Patients' and gynecologists' views on sentinel lymph node mapping in low- and intermediate-risk endometrial cancer: a Dutch vignette study.

OBJECTIVE: Sentinel lymph node (SLN) mapping in endometrial cancer is gaining ground. However, patient views on this new technique are unknown. The aim of this study was to determine factors important to patients and gynecologists when considering SLN mapping in low- and intermediate-risk endometrial cancer. METHODS: We performed a vignette study. Patients who underwent a total hysterectomy for low- or intermediate-risk endometrial cancer between 2012 and 2015 were invited. Dutch gynecologists specializing in gynecologic oncology were also invited. We based the selection for attributes in the vignettes on literature and interviews: risk of complications of SLN mapping; chance of finding a metastasis; survival gain; risk of complications after radiotherapy; operation time; and hospital of surgery (travel time). We developed a questionnaire with 18 hypothetical scenarios. Each attribute level varied and for each scenario, participants were asked how strongly they would prefer SLN on a scale from 1 to 7. The strength of preference for each scenario was analyzed using linear mixed effects models. RESULTS: A total of 38% of patients (41/108) and 33% of gynecologists (42/126) participated in the study. Overall, they had a preference for SLN. The mean preference for patients was 4.29 (95% CI 3.72 to 4.85) and 4.39 (95% CI 3.99 to 4.78) for gynecologists. Patients' preferences increased from 3.4 in the case of no survival gain to 4.9 in the case of 3-year survival gain (P<0.05) and it decreased when travel time increased to >60 min (-0.4, P=0.024), or with an increased risk of complications after adjuvant radiotherapy (-0.6, P=0.002). For gynecologists all attributes except travel time were important. CONCLUSIONS: Overall, patients and gynecologists were in favor of SLN mapping in low- and intermediate-risk endometrial cancer. Most important to patients were survival gain, travel time, and complication risk after adjuvant radiotherapy. These preferences should be taken into account when counseling about SLN mapping.

Sentinel lymph node mapping in endometrial and cervical cancer: a survey of practices and attitudes in gynecologic oncologists.

OBJECTIVE: To determine patterns among gynecologic oncologists in sentinel lymph node mapping (SLNM) for endometrial cancer (EC) and cervical cancer (CC). METHODS: A online survey assessing the practice of SLNM, including incidence, patterns of usage, and reasons for non-use was distributed to Society of Gynecologic Oncology candidate and full members in August 2017. Descriptive statistics and univariate analysis was performed. RESULTS: The 1,117 members were surveyed and 198 responses (17.7%) were received. Of the 70% (n=139) performing SLNM, the majority reported use for both CC and EC (64.0%) or EC alone (33.1%). In those using SLNM in EC, the majority (86.6%) performed SLNM in >50% of cases for all patients (56.3%), International Federation of Gynecology and Obstetrics grade 1 (43.0%) and 2 (42.2%). Reported benefits of SLNM in EC were reduced surgical morbidity (89.6%), lymphedema (85.2%), and operative time (63.7%). Among those using SLNM for CC, the majority (73.1%) did so in >50% of cases. In EC, 77.2% and 21.3% reported that micro-metastatic disease (0.2-2.0 cm) and isolated tumor cells (ITCs) should be treated as node positive, respectively. In those not using SLNM for EC (n=64) and CC (n=105), concerns were regarding efficacy of SLNM and lack of training. When queried regarding training, 73.7% felt that SLNM would impact skill in full lymphadenectomy (LND). CONCLUSION: The SLNM is utilized frequently among gynecologic oncologists for EC and CC staging. Common reasons for non-uptake include uncertainty of current data, lack of training and technology. Concerns exist regarding impact of SLNM in fellowship training of LND.

