyclines
Non-Small Cell Lung Carcinoma
Japan
Thorax
Confidence Intervals
amrubicin
Poisons
Interstitial Lung Diseases
Leukopenia
Diagnostic Imaging
Therapeutics
Neutropenia
Intravenous Injections
Thrombocytopenia
Alkaline Phosphatase
Anemia
Safety
Survival
Incidence

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1) : West Japan Thoracic Oncology Group (WJTOG) trial. / Sawa, Toshiyuki; Yana, Takashi; Takada, Minoru; Sugiura, Takahiko; Kudoh, Shinzoh; Kamei, Tadashi; Isobe, Takeshi; Yamamoto, Hidehiko; Yokota, Soichiro; Katakami, Nobuyuki; Tohda, Yuji; Kawakami, Akira; Nakanishi, Yoichi; Ariyoshi, Yutaka.

In: Investigational New Drugs, Vol. 24, No. 2, 01.03.2006, p. 151-158.

Research output: Contribution to journalArticle

Sawa, T, Yana, T, Takada, M, Sugiura, T, Kudoh, S, Kamei, T, Isobe, T, Yamamoto, H, Yokota, S, Katakami, N, Tohda, Y, Kawakami, A, Nakanishi, Y & Ariyoshi, Y 2006, 'Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1): West Japan Thoracic Oncology Group (WJTOG) trial', Investigational New Drugs, vol. 24, no. 2, pp. 151-158. https://doi.org/10.1007/s10637-006-5937-2
Sawa, Toshiyuki ; Yana, Takashi ; Takada, Minoru ; Sugiura, Takahiko ; Kudoh, Shinzoh ; Kamei, Tadashi ; Isobe, Takeshi ; Yamamoto, Hidehiko ; Yokota, Soichiro ; Katakami, Nobuyuki ; Tohda, Yuji ; Kawakami, Akira ; Nakanishi, Yoichi ; Ariyoshi, Yutaka. / Multicenter phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer (Study 1) : West Japan Thoracic Oncology Group (WJTOG) trial. In: Investigational New Drugs. 2006 ; Vol. 24, No. 2. pp. 151-158.
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abstract = "Purpose: Amrubicin is a novel 9-aminoanthracycline. This multicenter phase II study was conducted to evaluate the efficacy and safety of amrubicin in patients with non-small-cell lung cancer (NSCLC). Patients and methods: Sixty-one previously untreated patients with stage III or IV NSCLC were entered this study. The patients were required to have cytologically or histologically proven measurable NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Amrubicin was administered by daily intravenous injection at 45 mg/m2/day for 3 consecutive days every 3 weeks. At least 3 cycles of treatment were administered to each patient. Results: All 61 patients registered in this trial were eligible and assessable for efficacy and toxicity. Of them, 17 patients achieved objective responses, consisting of one complete response and 16 partial responses, and the overall response rate was 27.9{\%} (95{\%} confidence interval [CI], 17.1{\%} to 40.8{\%}). The median survival time was 9.8 months (95{\%} CI, 7.7 months to 14.9 months). The major toxicity was myelosuppression. The incidences of grade 3 or 4 toxicity were 72.1{\%} for neutropenia, 52.5{\%} for leukopenia, 23.0{\%} for anemia, and 14.8{\%} for thrombocytopenia. As noticeable toxic events, grade 3 hypotention and alkaline phosphatase elevation were transiently observed in one patient each. In addition, three patients who had had asymptomatic interstitial pneumonitis, identified by diagnostic imaging before treatment, aggravated after amrubicin treatment; two of them died. Other non-hematologic toxicities were relatively mild. Conclusion: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.",
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AU - Sawa, Toshiyuki

AU - Yana, Takashi

AU - Takada, Minoru

AU - Sugiura, Takahiko

AU - Kudoh, Shinzoh

AU - Kamei, Tadashi

AU - Isobe, Takeshi

AU - Yamamoto, Hidehiko

AU - Yokota, Soichiro

AU - Katakami, Nobuyuki

AU - Tohda, Yuji

AU - Kawakami, Akira

AU - Nakanishi, Yoichi

AU - Ariyoshi, Yutaka

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N2 - Purpose: Amrubicin is a novel 9-aminoanthracycline. This multicenter phase II study was conducted to evaluate the efficacy and safety of amrubicin in patients with non-small-cell lung cancer (NSCLC). Patients and methods: Sixty-one previously untreated patients with stage III or IV NSCLC were entered this study. The patients were required to have cytologically or histologically proven measurable NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Amrubicin was administered by daily intravenous injection at 45 mg/m2/day for 3 consecutive days every 3 weeks. At least 3 cycles of treatment were administered to each patient. Results: All 61 patients registered in this trial were eligible and assessable for efficacy and toxicity. Of them, 17 patients achieved objective responses, consisting of one complete response and 16 partial responses, and the overall response rate was 27.9% (95% confidence interval [CI], 17.1% to 40.8%). The median survival time was 9.8 months (95% CI, 7.7 months to 14.9 months). The major toxicity was myelosuppression. The incidences of grade 3 or 4 toxicity were 72.1% for neutropenia, 52.5% for leukopenia, 23.0% for anemia, and 14.8% for thrombocytopenia. As noticeable toxic events, grade 3 hypotention and alkaline phosphatase elevation were transiently observed in one patient each. In addition, three patients who had had asymptomatic interstitial pneumonitis, identified by diagnostic imaging before treatment, aggravated after amrubicin treatment; two of them died. Other non-hematologic toxicities were relatively mild. Conclusion: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.

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