[Results of a prospective randomized investigation [Russia (St.Petersburg)/WHO] to evaluate the significance of self-examination for the early detection of breast cancer]. / Rezul'taty prospektivnogo randomizirovannogo isledovaniia [Rossiia (Sankt-Peterburg)/VOZ] znacheniia samoobsledovaniia v rannem vyiavlenii raka molochnoi zhelezy.

Indications for puncture or excision biopsy were significantly higher in the study group (7.5%) as compared with control (3.5%) (p < 0.01) in a randomized prospective controlled trial of a comprehensive breast cancer screening (123,748) carried out in the framework of a self-examination education program. In the self-examination group, detection rates were higher both for benign (1.1%) and malignant (0.85%) tumors than in control (0.5% and 0.69%, respectively) (p < 0.05). Early stage (T1NOMO, Tis) distribution difference in the study group and controls was insignificant--23 and 17.6%, respectively. Compliance with the program requirements including monthly or bimonthly self-examination was followed by higher 15-year survival rates (53.2%) in 70-75% as compared with controls(45.8%) (p = 0.05105): yet it did not affect mortality.

[Interim results of a prospective randomized study of self-examination for early detection of breast cancer (Russia/St.Petersburg/WHO)]. / Promezhutochnye rezul'taty prospektivnogo randomizirovannogo issledovaniia (Rossiia/Sankt-Peterburg/VOZ) znacheniia samoobsledovaniia v rannem vyiavlenii raka molochnoi zhelezy.

Training in breast self-examination (BSE) technique involved 57,712 women, aged 40-64, at 14 out of randomly selected out-patient hospitals in St. Petersburg (1985-1989). Another 64,759 women selected at another 14 out-patient hospitals were in control. All patients with detected tumor pathology of the breast were biopsied and treated at the Institute's Clinic. The study focused on breast cancer incidence, survival and mortality. More women in the BSE group sought medical advice for suspected pathology (4,300) than those in control (2,438; p < 0.05). There were 493 cases of breast cancer in the BSE group with 157 fatalities, 446 cases of breast cancer with 167 fatalities in the control group. There was no significant difference in tumor stage. Nine-year survival (after Kaplan-Meyer) from the time of tumor detection was 65% in the study group and 55% in control (log rank 0.774; p > 0.05). There has been no significant difference in death rates in both groups for the past ten years. The study is to continue until the year 2001.

[The effectiveness of adjuvant chemotherapy with anthracyclines (adriablastin, doxorubicin) for stage-IIb-IIIa breast cancer]. / Effektivnost' ad''iuvantnoi khimioterapii antratsiklinami (adriablastinom, doksorubitsinom) u bol'nykh rakom molochnoi zhelezy IIb-IIIa stadii.

The effectiveness of adjuvant treatment with anthracyclins (adriablastin, doxorubicin) and standard CMF regimens for breast tumors has been compared. The study included 349 patients with stage IIB-IIIA tumors (T1-2N2M0, T3N0-2M0) (mean age-46 years) during 1985-1990 follow-up-60.38 months. In the doxorubicin group, overall 5-year survival was 73 +/- 8%, in the CMF group-62 +/- 8%. Recurrence-free 5-year survival was 62 +/- 8 and 55 +/- 8%, respectively. The differences are not significant. A stage-related analysis established a significant difference in overall survival in patients with T1-2N2M0 tumors (c-sqare 9.92, p < 0.01). However, due to a small number of cases, the phenomenon requires further study. Although adriablastin treatment involved a significantly higher frequency of carciotoxic symptoms, complete alopecia and dyspeptic complication, a systemic administration of cardioxan and effective antiemetic drugs was lacking.

[Breast-preserving (conservative) therapy of breast cancer]. / Organosokhraniaiushchee (konservativnoe) lechenie raka molochnoi zhelezy.

Conservative surgery (sectoral or segmental + axillary dissection) was performed in 278 patients with breast cancer (T1-2N0M0) at the Institute Clinic in 1990-1995. Following thorough morphological examination. 148 patients (53.2%) were selected to form a clinical study group for an investigation of the role of postoperative radiotherapy in the conservative treatment of breast cancer. Two groups-irradiation of the remaining breast tissue and controls-were formed on the basis of randomized data. Follow-up continued 3-60 months (average duration-37.7 months). Local recurrence was detected in 3 out of 73 (4.2%) patients of group I. A similar relapse was detected in 6 out of 75 (8.0%) patients of group II. No significant difference in total survival rates in the two groups was observed (97.3 and 96.0%; p > 0.05).

[Postoperative hormone therapy of breast cancer (analysis of overall survival)]. / Posleoperatsionnaia gormonoterapiia raka molochnoi zhelezy (analiz obshchei vyzhivaemosti)

A third series of randomized evaluation of postoperative (adjuvant) hormone therapy (tamoxifen, sinestrol and orimeten) was carried out in breast cancer patients. The study group involved 1.332 reproductive and postmenopausal females with stage I-III tumors. The investigation established quite a range of 10-year survival evidence versus stage and reproductive status; however, no significant differences were recorded in either of the groups. Untoward side-effects were more frequent when treating with diethyl-stilbestrol (over 30%) than with tamoxifen (3.5%). No significant differences were registered in five-year total and recurrence-free survival in the treatment with orimeten or tamoxifen.

