Method for predicting remote metastases after radical prostatectomy in prostate carcinoma patients

FIELD: medicine.

SUBSTANCE: method involves determining preoperative factors like clinical stage of prostate neoplasm, prostate-specific antigen level, prostate capsule invasion with tumor from rectal finger palpation test data, prostate capsule invasion with tumor from transrectal ultrasonic examination data, the number of positive biopsy bars in carrying out transrectal prostate biopsy, neoplasm differentiation stage from transrectal ultrasonic examination, malignance degree from transrectal ultrasonic examination according to Glisson scale. Histological examination results are evaluated after previously done transurethral prostate resection. Postoperative factors like pathological neoplasm development stage, malignance degree from morphologic examination data according to Glisson scale and prostate tumor invasion into seminal vesicles from morphologic examination data are also determined. Remote metastasis index is calculated from formula M=0.24xT - 0.010xP + 0.87xR + 0.02xC + 0.15xB - 1.12xD + 0.07xKG + 0.38xH - 0.38xpT + 0.11xPG + 2.02xV, where M is the remote metastasis index, T is the clinical prostate neoplasm stage: 1 - T1; 2 - T2; 3 - T3; P is the prostate-specific antigen level before operation in ng/ml; R is the prostate capsule invasion with tumor according to rectal finger palpation test data: 0 - no invasion; 1 invasion available; C is the prostate capsule invasion with tumor according to transrectal ultrasonic examination data: 0 - no invasion; 1 invasion available; B is the number of positive biopsy bars in carrying out transrectal prostate biopsy: 1-6; D is the neoplasm differentiation stage from transrectal prostate biopsy: 1 low level differentiation degree;2 - moderate level differentiation degree; 3 - high level differentiation degree; KG is the malignance degree according to transrectal prostate biopsy data using Glisson scale 2-10; H is the histological examination after previously done transurethral prostate resection: 0 - not applied; 1 - benign prostate hyperplasia; 2 - prostate adenocarcinoma; pT is the pathological neoplasm development stage: 1 - pT2a; 2 - pT2b; 3 - pT3a; 4 - pT3b; PG is the malignance degree from morphologic examination data according to Glisson scale: 2-10; V is the prostate tumor invasion into seminal vesicles from morphologic examination data: 0 - no invasion; 1 invasion available; and if M>-1.55, remote metastasis formation is predicted.

EFFECT: high accuracy of prognosis.

1 tbl

 

The invention relates to medicine, namely to oncological urology, and can be used for predicting distant metastasis after radical prostatectomy in patients with prostate cancer.

In the meet the authors of studies were identified individual risk factors for the occurrence of distant metastases in patients with prostate cancer. Leading of them are positive surgical margin, the degree of malignancy of tumors of the prostate Gleason score the morphological examination, and the percentage (%) containing cancer cells biopsy columns according to transrectal biopsy of the prostate [Bott S.R., Kibry RS Avoidance management of positive surgical margins before, during and after radical prostatectomy Prostate-Cancer-Prostatic-Dis 2002; 5(4): 252-263].

Less important risk factors are clinical stage of the tumor and perineurally tumor invasion [S.R. Nelson, Rubin M.A., Strawderman M. et at. Preoperative parameters for predicting early prostate cancer recurrence after radical prostatectomy Urology 2002; 59 (5): 740-745].

A known method for predicting distant metastasis after radical prostatectomy in patients with prostate cancer, characterized by the fact that risk factors are the degree of malignancy of tumors of the prostate, its histopathological stage, and preoperative level prostatespecific antigen (PSA) in plasma of blood is I. The prediction of distant metastasis the worse, the higher the degree of malignancy of tumors of the prostate, above its phase according to the results of morphological studies, as well as when pre-operative PSA levels in the blood plasma is above 10 ng/ml [Andersson J., Ekman, R., Egevad L., Hellstrom M. Relatively high risk of treatment failure after prostatectomy: tumor grade, histopatological stage and the preoperative serum PSA level are key prognosticators. Scand-J-Urol-Nephrol. 2001 Dec; 35 (6): 453-458].

