INVENTION
Russian Federation Patent RU2241991

METHOD FOR PREDICTING SURVIVAL IN PATIENTS WITH STOMACH CANCER

Name of the inventor: Poroshenko AB (RU); Orel LA (RU); Dimitrenko AP (RU)
The name of the patentee: Rostov Research Institute of Oncology (RU); Poroshenko Anatoly Borisovich (RU); Lidia Oryol (RU); Dimitrenko Alexei Petrovich (RU)
Address for correspondence: 344037, Rostov-on-Don, 14 line 63, the Rostov Research Institute of Oncology
Starting date of the patent: 2003.04.03

The invention relates to medicine, namely to oncology. The essence of the method: in women with menopause between 50 and 59 years suffer from NSS radical surgical treatment, after verification of signet ring cell histological structure of the tumor predict unfavorable course of the disease. The method allows a more personalized plan of treatment and preventive measures.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely, to oncology and can be used to predict survival after surgical treatment of organ radical gastric cancer.

TNM-classification of gastric cancer, as an expression of the phased model, originally aimed at predicting treatment outcomes (Koong HN, Chan HS, Nambiar R., Soo, KC et al Gastric cancers in Singapore: poor prognosis arising from late presentation - The Australian and.. New Zealand Journal of Surgery -. V.66 -. N.12 -. P.813-5 -. 1996). However, despite the emergence of new versions (TNM-1997; TNM-2000), the need to improve the forecast accuracy is maintained.

A good combination is considered to be research-oriented search for additional, corrective phased model "systemic" predictors, feeling the relevance of the search and the study of which is becoming more acute, the more "gentle" can be a component of cytoreductive therapy.

However, while almost all the innovations of the system methodology does not eliminate the annoying blunders, and stratification of individual differences has been and remains a challenge requiring randomization during an already expensive clinical trials of new anti-tumor agents.

According to the applicant, it is not least due to the "Retargeted" Basic Research on the subsystem "tumor". While the long-term outcomes is largely, if not entirely, determined by individual differences subsystem "tumor" - a principle which underlies the claimed "method for predicting the survival of patients with gastric cancer."

Formally, to analogues of the claimed technical solution may include numerous studies in which the age of the subject at the time of surgical treatment stage appears as an independent predictor of life expectancy (eg, Winslet MC, Mohsen YM, Powell J. et al. The influence of age on the surgical management of carcinoma of the stomach - European Journal of Surgical Oncology:. the Journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology - V.22 - N.3 - P 220-4 - 1996.... . Cimerman, M., Repse, S., Jelenc, F., Omejc, M., Bitenc, M., Lamovec, J. Comparison of Lauren's, Ming's and WHO histological classifications of gastric cancer as a prognostic factor for operated patients. -. Int Surg -. V 79. - №1 P 27-32)..

It is noteworthy that in the M.Cimerman et al., Notes that (i) performed within 50-70 years, (ii) cases of alleged radical resections (supposedly radically resected) (iii) signet ring cell carcinoma of the stomach (iv) complies worse prognosis.

But still, in essence, the prototype of the claimed technical solution should be considered a model of stability of a unilateral reduction of cancer (Poroshenko AB On the nature of a unilateral reduction of cancer stability -. Methods and mechanisms to enhance the anti-tumor protection -. Moscow -. 1993. - S.211- 261), which postulates the possibility of restoring the stability of anti-symmetry, which is a violation for a critical - perimenopausal period ontogeny manifest violation of the symmetry of cancer incidence.

In the female body symmetry breaking cancer stability may be due to: (i) the rigidity of the hypothalamic-gonadal axis, the mobility of which is violated regularly in the run-up to menopause (active script); (Ii) "manifestation" There was originally one-sided anti-deficit sustainability, which up until menopause leveled mobility hypothalamic-gonadal axis (passive scenario).

