Background 30-day mortality might be a useful indicator of avoidable harm to patients from systemic anticancer treatments, but data for this indicator are limited. The Systemic Anti-Cancer Therapy (SACT) dataset collated by Public Health England allows the assessment of factors affecting 30-day mortality in a national patient population. The aim of this first study based on the SACT dataset was to establish national 30-day mortality benchmarks for breast and lung cancer patients receiving SACT in England, and to start to identify where patient care could be improved.Methods In this population-based study, we included all women with breast cancer and all men and women with lung cancer residing in England, who were 24 years or older and who started a cycle of SACT in 2014 irrespective of the number of previous treatment cycles or programmes, and irrespective of their position within the disease trajectory. We calculated 30-day mortality after the most recent cycle of SACT for those patients. We did logistic regression analyses, adjusting for relevant factors, to examine whether patient, tumour,or treatment-related factors were associated with the risk of 30-day mortality. For each cancer type and intent, we calculated 30-day mortality rates and patient volume at the hospital trust level, and contrasted these in a funnel plot.Findings Between Jan 1, and Dec, 31, 2014, we included 23 228 patients with breast cancer and 9634 patients with non-small cell lung cancer (NSCLC) in our regression and trust-level analyses. 30-day mortality increased with age for both patients with breast cancer and patients with NSCLC treated with curative intent, and decreased with age for patients receiving palliative SACT (breast curative: odds ratio [OR] 1.085, 99% CI 1.040-1.132; p<0.0001; NSCLC curative: 1.045, 1.013-1.079; p=0.00033; breast palliative: 0.987, 0.977-0.996; p=0.00034; NSCLC palliative: 0.987, 0.976-0.998; p=0.0015). 30-day mortality was also significantly higher for patients receiving their first reported curative or palliative SACT versus those who received SACT previously (breast palliative: OR 2.326 99% CI 1.634-3.312; p<0.0001; NSCLC curative: 3.371, 1.554-7.316; p<0.0001; NSCLC palliative: 2.667, 2.109-3.373; p< 0.0001), and for patients with worse general wellbeing (performance status 2-4) versus those who were generally well (breast curative: 6.057, 1.333-27.513; p=0.0021; breast palliative: 6.241, 4.180-9.319; p<0.0001; NSCLC palliative: 3.384, 2.276-5.032; p< 0.0001). We identified trusts with mortality rates in excess of the 95% control limits; this included seven for curative breast cancer, four for palliative breast cancer, five for curative NSCLC, and seven for palliative NSCLC.Interpretation Our findings show that several factors affect the risk of early mortality of breast and lung cancer patients in England and that some groups are at a substantially increased risk of 30-day mortality. The identification of hospitals with significantly higher 30-day mortality rates should promote review of clinical decision making in these hospitals. Furthermore, our results highlight the importance of collecting routine data beyond clinical trials to better understand the factors placing patients at higher risk of 30-day mortality, and ultimately improve clinical decision making. Our insights into the factors aff ecting risk of 30-day mortality will help treating clinicians and their patients predict the balance of harms and benefits associated with SACT.

