14. Quality indicators – Endometrial Cancer
Quality indicators are measured variables whose collection serves to assess the quality of the underlying structures, processes or results. Quality indicators are an important quality management tool. The aim of their use is the continuous improvement of care by presenting the results of care, critically reflecting on them and improving them if necessary. The present selection of quality indicators was created according to the methodology of the Oncology Guidelines Program [931]. For the derivation process, a “Quality Indicators Working Group” (AG QI) was constituted. This created the final set of quality indicators based on the already existing quality indicators of the Guideline in Endometrial Cancer 2018, the new strong recommendations (“should”) of the updated guideline Endometrial Cancer, the results of the existing quality indicators from the certified gynecological cancer centers of the German Cancer Society and the results of the search for existing national and international quality indicators. The exact procedure and composition of the WG QI are outlined in the Guideline Report.
After two online meetings of this working group, 5 new quality indicators (QIs) were defined and adopted, so that the final set consists of 9 QIs.
The numerator is always a subset of the denominator.
Quality indicators 2, 3, 4, 8, and 9 are to be documented with the oncology baseline data set of the cancer registries (as of 05/2022).
No LNE for endometrial cancer c/pT1a, G1/2, cN0, LVSI neg (modified 2022).
Numerator
Female patients of the denominator with systematic LNE
Denominator
All patients with initial diagnosis of endometrial cancer, c/p T1a, G1/G2, cN0, LVSI neg.
Quality target / reference range
EC A, LoE 1
Quality Objective: No systematic lymphadenectomy for endometrial
cancer c/p T1a, G1/G2, cN0, LVSI neg.
Reference recommendations
In low-risk type I endometrial carcinoma pT1a, G1/2, no bulky nodes, systematic lymphadenectomy shall not be performed.
- Recommendation grade
- A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
- Level of evidence
- 1
- Consensus
- Consent
- References
- [505]
Change note
In type I endometrial carcinoma pT1a, G1/2, no bulky nodes, (low risk), systematic lymphadenectomy should not be performed.No adjuvant chemotherapy for type I endometrial cancer stage pT1a/b, G1 or G2, cN0/pNsn0 p53-wt (modified 2022).
Numerator
Patients of the denominator with adjuvant chemotherapy.
Denominator
All patients with initial diagnosis of endometrioid or other type I endometrial cancer (ICD-0: 8380/3, 8570/3, 8263/3, 8382/3, 8480/3), pT1a/b G1 cN0/pNsn0 p53-wt or pT1a/b G2 cN0/pNsn0, p53-wt
Quality target / reference range
EC, strong consensus
Quality Objective:
No adjuvant chemotherapy for type I endometrial carcinoma pT1a/b G1 cN0/pNsn0 p53-wt o. pT1a/b G2 cN0/pNsn0 p53-wt
Reference recommendations
Patients with primary type I endometrial carcinoma stage pT1a/b G1 and G2 cN0/ pNsn0, p53-wt, shall not receive adjuvant chemotherapy.
- Consensus
- Strong consensus
Change note
Patients with endometrioid or other type I endometrial carcinoma (ICD-0: 8380/3, 8570/3, 8263/3, 8382/3, 8480/3) at stage pT1a/b G1 and G2 cN0/pN0 should not receive adjuvant chemotherapy.Social service counseling
Numerator
Number of patients with counseling by social services
Denominator
All patients with initial diagnosis of endometrial cancer and treatment at the facility.
Quality target / reference range
EC, consensus
Quality objective:
Consultations by social services as frequently as possible
Reference recommendations
Medical-oncological rehabilitation serves the specific treatment of disease and therapy sequelae. All patients with endometrial carcinoma shall be informed and advised about the legal options for applying for and receiving rehabilitation services.
- Consensus
- Strong consensus
Presentation at the tumor conference (modified 2022)
Numerator
Patients of the denominator with presentation in the tumor conference
Denominator
All patients with endometrial cancer
Quality target / reference range
EC, strong consensus
Quality objective:
Presentation of patients at the tumor conference as often as possible
Notes
Participating tumor conference: surgeon, radiologist, pathologist, radiation oncologist, gynecologic oncologist, medical oncologist (if system therapy is performed by medical l oncologist).
