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Background: In recent years, preoperative volume reduction of locally advanced breast cancers, resulting in higher rates of breast-conserving surgery (BCS), has become increasingly important also in postmenopausal women. Clinical interest has come to center on the third-generation nonsteroidal aromatase inhibitors (AIs), including letrozole, for such neoadjuvant endocrine treatment. This usually lasts 3-4 months and has been extended to up to 12 months, but optimal treatment duration has not been fully established., Methods: This study was designed as a multicenter, open-label, single-arm, exploratory phase IIb/III clinical trial of letrozole 2.5 mg, one tablet daily, for 4-8 months. The primary objective was to investigate the effect of neoadjuvant treatment duration on tumor regression and BCS eligibility to identify optimal treatment duration. Tumor regression (by clinical examination, mammography, and ultrasound), shift towards BCS eligibility, and safety assessments were the main outcome measures. Standard parametric and nonparametric descriptive statistics were performed., Results: Letrozole treatment was received by 32 of the enrolled 33 postmenopausal women (median (range): 67.0 (56-85) years) with unilateral, initially BCS-ineligible primary breast cancer (clinical stage > or = T2, N0, M0). Letrozole treatment duration in the modified intent-to-treat (ITT; required 4 months' letrozole treatment) analysis population (29 patients) was 4 months in 14 patients and > 4 months in 15 patients. The respective per-protocol (PP) subgroup sizes were 14 and 11. The majority of partial or complete responses were observed at 4 months, though some beneficial responses occurred during prolonged letrozole treatment. Compared with baseline, median tumor size in the ITT population was reduced by 62.5% at Month 4 and by 70.0% at final study visit (Individual End). Similarly, in the PP population, respective reductions were 64.0% and 67.0%. Whereas initially all patients were mastectomy candidates, letrozole treatment enabled BCS (lumpectomy) in 22 ITT (75.9%) and 18 PP (72.0%) patients., Conclusion: Over half of patients become BCS-eligible within 4 months of preoperative letrozole treatment. While prolonged treatment for up to 8 months can result in further tumor volume reduction in some patients, there is no clear optimum for treatment duration. Letrozole has a favorable overall safety and tolerability profile., Trial Registration: ClinicalTrials.gov identifier NCT00535418.

Background: The overexpression of syndecan-1 in breast carcinomas correlates with poorer prognosis and an aggressive phenotype. The effect of syndecan-1 expression on tumor response to neoadjuvant chemotherapy was determined in locally advanced breast cancer., Patients and Methods: Semi-quantitative syndecan-1 immunohistochemistry was performed in pre-chemotherapy breast cancer biopsies of 37 patients undergoing high-dose neoadjuvant treatment with cyclophosphamide and epirubicin., Results: 43.2% of breast carcinomas stained positive for syndecan-1. Syndecan-1 expression was more frequent in ductal invasive carcinomas than in other histological types (p=0.062). The pathological response to chemotherapy was decreased in syndecan-1-positive patients: 37.5% of syndecan-1-positive vs. 19% of syndecan-1-negative patients attained pathologically "no change". No syndecan-1-positive patient showed complete remission. Also, a correlation between syndecan-1 immunostaining intensity and response to chemotherapy was observed. Of the responding tumors, none showed strong syndecan-1 expression (Score 3+), whereas 20% of the non-responding tumors were strongly syndecan-1-positive., Conclusion: Syndecan-1-expressing breast carcinomas show a trend towards a decreased response to chemotherapy.

Endothelin-1 (ET-1) and its receptors (ETAR and ETBR), referred to as the endothelin (ET) axis, are overexpressed in breast carcinomas and appear to influence tumour growth and progression. The objective of this study was to determine the effect of expression of the ET axis in breast carcinomas on response to cytotoxic chemotherapy. The study included 44 patients with locally advanced breast cancer participating in a prospective phase III study evaluating high-dose neoadjuvant chemotherapy of epirubicin and cyclophosphamide. Expression of ET-1, ETAR and ETBR was determined by semiquantitative immunohistochemical analysis of breast cancer tissue from prechemotherapy tru-cut biopsies. Immunohistochemical staining was positive for ET-1 in 61.5%, for ETAR in 35% and for ETBR in 35.9% of breast carcinomas. Pathological response to chemotherapy was significantly decreased in ETAR-positive patients (P=0.002). In total, 50% of ETAR-positive patients as compared to 7.7% of ETAR-negative patients attained pathologically 'no change'. Logistic regression confirmed ETAR as an independent predictive marker for pathological response (P=0.009). These data indicate that increased expression of ETAR in breast carcinomas is associated with resistance to chemotherapy. Determination of ETAR status may serve as a predictive marker for identifying patients less likely to be responsive to conventional chemotherapy.

