Leitlinienprogramm OnkologieSoft Tissue Sarcoma

11. Quality indicators – Soft Tissue Sarcoma

Version 1.1 · May 2022 · AWMF 032/044OL
Leitlinienprogramm Onkologie · Deutsche Krebsgesellschaft · Deutsche Krebshilfe · AWMF

Quality indicators are measured variables whose collection serves to assess the quality of the underlying structures, processes or results. Quality indicators are an important management tool. The aim of their use is the continuous improvement of care by presenting outcomes, critically reflecting on them and, if necessary, improving them. The present selection of quality indicators was defined according to the methodology of the guideline program oncology [791]. For the definition process, a „working group Quality Indicators“ (AG QI) was constituted. This created the final set of quality indicators based on the strong recommendations („should“) of the newly developed guideline and the results of the search for existing national and international quality indicators. The exact procedure and composition of the WG QI are presented in the guideline report.

After two online meetings of this WG, the final set of 14 quality indicators was adopted.

In addition, the WG makes as a recommendation that local disease-free survival (DFS), metastasis-free survival, and overall survival (OS) are provided by cancer registries, both for the guideline group updating the S3 guideline Adult Soft Tissue Sarcomas and for the individual certified sarcoma center.

Pre-therapeutic presentation in the tumor board (initial diagnosis of soft tissue sarcoma)

Numerator

Patients of the denominator presented in the pre-therapeutic tumor board.

Denominator

All patients with initial diagnosis of soft tissue sarcoma. Participants Tumor Board: surgical discipline with treatment focus on soft tissue sarcomas, hematol-ogy/oncology, pathology, radiology and radiation oncology.

Quality target / reference range

EC

Quality objective: Pretherapeutic presentation of pa-tients with first diagnosis soft tissue sarcoma in the interdisciplinary tumor board as often as possible

Reference recommendations

4.2 · Consensus-based Recommendation 2021

The planning of sarcoma treatment shall take place pre-therapeutically in the interdisciplinary tumor board. At least one surgical discipline with a focus on soft tissue sarcomas, as well as hematology/oncology, pathology, radiology, and radiation oncology shall be represented. Location-specific expertise should be consulted on a case-by-case basis.

Consensus
Strong consensus

Recommendation in chapter

Treatment in the certified sarcoma center

Numerator

Patients of the denominator with care in certified sarcoma center

Denominator

All patients with soft tissue sarcoma

Quality target / reference range

EC

Quality objective: Treatment of as many patients with soft tissue sarcoma as possible in certified sarcoma centers

Reference recommendations

4.1 · Consensus-based Recommendation 2021

The diagnosis and therapy of soft tissue sarcoma shall be performed by or in coordination with a certified sarcoma center or associated cooperation partner.

Consensus
Strong consensus

Recommendation in chapter

Complete report of findings after resection of soft tissue sarcoma

Numerator

Patients of the denominator with report of findings indicating: Grading according to FNCLCC; Minimum distances to relevant resection margins and critical structures; WHO classification; Dignity group-ICD-O

Denominator

All patients with initial diagnosis of soft tissue sarcoma and resection. Dignity groups: benign, intermediate (locally aggressive), intermediate (rarely metastatic) or malignant. FNCLCC: see in chapter 4.1.4.3, table "FNCLCC Grading System: Definition of Parameters" and table "FNCLCC Grading System: Tumor Differentiation Score According to Histologic Type".

Quality target / reference range

4.19: EK; 4.20: EK; 4.24: EK

Quality objective: Complete report of findings after resection of a soft tissue sarcoma as often as possible.

Notes

Reference recommendations

4.21 · Consensus-based Recommendation 2021

The minimum distances to relevant resection margins and critical structures shall be specified in the histopathological findings. R0 status is defined as „no tumor on ink“.

Consensus
Strong consensus

Recommendation in chapter

4.25 · Consensus-based Recommendation 2021

Histopathological subtyping shall be performed according to the currently valid WHO classification.

The tumor shall be classified into the diagnostic groups benign, intermediate (locally aggressive), intermediate (rarely metastatic) or malignant.

