Adjuvant postoperative radiotherapy, chemotherapy, and immunotherapy in stage III breast cancer. II. 5-year results and influence of levamisole

Abstract

One hundred twenty pathologically confirmed operable Stage III breast cancer patients were randomized to receive either postoperative radiotherapy or chemotherapy, or a combination of these, with or without levamisole immunotherapy. Radiotherapy was given to regional lymph nodes and chest wall. Chemotherapy consisted of six cycles of vincristine, doxorubicin, and cyclophosphamide. Radiotherapy provided local and chemotherapy systemic control over the tumor, but the best patient-saving results were achieved with a combination of radiotherapy and chemotherapy. This clinical trial was commenced in 1976, and the first 60 of 120 patients also received oral levamisole, 150 mg/day, on 2 consecutive days weekly as immunotherapy. All patients were followed for at least 5 years. At this stage levamisole seems to increase disease-free and overall survival in all three treatment arms (radiotherapy, chemotherapy, combined treatment). Significance is reached in disease-free survival (P = 0.035) and overall survival, adjusted for all other treatment modalities (P = 0.019).

Clinical practice guidelines for the care and treatment of breast cancer: 15. Treatment for women with stage III or locally advanced breast cancer

“…11,26,27 The number of patients in these trials was small. Two trials showed improved DFS with anthracyclinebased chemotherapy over no chemotherapy (level I evidence) 11 and over a CMF-vincristine-prednisone regimen (level II evidence). 27 A third trial showed no difference in DFS or OS between CMF and a CMF-epirubicinvincristine regimen (level II evidence) ( Table 2).…”

“…11,12 One of these studies 11 reported a benefit with chemotherapy (level I evidence). The metaanalysis of the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) 5,6 included a subset of patients with large operable tumours.…”

“…20 Choice of chemotherapy have addressed the issue of the type of chemotherapy to be used. 11,26,27 The number of patients in these trials was small. Two trials showed improved DFS with anthracyclinebased chemotherapy over no chemotherapy (level I evidence) 11 and over a CMF-vincristine-prednisone regimen (level II evidence).…”

Radiation therapy for operable breast cancer

“…40 The radiated patients had a longer time to local recurrence, but no significant difference in disease-free survival. Yet Grohn et al 41 and Klefstrom et al 42 found megavoltage radiation therapy was associated with improved survival. In this randomized trial, when selection biases for treatment were removed, patients receiving combined radiation and chemotherapy had the best overall survival and lowest local recurrence rates compared with either therapy alone.…”

Clinical practice guidelines for the care and treatment of breast cancer: 16. Locoregional post-mastectomy radiotherapy

“…19 The majority of the trials included pre-and postmenopausal women with node-positive disease who underwent modified radical mastectomy. [5][6][7][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] The adjuvant chemotherapy regimen most commonly used was cyclophosphamide, methotrexate and fluorouracil (CMF). The median duration of follow-up was 7.5-14.5 years.…”