Feasibility of Preoperative Chemotherapy With or Without Radiation Therapy in Localized Soft Tissue Sarcomas of Limbs and Superficial Trunk in the Italian Sarcoma Group/Grupo Español de Investigación en Sarcomas Randomized Clinical Trial: Three Versus Five Cycles of Full-Dose Epirubicin Plus Ifosfamide

2015 ◽  
Vol 33 (31) ◽  
pp. 3628-3634 ◽  
Author(s):  
Elena Palassini ◽  
Stefano Ferrari ◽  
Paolo Verderio ◽  
Antonino De Paoli ◽  
Javier Martin Broto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Soft Tissue ◽  
Randomized Clinical Trial ◽  
Preoperative Chemotherapy ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Wound Complications ◽  
Hematologic Toxicity ◽  
Grade 3

Purpose We report on feasibility of preoperative chemotherapy with or without radiation therapy (RT) in the context of a phase III randomized clinical trial involving localized, high-risk, soft tissue sarcomas. Patients and Methods Of 321 eligible patients, 161 were randomly assigned to three preoperative cycles of epirubicin 120 mg/m2 plus ifosfamide 9 g/m2, and 160 were randomly assigned to three preoperative plus two postoperative cycles. Among them, 303 patients were included in this analysis; 169 were male and 134 were female, with a median age of 48 years (range, 15 to 79 years). One hundred fifty-two patients received concurrent RT preoperatively at a total dose of 44 to 50 Gy. Preoperative chemotherapy-related hematologic toxicity and early postoperative complications were reported. The influence of RT, age, and sex on hematologic grade 3 or 4 toxicities and wound complications was analyzed. Chemotherapeutic dose intensity (DI) was analyzed. Results Among the patients, 61.4%, 22.4%, and 23.8% experienced, grade 4 leucopenia, grade 3 or 4 anemia, and grade 3 or 4 thrombocytopenia, respectively. Respective rates were 66.4%, 24.3%, and 31.6% when RT was added preoperatively, and 56.3%, 20.5%, and 15.9% when preoperative chemotherapy was administered alone. Patient age affected grade 3 or 4 thrombocytopenia. Grade 4 leucopenia and grade 3 or 4 anemia presented 2.5 times more frequently in female patients than in male patients. Wound complications were observed in 13.5% of patients: 17% with preoperative RT and 10% without. Chemotherapeutic DI was greater than 90%, even in patients receiving preoperative RT and in patients age 65 years or older. Conclusion This preoperative chemotherapy is feasible and can also be proposed for selected elderly patients. Grade 3 or 4 hematologic toxicity was common, but DI was excellent. Concurrent preoperative RT is safe, although an increased rate of grade 4 thrombocytopenia and limited increase in wound complications may be observed.

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.

scholarly journals Wound Complications of Adjuvant Radiation Therapy in Patients with Soft-Tissue Sarcomas

1989 ◽  
Vol 210 (1) ◽  
pp. 93-99 ◽  
Author(s):  
MARCIA V. ORMSBY ◽  
BASIL S. HILARIS ◽  
DATTATREYUDU NORI ◽  
MURRAY F. BRENNAN
Keyword(s):  
Radiation Therapy ◽  
Soft Tissue ◽  
Soft Tissue Sarcomas ◽  
Wound Complications ◽  
Adjuvant Radiation ◽  
Adjuvant Radiation Therapy

scholarly journals The Future of Radiation Oncology in Soft Tissue Sarcoma

2018 ◽  
Vol 25 (1) ◽  
pp. 107327481881550
Author(s):  
Arash O. Naghavi ◽  
George Q. Yang ◽  
Kujtim Latifi ◽  
Robert Gillies ◽  
Howard McLeod ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Radiation Therapy ◽  
Soft Tissue ◽  
Personalized Medicine ◽  
Soft Tissue Sarcoma ◽  
Radiation Oncology ◽  
Soft Tissue Sarcomas ◽  
Clinicopathologic Features ◽  
The Future ◽  
Treatment Paradigm

Radiotherapy (RT) is an important component of the treatment of soft tissue sarcomas (STS) and has been traditionally incorporated with a homogenous approach despite the reality that STS displays a known heterogeneity in clinicopathologic features and treatment outcomes. In this article, we explore the principle components of personalized medicine, including genomics, radiomics, and treatment response, along with their impact on the future of radiation therapy for STS. We propose a shift in the treatment paradigm for STS from a one-size-fits-all technique to one that implements the tenets of personalized medicine and includes the framework for a potential clinical trial technique in this heterogeneous disease.

Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas.

1993 ◽  
Vol 11 (7) ◽  
pp. 1269-1275 ◽  
Author(s):  
J H Edmonson ◽  
L M Ryan ◽  
R H Blum ◽  
J S Brooks ◽  
M Shiraki ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Tumor Regression ◽  
Single Agent ◽  
Soft Tissue Sarcomas ◽  
Phase Iii ◽  
Significant Survival ◽  
Receive Treatment ◽  
Grade 3 ◽  
Group B ◽  
Survival Differences

PURPOSE This three-armed phase III study in adults with advanced soft tissue sarcomas was planned as a comparison of objective regression rates, toxicity, and survival of patients receiving doxorubicin alone, ifosfamide plus doxorubicin, and mitomycin plus doxorubicin plus cisplatin. PATIENTS AND METHODS Between December 1987 and July 1990, 279 patients with histologically confirmed sarcomas were enrolled to receive treatment A (doxorubicin 80 mg/m2), treatment B (ifosfamide 7.5 g/m2 plus doxorubicin 60 mg/m2), or treatment C (mitomycin 8 mg/m2 plus doxorubicin 40 mg/m2 plus cisplatin 60 mg/m2). RESULTS Of 262 assessable patients, 74 (29%) achieved objective tumor regression. Objective regression occurred in 20% of the 90 patients who received doxorubicin alone (complete remission [CR] rate, 2%), in 34% of the 88 who received ifosfamide plus doxorubicin (CR rate, 3%), and in 32% of the 84 who received mitomycin plus doxorubicin plus cisplatin (CR rate, 7%). With grade 3 or greater myelosuppression in 53% of group A, 80% of group B, and 55% of group C, regimen B was significantly more myelosuppressive than either regimen A or C (P = .01) with two, three, and one treatment-related deaths, respectively. Synovial sarcomas were responsive to ifosfamide plus doxorubicin, especially among patients younger than 40 years of age. CONCLUSION Ifosfamide plus doxorubicin produced a significantly higher regression rate (P = .03) than did doxorubicin alone; however, this was achieved at a level of myelosuppression significantly more intense than that produced by the single agent or by the three-drug combination. Mitomycin, doxorubicin, and cisplatin also appeared to be more active than the single agent; however, at a myelosuppression level similar to that of doxorubicin alone, this trend (P = .07) did not attain the usual level for significance. No significant survival differences were observed.

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