Primary surgery versus no surgery in synchronous metastatic breast cancer: patient-reported quality-of-life outcomes of the prospective randomized multicenter ABCSG-28 Posytive Trial.

BACKGROUND: The ABCSG-28 trial compared primary surgery followed by systemic therapy versus primary systemic therapy without surgery in patients with de novo stage IV BC. The present report describes QoL results of this trial. METHODS: Ninety patients with primary operable MBC were randomised to surgery of the primary tumor followed by systemic therapy or to primary systemic therapy without surgery. QoL analyses covering the results at baseline, 6,12,18 and 24 months follow up of 79 (88%) patients, was assessed with the EORTC QLQ-C30 and QLQ-BR23 questionnaires. RESULTS: There were no statistically significant differences in any of the scales of the QLQ-C30 and QLQ-BR23 questionnaires between the two groups over the time. Baseline global health status and physical functioning were predictors for OS (patients with a higher score lived longer (p=0.0250, p=0.0225; p=0.0355, p=0.0355)). Global health status, social functioning scale, breast symptoms and future perspective were predictors for longer TTPd (p=0.0244; p=0.0140, p=0.020; p=0.0438, p=0.0123). Patients in both arms reported significant improvement on the emotional functioning scale. Cognitive functioning decreased over time in both groups. Younger women had clinically relevant better physical and sexual functioning scores (p=0.039 and 0.024). CONCLUSION: Primary surgery does not improve nor alter QoL of patients with de novo stage IV BC. Global health status and physical functioning were predictors for OS and could be use as additional marker for prediction of OS and TTTd in patients with de novo stage IV BC. TRIAL REGISTRATION: The trial is registered on clinicaltrial.gov (NCT01015625, date of registration:18/11/2009).

Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial.

BACKGROUND: Comparative studies on the use of meshes and acellular dermal matrices (ADM) in implant-based breast reconstruction (IBBR) have not yet been performed. METHODS: This prospective, randomized, controlled, multicenter pilot study was performed at four Austrian breast cancer centers. Fifty patients with oncologic or prophylactic indication for mastectomy and IBBR were randomized to immediate IBBR with either an ADM (Protexa(®)) or a titanized mesh (TiLOOP(®) Bra). Complications, failed reconstruction, cosmetic outcome, patients' quality of life and the thickness of the overlying tissue were recorded immediately postoperatively and 3 and 6 months after surgery. RESULTS: 48 patients participated in the study (Protexa(®) group: 23; TiLOOP(®) Bra group: 25 patients). The overall complication rate was 31.25% with similar rates in both groups (Protexa(®) group: 9 versus TiLOOP(®) Bra group: 6; p = 0.188). There was a higher incidence of severe complications leading to failed reconstructions with implant loss in the Protexa(®) group than in the TiLOOP(®) Bra group (7 versus 2; p < 0.0001). An inverted T-incision technique led to significantly more complications and reconstructive failure with Protexa(®) (p = 0.037, p = 0.012, respectively). There were no significant differences in patients' satisfaction with cosmetic results (p = 0.632), but surgeons and external specialists graded significantly better outcomes with TiLOOP(®) Bra (p = 0.034, p = 0.032). CONCLUSION: This pilot study showed use of TiLOOP(®) Bra or Protexa(®) in IBBR is feasible leading to good cosmetic outcomes and high patient satisfaction. To validate the higher failure rates in the Protexa(®) group, data from a larger trial are required. NCT02562170.

Axillary Dissection in the Case of Positive Sentinel Lymph Nodes: Results of the Innsbruck Consensus Conference.

