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M Overgaard

Publications and source records attributed to M Overgaard.

At least 37 records · Page 2Linked to original sources

Importance of overall treatment time for the outcome of radiotherapy of advanced head and neck carcinoma: dependency on tumor differentiation.

PURPOSE: Accelerated repopulation of tumor cells during radiotherapy has been suggested as an important cause of treatment failure in squamous cell carcinoma of the head and neck. Due to tumor heterogeneity, not all tumors may benefit from accelerated radiotherapy at the expense of a lower total dose. This analysis evaluates the impact of histological differentiation on loco-regional control in relation to treatment duration. PATIENTS AND METHODS: A total of 501 patients with advanced supraglottic and pharyngeal squamous cell carcinoma with known histopathological grading were treated with planned split-course (191 patients) or continuous radiotherapy (310 patients) in two consecutive randomized controlled trials. Irradiation was given 2 Gy per fraction, 5 fractions per week to a dose of 66-68 Gy in 9.5 or 6.5 weeks, respectively. RESULTS: Overall, split-course and continuous treatment resulted in a 5-year loco-regional control of 30% and 41% (P = 0.007), respectively. However, the detrimental effects of split-course were only found in moderately and well-differentiated tumors, where the 5-year tumor controls were 38% and 21% after continuous and split-course treatment, respectively (P = 0.001). In contrast, in poorly differentiated tumors loco-regional control was obtained in 44% of the cases for continuous and 40% for split-course treatment (P = 0.63). CONCLUSIONS: It is suggested that the ability to accelerate repopulation may be lost by dedifferentiation, and that prolongation of the overall treatment time only lead to reduced loco-regional control in well to moderately differentiated tumors.

Carcinoma, Squamous Cell↗

Neoadjuvant chemotherapy with cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the head and neck: a randomized phase III study.

BACKGROUND AND PURPOSE: In 1986 a prospective, randomized, multi-centre trial for evaluation of neoadjuvant chemotherapy with cisplatin and 5-fluorouracil in the treatment of advanced squamous cell carcinoma of the head and neck was initiated. As survival in this group of patients is poor the purpose was to find a possible survival benefit of the chemotherapy in addition to radiotherapy compared to radiotherapy only. METHODS: Four-hundred sixty-one patients from Denmark, Norway and Sweden with tumors in oral cavity, oropharynx, hypopharynx and larynx were randomized to receive either standard treatment (radiotherapy or radiotherapy followed by surgery) or neoadjuvant chemotherapy followed by standard treatment. Chemotherapy included three courses of cisplatin 100 mg/m2 i.v. infusion on day 1 followed by 5-fluorouracil 1000 mg/m2 per day continuous i.v. infusion for 120 hours. Radiotherapy 64-70 Gy in 2 Gy per fraction, 5 times/week, was given to patients in both treatment arms. RESULTS: Response rate was 71% for patients randomized to chemotherapy-radiotherapy and 66% for patients randomized to standard treatment (not statistically significant). Residual tumors were excised if possible. After surgery 62% of the patients randomized to chemotherapy-radiotherapy and 60% of the patients in the standard treatment group were clinically tumor free. CONCLUSIONS: No statistically significant benefit in survival was observed for patients treated with neoadjuvant chemotherapy followed by radiotherapy. Nor was there any impact of chemotherapy on the number of patients achieving loco-regional tumor control after primary treatment.

Adult↗

Cancer of the nasal cavity and paranasal sinuses. A clinico-pathological study of 277 patients.

In the period 1963-1991, a total of 277 consecutive patients with malignant tumours of the nasal cavity and paranasal sinuses were treated at Aarhus University Hospital. The major histological types included squamous cell carcinoma (46%), lymphoma (14%), adenocarcinoma (13%), and malignant melanoma (9%). Kaplan-Meier estimates of 5-year corrected survival (death from cancer) showed the best prognosis for adenoid cystic carcinoma (87%), adenocarcinoma (65%) and lymphoma (56%), and the poorest prognosis for undifferentiated carcinoma (17%) and malignant melanoma (24%). The 5-year corrected survival for squamous cell carcinoma was 35%. Of the 180 patients with treatment failure, the vast majority occurred locally (n = 166); a minor proportion was regional (n = 23) or distant (n = 30). For the 195 patients with carcinoma, the following parameters were of statistical prognostic significance (5-year corrected survival): histological differentiation (moderate-well 65% vs. poor 22%), primary T-site (nasal cavity 56% vs. maxillary antrum 39% vs. other sinuses 24%), tumour stage (T2 68% vs. T3 37% vs. T4 29%), nodal stage (N0 48% vs. N1-3 21%), treatment (radiotherapy + surgery 56% vs. radiation alone 35%).

