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Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection.

ABSTRACT: Purpose: There are limited data regarding the use of hypofractionated radiation therapy (RT) for soft tissue sarcoma. We report early oncologic outcomes and wound complications of patients undergoing preoperative hypofractionated (5 fraction) RT followed by immediate surgical resection.

Methods and materials: An institutional review board-approved database of patients treated with preoperative RT for soft tissue sarcoma was queried. Patients treated with a hypofractionated dosing regimen followed by immediate (within 7 days) planned wide surgical resection were identified.

Results: Between 2016 and 2019, 16 patients met eligibility criteria. The median patient age was 64 years old (range, 33-88). Ten of the sarcomas were located in the lower extremity, 4 in the upper extremity, and 2 were located in the trunk. Four patients had metastatic disease at diagnosis. The majority of the patients received a total radiation dose of 30 Gy in 5 fractions (range, 27.5-40 Gy) on consecutive days. All patients were planned with intensity modulated radiation therapy or volumetric arc therapy. The median time to surgical resection after the completion of RT was 1 day (range, 0-7 days). The median time from initial biopsy results to completion of primary oncologic therapy was 20 days (range, 16-35). Ten patients achieved R0 resection, whereas the remaining 6 patients achieved R1 resection. Of the 13 patients assessed for local control, no patients developed local failure. Within the median follow-up time of 10.7 months (range, 1.7-33.2), 5 patients developed wound healing complications (31%), of which only 3 patients (19%) required return to the operating room.

Conclusions: Treatment of soft tissue sarcoma with preoperative hypofractionated RT followed by immediate resection resulted in a median of 20 days from biopsy results to completion of oncologic therapy. Early outcomes demonstrate favorable wound healing. Further prospective data with long-term follow-up is required to determine the oncologic outcomes and toxicity of hypofractionated preoperative RT.

SUBMITTER: Parsai S

PROVIDER: S-EPMC7718495 | biostudies-literature | 2020 Nov-Dec

REPOSITORIES: biostudies-literature

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Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection.

Parsai Shireen S Lawrenz Joshua J Kilpatrick Scott S Rubin Brian B Hymes Cory C Gray Michele M Mesko Nathan N Shah Chirag C Nystrom Lukas L Scott Jacob G JG

Advances in radiation oncology 20200629 6

<h4>Purpose</h4>There are limited data regarding the use of hypofractionated radiation therapy (RT) for soft tissue sarcoma. We report early oncologic outcomes and wound complications of patients undergoing preoperative hypofractionated (5 fraction) RT followed by immediate surgical resection.<h4>Methods and materials</h4>An institutional review board-approved database of patients treated with preoperative RT for soft tissue sarcoma was queried. Patients treated with a hypofractionated dosing re ...[more]

PMID: 33305088

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Project description:IntroductionAlthough the introduction of multimodal treatment of soft tissue sarcoma improved local tumour control, local failure still occurs in a good number of patients. Therefore, further improvement of current treatment strategies is necessary. The proposed study treatment will combine standard external beam radiation and the orally administered receptor tyrosine kinase inhibitor sunitinib.Methods and analysisPatients with soft tissue sarcoma will receive sunitinib and irradiation as neoadjuvant treatment. Radiotherapy will be administered as intensity modulated radiation therapy with a total dose of 50.4 Gy in 28 fractions (5 1/2 weeks). Patients will receive sunitinib daily for 2 weeks prior to and then concurrently with irradiation. Sunitinib will be given in two dose levels. The first dose level will be 25 mg sunitinib per os daily. The second dose level will be 37.5 mg. A dose modification schedule according to a 3+3 design will be applied. Restaging and tumour resection will be performed 6 weeks after completion of sunitinib and irradiation. Primary outcome measures will be the dose-limiting toxicity and maximal tolerated dose of sunitinib administered concurrently with irradiation. Toxicity of the study treatment will be documented according to Common Terminology Criteria of Adverse Events (CTCAE) 4.0. Secondary outcome measures will be the response to the study treatment and morbidity of the tumour resection. Imaging response will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria comparing MRI performed prior to and 6 weeks after completion of study treatment. Pathological response will be determined evaluating the fraction of non-viable tumour in the resection specimen. Resection morbidity will be evaluated according to CTCAE 4.0.Ethics and disseminationApproval was obtained from the ethics committee II of the University of Heidelberg, Germany (Reference number 2011-064F-MA). Furthermore, the study was approved by the German Federal Institute for Drugs and Medical Devices (Reference number 4037708).Trial registration eudract2007-002864-87 Clinicaltrials.gov: NCT01498835.