The ICD-O coding (if available) shall be added as additional information.

Consensus
Strong consensus

Recommendation in chapter

Risk assessment GIST

Numerator

Patients of the denominator with risk assessment of GIST.

Denominator

All patients with initial diagnosis of localized GIST, M0 and resection.

Quality target / reference range

EC

Quality objective: To assess the risk of recurrence after resection of a GIST, M0, as frequently as possible.

Reference recommendations

4.37 · Consensus-based Recommendation 2021

An assessment of individual recurrence risk shall be performed on the resected primary localized GIST without evidence of distant metastases (cM0) to assess the indication for adjuvant imatinib therapy.

Consensus
Strong consensus

Recommendation in chapter

Mutation analysis GIST

Numerator

Patients of the denominator with mutation analysis of the genes KIT (exon 9, 11) and PDGFRA (exon 18).

Denominator

All patients with initial diagnosis of intermediate/high risk GIST and/or M1. Risk classification GIST: see chapter 10.1.1.3 of the guideline.

Quality target / reference range

EC

Quality Objective: To perform mutation analysis as frequently as possible in intermediate/high risk GIST and/or M1.

Reference recommendations

4.38 · Consensus-based Recommendation 2021

For every intermediate/high risk GIST as well as for every metastatic GIST, a mutation analysis of at least the KIT (exon 9, 11) and PDGFRA (exon 18) genes shall be performed.

If no mutation can be detected in these three loci, further hot spot regions shall be investigated by molecular pathology or the case should be sent to a reference laboratory.

Consensus
Strong consensus

Recommendation in chapter

Primary histological confirmation of soft tissue sarcomas

Numerator

Patients of the denominator with pre-therapeutic histologic backup.

Denominator

All patients with soft tissue sarcoma and therapy, except superficial soft tissue sarcomas ≤3cm. Therapy: surgery, radiation, chemotherapy, hyperthermia, isolated limb perfusion.

Quality target / reference range

5.1: EK; 5.3: EK

Quality objective: Histological confirmation of soft tissue sarcomas, except for superficial soft tissue sarcomas ≤3cm, as often as possible before therapy.

Reference recommendations

5.1 · Consensus-based Recommendation 2021

When there is clinical suspicion and/or imaging suspicion of soft tissue sarcoma, this shall be confirmed on histology.

Consensus
Strong consensus

Recommendation in chapter

5.3 · Consensus-based Recommendation 2021

In cases of clinical suspicion and/or imaging suspicion of soft tissue sarcoma that is smaller than 3 cm in diameter and superficially located, primary R0 resection may be performed.

Consensus
Strong consensus

Recommendation in chapter

R0 resection for soft tissue sarcoma

Numerator

Patients of the denominator with R0 resection

Denominator

All patients with initial diagnosis of soft tissue sarcoma and resection.

Quality target / reference range

GRADE: moderate-high

Quality objective: R0 resection of primary soft tissue sarcomas as often as possible (except planned R1 resections).

Reference recommendations

5.6 · Evidence-based Recommendation 2021

Resection of primary soft tissue sarcoma of the extremities shall be performed as a wide resection. The goal is an R0 resection.

Recommendation grade
A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
Level of evidence
⊕⊕⊕⊝

Local recurrence


⊕⊕⊕⊕

Overall survival


⊕⊕⊕⊝

Metastasis-free survival

Consensus
Consent
References
[152] [153] [154] [155] [156] [157] [158] [159] [160] [161] [162]

Recommendation in chapter

Hysterectomy without morcellement for sarcoma confined to the uterus.

Numerator

Patients of the denominator with hysterectomy without morcellation.

Denominator

All patients with sarcoma confined to the uterus (ICD-O T C54, C55 iVm morphology codes chapter 13.1), M0 with hysterectomy.

Quality target / reference range

5.44: EK; 5.48: EK

Quality objective: Hysterectomy without morcellation for sarcoma confined to the uterus as frequently as possible.

Reference recommendations

5.44 · Consensus-based Recommendation 2021

In leiomyosarcoma confined to the uterus, complete removal of the uterus shall be performed without morcellement or uterine injury.

