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Investigational New Drugs

, Volume 25, Issue 3, pp 253–258 | Cite as

Phase II study of amrubicin in previously untreated patients with extensive-disease small cell lung cancer: West Japan Thoracic Oncology Group (WJTOG) study

  • Takashi Yana
  • Shunichi Negoro
  • Minoru Takada
  • Soichiro Yokota
  • Yoshiki Takada
  • Takahiko Sugiura
  • Hidehiko Yamamoto
  • Toshiyuki Sawa
  • Masaaki Kawahara
  • Nobuyuki Katakami
  • Yutaka Ariyoshi
  • Masahiro Fukuoka
Phase II Studies

Summary

Purpose: To evaluate the efficacy and safety of amrubicin, (+)-(7S, 9S)-9-acetyl-9-amino-7-[(2-deoxy-β-D-erythro-pentopyranosyl )oxy ]-7,8,9,10-tetrahydro-6,11-dihydroxy-5,12-naphthacenedione hydrochloride, in previously untreated patients with extensive-disease small cell lung cancer (SCLC).

Patients and methods: A total of 35 previously untreated patients with extensive-disease SCLC were entered into the study. Amrubicin was given by daily intravenous infusion at 45 mg/m2/day for 3 consecutive days, every 3 weeks. Unless there was tumor regression of 25% or greater after the first cycle, or 50% or greater after the second cycle, treatment was switched to salvage chemotherapy in combination with etoposide (100 mg/m2, days 1, 2, and 3) and cisplatin (80 mg/m2, day 1).

Results: Of the 35 patients entered, 33 were eligible and assessable for efficacy and toxicity. Of the 33 patients, 3 (9.1%) had a complete response (95% confidence interval [CI], 1.9–24.3%) and 22 had a partial response, for an overall response rate of 75.8% (95% CI, 57.7–88.9%). Median survival time was 11.7 months (95% CI, 9.9–15.3 months), and 1-year and 2-year survival rates were 48.5% and 20.2%, respectively. The most common toxicity was hematologic. Non-hematologic toxicity of grade 3 or 4 was only seen in 3 patients with anorexia (9.1%) and 1 patient with alopecia (3.0%). Salvage chemotherapy was administered to only 6 patients.

Conclusion: Amrubicin was active for extensive-disease SCLC with acceptable toxicity. Further studies in combination with other agents for SCLC are warranted.

Keywords

Amrubicin Small cell lung cancer Anthracycline Previously untreated patients Phase II study 

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Copyright information

© Springer Science+Business Media, LLC 2006

Authors and Affiliations

  • Takashi Yana
    • 1
    • 12
  • Shunichi Negoro
    • 2
  • Minoru Takada
    • 1
  • Soichiro Yokota
    • 3
  • Yoshiki Takada
    • 4
  • Takahiko Sugiura
    • 5
  • Hidehiko Yamamoto
    • 6
  • Toshiyuki Sawa
    • 7
  • Masaaki Kawahara
    • 8
  • Nobuyuki Katakami
    • 9
  • Yutaka Ariyoshi
    • 10
  • Masahiro Fukuoka
    • 11
  1. 1.Department of Internal MedicineOsaka Prefectural Habikino HospitalHabikinoJapan
  2. 2.Department of Clinical OncologyOsaka City General HospitalOsakaJapan
  3. 3.Department of Internal MedicineNational Toneyama Hospital for Chest DiseasesToyonakaJapan
  4. 4.Department of RadiologyHyogo Medical Center for AdultsAkashiJapan
  5. 5.Department of Internal MedicineAichi Cancer Center HospitalNagoyaJapan
  6. 6.Department of Internal MedicineAso Iizuka HospitalIizukaJapan
  7. 7.Division of Respiratory MedicineGifu Municipal HospitalGifuJapan
  8. 8.Department of Internal MedicineNational Kinki Central Hospital for Chest DiseaseSakaiJapan
  9. 9.Division of Pulmonary MedicineKobe City General HospitalKobeJapan
  10. 10.Department of Internal MedicinePrefectural Aichi HospitalOkazakiJapan
  11. 11.Department of Medical OncologyKinki University School of MedicineOsakasayamaJapan
  12. 12.Division of Respiratory MedicineKKR Otemae HospitalOsakaJapan

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