Aged↗

Radiotherapy-related lung fibrosis enhanced by tamoxifen.

BACKGROUND: Tamoxifen is an anti-estrogen with proven efficacy and low toxicity in the treatment of breast cancer. However, tamoxifen has been shown to exert a number of nonhormonal as well as hormonal effects. One nonhormonal effect of tamoxifen is the induction of transforming growth factor-beta (TGF-beta) secretion. TGF-beta has been implicated in the pathogenesis of radiation-induced fibrosis. PURPOSE: We investigated the development of lung fibrosis in breast cancer patients who were treated after mastectomy with radiotherapy, with or without simultaneous adjuvant treatment with tamoxifen. METHODS: Data from 196 women were included in the analysis. Eighty-four women were postmenopausal patients who participated in a randomized trial testing tamoxifen as an adjuvant to postmastectomy radiotherapy. The radiotherapy technique employed an 8-MV photon field covering the axillary and the infraclavicular and supraclavicular regions of the affected side of the chest; the chest wall was treated with an abutted electron field. Optical density changes in pretreatment and post-treatment chest x-ray films were used to monitor the development of lung fibrosis; lung reactions were assessed in the photon-irradiated field only. Logistic regression analysis was used to explore relationships between radiation dose and the development of lung fibrosis in patients either receiving or not receiving tamoxifen. All P values are from two-sided tests. RESULTS: Among the 84 women who participated in the randomized trial of radiotherapy plus tamoxifen (n = 38) versus radiotherapy alone (n = 46), there was a significant association between tamoxifen treatment and the incidence of marked lung fibrosis (relative risk = 2.0; 95% confidence interval [CI] = 1.2-3.5; P = .01). When logistic regression analysis was used to evaluate data from all 196 patients, a highly significant relationship was found between the incidence of lung fibrosis and total radiation dose (P = .0005). In the full analysis, an increased risk of marked lung fibrosis was found again for patients who received tamoxifen simultaneously with radiotherapy (with patients receiving radiotherapy alone as the referent, odds ratio = 2.9; 95% CI = 1.3-6.3; P = .007). Patient age and menopausal status did not significantly influence the results. CONCLUSION: Tamoxifen treatment during postmastectomy radiotherapy enhances the risk of radiation-induced lung fibrosis. IMPLICATIONS: In view of pre-existing data, we hypothesize that tamoxifen mediates the enhancement of radiation-induced lung fibrosis through the induction of TGF-beta secretion. If this hypothesis is correct, new strategies might be devised for preventing or reducing radiation-induced fibrosis. Because we studied a relatively small portion of the irradiated lung, we cannot recommend changes in current therapeutic measures; however, we strongly encourage additional studies of lung fibrosis in patients receiving tamoxifen and radiotherapy.

Aged↗

Quantitative assessment of radiation-induced lung changes by computerized optical densitometry of routine chest x-rays.

PURPOSE: To develop a quantitative assay of radiological lung changes after postmastectomy radiotherapy applicable for analysis of routine chest x-rays. METHODS AND MATERIALS: The assay relies on measurement of the optical density of chest x-rays by means of a standard personal computer-controlled film densitometer used for scanning dosimetry films. Density profiles were recorded at 1 mm steps along two reference lines in each lung. The crossing between the clavicula and the first rib in the x-ray projection was used as an easily identifiable anatomical landmark and was used to establish two parallel cranio-caudal reference lines separated by 20 mm. The starting point for recording optical densities was 5 mm below a line perpendicular to the reference lines and tangent to the top of the lung. Data were stored in a computer file for subsequent processing. The optical film densities in the apex of the lungs were converted into equivalent absorber thickness (EAT). To minimize the dependency on technical factors, the unirradiated lung was used as a control. Lung density changes were quantified by the relative change in EAT (REAT), which was evaluated as the difference between the summed EATs along the reference lines in the two lungs, corrected for any pretreatment difference in lung density, and taken as a percentage of the pretreatment EAT value of the lung. RESULTS: Four different test were carried out to investigate the reproducibility and validity of the proposed assay. (a) An anthropomorphic phantom was used to test the relationship between REAT and the layer of plastic absorber placed in front of one lung. A linear relationship was found with a correlation coefficient of 0.9993. (b) A series of 10 repeat measurements of the same arbitrarily chosen x-ray showed a mean REAT value of 9.8%, with a standard deviation of 0.21%. (c) Forty-three chest x-rays exposed on the same day were available from the clinical series. These were treated as double determinations of REAT values, and the standard deviation was estimated at 1.35%. (d) REAT values estimated with this assay were significantly correlated with the scores of two experienced specialists, an oncologist and a radiologist (Spearman's rank correlation coefficient being 0.605, p < 10(-8)). CONCLUSION: This assay quantifies radiation-induced lung injury from routine chest x-rays. Thus, it is possible to take advantage of the very large retrospective materials available in most oncological institutions. The assay has been validated in a phantom experiment and shown to be reproducible. Furthermore, it is technically easy to perform.