Reference recommendations
All patients with endometrial cancer shall be presented at an interdisciplinary tumor conference.
- Consensus
- Strong consensus
Immunohistochemical determination of p53 and the MMR proteins (new 2022)
Numerator
Patients of the denominator with immunohistochemical determination of p53 u. the MMR proteins
Denominator
All patients with histologically confirmed diagnosis of endometrial carcinoma (incl. M1)
Quality target / reference range
EC A, LoE 4
Quality objective:
Determination of p53 and MMR proteins as frequently as possible.
Reference recommendations
In all histologically diagnosed primary EC, immunohistochemical determination of p53 as well as MMR proteins shall be performed.
POLE investigation (new 2022)
Numerator
Female patients of the denominator with POLE examination
Denominator
All patients with initial diagnosis of endometrial cancer >pT1a and/or G3 and/or p53-abn and/or LVSI pos. and/or MSI/MMR pos. or initial diagnosis of type 2 endometrial cancer (serous, clear cell, carcinosarcoma) (ICD-0: 8441/3, 8441/2; 8310/3; 8950/3)
Quality target / reference range
EC A, LoE 4
Quality objective:
POLE examination as often as possible
Reference recommendations
In G3 or in intermediate, high intermediate, and high-risk EC, mutational analysis of the exonuclease domain of POLE shall be performed.
Postoperative vaginal brachytherapy alone (new 2022)
Numerator
Denominator patients with postoperative vaginal brachytherapy alone
Denominator
All patients with initial diagnosis of endometrial cancer stage pT1b, G1 or G2 pNX/0, p53-wt, L1CAM negative, without extensive LVSI with surgery
Quality target / reference range
EC A, LoE 2
Quality objective:
Vaginal brachytherapy alone as often as possible
Reference recommendations
In stage pT1b, G1 or G2 pNX/0 and in stage pT1a (with myometrial involvement), G3 pNX/0, endometrioid endometrial carcinoma (type I), p53-wt, L1CAM negative, no extensive LVSI, postoperative vaginal brachytherapy alone shall be performed.
- Recommendation grade
- A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
- Level of evidence
- 2
- Consensus
- Consent
- References
- [595] [596] [597] [598] [342] [289]
Change note
In stage pT1b, G1 or G2 pNX/0 and in stage pT1a (with myometrial involvement), G3 pNX/0, endometrioid EC (type I), vaginal brachytherapy alone should be performed postoperatively to reduce the risk of vaginal recurrence.Percutaneous radiotherapy with simultaneous chemotherapy (PORTEC 3 regimen) (new 2022)
Numerator
Patients of the denominator with concurrent chemotherapy (PORTEC 3 regimen)
Denominator
All patients with initial diagnosis of endometrioid (morphology code: 8380/3) endometrial carcinoma pT1b or pT2, p53-abn, POLE-wt and percutaneous radiotherapy
Quality target / reference range
EC A, LoE 3
Quality objective:
Simultaneous chemotherapy as often as possible (PORTEC 3 regimen)
Reference recommendations
Patients with endometrioid endometrial carcinoma (type 1) stage pT1b and pT2 p53-abn, POLE-wt shall receive percutaneous radiotherapy in combination with chemotherapy (PORTEC 3 regimen).
Adjuvant chemotherapy with carboplatin and paclitaxel (new 2022)
Numerator
Patients of the denominator with chemotherapy with carboplatin and paclitaxel
Denominator
Patients with initial diagnosis of endometrial cancer and adjuvant chemotherapy
Quality target / reference range
EC A, LoE 2
Quality objective:
Adjuvant chemotherapy with carboplatin and paclitaxel as often as possible.
Reference recommendations
Adjuvant chemotherapy for endometrial cancer shall be given with carboplatin AUC 6 and paclitaxel 175 mg per square meter. After percutaneous radiotherapy, carboplatin AUC 5 should be dosed.