Background: A clinically significant improvement in median overall survival (OS) has been reported for fulvestrant 500 mg vs fulvestrant 250 mg (26.4 months vs 22.3 months, respectively; hazard ratio [HR] 0.81; 95% confidence interval (CI) 0.69, 0.96; nominal p=0.02) in the Phase III COmparisoN of Faslodex In Recurrent or Metastatic breast cancer (CONFIRM) study, following failure on prior endocrine therapy. Therefore, further evidence for OS effects of fulvestrant 500 mg was sought. The Fulvestrant fIRst-line Study comparing endocrine Treatments (FIRST) compares fulvestrant 500 mg with anastrozole in the earlier first-line treatment setting for postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. In the primary analysis (6 months after last patient was randomized) fulvestrant 500 mg was at least as effective as anastrozole for clinical benefit rate (primary endpoint) and showed a significantly longer time to progression (TTP; median TTP not reached for fulvestrant 500 mg vs 12.5 months for anastrozole; HR 0.63; 95% CI 0.39, 1.00; p=0.05). In a follow-up analysis when 79.5% of patients (pts) had discontinued study treatment, median TTP was 23.4 months for fulvestrant 500 mg vs 13.1 months for anastrozole (HR 0.66; 95% CI 0.47, 0.92; p=0.01). Here we report OS from FIRST. Methods: FIRST is a Phase II, randomized, open-label, multicenter study (NCT00274469) comparing fulvestrant 500 mg (500 mg im on Days 0, 14 and 28, and every 28 days thereafter) with anastrozole (1 mg/day po). Pts were postmenopausal women with locally advanced or metastatic HR+ breast cancer who had not received prior endocrine therapy for locally advanced or metastatic disease. Kaplan-Meier curves of OS (time from randomization to death from any cause) will be compared by unadjusted log-rank test. Pts not known to have died including those lost to follow-up or with no survival information will be right-censored at last known date alive. Serious adverse events will also be reported. Results: In total, 205 pts (median age 67.0 years) were randomized from 62 centers in 9 countries (fulvestrant 500 mg: n=102; anastrozole: n=103). The first pt enrolled on Feb 6, 2006. As of May 14, 2014, 40/205 pts (19.5%) were alive across both treatment groups. 4 pts (2.0%) were lost to follow-up, 130 pts (63.4%) had died, and 31 pts [15.1%] did not participate in the OS follow-up (20 pts due to non-participation of center in the OS follow-up; other reasons included withdrawal of consent). A total of 130 events had occurred; preliminary data indicate a median OS of 50 months in the total study population. Data cut-off is planned for when approximately 65% pts have died, expected in Aug 2014. Comparative data between fulvestrant 500 mg and anastrozole for OS will be presented. Conclusions: We understand FIRST to be the only study that has demonstrated improved efficacy (ie TTP) for an alternative hormone therapy over a third-generation aromatase inhibitor for treatment of HR+ advanced breast cancer. Improved OS results would provide additional support for superior efficacy of fulvestrant 500 mg over anastrozole as first-line endocrine therapy for postmenopausal women with HR+ locally advanced or metastatic breast cancer. Citation Format: John FR Robertson, Antonio Llombart-Cussac, David Feltl, John Dewar, Marek Jasiowka, Nicola Hewson, Yuri Rukazenkov, Matthew J Ellis. Fulvestrant 500 mg versus anastrozole as first-line treatment for advanced breast cancer: Overall survival from the Phase II ‘FIRST’ study [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr S6-04.

Introduction: As part of the TARGIT-A trial, breast cancer patients were prospectively randomised to either EBRT or a single dose of IORT, with comparable results in local recurrence and complication rates. Our aim was to compare follow-up mammographic findings and rates of adjunctive ultrasound and biopsy between the two groups.

Fulvestrant fIRst-line Study comparing endocrine Treatments is a phase II, randomized, open-label study comparing fulvestrant 500 mg with anastrozole 1 mg as first-line endocrine therapy for postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. At data cut-off, only 36 % of patients had progressed and the median time to progression (TTP) had not been reached for fulvestrant. Here, we report follow-up data for TTP for fulvestrant 500 mg versus anastrozole 1 mg. Key inclusion criteria were postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally advanced or metastatic breast cancer and no prior endocrine therapy. Key exclusion criteria were presence of life-threatening metastases and prior treatment with a non-approved drug. Fulvestrant was administered 500 mg/month plus 500 mg on day 14 of month 1; anastrozole was administered 1 mg/day. TTP was defined by modified Response Evaluation Criteria in Solid Tumors v1.0 before data cut-off for the primary analysis, and investigator opinion after data cut-off. Best overall response to subsequent therapy and serious adverse events are also reported. In total, 205 patients received fulvestrant 500 mg (n = 102) or anastrozole (n = 103). Follow-up analysis was performed when 79.5 % of patients had discontinued study treatment. Median TTP was 23.4 months for fulvestrant versus 13.1 months for anastrozole; a 34 % reduction in risk of progression (hazard ratio 0.66; 95 % confidence interval: 0.47, 0.92; P = 0.01). Best overall response to subsequent therapy and clinical benefit rate for subsequent endocrine therapy was similar between the treatment groups. No new safety concerns for fulvestrant 500 mg were documented. These longer-term, follow-up results confirm efficacy benefit for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for HR+ advanced breast cancer in terms of TTP, and, importantly, show similar best overall response rates to subsequent endocrine therapy.