Female↗

Relationship between the in vitro radiosensitivity of skin fibroblasts and the expression of subcutaneous fibrosis, telangiectasia, and skin erythema after radiotherapy.

OBJECTIVE: To investigate if the occurrence of subcutaneous fibrosis after radiotherapy in an unselected group of breast cancer patients is related to cellular radiosensitivity of skin fibroblasts as measured in a clonogenic assay. MATERIALS AND METHODS: An in vitro colony-forming assay of normal fibroblast radiosensitivity was applied to primary skin biopsies from 31 breast cancer patients who received post-mastectomy radiotherapy with large doses per fraction (2.7-3.9 Gy) more than 10 years earlier. Three clinical normal-tissue endpoints were assessed. Two late endpoints, subcutaneous fibrosis and telangiectasia, were evaluated in three treatment fields by a single experienced clinician. In addition, skin erythema had been assessed at the end of treatment by members of the staff and junior staff. From previous analyses of normal tissue response, individual clinical radiosensitivity could be assessed as "excess risk' of each of the three reactions. This was defined as the difference between the actual observed response in the patient and the expected response estimated from individual treatment characteristics in a linear quadratic (LQ) mixture model and, for the two late endpoints, with correction for the follow-up time. This clinical radioresponsiveness was compared with the in vitro radiosensitivity of the skin fibroblasts. To this end, the fractions of colony-forming cells after graded single doses were fitted by an LQ survival curve using non-linear regression from which the surviving fraction at 3.5 Gy (SF3.5) was estimated. Assessment at 3.5 Gy was chosen to reflect the fraction size during clinical radiotherapy. RESULTS: A statistically significant variability of in vitro radiosensitivity between patients could be detected for both SF2 (P = 0.0095) and SF3.5 (P = 0.0008). A significant correlation was observed between SF3.5 and excess risk of fibrosis (rs = -0.46, P = 0.009) while no association was found between fibroblast radiosensitivity and either the occurrence of severe skin telangiectasia or the acute endpoint skin erythema. CONCLUSION: These results suggest that variability in the occurrence of subcutaneous fibrosis, but not telangiectasia or erythema, after radiotherapy is partly accounted for by differences in cellular radiosensitivity of normal skin fibroblasts.

Adult↗

Pretreatment oxygenation predicts radiation response in advanced squamous cell carcinoma of the head and neck.

BACKGROUND AND PURPOSE: Hypoxic tumor cells are known to be relatively radioresistant. The aim of the study was to correlate oxygenation status and radiation response in advanced squamous cell carcinomas of head and neck. METHODS AND PATIENTS: Pretreatment oxygenation status was measured in 34 lymph nodes and one primary tumor neck using oxygen electrodes. The primary oxygenation endpoint was the fraction of pO2 values less than 2.5 mmHg. Patients received standardized, conventional, external radiotherapy 66-68 Gy in 33-34 fractions. RESULTS: Sixteen patients had loco-regional failure. Among these 16 patients the median of the fraction of pO2 values less than 2.5 mmHg was 22% (range 0-95%) as compared to 6% (range 0-51%) among patients with loco-regional tumor control. When separating all 35 patients by the median of the fraction of pO2 values less than 2.5 mmHg and comparing the 2 years actuarial tumor control probability using Kaplan-Meier estimates, the most hypoxic subgroup had significantly lower loco-regional tumor control (P = 0.013, Logrank test). By univariate regression analysis the fraction of pO2 values less than 2.5 mmHg was found to be significant as continuous variable (P = 0.010). Finally, by Cox multiple regression analysis the fraction of pO2 values less than 2.5 mmHg was found to be the strongest independent variable in predicting radiation response when using tumor control in the site of pO2 assessment as treatment endpoint (P = 0.018). CONCLUSION: These results suggest that pretreatment tumor oxygenation status is predictive of radiation response, when using the fraction of pO2 values less than 2.5 mmHg as endpoint.

