Sentinel node biopsy in breast cancer has a greater node positivity rate than axillary node sample: Results from a retrospective analysis

Background

Sentinel node biopsy as a surgical method of axillary staging for early breast cancer has been widely accepted as an alternative to traditional four-node axillary node sampling, and is the recommended technique by the Association of Breast Surgery in the United Kingdom. In selected units axillary sampling has been compared with either radioisotope sentinel node or blue dye only techniques with comparable node positivity rates. There are no studies directly comparing combined method sentinel node biopsy (SNB) with conventional axillary (four) node sampling (ANS).

Methods

Data for all patients undergoing axillary staging by axillary node sample or sentinel node biopsy were collected, including those proceeding to axillary clearance as a second procedure, but excluding those undergoing axillary clearance as a first procedure.

Results

From January 2005 to January 2011, 641 axillary staging procedures were performed (SNB n = 231 (36.0%), ANS n = 410 (64.0%)). Baseline tumour characteristics were similar for the two groups except for a higher frequency of breast conservation in the SNB group (95.6 vs. 75.6%; p < 0.0001). The proportion of cases with positive nodes was higher in the SNB group (20.8 vs. 14.4%; p = 0.042). In patients who had presented with symptomatic disease, there was a significantly higher node positivity rate with SNB (30.9%) than with ANS (15.5%; p = 0.002), despite similar baseline characteristics in both groups.

Conclusion

Combined method sentinel node biopsy is more sensitive at detecting low volume axillary disease than traditional four-node sample.     

The value of sentinel lymph node biopsy in ductal carcinoma in situ (DCIS) and DCIS with microinvasion of the breast

Aim

Ductal carcinoma in situ (DCIS) refers to the preinvasive stage of breast carcinoma and should not give axillary metastases. Its diagnosis, however, is subject to sampling errors. The role of sentinel lymph node biopsy (SLNB) in management of DCIS or DCISM (with microinvasion) remains unclear. The purpose of this study was to review our experience with SLNB in DCIS and DCISM.

Methods

A review of 51 patients with a diagnosis of DCIS (n = 45) or DCISM (n = 6), who underwent SLNB and a definitive breast operation between January 1999 and December 2006, was performed.

Results

In 10 patients (19.6%) definitive histology revealed an invasive carcinoma. SLN (micro)metastases were detected in 5 out of 51 patients, of whom 2 had a preoperative diagnosis of grade III DCIS and 3 of DCISM. Three patients (75%) had micrometastases (<2 mm) only. In 2 patients, histopathology demonstrated a macrometastasis (>2 mm). All 5 patients underwent axillary dissection. No additional positive axillary lymph nodes were found.

Conclusions

In case of a preoperative diagnosis of grade III DCIS or a grade II DCIS with comedo necrosis and DCIS with microinvasion, an SLNB procedure has to be considered because in almost 20% of the patients an invasive carcinoma is found after surgery. In this case the SLNB procedure becomes less reliable after a lumpectomy or ablation has been performed. SLN (micro)metastases were detected in nearly 10% of the patients. The prognostic significance of individual tumour cells remains unclear.     

The value of intraoperative frozen section examination of sentinel lymph nodes in breast cancer

Background

Sentinel node biopsy is a standard diagnostic component for the treatment of patients with a primary mammary carcinoma. By concomitantly performing intraoperative lymph node biopsy and primary tumor resection, patients with a positive sentinel node (SN) are not subjected to the inconvenience and risks of second surgical intervention. The aim of this retrospective study was to determine the sensitivity, accuracy and long-term consequences of the frozen section (FS) examination of the SN in breast cancer patients.

Methods

Sentinel lymph node biopsy was performed in 615 patients with an invasive tumor of the breast. Frozen sections of the SN were taken from the optimal cross-sectional surface. Serial sections were made from the remaining SN and stained using hematoxylin–eosin and immunohistochemistry.