The prognosis of breast cancer is most heavily influenced by the status of the axillary nodes. Until a few years ago, this knowledge was gained through radical axillary lymph node clearance. In the meantime, sentinel lymph node clearance has become an established part of the surgical treatment of breast cancer. With the development of this procedure, the morbidity caused by axillary dissection has been reduced significantly. Although comprehensive prospective, randomised data regarding the safe use of the sentinel concept are only now available, the focus currently, however, is on the question of whether in the case of positive sentinel lymph nodes, an axillary dissection can be done away with altogether without having any negative impact on the risk of loco-regional recurrence or on progression-free survival and overall survival. The results of the American ACOSOG-Z001 study have changed the fundamental perspective of this. In this study on the advantages of axillary dissection following the confirmation of tumour tissue in the sentinel lymph nodes, there were no statistically significant advantages from axillary dissection for women with a favourable overall risk profile who had received radiotherapy and systemic therapy. If this concept takes hold, the surgical treatment of node-positive breast cancer, at least in the axilla, would be reduced to a minimum, and the focus of treatment would in future lie more on the systemic treatment of this condition. As part of an interdisciplinary consensus meeting, a standardised approach for Austria with regard to this question was decided upon.

Lymphatic mapping in patients with primary or recurrent breast cancer following previous axillary surgery.

AIMS: To evaluate the feasibility of lymphatic mapping in breast cancer patients after previous axillary surgery and to identify parameters associated with mapping failure. METHODS: Lymphatic mapping using peritumoural injection of blue dye and a radiocolloid was attempted in 30 patients with primary (n=7) or recurrent (n=23) breast cancer and a history of previous axillary lymph node dissection or sentinel node biopsy. RESULTS: Lymphatic mapping identified a mean number of 1.6 (range 1-3) lymph nodes in 19 of 30 patients (identification rate 63%). The lymph nodes were removed from the ipsilateral axilla (n=13), the internal mammary chain (n=2), both the internal mammary nodes and the axilla (n=2), the interpectoral space (n=1) and the contralateral axilla (n=1). Four of 19 patients revealed a positive lymph node. Fifteen of 19 patients had a negative lymph node. Axillary lymph node dissection was done in 13 of 15 patients but found no positive nodes (false negative rate=0). A negative lymphoscintigram (p<0.001) and a number of more than 10 lymph nodes removed at the time of initial surgery (p=0.02) were significantly associated with a mapping failure. CONCLUSION: Lymphatic mapping following prior axillary surgery was accurate but associated with a low identification rate. The lymphatic drainage pattern was unpredictable and the use of a radionuclide was necessary for a successful mapping procedure.

Intraoperative frozen section examination of the sentinel lymph node in breast cancer.

AIM OF THE STUDY: Intraoperative frozen section (FS) examination of the Sentinel node (SN) in breast cancer patients is questioned due to the relatively high number of positive SN(s) found in the permanent histological examination. This study reviews the data of the Austrian sentinel node study group on FS examination of the SN and tries to identify patients with a high risk of incorrect negative results. METHODS: 2326 breast cancer patients of the Austrian Sentinel node study group who underwent SN biopsy and intraoperative FS examination of the SN were further analysed for incorrect negative results and clinicopathologic factors indicating a higher rate of incorrect negative results. RESULTS: The FS of the SN was positive in 513 of 2326 patients (22.1%) and negative in 1813 of 2326 patients (77.9%). Permanent histological examination revealed a metastatic SN in 282 of 1813 patients. (incorrect negative rate 15.6%). 158 of 282 patients (56%) were found through H&E serial sectioning, whereas 124 of 282 patients (44%) were only seen in immunohistochemistry. Micrometastases, lobular histology and preoperative chemotherapy were associated with a higher rate of incorrect negative results. CONCLUSION: Incorrect negative results of FS examination are seen in 15% of patients and require a secondary axillary lymph node dissection. The disadvantage of missing a positive SN through FS is by far outweighed by the advantage of a single stage operation in case of a positive SN.

Prediction of non-sentinel lymph node status in breast cancer with a micrometastatic sentinel node.