Biopsia del ganglio centinela y quimioterapia neoadyuvante en pacientes con cáncer de mama: nuestra experiencia / Sentinel lymph node biopsy and neoadjuvant chemotherapy in breast cancer patients: our experience

Objetivo. Revisar nuestra experiencia en la biopsia selectiva del ganglio centinela (BGC) en pacientes con cáncer de mama operable tratadas con quimioterapia neoadyuvante (QTN). Material y métodos. Estudio prospectivo, enero de 2008/diciembre de 2014, 235 BGC en pacientes con cáncer de mama infiltrante T1-3/N0-1, tratadas con epirrubicina/ciclofosfamida, docetaxel y trastuzumab en Her2/neu positivas. El estatus axilar se estableció por exploración física, ecografía axilar y punción de ganglios sospechosos. El día antes de la cirugía se inyectaron periareolarmente 74-111 MBq de 99mTc-nanocoloide de albúmina. Al finalizar el tratamiento se realizó BGC y linfadenectomía axilar. El GC se analizó por cortes de congelación, hematoxilina-eosina, inmunohistoquímica o one-step nucleic acid amplification. Se determinaron tasa de identificación (Id.GC) y falsos negativos (FN). Resultados. Grupo I BGC pre-QTN pacientes cN0 de inicio: n = 73, Id.GC 97,2% (IC 95% 90,5-99,2). Grupo II 2.a BGC pos-QTN pacientes pN1(gc) de inicio: n = 31, Id.GC 61,3% (IC 95% 43,8-76,3), FN 18,2% (IC 95% 5,1-47,7). Grupo III BGC pos-QTN pacientes cN0 de inicio: n = 54, Id.GC 96,3% (IC 95% 87,5-99,0), FN 9,5% (IC 95% 2,7-28,9). Grupo IV BGC pos-QTN pacientes cN1 de inicio, ycN0 posneoadyuvancia: n = 77, Id.GC 83,1% (IC 95% 73,2-89,8), FN 8,3% (IC 95% 2,9-21,8). Conclusiones. La identificación de la BGC pre-QTN es excelente. En pacientes pN1(gc) al diagnóstico, una 2.a BGC pos-QTN no es válida para su aplicación clínica. La BGC pos-QTN puede realizarse con fiabilidad en pacientes cN0 y cN1 de inicio, con axila clínicamente negativa al finalizar la neoadyuvancia (ycN0), y linfadenectomía axilar si el resultado del GC es positivo o no se identifica en la cirugía, en el ámbito de un equipo multidisciplinar con experiencia (AU)

Aim. To analyze our experience of sentinel lymph node biopsy (SLNB) in patients with operable breast cancer treated with neoadjuvant chemotherapy (NAC). Material and methods. A prospective study was conducted between January 2008 and December 2014 in 235 SLNB in patients with infiltrating breast carcinoma T1-3/N0-1 treated with epirubicin/cyclophosphamide, docetaxel and trastuzumab in Her2/neu-positive patients. Axillary evaluation included physical examination and ultrasound, with guided core needle biopsy of any suspicious lymph nodes. The day before surgery, 74-111 MBq of 99mTc-albumin nanocolloid was injected periareolar. Following NAC, patients underwent SLNB and axillary lymph node dissection. SLN were examined with hematoxylin-eosin staining and immunohistochemical analysis or one-step nucleic acid amplification. The identification rate (IR) and false-negative rate (FNR) were determined. Results. Group I SLNB pre-NAC in patients cN0 at diagnosis: n = 73, IR 97.2% (95%CI: 90.5-99.2). Group II 2nd SLNB pos-NAC in patients pN1(sn) at diagnosis: n = 31, IR 61.3% (95%CI: 43.8-76.3), FNR 18.2% (95%CI: 5.1-47.7). Group III SLNB pos-NAC in patients cN0 at diagnosis: n = 54, IR 96.3% (95%CI: 87.5-99.0), FNR 9.5% (95%CI: 2.7-28.9). Group IV SLNB pos-NAC in patients cN1 at diagnosis and ycN0 post-treatment: n = 77, IR 83.1% (95%CI: 73.2-89.8), FNR 8.3% (95%CI: 2.9-21.8). Conclusions. The detection rate for SLNB prior to NAC is excellent. A second SLNB after NAC in women with a positive SLN at diagnosis is not useful. SLNB after NAC is feasible in cN0 and cN1 patients at diagnosis, clinically axillary node-negative after therapy (ycN0), with subsequent axillary lymph node dissection if the SLNB is positive or not identified during surgery, when performed by an experienced multidisciplinary team (AU)

Supportive care needs, anxiety, depression and quality of life amongst newly diagnosed patients with localised invasive cutaneous melanoma in Queensland, Australia.

