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SEE-FIM Protocol

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  • Schematic of the components of the fallopian tube (upper right). Below are microscopic images taken from cross sections of the ampulla (left) and longitudinal sections of the infundibulum and fimbria (center right). A focus of early high grade serous carcinoma discovered in the fimbria is seen at the far right. The left panel illustrates the SEE-FIM protocol.
    Schematic of the components of the fallopian tube (upper right). Below are microscopic images taken from cross sections of the ampulla (left) and longitudinal sections of the infundibulum and fimbria (center right). A focus of early high grade serous carcinoma discovered in the fimbria is seen at the far right. The left panel illustrates the SEE-FIM protocol.

SEE-FIM Protocol

1 Definition

The SEE-FIM protocol is a pathology dissection protocol for Sectioning and Extensively Examining the Fimbria (SEE-FIM). This and similarly designed protocols are intended to provide for the optimal microscopic examination of the distal fallopian tube (fimbria) to identify either cancerous or precancerous conditions in this organ.[1][2]

2 Background

Women with either a strong family history of breast and ovarian cancer or a documented inherited (germline) mutation in a BRCA gene are encouraged to consider risk reduction salpingo-oophorectomy (RRSO). The surgery is ideally conducted prior to the time that the risk of developing HGSC became too great to defer the procedure, which was age 35 for women with BRCA1 and 45 for BRCA2 mutations. Removal of both tubes and ovaries has reduced the risk of subsequent HGSC by 85% [see BRCA mutation].[3]

Beginning in 2000, case reports described early and often non-invasive HGSCs in the fallopian tubes which were called serous tubal intraepithelial carcinomas or STICs.[4][5][6][7] These studies were conducted on ovaries and fallopian tubes from asymptomatic women with germline BRCA mutations who underwent RRSO.

3 Introduction of the SEE-FIM protocol

2.1 Conception

The SEE-FIM protocol was introduced in 2005 and required examining all of the fallopian tube, specifically the sectioning and examination of the distal one-third (infundibulum and fimbria).[1] Early HGSCs, once considered rare, were suddenly encountered frequently in this portion of the tube. Thus, the SEE-FIM protocol was adopted by many to identify or exclude these tumors during pathologic examination of the fallopian tubes in risk reduction salpingo-oophorectomies.[8][9]

2.2 Method

The SEE-FIM protocol consists of five steps (See Figure):

  1. The tube is fixed for at least 2 hours in laboratory fixative.
  2. The distal one third is amputated.
  3. The distal one third is sectioned in the longitudinal (sagittal) plane as thinly as possible and submitted for processing.
  4. The remainder of the tube is sectioned in the transverse (cross section) plane every 1-2 millimeters and submitted for processing.
  5. Sections are stained with hematoxylin and eosin and are examined by the pathologist with attention to the epithelial cells and the presence of any evidence of a malignancy or precancerous condition.[1]

4 Acceptance in pathology practice

As of 2018, the SEE-FIM protocol was being used by 85% of academic pathology practices and 65% of private practices in the United States and elsewhere in the World.[8] [10][11][12][13]

Routine use of the SEE-FIM protocol has been recommended by the College of American Pathologists and the International Society of Gynecologic Pathologists when processing fallopian tubes in risk reduction surgeries, and cases of ovarian and uterine serous cancer.[14][15] It is also recommended in the reporting guidelines for gynecologic cancer sponsored by the British Gynecologic Cancer Society.[16] It is also part of routine protocols in academic institutions and was employed to ascertain the frequency of STIC in a large population-based study.[17][18]

5. Indications for the Protocol

The primary purpose of the SEE-FIM protocol is to detect small cancers in the fallopian tube that are not visible to the naked eye and permit accurate staging of HGSCs. It is used most often in the following scenarios.

5.1 Prophylactic salpingectomy

In RRSO specimens from healthy women at increased risk for HGSC, the presence of an early HGSC (STIC) imposes a significant risk of a later recurrence, computed at 10% and 27% at 5 and 10 years. In contrast, if no abnormality is found the risk is less than 1%.

5.2 Opportunistic salpingectomy

This procedure has been introduced to remove the fallopian tubes when convenient after the cessation of childbearing. The protocol is used to exclude occult cancer.

5.3 Surgical excision specimens from women with HGSC

The protocol is used to pinpoint tumor origin and permit accurate staging of the tumor. .[19][20] .[21][22][23] One study of 347 women using the SEE-FIM protocol identified neoplasia in over 5% with STIC in 4%.[24] Another study with rigorous evaluation of the fallopian tubes and ovaries disclosed a detection rate of 9.1%.[25] In all of these studies neoplasia was more likely to be detected in women with BRCA1 (versus BRCA2) mutations.