Carcinoma, Squamous Cell↗

Evidence for a positive correlation between in vitro radiosensitivity of normal human skin fibroblasts and the occurrence of subcutaneous fibrosis after radiotherapy.

A colony-forming assay of human skin fibroblast radiosensitivity was established in our laboratory and applied to primary skin biopsies from 12 women belonging to an unselected group of patients who received postmastectomy radiotherapy 10-12 years prior to this study. The aim was to investigate the relationship between in vitro radiosensitivity and the occurrence of subcutaneous fibrosis after radiotherapy. Early generations of normal skin fibroblasts in exponential growth were irradiated at room temperature at a high dose-rate to estimate the surviving fraction of colony-forming cells after single doses ranging from 1 to 8 Gy. A linear-quadratic cell survival curve was fitted to the data and from these fits the surviving fraction at 3.5 Gy (SF3.5) was estimated. Replicate experiments of different cell generations were made to validate the assay, and the between-patients variability was significantly larger than the assay variability for both SF2(p = 0.002) and SF3.5 (p = 0.04). Patients were treated in the period 1978-1982 with a dose per fraction between 2.7 and 3.9 Gy, a total of 12 fractions at two fractions per week. They were evaluated with respect to the occurrence of marked subcutaneous fibrosis in a total of 36 independent treatment fields. In each treatment field the total dose and dose per fraction at the relevant dosimetric reference depth as well as the length of follow-up were recorded. A previously derived LQ mixture model was applied to these data in order to determine the probability of marked fibrosis in that particular field. From this probability and the actually observed fibrosis, the excess risk of fibrosis was calculated, and this was averaged over the three treatment fields to obtain a single measure of clinical radiosensitivity. Increasing values of SF3.5 were statistically significantly correlated with decreasing probabilities of developing subcutaneous fibrosis (p = 0.014, Spearman's rank correlation test). Thus, this pilot study has demonstrated a positive correlation between in vivo radiosensitivity and normal skin fibroblasts and the clinical expression of subcutaneous fibrosis.

Breast Neoplasms↗

Quantitative magnetic resonance for assessment of radiation fibrosis after post-mastectomy radiotherapy.

Subcutaneous fibrosis is a serious complication of post-mastectomy radiotherapy with a pronounced influence on skin conditions, shoulder movement and arm oedema. To establish safer radiotherapy schedules, precise evaluation of the tissue damage is required. A feasibility study was performed to assess the value of calculated relaxation times from magnetic resonance (MR) images for quantitative characterization of different degrees of subcutaneous fibrosis after post-mastectomy radiotherapy. A surface coil was applied to the irradiated area, as well as to unirradiated skin, to obtain appropriate MR coronal slices for acquisition of calculated values using a mixed imaging sequence technique. 14 patients with clinically diagnosed subcutaneous fibrosis were examined, 10 of whom had severe fibrosis. The mean T2 values of the treated and untreated side were 53.0 and 56.7, respectively. A statistically significant decrease of the calculated T2 values on the treated side was observed. No correlation was found between the clinically assessed fibrosis and the calculated relaxation times. The findings indicate that despite a general decrease of T2 calculated values, the large variation in the relaxation times restricts the value of MR, as applied in this study, in differentiating between different degrees of fibrosis in normal tissues after radiotherapy.

Aged↗

[Malignant parotid tumors. Therapeutic results and prognosis in 110 consecutive patients].

The UICC 1987 TNM classification system was used to retrospectively analyze the treatment results and prognostic factors in 110 consecutive patients diagnosed and treated from 1970 to 1986. Treatment consisted of surgery, radiotherapy, or a combination. Malignant mixed tumours were seen in 28% of the patients, mucoepidermoid tumours in 18%, adenoid cystic tumours in 15%, acinic tumours in 13%, undifferentiated tumours in 11%, adenocarcinomas in 10%, and other types in 5%. Ten-year corrected survival was 52%, and significant differences in survival were found between: 1. patients with disease stage I-IV (I: 85%, II: 69%, III: 43%, IV: 14%); 2. those with local tumour extension (34%) and without local tumour extension (79%); 3. patients with facial nerve palsy (0%) and without facial nerve palsy (57%); 4. those with low- or intermediate-grade tumours (69% combined) and those with high-grade malignant tumours (30%). Forty-five percent of the patients were cured after primary treatment, as were an additional 22% of those treated for local or neck node recurrences. It is concluded that there is a good correlation between TNM classification of UICC 1987 (stage and local extension of tumour) and prognosis, and that facial nerve palsy and grade of malignancy are important prognostic factors.