A known method for predicting distant metastasis after radical prostatectomy in patients with prostate cancer, according to which tumor invasion in the seminal vesicles, pre-operative PSA levels above 10 ng/ml, the degree of malignancy of tumors of the prostate Gleason score above 7 points, sprouting tumor capsule of the prostate is characterized by a high risk of metastasis [Salomon L., Levrel O, Taille, A. et al. Seminal vesicle invasion after radical prostatectomy: a study of risk factors for progression. Prog-Urol. 2002 Sep.; 12 (4): 621-627].

All these methods have drawbacks:

1. All met the authors of the works there is no comprehensive assessment of risk factors for distant metastasis of prostate carcinoma after radical prostatectomy.

2. Not taken into account the clinical relevance of each risk factor.

3. Not assess the likelihood of distant metastases in numeric equivalent.

4. About the no mathematical model, describe the pattern of disease in the postoperative period in relation to the risk of distant metastasis.

The objective of the invention is an integrated risk assessment with the clinical significance of each factor in the numeric equivalent.

The problem is solved in that for predicting distant metastasis after radical prostatectomy in patients with prostate cancer according to the invention identify preoperative factors: clinical stage neoplasms of the prostate, the PSA level sprouting tumor capsule of the prostate according to the results of a digital rectal exam, tumor spreading into the capsule of the prostate according to the results of transrectal ultrasound, the number of positive biopsy columns with transrectal biopsy of the prostate, the degree of differentiation of tumors with transrectal biopsy of the prostate, the degree of malignancy of tumors with transrectal biopsy of the prostate Gleason score, evaluate the results of histological examination after completed earlier transurethral resection of the prostate, as well as determine postoperative factors: the pathological stage of the tumor, the degree of malignancy of the Gleason score according to the results of morphological studies of the PoWPA is the growth of the tumor of the prostate seminal vesicles according to the results of morphological studies, and then calculate the rate of distant metastasis by the formula

M=0,24×T-0,010×P+0,87×R+0,02×+0,15×1,12×D+0,07×KG+0,38×N-0,38×RT+0,11×PG+2,02×V,

where:

M - indicator of distant metastasis;

T - clinical stage neoplasm of prostate (1-T1; 2-T2; 3-T3);

R - PSA levels before surgery, ng/ml;

R - sprouting tumor capsule of the prostate according to the results of a digital rectal exam (0 - not germinate; 1 - germinate);

With the sprouting tumor capsule of the prostate according to the results of transrectal ultrasound (0 - not germinate; 1 - germinate);

In the number of positive biopsy columns with transrectal biopsy of the prostate (1-6);

D is the degree of differentiation of tumors with transrectal biopsy of the prostate (1 - high; 2 - sredneperesechennoy; 3 - well-differentiated tumor);

KG - the degree of malignancy of tumors with transrectal biopsy of the prostate Gleason score (2-10);

N - histological examination after completed earlier transurethral resection of the prostate (0 = not performed; 1 - benign prostatic hyperplasia; 2 - adenocarcinoma of the prostate);

RT - pathological stage of the tumor (1 - RCA, 2 - 2b, 3 - RCA, 4 - p3b);

PG - the degree of malignancy by W the ale Gleason on the results of morphological studies (2-10);

V - spreading tumor of the prostate seminal vesicles according to the results of morphological studies (0 - not germinate; 1 - germinate)

and when the value of M>-1,55 predict distant metastasis. Value of M, less than or equal to -1,55, prognosis is good (low risk of metastasis); when the value of M, the larger -1,55, the prognosis is poor (high risk of metastasis.)

The basis of the invention was based on the results of examination and surgical treatment of 150 patients with localized cancer of the prostate. The average age of patients was 61,5±0.4 years ( from 49 to 71 years). All patients underwent radical pozadina prostatectomy. The survey was conducted in collaboration with University urology godance (Denmark) in the period from 1996 to 2003

Preoperative comprehensive examination of patients included determination prostatespecific antigen (PSA) in the blood plasma, transrectal (TR) ultrasound examination of the prostate and seminal vesicles. If necessary, performed computer and magnetic resonance imaging of the pelvic organs. The diagnosis of prostate cancer was determined on the basis of morphological studies of prostate tissue obtained at TR biopsy under ultrasound control. In the presence of Ki is mahogany foci was carried out aiming each biopsy suspicious for tumor tissue. The degree of malignancy of tumors was determined by the Gleason score. This technique was also used in postoperative pathological examination of tissue from the prostate. Just was analyzed over two hundred clinical and morphological factors.

