International journal of radiation oncology, biology, physics
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Int. J. Radiat. Oncol. Biol. Phys. · Jan 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialTherapy of small breast cancer: a prospective study on 1036 patients with special emphasis on prognostic factors.
In 1983, The German Breast Cancer Study Group, sponsored by the Federal Ministry of Research and Technology, started a prospective multicenter trial on the treatment of early breast cancer pT1 pN0 M0. Treatment consisted of initial tumorectomy with microscopically free margins and lower axillary dissection. After conformation of a pT1 pN0-stage, additional treatment was either mastectomy or adjuvant radiotherapy (50 Gy in 25 fractions to the entire breast plus 12 Gy electron boost). ⋯ Age, menopausal status, hormone receptor status, histological tumor type, and treatment (mastectomy vs breast preservation) were not significant. P-185-expression was dependent on tumor grade and was the strongest prognostic factor in an univariate and multivariate analysis (p less than 0.001). The results emphasize the central role of tumor grade for prognosis and suggest the independent prognostic significance of the c-erb-B2 oncogen (corresponding to p-185) in pN0-patients.
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Int. J. Radiat. Oncol. Biol. Phys. · Jan 1992
Randomized Controlled Trial Clinical TrialReduction of pain and local complications when buffered lidocaine solution is used as a local anesthetic in conjunction with hyperthermia treatments: results of a randomized trial.
Unbuffered lidocaine (pH = 6.5) is commonly employed as a local anesthetic prior to transcutaneous placement of catheters for use in temperature monitoring during hyperthermia treatments. The most frequent complaint associated with this procedure is stinging or burning pain at the injection site. Tender firm subcutaneous nodules at sites of lidocaine infiltration for catheter placement have also been noted in fields treated with radiation and hyperthermia. ⋯ Treatment fields that received the buffered anesthetic had a statistically significant reduction in the pain associated with infiltration of lidocaine (p less than 0.05) without any compromise in its therapeutic efficacy as observed on a linear Visual Analog Scale. Furthermore, the incidence of subcutaneous nodules was lower in the fields treated with the buffered solution (1/23 vs 7/29, p = 0.05 for buffered and unbuffered solutions, respectively). The results of this trial support the use of buffered lidocaine prior to catheter placement for hyperthermia treatments as a method of reducing pain at infiltration and the subsequent development of subcutaneous nodules.
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Int. J. Radiat. Oncol. Biol. Phys. · Jan 1992
Randomized Controlled Trial Clinical TrialCombined hyperthermia and irradiation in the treatment of superficial tumors: results of a prospective randomized trial of hyperthermia fractionation (1/wk vs 2/wk).
From December 1984 to December 1989, 240 superficially located recurrent/metastatic malignant lesions (173 patients) were enrolled in a prospective randomized study of one versus two hyperthermia fractions per week. In the majority of patients, the dose of radiation therapy was less than 4000 cGy over 4 to 5 weeks. Stratification was by tumor size, site, and histology. ⋯ There was no difference between the two treatment arms. Cox regression analyses were performed to study the prognostic significance of patient characteristics, tumor characteristics, and treatment parameters. Detailed analysis and results are presented.