Adolescent↗

Clinical correlations between late normal tissue endpoints after radiotherapy: implications for predictive assays of radiosensitivity.

The discovery that certain genetic syndromes are associated with a high cellular radiosensitivity has stirred interest in the concept that radiosensitivity of persons in general should have a genetic component. This has motivated research into assays for prediction of cellular normal tissue radiosensitivity. If such an intrinsic factor were a major factor in the development of late normal tissue injury, this should be detectable as a correlation between the probability of developing injury in different tissues. This hypothesis is tested in a series of 229 patients treated with postmastectomy radiotherapy and evaluated with respect to a number of late endpoints 16 to 71 months after the end of treatment. In each patient, the presence of marked subcutaneous fibrosis and telangiectasia were evaluated in two different treatment areas: in a photon field underneath a 5-mm wax bolus and in an abutted electron field used for treating the chest wall. The use of two different doses per fraction and the fact that a single anterior photon field was used with the dose prescribed at the level of the mid-axilla, led to a substantial variation in total dose and dose per fraction in these patients. A non-tissue-specific patient-to-patient difference in radiosensitivity would cause higher than expected reactions in one treatment area to be correlated with higher than expected reactions in the other area. For each of the two endpoints, telangiectasia or subcutaneous fibrosis, patients experiencing stronger than expected reactions in one treatment area tended to do so in the other area as well. Thus, a strong host factor appears to exist for a specific endpoint. It is an open question whether this is explained by individual variability in intrinsic radiosensitivity, progression rate of injury or other. Contrary to this, no significant correlation was seen when pairing the two late end-points, fibrosis and telangiectasia. Thus, patients showing stronger than expected fibrosis developed on average marked telangiectasia with a probability well predicted from their total dose and dose per fraction. These findings suggest that an assay for clinical expression of late injury would have to be specific for that type of injury.

Breast Neoplasms↗

Decreased efficacy of cyclophosphamide, epirubicin and 5-fluorouracil in metastatic breast cancer when reducing treatment duration from 18 to 6 months.

The impact of treatment duration on survival and progression-free survival is uncertain in metastatic breast cancer. In this trial 359 patients were randomised to receive cyclophosphamide, epirubicin and 5-fluorouracil (CEF) once every 3 weeks for a maximum of 18 months or identical chemotherapy for a maximum of 6 months. Following progressive disease (PD) or severe toxicity CEF was discontinued before the scheduled maximum duration. A second series of CEF continued for a maximum of 12 months was offered to patients with PD more than 3 weeks after completing a maximum of 6 months of CEF. Both groups received tamoxifen (30 mg daily) until PD, and premenopausal patients also received ovarian irradiation. After 6 months 254 evaluable patients were unprogressive. Survival and progression-free survival were significantly longer in 127 patients continuing CEF than in 127 patients interrupting CEF at 6 months (chi 2 = 17.6, P = 0.00003 and chi 2 = 4.7, P = 0.03, respectively). The results of the second series of CEF were discouraging with only one complete response in 44 evaluable patients. In conclusion, prolonged chemotherapy for 18 months is superior to identical chemotherapy for 6 months in the treatment of metastatic breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗

A randomized feasibility study evaluating the effect of radiotherapy alone or combined with 5-fluorouracil in the treatment of locally recurrent or inoperable colorectal carcinoma.

