Significant Reduction of Late Toxicities in Patients With Extremity Sarcoma Treated With Image-Guided Radiation Therapy to a Reduced Target Volume: Results of Radiation Therapy Oncology Group RTOG-0630 Trial

Wang, Dian; Zhang, Qiang; Eisenberg, Burton L.; Kane, John M.; Li, X. Allen; Lucas, David R.; Petersen, Ivy A.; DeLaney, Thomas F.; Freeman, Carolyn R.; Finkelstein, Steven E.; Hitchcock, Ying J.; Bedi, Manpreet; Singh, Anurag K.; Dundas, George; Kirsch, David G.

doi:10.1200/jco.2014.58.5828

Cited by 239 publications

(176 citation statements)

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“…This risk is probably partly related to patient and tumor characteristics (e.g. obesity, diabetes, smoking habits and the location of the sarcoma especially those in proximity to major neurovascular structures in the lower extremities), as well as radiotherapy parameters such as total dose, fraction size, treatment volume, skin flap sparing and sophisticated RT techniques [6, 13, 36–38, 71]. The approach of a reduced preoperative RT dose in combination with sensitizing agents could be a great step forward if such combinations could maintain or improve local control in association with a reduction in perioperative and long-term morbidity (see figure 2), ideally improving late functional outcome and quality of life for these patients.…”

Section: Discussionmentioning

confidence: 99%

Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies

Haas

Miah

Lepéchoux

et al. 2016

Radiotherapy and Oncology

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Introduction This critical review aims to summarize published data on limb sparing surgery for extremity soft tissue sarcoma in combination with pre-operative radiotherapy (RT). Methods This review is based on peer-reviewed publications using a PubMed search on the MeSH headings “soft tissue sarcoma” AND “preoperative radiotherapy”. Titles and abstracts screened for data including “fraction size AND/OR total dose AND/OR overall treatment time”, “chemotherapy”, “targeted agents AND/OR tyrosine kinase inhibitors”, are collated. Reference lists from some articles have been studied to obtain other pertinent articles. Additional abstracts presented at international sarcoma meetings have been included as well as information on relevant clinical trials available at the ClinicalTrials.gov website. Results Data are presented for the conventional regimen of 50–50.4 Gy in 25–28 fractions in 5–6 weeks preoperative external beam RT with respect to the regimen’s local control probability compared to surgery alone, as well as acute and late toxicities. The rationale and outcome data for hypofractionated and/or reduced dose regimens are discussed. Finally, combination schedules with conventional chemotherapy and/or targeted agents are summarized. Conclusion Outside the setting of well-designed prospective clinical trials, the conventional 50 Gy in 5–6 weeks schedule should be considered as standard. However, current and future studies addressing alternative fraction size, total dose, overall treatment time and/or combination with chemotherapy or targeted agents may reveal regimens of equal or increased efficacy with reduced late morbidities.

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Section: Discussionmentioning

confidence: 99%

Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies

Haas

Miah

Lepéchoux

et al. 2016

Radiotherapy and Oncology

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“…Long term toxicities from RT are important to monitor as efforts to improve local control rates continue 16,26,31 . Dose reduction has traditionally been used to try to decrease RT-related toxicities; our trial attempted to decrease treatment volume, while maintaining intensified RT dosing for patients with larger tumors at diagnosis.…”

Section: Discussionmentioning

confidence: 99%

Limited Margin Radiation Therapy for Children and Young Adults With Ewing Sarcoma Achieves High Rates of Local Tumor Control