BACKGROUND: Axillary lymph node dissection (ALND) may not be necessary in women with breast cancer who have micrometastasis in a sentinel node (SN), owing to the low risk of non-SN (NSN) involvement. The aim of this study was to identify a subgroup of women with a micrometastatic SN and a negligible risk of positive NSNs in whom ALND may be avoided. METHODS: Some 237 of 241 women with a macrometastatic SN and 122 of 138 with a micrometastatic SN underwent completion ALND and were compared with respect to NSN involvement. The 122 patients with SN micrometastasis were further analysed to determine factors that could predict the risk of positive NSNs. RESULTS: A total of 121 (51.1 per cent) of 237 women with SN macrometastasis had positive NSNs compared with 22 (18.0 per cent) of 122 with SN micrometastasis (P < 0.001). Multivariate analysis showed that size of SN micrometastasis (odds ratio 3.49 (95 per cent confidence interval (c.i.) 1.32 to 9.23); P = 0.012) and presence of lymphovascular invasion (odds ratio 0.23 (95 per cent c.i. 0.05 to 1.00); P = 0.050) were significantly associated with positive NSNs. SN micrometastasis less than 0.5 mm in diameter combined with absence of lymphovascular invasion was associated with an 8.5 per cent risk of NSN involvement. CONCLUSION: Size of micrometastasis and presence of lymphovascular invasion were significantly related to the risk of finding additional positive axillary lymph nodes when the SN contained only micrometastasis.

The impact of preoperative breast biopsy on the risk of sentinel lymph node metastases: analysis of 2502 cases from the Austrian Sentinel Node Biopsy Study Group.

Preoperative breast biopsy might cause disaggregation of tumour cells and tumour cell spread. The purpose of this study was to investigate the impact of preoperative biopsy on the rate of metastases to the sentinel lymph node (SLN) of patients with primary breast cancer. We report the results of 2502 patients with primary breast cancer, who were operated, and a sentinel node biopsy was performed. The association of preoperative biopsy with the risk of SLN metastases was examined by regression analyses and tested for possible confounding well-known factors for axillary node metastases. In all, 1890 patients were available for final analyses; 1048 (55.4%) patients had a preoperative diagnosis performed by fine-needle aspiration or core biopsy; 641 (33.9%) patients had a positive SLN when conventional H&E and IHC staining was performed. Patients with preoperative breast biopsy showed a 1.37 times (95% CI, 1.13-1.66) increased risk of SLN metastases on univariate analysis, but this result was not persistent when analysis was adjusted for other relevant factors for axillary node metastases, OR 1.09 (95% CI, 0.85-1.40). In addition, subgroup analyses of the risk for occult micro metastases to the SLN (detected by IHC only) on H&E-negative cases also showed no increased risk associated with preoperative biopsy, OR 1.07 (95% CI, 0.69-1.65). The conclusion, based on the present data, is that preoperative breast biopsy does not cause artificial tumour cell spread to the SLN, with possible negative impact on the prognosis of breast cancer.

Closure of the cystic duct during laparoscopic cholecystectomy with a new feedback-controlled bipolar sealing system in case of biliary obstruction--an experimental study in pigs.

BACKGROUND/AIMS: The excellent results of new devices like the new bipolar feedback-controlled sealing system (LigaSure) for closure of blood vessels encouraged surgeons to use these instruments for other structures like bile ducts. The aim of this study was to evaluate the feasibility of closure of cystic duct in case of biliary obstruction. METHODOLOGY: Ten domestic pigs underwent laparoscopic cholecystectomy sealing the cystic duct with LigaSure. The common bile duct was closed with an endoclip to create a biliary hypertension. On the 12th postoperative day blood samples were taken for liver enzymes. At autopsy on day 15 the pigs were investigated for bile leaks or biliary peritonitis. The cystic duct was resected for histological examination. RESULTS: Seven pigs survived, one pig died during introduction of anesthesia, one on the 1st and one on the 2nd postoperative day without any findings at the autopsy. One pig out of 7 had a bile leak; the other 6 were without any sign of leakage. Histologically 3 pigs had a regular coagulation zone at the cystic duct, 3 had a total necrosis, one a partial necrosis of the mucosa only. CONCLUSIONS: Though there was only one insufficiency, the feedback-controlled bipolar vessel sealer cannot be recommended for biliary surgery with regard to the high rate of necrosis stated in our experiment.