Results

Sentinel node frozen biopsy accurately predicted the state of the axilla in 559 (90.7%) patients. There were 50 false-negative findings in patients with sentinel node metastases. The sensitivity and specificity of the intraoperative frozen section examination were 71.6% and 100%, respectively. Follow-up (mean 36.3 months) of all false-negative cases showed no development of local axillary recurrence. The results demonstrated no significant relation between tumor size and frozen section sensitivity. Frozen section investigation was less sensitive in ascertaining micrometastases (sensitivity 61.1%) than macrometastases (sensitivity 84.0%, p < 0.001).

Conclusion

Intraoperative frozen section examination of the sentinel node is a useful predictor of axillary lymph node status in breast cancer patients. Seventy-two percent of the patients with metastatic disease were correctly diagnosed and spared a second surgical procedure.     

Partial breast irradiation for locally recurrent breast cancer within a second breast conserving treatment: Alternative to mastectomy? Results from a prospective trial

Purpose

To assess the outcome of multi-catheter pulse dose rate (PDR) brachytherapy of re-irradiation for local ipsilateral breast tumour recurrence (IBTR) in regard to local control, survival, morbidity and quality of life (QoL).

Patients and methods

Between 1999 and 2006, 39 patients were included with histologically confirmed IBTR, Karnofsky index ?80% and refusal of mastectomy. Exclusion criteria were multicentric invasive growth pattern, unclear surgical margins, distant metastasis and a postoperative breast not suitable for interstitial brachytherapy. Primary endpoint was local tumour control. Morbidity, cosmetic outcome and QoL were assessed in 24/39 patients.

Results

The five year actuarial local control rate was 93% after a mean follow up of 57 (±30) months with two second local relapses. Overall survival and disease free survival, both at 5 years, were 87% and 77%, respectively. Late side effects Grade 1-2 were observed in 20/24 patients after a mean follow-up of 30 (±18) months. Late side effects ?Grade 3 occurred in 4/24 patients. Cosmetic outcome was excellent to fair in 76% of women. Overall QoL was comparable to a healthy control group. Mean scores of scales and items of QLQ-BR23 were comparable to primary breast conserving therapy.

Conclusions

Accelerated PDR-brachytherapy following breast conserving surgery (BCS) for local IBTR results in local tumour control comparable to mastectomy. Morbidity is moderate; the cosmetic outcome is good and hardly any impairment on QoL is observed.     

Minimal access breast surgery – A single breast incision for breast conservation surgery and sentinel lymph node biopsy

Aims

Minimal access breast surgery (MABS) is a procedure that completes breast conservation surgery (BCS) and sentinel node biopsy (SNB) through a single incision. It allows access to axillary sentinel nodes via the breast incision and also provides access to the internal mammary nodes (IMN) as well as other nodal sites when needed. The aims of this study are to describe the MABS approach and to evaluate its safety and efficacy in cases undergoing BCS and SNB (axillary or IMN) for treatment of breast cancer.

Methods

The surgical technique for MABS is described. One hundred and three consecutive clinically lymph node negative patients undergoing BCS and SNB (axillary or IMN) were considered for MABS. Cases were classified according to the location of sentinel nodes dissected (axillary, internal mammary or other), the location of the tumour and whether MABS was used. The success of MABS was calculated based on the number of cases where BCS and SNB were completed through a single breast incision. Number of lymph nodes (LN) retrieved, rate of LN positivity, aesthetics and complications were documented.

Results

Eighty-six percent of cases of BCS with axillary-only SNB were completed with MABS. For cases of BCS with axillary and IMN SNB, MABS was successful for BCS and IMN SNB in 97% of cases and for BCS and SNB from both nodal regions in 63%. There was only one case, a woman with breast prostheses, who required three separate incisions. When axillary-only SNB cases were completed with MABS, an average of 2.9 axillary LN per case with a 29% axillary LN positivity rate was seen. When axillary and IMN SNB were completed with MABS for both regions, an average of 3.0 axillary LN per case were retrieved with an axillary LN positivity rate of 65%. When separate axillary and breast incisions were made, 2.7 LN per case were removed with an axillary LN positivity rate of 30%. Aesthetics were excellent and there were no complications associated with reaching the nodes through the breast incision.

