Melanoma Patient-Reported Quality of Life Outcomes Following Sentinel Lymph Node Biopsy, Completion Lymphadenectomy, and Adjuvant Interferon: Results from the Sunbelt Melanoma Trial.

BACKGROUND: Quality of life (QOL) and physical condition (PC) outcomes after sentinel lymph node biopsy (SLNB), completion lymph node dissection (CLND), and adjuvant therapy with interferon alfa-2b (IFN) were evaluated in this study. METHODS: Self-reported QOL and PC scores were evaluated in patients enrolled in a prospective, multicenter, randomized, clinical trial evaluating adjuvant IFN. After SLN biopsy, patients with a positive SLN underwent CLND then were randomized to adjuvant IFN or observation. QOL and PC scores were compared between patients who underwent SLNB alone, CLND without IFN, and CLND with IFN. Time to return to baseline QOL and PC scores reported at the time of SLNB was recorded and compared. RESULTS: There were statistically significant differences in time to return to baseline QOL (p = 0.0018) and PC (p = 0.0018) scores across the three treatment groups. The time to return to baseline QOL and PC scores was similar for SLND and CLND alone. Differences in time to return to baseline QOL and PC were sustained when stratified by recurrence status but did not differ significantly for different lymph node regions. There was a delay in return to baseline QOL and PC condition scores that was sustained beyond the cessation of IFN therapy. CONCLUSIONS: CLND is well-tolerated with a similar effect on self-reported QOL outcomes in both the short- and long-term compared with SLNB alone. IFN therapy is associated with worse QOL outcomes compared with SLNB and CLND, an effect that may be sustained following cessation of adjuvant IFN.

The lymph node ratio has limited prognostic significance in melanoma.

BACKGROUND: The importance of the lymph node ratio (LNR) after regional lymphadenectomy for cutaneous melanoma is unknown. MATERIALS AND METHODS: A post hoc analysis was performed for patients after the completion of lymphadenectomy for cutaneous melanoma. LNR was calculated as the number of tumor-positive nodes divided by the total number of lymph nodes. Comparison of disease-free survival (DFS) and overall survival (OS) and univariate and multivariate analyses with regard to LNR was performed. Comparison of the performance of LNR to other measurements of lymph node disease was performed. RESULTS: A LNR of 0.10 was a significant cutoff point for determining DFS and OS. On multivariate analysis, LNR >0.10 was an independent predictor of DFS and OS without other measures of lymph node disease burden. Patients with LNR >0.10 had worse DFS and OS. Absolute counts of tumor-positive lymph nodes differentiated survival differences better than LNR. LNR was not a significant predictor of survival in patients with neck or axillary dissections but was for inguinal dissections. In multivariate analysis of alternative nodal measures, LNR was an inferior prognostic factor. CONCLUSIONS: A LNR >0.10 has a negative prognostic significance when it is the only measurement of lymph node disease considered but is an inferior prognostic factor to alternative measures of lymph node disease.

Final Analysis of a Phase 2 Trial of Once Weekly Hypofractionated Whole Breast Irradiation for Early-Stage Breast Cancer.