- Recommendation grade
- A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
- Level of evidence
- 2
- Consensus
- Strong consensus
- References
- [635] [636] [606]
Change note
Adjuvant chemotherapy for endometrial cancer should be given with carboplatin AUC 6 and paclitaxel 175 mg per square meter. When combined with percutaneous radiotherapy, carboplatin AUC 5 should be dosed. Adriamycin and cisplatin may also be used if contraindications exist.Evidence tables (1)
NomuraH_2019Evidence tables
NomuraH_2019
| Nomura, H. et al. Effect of Taxane Plus Platinum Regimens vs Doxorubicin Plus Cisplatin as Adjuvant Chemotherapy for Endometrial Cancer at a High Risk of Progression: A Randomized Clinical Trial. JAMA Oncol. 5. 833-840. 2019 | |||
|---|---|---|---|
| Population | Intervention - Comparison | Outcomes/Results | |
| Evidence level: 2 Study type: Multicenter, open label, phase 3 randomized trial. Number of Patient: 788 patients were enrolled at 118 clinical sites. Recruitung Phase: November 24, 2006, through January 7, 2011. Inclusion Criteria: Patients with endometrial cancer at a high risk of progression following surgery. (1)patients who had undergone total abdominal hysterectomy with bilateral salpingooophorectomy and pelvic lymph node dissection in which the residual tumor was 2 cm or less, (2) patients scheduled to receive chemotherapy within 8 weeks postsurgery, (3) patients without prior chemotherapy or radiotherapy, (4) patients aged between 20 and 74 years at registration, (5) patients having an Eastern Cooperative Oncology Group performance status of 0 to 2, and (6) patients with adequate function of major organs (eg, bone marrow, heart, liver, kidneys). Exclusion Criteria: Sarcomatous component, serious complications, concurrent infection, or a simultaneous cancer or a history of other cancer within the past 5 years. |
Intervention: docetaxel plus cisplatin or paclitaxel plus carboplatin Comparison: doxorubicin plus cisplatin |
Primary: Progression-free survival (PFS). Secondary: Overall survival, occurrence of adverse events (AEs), tolerability of treatment, and status of lymph node dissection. Results: AP: 263 patients to the doxorubicin plus cisplatin treatment group, DP: 263 patients to the docetaxel plus cisplatin treatment group, and TC: 262 patients to the paclitaxel plus carboplatin treatment group. After median of follow-up of seven years: The 5-year PFS was AP: 73.3% DP: 79.0% TC: 73.9% with no significant differences among the 3 groups(2-sided P = .12). The 5-year overall survival was AP: 82.7% DP: 88.1% TC: 86.1% with no significant differences among the 3 groups (2-sided P = .67). The number of patients who did not complete 6 cycles was 53 (20.1%) for the doxorubicin plus cisplatin group, 45 (17.1%) for the docetaxel plus cisplatin group, and 63 (24.0%) for the paclitaxel plus carboplatin group. Tolerability of these regimens were not statistically different. Author's Conclusion: In conclusion, taxane plus platinum regimens did not demonstrate a survival benefit over treatment with doxorubicin plus cisplatin; therefore, doxorubicin plus cisplatin remains the standard postoperative adjuvant chemotherapy regimen for endometrial cancer at a high risk of progression. Nevertheless, considering efficacy and tolerability, taxane plus platinum regimens may be an alternative to treatment with doxorubicin plus cisplatin. |
|
| Methodical Notes | |||
| Funding Sources: See publication COI: see publication Randomization: 1:1:1 ratio using surgical stage (I or II vs III or IV) and tumor histology (G1 or G2 vs G3 or histology with a poor prognosis) as stratification factors. Blinding: n.a. Dropout Rate/ITT-Analysis: To robustly detect these clinical improvement swith 80% power, which is defined by the probability that the global null hypothesis and any paired null hypotheses were rejected simultaneously, under the aforementioned procedure in an enrollment period of 4 years and a follow-up period of 5 years, 250 patients per treatment group were required in 10 000 simulation studies.The recruitment target was 260 patients with 10 dropouts per treatment group. Notes: Oxford CEBM Level of evidence 2011: EL 2 (randomized trial) |
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