Conclusion

MABS is a feasible option for the majority of women undergoing BCS and SNB and it does not compromise the success of SNB.     

Margin width and local recurrence after breast conserving surgery for ductal carcinoma in situ

Introduction

Ductal Carcinoma in situ (DCIS) represents 5% of symptomatic and 20–30% of screen detected cancers. Breast conserving surgery (BCS) ± radiotherapy is performed in over 70% of women with DCIS. What constitutes an adequate margin for BCS remains unclear.

Lymph nodes in the tail of the breast can be missed in standard axillary dissection

Aims

To determine whether excision of the tail of the breast usually by mastectomy or occasionally wide excision together with formal level 1 axillary node dissection (AND) for early breast cancer influences the quantity of harvested lymph nodes and the detection of axillary metastases.

Methods

Multiple regression and binary logistic regression analysis were performed on lymph node harvest data for level 1 AND performed prior to the adoption of sentinel node biopsy during a five year period from 1997 to 2001 at the Leicestershire Breast Unit, comparing AND with and without excision of the tail of the breast.

Results

One thousand six hundred and forty-eight level 1 ANDs were performed with a median node harvest of 14 (3–44). Multiple regression analysis identified that the total node harvest was increased by 1.03 nodes if the tail of the breast was excised (p < 0.001) and this was independent of the effect on node count of node positivity. Operating surgeon and reporting pathologist did not influence node count.

Conclusions

The results of this study indicate that low axillary nodes may be missed by AND without excision of the tail of the breast and support the use of targeted sentinel node biopsy that should identify an involved node at any site.     

Internal mammary lymph drainage and sentinel node biopsy in breast cancer – A study on 1008 patients

Introduction

Nowadays, axillary sentinel node (SN) biopsy is a standard procedure in the staging of breast cancer. Although the internal mammary (IM) lymph node status is a major independent prognostic factor in breast cancer patients, sampling of IM sentinel nodes (IMSNs) is not performed routinely. The aim of this study was to determine the likelihood of finding IM lymph node metastases in case of IM hotspots on lymphoscintigraphy and evaluate the relevance of IMSN biopsy as a method to improve staging.

Patients and methods

Between April 1997 and May 2006, a total of 1008 consecutive patients with clinically node-negative operable primary breast cancer were enrolled in a prospective study on SN biopsy. Both axillary and IMSNs were sampled, based on lymphoscintigraphy, intraoperative gamma probe detection and blue dye mapping, using 10 mCi (370 MBq) ^99mTc-nanocolloid injected peritumorally, and 0.5–1.0 ml Patent Blue V injected intradermally.

Results

Lymphoscintigraphy showed axillary sentinel nodes in 98% (989/1008) and IMSNs in 20% of the patients (196/1008). Sampling the IM basin, as based on the results of lymphoscintigraphy, was successful in 71% of the patients (139/196) and revealed metastases in 22% (31/139). In 29% of the patients with positive IMSNs (9/31) no axillary metastases were found.

Conclusion

Evaluation of IMSNs improves nodal staging in breast cancer. Patients with IM hotspots on lymphoscintigraphy have a substantial risk (22%) of metastatic involvement of the IM chain. In addition, true IM node-negative patients can be spared the morbidity associated with adjuvant radiotherapy.     

Breast reconstruction following mastectomy for invasive breast cancer by free flaps from the abdomen is oncologically safe

Aims

To report the long-term results of oncological safety of breast reconstruction by autologous tissue following mastectomy for invasive breast cancer.

Methods

One-hundred-fifty-six consecutive patients with invasive breast cancer treated with mastectomy and reconstruction by autologous tissue were reviewed throughout (from 1987 to 2003 with median follow up time of 66 months).

Results

Median patient age was 45.9 years (range 26–68). The 157 observed tumors had mean diameter of 25 ± 19 mm, 70 of them were poorly differentiated, and 137 were invasive ductal carcinoma. Multifocal disease was present in 44 patients. Breast reconstruction was carried out only by autologous tissue (free flaps were used in 95% and free TRAM flap transfer was the most common reconstructive procedure). There was only one local recurrence as first site of recurrence, thus yielding a local recurrence rate of 0.6%.