PURPOSE: We hypothesize that 5-fraction once weekly hypofractionated (WH) whole breast irradiation (WBI) would be safe and effective after breast-conserving surgery for medically underserved patients with breast cancer. We report the protocol-specified primary endpoint of in-breast tumor recurrence (IBTR) at 5 years. METHODS AND MATERIALS: After provided informed consent, patients were treated with WH-WBI after breast-conserving surgery were followed prospectively on an institutional review board-approved protocol. Women included in this study had stage 0-II breast cancer treated with negative surgical margins and met prespecified criteria for being underserved. WH-WBI was 28.5 or 30 Gy delivered to the whole breast with no elective coverage of lymph nodes. The primary endpoint was IBTR at 5 years. Secondary endpoints were distant disease-free survival, recurrence-free survival, overall survival, adverse events, and cosmesis. RESULTS: One hundred fifty-eight patients received WH-WBI on protocol from 2010 to 2015. Median follow-up was 5.5 years (range, 0.2-10.0 years). Stage distribution was 22% ductal carcinoma in situ, 68% invasive pN0, and 10% invasive pN1. Twenty-eight percent of patients had grade 3 tumors, 10% were estrogen receptor negative, and 24% required adjuvant chemotherapy. There were 6 IBTR events. The 5-, 7-, and 10-year risks of IBTR for all patients were 2.7% (95% confidence interval [CI], 0.89-6.34), 4.7% (95% CI, 1.4-11.0) and 7.2% (95% CI, 2.4-15.8), respectively. The 5-, 7-, and 10-year rates of distant disease-free survival were 96.4%, 96.4%, and 86.4%; the recurrence-free survival rates were 95.8%, 93.6%, and 80.7%; and the overall survival rates were 96.7%, 88.6%, and 76.7%, respectively. Improvement in IBTR-free time was seen in ductal carcinoma in situ, lobular histology, low-grade tumors, T1 stage, Her2-negative tumors, and receipt of a radiation boost to the lumpectomy bed. CONCLUSIONS: Postoperative WH-WBI has favorable disease-specific outcomes that are comparable to those seen with conventional and moderately hypofractionated radiation techniques. WH-WBI could improve access to care for underserved patients with stage 0-II breast cancer.

Factors Influencing Time to Decrease in Intraoperative Parathyroid Hormone (ioPTH) Levels in Patients Undergoing Focused Parathyroidectomy (FP).

The aim of this study was to evaluate potential factors affecting the time period in which a 50 per cent parathyroid hormone (PTH) drop is observed. Eight-seven patients undergoing focused parathyroidectomy between 2011 and 2015, whose PTH values dropped to within normal range, were grouped according to whether they required > or ≤15 minutes after gland excision to achieve a 50 per cent PTH. Groups were compared according to preoperative PTH, calcium, age, glomerular filtration rate, and adenoma weight. Lower preoperative and preincision PTH levels were associated with requiring >15 minutes to achieve a >50 per cent drop in ioPTH. Time to >50 per cent ioPTH drop did not affect cure rates at one year, though a >15 minutes requirement was associated with higher serum calcium levels (P = 0.015). Lower baseline PTH and preincision PTH levels are significantly associated with a >15 minutes postexcision time to achieve a >50 per cent drop in ioPTH. Future analyses are warranted to determine whether a longer postexcision time threshold before proceeding with four-gland exploration is warranted in patients with primary hyperparathyroidism and mildly elevated preoperative PTH.

First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer.

PURPOSE: To report early outcome analysis of a prospective institutional phase 2 trial of weekly hypofractionated breast irradiation (WHBI) for patients undergoing breast-conserving surgery (BCS). METHODS AND MATERIALS: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins received whole-breast radiation therapy to 30 or 28.5 Gy in 5 weekly fractions with or without an additional boost. The eligibility criteria were the same as for NSABP (National Surgical Adjuvant Breast and Bowel Project) B39/RTOG (Radiation Therapy Oncology Group) 0413, and there were no restrictions on age, breast size, tumor grade, receptor status, or the use of cytotoxic chemotherapy for otherwise eligible patients. The primary endpoint was ipsilateral breast tumor recurrence. Patients were also evaluated for acute toxicity (Common Terminology Criteria for Adverse Events version 3.0), cosmesis (Harvard Scale), development of distant metastatic disease, and overall survival. RESULTS: Between January 2011 and October 2015, 158 eligible patients underwent WHBI immediately following BCS. The median age was 60 years (range, 30-84 years), and the median follow-up period was 3 years. Ipsilateral breast tumor recurrence developed in a total of 2 patients (1.3%), 1 in conjunction with widespread metastatic disease. Distant metastatic disease developed in 4 patients (2.5%), and the 3-year disease-free survival and overall survival rates were 97.5% and 96.2%, respectively. The most common grade 1 or 2 acute toxicities were breast pain, radiation dermatitis, and fatigue. There were 2 grade 3 events (1.3%): pain requiring narcotic analgesics (1) and posttreatment infection requiring hospitalization (1). The rate of excellent or good cosmesis versus fair or poor cosmesis was 82.3% versus 17.7%. The rate of significant cosmetic change from baseline to last follow-up (dropping from excellent or good to fair or poor) was 11.6%. CONCLUSIONS: Early outcomes after WHBI are favorable and parallel those seen with daily hypofractionated whole-breast irradiation. With broader entry criteria than all previous reports of WHBI, this study will facilitate comparison to the results of NSABP B39/RTOG 0413. With continued follow-up, future reports will assess cosmetic stability and disease-specific outcomes.

