Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Al Husaini, 2012

Type of study:

Retrospective cohort, single institution

Setting and country:

King Faisal Specialist hospital, Saudi Arabie, 1976-2010

Funding and conflicts of interest:

NA

Inclusion criteria:

Patients with histologically proven pure dysgerminoma

Exclusion criteria:

NA

N total at baseline:

N= 65

Important prognostic factors

stage IA: 21 (32.3%)

stage IC: 12 (18.5%)

stage IIA/IIB: 2 (3%)

stage IIIA/IIIB : 4 (6.2%)

stage IIIC: 18 (27.6%)

stage IV: 4 (6.2%)

4 with unknown stage

USO: 50 (76.9%)

BSO: 4 (6.2%)

BSO + hysterectomy: 8 (12.3%)

Biopsy only: 3 (4.6%)

Surgical outcome:

Optimal debulking: 44 (67.7%)

Residual disease 18 (27.7%)

Unknown 3 (4.6%)

Postoperative therapy

Chemotherapy: 40 (61.5%)

Radiation therapy: 4 (6.2%)

No adjuvant: 21 (32.3%)

All chemotherapy regimens were platinum based, most common was bleomycine, etoposide, cisplatin (BEP) (30 patients, 75%).

Radiation therapy: 4 (6.2%)

No adjuvant: 21 (32.3%)

Median follow-up period for survivors was 54 months (range 0.3 – 428 months).

Recurrence:

6 out of 65 patients (9.2%).

5 out of 6 recurrences were in patients who did not received adjuvant therapy.

Disease free survival:

Total group:

5 year DFS: 88% (95% CI 78%-97%)

Adjuvant chemotherpy  vs no adjuvant chemotherapy:

HR=0.09 (95% CI 0.01-0.84), p=0.034

Overall survival:

Total group:

5 year OS: 95.2% (95% CI 89.3% – 100%)

Bergamini, 2020

Type of study:

Retrospective pooled analysis

Setting and country:

Patients diagnosed and followed in MITO centres (Multicenter Italian Trials in Ovarian Cancer) or Charing Cross Hospital (CXH)

Funding and conflicts of interest: none

Inclusion criteria:

Postpuberal patients

Stage I pure immature teratoma, 1985-2018

Exclusion criteria:

Patients with incomplete data or follow-up information

N total at baseline: 108 patients

Important prognostic factors²:

Stage 1A: 66 (61.1%)

Stage 1B: 3 (2.8%)

Stage 1C: 39 (36.1%)

Grade 1: 31 (28.7%)

Grade 2: 41 (38%)

Grade 3 36 (33.3%)

Adjuvant chemotherapy: 27 patients

Fertility sparing (FS) or radical surgery (RS) or CSS (peritoneal biopsies, omentectomy, peritoneal washing, +- LN)

Fertility sparing surgery: 92.6%

Radical surgery: 7.4%

Complete surgical staging: 80%

Chemotherapy: BEP every 3 weeks for 3 to 5 cycles or cisplatin/vincristine/methotrexate/

bleomycine / actinomycine / cyclophosphamide / etoposide (POMB/ACE) every 3 weeks for 10-12 weeks. 

Surveillance : 81 patients

Until 2020, median follow-up 64.3 months (IQR 22.2-101.7)

Recurrence as IT:

Chemotherapy group 2/27 = 7.4%,

Surveillance group 9/81 = 11.1%, p=0.72

Median time to relapse with IT was 17.8 months 

Disease free survival:

5 years DFS: 92% and 89% for adjuvant CT vs surveillance

Overall survival:

5 years OS: 100% and 98% respectively, p=0.56)

24 patients underwent surgery for suspected relapse.

13/24 patients (12%): mature teratoma

11/24 patients (10.2%): malignant relapse as G2-3 immature teratoma

Death:

1 patients in surveillance group who did no adhere recommended close follow up, got pregnant and recurrence was detected at 24^th months pregnancy

DaSilva, 2015

Type of study:

Retrospective single-institution cohort study

Setting and country:

Rio de Janeiro, Brazil, 2003-201

Funding and conflicts of interest:

None declared

Inclusion criteria:

Adult women diagnosed between 2003-2013 with ovarian germ cell tumors

Exclusion criteria:

Not described

N total at baseline:

30

Important prognostic factors²:

53.3% dysgerminoma; 26.7%, immature teratoma; 13.3%, endodermal sinus tumors; and 6.7% mixed cell germ tumors.

