Soft Tissue Sarcoma Treatment Protocols 

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Treatment protocols for soft tissue sarcoma are provided below, including recommendations for low- and high-grade soft tissue sarcomas, for metastatic disease, and for soft tissue sarcomas with special histologies.

See Soft-Tissue Sarcomas: What You Need to Know, a Critical Images slideshow, to help identify and treat some of these malignant tumors of mesenchymal origin.

Stage I:

Surgery is the primary treatment for stage I sarcoma; it is considered adequate when margins are > cm or if the fascia is still intact [1]

Re-resection or adjuvant external beam radiation therapy (XRT) is recommended to prevent local recurrence or if margins are < cm or when location complicates resection at the time of recurrence

Radiation therapy is associated with decreased local recurrence but not necessarily with improved overall survival

Definitive radiation therapy is recommended for patients who are not surgical candidates; radiation doses range from 70-80 Gy

II-III:

Tumors in this stage can be &gt; 5-10 cm and have a high risk of recurrence and potential metastases

For patients with resectable disease, surgery followed by radiation therapy with or without adjuvant chemotherapy or surgery alone is recommended; preoperative radiation therapy, chemotherapy, or chemoradiation prior to surgery are alternatives in select clinical situations

Patients with unresectable disease should be treated with definitive radiation therapy, chemotherapy, or definitive chemoradiation [2, 3, 4, 5, 6]

Role of radiation therapy in the locoregional management of soft tissue sarcoma:

Preoperative XRT:

of using preoperative therapy are that large tumors adjacent to critical organs may become resectable; a smaller treatment field is needed; and potentially less tumor seeding may occur during resection

The common dose for XRT is 50 Gy

Negative aspects of using this therapy include increased wound-healing complications [7, 8]

If margins are close (&lt; 1 cm) or positive, consider boost with brachytherapy, intraoperative radiation therapy (IORT), or postoperative XRT/intensity modulated radiation therapy (IMRT) at doses ranging from 10-26 GY [9]

Postoperative brachytherapy:

Common doses: brachytherapy, 45 Gy; XRT, 50 Gy

Consider re-resection if margins are positive

Consider XRT even when negative margins are achieved with re-resection and the patient is older and/or has stage III disease [10]

When re-resection is not an option, consider postoperative radiation therapy [11]

include the fact that wound-healing complications of preoperative radiation are avoided by giving radiation after surgery

Stage IV:

In metastatic disease, it is important to differentiate between limited and disseminated metastases

Limited metastasis involves only one organ and should be considered for resection for improved disease-free survival (DFS) and overall survival (OS)

Disseminated metastases can be managed with palliative therapy (radiation, chemotherapy, surgery, or supportive care alone)

Initiation of palliative chemotherapy should be based on histology, tumor growth rate, chemosensitivity, and associated symptoms

Adjuvant chemotherapy (in patients without metastasis and after surgical resection of a primary tumor) is not generally considered as first-line therapy [12, 13, 14]

Several single-agent and combination chemotherapies are used in metastatic disease; compared with single-agent chemotherapies, many combination therapies have higher response rates but greater toxicities and no survival advantage

The decision for combination therapies should be individualized and take age, performance status, and organ function into account

Combination therapies may require prophylactic growth factor support

Refer patients for clinical trials whenever possible

If the patient is asymptomatic and the tumor has a slow growth rate, then observation with close monitoring is a reasonable option

Patients with limited metastatic disease or recurrent disease after primary therapy should be considered for surgery, radiofrequency ablation (RFA), embolization, or radiation therapy with curative intent

There are no clear guidelines for metastatic and recurrent disease, as treatment depends on the disease-free interval, performance status, and histology

In stage IV sarcoma, patients with limited disease should also be considered for resection or other definitive intervention, as this is associated with improved disease-free survival

Consider re-resection for positive or close margins [15]

Prevention of local recurrence may require additional radiation and/or chemotherapy

Methotrexate, cisplatin, and taxanes are not considered active in most soft tissue sarcomas; however, important exceptions include osteosarcoma, uterine sarcoma, and angiosarcoma, respectively.