Prognostic factors in melanoma patients with tumor-negative sentinel lymph nodes.

BACKGROUND: Sentinel lymph node (SLN) biopsy for melanoma results in accurate nodal staging, which guides treatment decisions. Patients with a negative SLN biopsy in general have a favorable prognosis, but certain subsets are at increased risk for recurrence and death. This study aimed to identify risk factors predictive of prognosis in patients with a tumor-negative SLN biopsy for cutaneous melanoma. METHODS: In this post-hoc analysis of data from a multicenter prospective randomized trial, clinicopathologic data of patients with cutaneous melanoma ≥1.0 mm Breslow thickness and tumor-negative SLN were analyzed. Disease-free survival, overall survival (OS), and local and in-transit recurrence-free survival were compared by Kaplan-Meier analysis. Risk factors for worse survival were identified with Cox proportional hazard models. RESULTS: This analysis included 1,998 patients with tumor-negative SLN with a median follow-up of 70 months. Ulceration, Breslow thickness, nonextremity tumor location, and age ≥45 years were independent risk factors for worse disease-free survival and OS. Breslow thickness and ulceration were the only factors on multivariate analysis that predicted local and in-transit recurrence-free survival. Estimated 5-year OS rates ranged from 55.5 to 95.4% on the basis of the defined risk factors. CONCLUSION: There is a wide range of prognosis among patients with tumor-negative SLN. Breslow thickness, ulceration, age, and anatomic location of the primary melanoma are important independent factors predicting survival and recurrence among such patients. These factors can be used to stratify prognosis among patients with tumor-negative SLN to formulate rational long-term follow-up strategies as well as identify high-risk, SLN-negative patients for clinical trials of adjuvant therapy.

Efficacy of concurrent chemoradiotherapy for patients with locally recurrent or advanced inoperable breast cancer.

BACKGROUND: This study aimed to assess the efficacy and safety of chemoradiotherapy (CRT) for locally recurrent or advanced inoperable breast cancer. PATIENTS AND METHODS: Twenty patients treated between 2009 and 2013 were reviewed from a prospectively collected database. All patients had symptomatic recurrent or advanced breast cancer and had been deemed not to be ideal operative candidates. Treatment consisted of external beam radiotherapy to the primary tumor in the breast or regional lymph nodes, or both, concurrent with either capecitabine, paclitaxel, or cisplatin/etoposide chemotherapy. The grade of acute and late toxicity was evaluated, as was response to treatment, overall survival (OS), and local relapse-free survival (LRFS). RESULTS: Of the 20 patients, 9 (45%) presented with primary disease and 11 (55%) had recurrent disease. A total of 11 (55%) patients had evidence of metastatic disease. The overall clinical response rate was 100%, with a clinical complete response (CR) observed in 65% of patients and a clinical partial response (PR) observed in 35% of patients. At a median follow up of 25.3 months, 2-year LRFS was 73% and 2-year OS was 80%. Local control was significantly better in patients with an initial diagnosis (hazard ratio [HR], 0.139; 95% confidence interval [CI], 0.014-0.935) and in those who had not had previous in-field radiation (HR, 0.011; 95% CI, 0.005-0.512). The only grade ≥ 3 toxicity was acute dermatologic events (30%) and late dermatologic (15%) events. CONCLUSION: Concurrent CRT with capecitabine, paclitaxel, or cisplatin/etoposide for recurrent or advanced inoperable breast cancer is well tolerated with impressive clinical response rates and durable local control.

Operative failure rate and documentation of family history in young patients undergoing focused parathyroidectomy for primary hyperparathyroidism.

