Abstract Background The incidence of local recurrence (LR) after conservative surgery for early breast cancer without adjuvant therapy is unacceptably high even with favourable tumours. The aim of ...this study was to examine the effect of adjuvant therapies in tumours with excellent prognostic features. Methods Patients with primary invasive breast cancer <2 cm diameter, grade 1 or good prognosis special type, and node negative, treated by wide local excision (WLE) with clear margins were randomised into a 2 × 2 clinical trial of factorial design with or without radiotherapy and with or without tamoxifen. Trial entry was allowed to either comparison or both. Findings The actuarial breast cancer specific survival in 1135 randomised patients at 10 years was 96%. Analysis by intention to treat showed that LR after WLE was reduced in patients randomised to radiotherapy (RT) (HR 0.37, CI 0.22-0.61 p < 0.001) and to tamoxifen (HR 0.33, CI 0.15 – 0.70 p < 0.004). Actuarial analysis of patients entered into the four-way randomisation showed that LR after WLE alone was 1.9% per annum (PA) versus 0.7% with RT alone and 0.8% with tamoxifen alone. No patient randomised to both adjuvant treatments developed LR. Analysis by treatment received showed LR at 2.2% PA for surgery alone versus 0.8% for either adjuvant radiotherapy or tamoxifen and 0.2% for both treatments. Conclusions Even in these patients with tumours of excellent prognosis, LR after conservative surgery without adjuvant therapy was still very high. This was reduced to a similar extent by either radiotherapy or tamoxifen but to a greater extent by the receipt of both treatments.
Background
The aim was to determine long‐term overall, breast cancer‐specific and metastasis‐free survival as well as axillary relapse rate from a pooled analysis of two randomized trials in women ...with operable breast cancer. These trials compared axillary node sampling (ANS), combined with axillary radiotherapy (AXRT) if the sampled nodes were involved, with axillary node clearance (ANC).
Methods
Data from two clinical trials at the Edinburgh Breast Unit that randomized patients between 1980 and 1995 were pooled. Long‐term survival was analysed using Kaplan–Meier curves and Cox regression, with separate analyses for patients with node‐positive (ANS + AXRT versus ANC) and node‐negative (ANS versus ANC) disease.
Results
Of 855 women randomized, 799 were included in the present analysis after a median follow‐up of 19·4 years. Some 301 patients (37·7 per cent) had node‐positive disease. There was no evidence of a breast cancer survival advantage for ANS versus ANC in patients with node‐negative disease (hazard ratio (HR) 0·88, 95 per cent c.i. 0·58 to 1·34; P = 0·557), or for ANS + AXRT versus ANC in those with node‐positive breast cancer (HR 1·07, 0·77 to 1·50; P = 0·688). There was no metastasis‐free survival advantage for ANS versus ANC in patients with node‐negative tumours (HR 1·03, 0·70 to 1·51; P = 0·877), or ANS + AXRT versus ANC in those with node‐positive disease (HR 1·03, 0·75 to 1·43; P = 0·847). Node‐negative patients who underwent ANS had a higher risk of axillary recurrence than those who had ANC (HR 3·53, 1·29 to 9·63; P = 0·014). Similarly, among women with node‐positive tumours, the risk of axillary recurrence was greater after ANS + AXRT than ANC (HR 2·64, 1·00 to 6·95; P = 0·049).
Conclusion
Despite a higher rate of axillary recurrence with ANS combined with radiotherapy to the axilla, ANC did not improve overall, breast cancer‐specific or metastasis‐free survival. Axillary recurrence is thus not a satisfactory endpoint when comparing axillary treatments.
No difference in outcome
Background. Multifocal or multicentric breast cancer has been suggested as a contraindication for sentinel node biopsy (SNB). However, recent studies have demonstrated that all quadrants of the ...breast drain through common afferent channels to a common axillary sentinel node. This should mean that the presence of multifocal tumour should not affect the lymphatic drainage. The purpose of this study was to evaluate the feasibility and accuracy of SNB in patients with multifocal breast cancer using a peritumoural injection technique for sentinel lymph node (SN) mapping.
Methods. In the ALMANAC multicentre trial validation phase, we took SNB samples from 842 patients with node negative, invasive breast cancer with use of a blue dye and radiolabelled colloid mapping technique at the peritumoural injection site. All patients underwent standard axillary treatment after SNB. Seventy-five of the 842 patients had multifocal lesions on final histopathologic examination. The following analysis is focused on patients with multifocal lesions.
Results. A mean number of 2.4 SNs were identified in 71 of 75 patients (identification rate: 94.7%). Thirty-one patients had a positive SN, 40 a negative SN. Standard axillary treatment confirmed the SN to be negative in 37 of 40 patients, whereas three patients revealed positive non-sentinel lymph nodes (false-negative rate: 8.8%). Overall SN biopsy accurately predicted axillary lymph node status in 68 of 71 patients (95.8%).
Conclusion. SNB accurately staged the axilla in multifocal breast cancer and may become an alternative to complete axillary lymph node dissection in node negative patients with multifocal breast cancer.