Background: The Fulvestrant fIRst-line Study comparing endocrine Treatments (FIRST) compared fulvestrant 500mg with anastrozole as first-line endocrine therapy in postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer. Fulvestrant 500mg was at least as effective as anastrozole in terms of clinical benefit rate (CBR; primary study endpoint) and objective response rate (ORR); however, time to progression (TTP) was significantly longer with fulvestrant 500mg. We present an analysis of response to subsequent breast cancer therapy. Methods: FIRST is a Phase II, randomised, open-label, multicentre study comparing fulvestrant 500mg (500mg/month plus 500mg on Day 14 of Month 1) with anastrozole (1mg/day) as first-line endocrine therapy in postmenopausal women with advanced breast cancer. Following withdrawal from randomised treatment, best overall response (complete response [CR], partial response [PR], stable disease [SD] ≥24 weeks, SD <24 weeks, not evaluable, or progressive disease) to first subsequent systemic breast cancer therapy was determined by investigator opinion. ORR is the proportion of patients with a best overall response of CR or PR. CBR is defined as ORR plus SD ≥24 weeks. Results: In total, 205 patients received fulvestrant 500mg (n=102) or anastrozole (n=103). At data cut-off for the follow-up analysis for TTP, 63 patients in the fulvestrant 500mg group and 79 patients in the anastrozole group had progressed. Median TTP was 23.4 months for fulvestrant 500mg and 13.1 months for anastrozole (hazard ratio 0.66; 95% confidence interval, 0.47-0.92; p=0.01). The number of treatment failures was 76 in the fulvestrant 500mg group and 87 in the anastrozole group. A total of 64 (62.7%) patients in the fulvestrant 500mg group and 69 (67.0%) patients in the anastrozole group received subsequent systemic therapy for breast cancer (chemotherapy, endocrine therapy, novel targeted therapy or unknown). ORR to subsequent therapy was 23.4% (15/64 patients) in the fulvestrant 500mg group and 21.7% (15/69 patients) in the anastrozole group. CBR to subsequent therapy was 43.8% (28/64 patients) and 46.4% (32/69 patients) in the fulvestrant 500mg and anastrozole groups, respectively. Endocrine therapy was received by 34 (53.1%) patients in the fulvestrant 500mg group and 50 (72.5%) patients in the anastrozole group (most common endocrine therapies: anastrozole and letrozole in the fulvestrant 500mg group; fulvestrant and exemestane in the anastrozole group). Of those patients who received subsequent endocrine therapy, ORR was 8.8% (3/34 patients) for fulvestrant 500mg and 14.0% (7/50 patients) for anastrozole. CBR was 41.2% (14/34 patients) for fulvestrant 500mg and 42.0% (21/50 patients) for anastrozole. Conclusion: Patients who progress on either fulvestrant 500mg or anastrozole as first-line treatment for HR+ advanced breast cancer may experience comparable CBRs to first subsequent endocrine therapy.

Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy.Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2.5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00983684.Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1.20% (95% CI 0.53-2.71) in the targeted intraoperative radiotherapy and 0.95% (0.39-2.31) in the external beam radiotherapy group (difference between groups 0.25%, -1.04 to 1.54; p=0.41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3.3%] of 1113 vs external beam radiotherapy, 44 [3.9%] of 1119; p=0.44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0.5%]) than in the external beam radiotherapy group (23 patients [2.1%]; p=0.002).Interpretation For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks.