Regimens include the following  :

Doxorubicin 60 mg/m2 every 3 wk; doses as high as 75 mg/m2 can be given; however, this can be administered as a split dose over 3 d (25 mg/m2/day for 3 d); maximum lifetime dose is 475-600 mg/m2 or

Liposomal pegylated doxorubicin: doses as high as 50 mg/m2 every 4 wk have been used in clinical trials; however, this is associated with significant toxicity; commonly used doses include 30-35 mg/m2 every 4 wk; no maximum lifetime doses or

Ifosfamide 2000-3000 mg/m2/day IV over 3 h for 3-4 d plus mesna; repeat every 21 d or

Ifosfamide 5000 mg/m2 over 24 h plus  mesna 5000 mg/m2 over 24 h and an additional 400-600 mg/m2 for 2 h after completion of ifosfamide; repeat every 21 d (European schedule) or

Gemcitabine 1200 mg/m2 IV over 90-120min on days 1 and 8; repeat cycle every 21d or

Trabectedin 1.5 mg/m2 IV q3wk until disease progression or unacceptable toxicity; premedication require and infuse via central line over 24h [16, 17, 18, 19, 20, 21] or

Epirubicin 160 mg/m2 IV bolus every 3 wk with growth factor support [22] or

Dacarbazine 250 mg/m2 IV for 5 d or 800-1000 mg/m2 IV every 3 wk or

Pazopanib 800 mg PO qd (not indicated for liposarcoma outside of a clinical trial; FDA approved as second-line chemotherapy; recommend starting at a low dose of 200 mg for 2 weeks and slowly increasing the dose)

Combination chemotherapy regimens consist of any one of the regimens described below, including doxorubicin, ifosfamide, and mesna; doxorubicin and dacarbazine; mesna, doxorubicin, ifosfamide, and dacarbazine; or gemcitabine and docetaxel.

Doxorubicin, ifosfamide, and mesna (AIM) [3, 23, 6] :

Doxorubicin 20-25 mg/m2 IV push on days 1-3 plus

Ifosfamide 2000-3000 mg/m2 IV push bolus 3 h on days 1-3 plus

Mesna 225 mg/m2 IV over 1 h before ifosfamide and at 4 and 8 h after ifosfamide

Repeat every 21-28 d

Doxorubicin and dacarbazine (AD):

Doxorubicin 15 mg/m2/day IV continuous infusion on days 1-4 plus

Dacarbazine 250 mg/m2/day IV continuous infusion on days 1-4

Repeat every 3 wk [24]

Mesna, doxorubicin, ifosfamide, and dacarbazine:

Mesna 2.5 g/m2/day IV continuous infusion on days 1-4 plus

Doxorubicin 20 mg/m2/day IV continuous infusion on days 1-3 plus

Ifosfamide 2.5 g/m2/day IV continuous infusion on days 1-3 plus

Dacarbazine 300 mg/m2/day IV continuous infusion on days 1-3

Repeat every 3 wk [25]

Doxorubicin and olaratumab [26]

Gemcitabine and docetaxel [28, 29] :

Gemcitabine 900 mg/m2 IV over 30-90 min on days 1 and 8 plus docetaxel 75-100 mg/m2 IV over 60 min on day 8; repeat every 21 d; growth factors may be needed

Gemcitabine 900 mg/m2 IV over 30-90 min on days 1 and 8 plus docetaxel 35 mg/m2 IV over 60 min on day 1 and 8; repeat every 21 d; growth factors typically not needed; very well-tolerated schedule

See the list below:

Concurrent chemoradiation typicalliy is mainly used for extremity and trunk soft tissue sarcoma, as use in intra-abdominal/retroperitoneal sites has more significant toxicities.

Doxorubicin can be administered as a flat dose of 30 mg daily for 3 d, with concurrent radiation therapy.

Radiotherapy with ifosfamide is associated with significant toxicities, and full doses are difficult to administer beyond two cycles.

A single trial reported safe administration of gemcitabine at 700 mg/m2 along with 50 Gy over 25 fractions

There are sparse data on oral temozolomide 50 mg/m2 once daily for 7 d with radiation therapy (dose of 50.4 Gy)

Combination chemotherapy regimens (MAID [mesna, doxorubicin, ifosfamide, and dacarbazine]) with concurrent radiation therapy have higher response and prohibitive toxicities and therefore should be performed at centers with adequate experience with these regimens; there are no prospective studies comparing chemoradiation to radiation therapy alone

Consider adjuvant chemotherapy for chemosensitive, extremity/trunk, and high-risk lesions; consider age, performance status, size, grade, location, type of initial surgery, and margin status when discussing initiation of adjuvant therapy

When possible, patients should be referred to an NCCN-designated center and enrolled in clinical trials.