The effect of radiotherapy alone or given simultaneously with 5-FU in the treatment of locally recurrent or inoperable colorectal carcinoma was investigated in a randomized feasibility trial. Twenty-nine patients were randomized to radiotherapy alone (50 Gy/5 weeks + 10-20 Gy boost), and 30 patients to the same radiotherapy with weekly 5-FU (600 mg/m2) given before treatment every Monday during the first 5 weeks. The two groups were comparable with regard to age, sex, previous treatment, symptoms, tumour size and performance status. Treatment compliance to radiotherapy was the same in both groups with 87% receiving at least 50 Gy. Drug treatment was completed in 18/30 patients. Overall the treatment resulted in a significant palliative effect in 73% of evaluable patients with a median duration of 26 months, and objective response in 32% (8 CR, 11 PR), with a median duration of 18 months. The 3-year actuarial survival rate was 9% (median 12 months). Only patients who achieved CR became long-time survivors (63% 3-year actuarial survival). Similarly, performance status had a strong association with survival. Multivariate analysis showed complete response and high performance status to be the only parameters having prognostic influence on survival. Addition of 5-FU did neither influence the objective or symptomatic response, nor the development of distant metastases. However, addition of the drug resulted in an apparent increase in the frequency of severe acute radiation complications (33% vs. 13% after irradiation alone).

Adult↗

Auditory brain stem responses in patients after radiation therapy for nasopharyngeal carcinoma.

BACKGROUND: The study evaluated the incidence and severity of brain stem myelopathy occurring after radiation exposure in a cohort of patients who received external radiation exposure for nasopharyngeal carcinoma (NPC). METHODS: Brain stem function was investigated by auditory brain stem responses (ABR). RESULTS: Four of 21 patients who could be examined had aberrations in ABR. Three patients showed highly abnormal ABR, with no distinctive patterns or peaks. Two of these patients also showed clinical symptoms of brain stem dysfunction, including multiple palsies in cranial and peripheral nerves, whereas the third patient had no clinical signs of brain stem disorders. The fourth patient had minor conduction delays in ABR. The remaining group of 17 patients who could be examined had ABR latency and transmission times similar to those of the control group. None of these patients had neurologic symptoms. Dose-response analysis showed that patients who received radiation doses of 59 Gy or less to the brain stem had normal ABR, whereas four of six patients who received a dose of 68 Gy had manifest or subclinical brain stem dysfunction. CONCLUSIONS: The results emphasize the importance of protecting the brain stem from high-dose radiation when possible. The results also demonstrate the usefulness of ABR as a supplement to the clinical examination of patients with possible myelopathy occurring after radiation exposure.

Adult↗

Malignant parotid tumors in 110 consecutive patients: treatment results and prognosis.

The UICC 1987 classification system was used to retrospectively analyze the treatment results and prognostic factors in 110 consecutive patients. All of the patients had malignant parotid tumors which had been diagnosed and treated during the period from 1970 to 1986. Treatment consisted of surgery, radiotherapy, or a combination. Malignant mixed tumors were seen in 28% of the patients, mucoepidermoid tumors in 18%, adenoid cystic tumors in 15%, acinic tumors in 13%, undifferentiated tumors in 11%, adenocarcinomas in 10%, and other types in 5%. Ten-year corrected survival rate was 52%, and significant differences of survival were found between: 1. patients with disease stages I through IV (I: 85%; II: 69%; III: 43%; IV: 14%); 2. those with local tumor extension (34%) and without local tumor extension (79%); 3. patients with facial nerve palsy (0%) and without facial nerve palsy (57%); and 4. those with low- or intermediate-grade malignant tumors (69% combined) and those with high-grade malignant tumors (30%). After primary treatment, 45% of the patients were cured, and, additionally, 22% were salvaged after local or neck node recurrences. It is concluded that there is a good correlation between TNM classification of UICC 1987 (stage and local extension of tumor) and prognosis, and that facial nerve palsy and grade of malignancy are important prognostic factors.

Adolescent↗

Danish randomized trial comparing breast conservation therapy with mastectomy: six years of life-table analysis. Danish Breast Cancer Cooperative Group.

The Danish Breast Cancer Cooperative Group (DBCG) conducted a randomized trial comparing breast conservation with mastectomy in patients with invasive mammary carcinoma. From January 1983 to March 1989, the trial accrued a total of 1153 women. Of this number, 905 patients (79%) were randomly assigned to one of the two treatment options, whereas 248 patients (21%) did not accept randomization. Of the randomly assigned patients, 90% received the surgical option to which they had been originally assigned. In the breast conservation arm the tumor was excised with the intention of obtaining free margins determined at gross examination, and radiotherapy was subsequently administered to residual breast tissue. The axilla was dissected in all instances. Patient and tumor characteristics were similar in the two randomization arms. The median follow-up time was 40 months. At 6 years of life-table analysis the probability of recurrence-free survival was 70% in the breast conservation arm against 66% in the mastectomy arm. Survival figures were 79% against 82%, respectively.

Breast Neoplasms↗