Consensus
Consent

Recommendation in chapter

5.48 · Consensus-based Recommendation 2021

In high-grade endometrial stromal sarcoma confined to the uterus, complete removal of the uterus shall be performed without morcellation or uterine injury.

Consensus
Strong consensus

Recommendation in chapter

Pre/postoperative radiotherapy for soft tissue sarcoma.

Numerator

Patients of the denominator with preoperative or postoperative radiotherapy.

Denominator

All patients with initial diagnosis of soft tissue sarcoma of extremities or trunk (excluding cutaneous sarcomas ICD-0 T C44), G2 or G3, M0 and resection. ICD-O topography extremities or trunk: C47.1 - C47.8, C48.0, C49.1 – C49.8

Quality target / reference range

GoR: A; GRADE: low-moderate

Quality objective: To provide pre-operative or post-operative radiotherapy as frequently as possible for soft tissue sarcomas of the extremities or trunk (G2 or G3, M0).

Reference recommendations

5.66 · Evidence-based Recommendation 2021

For G2 and G3 soft tissue sarcomas, preoperative or postoperative radiotherapy shall be given.

Recommendation grade
A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
Level of evidence
⊕⊕⊕⊝

Overall survival (follow-up: 16 months)


⊕⊕⊕⊝

Disease-specific survival (follow-up: 76 months).


⊕⊕⊕⊝

Overall survival low-grade STS (follow-up: 67 months).


⊕⊕⊕⊝

Local recurrence (follow-up: 76 months)


⊕⊕⊕⊝

Free of distant metastases (follow-up: 76 months)


⊕⊕⊝⊝

Overall survival (follow-up: 240 months)


⊕⊕⊕⊝

Local recurrence (follow-up: 232.7 months)

Consensus
Strong consensus
References
[315] [316] [317] [318]

Recommendation in chapter

Pre-therapeutic presentation in the tumor board (recurrence and/or secondary distant metastasis of a soft tissue sarcoma).

Numerator

Patients of the denominator with pre-therapeutic presentation in the tumor board

Denominator

All patients with local recurrence and/or newly diagnosed secondary distant metastases of soft tissue sarcoma. Participants Tumor Board: surgical discipline with treatment focus on soft tissue sarcomas, hematology/oncology, pathology, radiology and radiation oncology.

Quality target / reference range

6.4: EK; 7.10: EK

Quality objective: Pretherapeutic presentation of recurrences and/or secondary distant metastasis of soft tissue sarcomas in the interdisciplinary tumor board as often as possible.

Reference recommendations

6.4 · Consensus-based Recommendation 2021

In local recurrences of soft tissue sarcomas not pretreated with neoadjuvant or adjuvant therapy, a multimodal therapy concept shall be defined in an interdisciplinary sarcoma board.

Consensus
Strong consensus

Recommendation in chapter

7.10 · Consensus-based Recommendation 2021

The indication for local therapy of metastases shall be multidisciplinary.

Consensus
Strong consensus

Recommendation in chapter

Post-operative presentation to the tumor board (local recurrence and R1/R2 resection of soft tissue sarcoma).

Numerator

Patients of the denominator who presented postoperatively to the tumor board

Denominator

All patients with local recurrence soft tissue sarcoma and R1/R2 resection. Participants Tumor Board: surgical discipline with treatment focus on soft tissue sarcomas, hematology/oncology, pathology, radiology and radiation oncology.

Quality target / reference range

EC

Quality objective: Post-operative presentation of R1-/R2-resected local recurrences of soft tissue sarcomas in the interdisciplinary tumor board as often as possible.

Reference recommendations

6.15 · Consensus-based Recommendation 2021

After incomplete resection of an isolated local recurrence, whether pretreated with chemotherapy according to guidelines or not, a multidisciplinary therapeutic decision shall be made.

Consensus
Strong consensus

Recommendation in chapter

First-line chemotherapy for soft tissue sarcoma

Numerator

Patients of the denominator with doxorubicin monotherapy or anthracycline-containing combination therapy.

Denominator

All patients with soft tissue sarcoma and first-line chemotherapy.