[Preliminary results of the Russia (St.Petersburg)/WHO program for the evaluation of the effectiveness of breast self-examination]. / Promezhutochnye rezul'taty programmy Rocciia (Sankt-Peterburg)/VOZ po otsenke éffektivnosti samoobsledovaniia molochnykh zhelez.

Although an absolute difference of 10% (65,4 vs. 54,9%) in 5- and 9-year survival in breast cancer patients was recorded between the self-examination and control groups a large-scale randomized population-controlled study of 122,471 females has failed to provide significant differences (Log-rank - 0,774, p > 0.05). No significant decrease in mortality was observed in the self-examination group as compared with the untrained controls. As a result of providing more information to the population on risk factors. twice as many of the trained females consulted oncologists. Also, the number of early detection of breast tumor (T1-2NOMO) in both groups was 1,5-2,5 times that recorded elsewhere. Since 3,55 per 1,000 patients with breast tumors per year, aged 50-59, died of cardio-vascular disease, i.e. 3,1 times the expected 1,16 per 1,000, more attention should be focused on timely diagnosis and treatment of concomitant cardio-vascular pathology.

The role of breast self-examination in early breast cancer detection (results of the 5-years USSR/WHO randomized study in Leningrad).

A randomized population-based study has been carried out since 1985 in Leningrad in order to evaluate the efficacy of breast self-examination (BSE) in early breast cancer detection. The population under study covers 120,310 women aged 40-64 years with no history of breast cancer. About half of these women were exposed to BSE training (60,221) and 60,098 women constituted the control group. BSE teaching was carried out on a person-to-person basis and each patient received the BSE calendar. BSE education sessions resulted in a higher frequency of visits to specialists with complaints about "pathology" of the breast, a higher rate of referral to a specialized institution for an examination, and a higher number of excision biopsies due to a benign lesion (RR = 1.5; 95% C.I. = 1.1 - 1.9) as compared with the control group. As a result of examination, 190 breast cancer patients in the BSE group and 192 patients in the control group were detected. Comparisons of patients from both groups with regard to the size of primary tumor and the incidence of metastatic lesion in the regional lymph nodes showed no differences. The study is ongoing and all cases of breast cancer in the BSE group will be registered up to 1994 and followed-up to 1999; information will then be available on the impact of BSE upon breast cancer mortality.

Clinical trials on adjuvant chemotherapy for breast cancer.

Clinical trial initiated in 1975 at the Petrov Research Institute of Oncology (Leningrad) included 1228 patients with breast cancer Stages I, II, and III. Adjuvant chemotherapy in patients with Stages I-II (P T0-2N0-1M0) leads to decrease in mortality rate by 24.3% in the case of monochemotherapy (thiotepa, six courses, 200 mg each course) and 32.4% in the case of polychemotherapy (thiotepa, methotrexate, 5-fluorouracil [TMF], cyclophosphamide, methotrexate, 5-fluorouracil [CMF], six course). There is a trend to higher (by 7.8%-9.8% versus control) rates of adjusted survival in the groups of patients with relatively early stages of breast cancer (P T0-2N0M0) subjected to adjuvant mono- and polychemotherapy. In the group of breast cancer patients (P T0-2N0-1M0) who received adjuvant polychemotherapy (TMF, CMF schemes) the survival rates are higher by 12.0%-16.6% than in the control group during the sixth, seventh, and eighth years of the follow-up. Favorable effect of adjuvant chemotherapy manifested by diminished mortality rate and prolonged survival was statistically significant only in the group of patients younger than 50 years.

[Synchronous bilateral breast cancers]. / O sinkhronnykh bilateral'nykh rakakh molochnoi zhelezy.

In application of mammography and aiming biopsy, synchronous carcinoma of contralateral breast may be detected in 2.4% of cases, on the average, 3 years earlier than by clinical examination only. Increased proliferation of contralateral breast tissue (a factor contributing to tumor development) is not a pathognomonic symptom since proliferation rate in ductal and lobular tissues decreases with age and in menopause. At least half metachronous carcinomas of the second breast should be considered synchronous ones overlooked in the course of primary treatment.

[Results of phase I study of the effectiveness of self-examination in a program of early detection of breast cancer]. / Rezul'taty pervogo étapa issledovaniia po otsenke éffektivnosti samoobsledovaniia v programme rannei diagnostike raka molochnoi zhelezy.

The paper deals with the results of the first phase of a WHO-sponsored study concerned with evaluation of the effectiveness of breast self-examination and carried out in Leningrad. The study was part of a program for early breast cancer diagnosis. 8,000 females were taught the procedure of self-examination. A randomized survey of a representative group of 400 females was conducted during the first 12 months using a special questionnaire. It was intended for evaluating the subjects' comprehension of the aims of the program, their attitude to it and their knowledge on cancer. Due to training as well as regular reminding, the percentage of women who practiced self-examination was as high as 75.1. The results of an analysis of refusals to carry out self-examination are presented.