Phase III Randomized Study of 4 Weeks of High-Dose Interferon-α-2b in Stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E1697).

Purpose To test the efficacy of 4 weeks of intravenous (IV) induction with high-dose interferon (IFN) as part of the Eastern Cooperative Oncology Group regimen compared with observation (OBS) in patients with surgically resected intermediate-risk melanoma. Patients and Methods In this intergroup international trial, eligible patients had surgically resected cutaneous melanoma in the following categories: (1) T2bN0, (2) T3a-bN0, (3) T4a-bN0, and (4) T1-4N1a-2a (microscopic). Patients were randomly assigned to receive IFN α-2b at 20 MU/m/d IV for 5 days (Monday to Friday) every week for 4 weeks (IFN) or OBS.

Localization Methods for Excisional Biopsy in Women With Nonpalpable Mammographic Abnormalities.

Introduction: With the advent and proliferation of breast cancer screening programs, more women are being diagnosed with mammographic abnormalities that require tissue diagnosis. If imaged-guided biopsy is not possible or previous image-guided biopsies reveal pathologies that require more extensive surgery, guided excisional biopsy/lumpectomy may be necessary.

Methods: Fifteen women were enrolled in the study of the feasibility of off-site or day-before wire-localization excisional biopsy of the breast with mammographic abnormalities.

Final Results of the Sunbelt Melanoma Trial: A Multi-Institutional Prospective Randomized Phase III Study Evaluating the Role of Adjuvant High-Dose Interferon Alfa-2b and Completion Lymph Node Dissection for Patients Staged by Sentinel Lymph Node Biopsy.

Purpose: The Sunbelt Melanoma Trial is a prospective randomized trial evaluating the role of high-dose interferon alfa-2b therapy (HDI) or completion lymph node dissection (CLND) for patients with melanoma staged by sentinel lymph node (SLN) biopsy.

Patients And Methods: Patients were eligible if they were age 18 to 70 years with primary cutaneous melanoma ≥ 1.0 mm Breslow thickness and underwent SLN biopsy.

Comparison of sentinel lymph node micrometastatic tumor burden measurements in melanoma.

Background: Multiple methods have been proposed to classify the micrometastatic tumor burden in sentinel lymph nodes (SLN) for melanoma. The purpose of this study was to determine the classification scheme that best predicts nonsentinel node (NSN) metastasis, disease-free survival (DFS), and overall survival (OS).

Study Design: A single reviewer reanalyzed tumor-positive SLN from a multicenter, prospective clinical trial of patients with melanoma ≥ 1.

Diversity of stage III melanoma in the era of sentinel lymph node biopsy.

Background: Sentinel lymph node (SLN) biopsy for melanoma often detects minimal nodal tumor burden. Although all node-positive patients are considered stage III, there is controversy regarding the necessity of adjuvant therapy for all patients with tumor-positive SLN.

Methods: Post hoc analysis was performed of a prospective multi-institutional study of patients with melanoma ≥ 1.

Metastasectomy for distant metastatic melanoma: analysis of data from the first Multicenter Selective Lymphadenectomy Trial (MSLT-I).

Background: For stage IV melanoma, systemic medical therapy (SMT) is used most frequently; surgery is considered an adjunct in selected patients. We retrospectively compared survival after surgery with or without SMT versus SMT alone for melanoma patients developing distant metastases while enrolled in the first Multicenter Selective Lymphadenectomy Trial.

Methods: Patients were randomized to wide excision and sentinel node biopsy, or wide excision and nodal observation.

gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma.

Background: Stimulating an immune response against cancer with the use of vaccines remains a challenge. We hypothesized that combining a melanoma vaccine with interleukin-2, an immune activating agent, could improve outcomes. In a previous phase 2 study, patients with metastatic melanoma receiving high-dose interleukin-2 plus the gp100:209-217(210M) peptide vaccine had a higher rate of response than the rate that is expected among patients who are treated with interleukin-2 alone.

Ulceration as a predictive marker for response to adjuvant interferon therapy in melanoma.

Objective: This analysis was performed to investigate the hypothesis that ulceration predicts improved response to adjuvant interferon (IFN) therapy.

Summary Background Data: Several studies have demonstrated that adjuvant therapy for high-risk melanoma patients with IFN alfa-2b improves disease-free survival (DFS), although the impact on overall survival (OS) is controversial. Recent data have suggested that IFN therapy may preferentially benefit patients with ulcerated primary melanomas.