Quality target / reference range

EC

Quality objective: To use doxorubicin monotherapy or anthracycline-containing combination therapy as frequently as possible in first-line chemotherapy.

Reference recommendations

7.2 · Consensus-based Recommendation 2021

The choice of systemic therapy shall be doxorubicin monotherapy or anthracycline-containing combination therapy, taking into account toxicity and goals.

Consensus
Strong consensus

Recommendation in chapter

Complete report of findings after resection GIST

Numerator

Patients of the denominator with reports of findings indicating: R status Primary location Number of mitoses per 5mm² Tumor rupture

Denominator

All patients with initial diagnosis of GIST and resection.

Quality target / reference range

EC

Quality objective: Complete report of findings after resection of a GIST as often as possible.

Reference recommendations

10.11 · Consensus-based Recommendation 2021

When diagnosing GIST on a resected tumor, R status, primary location, tumor size (largest longitudinal diameter), number of mitoses per 5 mm², and a determination of whether tumor rupture is present shall be included in the pathology report.

Consensus
Strong consensus

Recommendation in chapter

Postoperative mortality in retroperitoneal sarcoma.

Numerator

Patients of the denominator who died within 30d post-operatively.

Denominator

All patients with initial diagnosis of retroperitoneal sarcoma (RPS) (ICD-10 C48.0 or C48.8) and tumor resection.

Quality target / reference range

As a result of the discussion of the international QI, the LL defines as a specific objective that post-operative mortality should be collected for patients with retroperitoneal sarcoma (RPS). Since the basis is the existing international QI, its population is also adopted. 

Source wording:

QPI 11a - 30 Day Mortality Following Curative Oncological Treatment.

30-day mortality following curative treatment for extremity and retroperitoneal sarcoma.

Numerator: Number of patients with extremity or retroperitoneal sarcoma who receive oncological treatment with curative intent who die within 30 days of treatment.

Denominator: All patients with extremity or retroperitoneal sarcoma who receive curative oncological treatment.

Exclusions: No exclusions.

Source: Sarcoma National Managed Clinical Network, N., South East and West of Scotland Cancer Networks Audit Report Sarcoma Quality Performance Indicators. Clinical Audit Data: 01 April 2014 to 31 March 2015. 2016.

 

Reference recommendations

References

[791] Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF), Entwicklung von leitlinienbasierten Qualitätsindikatoren. Methodenpapier für das Leitlinienprogramm Onkologie, Version 2.1, 2017., http://www.leitlinienprogramm-onkologie.de/methodik/informationen-zur-methodik/

[152] Catena, F., Di Battista, M., Ansaloni, L., Pantaleo, M., Fusaroli, P., Di Scioscio, V., et.al. Microscopic margins of resection influence primary gastrointestinal stromal tumor survival, Onkologie, 2012. 35(11): p. 645-8., https://www.ncbi.nlm.nih.gov/pubmed/23147540

[153] Engstrom, K., Bergh, P., Gustafson, P., Hultborn, R., Johansson, H., Lofvenberg, R., et.al. Liposarcoma: outcome based on the Scandinavian Sarcoma Group register, Cancer, 2008. 113(7): p. 1649-56., https://www.ncbi.nlm.nih.gov/pubmed/18720363

[154] Gingrich, A. A., Bateni, S. B., Monjazeb, A. M., Darrow, M. A., Thorpe, S. W., Kirane, A. R., et.al. Neoadjuvant Radiotherapy is Associated with R0 Resection and Improved Survival for Patients with Extremity Soft Tissue Sarcoma Undergoing Surgery: A National Cancer Database Analysis, Ann Surg Oncol, 2017. 24(11): p. 3252-3263., https://www.ncbi.nlm.nih.gov/pubmed/28741123

[155] Jebsen, N. L., Trovik, C. S., Bauer, H. C., Rydholm, A., Monge, O. R., Hall, K. S., et.al. Radiotherapy to improve local control regardless of surgical margin and malignancy grade in extremity and trunk wall soft tissue sarcoma: a Scandinavian sarcoma group study, Int J Radiat Oncol Biol Phys, 2008. 71(4): p. 1196-203., https://www.ncbi.nlm.nih.gov/pubmed/18207661