Conclusions

Breast reconstruction by autologous tissue following mastectomy for invasive breast cancer is an oncologically safe procedure.     

Breast conserving surgery after neoadjuvant therapy for large primary breast cancer

Aim

The aim of this study was to evaluate the safety of breast conserving surgery in patients with breast tumours satisfactorily downstaged after neoadjuvant therapy.

Methods

A retrospective cohort study was undertaken to analyze the loco-regional recurrence (LRR) after breast conserving surgery. We enrolled 88 patients with breast cancer subjected to neoadjuvant therapy (NAT group) who achieved an objective response due to neoadjuvant treatment and compared them with 191 patients with early breast cancer (EBC group) who were submitted to primary conserving surgery. Lumpectomy or quadrantectomy with axillary lymph node dissection was performed in all patients who received adjuvant radiotherapy. Systemic adjuvant therapy was offered to all patients. The mean periods of observation were 61.3 months in the NAT group and 67.5 months in the EBC group.

Results

The mean age was 53 years in the NAT group and 56 years in the EBC group (p = 0.04). There was no histological type and histological grade difference between groups. In the NAT group, the mean diameter of residual tumour was lower and the mean volume of breast tissue resection was higher than in the EBC group (p = 0.01 and p = 0.002, respectively). The ipsilateral recurrence rate was 7.9% in the NAT group and 7.8% in the EBC group (p = 0.9). The most important predictive factor of recurrence in the NAT group was the age of patient.

Conclusion

Breast conserving therapy is a safe procedure in satisfactorily downstaged breast cancer after neoadjuvant therapy.     

Influence of internal mammary node irradiation on long-term outcome and contralateral breast cancer incidence in node-negative breast cancer patients

Background and purpose

There is no general consensus concerning irradiation (RT) of internal mammary nodes (IMN) in axillary node-negative breast cancer. Based on a large series of patients treated in a single institute and followed up for a long period of time, we looked at the influence of IMN RT on late outcome of these patients as well as the development of contralateral breast cancer (CBC).

Patients and methods

The study was based on 1630 node-negative breast cancer patients treated in our institution between 1975 and 2008 with primary conservative surgery and axillary dissection or sentinel node examination. All patients received post-operative breast RT. IMN RT was more frequent in inner or central tumours. Kaplan–Meier (K–M) overall survival (OS), cancer-specific survival (CSS), and disease-free survival (DFS) according to IMN RT were calculated for all patients and for patients with inner/central tumours. The K–M rate of contralateral breast cancer (CBC) was also analysed and correlated with IMN RT.

Results

Prognostic variables such as tumour size, histological grade, and hormone receptors were not significantly different in the groups having received IMN RT or not. Considering all patients, OS was strictly comparable in the 2 groups: 10-year values were 85% (IMN RT) and 86% (no IMN RT), respective values at 20 years were 66.6% and 61.0% (p = 0.95). However, in patients presenting with inner/central tumours, OS was significantly improved in the IMN RT group with respective values of 92.5% and 87.2% at 10 years, and 80.2% and 63.3% at 20 years: Hazard ratio (HR) = 0.56 (0.37–0.85); p = 0.0052. Again, CSS was improved in patients with inner/central tumours having received IMN RT, with 20-year rates of 89.5% versus 79.1% in patients not receiving IMN RT (p = 0.047). No difference in DFS was noticed. The actuarial rate of CBC development was comparable between patients having received IMN RT and other patients. However, considering only patients alive 10 years after primary breast surgery, the K–M rate of CBC at 20 years was 5.3% in patients without IMN RT and 7.2% in patients with such RT; HR = 2.47 (1.23–4.95); p = 0.008.

Conclusions

IMN RT in node-negative tumours was associated with increase in OS and CSS in patients with inner or centrally located lesions. An increase in CBC development was also noticed in long-survivors of IMN RT patients; however, these findings have to be interpreted with caution because of the difference in follow-up between the 2 groups. Further studies are warranted to investigate the potential role of IMN irradiation in the development of CBC.     