The maximum duration of the dynamic observation of patients in the postoperative period, the vast majority of patients was five years old.

The research made it possible to produce a comprehensive assessment of risk factors with regard to the informative importance of each factor. The results of the study are presented in the table.

A comprehensive assessment includes evaluating clinical (clinical stage of the tumor), laboratory (PSA level in the blood plasma before surgery), biopsy (degree of differentiation of prostate tumors, the number of positive biopsy columns with transrectal biopsy, the degree of malignancy of prostate tumor (the Gleason score) and morphological factors (degree of malignancy of tumors of the prostate at the pathomorphological examination of the removed tissue sample of the prostate and seminal vesicles, the pathological stage of the tumor, and others).

Table
Clinical-morphological risk factors of returns is i.i.d. metastasis in patients with prostate cancer after radical prostatectomy
Clinical - morphological factorsFP
Clinical stage neoplasms of the prostate, T12,8<0,0008
PSA levels before surgery, ng/ml3,85<0,005
Sprouting tumor capsule of the prostate according to the results of digital research per rectum12,07<0,001
Sprouting tumor capsule of the prostate according to the results of transrectal ultrasound6,8<0,001
The number of positive (containing cancer cells) biopsy of columns in transrectal biopsy of the prostate14,85<0,0004
The degree of differentiation of tumors with transrectal biopsy of the prostate38,54<0,00001
The degree of malignancy of tumors with transrectal biopsy of the prostate Gleason score14,94<0,0004
Results histological examination after completed earlier transurethral resection of the prostateof 4.44<0,03
The pathological stage of the tumor, RTfor 9.64<0,003
The degree of C is kachestvennosti neoplasms of the Gleason score according to the results of morphological studies (2-10) 10,07<0,002
Spreading tumor of the prostate seminal vesicles according to the results of morphological studies26,61<0,00001

The table shows that in the study were selected eleven most informative significant risk factors.

By the method of linear discriminant analysis was obtained mathematical formula with which it is possible to predict the likelihood of distant metastases of prostate carcinoma after radical prostatectomy.

The sensitivity of the method of 83.3%, specificity of the method - 91,2% predictive value of a positive result - 60%; predictive value of a negative result - 97,2%: total accuracy of prediction is 90.1%of

When using this formula with high accuracy predictions equal to 90.1% of (λ=0,7; p<0,00001), it becomes possible to predict the risk of distant metastasis after radical prostatectomy.

The invention is illustrated by the three clinical examples.

Example 1. Sick And 63 years old, was admitted to the clinic routinely diagnosed with prostate cancer stage T2 for surgery - radical prostatectomy. Before surgery, the PSA level in the blood plasma SOS is avsl of 8.1 ng/ml The results of the study per rectum palpation data about the presence of germination capsule of the prostate has been received, then as they had during transrectal ultrasound. The diagnosis was confirmed by the results of transrectal sextante biopsy of the prostate where cancer cells (recodification) was detected in three of the six columns, and the degree of malignancy of tumors was equal to 7 points on the Gleason score. In the past transurethral resection for benign prostatic hyperplasia is not performed. Held postoperative morphological study determined the patient has stage tumors 3b with invasion of the tumor tissue of the seminal vesicles. The degree of malignancy of the Gleason score was 8 points.

When calculating the indicator of distant metastasis M proposed formula he was 1,619 (i.e. more than -1,55), which allows us to predict distant metastasis. A year after a radical prostatectomy, the patient appeared distant metastases in the Ilium of the pelvis.

Example 2. Patient S., aged 57, was admitted to the hospital with a diagnosis of prostate cancer stage T2. When entering the PSA level in the blood plasma were 11.2 ng/ml When the research is per rectum palpation data about the presence of germination capsule of the prostate has been received. During transrectal ultrasound showed signs of germination capsule of the prostate. The results of transrectal biopsy of the prostate cancer cells (srednetemperaturnyi) was detected in four out of six biopsy columns, and the degree of malignancy of tumors, the Gleason score was 7 points. Two years ago, was performed transurethral resection for benign prostatic hyperplasia, the morphological study of the resected tissue was confirmed by the presence in a patient of benign prostatic hyperplasia in the absence of data about the presence of cancer cells. Was made radical pozadina prostatectomy. Held postoperative morphological examination revealed the patient has stage RTA tumors without invasion of the tumor into the seminal vesicles. The degree of malignancy of the Gleason score was 8 points.

