Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304)

Kazuhiro Tanaka, Junki Mizusawa, Haruhiko Fukuda, Nobuhito Araki, Hirokazu Chuman, Mitsuru Takahashi, Toshifumi Ozaki, Toru Hiruma, Hiroyuki Tsuchiya, Hideo Morioka, Hiroshi Hatano, Yukihide Iwamoto

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Objective: The efficacy of perioperative chemotherapy for soft tissue sarcomas is controversial and only a few prospective studies of pre-operative chemotherapy for soft tissue sarcomas in the extremities have been reported. We therefore carried out Phase II study of perioperative chemotherapy for patients with soft tissue sarcomas in the extremities. Methods: Patients with Stage III non-round cell soft tissue sarcomas in the extremities were eligible. The patients were treated with pre-operative chemotherapy consisting doxorubicin 60 mg/m<sup>2</sup> and ifosfamide 10 g/m<sup>2</sup> for three courses. After the tumor resection, two additional courses of the same regimen were carried out. Results: A total of 72 patients were enrolled and 70 patients were eligible. The median age of the patients was 49 years. The major pathological subtypes were synovial sarcoma in 20 and undifferentiated pleomorphic sarcoma in 17 patients. The protocol treatments were completed in 74% of the eligible cases. The 2 and 5-year progression-free survival rates were 75.7% (95% CI, 63.9-84.1%) and 63.8% (95% CI, 51.3-73.9%), respectively. The 5-year overall survivalwas 82.6% (95% CI, 71.3-89.7%). There was no treatment-related death. Grade 3 or 4 hematological toxicities (leukopenia and neutropenia) were observed in most of the patients. Conclusions: Although the toxicities of the regimen were significant, pre-operative chemotherapy followed by post-operative chemotherapy using doxorubicin and high-dose ifosfamidewas feasible. The outcome of the trial for the patients with high-grade soft tissue sarcomas in the extremities was favorable, and this regimen is promising for further investigation. This trial was registered at the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) as C000000096.

Original languageEnglish
Article numberhyv042
Pages (from-to)555-561
Number of pages7
JournalJapanese Journal of Clinical Oncology
Volume45
Issue number6
DOIs
Publication statusPublished - 2015 Jun 1

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Ifosfamide
Sarcoma
Doxorubicin
Extremities
Drug Therapy
Synovial Sarcoma
Leukopenia
Clinical Protocols
Neutropenia
Disease-Free Survival
Registries
Survival Rate
Clinical Trials
Prospective Studies

Keywords

  • Chemotherapy
  • Extremities
  • Multicenter study
  • Neoadjuvant therapy
  • Sarcoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

Cite this

Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304). / Tanaka, Kazuhiro; Mizusawa, Junki; Fukuda, Haruhiko; Araki, Nobuhito; Chuman, Hirokazu; Takahashi, Mitsuru; Ozaki, Toshifumi; Hiruma, Toru; Tsuchiya, Hiroyuki; Morioka, Hideo; Hatano, Hiroshi; Iwamoto, Yukihide.

In: Japanese Journal of Clinical Oncology, Vol. 45, No. 6, hyv042, 01.06.2015, p. 555-561.

Research output: Contribution to journalArticle

Tanaka, K, Mizusawa, J, Fukuda, H, Araki, N, Chuman, H, Takahashi, M, Ozaki, T, Hiruma, T, Tsuchiya, H, Morioka, H, Hatano, H & Iwamoto, Y 2015, 'Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304)', Japanese Journal of Clinical Oncology, vol. 45, no. 6, hyv042, pp. 555-561. https://doi.org/10.1093/jjco/hyv042
Tanaka, Kazuhiro ; Mizusawa, Junki ; Fukuda, Haruhiko ; Araki, Nobuhito ; Chuman, Hirokazu ; Takahashi, Mitsuru ; Ozaki, Toshifumi ; Hiruma, Toru ; Tsuchiya, Hiroyuki ; Morioka, Hideo ; Hatano, Hiroshi ; Iwamoto, Yukihide. / Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304). In: Japanese Journal of Clinical Oncology. 2015 ; Vol. 45, No. 6. pp. 555-561.
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abstract = "Objective: The efficacy of perioperative chemotherapy for soft tissue sarcomas is controversial and only a few prospective studies of pre-operative chemotherapy for soft tissue sarcomas in the extremities have been reported. We therefore carried out Phase II study of perioperative chemotherapy for patients with soft tissue sarcomas in the extremities. Methods: Patients with Stage III non-round cell soft tissue sarcomas in the extremities were eligible. The patients were treated with pre-operative chemotherapy consisting doxorubicin 60 mg/m2 and ifosfamide 10 g/m2 for three courses. After the tumor resection, two additional courses of the same regimen were carried out. Results: A total of 72 patients were enrolled and 70 patients were eligible. The median age of the patients was 49 years. The major pathological subtypes were synovial sarcoma in 20 and undifferentiated pleomorphic sarcoma in 17 patients. The protocol treatments were completed in 74{\%} of the eligible cases. The 2 and 5-year progression-free survival rates were 75.7{\%} (95{\%} CI, 63.9-84.1{\%}) and 63.8{\%} (95{\%} CI, 51.3-73.9{\%}), respectively. The 5-year overall survivalwas 82.6{\%} (95{\%} CI, 71.3-89.7{\%}). There was no treatment-related death. Grade 3 or 4 hematological toxicities (leukopenia and neutropenia) were observed in most of the patients. Conclusions: Although the toxicities of the regimen were significant, pre-operative chemotherapy followed by post-operative chemotherapy using doxorubicin and high-dose ifosfamidewas feasible. The outcome of the trial for the patients with high-grade soft tissue sarcomas in the extremities was favorable, and this regimen is promising for further investigation. This trial was registered at the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) as C000000096.",
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T1 - Perioperative chemotherapy with ifosfamide and doxorubicin for high-grade soft tissue sarcomas in the extremities (JCOG0304)

