Adjuvant tamoxifen versus tamoxifen plus CMF in the treatment of early breast cancer in Greece. Fifteen-year results of a randomised prospective trial and the potential risks of the antioestrogen.
BACKGROUND
CMF and Tamoxifen are the most commonly administered drugs for the adjuvant treatment of early-stage breast cancer. We present the 15-year follow-up of our 250-patient series and evaluate the oestrogenic side-effect of Tamoxifen on the endometrium.


METHODS
250 women entered this prospective study from 1981-1986. They had all undergone modified radical mastectomyl and were randomly assigned to receive either Tamoxifen only for 4 years or combination of Tamoxifen with 6 cycles of standard CMF. Abdominal sonogram was used to determine endometrial thickness, with 6 mm as cut-off limit for endometrial biopsy.


RESULTS
After 15.6 years of follow-up DFS and OS rates were better for the CMF + Tamoxifen, group (52.8% vs 39.2%--p = 0.043 and 57.6% vs 40.8%--p = 0.006 respectively). Only patients with more than 4 infiltrated nodes did not significantly benefit from adjuvant CMF. Postmenopausal women suffered more proliferative endometria compared to premenopausal ones (40.3% vs 15.6%), while life-threatening lesions (cancer and atypias) were found in 3.3% of the postmenopausal patients only.


CONCLUSIONS
CMF + Tamoxifen combination offers better long-term results for early-stage breast cancer patients. Dose reduction must be avoided if maximum results are to be achieved. More than 4 positive nodes seem to require additional chemotherapeutic manipulation. Tamoxifen's oestrogenic side-effect on the endometrium is quite common, but life-threatening lesions are rare, thus proving the drug's safety.
Breast Unit, Department of Surgery, University of Patras Medical School, Greece.
G
G
Vorgias
D
D
Koukouras
E
E
Tzoracoeleftherakis
V
V
Paleogianni
J
J
Androulakis
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004965:Estrogen Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006115:Greece; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D017698:Postmenopause; D017697:Premenopause; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D004965:Estrogen Antagonists; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D002945:Cisplatin; D005472:Fluorouracil; D008727:Methotrexate