Stage I 23,3%

Stage II 3,3%

Stage III 43,4%

Stage IV 30%

Complete surgical resection (R0) in 43.3%

BEP regimen (N=19)

No chemo (N=11)

Length of follow-up:

Not described. The median progression-free survival and the OS were not reached.

Loss-to-follow-up:

Not described

Of the 16 patients considered to have had an incomplete resection, 84,6% achieved an objective response (partial or complete response).

Just 4 patients (13.3%) had progressed (all had stage IV) and 5 (16.7%) had died up to the date of analysis.

No statistical analysis performed.

Derquin, 2020

Type of study:

Retrospective analysis based on a prospective data collection

Setting and country:

Multicenter, French Network for Rare Malignant Gynecological Tumors (TMRG)

Funding and conflicts of interest: none

Inclusion criteria:

Histologically proven ovarian germ cell tumors

Exclusion criteria:

non-ovarian germ cell tumors and mature teratoma with malignant transformation

N total at baseline: 147 patients 

Important prognostic factors²:

Stage Ia/b: 67 (45.6%)

Stage 1c: 34 (23.1%)

Stage 2: 8 (5.4%)

Stage 3: 27 (18.4%)

Stage 4: 9 (6.1%)

Unknown: 2 (1.4%)

Pure MOGCT, n=126

Dysgerminoma, n=40

Immature teratoma, n=52

Yolk Sac Tumor, n=32

Choriocarcinoma, n=2

Mixed MOGCT, n=21

Adjuvant chemo: 62 (62%)

Stage I (n=100)

76/100 complete peritoneal staging (75%), FSS 94 patients (94%), radical surgery 7 patients (6%)

Stage II-IV: all adjuvant chemo, n=44 (100%)

No chemo: 38 (28%)

Length of follow-up:

Median follow-up 51 months (40-62 months)

Loss-to-follow-up:

Survival follow-up data were available for 137 patients (93.2%) including 94 (93%) out of 101 patients at stage I

Disease free survival:

5 years DFS: 94.4 % versus 54.6% for patients treated with adjuvant chemotherapy or surveillance respectively, p<0.00001)

Overall survival:

5 years OS: 96.3% versus 97.8%, NS

Stage I

Surgery only;

relapse 13/35 (3 missing data), 37%

No relapse 22/35 (63%)

Relapse occurred in 3/3 patients with Yolk sac tumors, 6/16 with dysgerminoma, 3/15 immature teratoma en 1/1 other mixed tumors

Adjuvant CT;

Relapse 4/59 (3 missing data), 7%)

No relapse 55/59, 93%

Relapse occurred in 3/24 with YST en 1/24 with immature teratoma

Jorge, 2016

Type of study:

Retrospectieve analysis of National Cancer Database (NCB)

Setting and country:

United States

Funding and conflicts of interest: none

Inclusion criteria:

Women, 18 years or older with immature teratoma diagnosed from 1998-2012

Exclusion criteria:

Mixed germ cell tumors or with benign or borderline tumors

N total at baseline:  1045 patients

Important prognostic factors²:

Stage 1A; 502 (48%)

Stage 1B-C; 147 (14.1%)

Stage 1NOS; 77 (7.4%)

Stage II; 68 (6.5%)

Stage III; 143 (13.7%)

Stage IV; 25 (2.4%)

Unknown; 83 (7.9%)

Early stage (I/II): 76%

Grade 1; 231 (22.1%)

Grade 2; 249 (23.8%)

Grade 3; 387 (37%)

Unknown; 178 (17%)

Adjuvant chemotherapy

594 (56.8%) of 1045 received adjuvant chemotherapy

Stratified by stage:

50.1% of stage I

79.4% of stage II

84.6% of stage III

80.0% of stage IV

Stratification of stage I:

5.3% of stage Ia/grade 1

73% of stage 1a/grade 2-3

51.9% of stage 1b-1c/grade 1

78% of stage 1b-1c/grade 2-3

USO: 549 patients (52.5%)

BSO: 97 patients (9.3%)

Ovary/omentectomy: 286 (27.4%)

Debulking: 92 (8.8%)

None: 10 (1%)

Unknown: 11 (1.1%)

No adjuvant chemotherapy:  n= 405 (38.8%)

Unknown n=46 (4.4%)

Length of follow-up:

Median follow-up 61.6 months

Loss-to-follow-up:

83 patients with missing vital status or follow-up were excluded from multivariable analysis

Mortality

Adjusted HR=0.55 (0.29-1.06), NS

Advanced stage was the strongest predictor of survival.