OBJECTIVE: The aim of this paper is to determine levels of supportive care needs, anxiety, depression and symptoms amongst patients newly diagnosed with localised invasive primary melanoma and if these varied amongst patients who had a sentinel lymph node biopsy (SLNB). We also considered quality of life compared with general population norms. METHODS: Patients newly diagnosed with clinical stage IB-II invasive melanoma were ascertained through Queensland hospitals, specialist clinics and pathology laboratories. Validated surveys measured 46 need items (Supportive Care Needs Survey-Short Form + melanoma subscale), anxiety and depression (Hospital Anxiety and Depression Scale) and quality of life and symptoms (Functional Assessment of Cancer Therapy-Melanoma). Regression models compared outcomes according to whether or not participants had a SLNB. RESULTS: We surveyed 386 patients, 155 before and 231 after wide local excision, of whom 46% reported ≥1 moderate-level or high-level unmet need. The three highest needs were for help with fears about cancer spreading (17%), information about risk of recurrence (17%) and outcomes when spread occurred (16%). Those who had a SLNB were more likely to report a moderate or high unmet need for help with uncertainty about the future or with lymphoedema (p < 0.05). Overall, 32% of participants had anxiety and 15% had depression regardless of performance of SLNB. Melanoma-specific symptoms were worse in SLNB patients (p = 0.03). Compared with the general population, emotional well-being was lower amongst melanoma patients. CONCLUSIONS: A substantial proportion of newly diagnosed patients with localised invasive melanoma need further melanoma-specific information and support with psychological concerns. Patients who have a SLNB clear of disease may need help with symptoms after surgery.

Impact of sentinel node biopsy on long-term quality of life in breast cancer patients.

BACKGROUND: The aim of this study was to assess long-term quality of life (QoL) over a period of 6 years in women with breast cancer (BC) who underwent sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), or SLNB followed by ALND. METHODS: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ)-C30 and the EORTC-QLQ-BR-23 questionnaires were used to assess QoL before surgery, just after surgery, 6, 12 and 72 months later. The longitudinal effect of surgical modalities on QoL was assessed with a mixed model analysis of variance for repeated measurements. RESULTS: Five hundred and eighteen BC patients were initially included. The median follow-up was 6 years. During the follow-up, 61 patients died. None of the patients of the SLNB group developed lymphedema during follow-up and the relapse rate was similar in the different groups (P=0.62). Before surgery, global health status (P=0.52) and arm symptoms (BRAS) (P=0.99) QoL scores were similar whatever the surgical procedure. The BRAS score (P=0.0001) was better in the SLNB group 72 months after surgery. Moreover, during follow-up, patients treated with SLNB had lower arm symptoms scores than ALND patients and there was no difference for arm symptoms between patients treated with ALND and those treated with SLNB followed by complementary ALND. CONCLUSION: Long-term follow-up showed that SLNB was associated with less morbidity than ALND.