When calculating the indicator of distant metastasis M proposed formula he was -0,642 (more than -1,55), which allowed to predict distant metastasis. 9 months after radical prostatectomy the patient appeared distant metastases E. liver.

Example 3. Patient M., aged 63, was admitted with a diagnosis of localize the p prostate cancer stage T2 to viscolene radical prostatectomy. Before surgery, the PSA level in the blood plasma was 6.4 ng/ml According to the research results of palpation and ultrasound signs of germination capsule of the prostate was absent. When sextante biopsy of the prostate cancer cells (well differentiated) were detected in two of the six columns, and the degree of malignancy of tumors was equal to 5 points according to the Gleason score, in the past transurethral resection for benign prostatic hyperplasia is not performed.

Conducted after radical prostatectomy morphological examination revealed the patient's stage RTA tumor without tumor invasion of the seminal vesicles. The degree of malignancy of the Gleason score was 6 points. When calculating the indicator "M" in the proposed formula M=-2,014 (less than -1,55), i.e. the risk of metastasian low. During the four years of observation after surgery signs of distant metastasis was found.

The proposed method has the following advantages.

1. Allows us to predict the appearance of distant metastases of prostate carcinoma after radical prostatectomy based on a comprehensive assessment of the clinical-morphological factors with high probability forecasting 90.1% of λ =0,7; P < 0,00001).

2. Has the simplicity, accessibility and economic viability, as it is based on evaluating only put into wide practice laboratory and morphological methods and does not require the use of expensive laboratory equipment.

A method for predicting distant metastasis after radical prostatectomy in patients with prostate cancer, namely, that identify preoperative factors: clinical stage neoplasms of the prostate, level prostatespecific antigen (PSA), tumor spreading into the capsule of the prostate according to the results of a digital rectal exam, tumor spreading into the capsule of the prostate according to the results of transrectal ultrasound, the number of positive biopsy columns with transrectal biopsy of the prostate, the degree of differentiation of tumors with transrectal biopsy of the prostate, the degree of malignancy of tumors with transrectal biopsy of the prostate Gleason score, evaluate the results of histological examination after completed earlier transurethral resection of the prostate, as well as determine postoperative factors: pathological the stage of the tumor, the grade of malignancy of the Gleason score according to the results of morphological studies, roystonia tumor of the prostate seminal vesicles according to the results of morphological studies, calculate the rate of distant metastasis by the formula

M=0,24·T-0,010·P+0,87·R+0,02·+0,15·1,12·D+0,07·KG+0,38·N-0,38·RT+0,11·PG+2,02·V,

where M is an indicator of distant metastasis;

T - clinical stage tumor of the prostate: 1 - T1; 2 - T2; 3 - T3;

R - PSA levels before surgery, ng/ml;

R - sprouting tumor capsule of the prostate according to the results of a digital rectal exam: 0 - not germinate; 1 - sprouting;

With the sprouting tumor capsule of the prostate according to the results of transrectal ultrasound: 0 - not germinate; 1 - sprouting;

In the number of positive biopsy columns with transrectal biopsy of the prostate: 1-6;

D is the degree of differentiation of tumors with transrectal biopsy of the prostate: 1 - high; 2 - sredneperesechennoy; 3 - well-differentiated tumor;

KG - the degree of malignancy of tumors with transrectal biopsy of the prostate Gleason score: 2-10;

N - histological examination after completed earlier transretinol resection of the prostate: 0 - not performed; 1 - benign prostatic hyperplasia; 2 - adenocarcinoma of the prostate;

RT - pathological stage tumors: 1 - RCA, 2 - pT2b, 3 - RCA, 4 - 3b

PG - the degree of malignancy of the Gleason score according to the results of morphological studies: 2-10;

V - spreading tumor of the prostate seminal vesicles on the results of morphological analysis: 0 - not germinate; 1 - sprouting;

and when the value of M > -1,55 predict distant metastasis.



 

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EFFECT: higher accuracy of prediction.

2 ex, 3 tbl

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