The international consensus conference from St. Gallen concerning the treatment of early breast cancer concluded in 2003, that sentinel node biopsy was now accepted as method allowing axillary staging in breast cancer. This procedure may avoid complete lymph node dissection in appropriate cases. Since numerous questions associated with the technique are still not defined and the procedure itself is not yet standardized, the German Society of Senology defined the conditions for the routine clinical use of sentinel node biopsy in an interdisciplinary consensus meeting.

Primary systemic therapy (PST) represents the standard of care in patients with locally advanced breast cancer. In addition, there is increasing information on PST in operable breast disease that supports the use of PST in routine practice. However, current regimens and techniques vary. To address this concern, a group of representatives from breast cancer clinical research groups in France, Germany, Italy, the United Kingdom, and the United States reviewed all available data on prospective randomized trials in this setting. Recommendations are made regarding terminology, indications, regimen, diagnosis before treatment, monitoring of efficacy, tumor localization, surgery, pathologic evaluation, and postoperative treatment.

Objective: The status of the axillary lymph nodes is one of the most important prognostic factors in patients with breast cancer. A panel of molecular markers of tumor aggressiveness in addition to conventional clinical and histopathologic features were analyzed in an attempt to identify a subgroup of patients with a low risk of axillary lymph node metastases., Material and Methods: Data from 358 patients with T1 breast cancer who underwent level I/II axillary lymph node dissection (ALND) were investigated. Hormone receptor status, Ki-67, S-phase fraction, DNA ploidy, HER-2/neu, p53, epidermal growth factor receptor, urokinase type plasminogen activator, plasminogen activator inhibitor-1, bone marrow micrometastases as well as patient age, menopausal status, tumor site, tumor size, histologic type, tumor grade, carcinoma in situ, multifocality, and lymph vascular invasion (LVI) were studied to predict axillary lymph node status., Results: In a multivariate logistic regression analysis LVI (present v.s. not present), Ki-67 (> or = 18% v.s. < 18%), tumor size (1.1-2 cm v.s. < or = 1 cm), and histologic grade (G3 v.s. G1/2) were identified as independent predictive factors of axillary lymph node metastases. Approximately 13% of patients (n = 47) with well or moderately differentiated tumors less than or equal to 1 cm, no lymph vascular invasion, and a low Ki-67 staining were identified as having a low risk of axillary lymph node metastases of 4.3%. However, 20 patients with all four unfavorable predictive factors had a 75% incidence of axillary lymph node involvement., Conclusion: Primary tumor characteristics can be used to identify a subgroup of patients with a low risk of axillary lymph node metastases in T1 breast cancer. Preoperative risk assessment might be used to omit routine ALND in those patients at low risk of axillary lymph node metastases.

Timing of systemic treatment in primary operable breast cancer is subject to extensive investigation, suggesting that pathologic complete remission (pCR) might improve survival in this setting. The German Adjuvant Breast Cancer Group previously demonstrated the feasibility of a dose-dense biweekly schedule of 4 cycles doxorubicin 50 mg/m2 and docetaxel 75 mg/m2 (ddAT) +/- tamoxifen in the neoadjuvant setting to yield a pCR of 9.7% (Gepardo trial). Patients assigned to ddAT received prophylactic granulocyte colony-stimulating factor support (5 micro g/kg days 5-10). The current study (GeparDUO) was designed to assess whether the pCR rate, including no viable invasive and preinvasive tumor cells, achieved with ddAT was equivalent to sequential administration of doxorubicin/cyclophosphamide followed by docetaxel (AC-DOC) over 24 weeks in primary operable breast cancer. From June 1999 to September 2001, 913 patients were enrolled in this trial. In total, 395 patients randomized before August 1, 2000, were included in the second interim analysis. Safety data were available from 369 patients (ddAT, n = 191; AC-DOC, n = 178) demonstrating that toxicity of both regimens was tolerable. Grade 3/4 neutropenia occurred in 39.8% of patients receiving ddAT and in 69.3% of patients treated with AC-DOC. Efficacy data were available in 378 patients. A pCR occurred in 14.8% of the primary breast tumors. According to the recommendations of the data monitoring committee, recruitment to the study was halted as of September 2001 (n = 913/1000) due to the significant difference in pCR rates observed between the treatment arms. Surgery was documented in 380 patients. Breast conservation was possible in 288 cases (75.8%). The application of both schedules is safe and feasible in an outpatient setting. Although, results obtained from this interim analysis are encouraging, caution is recommended until the results obtained show statistical difference in pCR.