The guidance from the National Institute for Health and Clinical Excellence (NICE) on malignant cord compression argues that a committed, coordinated approach is needed.1 Following the Scottish audit (CRAG),2 all health boards in Scotland were advised to implement rapid referral systems and coordinate the process of early diagnosis. This Macmillan supported initiative has made good …

The aim of the study was to achieve earlier diagnosis of malignant cord compression (MCC) using urgent magnetic resonance imaging (MRI) for selected patients. A comparison was carried out of the current prospective audit of 100 patients referred by a general practitioner or a consultant over 32 months with both a previous national Clinical Research and Audit Group (CRAG) prospective audit (324 cases of MCC) and an earlier retrospective audit of 104 patients referred with suspected MCC. A telephone hotline rapid-referral process for patients with known malignancy and new symptoms (severe nerve root pain ± severe back pain) was designed. Patients were considered for urgent MRI after discussion with a senior clinician responsible for the hotline. Appropriate referrals were discussed with radiology and oncology ensuring timely MRI reporting and intervention. The main outcome measures are as follows: time from referral to diagnosis; time from the onset of symptoms to diagnosis; and mobility at diagnosis. A total of 50 patients (52%) of those scanned had either MCC (44) or malignant nerve root compression (6) compared with the earlier rate of 23 out of 104 patients (22%). Ten out of 44 MCC patients (23%) were paralysed at diagnosis, compared with 149 out of 324 (46%) in the CRAG audit. Time from reporting pain to diagnosis was 32 days compared with 89 days in the CRAG audit. Median time from referral to diagnosis was 1 day, again considerably shorter than the CRAG audit time of 15 days (interquartile (IQ) range: 3–66). In patients at risk of MCC, fast-track referral with rapid access to MRI reduces time between symptom onset and diagnosis, improves mobility at diagnosis and reduces the number of negative MRI scans.

PURPOSE:To compare the clinical activity of the pure antiestrogen fulvestrant at 500 mg/mo (double the approved dose) with the aromatase inhibitor anastrozole as first-line endocrine therapy for advanced hormone receptor-positive breast cancer in postmenopausal women.PATIENTS AND METHODS:FIRST (Fulvestrant First-Line Study Comparing Endocrine Treatments) is a phase II, randomized, open-label, multicenter study of a fulvestrant high-dose (HD) regimen (500 mg/mo plus 500 mg on day 14 of month 1) versus anastrozole (1 mg/d). The primary efficacy end point was clinical benefit rate (CBR), defined as the proportion of patients experiencing an objective response (OR) or stable disease for > or = 24 weeks. The primary analysis was performed 6 months after the last patient was randomly assigned.RESULTS:CBR was similar for fulvestrant HD (n = 102) and anastrozole (n = 103), 72.5% v 67.0%, respectively (odds ratio, 1.30; 95% CI, 0.72 to 2.38; P = .386). Objective response rate (ORR) was also similar between treatments: fulvestrant HD, 36.0%; anastrozole, 35.5%. Time to progression (TTP) was significantly longer for fulvestrant versus anastrozole (median TTP not reached for fulvestrant HD v 12.5 months for anastrozole; hazard ratio, 0.63; 95% CI, 0.39 to 1.00; P = .0496). Duration of OR and CB also numerically favored fulvestrant HD. Both treatments were well tolerated, with no significant differences in the incidence of prespecified adverse events.CONCLUSION:First-line fulvestrant HD was at least as effective as anastrozole for CBR and ORR and was associated with significantly longer TTP. Fulvestrant HD was generally well tolerated, with a safety profile similar to that of anastrozole.