Encuesta nacional sobre la actitud ante el hallazgo de metástasis en el ganglio centinela por cáncer de mama en distintas unidades hospitalarias / National survey on actions taken in breast units when finding sentinel node disease

Objetivo: En los últimos años, ha cambiado la indicación de la linfadenectomía axilar como gesto integrante del manejo del cáncer de mama, sobre todo desde la introducción de la biopsia del ganglio centinela. El objetivo es conocer la actitud actual en función de los hallazgos de enfermedad en éste. Pacientes y métodos: Se realizó un estudio descriptivo a partir de datos obtenidos de una encuesta, dirigida específicamente a unidades de mama españolas, sobre las consideraciones que, en el tratamiento quirúrgico y adyuvante, supone el hallazgo de metástasis en el ganglio centinela dependiendo de su carga tumoral. Resultados: Se recibieron un total de 66 encuestas cumplimentadas de 110 solicitadas (60%). El estudio del ganglio centinela se hace mayoritariamente de forma intraoperatoria (84,8%) y mediante la técnica de OSNA (69,7%). El hallazgo de células tumorales aisladas no conlleva linfadenectomía, aunque hay más variabilidad ante el hallazgo de macrometástasis y, sobre todo, de micrometástasis (en las que se realiza en un 86,3 y un 33,3%, respectivamente). En este sentido resulta llamativa la falta de uniformidad en los criterios para indicar o no la linfadenectomía y la asociación de tratamientos adyuvantes. Conclusiones: En la actualidad existe una gran variabilidad en la actitud ante el hallazgo de enfermedad ganglionar en el ganglio centinela en el cáncer de mama, especialmente en el caso de enfermedad considerada de baja carga tumoral (micrometástasis). Esta variabilidad se refiere tanto a la indicación de completar la linfadenectomía, como a la indicación de tratamientos adyuvantes en esos casos concretos (AU)

Aim: The indication for axillary lymphadenectomy has changed as a main aspect in the management of breast cancer in the last few years, overall since the introduction of sentinel node biopsy. The objective of this study was to find out the current attitude as regards the involvement of the sentinel node. Patients and methods: A descriptive study was performed using the data obtained from a survey aimed specifically at Spanish Breast Units as regards the surgical and adjuvant treatment decisions made when sentinel node metastases were found. Results: Sixty-six (60%) of the 110 questionnaires sent out were completed. Sentinel node analysis is mainly performed during surgery (84.8%) and by using the one-step nucleic acid amplification assay (OSNA) (69.7%). The diagnosis of isolated tumour cells does not lead to a lymphadenectomy, although there was a wide variation when macrometastases or micrometastases were found (axillary dissection was performed in 86.3% and 33.3%, respectively). There was notable lack of uniformity in the criteria to indicate whether or not to perform a lymphadenectomy, as well as in the adjuvant therapy combination to use. Conclusions: There is currently a wide variation in the attitudes of different Breast Units toward the finding of disease in the sentinel node, particularly when there is a low tumour load (micrometastases). This variability was seen in the indication of axillary lymphadenectomy as well as in the indication of adjuvant therapies in these cases (AU)

A pilot study to examine the experiences and attitudes of women with breast cancer towards one versus two-step axillary surgery.

PURPOSE: To elicit the views, experiences and preferences of women with clinically node negative breast cancer towards intra-operative sentinel lymph node biopsy (SLNB) analysis. METHODS: Focus groups with 14 women with breast cancer from two UK centres; one group had undergone the standard practice of waiting two weeks for results of their axillary surgery, the other had experienced the intra-operative SLNB analysis. RESULTS: Women generally were unaware about their lymph nodes, what their function is and how they are removed. Preference was indicated for intra-operative sentinel lymph node biopsy (SLNB) analysis provided clear descriptions were given about the risk of experiencing false negative and false positive results. DISCUSSION: Adopting an intra-operative analysis technique of axillary nodes was viewed as an excellent option by women from both centres. The immediacy of knowing the results was seen as a great advantage for their physical and psychological well being and more cost effective.

Sentinel lymph node biopsy and melanoma: 2010 update Part I.

