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13-cis-retinoic acid and interferon alpha-2a: effective combination therapy for advanced squamous cell carcinoma of the skin.
Lippman, S M; Parkinson, D R; Itri, L M; Weber, R S; Schantz, S P; Ota, D M; Schusterman, M A; Krakoff, I H; Gutterman, J U; Hong, W K.
  • Lippman SM; Department of Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030.
J Natl Cancer Inst ; 84(4): 235-41, 1992 Feb 19.
Article en En | MEDLINE | ID: mdl-1734084
ABSTRACT

BACKGROUND:

Retinoids (vitamin A derivatives) and interferon-alpha (IFN-alpha) are potent regulators of malignant cell differentiation and proliferation, and both have immunomodulatory and antiangiogenesis activity. A large body of preclinical and clinical data supports the use of combination therapy with 13-cis-retinoic acid (13-cRA) and IFN-alpha in patients with squamous cell carcinoma of the skin. This carcinoma is an extremely common and frequently severely disfiguring cancer, for which about 10% of patients remain uncured following standard local therapy.

PURPOSE:

Our purpose was to test whether a 20% or greater complete response rate could be achieved using a combination of these two agents in patients with advanced squamous cell carcinoma of the skin in whom local therapy had failed or was unfeasible or who had regional and/or distant metastases.

METHODS:

Thirty-two patients with heavily pretreated, advanced inoperable cutaneous squamous cell carcinoma of the skin were given a combination of oral 13-cRA (1 mg/kg per day) and subcutaneous recombinant human IFN alpha-2a (3 million units per day) for at least 2 months, unless disease progressed earlier, in a phase II trial.

RESULTS:

Nineteen (68%) of the 28 assessable patients responded, seven (25%) of whom had complete responses. Response rates were 93% (13 of 14) in patients with advanced local disease (six complete responses), 67% (four of six) in patients with regional disease (no complete responses), and 25% (two of eight) in patients with distant metastases (one complete response). The relationship between decreased response rate and increased extent of disease was highly statistically significant (P less than .005, chi-square test). The median response duration was greater than 5 months. No life-threatening toxic effects occurred in assessable patients treated with this combination, although dose reductions were required in 18 patients. The major limiting side effect in this elderly patient population (median age, 67 years) was cumulative fatigue.

CONCLUSION:

These results indicate that combined systemic therapy with 13-cRA and IFN alpha-2a is highly effective in patients with advanced squamous cell carcinoma of the skin.
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Banco de datos: MEDLINE Asunto principal: Neoplasias Cutáneas / Carcinoma de Células Escamosas / Protocolos de Quimioterapia Combinada Antineoplásica Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Año: 1992 Tipo del documento: Article
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Banco de datos: MEDLINE Asunto principal: Neoplasias Cutáneas / Carcinoma de Células Escamosas / Protocolos de Quimioterapia Combinada Antineoplásica Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Año: 1992 Tipo del documento: Article