A new bipolar feedback-controlled sealing system for closure of the cystic duct and artery.

BACKGROUND: Bile leaks are serious complications after laparoscopic cholecystectomy. The aim of this study was to evaluate the feasibility of closure of the cystic duct with a new feedback-controlled bipolar sealing system (LigaSure). METHODS: Ten domestic pigs underwent open cholecystectomy with the cystic duct and artery dissected and sealed with the new bipolar sealing system (LigaSure). Four and 8 days postoperatively, 5 pigs each were sacrificed and the closure of the cystic duct was evaluated. The cystic stump and the common bile duct were excised for histological examination. RESULTS: None of the pigs had a bile leak or a biliary peritonitis. There were no signs of postoperative bleeding or inflammation in Calot's triangle. Histology showed total necrosis of the cystic duct in the first two pigs due to too much energy used. The remaining specimens showed a regularly scaling zone without necrosis in 7 cases, and in one case a partial necrosis in the mucosa only was found. CONCLUSION: Cystic artery and cystic duct closure with the new device may be an alternative to the clip. Further trials should evaluate the feasibility and safety of the new device in the clinical setting.

Prospective randomized blind controlled trial comparing sutures, tape, and octylcyanoacrylate tissue adhesive for skin closure after phlebectomy.

BACKGROUND: The patient's view of the outcome after phlebectomy is mainly dependent on the cosmetic result. OBJECTIVE: To compare 5-0 monofilament sutures with tapes and tissue adhesive for wound closure after varicose vein surgery. METHODS: Seventy-nine patients undergoing varicose vein surgery were prospectively randomized in three groups (tissue adhesive, sutures, tape) for skin closure and compared. The follow-up 1 year postoperatively was done by a senior dermatologist who was blinded in the method of skin closure. RESULTS: The cosmetic outcome showed little advantage for the suture group. Taping the incisions is faster than suturing them but without significance; closure with tissue adhesive takes nearly the double of time. The closure for one incision with tissue adhesive is 40 times more expensive than with tapes and 14 times more expensive than with sutures. CONCLUSION: This study failed to demonstrate an advantage of tissue adhesive and tapes over monofilament sutures for skin closure after phlebectomy.

Follow-up of sentinel node negative breast cancer patients without axillary lymph node dissection.

BACKGROUND AND OBJECTIVES: The purpose of this study was to evaluate the feasibility of sentinel lymph node biopsy in breast cancer patients at our institution and to report the follow-up status of node-negative patients with removal of only the sentinel node. METHODS: A total of 247 breast cancer patients underwent sentinel node (SN) mapping between June of 1996 and September of 2000. The SN was identified by using a combination of vital blue dye and a radiolabeled colloid. RESULTS: A SN was identified in 227 of 247 patients (91.9%). One hundred forty-five were SN negative, 82 were SN positive. All SN-positive patients underwent axillary dissection of level I and II, whereas 83 patients with a negative SN had SN biopsy only. Median follow-up of these patients at 22 months revealed no axillary recurrence; the morbidity resulting from SN biopsy was negligible. CONCLUSIONS: Although the follow-up is very short, SN biopsy only in node-negative breast cancer patients had no negative impact on the axillary failure rate and resulted in negligible morbidity.

Sentinel lymph-node biopsy compared to axillary lymph-node dissection for axillary staging in breast cancer patients.