The reality of the existence of two anticancer stability reduction scenarios proves perimenopausal symmetry breaking morbidity described in breast cancer, renal cancer. (Poroshenko AV, Bakurov ED On the nature of lateral differences and sex-differences of the kidney cancer -13 Congress of ESUOE, Innsbruck, Austria, 1998. - European Urology, 34 |. 3 | 98 | -. P. 298. Poroshenko AB symmetry breaking perimenopausal breast cancer incidence -. "Oncology 2000" - 2nd Congress of CIS oncologists -. May 23-26 -. 2000 - Kiev -.. Ukraine Poroshenko AB premenopausal differences surgical treatment of kidney cancer -. The congress of oncologists of Russia -. Kazan -. 2000).

Here are the main shortcomings of the prototype chosen.

The term "anti-symmetry of stability" and its associated "unilateral reduction of cancer stability" is meant keeping the location of the part of the tumor, ie, the condition, disorienting in case of defeat of the body such as the stomach.

The term "active script" reducing cancer stability gives a clear perspective: the restoration of stability cancer after menopause, ie, after an average of 50 years. In patients older than 50 years, which corresponds "passive scenario" forecast is less than specified, since it does not stipulate how many years after menopause must prove himself "one-sided, which existed originally, anti-deficit sustainability," postulated in the chosen prototype model.

The aim of the invention is to improve the reliability of the forecast of organ after radical surgical treatment of gastric cancer with signet ring cell histologic structure.

The goal is achieved by the fact that women with menopause between 50 and 59 years suffer from NSS radical surgical treatment, after verification of signet ring cell histological structure of the tumor predict unfavorable course of the disease.

The invention is new, since the specialist oncologist claimed technical solution does not obviously follow from the state of development of medicine and related to oncology related areas of knowledge.

The novelty of the claimed technical solution is as follows.

The first forecast of organ after radical surgical treatment of gastric cancer is carried out taking into account the characteristics of the critical perimenopausal period of ontogenesis.

The first decision of the adverse prognosis of the disease puts a condition matching the age at the time of surgical treatment of menopausal phase (50-59 years) period of ontogenesis.

During the preparation of the proposed technical solutions used in sample 483 cases of gastric cancer (1991-2001.). Median follow-up after radical surgical treatment 24.0 (12.5 -55.0% 2575%) months., In the stratum full of observations 15.0 (8.5% 25-28.0% 75) months., In a censored stratum - 51.0 (-81.0% 26.0 2575%) months. In 44.67% of men (n = 291) and 48.44% in women (n = 192) had a signet ring tumor cell variant histological structure. Organ surgery (radical resection) were introduced proximal and distal subtotal resection of the stomach (n = 314; 65.01%). Gastrectomy were performed in 169 cases (34.99%). In survival analysis was used nonparametric Kaplan-Meier estimation.

Estimates of the incidence, stratified by sex and the results of follow-up, are the best illustration of the proposed technical solutions.

METHOD FOR PREDICTING SURVIVAL IN PATIENTS WITH STOMACH CANCER

Women (1), within 49-58 years undergoing radical organnosohranyayuschemu surgery, is not among the survivors of the first year and a half after radical treatment of organ-stage, ie not died in the first 6 years, since the median survival in this artificially truncated stratum 74.14 months. For comparison are presented kummulyaty incidence of deaths (2) during the first 2 years after the surgical phase of treatment. It is clearly seen that the cases of signet ring cell carcinoma are evenly distributed throughout the perimenopausal period of ontogenesis (40-60 years).

METHOD FOR PREDICTING SURVIVAL IN PATIENTS WITH STOMACH CANCER

As obvious expression of sex differences in cancer stability discussed phenomenon characteristic only of signet ring cell structure of stomach cancer (3), and is observed only among women who underwent NSS surgery. Women with signet ring cell carcinoma of the stomach after the executed within 50-59 gastrectomies can live more than 1.5 years (4).

