| Erol et al. (2016)(18) |
Turkey n=67 |
To assess the use of p57, HER2, CD117, and Bcl-2 in distinguishing complete hydatidiform mole (CHM), partial hydatidiform mole (PHM), and hydropic abortion (HA). Used mouse monoclonal anti-p57 (clone 25B2; 1:50) |
All CHMs were p57-negative; PHMs and HAs showed similar p57 positivity (74%). Genotyping used in 7 equivocal cases: confirmed 4 CHMs, 2 PHMs, 1 HA. |
p57 immunohistochemistry (IHC) is highly specific for CHM but not useful for distinguishing PHM from HA. Combining p57 with other markers (like HER2, CD117, Bcl-2) and genotyping improves diagnostic accuracy in challenging cases. |
| Triratanachat et al. (2016)(19) |
Thailand n=127 |
To evaluate the utility of p57 IHC in distinguishing CHM and PHM and identify key morphological features. Used mouse monoclonal anti-p57 (clone KP39, 1:200 Neomarker®) |
Concordance between hematoxilin and eosin (H&E) and p57 was 90.6%; 12 cases (9.4%) had discordant diagnosis. 107 CHM (p57-negative) and 20 PHM (p57-positive) after IHC. 34/107 p57-negative cases developed postmolar GTN versus. 1/20 p57-positive cases. |
p57 IHC improves diagnostic accuracy and should be used in all suspected cases of hydatidiform mole (HM). Histopathology alone has limitations, especially in early gestation. Molecular studies may be required in equivocal or discordant cases. |
| Samadder et al. (2017)(20) |
India n=53 |
To evaluate the role of p57 IHC in combination with histomorphology for differentiating between CHM, PHM, and HA. Used p57Kip2 Ab-6 antibody (Thermo Fisher Scientific®). |
96% of CHMs were p57-negative; 100% of PHMs and 95% of non-molar controls were p57-positive. 4 of 27 molar cases (14.8%) were discordant between initial morphology and IHC. 2 of 13 HA cases were reclassified as molar after IHC. One CHM case showed inconsistent staining, possible biparental mole or maternal chromossome (chr) 11 retention. |
p57 is reliable to identify CHM and is a valuable adjunct to morphology, especially in early gestation and ambiguous cases. Cannot reliably distinguish PM from HA, but aids significantly in improving diagnostic accuracy. |
| López et al. (2020)(21) |
Brazil n=108 |
To evaluate the utility of p57 IHC and HER2 Fluorescence In Situ Hybridization (FISH) using tissue microarray in the classification of HM. Used mouse monoclonal anti-p57 (clone Kp10/SP118, DAKO®); combined with HER2 FISH ploidy analysis. |
H&E: 57 CHM, 47 PHM, 4 inconclusive p57: 55% negative, 20% positive, 25% inconclusive HER2 FISH: 63% diploid, 30% triploid, 5% inconclusive Diagnostic changes occurred in 28 cases (26%), mainly from PHM to CHM. 73% of diagnoses were supported by p57; 71% by FISH; 75% by morphology |
The combination of histopathology, p57 IHC and HER2 FISH improves diagnostic accuracy in molar pregnancies. They have analyzed the use of p57 in association with the FISH HER2 technique, but they highlighted that p57 alone was responsible for 50% of diagnostic changes in the study. |
| Awosusi et al. (2020)(22) |
Nigeria n=100 |
To assess the value of p57 IHC as an ancillary tool for differentiating CHM and PHM. Used rabbit monoclonal antibody (clone EP2515Y, Abcam®). |
Original H&E diagnosis: 57 CHM, 37 PHM, 6 equivocal HMs; After p57 IHC: 68 CHM, 32 PHM. 10 cases reclassified: 8 initially PHM → CHM, 2 initially CHM → PHM 5/6 equivocal HMs reclassified as CHM No discordant staining patterns observed. |
p57 IHC is a reliable marker for distinguishing CHM from PHM and improves diagnostic accuracy, particularly in morphologically ambiguous or equivocal cases. Recommended as routine adjunct in histopathological diagnosis of HMs. |
Xing et al. (2021)(23) |
EUA n=2217 |
Prospective cohort to refine the diagnosis of HM using an algorithm incorporating p57 IHC and STR genotyping. Used mouse monoclonal anti-p57 (prediluted, Neomarkers®). |
99.8% of CHMs were p57-negative and 96.7% androgenetic 99% of PHMs were p57-positive and 97% diandric triploid 56 mosaic cases: 37 with p57-negative CHM component 5 CHMs were biparental (likely familial); 3 PHMs were p57-negative due to loss of maternal chr11 H&E alone had 55–75% accuracy; p57 + genotyping improved classification to 94% |
p57 is highly reliable for CHM diagnosis and correlates strongly with genotyping. However, interpretation must be integrated with morphology and genotyping to address unusual presentations (e.g., mosaicism, familial CHMs, donor egg gestations). |
| Zainal et al. (2021)(24) |
Malaysia n=82 |
To determine the role of p57 IHC in improving diagnostic accuracy of HM subtypes in comparison to initial H&E evaluation. Used mouse monoclonal anti-p57 Ab-6 clone 57P06 (Thermo Scientific, RTU®). |
H&E initially classified 39 CHM, 41 PHM, 2 unclassified. After p57 IHC, 66 CHM, 14 PHM, 2 non-molar. 33% diagnostic discrepancy between H&E and IHC results. 27 PHMs reclassified as CHM after IHC. |
p57 IHC significantly improves diagnosis of HM subtypes and should be routinely used in conjunction with H&E, especially in resource-limited settings. Limitations include inability to distinguish CHM from HA. |
| Wong et al. (2021)(25) |
Malaysia n=51 |
To assess the combined diagnostic accuracy of p57 IHC and DNA ploidy analysis by FISH in differentiating CHM, PHM, and non-molar abortion (NMA). Used rabbit monoclonal anti-p57 (Abcam®); DNA FISH for chr 11/16 and X/Y. |
H&E diagnosis: 18 CHM, 24 PHM, 9 NMA Final reclassification: 27 CHM (p57-/diploid), 9 PHM (p57+/triploid), 15 NMA (p57+/diploid) Diagnostic accuracy of H&E alone: CHM 78.4%, PHM 70.6%, NMA 88.2% 2 p57-discordant cases were excluded. |
H&E alone lack accuracy in differential diagnosis between HM types and NMA. p57 IHC is highly specific for CHM but insufficient alone to distinguish PHM from NMA. Combined with DNA ploidy analysis, it enhances diagnostic precision. An algorithmic approach is recommended in routine practice. |
| Usui et al. (2024)(17) |
Japan n=80 |
To evaluate the diagnostic value of combining p55 IHC and FISH analysis compared to STR genotyping for differentiating HM from NMA. Used rabbit polyclonal anti-p57 (Ab-7, clone RB-1637-R7, Thermo Fisher®) |
44 CHMs (p57- / diploid), 20 PHMs (p57+ / triploid), 14 non-molar abortions (p57+ / diploid) 10 cases had initial misdiagnoses corrected after FISH (8 PHMs misclassified as abortion; 2 abortions as PHM) 2 mosaic cases showed discordant p57 staining (cytotrophoblast +, stroma −) 1 CHM was p57-positive due to retained maternal chr11 (false negative) |
Combined use of p57 IHC and FISH increases diagnostic accuracy, particularly in ambiguous or discordant cases and distinguishing PHM from abortion. Some rare exceptions, like mosaicism and maternal chromosome retention, highlight the need for integrated diagnostic workflows. |