Adjuvant and neoadjuvant chemotherapy (NAC) with ifosfamide (IFO) and doxorubicin hydrochloride (ADM) for high-grade soft tissue sarcomas (STS) in the extremities: Japan Clinical Oncology Group study JCOG030404.

Tanaka, Kazushi; Mizusawa, Junki; Fukuda, Hiroyuki; Araki, Nobuhito; Chuuman, Hirokazu; Takahashi, Mamiko; Ozaki, Tomohiro; Hiruma, Toru; Tsuchiya, Hideo; Morioka, H.; Morita, Toyohiko; Wada, Tomoko; Hatori, Masahiro; Yoshida, Youichiro; Toguchida, Junya; Abe, Sumiko; Matsumine, Akihiko; Yokoyama, Rei; Iwamoto, Yasuo

doi:10.1200/jco.2011.29.15_suppl.10078

Cited by 3 publications

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“…The first patient was enrolled in July 2004, and patient accrual was finished in September 2008. Although the follow-up period was still relatively short, the survival outcome of the trial for the patients with high-grade STS in the extremities was far better than expected (8). There was no treatment-related death.…”

Section: Jcog 0304mentioning

confidence: 88%

The Activity of the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group

Iwamoto

Tanaka²

2012

Japanese Journal of Clinical Oncology

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The Bone and Soft Tissue Tumor Study Group (BSTTSG) of the Japan Clinical Oncology Group (JCOG) was established in 2002. At present, 26 institutions are participating as active members of the BSTTSG of the JCOG. In 2004, the first BSTTSG trial, JCOG 0304, was initiated. JCOG 0304 was a Phase II study of perioperative chemotherapy with doxorubicin and ifosfamide for patients with operable, high-grade, non-round cell soft tissue sarcomas (T2bN0M0) arising in the extremities. The results of JCOG 0304 suggested the efficacy of the perioperative chemotherapy on operable soft tissue sarcoma in the extremities and led to planning of the subsequent clinical trial for the disease. The BSTTSG has currently been conducting a Phase III trial, JCOG 0905, to investigate the superiority of the addition of ifosfamide to the standard chemotherapy with methotrexate, cisplatin and doxorubicin for operable, high-grade osteosarcoma. The BSTTSG is also conducting a JCOG ancillary study, JCOG 0905-A1, to evaluate the gene expression profiles of osteosarcoma treated in the JCOG 0905 study. The BSTTSG will further try to develop new standard therapy for bone and soft tissue tumors.

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Section: Jcog 0304mentioning

confidence: 88%

The Activity of the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group

Iwamoto

Tanaka²

2012

Japanese Journal of Clinical Oncology

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“…In September 2007, trabectedin, the first anti-cancer derivative drug, was approved by the European Drug Administration to treat patients with advanced sarcoma after treatment with Doxorubicin has failed (11,12). At present, trabectedin is used in nearly 80 countries worldwide to treat adult advanced STS after the failure of anthracycline and ifosfamide treatments, or to treat those who cannot be treated with anthracycline and ifosfamide (13,14).…”

Section: Original Articlementioning

confidence: 99%

Comparison between trabectedin and doxorubicin in soft-tissue sarcomas: a systematic review and meta-analysis

Dang¹,

Fu²,

Zhang³

et al. 2021

Ann Transl Med

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Background: This study sought to evaluate the differences between trabectedin and doxorubicin in the treatment of soft-tissue sarcoma (STS).Methods: Multiple databases, including PubMed, Web of Science, Cochrane Library, and China National Knowledge Infrastructure, were searched to retrieve relevant articles. Ultimately, the full text of 10 studies involving the use of trabectedin and doxorubicin in STS were reviewed. Review Manager 5.2 was used to evaluate the heterogeneity of the results of the selected articles. Forest plot, bias, and sensitivity analyses were carried out on the included articles.Results: Ten papers that met the criteria were included in this analysis. STS patients receiving trabectedin had longer progression-free survival than those receiving doxorubicin [overall mean difference (MD) =1.36, 95% confidence interval (CI): 1.04, 1.68, I 2 =6%, fixed-effects model]. The experimental group also had a longer overall survival period than the control group (MD =3.92, 95% CI: 0.23, 7.60, P=0.04 and I 2 =83%, random-effects model), and the experimental group had a better disease control rate than the control group (relative risk =1.2, P=0.03 and I 2 =45%, fixed-effects model). From the publication bias analysis and sensitivity analysis, we can guarantee the results are robust and unbiased.Discussion: Our research showed that STS patients who received trabectedin had better clinical effects and a longer survival time than those who received doxorubicin.

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“…The primary endpoint of this study was 2-year progression-free survival (PFS), which was 75.7% (95% CI 63.8 -84.1%) and was much higher than the expected 2-year PFS (55%). The 5-year PFS [64.9% (95% CI 52.5 -74.7%)] and OS [83.0% (95% CI 72.1 -90.0%)] were higher than those of clinical T2bN0M0 NRC-STS patients undergoing only surgery (5-year PFS: 30% and OS: 50%) (10,11). Grade 3/4 hematological toxicities were observed in almost all patients, but on the basis of this promising efficacy, perioperative chemotherapy with AI has been considered acceptable as current standard treatment for highgrade T2bN0M0 NRC-STS.…”

Section: Introductionmentioning

confidence: 99%

“…In JCOG0304, the incidences of Grade 3/4 neutropenia, anemia and febrile neutropenia were 98.6, 55.6 and 18.2%, respectively. The incidences of Grade 3/4 toxicities observed in GD were reported to be lower than in AI: neutropenia: 30-70%, anemia: 20-30%, febrile neutropenia: 10% and pneumonitis: 3% (11). Second, GD can be administered in an outpatient setting.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Phase II/III Trial of Perioperative Chemotherapy with Adriamycin Plus Ifosfamide Versus Gemcitabine Plus Docetaxel for High-grade Soft Tissue Sarcoma: Japan Clinical Oncology Group Study JCOG1306

Kataoka¹,

Tanaka

Mizusawa³

et al. 2014

Japanese Journal of Clinical Oncology

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A randomized Phase II/III trial was planned to commence in March 2014. Perioperative chemotherapy with adriamycin plus ifosfamide is the current standard treatment for T2bN0M0 high-grade non-round cell soft tissue sarcoma. The purpose of this study is to confirm the noninferiority of perioperative chemotherapy with gemcitabine and docetaxel to adriamycin plus ifosfamide for patients with T2bN0M0 or any TN1M0 non-round cell soft tissue sarcoma in the extremities and body wall. A total of 140 patients will be accrued from 28 Japanese institutions over 6 years. The primary endpoint in the Phase II part is the proportion of completion of preoperative chemotherapy without progressive disease and overall survival in the Phase III part. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, pathological response rate, proportion of preservation of diseased limbs, disease control rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000013175

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Adjuvant and neoadjuvant chemotherapy (NAC) with ifosfamide (IFO) and doxorubicin hydrochloride (ADM) for high-grade soft tissue sarcomas (STS) in the extremities: Japan Clinical Oncology Group study JCOG030404.

Cited by 3 publications

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The Activity of the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group

The Activity of the Bone and Soft Tissue Tumor Study Group of the Japan Clinical Oncology Group

Comparison between trabectedin and doxorubicin in soft-tissue sarcomas: a systematic review and meta-analysis

A Randomized Phase II/III Trial of Perioperative Chemotherapy with Adriamycin Plus Ifosfamide Versus Gemcitabine Plus Docetaxel for High-grade Soft Tissue Sarcoma: Japan Clinical Oncology Group Study JCOG1306

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