UNLABELLED: Sentinel lymph node biopsy for melanoma was introduced in the early 1990s as a minimally invasive method of identifying and pathologically staging regional lymph node basins in patients with clinical stage I/II melanoma. Numerous large trials have demonstrated that sentinel lymph node evaluation has utility in improving accuracy of prognostication and for risk stratifying patients into appropriate groups for clinical trials. However, there remains a great deal of controversy regarding the therapeutic role of removal of the remainder of locoregional lymph nodes should metastatic cells be identified in the sentinel node. This CME article will outline a brief history of the sentinel node concept before reviewing updates in surgical technique, histopathologic evaluation of nodal tissue, and cost effectiveness of sentinel node biopsy. LEARNING OBJECTIVES: After completing this learning activity, participants should be able to describe the concept of sentinel lymph node biopsy, to discuss the risks and benefits associated with this procedure, and to summarize the role of sentinel lymph node biopsy in management of patients with melanoma.

[Evaluation of the anxiety state in patients receiving radioiodine treatment or who undergo a sentinel lymph node examination in the Nuclear Medicine Department]. / Valoración del estado de ansiedad de los pacientes que reciben un tratamiento con radioyodo o son sometidos a una exploración de ganglio centinela en el servicio de Medicina Nuclear.

OBJECTIVE: To analyze the presence of anxiety in patients referred to a Nuclear Medicine Department (NMD). MATERIAL AND METHODS: A total of 148 patients were included: 67 were referred for radioiodine therapy, 48 with hyperthyroidism (HT), 19 with differentiated thyroid carcinoma (DTC), and 81 were referred for detection and biopsy of the sentinel node in breast cancer (BC). The following documents were filled out: personal data, a state-trait anxiety inventory, a scale of pre-disposing factors causing anxiety and an information questionnaire. Anxiety-predisposing factors and the influence of the information on the presence of anxiety were studied. RESULTS: HT patients: 47% had anxiety in the moment of the visit that was not related to the level of information received. The factor that worried them the most was the radioiodine administration. Being the first visit to a NMD significantly influenced (p<0.05) on the presence of anxiety. DTC patients: 42% had anxiety in the moment of the visit not related to the level of information received. The factor that worried them the most was the illness itself. No factor had a significant influence on the presence of anxiety. BC patients: 53% had anxiety in the moment of the visit that was not related to the level of information received. What worried them the most were the results. Having anxiety and/or depression significantly influenced (p<0.05) the presence of anxiety. CONCLUSION: The quantity of information given before a procedure in a NMD does not influence on the presence of anxiety. Nevertheless, it is our duty to give the best possible information.

Informational needs of patients with melanoma and their views on the utility of investigative tests.

BACKGROUND: The aim of the study was to identify the informational needs of patients with melanoma on disease status and prognosis, and to ascertain their views on the utility of positron emission tomography (PET) and sentinel node biopsy (SNB). PATIENTS AND METHODS: Patients attending the weekly melanoma outpatient clinic at St Thomas' Hospital London UK between February and August 2007 participated in this cross-sectional survey. Views of 106 melanoma patients were elicited using a face-to face semi-structured questionnaire. RESULTS: The majority of participants wanted to know everything about their disease (88%). Prognostic information (> 85%) and information on palliative care input (97%) were highly valued. More than 50% expected the doctor to impart this information without negotiation. Nearly 70% of the responders who had previously had a PET scan felt they should decide if and when the scans should be performed. Fifty three percentage had undergone the SNB because the doctor had suggested it. CONCLUSIONS: Patients with melanoma want detailed and prompt information about their disease including prognosis. Regular PET scans provide reassurance. The role of SNB is not clear to all patients.

Patients' view on intraoperative diagnosis of sentinel nodes in breast cancer: is it an automatic choice?