Talleur

Navid

Spunt

et al. 2016

International Journal of Radiation Oncology*Biology*Physics

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Purpose Determine the rate of local failure (LF) using focal conformal, limited margin radiotherapy (RT) and dose escalation for tumors ≥ 8cm (greatest dimension at diagnosis) in children and young adults with Ewing sarcoma (EWS). Methods and Materials Eligible patients with EWS were treated on a Phase II institutional trial of focal conformal, limited margin RT using conformal or intensity modulated techniques. The treatment volume incorporated a 1cm constrained margin (CTV1) around the gross tumor. Unresected tumors, <8cm at diagnosis, received a standard dose of 55.8Gy and tumors ≥8cm an escalated dose to 64.8Gy. Patients with microscopic residual disease after resection received adjuvant RT to 50.4Gy. Adjuvant brachytherapy was permitted in selected patients. Results Forty-five patients were enrolled, 26 with localized and 19 with metastatic disease. Median (range) age, tumor size and follow-up were 13.0 years (2.9–24.7), 9.0cm (2.4–17.0) and 54.5 months (1.9–122.2), respectively. All patients received systemic chemotherapy. The median (range) RT dose for all patients was 56.1Gy (45–65.5). Seventeen patients received adjuvant, 16 standard dose and 12 escalated dose RT. Failures included 1 local, 10 distant and 1 local/distant. The estimated 10-year cumulative incidence of LF was 4.4% ± 3.1%, with no statistical difference seen between RT treatment groups and no local failures in the escalated dose RT treatment group. Conclusions Treatment with focal conformal, limited margin RT, including dose escalation for larger tumors, provides favorable local tumor control in EWS.

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“…Late radiation toxicity grade will be reported according to the Radiation Therapy Oncology Group (RTOG-0630) [9]. …”

Section: Methodsmentioning

confidence: 99%

Neoadjuvant Hypofractionated Radiotherapy and Chemotherapy in High-Grade Extremity Soft Tissue Sarcomas: Phase 2 Clinical Trial Protocol

et al. 2017

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BackgroundNeoadjuvant radiotherapy (RT) and chemotherapy are applied to large, high-grade extremity soft tissue sarcomas to treat metastatic disease earlier and sterilize margins to perform R0 surgery. However, preoperative RT increases wound complication rates (rWC), delaying adjuvant chemotherapy or preventing it from being administered altogether. Hypofractionated neoadjuvant RT can be offered in this situation, concomitant to chemotherapy, allowing patients to receive chemotherapy as a preoperative treatment in less time with an acceptable rWC.ObjectiveThe objectives of this protocol are to maintain low rates of morbidity and mortality compared to literature data, improving survival rates and avoiding poor responders from receiving unnecessary adjuvant chemotherapy.MethodsThis noncontrolled, single-arm, phase 2 clinical trial recruited patients aged over 18 years with high-grade soft tissue sarcomas in the girdles or extremities. Three neoadjuvant chemotherapy (ifosfamide and doxorubicin) cycles were administered with 5 days of hypofractionated RT (25 Gy in 5 fractions) in the second cycle of doxorubicin only. Viable cell counts in the surgical specimen were measured, and patients in whom this value was less than 30% continued to receive an additional 3 full chemotherapy cycles as adjuvant treatment.ResultsPrimary endpoint will be disease-specific survival measured by the evaluation of local and distant recurrence after neoadjuvant treatment. The secondary endpoints will be wound complication and amputation rates and chemotherapy toxicity. We also will record the viable cell rates after the schema and correlate this with survival.ConclusionsAs seems with other solid tumors, hypofractionated RT has comparable efficacy and safety as conventional fractionation. This modality of treatment combined with chemotherapy could increase the pathological response rates and improve the outcomes of select patients.Trial RegistrationClinicalTrials.gov NCT02812654; https://clinicaltrials.gov/ct2/show/NCT02812654 (Archived by WebCite at http://www.webcitation.org/6qC3puBOy)

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Significant Reduction of Late Toxicities in Patients With Extremity Sarcoma Treated With Image-Guided Radiation Therapy to a Reduced Target Volume: Results of Radiation Therapy Oncology Group RTOG-0630 Trial

Cited by 239 publications

References 15 publications

Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies

Preoperative radiotherapy for extremity soft tissue sarcoma; past, present and future perspectives on dose fractionation regimens and combined modality strategies

Limited Margin Radiation Therapy for Children and Young Adults With Ewing Sarcoma Achieves High Rates of Local Tumor Control

Neoadjuvant Hypofractionated Radiotherapy and Chemotherapy in High-Grade Extremity Soft Tissue Sarcomas: Phase 2 Clinical Trial Protocol

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