[156] Jebsen, N. L., Engellau, J., Engstrom, K., Bauer, H. C., Monge, O. R., Muren, L. P., et.al. Patterns of local recurrence and dose fractionation of adjuvant radiation therapy in 462 patients with soft tissue sarcoma of extremity and trunk wall, Int J Radiat Oncol Biol Phys, 2013. 86(5): p. 949-55., https://www.ncbi.nlm.nih.gov/pubmed/23725998

[157] Li, B., Luo, C. H., Zheng, W., Risk factors for recurrence and survival in patients with primary retroperitoneal tumors, J BUON, 2013. 18(3): p. 782-7., https://www.ncbi.nlm.nih.gov/pubmed/24065499

[158] Seagle, B. L., Shilpi, A., Buchanan, S., Goodman, C., Shahabi, S., Low-grade and high-grade endometrial stromal sarcoma: A National Cancer Database study, Gynecol Oncol, 2017. 146(2): p. 254-262., https://www.ncbi.nlm.nih.gov/pubmed/28596015

[159] Sinnamon, A. J., Neuwirth, M. G., McMillan, M. T., Ecker, B. L., Bartlett, E. K., Zhang, P. J., et.al. A prognostic model for resectable soft tissue and cutaneous angiosarcoma, J Surg Oncol, 2016. 114(5): p. 557-563., https://www.ncbi.nlm.nih.gov/pubmed/27378102

[160] Stahl, J. M., Corso, C. D., Park, H. S., An, Y., Rutter, C. E., Han, D., et.al. The effect of microscopic margin status on survival in adult retroperitoneal soft tissue sarcomas, Eur J Surg Oncol, 2017. 43(1): p. 168-174., https://www.ncbi.nlm.nih.gov/pubmed/27335080

[161] Trovik, C. S., Bauer, H. C., Alvegard, T. A., Anderson, H., Blomqvist, C., Berlin, O., et.al. Surgical margins, local recurrence and metastasis in soft tissue sarcomas: 559 surgically-treated patients from the Scandinavian Sarcoma Group Register, Eur J Cancer, 2000. 36(6): p. 710-6., https://www.ncbi.nlm.nih.gov/pubmed/10762742

[162] Trovik, L. H., Ovrebo, K., Almquist, M., Haugland, H. K., Rissler, P., Eide, J., et.al. Adjuvant radiotherapy in retroperitoneal sarcomas. A Scandinavian Sarcoma Group study of 97 patients, Acta Oncol, 2014. 53(9): p. 1165-72., https://www.ncbi.nlm.nih.gov/pubmed/25000415

[315] Beane, J. D., Yang, J. C., White, D., Steinberg, S. M., Rosenberg, S. A., Rudloff, U., Efficacy of adjuvant radiation therapy in the treatment of soft tissue sarcoma of the extremity: 20-year follow-up of a randomized prospective trial, Ann Surg Oncol, 2014. 21(8): p. 2484-9., https://www.ncbi.nlm.nih.gov/pubmed/24756814

[316] Pisters, P. W., Harrison, L. B., Leung, D. H., Woodruff, J. M., Casper, E. S., Brennan, M. F., Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma, J Clin Oncol, 1996. 14(3): p. 859-68., https://www.ncbi.nlm.nih.gov/pubmed/8622034

[317] Pisters, P. W., Harrison, L. B., Woodruff, J. M., Gaynor, J. J., Brennan, M. F., A prospective randomized trial of adjuvant brachytherapy in the management of low-grade soft tissue sarcomas of the extremity and superficial trunk, J Clin Oncol, 1994. 12(6): p. 1150-5., https://www.ncbi.nlm.nih.gov/pubmed/8201376

[318] Brennan, M. F., Hilaris, B., Shiu, M. H., Lane, J., Magill, G., Friedrich, C., et.al. Local recurrence in adult soft-tissue sarcoma. A randomized trial of brachytherapy, Arch Surg, 1987. 122(11): p. 1289-93., https://www.ncbi.nlm.nih.gov/pubmed/3314794