UNLABELLED: Intraoperative detection of sentinel node metastases in breast cancer enables immediate axillary lymph node dissection. This approach, however, introduces uncertainty for patients as to the extent of surgery. Waking to find a surgical drain implies more extensive surgery and worse prognosis disease. False negative diagnoses may cause disappointment. AIM: To evaluate patients' views and preferences on intraoperative diagnosis of sentinel nodes in breast cancer. METHODS: Questionnaire based survey of 100 patients who had previously undergone sentinel node biopsy with intraoperative diagnosis using touch imprint cytology (TIC). Patients were encouraged to add free text comments. RESULTS: Sixty-four patients responded to the questionnaire. Patients rated the information provided and their understanding of the procedure highly. Fifty-nine percent of respondents overestimated the sensitivity of TIC. Ninety-five percent of patients would choose to undergo intraoperative diagnosis in future if required. Five percent of patients would choose not to undergo intraoperative diagnosis, citing the resultant uncertainty, disappointment on waking and needing time to come in terms with the diagnosis of metastases as reasons. CONCLUSION: Given the choice, most patients would choose intraoperative diagnosis, though a minority would explicitly not, due to the adverse psychological effect thereof. Despite a good understanding of the procedure, the majority of patients overestimate the sensitivity of intraoperative diagnosis of sentinel nodes, which may heighten disappointment when a false negative diagnosis occurs. Intraoperative diagnosis should not be the automatic choice and patients should be actively involved in this decision making process.

Quality of life after sentinel lymph node biopsy in early breast cancer.

AIM: This study assessed the effects of multiple therapeutic factors on quality of life (QOL) in the treatment of breast cancer. METHODS: We surveyed 179 recurrence-free women with early breast cancer who had undergone a sentinel lymph node procedure, between January 1999 and June 2001. Age, tumour size, breast and axillary procedure, nodal status, chemotherapy, supra-clavicular fossa radiotherapy, and hormone therapy were tested as possible factors associated with poor QOL. RESULTS: Information on QOL was obtained for 148 out of 179 patients. Age less than 55 years and chemotherapy were factors associated with impairment of physical well-being. Tumour size was associated with poor socio-familial well-being. Factors associated with altered arm subscale scores were age <55, axillary procedure, nodal status, chemotherapy and supra-clavicular fossa radiotherapy. Unexpectedly, sentinel lymph node (SLN) procedure delayed the onset of chemotherapy if the metastatic status of SLN was not diagnosed intra-operatively. CONCLUSION: Efforts are needed to improve the QOL of young patients. Axillary procedure affects only QOL related to arm morbidity.

The learning curve for sentinel node biopsy in malignant melanoma.

Sentinel node biopsy (SNB) has emerged as an accurate means of identifying nodal micrometastasis in cutaneous melanoma. In order to assess our learning curve, we compared our first 30 cases with our subsequent 30 cases. A total of 60 patients underwent SNB for cutaneous melanoma, using preoperative lymphoscintigraphy together with the intraoperative use of a Neoprobe and Patent Blue V dye. At least one sentinel node was identified in 93% of patients (90% in our first 30 cases; 97% in our subsequent 30 cases). Sentinel nodes contained tumour in 21% of cases. Of the sentinel nodes that contained tumour in the first 30 cases, 87% were identified by Neoprobe examination and 60% using blue dye. In the second 30 cases, the tumour-containing sentinel nodes were identified in all cases by both the Neoprobe and the blue dye. The sentinel node appeared to be the only involved node in 71% of patients. In the first 30 patients, one patient with a negative sentinel node developed nodal recurrence. These data confirm the feasibility of the sentinel-node technique in cutaneous melanoma. However, there is a learning curve, and the technique should be performed only by limited numbers of people with suitable training.

Psychosocial benefits of sentinel lymph node biopsy in the management of cutaneous malignant melanoma.

Lymphoscintigraphy combined with sentinel lymph node biopsy has become a powerful and sensitive tool in establishing nodal spread in cutaneous melanoma, as well as in breast and other cancers. Although the technique is reliable and validated, there is, as yet, no proven clinical benefit. A suggested benefit of sentinel lymph node biopsy is that a negative biopsy may decrease the psychological morbidity associated with malignancy by reassuring the patient that he or she has localised disease. We studied a group of patients with cutaneous melanoma who underwent sentinel lymph node biopsy, and found that although they did gain some psychosocial benefit from the procedure, this was short term and they were still significantly concerned about their disease status.