Objective: The German Adjuvant Breast Cancer Study Group (GABG) conducts trials of preoperative chemotherapy in patients with primary breast cancer using a combination of doxorubicin and docetaxel (ADoc). -, Patients and Methods: We conducted a parallel-grouped phase IIa-study with 42 patients with a conventionally dosed and a dose-dense ADoc-schedule (4 cycles of Doxorubicin 50 mg/m(2), Docetaxel 75 mg/m(2) i. v. day 1, q day 15 or 22; G-CSF day 3-15 only for the dose-dense schedule) and a randomized phase IIb-study (GEPARDO-Study) with 250 patients with ADoc +/- Tamoxifen. Biological factors were determined immunohistochemically on 197 core biopsies before treatment. A comparison to a sequential AC-Doc regimen including 913 patients has been completed recently. -, Results: ADoc can be applicated on schedule in 93 % of all patients. The dose-dense regimen shows a tendency to more toxicity but also to more efficacy. The rate of complete pathological remissions (pCR) was 9.7 %. No difference was found between chemo- and chemoendocrine treatment. Clinically negative lymphnodes and a negative estrogen receptor status is predictive for a higher pCR-rate. To date no differences in toxicity could be found between ADoc and AC-Doc. -, Conclusions: The dose-dense ADoc regimen is well tolerated and highly effective as preoperative therapy of breast cancer.

Purpose: To investigate the effect of adding tamoxifen to a preoperative dose-dense doxorubicin and docetaxel regimen on the pathologic response of primary operable breast cancer., Patients and Methods: Patients (tumor size > or = 3 cm, N0 to 2, M0) were prospectively randomized to receive every 14 days a total of four cycles of doxorubicin 50 mg/m2 and docetaxel 75 mg/m(2), either with (ADocT) or without (ADoc) simultaneous tamoxifen. Granulocyte colony-stimulating factor (G-CSF) was routinely given on days 5 to 10. Surgery followed 8 to 10 weeks after the start of treatment., Results: Within 14 months, 250 patients were included in the study at 56 centers. Of 992 planned cycles, 97.9% were administered. Pathologically complete remission (pCR) with no detectable viable tumor cells was achieved in 9.7%. There was a nonsignificant difference of -1.2% in favor of ADoc, with a 95% confidence interval of -8.6% to 6.2%. A further 2.4% had only noninvasive tumor residues, and 13.8% had focal invasive residues. Complete and partial responses detected by palpation were observed in 28.9% and 52.4%, respectively. The response rates (complete and partial) by best appropriate imaging methods were 77.5% and 67.5% for ADocT and ADoc, respectively. Breast conservation was possible in 68.8% of the patients. A tendency toward more frequent toxic events was observed with ADocT treatment. Significant predictors of pCR to chemotherapy were negative lymph node and negative estrogen receptor status., Conclusion: A dose-dense regimen of ADoc with G-CSF offers high compliance, moderate toxicity, and rapid efficacy as a form of preoperative chemotherapy in operable breast cancer. Concurrent treatment with tamoxifen for 8 weeks could not improve the pathologic response rate.