AU - Tanaka, Kazuhiro

AU - Mizusawa, Junki

AU - Fukuda, Haruhiko

AU - Araki, Nobuhito

AU - Chuman, Hirokazu

AU - Takahashi, Mitsuru

AU - Ozaki, Toshifumi

AU - Hiruma, Toru

AU - Tsuchiya, Hiroyuki

AU - Morioka, Hideo

AU - Hatano, Hiroshi

AU - Iwamoto, Yukihide

PY - 2015/6/1

Y1 - 2015/6/1

N2 - Objective: The efficacy of perioperative chemotherapy for soft tissue sarcomas is controversial and only a few prospective studies of pre-operative chemotherapy for soft tissue sarcomas in the extremities have been reported. We therefore carried out Phase II study of perioperative chemotherapy for patients with soft tissue sarcomas in the extremities. Methods: Patients with Stage III non-round cell soft tissue sarcomas in the extremities were eligible. The patients were treated with pre-operative chemotherapy consisting doxorubicin 60 mg/m2 and ifosfamide 10 g/m2 for three courses. After the tumor resection, two additional courses of the same regimen were carried out. Results: A total of 72 patients were enrolled and 70 patients were eligible. The median age of the patients was 49 years. The major pathological subtypes were synovial sarcoma in 20 and undifferentiated pleomorphic sarcoma in 17 patients. The protocol treatments were completed in 74% of the eligible cases. The 2 and 5-year progression-free survival rates were 75.7% (95% CI, 63.9-84.1%) and 63.8% (95% CI, 51.3-73.9%), respectively. The 5-year overall survivalwas 82.6% (95% CI, 71.3-89.7%). There was no treatment-related death. Grade 3 or 4 hematological toxicities (leukopenia and neutropenia) were observed in most of the patients. Conclusions: Although the toxicities of the regimen were significant, pre-operative chemotherapy followed by post-operative chemotherapy using doxorubicin and high-dose ifosfamidewas feasible. The outcome of the trial for the patients with high-grade soft tissue sarcomas in the extremities was favorable, and this regimen is promising for further investigation. This trial was registered at the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) as C000000096.

AB - Objective: The efficacy of perioperative chemotherapy for soft tissue sarcomas is controversial and only a few prospective studies of pre-operative chemotherapy for soft tissue sarcomas in the extremities have been reported. We therefore carried out Phase II study of perioperative chemotherapy for patients with soft tissue sarcomas in the extremities. Methods: Patients with Stage III non-round cell soft tissue sarcomas in the extremities were eligible. The patients were treated with pre-operative chemotherapy consisting doxorubicin 60 mg/m2 and ifosfamide 10 g/m2 for three courses. After the tumor resection, two additional courses of the same regimen were carried out. Results: A total of 72 patients were enrolled and 70 patients were eligible. The median age of the patients was 49 years. The major pathological subtypes were synovial sarcoma in 20 and undifferentiated pleomorphic sarcoma in 17 patients. The protocol treatments were completed in 74% of the eligible cases. The 2 and 5-year progression-free survival rates were 75.7% (95% CI, 63.9-84.1%) and 63.8% (95% CI, 51.3-73.9%), respectively. The 5-year overall survivalwas 82.6% (95% CI, 71.3-89.7%). There was no treatment-related death. Grade 3 or 4 hematological toxicities (leukopenia and neutropenia) were observed in most of the patients. Conclusions: Although the toxicities of the regimen were significant, pre-operative chemotherapy followed by post-operative chemotherapy using doxorubicin and high-dose ifosfamidewas feasible. The outcome of the trial for the patients with high-grade soft tissue sarcomas in the extremities was favorable, and this regimen is promising for further investigation. This trial was registered at the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) as C000000096.

KW - Chemotherapy

KW - Extremities

KW - Multicenter study

KW - Neoadjuvant therapy

KW - Sarcoma

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