Patient preference for dissection of sentinel nodes outside level I-II of the axilla.

In this study patients' and female doctors' opinions about harvesting sentinel nodes outside the axilla are evaluated and patients' ability to understand the concept of sentinel node biopsy is investigated. Information leaflets and questionnaires were mailed to 100 patients with breast cancer who had undergone sentinel node biopsy and to 300 female doctors. Seventy-three (73%) patients and 148 (49%) female doctors returned the questionnaire. Fifty-eight (79%) breast cancer patients and 71 (48%) female doctors wanted harvesting to be done in order to determine whether the nodes were involved. Sixty-six (90%) patients and 128 (86%) female doctors wanted the procedure if it changed the treatment. Sixty (82%) patients understood the outcome of the sentinel node procedure. Patients with breast cancer seem to value the information gained by harvesting sentinel nodes outside the axilla and want the procedure if there is even the slightest possibility that it might change the adjuvant treatment.

What doctors and patients think about false-negative sentinel lymph nodes in vulvar cancer.

The sentinel lymph node procedure is a relatively new, minimally-invasive method for the assessment of nodal status in malignancies such as breast cancer, cutaneous melanoma and vulvar cancer. Although highly accurate, this new method is inevitably associated with a certain false-negative rate, possibly leading to worse survival in a small subset of patients. The clinical implementation of the sentinel lymph node procedure is therefore a matter of ongoing debate, especially among doctors. The aim of this study was to assess opinions on the acceptable false-negative rate of the sentinel lymph node procedure in patients with vulvar cancer, who in the past had undergone standard routine radical vulvectomy and complete inguinofemoral lymphadenectomy (and frequently experienced complications), and in gynecologists treating patients with vulvar cancer. Structured questionnaires were sent to both patients and gynecologists. The patients had been treated for vulvar cancer between 1985 and 1993, and were all in complete remission with a median follow-up of 118 months (range: 76-185). Questions to the patients dealt with experienced side-effects of the standard treatment and opinion on the acceptable false-negative rate of the sentinel lymph node procedure. The response rate among patients was 91% (106/117). Forty per cent of the patients experienced one or more infections in the legs (cellulitis) and 49% of the patients still experience either severe pain and/or severe lymphedema in the legs. Sixty-six per cent of the patients preferred complete inguinofemoral lymphadenectomy in preference to a 5% false-negative rate of the sentinel lymph node procedure of 5%. Their preference was not related to age or the side-effects they had experienced. The response rate among gynecologists was 80% (80/100), of whom 60% were willing to accept a 5-20% false-negative rate of the sentinel lymph node procedure. While gynecologists may consider the sentinel lymph node procedure to be a promising diagnostic tool, the majority of vulvar cancer patients, who have undergone complete inguinofemoral lymphadenectomy in the past and have frequently experienced complications, would not advise introduction of this technique because they do not want to take any risk of missing a lymph node metastasis.

Methodological questions in sentinel lymph node analysis in breast cancer patients.

BACKGROUND: The sentinel lymph node (SLN) procedure has been proposed to women with breast cancer with clinically negative axillary lymph nodes, in order to avoid conventional axillary lymph node dissection and its associated side-effects. Methodological aspects of the validation of the SLN procedure are questioned here. MATERIALS AND METHODS: The results of relevant published studies are reviewed, with emphasis on pathological techniques. The ability of the SLN procedure to diagnose lymph node metastases, the extent to which axillary lymph node dissection contributes to treatment, apart from identification of the stage, and the effect of a modified staging procedure on treatment strategies are analyzed. RESULTS AND CONCLUSION: Both the sensitivity and the negative predictive value of the SLN procedure are overestimated if the probability of missing lymph node metastases is not taken into account, even when a complete axillary dissection is performed as a control. The SLN strategy and its effects on staging and treatment cannot be evaluated by comparison with conventional axillary lymph node dissection in a one-arm study but require carefully designed randomized trials.