Axillary recurrences after negative sentinel lymph node biopsy under local anaesthesia for breast cancer: A follow-up study after 5 years

Introduction

Sentinel lymph node biopsy (SLNB) is accepted as a standard surgical staging procedure for determining the tumour status of the regional lymph nodes. Until September 2000 we performed SLNB in general anaesthesia. Since 1999, after validation of the SLNB concept, axillary dissection was omitted in SLN-negative patients. This study presents our data after SLNB under local anaesthesia after a follow-up of at least 5 years.

Materials and methods

Between September 2000 and May 2003, 356 SLNBs were performed under local anaesthesia without sedation in patients with proven breast cancer (T4-tumours and small in situ carcinomas excluded) and without clinically or ultrasound guided cytological evidence of axillary node involvement. Lymphatic mapping and SLN identification were performed through the combination of blue dye and 99 m Tc-nanocolloid. All positive SLNs were followed by an axillary dissection up to level three. SLN-negative patients were followed without axillary clearance.

Results

In 353/356 SLNBs at least one sentinel node was found. 254/353 SLNs were tumour free. After a median follow-up of 73 months loco-regional and distant events were encountered in 10/353 SLNBs. Four patients (SLN-negative) showed tumour localization in the residual breast or chest wall (1.1%). Three patients (SLN-negative) presented with supraclavicular metastases (0.8%). In three patients (one SLN-negative and two SLN-positive followed by ALND) an axillary recurrence was encountered (0.8%).

Conclusion

This survey confirms the safety of the SLNB under local anaesthesia in selecting patients for axillary lymph node dissection in breast cancer.     

The number of axillary nodes removed as a predictor of regional recurrence in node negative breast cancer

Purpose

To determine if the number of axillary nodes removed is a predictor of recurrence in node negative breast cancer.

Materials and methods

Five hundred thirty-six patients with T1-T2, N0 invasive breast cancer, treated with lumpectomy and axillary node dissection (AND), were reviewed from January 1, 1986 to December 31, 1992. Patients received radiation to whole breast only, without regional nodal radiation. There was no adjuvant chemotherapy or Tamoxifen given. Patients were grouped according to the number of axillary nodes dissected as follows: 1-5 nodes (91 patients), 6-10 nodes (225 patients) and >10 nodes (220 patients). Hazard ratios and p-values were determined for time to local recurrence, regional recurrence and for disease specific survival.

Results

Median follow-up was 11.2 years. The overall local recurrence and regional recurrence rates for the three groups were: 1-5 nodes, 9.9% and 8.8%, respectively, 6-10 nodes, 10.2% and 2.2%, respectively, and >10 nodes, 11.8% and 2.7%, respectively. The effect of number of axillary nodes removed was statistically significant only for regional recurrence (p = 0.017). There was no adverse effect on disease specific survival (p = 0.363).

Conclusion

The number of axillary nodes removed predicts only for regional recurrence in node negative breast cancer patients, with less than 6 nodes removed associated with higher regional recurrence. This may have clinical implications with the current practice of sentinel node biopsy (SNB) replacing axillary node dissection in early stage breast cancer.     

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.     

Ultrasound and fine needle aspiration cytology of the axilla in the pre-operative identification of axillary nodal involvement in breast cancer

Aims

Pre-operative diagnosis of axillary nodal involvement in breast cancer allows one-stage axillary surgery. We evaluated the efficacy of axillary ultrasound (US) with US guided fine needle aspiration cytology (FNAC) in the diagnosis of axillary nodal involvement.

Methods

Over a 13-month period, we performed US of 369 axillae in patients with screen-detected (n = 278) and symptomatic (n = 91) invasive carcinoma of the breast, at the same time as US of the primary tumour. If abnormal lymph nodes were demonstrated, a single US guided FNAC of the most abnormal node was performed. US and FNAC results were compared with the final histology of the surgically excised lymph nodes.