Biochemical markers of bone metabolism are strongly associated with skeletal complications in metastatic bone disease. The bisphosphonate clodronate reduces skeletal morbidity by inhibiting bone resorption. This study investigated the use of bone markers to assess the efficacy of oral clodronate across a range of clinically relevant doses. There were 125 patients with metastatic bone disease randomized to daily oral clodronate (800, 1,600, 2,400 and 3,200 mg) or placebo in a double-blind, multicenter study. Urinary N-terminal telopeptide of type I collagen (U-NTX), serum C-terminal telopeptide of type I collagen (S-CTX), urinary calcium (U-Ca), and bone alkaline phosphatase were measured weekly for a 6-week treatment period. Doses of ≥1,600 mg clodronate produced mean reductions of >40% in U-NTX, S-CTX and U-Ca, all significantly different from placebo (P = 0.0015, 0.001, 0.0036, respectively), after 6 weeks. Evaluation of least significant changes in markers suggested that the commonly used 1,600 mg dose was most appropriate for breast cancer patients. However, this dose was suboptimal for other (mainly prostate cancer) patients, who showed better response to 2,400 mg. The number of adverse events in the treatment arms was not significantly different from that in placebo, but a higher number of patients had diarrhea in the 3,200 mg arm and withdrew from the study. This trial is the first to explore the dose-response relationship of clodronate in oncology using specific markers of bone turnover. It has confirmed that the 1,600 mg dose is safe and effective for breast cancer patients but may be suboptimal for the other tumors studied.

BACKGROUND:Intraoperative radiotherapy (IORT) is promising approach that is being tested in randomised clinical trials. In the Targit (TARGeted Intraopeartive radioTherapy) trial IORT can be delivered at the time of primary surgery or as a second procedure. Patients prefer the single procedure of intraoperative radiotherapy even if it is under general anaesthetic to 6-weeks of daily visits for conventional external beam radiotherapy.CASE PRESENTATION:We report a case of a 70 year lady who underwent lumpectomy and axillary sampling and in whom we successfully administered IORT under local anaesthetic.CONCLUSION:In selected patients, this attractive option may make the procedure even more widely applicable.

The influence of emotion on moral judgments has become increasingly prominent in recent years. While explicit normative measures are widely used to investigate this relationship, event-related potentials (ERPs) offer the advantage of a preconscious method to visualize the modulation of moral judgments. Based on Gray and Wegner’s (2009) Dimensional Moral Model, the present study investigated whether the processing of neutral faces is modulated by moral context information. We hypothesized that neutral faces gain emotional valence when presented in a moral context and thus elicit ERP responses comparable to those established for the processing of emotional faces. Participants (N= 26, 13 female) were tested with regard to their implicit (ERPs) and explicit (morality rating) responses to neutral faces, shown in either a morally positive, negative, or neutral context. Higher ERP amplitudes in early (P100, N170) and later (EPN, LPC) processing stages were expected for harmful/helpful scenarios compared to neutral scenarios. Agents and patients were expected to differ for moral compared to neutral scenarios. In the explicit ratings neutral scenarios were expected to differ from moral scenarios. In ERPs, we found indications for an early modulation of moral valence (harmful/helpful) and an interaction of agency and moral valence after 80-120 ms. Later time sequences showed no significant differences. Morally positive and negative scenarios were rated as significantly different from neutral scenarios. Overall, the results indicate that the relationship of emotion and moral judgments can be observed on a preconscious neural level at an early processing stage as well as in explicit judgments.

8056 Background: The bisphosphonate clodronate is effective in the treatment of osteolytic bone metastases at an oral dose of 1600 mg per day. However other doses such as 2400 mg and 3200 mg have also been used. Using bone markers as surrogate biomarkers for osteolysis, the purpose of the study was to investigate the efficacy of oral clodronate (BONEFOS®) across a range of doses in patients with tumour induced osteolysis. Methods: 125 patients with metastatic bone disease (87 breast, 33 prostate and 5 other tumour types) were randomized to oral clodronate (800, 1600, 2400 and 3200 mg) or placebo in a phase II double blind, dose ranging, multicentre study with ethical approval. During 6 weeks of treatment, bone markers were assessed weekly. Results: Doses of 1600 mg or above were all effective in producing a mean fall in both urinary N-telopeptide (NTX, see table for breast data) and C-telopeptide of over 40 % from baseline values. Moreover, effects of clodronate were seen by 1 week. The 800mg dose gave a smaller effect and placebo gave no effect. The number of adverse events in the treatment arms was not significantly different from the placebo arm, except for the 3200 mg dose, where a higher number of patients had significant diarrhoea. Conclusions: This is the first such dose-ranging study with clodronate, where bone markers have been used as the primary end-point to assess efficacy. The data are consistent with the known clinical use of 1600 mg daily, but suggest that 2400 mg may also be used without increased toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Schering OY Schering OY Schering OY Schering OY