Purpose: To assess the toxicity and efficacy of preoperative chemotherapy with doxorubicin and docetaxel in patients with primary operable breast cancer., Patients and Methods: Forty-two patients with histologically confirmed primary breast cancer tumors of at least 2 cm in diameter received doxorubicin (50 mg/m(2) intravenously [IV] over 15 minutes) and docetaxel (75 mg/m(2) IV over 1 hour) every 14 (24 patients) or 21 (18 patients) days for four cycles., Results: The median size of the primary tumor decreased significantly, from 4 cm (range, 2 to 10 cm) to 2 cm (range, 0 to 5 cm) on physical examination and from 3.4 cm (range, 1 to 8 cm) to 1. 8 cm (range, 0 to 4 cm) on sonography (P <.001). The overall response rate as assessed by physical examination was 93%, and complete remission of the primary tumor occurred in 33% of patients. The remission rate as assessed by sonographic measurement was 67%. Two patients (5%) had histologically confirmed complete responses. Sonography was more reliable than palpation in predicting histologically determined response. No grade 4 toxicity was noted, and grade 3 toxicity was reported with alopecia (95%), lethargy (17%), loss of appetite (10%), stomatitis (7%), leukopenia (5%), skin desquamation (5%), infection (5%), motor neuropathy (2%), and nausea (2%). The 3-week schedule was associated with less toxicity than the 2-week schedule., Conclusion: Preoperative combination chemotherapy with doxorubicin and docetaxel is highly effective and feasible in primary operable breast cancer.

Preoperative chemotherapy represents the standard procedure in inflammatory breast cancer. However, only recently it could be demonstrated that preoperative chemotherapy is beneficial even for patients with operable primary breast cancer. The number of breast conserving surgeries could be increased significantly. Furthermore this in vivo chemosensitivity assay can provide important prognostic as well as predictivy informations. Preoperative chemotherapy is not associated with an increased risk for the patients as outcome is similar to patients with conventional adjuvant treatment. We investigated new regimens to improve this type of chemotherapy and reached a remission rate of 93% with a combination of adriamycin and docetaxel (ADoc). A randomized study (GEPARDO-study) comparing ADoc with ADoc + tamoxifen has recently been started in Germany by the German Adjuvant Breast Cancer Study Group (GABG).

From May 1, 1992, to April 30, 1993, we performed 307 ultrasonic guided high-speed punch biopsies. In 119 of the 307 women, we dispensed with further surgical and histological procedures when the tentative diagnosis from complementary mammary diagnostic procedures revealed no pathological findings and concurred with the histological results of the punch biopsy. In 188 women, the biopsy was followed by surgical intervention and correlation of the histological findings. This group of patients showed a sensitivity of 98%, a specificity and positive prognostic value of 100%, and a negative prognostic value of 91%. If we combine the results of the complementary mammary diagnostic (including the punch biopsy), then the sensitivity, specificity, and positive and negative prognostic values for this surgically and histologically confirmed group of patients all reach 100%. In trained hands, the ultrasonic guided high-speed punch is a reliable means of determining the histological nature of lesions detected in ultrasonic scans. This technique has been perfected in our facility. Along with preoperative carcinoma detection, it permits us to avoid unnecessary operations when under defined conditions there are no pathological findings.

Purpose: The prognostic value of proliferative activity (percentage of S-phase cells = SPF) was determined in head and neck and nodal negative breast carcinomas and correlated with treatment outcome and analysis of recurrence., Methods and Material: SPF of 171 primary squamous cell carcinomas of the head and neck and 183 nodal negative breast carcinomas was determined by one-dimensional flow cytometry., Results: For the whole population of head and neck carcinomas slowly proliferating tumors (SPF < median) had a better five-year survival rate (28%) than fast proliferating tumors (S-phase > median; 20% p < 0.05). Failure analysis revealed that the better survival of slowly proliferating tumors was due to the higher loco-regional control rate (62%) compared to fast proliferating tumors (43%; p < 0.05). Stepwise multivariate analysis revealed treatment modality (p = 0.107), SPF (p = 0.026) and UICC stage (p = 0.044) as independent prognostic factors for loco-regional recurrences and SPF (p = 0.0143) for three-year overall survival. In nodal negative breast cancer slowly proliferating tumors (SPF < median) had a better NED survival (92%) compared to fast proliferating tumors (SPF > median; NED survival 63%). The analysis of recurrence revealed a higher rate of distant metastases (15.7%) and of loco-regional recurrences (21%) for fast proliferating tumors as compared to slowly proliferating tumors (distant metastases: 1.1%; loco-regional recurrences 4.5%). Stepwise multivariate analysis showed that SPF (p = 0.001) was the only independent prognostic factor for NED survival; grading (p = 0.022), age (p = 0.003) and SPF (p = 0.007) for freedom from distant metastases; SPF (p = 0.0039), grading (p = 0.0956) and method of surgical treatment (p = 0.0715) for loco-regional recurrences., Conclusions: SPF has a relevant prognostic power for squamous cell head and neck cancer and nodal negative breast cancer.

