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Axillary dissection or irradiation of the axilla: Treatment results in postmenopausal women with clinically node negative breast cancer
Proceedings of the 43rd Annual ASTRO Meeting
Materials and Methods: Between April 1991 and December 1998, one hundred and twenty-five patients with invasive breast cancer were treated with MRM and were found to have 1-3 positive axillary nodes by H&E staining. The median number of nodes examined was 17, ranged from 7 to 33. One hundred and ten patients (110) who had no adjuvant radiotherapy and had a minimum follow-up of 25 months, were included in this study. Sixty-nine patients received adjuvant chemotherapy and 84 patients had adjuvant hormonotherapy with tamoxifen. Patient-related characteristics (age, menopausal status, medial/lateral quadrant of tumor location, T stage, tumor size, estrogen/progesterone receptor protein status, nuclear grade, extracapsular extension, lymphovascular invasion, number of involved axillary nodes) and treatment-related factors (chemotherapy, hormonotherapy) were analyzed for their impact on LRR. Cytokeratin staining (CK) was also used for axillary nodal tissue in 109 of 110 patients to detect any nodal involvement not identified by H&E staining. The median follow-up was 54 months. Results: Seventeen of 110 patients without radiotherapy had LRR during follow-up. The 4-year LRR rate was 16.1% (95% CI: 9.1%-23.1%). All but one LRRs were isolated LRR without preceding or simultaneous distant metastasis. Thirty-three of 109 patients had more number of axillary nodes involved detected by CK than by H&E staining. According to univariate analysis, age less than 40 (p⫽0.006), T2 classification (p⫽0.04), tumor size ⱖ3cm (p⫽0.002), negative estrogen receptor protein (ERP) status (p⫽0.02), the presence of lymphovascular invasion (p⫽0.02), and no tamoxifen therapy (p⫽0.0006), were associated with significantly higher rate of LRR. The number of nodes involved from either H&E or CK staining failed to show any impact on LRR (4-year rates: 16.5% for 1-3 vs. 15.4% for ⱖ4 nodes, p⫽0.89). Tumor size (p⫽0.006) was the only risk factor for LRR with statistical significance in multivariate analysis. Based on the four patient-related factors (age⬍40, tumor ⱖ3cm, negative ERP, and lymphovascular invasion), high-risk group (with 3 or 4 factors) had the 4-year LRR rate of 66.7% (95% CI: 42.8%-90.5%), as compared to 7.8% (95% CI: 2.2%-13.3%) for low-risk group (with 0-2 factors) (p⫽0.0001). For the 110 patients who received no adjuvant radiotherapy, LRR was associated with a 4-year distant metastasis rate of 49.0% (9/17, 95% CI: 24.6%-73.4%). For patients without LRR, it was 13.3% (15/93, 95% CI: 6.3%-20.3%) (p⫽0.0001). The 4-year survival rates for patients with and without LRR were 75.1% (95% CI: 53.8%-96.4%) and 88.7% (95% CI: 82.1%-95.4%) (p⫽0.049), respectively. LRR was independently associated with higher risk of distant metastasis and worse survival in multivariate analysis. Conclusion: LRR after mastectomy is not only a substantial clinical problem, but has a significant impact on the outcome of patients with T1 or T2 primary tumor and 1-3 positive axillary nodes. Patients who had tumor size ⱖ3cm may need adjuvant radiation treatment. CK staining failed to offer significant information with impact on LRR.