Background. Breast conservation is now established treatment for patients with small breast cancers. The authors reviewed a large series of patients with long term follow-up who underwent conservative treatment. Clinical and pathologic factors were analyzed to identify patients at an increased risk of relapse in the breast (local relapse) or development of a contralateral tumor.Methods. Seven hundred fifty-seven patients with unilateral invasive breast cancer (TO-2, NO-1, MD) were treated conservatively (wide local excision and radiotherapy) at the Institut Gustave-Roussy between 1970 and 1982. The median follow-up was 9 years. The risk of local relapse or development of a contralateral tumor (as first event) was studied by univariate analysis for the main clinical, pathologic, and treatment factors. Those found to be significant were entered into a Cox proportional regression analysis.Results. Fifty-one patients relapsed in the treated breast (actuarial local relapse rates at 5 and 10 years were 5% and 8%, respectively) and 34 in the contralateral breast (actuarial contralateral tumor rates at 5 and 10 years were 3% and 6%, respectively). Multivariate analysis of the risk factors for local relapse showed that only age younger than 40 years (P < 0.02) or inadequate surgical excision (P < 0.02) were significant. No particular risk factors for contralateral tumor development were identified.Conclusions. Overall, for most patients, the risk of local relapse or of developing a contralateral tumor was low. A small number of young patients with inadequately excised tumors are at higher risk of local relapse, need more meticulous surgery, and may merit higher dose radiotherapy.

Between 1970 and April 1982, 592 women with T1, small T2, N0, N1, M0 breast cancer were managed by lumpectomy, axillary dissection and radiotherapy at the institut Gustave-Roussy (IGR). The overall cosmetic result and the degree of asymmetry, fibrosis and telangiectasia of the treated breast were assessed by the radiation oncologist at each follow-up visit. The changes in these cosmetic parameters with time are shown. At 5 years the overall cosmetic result was excellent in 58%, good in 38% and fair or poor in 8%. A multivariate analysis was performed of the factors associated with a cosmetic defect. The most significant factors were tumour size, the presence of defect after surgery and the daily applied dose per fraction to the breast. Surgical and radiotherapy technique (especially alternate day fractionation) can significantly affect the cosmetic result obtained.

Between June 1970 and April 1982, 592 patients with unilateral T1 and small T2 breast cancers were managed conservatively at the Institut Gustave-Roussy. The treatment policy for the axilla was to perform a lower axillary dissection and to proceed to axillary clearance ( +/- radiotherapy) in patients with axillary invasion by tumor (N+). Some N+ patients had only lower axillary dissection and radiotherapy. Five hundred fifty-eight patients underwent axillary surgery which was a lower axillary dissection in 374 patients (67%) and axillary clearance in 184 patients (33%). There was axillary invasion in 198 cases (36%). Only five patients relapsed in the axilla and the probability of axillary relapse at 5 years was 1.2%. There were no axillary relapses in N+ patients who had had an axillary clearance whether irradiated or not. The incidence of upper limb complications was significantly greater in patients undergoing axillary surgery and radiotherapy compared with axillary surgery alone (p less than 0.0001). It is concluded that a lower axillary dissection accurately identifies N-patients and an axillary clearance in N+ patients ensures good local control and avoids the morbidity associated with axillary irradiation.