Leiomyosarcoma:

A phase II study randomized patients with leiomyosarcomas to gemcitabine (1200 mg/m2 IV on days 1 and 8; every 21 d) alone or gemcitabine (900 mg/m2 IV over 90 min on days 1 and 8) and docetaxel (100 mg/m2 IV over 90 min on day 8; every 21 d) and reported higher response rates in the dual chemotherapy arm (32% vs 27%), with a 3% complete response (CR) and significantly improved progression-free survival (6.3 vs 3 mo) [30]

Several phase II trials have demonstrated the activity of temozolomide in sarcoma, with efficacy particularly notable in leiomyosarcoma [31, 32]

Temozolomide can be administered as a 6-wk, continuous oral schedule at a dose of 75 mg/m2 or BID on a 12-h schedule for 5 d as an oral bolus dose of 200 mg/m2 followed by 9 doses of 90 mg/m2 every 4 wk

Angiosarcoma:

Treatment is wide excision and irradiation; however, angiosarcoma is highly aggressive and has a propensity for local recurrence, multifocal spread, and early hematogenous dissemination

Angiosarcomas have a 5-y overall survival rate of 10-30%; radiation-associated angiosarcomas are thought to have worse outcomes

Systemic treatment of angiosarcomas include doxorubicin or ifosfamide, with responses in the range of 10-20%; angiosarcomas are also highly sensitive to taxanes; pegylated-liposomal doxorubicin has also been shown to have activity in this disease [33]

A phase II clinical trial of 30 patients with unresectable or metastatic angiosarcoma (ANGIOTAX study) demonstrated a 2-mo and 4-mo progression-free survival of 74% and 42%, respectively, with weekly paclitaxel administered at a dose of 80 mg/m2 on days 1, 8, and 15 in a 4-wk cycle; an overall response rate of 19% was observed [34]

Docetaxel has also been shown to be promising, with 6 out of 9 patients treated achieving major responses [35]

A phase II trial of sorafenib that included 37 patients with vascular sarcomas achieved one CR, four partial responses (PR), and an overall response rate of 14%; overall median progression-free survival was 3.2 mo; the median OS was 14.3 mo; patients with angiosarcoma had the greatest degree of tumor shrinkage overall of all vascular sarcoma subtypes [36]

Single-agent bevacizumab can achieve a response rate of 12% and tumor stabilization in 62% [37]

Synovial sarcoma:

Chemosensitive disease with particular sensitivity to ifosfamide

A case series of 13 patients with synovial sarcoma treated with high-dose ifosfamide showed response in all patients, with four CRs achieved [38]

A single-institution study of 100 patients treated with doxorubicin and/or ifosfamide showed a median survival of 22 mo; single-agent doxorubicin or ifosfamide achieved responses in 25% of patients treated, but combination therapy achieved a response rate of 58% [39]

Overview

What &#097;&#114;&#101; &#116;&#104;&#101; treatment protocols &#102;&#111;&#114; soft tissue sarcoma?

What &#097;&#114;&#101; &#116;&#104;&#101; treatment recommendations &#102;&#111;&#114; low-grade soft tissue sarcoma?

What &#097;&#114;&#101; &#116;&#104;&#101; treatment recommendations &#102;&#111;&#114; high-grade soft tissue sarcoma?

What &#105;&#115; &#116;&#104;&#101; role &#111;&#102; preoperative &#102;&#111;&#114; X-ray therapy (XRT) &#105;&#110; &#116;&#104;&#101; treatment &#111;&#102; soft tissue sarcoma?

What &#105;&#115; &#116;&#104;&#101; role &#111;&#102; postoperative brachytherapy &#105;&#110; &#116;&#104;&#101; treatment &#111;&#102; soft tissue sarcoma?

What &#097;&#114;&#101; &#116;&#104;&#101; treatment recommendations &#102;&#111;&#114; metastatic soft tissue sarcoma?

What &#097;&#114;&#101; &#116;&#104;&#101; single-agent chemotherapy options &#117;&#115;&#101;&#100; &#105;&#110; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma?

What &#097;&#114;&#101; &#116;&#104;&#101; chemotherapy regimens &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma?

Which chemotherapy agents &#097;&#114;&#101; &#117;&#115;&#101;&#100; &#105;&#110; combination regimens &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma?