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Axillary Dissection or Irradiation of the Axilla: Treatment Results in Postmenopausal Women with Clinically Node Negative Breast Cancer
U. Ruhl1, M. Albrecht1, K. Zink2, W. Busch3 1 Radiation Oncology, Moabit Hospital, Berlin, Germany, 2Medical Physics, Moabit Hospital, Berlin, Germany, 3 Gynecology, Moabit Hospital, Berlin, Germany Purpose: Axillary dissection provides information about subclinical metastatic lymph node involvement which is connected with an increased risk of occult dissemination of disease and also is supposed to prevent axillary relapse in patients with breast cancer. However surgery is often followed by serious treatment induced morbidity. Since today decisions for adjuvant systemic therapy are made according to a variety of features provided by the tumor and the patient itself (histopathology, receptor status, growth rate, performance status, concomitant diseases) the necessity for this surgical procedure as a diagnostic tool can be questioned.Therefore a prospective trial was performed to evaluate the effectiveness of axillary irradiation with regard to local and regional tumor control, survival rates and axillary morbidity in comparison to surgery. Materials and Methods: 660 women with breast cancer after breast conserving surgery have been irradiated in our department between 1986 and 1993. 294 of them were postmenopausal and had a clinical negative axilla at the time of diagnosis. 166 women had been referred from other hospitals after surgery including axillary dissection of level I and II, they were irradiated to the breast only and are compared to the 129 patients of our institution who were treated with breast conserving surgery alone and irradiated to the breast, axilla and supraclavicular nodes.The median follow-up time is ⬎10 years. Results: Both patient groups were comparable with regard to age, tumor size, receptor status, although the cohort with irradiation of the axilla had slightly more unfavorable features. At 10 years the incidence of local axillary failures was 3% in the surgically treated, 5% in the irradiated axillae. Local tumor control in the breast was 90 vs. 94%, disease free survival 81 vs. 75%, the incidence of distant metastases and overall survival at 10 years (66 vs, 68%) are nearly identical and do not show any disadvantage for the irradiated patients. In contrast, the treatment induced morbidity like permanent lymph edema of the breast or arm, pain or shoulder problems is significant higher in the surgically treated group (26 % vs. 1 %, p value ⬍.0001). Conclusion: In cN0 postmenopausal breast cancer patients axillary dissection can safely be replaced by irradiation without loosing on tumor control or survival, treatment induced morbidity is significantly lower without surgery.
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Longer Follow-Up of Randomized Trials on Adjuvant Radiotherapy for Breast Cancer Stresses the Overall Survival Benefit due to Radiotherapy
J. Van de Steene, V. Vinh-Hung, G. Storme Radiotherapy, Oncology Centre, AZ-VUB, Brussels, Belgium Purpose: To evaluate the survival effects due to adjuvant radiotherapy for early breast cancer, when follow-up time of the studies increases. Materials and Methods: Time-lapse and cohort analysis of the trials / results published by Cuzick (Cancer Treat Rep 1987) and the EBCTCG (Oxford 1990, N Engl J Med 1995, Lancet 2000) of the unconfounded radiotherapy trials (surgery (S) versus same surgery plus radiotherapy (SRT)). Details on begin year, number of patients and fraction dose used in the trial are
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Materials and Methods: Between April 1991 and December 1998, one hundred and twenty-five patients with invasive breast cancer were treated with MRM and were found to have 1-3 positive axillary nodes by H&E staining. The median number of nodes examined was 17, ranged from 7 to 33. One hundred and ten patients (110) who had no adjuvant radiotherapy and had a minimum follow-up of 25 months, were included in this study. Sixty-nine patients received adjuvant chemotherapy and 84 patients had adjuvant hormonotherapy with tamoxifen. Patient-related characteristics (age, menopausal status, medial/lateral quadrant of tumor location, T stage, tumor size, estrogen/progesterone receptor protein status, nuclear grade, extracapsular extension, lymphovascular invasion, number of involved axillary nodes) and treatment-related factors (chemotherapy, hormonotherapy) were analyzed for their impact on LRR. Cytokeratin staining (CK) was also used for axillary nodal tissue in 109 of 110 patients to detect any nodal involvement not identified by H&E staining. The median follow-up was 54 months. Results: Seventeen of 110 patients without radiotherapy had LRR during follow-up. The 4-year LRR rate was 16.1% (95% CI: 9.1%-23.1%). All but one LRRs were isolated LRR without preceding or simultaneous distant metastasis. Thirty-three of 109 patients had more number of axillary nodes involved detected by CK than by H&E staining. According to univariate analysis, age less than 40 (p⫽0.006), T2 classification (p⫽0.04), tumor size ⱖ3cm (p⫽0.002), negative estrogen receptor protein (ERP) status (p⫽0.02), the presence of lymphovascular invasion (p⫽0.02), and no tamoxifen therapy (p⫽0.0006), were associated with significantly higher rate of LRR. The number of nodes involved from either H&E or CK staining failed to show any impact on LRR (4-year rates: 16.5% for 1-3 vs. 15.4% for ⱖ4 nodes, p⫽0.89). Tumor size (p⫽0.006) was the only risk factor for LRR with statistical significance in multivariate analysis. Based on the four patient-related factors (age⬍40, tumor ⱖ3cm, negative ERP, and lymphovascular invasion), high-risk group (with 3 or 4 factors) had the 4-year LRR rate of 66.7% (95% CI: 42.8%-90.5%), as compared to 7.8% (95% CI: 2.2%-13.3%) for low-risk group (with 0-2 factors) (p⫽0.0001). For the 110 patients who received no adjuvant radiotherapy, LRR was associated with a 4-year distant metastasis rate of 49.0% (9/17, 95% CI: 24.6%-73.4%). For patients without LRR, it was 13.3% (15/93, 95% CI: 6.3%-20.3%) (p⫽0.0001). The 4-year survival rates for patients with and without LRR were 75.1% (95% CI: 53.8%-96.4%) and 88.7% (95% CI: 82.1%-95.4%) (p⫽0.049), respectively. LRR was independently associated with higher risk of distant metastasis and worse survival in multivariate analysis. Conclusion: LRR after mastectomy is not only a substantial clinical problem, but has a significant impact on the outcome of patients with T1 or T2 primary tumor and 1-3 positive axillary nodes. Patients who had tumor size ⱖ3cm may need adjuvant radiation treatment. CK staining failed to offer significant information with impact on LRR.