Breast preservation has become an important option in the treatment of breast cancer patients. The selection of patients should be based upon history, actual clinical situation, mammographic and morphologic parameters. After careful evaluation of all those factors the surgical treatment and eventually an adjuvant postsurgical irradiation can be tailormade according to the associated individual risk-profile.

Background and Methods: The clinical staging system of cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO) entails a large measure of subjectivity. This study analyzed the results of 1028 patients with cervical cancer at three reference centers. All patients had radical surgery, and all surgical specimens were processed as histologic giant sections with precise volumetry of the tumor., Results: The interpretation of the histologic findings of parametrial invasion, vascular involvement, and lymph node involvement was found to differ somewhat among the three centers. However, all these findings were associated with tumor size. Survival rates correlated more consistently with tumor volume than with clinical or histologic stage. Five-year survival rates ranged from 91% for patients with tumors smaller than 2.5 cm3 to 70% for those with tumors 10-50 cm3. The 5-year survival rate of 24 patients with tumors larger than 50 cm3 (71% of whom had lymph nodes with positive findings) was 48%. Survival rates were identical among the three centers for patients with tumors smaller than 10 cm3, despite different degrees of surgical radicality. In contrast, more radical surgery was associated with significantly better survival rates in patients with larger tumors., Conclusions: The results of this study indicate that volumetry of the tumor permits a more accurate assessment of therapeutic results in patients with cervical cancer than does the FIGO classification. Pretherapeutic assessment of tumor volume is possible with magnetic resonance imaging. It seems that maximum parametrial resection is not necessary for patients with smaller tumors (smaller than 10 cm3), but truly radical surgery in patients with bulky tumors achieves better results than those usually expected in Stage IIb cervical cancer and at least comparable to those of radiation therapy.

In a multicentre trial, 78 patients with a variety of malignancies, who had experienced insufficient control of emesis (greater than or equal to 3 episodes within 24 hours) while receiving standard antiemetics during previous chemotherapy, were randomly assigned to receive tropisetron 5mg once daily for 5 days or conventional antiemetic drugs. No attempt was made to standardise the conventional antiemetic treatment, which was given according to the usual practice of the participating institutions. Emesis was evaluated by counting emetic episodes and nausea by asking the patients to record on a diary chart the duration and severity of the nausea. Emesis was much better controlled with tropisetron than with standard drugs, complete control during the first 24 hours being achieved in 42% and 8% of patients, respectively, (p less than 0.001). Nausea was of significantly shorter duration (6.9 vs 10.3 hours; p less than 0.01) and was less severe (p less than 0.005) in the tropisetron group. The patients' overall assessment of treatment outcome was markedly better for tropisetron than for the standard antiemetic therapy. The superior efficacy of tropisetron was especially marked during the first 24 hours. For delayed nausea, no significant difference between treatments was seen. No serious adverse effects were observed.

From 1970 to 1987, 331 breast cancer patients of the Department of Gynaecology of the University of Erlangen were treated by conservative breast surgery. Adjuvant radiotherapy of the remaining breast was applied to only one-third of the patients. 30 patients (9.8%) had a local recurrence. This study analyses the 21 patients with local recurrence after breast conserving therapy, treated afterwards again in our hospital. 60% of the recurrences occurred within 2 years after the primary treatment. In 18 cases, the recurrences were located in the vicinity of the segmental resection area, in 3 cases the recurrences were diagnosed as new second primaries in the ipsilateral breast. 19 of the 21 recurrences were diagnosed by palpation, 2 cases were detected by mammography examination only. The palpable recurrences could only be shown in the mammography in 14 cases. We conclude, that for patients with breast conserving therapy, a mammographic examination need not be increased in frequency, but a quarterly examination by palpation should be extended over more than 2 years.

