Short, full-dose adjuvant chemotherapy (CT) in high-risk adult soft tissue sarcomas (STS): Long-term follow-up of a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 11045-11045
Author(s):  
Elena Palassini ◽  
Stefano Ferrari ◽  
Javier Martin Broto ◽  
Paolo Verderio ◽  
Antonio Lopez-Pousa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Soft Tissue ◽  
Randomized Clinical Trial ◽  
Soft Tissue Sarcomas ◽  
Full Dose ◽  
Long Term Follow Up

Short, Full-Dose Adjuvant Chemotherapy in High-Risk Adult Soft Tissue Sarcomas: A Randomized Clinical Trial From the Italian Sarcoma Group and the Spanish Sarcoma Group

2012 ◽  
Vol 30 (8) ◽  
pp. 850-856 ◽  
Author(s):  
Alessandro Gronchi ◽  
Sergio Frustaci ◽  
Mario Mercuri ◽  
Javier Martin ◽  
Antonio Lopez-Pousa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Soft Tissue ◽  
Randomized Clinical Trial ◽  
Cox Model ◽  
Phase Iii ◽  
Full Dose ◽  
Preoperative Ct ◽  
To Receive

PurposeA previous randomized clinical trial by the Italian Sarcoma Group (ISG) had shown a survival benefit of adjuvant chemotherapy (CT) in high-risk extremity soft tissue sarcoma (STS). However, the dose-intensity of the last two cycles was suboptimal. We then undertook a multicentric international phase III study to compare three and five cycles of the same CT.Patients and MethodsPatients were randomly assigned either to receive three cycles of preoperative CT with epirubicin 120 mg/m2and ifosfamide 9 g/m2and granulocyte colony-stimulating factor (arm A) or to receive the same three cycles of preoperative CT followed by two further cycles of postoperative CT (arm B). Noninferiority of the primary end point, overall survival (OS), was assessed by the CI of the hazard ratio (HR; arm A/arm B) obtained from the Cox model.ResultsBetween January 2002 and April 2007, 328 patients were recruited (164 patients in each arm). At a median follow-up of 63 months (interquartile range, 49 to 77 months), 100 deaths were recorded, 49 in arm A and 51 in arm B. Five-year OS probability was 0.70 for the entire group of patients (0.68 in arm A and 0.71 in arm B). The HR of arm A versus arm B was 1.00 (90% CI, 0.72 to 1.39).ConclusionIn this population of patients with high-risk localized STS, three cycles of full-dose preoperative CT were not inferior to five cycles. The outcome compares favorably with the expected survival of patients with high-risk STS and was superimposable on the CT arm of the previous ISG trial.

Long-term follow-up of women enrolled in a randomized trial of adjuvant chemotherapy for early stage ovarian cancer (ICON1)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5509-5509 ◽  
Author(s):  
A. C. Swart
Keyword(s):  
Ovarian Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Treatment ◽  
Early Stage ◽  
Risk Groups ◽  
P Value ◽  
Long Term Follow Up

5509 Background: ICON1 and a meta-analysis of all relevant trials demonstrated an improvement in 5 year recurrence-free and overall survival (RFS and OS) for women with early-stage epithelial ovarian cancer (ES EOC) treated with adjuvant chemotherapy compared to no adjuvant chemotherapy. We aimed to determine if this initial benefit is maintained long-term and whether benefit is different with different risk groups of patients defined by stage, grade and histology. Method: 477 women with ES EOC were recruited from centres in Italy (271 women) UK (195) Switzerland (11) between August 1991 and January 2000. 5-year results were presented at ASCO 2001. Systematic long-term follow up was planned and completed in May 2006. Results: With a median follow-up of 9.2 years, 168 women have developed recurrent disease or died and 144 women have died. The Hazard Ratio (HR) for RFS of 0.70 in favour of adjuvant chemotherapy (95% CI 0.52–0.95 p= 0.023) translated into an improvement of 10-year absolute RFS of 10% from 57 to 67%. For OS, HR was 0.74 (95% CI 0.53–1.02 p= 0.066), a corresponding improvement in 10-year absolute OS of 8% from 64% to 72%. 26% of patients died from causes other than ovarian cancer. Stage I patients were grouped as low (Ia, grade 1), medium (Ia grade 2, Ib or Ic grade 1) and high risk (Ia, grade 3, Ib or IC grade 2 or 3, any clear cell). The test of interaction between risk groups and adjuvant treatment for RFS and OS was 0.055 and 0.13, respectively. The HR, 95%CI and p value are summarised in the table . Conclusions The long-term benefit of adjuvant treatment on RFS is confirmed. There is clear evidence that adjuvant chemotherapy reduces the risk of recurrence/death or death alone in high-risk patients but not in the low-risk group. [Table: see text] [Table: see text]

scholarly journals Long-term follow-up of patients treated with neoadjuvant chemotherapy and radiotherapy for large, extremity soft tissue sarcomas

Cancer ◽  
2011 ◽  
Vol 118 (15) ◽  
pp. 3758-3765 ◽  
Author(s):  
John T. Mullen ◽  
Wendy Kobayashi ◽  
Jing Jing Wang ◽  
David C. Harmon ◽  
Edwin Choy ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Neoadjuvant Chemotherapy ◽  
Soft Tissue Sarcomas ◽  
Long Term Follow Up
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