Mangili

2017

Type of study:

Multicenter retrospective cohort study

Setting and country:

Italy

Funding and conflicts of interest: No funding

Inclusion criteria:

Stage I MOGCTs

Exclusion criteria:

-

N total at baseline:

144

Adjuvant chemotherapy n=73

No adjuvant chemotherapy n=71

Length of follow-up:

59 months

Overall survival:

5-years OS rate

I: 93.7%

C: 94.2%

Mikuš

2020

Type of study:

Single center retrospective observational study

Setting and country:

Croatia

Funding and conflicts of interest:

No funding

Inclusion criteria:

MOGCT treated with FSS

Exclusion criteria:

-

N total at baseline:

27

Adjuvant chemotherapy (BEP, TP and VAC) n=22

No adjuvant chemotherapy n=5

Length of follow-up:

49,6 months

At the time of analysis all patients were alive and disease free

Nasioudis

2017

Type of study:

Multi-center retrospective study

Setting and country:

USA

Funding and conflicts of interest:

No conflict of interest

Inclusion criteria:

Ovarian yolk sac tumor between 2004-2014

Exclusion criteria:

-

N total at baseline:

561

No differences based on disease stage

Adjuvant chemotherapy (BEP) n=414

No adjuvant chemotherapy n=65

Length of follow-up:

60,3 months

Overall survival:

5 year OS 85.5% vs 77.1%.

OS (P=0.016 log-rank P test)

Even when examining stage I patients (P=0.062)

Park 2016

Type of study:

Retrospective cohort study

Setting and country:

Korea

Funding and conflicts of interest:

None

Inclusion criteria:

Stage I MOGCT after surgery

Exclusion criteria:
-

N total at baseline:

135

All patients were surgically staged

Adjuvant chemotherapy (BEP in 89, BEC in 2, VBP in 1, VAC in 1) n=93

Use of chemotherapy was decided by attending physician (bias)

No adjuvant chemotherapy n=42

Length of follow-up:

98 months

Disease free survival:

5 year DFS 93% vs 67%  (p=0.001 univariate; p=0.039 multivariate)

Solheim 2013

Type of study:

Retrospective cohort study

Setting and country:

Norway

Funding and conflicts of interest:

None

Inclusion criteria:

MOGCT between 1953-2009

Exclusion criteria:

-

N total at baseline:

351

Equal number of different MOGCT histologies (disgerminoma, teratoma, other)

Treatment after 1980 (when cisplatin-based chemotherapy was introduced) n=163

Treatment before 1980 n=188

Length of follow-up:

9.8 years

Cancer specific survival:

20-year ovarian cancer-specific survival increased from 59% (95% CI 51% to 66%) before 1980 to 88% (95% CI 83%-93%) thereafter.

Simultaneous improvement in diagnostics around 1980 and 2020

Study reference

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?¹

(unlikely/likely/unclear)

Bias due to  insufficiently long, or   incomplete follow-up, or differences in follow-up between treatment groups?²

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome ?³

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all  important prognostic factors?⁴

(unlikely/likely/unclear)

Al Husaini, 2012

Unlikely

Unlikely

Unlikely

Likely, small groups and no adjustment

Bergamini, 2020

Unlikely

Unlikely 

Unlikely

Likely, small groups

DaSilva, 2015

unlikely

Unclear, not described

Unlikely

Likely, small groups but no statistical analysis performed

Derquin, 2020

Unlikely

Unlikely

Unlikely

Likely, due to small numbers only univariable analysis was performed

Jorge, 2016

Likely, patient population too heterogeneous

Unclear, 83/1045 patients with missing vital status or follow-up

Unlikely

Unlikely

Mangili 2017

Unlikely

Unlikely

Unlikely

likely, small groups and only univariable analysis was performed

Mikuš 2020

Unlikely

Likely, at the time of analysis all patients were alive and disease free

Unlikely

Unclear, at the time of analysis all patients were alive and disease free

Nasioudis 2017

Unlikely

Unlikely

Unlikely

Unlikely, however small groups

Park 2016

Unlikely

Unlikely

Unlikely

Unlikely, however, small groups

Solheim 2013

Unlikely

Unlikely

Unlikely

Likely, small groups and only univariable analyses were performed

Referentie 

Reden voor exclusie

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1 regel over verschil tussen PDS en NAC + IDS bij stadium II-IV kiemceltumoren

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Gaat over neo adjuvante chemotherapie. Geen full text

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gaat over NACT en niet over adjuvante chemotherapie. Geen full text

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letter to the author

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gaat over sertoli leydig cel tumor

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geen full text

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gaat over testis

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geexcludeerd

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