AIMS: The purpose of this study was to evaluate the feasibility of sentinel lymph-node biopsy in breast cancer patients at our institution and to compare the results of sentinel node (SN) biopsy to standard axillary lymph-node dissection (ALND). METHODS: In a retrospective study the percentage of lymph-node positive patients and the number of micrometastases in 165 breast cancer patients following SN biopsy was compared to 195 patients who underwent ALND of level I and II without SN biopsy. The SN was identified using a combination of vital blue dye and a radiolabelled colloid. RESULTS: Patients and tumour characteristics were comparable between both groups. SN biopsy found no significant difference in the number of node positive T1 cancer patients (SN group: 31/108 (28.7%) -- ALND group: 21/92 (22.8%)) and T2 tumours (SN group: 27/57 (47.4%) -- ALND group: 49/103 (47.6%)) between both groups. Micrometastases were more frequently found in the SN group when compared to the ALND group (six of 70 positive nodes) (P=0.04). CONCLUSION: SN biopsy may be as accurate as standard axillary lymph-node dissection for the evaluation of the axillary lymph-node status in breast cancer patients.

[Spiral CT cholangiography is not suitable for routine diagnosis before laparoscopic cholecystectomy]. / Die Spiral-CT-Cholangiographie ist für die Routinediagnostik vor laparoskopischer Cholecystektomie nicht geeignet.

INTRODUCTION: The purpose of this prospective controlled study was to evaluate the diagnostic potential of spiral computed tomographic (CT) cholangiography in patients undergoing laparoscopic cholecystectomy. METHODS: 60 patients (17 men, 43 women, mean age 54.5 years, range 15-84 years) with symptomatic cholecystolithiasis were included in this study. After infusion of meglumine jodoxamate, all patients underwent upper abdominal spiral CT. The results of the spiral CT scan were then compared with endoscopic retrograde cholangiography (ERC) or intraoperative cholangiography. RESULTS: In 53 patients (88%) CT cholangiography was considered to be technically adequate for interpretation, but was suboptimal in 4 patients (7%) and nondiagnostic in 3 patients (5%), respectively. CT cholangiography showed a stone free common bile duct in 51 patients which was correct in all cases. CT cholangiography predicted a common bile duct stone in 6 patients which proved to be correct in 4 patients but was found to be incorrect in 2 patients. CONCLUSION: Spiral CT cholangiography is useful for the diagnosis of common bile duct stones. Because of the low positive predicting value routine use before laparoscopic cholecystectomy is not justified.

Sentinel-node biopsy in axillary lymph-node staging for patients with multicentric breast cancer.

Multicentric breast cancer is thought to be a contraindication for sentinel-node biopsy by most clinicians. In a prospective study we took sentinel-node biopsy samples from 19 patients with multicentric invasive breast cancer with use of a blue dye and radiolabelled colloid mapping technique at the subareolar injection site. All patients underwent complete axillary dissection after sentinel-node biopsy. Nine patients had tumour-free and ten had metastatic sentinel nodes. The sentinel-node status was in concordance with the axillary sample in all patients. Sentinel-node biopsy might become an alternative to complete axillary dissection in patients with multicentric breast cancer with clinically negative lymph nodes.

[Surgical and plastic reconstructive therapy of breast carcinoma]. / Chirurgische und plastisch-rekonstruktive Therapie des Mammakarzinoms.

Breast conserving surgery is the therapy of choice in breast cancer patients and may avoid mastectomy in most of the patients. New treatment options such as sentinel lymph node biopsy may avoid complete axillary dissection in selective patients. Plastic reconstructive procedures like immediate reconstruction or oncoplastic surgery decrease physical sequelae and increase the quality of life and should be offered to all breast cancer patients: Modern breast cancer management requires intense cooperation of all cancer subdisciplines.

Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma.