Primary hyperparathyroidism in multiple endocrine neoplasia type I usually affects all parathyroid glands, making focused parathyroidectomy (FP) inappropriate. The risk of previously undiagnosed multiple endocrine neoplasia type I in a younger patient with primary hyperparathyroidism is higher than in an older patient. We hypothesized that FP may lead to a higher failure rate in younger versus older patients. A retrospective review was performed of a single-institution database of patients who underwent parathyroidectomy for primary hyperparathyroidism. Routine statistical analysis was performed, including Fisher's exact test. A total of 635 patients were included. Operative failure occurred in 7/55 (13%) younger patients and 21/580 (4%) older patients (P = 0.007). In conclusion, operative failure occurred in a statistically significantly higher percentage of younger versus older patients undergoing FP. This is partly explained by undiagnosed multiple endocrine neoplasia syndrome type I in the younger patient group. Endocrine surgeons must make every effort to preoperatively identify multiple endocrine neoplasia syndrome type I in the younger patient population.

Delay of adjuvant chemotherapy after elective mastectomy and immediate reconstruction in breast-conservation candidates: a matched-pair analysis.

OBJECTIVES: To analyze factors that influence the timing of adjuvant chemotherapy in patients who are candidates for breast-conservation therapy (BCT) but elect mastectomy with immediate reconstruction (M-IR). METHODS: We identified 35 consecutively treated patients with stage I or II breast cancer between 2004 and 2009 who underwent M-IR and adjuvant chemotherapy from the University of Louisville Cancer Registry. We matched these patients for age and AJCC stage to 35 controls who underwent BCT and adjuvant chemotherapy. We examined the timing and delay of initiation of chemotherapy using univariate logistic regression and McNemar test for matched pairs. RESULTS: For the 70 patients evaluated, the median age was 46 years (range, 30 to 65 y), and the distribution for stage I, IIA, and IIB was 22.9%, 65.7%, and 11.4%, respectively. The 2 groups were well balanced in terms of race, rural/urban status, smoking, diabetes, insurance coverage, and histology. For BCT and M-IR, the median time to chemotherapy initiation was 38 days (range, 25 to 103 d) and 55 days (range, 30 to 165 d), respectively. Patients undergoing M-IR were more likely to experience any delay (>45 d; 54.3% vs. 22.9%; P<0.001) and/or significant delay (>90 d; 20.0% vs. 2.9%; P<0.001). On univariate logistic regression analysis, surgery type had a major impact on delay of chemotherapy (odds ratio=8.35; 95% confidence interval, 2.86-24.4; P<0.001). CONCLUSIONS: The use of M-IR in breast-conservation candidates independently predicts for delay in initiation of adjuvant chemotherapy. Further study is needed to qualify the causes and clinical significance of these delays.

Addition of an iliac/obturator lymph node dissection does not improve nodal recurrence or survival in melanoma.

BACKGROUND: Controversy exists regarding the value and indications for inguinal dissection alone or in combination with an iliac/obturator lymph node dissection for melanoma. STUDY DESIGN: We reviewed patients from a multicenter prospective clinical trial and a single center who underwent inguinal dissection alone or combined with an iliac/obturator dissection for cutaneous melanoma. Analyses were stratified and compared by microscopic or macroscopic (palpable or detected by imaging) disease. RESULTS: The study was composed of 134 patients with a median follow-up of 39 months. Indications for inguinal dissection were microscopic disease in 94 (70%) patients and macroscopic nodal disease in 40 (30%) patients. An iliac/obturator dissection yielded tumor-positive pelvic nodes in 25% vs 55% in the microscopic vs macroscopic groups, respectively (p = 0.10). No risk factors for positive pelvic nodes were identified. For both microscopic and macroscopic disease, addition of an iliac/obturator dissection to an inguinal dissection did not significantly reduce the risk of pelvic nodal recurrence. Five-year overall survival rates for 4 groups were compared: microscopic disease, inguinal dissection alone (72%); microscopic disease, iliac/obturator dissection (68%); macroscopic disease, inguinal dissection alone (51%); and macroscopic disease, iliac/obturator dissection (44%) (p = 0.0163). On survival analysis, addition of an iliac/obturator dissection in either microscopic or macroscopic disease did not affect disease-free survival or regional lymph node recurrence-free survival. CONCLUSIONS: The addition of an iliac/obturator dissection to an inguinal dissection for both microscopic and macroscopic nodal disease did not significantly affect lymph node recurrence rates, disease-free survival, or overall survival.