Abstract Aim The TELEMAM trial aimed to assess the clinical effectiveness and costs of telemedicine in conducting breast cancer multi-disciplinary meetings (MDTs). Methods Over 12 months 473 MDT ...patient discussions in two district general hospitals (DGHs) were cluster randomised (2:1) to the intervention of telemedicine linkage to breast specialists in a cancer centre or to the control group of ‘in-person’ meetings. Primary endpoints were clinical effectiveness and costs. Economic analysis was based on a cost-minimisation approach. Results Levels of agreement of MDT members on a scale from 1 to 5 were high and similar in both the telemedicine and standard meetings for decision sharing (4.04 versus 4.17), consensus (4.06 versus 4.20) and confidence in the decision (4.16 versus 4.07). The threshold at which the telemedicine meetings became cheaper than standard MDTs was approximately 40 meetings per year. Conclusion Telemedicine delivered breast cancer multi-disciplinary meetings have similar clinical effectiveness to standard ‘in-person’ meetings.
Background: Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and ...mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment. Methods: The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided. Results: The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval CI = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P<.001), and axillary operative time was reduced (P = .055). Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout (all P≤.003). These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group (P>.05). Conclusion: Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.
Summary Background As trials of 5 years of tamoxifen in early breast cancer mature, the relevance of hormone receptor measurements (and other patient characteristics) to long-term outcome can be ...assessed increasingly reliably. We report updated meta-analyses of the trials of 5 years of adjuvant tamoxifen. Methods We undertook a collaborative meta-analysis of individual patient data from 20 trials (n=21 457) in early breast cancer of about 5 years of tamoxifen versus no adjuvant tamoxifen, with about 80% compliance. Recurrence and death rate ratios (RRs) were from log-rank analyses by allocated treatment. Findings In oestrogen receptor (ER)-positive disease (n=10 645), allocation to about 5 years of tamoxifen substantially reduced recurrence rates throughout the first 10 years (RR 0·53 SE 0·03 during years 0–4 and RR 0·68 0·06 during years 5–9 both 2p<0·00001; but RR 0·97 0·10 during years 10–14, suggesting no further gain or loss after year 10). Even in marginally ER-positive disease (10–19 fmol/mg cytosol protein) the recurrence reduction was substantial (RR 0·67 0·08). In ER-positive disease, the RR was approximately independent of progesterone receptor status (or level), age, nodal status, or use of chemotherapy. Breast cancer mortality was reduced by about a third throughout the first 15 years (RR 0·71 0·05 during years 0–4, 0·66 0·05 during years 5–9, and 0·68 0·08 during years 10–14; p<0·0001 for extra mortality reduction during each separate time period). Overall non-breast-cancer mortality was little affected, despite small absolute increases in thromboembolic and uterine cancer mortality (both only in women older than 55 years), so all-cause mortality was substantially reduced. In ER-negative disease, tamoxifen had little or no effect on breast cancer recurrence or mortality. Interpretation 5 years of adjuvant tamoxifen safely reduces 15-year risks of breast cancer recurrence and death. ER status was the only recorded factor importantly predictive of the proportional reductions. Hence, the absolute risk reductions produced by tamoxifen depend on the absolute breast cancer risks (after any chemotherapy) without tamoxifen. Funding Cancer Research UK, British Heart Foundation, and Medical Research Council.
Aims: There are no uniformly agreed guidelines regarding the treatment of local breast cancer in patients who have stable metastatic disease. The aim of this study was to define the role of breast ...surgery in the management of stage IV disease by reviewing the clinical outcome in patients with stage IV disease submitted to surgery in a regional breast cancer unit.
Methods: All patients who underwent breast surgery from 1993 to 1999 and had known metastatic disease or who were diagnosed with metastases within one month of surgery were identified and their clinical outcome was studied using death and local recurrence as end points.
Results: Median survival after breast surgery was 23 months. Ten of the 20 patients were alive with no local disease at 20 months mean follow-up. Three of 10 patients who died developed local recurrence and had local disease at the time of death.
Conclusion: The local surgery does have a role in controlling the primary cancer and controlling local symptoms in a selected group of patients with stable metastatic disease.
The concept of sentinel node biopsy has been validated for female breast cancer patients whereas, ALND remains the standard of care for male breast cancer patients with similar tumours. We evaluated ...the results of SLN biopsy in male breast cancer patients with clinically negative axillae.
This study included all male breast cancer patients who underwent SLN biopsy between February 1998 and October 2003. All patients had negative axillae on clinical examination. All patients underwent pre-operative lymphoscintigraphy. SLN biopsy was performed using a combination of Patent blue V and 99mTc-radiolabelled colloidal albumin injected peritumourally.
Nine patients, 26–79 years of age, were included in the study. Pre-operative lymphoscinitgraphy identified SLNs in all patients. Intraoperatively, SLNs were successfully localised in all patients. The mean number of SLNs encountered was 2.4. Five patients had a positive SLN, four a negative SLN. Five patients (one with a negative SLN, four with a positive SLN) had been elected pre-operatively to undergo ALND regardless of findings on SLN biopsy. ALND confirmed the SLN to be negative in one patient (false-negative rate: 0%) and three of the four patients with positive SLN(s) had additional positive nodes in the axilla. SLN biopsy accurately predicted axillary lymph node status in these five patients.
These findings compare favourably with findings reported in the literature regarding SLN biopsy in female breast cancer patients. SLN biopsy accurately staged the axilla in male breast cancer patients and should be considered for axillary staging in male breast cancer patients with clinically negative axillae.
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