The thermolability of steroid hormone receptors was examined in a prospective study at the Gynaecology and Obstetrics Division, University of Erlangen, to clarify the cause of false negative hormone receptor findings. The loss of steroid hormone receptor content was measured in relation to the duration of operation, the time and duration of preservation. The investigations show a high thermolability of the steroid receptors. This is of considerable significance in conventional operations. Compared to the determination of hormone receptors at the time of biopsy for histological verification of the putative diagnosis of breast cancer, analysis at the end of the modified radical mastectomy and segment resection or excision of recurrences only detected 43% of the content of oestrogen receptors and 50% of the content of progesterone receptors. After storage of the surgical preparation for one hour at room temperature, the yield of oestrogen receptors fell to 35% and that of progesterone receptors fell to 31% of the original receptor content. A fresh determination of hormone receptors after cryopreservation for one to two weeks at -40 degrees C postoperatively showed only a minor loss of receptors amounting to 5.3% of the oestrogen receptors and 6.6% of progesterone receptors. On the other hand, cryopreservation at the same low minus temperature for five to six months, reduces the yield of oestrogen receptors by 34.6% and that of progesterone receptors by 33.9% compared to the intraoperative analysis.

More than 60 breast cancer specimens were screened for their expression status of 25 different proto-oncogenes. The screening method is based on in vitro synthesis of a radioactive cDNA copied from the total cellular RNA of tumor tissue. This cDNA is hybridized to cloned oncogene probes which are immobilized to a GeneScreen membrane. Frequently multiple oncogenes were found expressed although expression levels were rather moderate. 25-30% of the analyzed tumors showed significant expression of either erbB, src, raf1, lck or H-ras. Although neu expression--an oncogene believed to be particular relevant as prognostic parameter for mamma carcinoma--was screened for most of the tumors with a heterologous gene probe, expression signals could be detected in about 20% cases. The only notable correlation with classical clinical parameters such as tumor size and proliferation stage, hormone receptor status and different DNA indices was the observation that tumors lacking the progesterone receptor frequently express multiple oncogenes. Advantages and limitations of the cDNA/dot-blot screening for oncogene expression are discussed.

To check the question as to the prognostic significance of oestrogen and progesterone receptors in invasive breast cancer, the course of the disease was registered in 660 patients in the context of a retrospective study. These patients had been operated on with the objective of curing breast cancer between 1976 and 1984. A receptor analysis of these patients is available with regard to both receptor types. Positive progesterone receptors could be detected in 38%, positive oestrogen receptors in 70%. Values over 15 fmol/mg tissue protein were rated as positive. The proportion of oestrogen-receptor-positive tumours increased with the age of the patients. On the other hand, the progesterone receptor did not show this dependence. During analysis of the median receptor concentrations as well as of the progesterone combinations, a correlation between the axillary lymph node status and the hormone receptor status of the primary tumour could not be observed for the two receptor types. The survival time in relation to the oestrogen receptor status did not indicate any significant effect on survival time. On the other hand, the improvement of survival time depending on the positive progesterone receptor status was highly significant in statistical terms (p less than 0.001) especially in nodal-positive patients. Both patients with axillary lymph node metastases and positive progesterone status, compared with patients without lymph node invasion and a negative progesterone status, had the same survival rate.

A hand-held probe has been used to localise the 131I-labelled antibody OC125 during second-look operation (SLO) in 22 ovarian cancer patients. In six patients microscopic cancer was detected with the procedure and a further six patients with areas of increased radioactivity during SLO developed recurrent disease within 1-4 months. We suggest examining resection guided by antibodies as a possible means of removing antigen-producing cancerous tissues during surgery.

Benign and malignant tissue samples of 19 ovarian cancer patients who received an intravenous infusion of radiolabelled F(ab')2 fragments of OC125 were examined for expression of CA125 and the cellular location of the injected antibodies. CA125 could be detected by immunohistochemistry in 47 of 71 biopsies containing cancer cells, but not in 258 biopsies with benign tissue. F(ab')2 fragments were found in 34 of these 47 biopsies. The diffuse intracytoplasmic staining pattern seemed to indicate that the injected antibodies had crossed the membranes of the cancer cells. Since the antibody could not be detected in benign tissues, further applications of OC125 for diagnostic and therapeutic purposes seems to be justified.

112 patients with carcinoma of the cervix had a scalene lymph nodes biopsy. In 22 cases (20%) metastases to the scalene lymph nodes were detected. In these cases, systemic spread of the disease beyond curative surgical or radiation therapy possibilities had to be considered. In our findings, patients with positive scalene lymph nodes had a mean survival time of 10 months after detection of the metastases in the scalene lymph nodes. Considering the systemic dissemination of the disease, patients with positive scalene lymph nodes may be treated only by palliative methods and can be spared further high-risk noncurative treatment.