Project description:Soft-tissue sarcoma (STS) represent a rare tumor entity, accounting for less than 1% of adult malignancies. The cornerstone of curative intent treatment is surgery with free margins, although the extent of the surgical approach has been subject to change in the last decades. Multimodal approaches usually including radiation therapy have replaced extensive surgical procedures in order to preserve functionality while maintaining adequate local control. However, the possibility to apply adequate radiation doses by external beam radiation therapy (EBRT) can be limited in some situation especially in case of directly adjacent organs at risk with low radiation tolerance. Application of at least a part of the total dose via intraoperative radiation therapy (IORT) with a single fraction during the surgical procedure may overcome those limitations, because radiosensitive structures can be moved out of the radiation field resulting in reduced toxicity while the enhanced biological effectivity of the high single dose improves local control. The current review summarizes rationale, techniques, oncological and functional outcomes including possible pitfalls and associated toxicities based on the published literature for IORT focusing on extremity and retroperitoneal STS. In extremity STS, combination of limb-sparing surgery, IORT and pre- or postoperative EBRT with moderate doses consistently achieved excellent local control rates at least comparable to approaches using EBRT alone but usually including patient cohorts with higher proportions of unfavourable prognostic factors. Further on, IORT containing approaches resulted in very high limb preservation rates and good functional outcome, probably related to the smaller high dose volume. In retroperitoneal STS, the combination of preoperative EBRT, surgery and IORT consistently achieved high local control rates which seem superior to surgery alone or surgery with EBRT at least with regard to local control and in some reports even to overall survival. Further on, preoperative EBRT in combination with IORT seems to be superior to the opposite combination with regard to local control and toxicity. No major differences in wound healing disturbances or postoperative complication rates can be observed with IORT compared to non-IORT containing approaches. Neuropathy of major nerves remains a dose limiting toxicity requiring dose restrictions or exclusion from target volume. Gastrointestinal structures and ureters should be excluded from the IORT area whenever possible and the IORT volume should be restricted to the available minimum. Nevertheless, IORT represents an ideal boosting method if combined with EBRT and properly executed by experiences users which should be further evaluated preferably in prospective randomized trials.

Project description:BackgroundThe role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event, resulting in 5-year overall survival rates of only 50-60%. Neo-adjuvant and adjuvant chemotherapy (CTX) has been applied to achieve pre-operative cytoreduction, assess chemosensitivity, and to eliminate occult metastasis. Here we report on the results of our non-randomized phase II study on neo-adjuvant treatment for high-risk STS.MethodPatients with potentially curative high-risk STS (size ≥ 5 cm, deep/extracompartimental localization, tumor grades II-III [FNCLCC]) were included. The protocol comprised 4 cycles of neo-adjuvant chemotherapy (EIA, etoposide 125 mg/m(2) iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m(2) day 1, pegfilgrastim 6 mg sc day 5), definitive surgery with intra-operative radiotherapy, adjuvant radiotherapy and 4 adjuvant cycles of EIA.ResultBetween 06/2005 and 03/2010 a total of 50 subjects (male = 33, female = 17, median age 50.1 years) were enrolled. Median follow-up was 30.5 months. The majority of primary tumors were located in the extremities or trunk (92%), 6% originated in the abdomen/retroperitoneum. Response by RECIST criteria to neo-adjuvant CTX was 6% CR (n = 3), 24% PR (n = 12), 62% SD (n = 31) and 8% PD (n = 4). Local recurrence occurred in 3 subjects (6%). Distant metastasis was observed in 12 patients (24%). Overall survival (OS) and disease-free survival (DFS) at 2 years was 83% and 68%, respectively. Multivariate analysis failed to prove influence of resection status or grade of histological necrosis on OS or DFS. Severe toxicities included neutropenic fever (4/50), cardiac toxicity (2/50), and CNS toxicity (4/50) leading to CTX dose reductions in 4 subjects. No cases of secondary leukemias were observed so far.ConclusionThe current protocol is feasible for achieving local control rates, as well as OS and DFS comparable to previously published data on neo-/adjuvant chemotherapy in this setting. However, the definitive role of chemotherapy remains unclear in the absence of large, randomized trials. Therefore, the current regimen can only be recommended within a clinical study, and a possibly increased risk of secondary leukemias has to be taken into account.Trial registrationClinicalTrials.gov NCT01382030, EudraCT 2004-002501-72.

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Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection.

Publications

Early Outcomes of Preoperative 5-Fraction Radiation Therapy for Soft Tissue Sarcoma Followed by Immediate Surgical Resection.

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