BACKGROUND: Axillary lymph node dissection for staging the axilla in breast carcinoma patients is associated with considerable morbidity, such as edema of the arm, pain, sensory disturbances, impairment of arm mobility, and shoulder stiffness. Sentinel lymph node biopsy electively removes the first lymph node, which gets the drainage from the tumor and should therefore be associated with nearly zero morbidity. METHODS: Postoperative morbidity (increase in arm circumference, subjective lymphedema, pain, numbness, effect on arm strength and mobility, and stiffness) of the operated arm was prospectively compared in 35 breast carcinoma patients after axillary lymph node dissection (ALND) of Level I and II and 35 patients following sentinel lymph node (SN) biopsy. RESULTS: Patient characteristics were comparable between the two groups. Postoperative follow-up was 15.4 months (range, 4-28 months) in the SN group and 17.0 months (range, 4-28 months) in the ALND group. Following axillary dissection, patients showed a significant increase in upper and forearm circumference of the operated arm compared with the SN patients, as well as a significantly higher rate of subjective lymphedema, pain, numbness, and motion restriction. No difference between the two groups was found regarding arm stiffness or arm strength, nor did the type of surgery affect daily living. CONCLUSIONS: SN biopsy is associated with negligible morbidity compared with complete axillary lymph node dissection.

Role of laparoscopic surgery in treatment of mesenteric cysts.

Mesenteric cysts are rare benign intraabdominal lesions without typical clinical findings. Treatment is indicated if they become symptomatic due to enlargement of the cyst. We report 3 patients who were treated by laparoscopic surgery. In 3 patients (3 women, ages 18, 18, 46 years) admitted to our hospital with uncharacteristic abdominal pain, a mesenteric cyst 4.5-18 cm in diameter was diagnosed by ultrasonography and CT scan or MRI. One cyst was partially resected laparoscopically by unroofing of the surface, and the other two were resected completely. There were no intra- or postoperative complications. During follow-up, cyst recurrence was diagnosed in the patient with cyst unroofing 10 months after surgery, and complete cyst resection was successfully performed laparoscopically. Mesenteric cysts can be successfully managed laparoscopically. In order to prevent recurrence, complete resection should be performed.

Diagnostic laparoscopy through the right lower abdominal incision following open appendectomy.

BACKGROUND: Diagnostic laparoscopy through the right lower abdominal incision following open appendectomy for suspected acute appendicitis may help in making the correct diagnosis in the absence of pathology of the appendix. METHODS: Fourteen patients with a clinical diagnosis of acute appendicitis underwent diagnostic laparoscopy through the right lower quadrant incision after open appendectomy to exclude further pathology in the case of a noninflamed appendix. RESULTS: In 10 of the 14 patients, laparoscopy helped to correct the diagnosis. In two patients, the etiology of the acute right lower abdominal pain remained unclear. In two others, histological examination showed acute appendicitis despite a normal macroscopic appearance. CONCLUSIONS: Diagnostic laparoscopy through the right lower quadrant incision may help to correct the diagnosis in patients who are operated on for clinically acute appendicitis but in whom no acute appendicitis or other pathological findings are seen.

[Clinical application of biopsy of the sentinel lymph node in breast carcinoma]. / Klinische Anwendung der Biopsie des leitenden Lymphknotens beim Mammacarcinom.

Sentinel lymph node (SN) biopsy in primary breast cancer seems to be an alternative to complete axillary lymph node dissection for evaluation of the axillary lymph node status in selected patients. Following evaluation of the technique of SN biopsy, we applied SN biopsy clinically to 23 selected patients. A lymphoscintigraphy was performed preoperatively to evaluate lymphatic drainage. The SN was identified in the operating room by use of a hand-held gamma camera and a blue vital dye. The SN was found in all 23 patients. In 17/23 the SN was tumor free and no axillary dissection was performed; 6/23 showed a positive SN and complete axillary dissection was done. Intraoperative lymphatic mapping and SN biopsy may be the treatment of choice for evaluation of axillary node status in selected patients, for it combines accurate nodal staging and low morbidity.