What &#105;&#115; &#116;&#104;&#101; AIM regimen &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma treatment?

What &#105;&#115; &#116;&#104;&#101; AD regimen &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma treatment?

What &#105;&#115; &#116;&#104;&#101; mesna, doxorubicin, ifosfamide, &#097;&#110;&#100; dacarbazine regimen &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma?

What &#105;&#115; &#116;&#104;&#101; doxorubicin &#097;&#110;&#100; olaratumab regimen &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma?

What &#105;&#115; &#116;&#104;&#101; gemcitabine &#097;&#110;&#100; docetaxel regimen &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; metastatic soft tissue sarcoma?

What &#097;&#114;&#101; considerations &#102;&#111;&#114; &#116;&#104;&#101; &#117;&#115;&#101; &#111;&#102; chemotherapy &#105;&#110; &#116;&#104;&#101; treatment &#111;&#102; soft tissue sarcoma?

When &#105;&#115; referral &#116;&#111; &#097;&#110; NCCN-designated center indicated &#102;&#111;&#114; &#116;&#104;&#101; treatment &#111;&#102; soft tissue sarcoma?

What &#097;&#114;&#101; treatment recommendations &#102;&#111;&#114; leiomyosarcoma?

What &#097;&#114;&#101; treatment recommendations &#102;&#111;&#114; angiosarcoma?

What &#097;&#114;&#101; treatment recommendations &#102;&#111;&#114; synovial sarcoma?

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Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15. 20(12):2824-31. [Medline].

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Judson I, Radford JA, Harris M, Blay JY, van Hoesel Q, le Cesne A. Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL/CAELYX) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma: a study by the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2001 May. 37(7):870-7. [Medline].

Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10. 26(32):5269-74. [Medline].

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Agulnik M, Okuno SH, Von Mehren M, et al. An open-label multicenter phase II study of bevacizumab for the treatment of angiosarcoma. J Clin Oncol. 2009. 7:15s:(suppl; abstr 10522).

Rosen G, Forscher C, Lowenbraun S, Eilber F, Eckardt J, Holmes C, et al. Synovial sarcoma. Uniform response of metastases to high dose ifosfamide. Cancer. 1994 May 15. 73(10):2506-11. [Medline].

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from Memorial Sloan-Kettering – Mrinal M Gounder, MD Attending Physician in Medical Oncology, Sarcoma and Developmental Therapeutics Service, Memorial Sloan-Kettering Cancer Center

Disclosure: Nothing to disclose.

from Memorial Sloan-Kettering – Richard D Carvajal, MD Assistant Member, Department of Medicine, Memorial Sloan-Kettering Cancer Center; Assistant Professor of Medicine, Weill Cornell Medical College

from Memorial Sloan-Kettering – Richard D Carvajal, MD is a member of the following medical societies: American Association &#102;&#111;&#114; Cancer Research, American College &#111;&#102; Physicians, American Society &#111;&#102; Clinical Oncology

Disclosure: Received consulting fee from Novartis for consulting; Received consulting fee from Morphotek for consulting.

Mary L Windle, PharmD Adjunct Associate Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Nothing to disclose.

Christopher D Braden, DO Hematologist/Oncologist, Chancellor Center for Oncology at Deaconess Hospital; Medical Director, Deaconess Hospital Outpatient Infusion Centers; Chairman, Deaconess Hospital Cancer Committee

Christopher D Braden, DO is a member of the following medical societies: American Society &#111;&#102; Clinical Oncology, American Society &#111;&#102; Hematology

Disclosure: Nothing to disclose.

Edwin Choy, MD, PhD Assistant Professor of Medicine, Harvard Medical School; Director of Sarcoma Clinical Research, Clinical Director of Sarcoma Oncology, Department of Medicine, Division of Hematology/Oncology, Dana Farber/Harvard Cancer Center, Massachusetts General Hospital

Edwin Choy, MD, PhD is a member of the following medical societies: American Society &#111;&#102; Clinical Oncology, Children&#8217;s Oncology Group, Connective Tissue Oncology Society, Radiation Therapy Oncology Group, Sarcoma Alliance for Research through Collaboration

Disclosure: Received honoraria from Amgen, Daiichi Sankyo, and EMC Serono for advisory board participation; Received consulting fee from Pfizer for consulting; Received consulting fee from NPS Pharmaceuticals for consulting.

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