Results

Among the 369 axillae studied, 102 had nodal macrometastases and 38 (37%) were identified by US guided FNAC. The rate was 33% in screen-detected and 44% in symptomatic patients. Sensitivity increased with increasing numbers of positive axillary nodes, and the more abnormal the appearances of the nodes on US.

Conclusion

US with FNAC of the most abnormal node allows pre-operative detection of a third of node positive axillae in screen-detected and over 40% of those with symptomatic breast cancer, allowing one-stage axillary surgery avoiding the sentinel node biopsy step in these patients.     

Clinical impact of false-negative sentinel lymph nodes in breast cancer

Aims

To evaluate the incidence of false-negative (FN) sentinel lymph node (SLN) cases, their correlation with a series of clinico-pathologic parameters and their impact on adjuvant treatment indications and on clinical axillary relapse in the setting of a multicentric clinical trial comparing SLN biopsy with axillary lymph node dissection (ALND).

Methods

A series of 697 patients with primary breast cancer ≤ 3 cm were randomized to SLN biopsy associated with ALND (ALND arm) or to SLN biopsy followed by ALND only if the SLN was metastatic (SLN arm). The FN SLN rate was assessed in the ALND arm. A series of 11 clinico-pathological parameters were tested for a possible association with FN results. The indications for adjuvant treatments were evaluated by considering both the FN nodal stages, as indicated by the SLN, and the true positive axillary status, as indicated by completion ALND. The occurrence of clinically evident axillary recurrences was evaluated in the two arms.

Results

The FN rate was 16.7%. Of the clinico-pathologic parameters tested, only a tumour size ≤ 2 cm and the presence of a single metastatic axillary node was significantly associated with a risk of FN (p = 0.033 and p = 0.018, respectively). The FN SLN would have led to different adjuvant therapy indications in 12/18 cases. At 56 months, no clinically evident axillary nodal recurrences were present in the ALND arm patients, whereas one case of axillary recurrence was detected in the SLN arm patients.

Conclusions

FN SLN biopsy is not uncommon, especially in the presence of a small primary tumour with a single nodal metastasis. An FN finding can lead to less than optimal adjuvant treatment. However, the clinical impact of FN in terms of axillary recurrence at 56 months was minimal.     

Improvements in breast cancer survival over time,related to adjuvant treatment and node status

Background

There has been an increase in the use and effectiveness of adjuvant treatment for operable breast cancer and the aim of this study was to examine whether this has resulted in improved survival for all prognostic groups.

Methods

A retrospective study of 1517 patients with invasive breast cancer treated between 1980 and 2002 was carried out. The use of adjuvant treatment was compared between two time periods in patients based on nodal status, and survival was calculated by Kaplan–Meier life table analysis. Independent predictors for recurrence-free survival (RFS) were determined by Cox regression analysis.

Results

The use of adjuvant therapy increased for all prognostic groups. On multivariate analysis the use of radiotherapy and endocrine therapy was positively associated with RFS which was significant in the second time period. Outcome in node positive patients improved: five-year RFS from 59% to 76%, p < 0.01 and breast cancer specific survival (BCSS) from 70% to 83%, p < 0.01. However, there was no survival improvement in the larger group of node negative patients; BCSS 93% versus 95%, p = 0.99. Within the node negative group, patients with tumours ≥ 2 cm had an improved RFS from 80% to 88%, p = 0.02.

Conclusion

The increased use of adjuvant therapy was associated with an improved outcome in node positive patients. For node negative patients with good prognostic features the evidence of benefit was marginal.     

Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer

Background

This phase III clinical study was designed to investigate whether 6 cycles of epirubicin plus docetaxel (ED) is more effective than 4 cycles of ED as neoadjuvant chemotherapy (NC) in patients with stage II or III breast cancer.

Patients and methods

Women with breast cancer that had tumors larger than 3 cm were prospectively randomized to receive 4 or 6 cycles of epirubicin 75 mg/m² and docetaxel 75 mg/m² every 3 weeks. The primary end point was the clinical response to NC.