5.13 Discovery of and characterization of a serous carcinogenic “sequence” in the fimbria

Mutations in the tumor suppressor gene TP53 are consistently found in HGSCs. Small benign epithelial alterations containing the same mutations and termed “p53 signatures” have been described in the distal fallopian tube in both women with BRCA mutations and those in the general population.[26][27] Careful inspection of the distal tube with the SEE-FIM protocol revealed that tubes from up to 70% of women with BRCA mutations and 50% of women in general harbored p53 signatures.[28] Much less common are proliferations containing TP53 mutations that display changes intermediate between the p53 signature and STIC that were termed serous tubal intraepithelial lesions (STIL).[29] Together this continuum of epithelial changes in the fimbria linked to TP53 mutations further connected the fallopian tube to the development of HGSC.[30]

5.141 Determining the prevalence of early cancers (STICs) in the general population

Clinically derived population-based studies using the SEE-FIM protocol were conducted to determine the frequency of STICs in women who were not considered at high risk for HGSC. The estimated prevalence of STIC in these populations has been computed at 1.2 and 0.85 per 1000 women.[18][31] For comparison, the lifetime risk of ovarian cancer is approximately 13 per 1000 women.

5.142 Applications of SEE-FIM to ascertain recurrence risk in patient care.

For women in whom very early cancers (STICs) were discovered, earlier studies placed the risk of later relapse and disseminated HGSC at approximately 5-10%.[20][32][33] A more recent study analyzing multiple studies (meta-analysis) estimated the recurrence risks at 5 and 10 years to be 10% and 27% respectively. Consequently, thorough examination of the fallopian tubes has been recommended to ascertain the risk of a later recurrence.[34] Conversely, if no malignancy was found at risk reduction salpingectomy, the likelihood of a later HGSC is reported to be less than 1%. As a result, the SEE-FIM or comparable protocols have been endorsed to ascertain the likelihood of an early cancer in the distal tube and either alert the patient and their physician to the risk of recurrence or reassure them when no abnormality was found.[34][35]

5 Protocol contribution to the field of ovarian cancer pathogenesis and prevention

5.1 Prevention of HGSC by salpingectomy

5.11 Prevention of HGSC in women at low risk

Retrospective studies suggest that preemptive salpingectomy will reduce the incidence of later ovarian cancer by approximately 50%. Professional societies in the USA and throughout the world have issued statements addressing "opportunistic salpingectomy" (salpingectomy at the time of hysterectomy for benign conditions, other intra-abdominal procedures, or sterilization) as a potential means for reducing HGSC risk.[36][37][38][39] A recent study updating data that were accumulated over 10 years failed to identify a case of HGSC in over 25,000 women who had undergone opportunistic salpingectomy [see Prophylactic salpingectomy].[40] Studies such as this rely on the SEE-FIM or a comparable protocol to ensure that the normal appearing fallopian tubes in these patients do not harbor an occult malignancy.

5.12 Prevention of HGSC in high risk women by risk reduction salpingectomy (RRS)

Currently, preventing HGSC in women with germ-line BRCA mutations entails removal of both the ovaries and fallopian tubes. However, because so many HGSCs appear to have their origin in the fallopian tube, clinical trials are ongoing that offer salpingectomy alone for selected women with BRCA mutations who strongly desire a longer interval of preservation of ovarian function. These trials also rely on the the SEE-FIM or a comparable protocol to exclude the presence of occult HGSC and are in progress.[41]

7 See also

High grade serous carcinoma, BRCA mutation, Fallopian tube cancer, Ovarian cancer, Ovarian Cancer Research Alliance, Prophylactic salpingectomy

8 Abbreviations

BRCA – Breast cancer associated tumor suppressor genes, including BRCA1 and BRCA2. Inherited (germline) loss of a BRCA gene imposes an increased risk of breast and ovarian cancer.

TP53 – A tumor suppressor gene that is mutated in High grade serous carcinoma.

RRSO – Risk reduction salpingo-oophorectomy, traditionally employed to reduce the risk of future HGSCs in women with BRCA1 or BRCA2 germ-line mutations or women otherwise presumed to be at increased risk for this tumor.

RRS – Risk reduction salpingectomy, intended to reduce the risk of future HGSCs without removal of the ovaries.

HGSC – Extrauterine high grade serous carcinoma, historically the most common and most lethal “ovarian” carcinoma.

STIC – Serous tubal intraepithelial carcinoma, a non-invasive precursor to high grade serous carcinoma

References

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