Prognostic factors in young women with cutaneous melanoma.

BACKGROUND: Gender is an established prognostic factor in cutaneous melanoma; women as a group have a better overall prognosis than men. However, the investigators hypothesized that melanoma in young women may have distinct clinicopathologic features and biologic behavior compared with melanoma in older women, possibly related to tanning bed use and excessive acute episodes of sun exposure. METHODS: A retrospective analysis was performed of a large multicenter study that accrued patients between 1996 and 2003 and included patients aged 18 to 70 years with cutaneous melanoma ≥1 mm Breslow thickness and no evidence of regional or distant metastatic disease. All women with follow-up data were included. Univariate and multivariate analyses as well as Kaplan-Meier (KM) analysis were performed to test for differences in clinicopathologic variables, disease-free survival (DFS), and overall survival (OS) between female patients ≤40 and >40 years of age. RESULTS: A total of 1,056 female patients were divided into 2 groups: those >40 years of age (n = 757 [71.7%]) and those ≤40 years of age (n = 299 [28.3%]). Overall, there were no differences in Breslow thickness, ulceration, or sentinel lymph node status between groups. Compared with older women, younger women were more likely to have truncal melanomas (39.5% vs 29.5%, P = .0017) and less likely to have regression of the primary tumor (6.4% vs 11.5%, P = .0208). The mean number of sentinel lymph nodes removed was 2.82 for younger women and 2.29 for older women (P < .0001). Multivariate analysis revealed that Breslow thickness, ulceration, and tumor-positive sentinel lymph node were associated with worse DFS in both the younger and older groups; truncal location was associated with worse DFS in the younger group only. The same factors were predictive of OS in both groups, except that ulceration was not significant in the younger patient group. In the younger patient group, the 5-year KM DFS rates were 78.1% for truncal melanomas and 92.5% for nontruncal melanoma locations (P = .0009); the corresponding 5-year KM OS rates were 76.6% and 93.9% (P = .0003). In the older patient group, the 5-year KM DFS rates were 84.1% for truncal and 82.8% for nontruncal melanomas (P = NS), and the corresponding 5-year KM OS rates were 81.6% and 87.5% (P = .0049). CONCLUSIONS: Although women with cutaneous melanoma tend to have a better prognosis than men, women ≤40 years of age with primary melanoma of the trunk may represent a subgroup at higher risk for disease recurrence and metastasis.

A phase 2 trial of once-weekly hypofractionated breast irradiation: first report of acute toxicity, feasibility, and patient satisfaction.

PURPOSE: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). METHODS AND MATERIALS: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). RESULTS: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity-pain requiring a course of narcotic analgesics-was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. CONCLUSIONS: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.

Outcomes and prognostic factors in superficial spreading melanoma.

BACKGROUND: Prognostic factors and risk factors for positive sentinel lymph node (SLN) biopsy results are important to identify in superficial spreading melanoma (SSM). METHODS: A single-center database and a prospective clinical trial database were reviewed for all patients with diagnoses of SSM. Logistic regression, Kaplan-Meier survival analysis, and univariate and multivariate Cox models were used. RESULTS: A total of 1,643 patients with SSM were identified. Independent risk factors for positive SLN biopsy results were Breslow thickness (BT) ≥2.0 mm, age <60 years, and presence of ulceration. BT ≥2.0 mm, ulceration, lymphovascular invasion, and positive SLN and positive non-SLN biopsy results were independent risk factors for worse disease-free survival. Independent overall survival risk factors included BT ≥2.0 mm, age ≥60 years, ulceration, nonextremity tumor location, lymphovascular invasion, and positive SLN biopsy results. CONCLUSIONS: BT, ulceration, lymphovascular invasion, and SLN and non-SLN status are important risk factors for SSM.