Results

A total of 176 patients were randomly assigned, and 150 patients were assessable for efficacy and toxicity. Groups were well balanced for clinicopathologic parameters. The median age was 42 years (range 30–58). Overall clinical response was observed in 72% with ED4 and 82% with ED6. pCR was observed in 11% with ED4 and in 24% with ED6 (p = 0.047). 47% of the ED4 group underwent breast conserving surgery (BCS) whereas 58% of ED6 group underwent BCS. Grade 3/4 neutropenia was observed in 27% in ED4 and 31% in ED6. Febrile neutropenia occurred in 17% with ED4 and 19% with ED6. Grade 3 mucositis was observed in 8% with ED4 and in 6% with ED6.

Conclusion

Six cycles of ED enhanced the rates of pCR and BCS compared with 4 cycles without increasing treatment-related toxicities.     

Sentinel lymph node biopsy is associated with improved survival compared to level I & II axillary lymph node dissection in node negative breast cancer patients

Objective

The few long-term follow-up data for sentinel lymph node (SLN) negative breast cancer patients demonstrate a 5-year disease-free survival of 96–98%. It remains to be elucidated whether the more accurate SLN staging defines a more selective node negative patient group and whether this is associated with better overall and disease-free survival compared with level I & II axillary lymph node dissection (ALND).

Methods

Three-hundred and fifty-five consecutive node negative patients with early stage breast cancer (pT1 and pT2 ≤ 3 cm, pN0/pN_SN0) were assessed from our prospective database. Patients underwent either ALND (n = 178) in 1990–1997 or SLN biopsy (n = 177) in 1998–2004. All SLN were examined by step sectioning, stained with H&E and immunohistochemistry. Lymph nodes from ALND specimens were examined by standard H&E only. Neither immunohistochemistry nor step sections were performed in the analysis of ALND specimen.

Results

The median follow-up was 49 months in the SLN and 133 months in the ALND group. Patients in the SLN group had a significantly better disease-free (p = 0.008) and overall survival (p = 0.034). After adjusting for other prognostic factors in Cox proportional hazard regression analysis, SLN procedure was an independent predictor for improved disease-free (HR: 0.28, 95% CI: 0.10–0.73, p = 0.009) and overall survival (HR: 0.34, 95% CI: 0.14–0.84, p = 0.019).

Conclusions

This is the first prospective analysis providing evidence that early stage breast cancer patients with a negative SLN have an improved disease-free and overall survival compared with node negative ALND patients. This is most likely due to a more accurate axillary staging in the SLN group.     

Phase II trial of proton beam accelerated partial breast irradiation in breast cancer

Background and purpose

Here, we report the results of our phase II, prospective study of proton beam accelerated partial breast irradiation (PB-APBI) in patients with breast cancer after breast conserving surgery (BCS).

Materials and methods

Thirty patients diagnosed with breast cancer were treated with PB-APBI using a single-field proton beam or two fields after BCS. The treatment dose was 30 cobalt gray equivalent (CGE) in six CGE fractions delivered once daily over five consecutive working days.

Results

All patients completed PB-APBI. The median follow-up time was 59 months (range: 43–70 months). Of the 30 patients, none had ipsilateral breast recurrence or regional or distant metastasis, and all were alive at the last follow-up. Physician-evaluated toxicities were mild to moderate, except in one patient who had severe wet desquamation at 2 months that was not observed beyond 6 months. Qualitative physician cosmetic assessments of good or excellent were noted in 83% and 80% of the patients at the end of PB-APBI and at 2 months, respectively, and decreased to 69% at 3 years. A good or excellent cosmetic outcome was noted in all patients treated with a two-field proton beam at any follow-up time point except for one. For all patients, the mean percentage breast retraction assessment (pBRA) value increased significantly during the follow-up period (p = 0.02); however, it did not increase in patients treated with two-field PB-APBI (p = 0.3).

Conclusions

PB-APBI consisting of 30 CGE in six CGE fractions once daily for five consecutive days can be delivered with excellent disease control and tolerable skin toxicity to properly selected patients with early-stage breast cancer. Multiple-field PB-APBI may achieve a high rate of good-to-excellent cosmetic outcomes. Additional clinical trials with larger patient groups are needed.