Polyadenylic-polyuridylic acid plus locoregional and pelvic radiotherapy versus chemotherapy with CMF as adjuvants in operable breast cancer

In this study, patients with operable breast cancer T2 or T3, treated by mastectomy + axillary dissection and with invaded axillary nodes (N+), were randomized to receive either: 1. postoperative loco-regional and pelvic radiotherapy (RX) and Poly(A).Poly(U) (AU), 60 mg IV once a week for 6 weeks, or 2. CMF (cyclophosphamide 100 mg/sqm P.O. on days 1-14, methotrexate 40 mg/sqm IV on day 1 and 8, fluorouracil 600 mg/sqm IV on day 1 and 8; monthly cycle, for 6 months). Between March 1982 and December 1985, 517 patients were enrolled, 257 of whom were treated by RX+AU and 260 with CMF. The main clinical, pathological and prognostic characteristics were equally distributed in the two groups. The present analysis was conducted after a mean follow-up of 69 months (S.D.=13). There was no significant difference in the overall survival (OS) between the two groups (test adjusted by center and menopausal status); The five-year OS rate was 74 percent in the RXAU group and 77 percent in the CMF group. Relapse-free survival (RFS) was significantly higher (p=0.05) in the RXAU group compared to the CMF group; the five-year RFS rates were 57 and 46 percent respectively. This short, well-tolerated combined RXAU treatment appears to be as efficient as CMF and might offer an alternative to chemo- or hormonotherapy, in case of contraindications to these treatments. (author). 18 refs.; 6 figs.; 3 tabs