Annalisa

6 months ago

Comments 

We are looking for a prognostic index to use into a decision-making process for management of uterine masses patients, not for a screening test.

 Annalisa Di Cello, PhD,a* , Marco Franzon, b and Massimo Borelli, PhD,c.

aUnit of Obstetrics and Gynaecology, Maternal and Child Department, Giovanni Paolo II Hospital, 88046 Lamezia Terme, Catanzaro, Italy.

bDepartment of Life Sciences, University of Trieste, Trieste, Italy.

cPhD School of PhD Programmes Life Sciences and technologies, University “Magna Graecia” of Catanzaro, Italy

In April 2014, following the FDA warning against the use of power morcellators (1), we began to investigate what was the trend of LDH isoenzymes levels in women undergoing surgery for uterine mass. However, we never had in mind to create a test of screening for uterine sarcomas.

It would really be like trying to find a needle in a haystack (2)! However, it is also unacceptable to think that a gynecologist can put down the "laparoscope" and surgically treat all fibroids by laparotomic approach. Since there are no parameters to identify women not at risk of uterine sarcoma (only in these patients the FDA allows to use the power morcellator) and all other strategies (including morcellation into the endo-bag) are not totally sure in avoiding the spread of cancer tissue into the abdominal cavity, there would be no other possible solution to laparotomy in all cases.

Based on these observations, our goal was to identify a tool that would help us to interpret the values of biomarkers, such as the total LDH and LDH isoenzymes, which are mostly required to patient by both gynecologists and general practitioner, without they have a common idea on how to correctly interpret the results (3).

Cohen Rassier and Stewar (2), properly point out limits of U.M.G. risk index study that we ourselves had already underlined into the discussion of the paper: a) retrospective design of the study; b) unbalanced number of fibroids compared to sarcomas; c) high number of sarcomas, compared to global epidemiologic data, due to the fact that we are one of the few oncological centres of the South of Italy and considering that only fibroids surgically treated were analyzed (untreated fibroids, which are a very large proportion, were not considered).

Once results of our retrospective analysis (3) suggests that the integration of LDH isoenzyme into a mathematical model (we named UMG risk index) could be an inexpensive and accurate prognostic index, we decided to start a prospective multicentric study to assess the value of the score and, moreover, to create an algorithm easy to use and sufficiently accurate to help clinicians into the decision-making process for management of patients with uterine masses.

Specifically, we are working now to propose an algorithm for the management of all uterine masses (fibroid, sarcomas, adenomyosis) in which a simple score based on the dosage of tumor markers (specifically LDH, LDH isoenzymes, Ca125), could be integrated with other clinical and/or ultrasound data and, in case of a suspicious mass, with a pelvic magnetic resonance evaluation.

Preliminary data, will be published soon.

It is true that one must be cautious in using the UMG score into a clinical setting, but it is also true that in front of an urgent need, such as that of identifying a niche of patients in which laparoscopy can still be used, the validation of a score with a high accuracy, sensitivity and specificity, should instead be incentivized.

We would be thrilled if some other groups, like Spivack et al. (4), sharing the purpose, tested our score in their own population, in order to disown it or, why not, to validate it, or, even better, to improve it.

The widely intent, should be not to offer the clinician a screening test for the diagnosis of uterine sarcomas. It is difficult, or quite impossible, to identify a test for the screening of a rare disease like a uterine sarcoma. The goal, in our opinion, is to offer gynecologists a useful tool for identifying low-risk woman in which laparoscopy can still be used, despite the FDA warning (1).

We are sure that only a large multicentric study can really give an accurate and easy to use tool in the hands of the gynecologist (gynecologist oncologist and laparoscopist gynecologist), to help him in choosing the best surgical approach for women.  A choice that on the one hand, looks at oncological safety (choosing laparotomy and more extensive surgery as the safest approach in women at risk for sarcoma), but, on the other hand, which also looks at the fertility preservation (choosing laparoscopy and myometrial preservation in low- or no-risk women).

References 

• Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. 2014 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm
• 2) Sarah L Cohen Rassier, Elizabeth A Stewart. Finding the needle in the haystack. Fertil Steril 2021;115(1):87-88.
• Di Cello A, Borelli M, Marra ML, Franzon M, D'Alessandro P, Di Carlo C, Venturella R, Zullo F. A more accurate method to interpret lactate dehydrogenase (LDH) isoenzymes' results in patients with uterine masses. Eur J Obstet Gynecol Reprod Biol. 2019;236:143-147.
• Specificity of the lactate dehydrogenase isoenzyme index as a preoperative screen for uterine sarcoma before myomectomy. Spivack LE, Glantz JC, Lennon C, Bhagavath B.Fertil Steril. 2021;115(1):174-179.