Incidence of sentinel lymph node involvement in a modern, large series of desmoplastic melanoma.

BACKGROUND: Recent studies have suggested that sentinel lymph node (SLN) biopsy is of limited value in desmoplastic melanoma. This study was performed to compare the rate of positive SLN biopsy in the Surveillance, Epidemiology, and End Results (SEER) database with that of a multi-institutional clinical trial and to investigate relevant prognostic factors in desmoplastic melanoma. STUDY DESIGN: Patients with desmoplastic melanoma ≥1.0 mm Breslow thickness, who underwent SLN biopsy in a multi-institutional prospective clinical trial, were combined with a single institution melanoma database (combined database) and compared with patients from the SEER database (1998 to 2009). Disease-free survival (DFS) and overall survival (OS) were summarized using Kaplan-Meier curves and compared using Cox proportional hazard models. RESULTS: The rate of positive SLN in the combined database was 17.0% (8 of 47). By comparison, the rate of positive SLN in SEER was lower: 2.5% (15 of 594). On multivariable analysis, Breslow thickness ≥2.6 mm (hazard ratio 8.17, 95% CI 1.26 to 160.1; p = 0.0259) and an interaction between SLN status and ulceration (p = 0.0013) were independent risk factors for worse OS in the combined database; patients with ulceration and a positive SLN had significantly worse OS. In the combined database on multivariable analysis, SLN positivity (p = 0.0161) and ulceration (p = 0.0004) were independent risk factors for worse DFS. CONCLUSIONS: The rate of positive SLN in desmoplastic melanoma may be higher than that reported in the SEER database. Sentinel lymph node biopsy may be considered as part of the comprehensive staging of desmoplastic melanoma ≥1.0 mm Breslow thickness.

Implications of anomalous pectoralis muscle in reconstructive breast surgery: the oblique pectoralis anterior.

INTRODUCTION: Many case reports have described anatomical variants of the pectoralis muscles. However, there is a paucity of published literature on the consequence of such presentations in reconstructive breast surgery. METHODS: A 45-year-old female patient with breast cancer presented for left mastectomy and immediate reconstruction with tissue expander. During mastectomy, she was noted to have an extra muscle anterior to her pectoralis major muscle. This variant had not previously been described in the literature and was therefore named the oblique pectoralis anterior. After inspection of the aberrant musculature, the decision was made to release the inferolateral insertion of the accessory muscle with the inferior edge of pectoralis major. An adequate pocket for the expander was created. RESULTS: After routine expansion and implant exchange, muscular coverage of the implant from pectoralis major and the oblique pectoralis anterior muscle approximated 70%. The patient was left with good symmetry and a cosmetic result, despite the challenges presented by her anomalous chest wall musculature. DISCUSSION: Prior knowledge of the various anatomic aberrations described in the literature can prepare a surgeon to properly incorporate and utilize the variant anatomy, should it be encountered, to benefit the outcome of the operation.

Unique prognostic factors in acral lentiginous melanoma.

BACKGROUND: This study was performed to identify clinicopathologic factors associated with survival in acral lentiginous melanoma. METHODS: A post hoc analysis of a prospective clinical trial and local database was performed in all patients with acral lentiginous melanomas. Multivariate analyses of factors associated with a tumor-positive sentinel lymph node (SLN) biopsy, disease-free survival (DFS), overall survival (OS), and local and in-transit recurrence-free survival (LITRFS) were performed. Kaplan-Meier survival analyses were performed. RESULTS: Eighty-five patients were identified. Age younger than 59 years and Breslow thickness (BT) of 2.0 mm or greater were independent risk factors for a positive SLN. SLN status was the only independent risk factor for DFS and LITRFS on multivariate analysis. A BT of 2.0 mm or greater was the only independent risk factor for OS. SLN status distinguished differences in DFS, OS, and LITRFS on Kaplan-Meier analysis. CONCLUSIONS: SLN status is the dominant factor for recurrence and survival in acral lentiginous melanoma. BT and ulceration are less important in this histologic subtype.

