Primary (neoadjuvant) chemotherapy and radiotherapy compared with primary radiotherapy alone in stage IIb-IIIa breast cancer.

BACKGROUND: A phase III randomized trial was activated to evaluate the efficacy of preoperative combined chemotherapy and radiotherapy as compared to preoperative radiation therapy alone, in patients with breast cancer presenting with a clinical stage of IIb-IIIa (TNM classification). PATIENTS AND METHODS: From 1985 to 1990, 271 patients, aged 27-55 years, with stage IIb-IIIa breast cancer were randomized to receive either one or two courses of thiotepa 20 mg (i.m. injection) on the days 1, 3, 5, 7, 9, 11 (total dose per course 120 mg), methotrexate 40 mg/m2, i.v. on days 1 and 8, and 5-fluorouracil 500 mg/m2, i.v. on days 1 and 8 (TMF regimen) plus radiotherapy (Group I, 137 patients), or preoperative radiation therapy only (Group II, 134 patients). After the preoperative treatment all patients underwent mastectomy and complete axillary clearance, and then received 4-6 courses of TMF. The trial was conducted in a single institution (N.N. Petrov Research Institute of Oncology, St. Petersburg). RESULTS: Histopathological assessment of the mastectomy specimens showed complete regression of the tumour in 29.1% of the patients in group I and in 19.4% of the patients e.c. in group II. The estimated 5-year overall survival percentages were 86.1% for group I, and 78.3% for group II (P > 0.05). 5-year disease-free survival percentages were 81.0% and 71.6%, respectively (p < 0.05). CONCLUSIONS: Despite the low number of the patients included in the trial, we were able to detect a significant improvement in treatment results with a combination of chemotherapy and radiation therapy given prior to mastectomy over those of local therapy alone with radiation therapy followed by mastectomy, for average- and high-risk patients with operable breast cancer.

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.