METHOD FOR PREDICTING SURVIVAL IN PATIENTS WITH STOMACH CANCER

Concluding summary calculations to illustrate the claimed technical solution is to provide assessments of the interaction of age and TNM-stage, taking into account the sex of the subject and scope of the operational benefits. Women with signet ring cell carcinoma in a stratum of radical resection of these interactions are not significant (df = 6;. MLH Chi.squ = 6,94; p = 0,32). The stratum gastrectomies (df = 6;. MLH Chi.squ = 10,53; p = 0,10) there is a tendency of increasing cases of III stage of the process within the age range of 50-59 years.

METHOD FOR PREDICTING SURVIVAL IN PATIENTS WITH STOMACH CANCER

The invention involves an inventive step, since the claimed technical solution does not obviously follow from the state of current knowledge in the field of oncology.

The claimed method is not obvious, is not known in the medical literature and clinical practice, neither in Russia, nor in the CIS or abroad.

Comparative analysis with the selected prototype allows us to conclude that the combination of features of the claimed technical solution has substantial differences in the approach to achieve the goal - to increase reliability of organ prognosis after radical surgical treatment of gastric cancer with signet ring cell histologic structure.

Symmetry cancer stability, minimizing the risk of cancer (Poroshenko AB On the nature of a unilateral reduction of cancer stability -. Methods and mechanisms to enhance the anti-tumor protection -. Moscow -. 1993. - S.211-261) means the species norm menopausal ontogenesis (50 -60 years).

Accordingly, the occurrence of cancer is regarded as a manifestation of the failure "tumor" subsystem to ensure symmetry with the onset of menopause, cancer stability.

Until about 58-59 years of symmetry breaking anti-sustainability is firmly burden the prognosis of the extent to which the activity will keep reflexogenic zone genitals, expresses this asymmetry.

I would like to once again highlight that the decrease in cancer stability at all should not be considered as an intrinsic property of menopausal ontogeny. According to the applicant, this is the period of individual development in the evolution of programmed to restore symmetry (harmony) of the female body. But to achieve this level of functional state, providing optimum anti-sustainability, it is possible only in the absence of damage - the fundamental causes of disease.

The invention is industrially applicable because it can be used in health care: Research Institute of Oncology, Oncology Center, and the institutions and whose potential allows for a radical surgical treatment of gastric cancer. The claimed technical solution can be used to improve the reliability of a favorable prognosis after radical surgical treatment of organ signet ring cell carcinoma of the stomach.

"A method for predicting survival in patients with gastric cancer" is as follows.

In women with menopause between 50 and 59 years suffer from NSS radical surgical treatment, after verification of signet ring cell histological structure of the tumor predict unfavorable course of the disease.

Examples of specific application "Method for predicting survival in patients with gastric cancer."

K., IB №7285 / l. '51. Cancer of the stomach outlet, infiltrative growth form. Stage II, T 3 N 0 M 0. Operation: distal gastrectomy. According to the results of histological examination: undifferentiated carcinoma, areas signet ring cell carcinoma. It concluded: forecasted unfavorable course of the disease. Life expectancy was 17.0 months.

AP, IB №13706 / in. 67 years. Cancer of the stomach outlet, infiltrative-ulcerative form of growth. Phase IIIa, T 2 N 0 M 2. Operation: distal gastrectomy. According to the results of histological examination: undifferentiated carcinoma, areas signet ring cell carcinoma. It concluded: projected a favorable course of the disease.

Life expectancy was 40.0 months.

Technical and economic efficiency, "a method for predicting survival in patients with gastric cancer."

Technical and economic efficiency, "a method for predicting survival in patients with gastric cancer" is that additional equipment and reagents, trained personnel is not required for its implementation. To predict the unfavorable course of the disease after radical surgical treatment of organ signet ring cell carcinoma of the stomach enough to the age of the patient with menopause was within 50-59 years. The claimed technical solution allows to identify a new stratum in clinical trials, more individually planned treatment and preventive measures.

CLAIM

A method for predicting survival in patients with gastric cancer, characterized in that in women with menopause between 50 and 59 years undergoing NSS radical surgical treatment, after verification of signet ring cell histological structure of the tumor, predicts unfavorable course of the disease.

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Publication date 06.01.2007gg