Outcomes and prognostic factors in nodular melanomas.

BACKGROUND: The nodular subtype of cutaneous melanoma has a more pronounced vertical phase and less of a radial growth phase compared with other histologic subtypes. This study was performed to determine prognostic factors and outcomes for nodular melanomas. METHODS: A post hoc analysis of a prospective clinical trial was performed in all patients with nodular histologic subtype. Univariate and multivariate analyses of factors associated with disease-free survival (DFS), overall survival (OS), and local and in-transit recurrence-free survival (LITRFS) were performed. Kaplan-Meier survival analyses were performed. RESULTS: There were 736 patients available for analysis, and 189 (25.7%) were sentinel lymph node (SLN) positive. Breslow thickness of ≥2.3 mm, presence of ulceration, nonextremity tumor location, positive SLN, and non-SLN-positive status were independent risk factors for worse OS and DFS. Kaplan-Meier analysis demonstrated that ulceration predicted worse OS and DFS in all nodular melanoma patients, and in both SLN-positive and -negative subsets. The presence of ulceration and a positive SLN together predicted significantly worse DFS and OS. CONCLUSION: The most important risk factors that determine prognosis in nodular melanomas are SLN status and ulceration. The presence of both a positive SLN and ulceration significantly affect DFS and OS, and to a lesser degree LITRFS.

Clinicopathologic and survival differences between upper and lower extremity melanomas.

This analysis was performed to compare differences in clinicopathologic factors, sentinel lymph node (SLN) status, and survival between upper extremity (UE) and lower extremity (LE) melanoma patients. Post hoc analysis of a prospective clinical trial was performed of all patients with extremity melanomas with complete data. Survival was evaluated with Kaplan-Meier analysis. Univariate and multivariate analyses were performed. A total of 1115 patients aged 18 to 70 years with extremity melanomas ≥ 1.0 mm Breslow thickness were analyzed; all underwent SLN biopsy with completion lymphadenectomy for a tumor-positive SLN. Compared with UE patients, LE melanoma patients were younger, predominantly female, and had a higher rate of SLN metastasis. Kaplan-Meier analysis revealed worse 5-year disease-free survival (DFS) and worse local and in-transit recurrence-free survival in LE versus UE melanoma patients, but no difference in overall survival (OS). Subgroup analysis revealed that older patients (age > 51 years) with LE melanomas had worse DFS, local and in-transit recurrence-free-survival, and OS. LE tumor location was not an independent risk factor for OS or DFS. Compared with UE melanoma patients, those with LE melanomas have a greater risk of tumor-positive SLN and local/in-transit recurrence.

Minimally invasive parathyroid surgery, the Norman 20% rule: is it valid?

The 20 per cent rule proposed by Norman established a guideline using radioactivity in the minimally invasive radioguided parathyroidectomy (MIRP) technique to localize and confirm removal of an abnormal parathyroid gland in patients with primary hyperparathyroidism. If radioactivity in the resected gland was at least 20 per cent of excision site/background radioactivity, the 20 per cent rule was satisfied. Patients meeting these criteria underwent unilateral MIRP without intraoperative parathyroid hormone assay or intraoperative frozen section. The study aim was to independently evaluate the 20 per cent rule in MIRP patients with primary hyperparathyroidism. Using the University of Louisville Parathyroid Database from January 1, 1999 to December 31, 2007, 216 MIRP patients with complete radioguided and postoperative management data were identified. The average percentage of ex vivo parathyroid gland radioactivity compared with excision site/background radioactivity was 107 per cent with a range from 14 to 388 per cent. For 99 per cent (196/198) radioactivity recorded from the excised gland was at least 20 per cent of radioactivity recorded from the excision site. Normocalcemia was documented in 98.5 per cent (195/198) at 12 month follow-up. Our data supports the 20 per cent rule in that in 99 per cent of MIRP patients the resected gland radioactivity was at least 20 per cent of excision site radioactivity allowing localization and confirmation of an overactive gland without intraoperative parathyroid hormone monitoring or tissue analysis.