Tamoxifen vs Tamoxifen plus 13-cis-retinoic acid vs Tamoxifen plus Interferon alpha-2a as first-line endocrine treatments in advanced breast cancer: updated results of a phase II, prospective, randomised multicentre trial.
OBJECTIVE
To demonstrate the efficacy of 13-cis-retinoic acid (RA) or Interferon alpha-2a (IFN alpha-2a) with Tamoxifen (TAM) in the treatment of advanced breast cancer.


METHODS
Ninety-nine postmenopausal patients with advanced breast cancer, and a positive or unknown estrogen (ER) or progesterone (PgR) receptor status, were randomised to receive TAM 20 mg/m2/day orally (arm A), or TAM plus RA 1 mg/kg/day orally (arm B), or TAM plus IFN alpha-2a 3 MU thrice a week intramuscular (arm C). The three treatment groups were well balanced in terms of the main prognostic factors.


RESULTS
Response was evaluable in 32 of the patients in arm A, 32 in arm B, and 30 in arm C. Intention-to-treat analysis showed no significant difference of response rate in the three arms (44% vs 38% vs 42%). After an eight years median follow-up, there was no significant between-group difference in median overall survival: 47.4 vs 38.2 vs 45.1 months. Side effects were negligible in arm A, but cutaneous (39%) and mucosal (62%) toxicities were frequent in arm B, and flu-like syndrome and/or myalgia (46%) in arm C.


CONCLUSIONS
The administration of RA or IFN alpha-2a does not add anything to the therapeutic effects of TAM.
Chiesa
Matteo Dalla
MD
Oncology Division, Hospital of Cremona, Cremona, Italy. mdallachiesa@yahoo.it
Passalacqua
Rodolfo
R
Michiara
Maria
M
Franciosi
Vittorio
V
Di Costanzo
Francesco
F
Bisagni
Giancarlo
G
Camisa
Roberta
R
Buti
Sebastiano
S
Tomasello
Gianluca
G
Cocconi
Giorgio
G
D000284:Administration, Oral; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003627:Data Interpretation, Statistical; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D015474:Isotretinoin / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D017698:Postmenopause; D011379:Prognosis; D011446:Prospective Studies; D011994:Recombinant Proteins; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D013629:Tamoxifen; D015474:Isotretinoin