195
Axillary Dissection or Irradiation of the Axilla: Treatment Results in Postmenopausal Women with Clinically Node Negative Breast Cancer
U. Ruhl1, M. Albrecht1, K. Zink2, W. Busch3 1 Radiation Oncology, Moabit Hospital, Berlin, Germany, 2Medical Physics, Moabit Hospital, Berlin, Germany, 3 Gynecology, Moabit Hospital, Berlin, Germany Purpose: Axillary dissection provides information about subclinical metastatic lymph node involvement which is connected with an increased risk of occult dissemination of disease and also is supposed to prevent axillary relapse in patients with breast cancer. However surgery is often followed by serious treatment induced morbidity. Since today decisions for adjuvant systemic therapy are made according to a variety of features provided by the tumor and the patient itself (histopathology, receptor status, growth rate, performance status, concomitant diseases) the necessity for this surgical procedure as a diagnostic tool can be questioned.Therefore a prospective trial was performed to evaluate the effectiveness of axillary irradiation with regard to local and regional tumor control, survival rates and axillary morbidity in comparison to surgery. Materials and Methods: 660 women with breast cancer after breast conserving surgery have been irradiated in our department between 1986 and 1993. 294 of them were postmenopausal and had a clinical negative axilla at the time of diagnosis. 166 women had been referred from other hospitals after surgery including axillary dissection of level I and II, they were irradiated to the breast only and are compared to the 129 patients of our institution who were treated with breast conserving surgery alone and irradiated to the breast, axilla and supraclavicular nodes.The median follow-up time is ⬎10 years. Results: Both patient groups were comparable with regard to age, tumor size, receptor status, although the cohort with irradiation of the axilla had slightly more unfavorable features. At 10 years the incidence of local axillary failures was 3% in the surgically treated, 5% in the irradiated axillae. Local tumor control in the breast was 90 vs. 94%, disease free survival 81 vs. 75%, the incidence of distant metastases and overall survival at 10 years (66 vs, 68%) are nearly identical and do not show any disadvantage for the irradiated patients. In contrast, the treatment induced morbidity like permanent lymph edema of the breast or arm, pain or shoulder problems is significant higher in the surgically treated group (26 % vs. 1 %, p value ⬍.0001). Conclusion: In cN0 postmenopausal breast cancer patients axillary dissection can safely be replaced by irradiation without loosing on tumor control or survival, treatment induced morbidity is significantly lower without surgery.
196
Longer Follow-Up of Randomized Trials on Adjuvant Radiotherapy for Breast Cancer Stresses the Overall Survival Benefit due to Radiotherapy
J. Van de Steene, V. Vinh-Hung, G. Storme Radiotherapy, Oncology Centre, AZ-VUB, Brussels, Belgium Purpose: To evaluate the survival effects due to adjuvant radiotherapy for early breast cancer, when follow-up time of the studies increases. Materials and Methods: Time-lapse and cohort analysis of the trials / results published by Cuzick (Cancer Treat Rep 1987) and the EBCTCG (Oxford 1990, N Engl J Med 1995, Lancet 2000) of the unconfounded radiotherapy trials (surgery (S) versus same surgery plus radiotherapy (SRT)). Details on begin year, number of patients and fraction dose used in the trial are
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