Second primary melanomas: incidence and outcome.

The objective of this study was to determine the incidence of multiple primary melanomas (MPM) and other cancers types among patients with melanoma. Factors associated with development of MPM were assessed in a post hoc analysis of the database from a multi-institutional prospective randomized trial of patients with melanoma aged 18 to 70 years with Breslow thickness 1 mm or greater. Disease-free survival (DFS) and overall survival (OS) were evaluated by Kaplan-Meier analysis.

The prognostic significance of nonsentinel lymph node metastasis in melanoma.

Background: We hypothesized that metastasis beyond the sentinel lymph nodes (SLN) to the nonsentinel nodes (NSN) is an important predictor of survival.

Materials And Methods: Analysis was performed of a prospective multi-institutional study that included patients with melanoma ≥ 1.0 mm in Breslow thickness.

Prognostic information from sentinel lymph node biopsy in patients with thick melanoma.

Hypothesis: Sentinel lymph node (SLN) biopsy provides valuable prognostic information for patients with thick (T4) melanoma.

Design: Post hoc analysis of data from a prospective, randomized trial.

Setting: Academic and private hospitals.

The impact on morbidity and length of stay of early versus delayed complete lymphadenectomy in melanoma: results of the Multicenter Selective Lymphadenectomy Trial (I).

Background: Complete lymph node dissection, the current standard treatment for nodal metastasis in melanoma, carries the risk of significant morbidity. Clinically apparent nodal tumor is likely to impact both preoperative lymphatic function and extent of soft tissue dissection required to clear the basin. We hypothesized that early dissection would be associated with less morbidity than delayed dissection at the time of clinical recurrence.

Adherence to the National Quality Forum (NQF) breast cancer measures within cancer clinical trials: a review from ACOSOG Z0010.

Background: In 2007, the National Quality Forum (NQF) released four performance measures for the treatment of breast cancer. We proposed to study the degree of adherence with these measures among participating institutions in a multi-institutional trial.

Methods: American College of Surgeons Oncology Group (ACOSOG) Z0010 enrolled breast cancer patients onto a phase II trial studying the prognostic significance of bone marrow and sentinel node micrometastases.

Should all patients with melanoma between 1 and 2 mm Breslow thickness undergo sentinel lymph node biopsy?

Background: Sentinel lymph node (SLN) biopsy generally is recommended for patients who have melanoma with a Breslow thickness > or = 1 mm. Most patients with melanoma between 1 mm and 2 mm thick have tumor-negative SLNs and an excellent long-term prognosis. The objective of the current study was to evaluate prognostic factors in this subset of patients and determine whether all such patients require SLN biopsy.

Factors associated with false-negative sentinel lymph node biopsy in melanoma patients.

Introduction: Some melanoma patients who undergo sentinel lymph node (SLN) biopsy will have false-negative (FN) results. We sought to determine the factors and outcomes associated with FN SLN biopsy.

Methods: Analysis was performed of a prospective multi-institutional study that included patients with melanoma of thickness > 1.

Erratum to: Axillary recurrence rate following negative sentinel node biopsy for invasive breast cancer: long-term follow-up.

Objective: Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection (ALND) as the staging procedure for breast cancer. SLN biopsy causes less morbidity and is more cost effective than complete ALND. Lymphatic mapping and SLN biopsy have a low false-negative rate, but long-term outcomes in large consecutive series of patients are unavailable.

Axillary recurrence rate following negative sentinel node biopsy for invasive breast cancer: long-term follow-up.

Objective: Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection (ALND) as the definitive nodal staging procedure for breast cancer. SLN biopsy has been proven to cause less morbidity and be more cost effective than complete ALND. Short-term follow-up has shown that lymphatic mapping and SLN have a low false-negative rate, but there is limited data demonstrating long-term outcomes within a large consecutive series of patients.

The number of lymph nodes involved with metastatic disease does not affect outcome in melanoma patients as long as all disease is confined to the sentinel lymph node.

Background: In melanoma, a direct relationship exists between the number of nodes involved with metastatic disease and prognosis. This study was undertaken to determine whether an individual with metastatic disease confined to the sentinel lymph nodes (SLNs) would have a better prognosis than individuals with metastatic disease that has spread to the non-SLNs, regardless of the number of nodes involved.

Methods: The study group consists of 229 melanoma patients with a positive SLN who underwent regional nodal dissection.

Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011.

Purpose: Patients with breast cancer metastasis to the sentinel lymph nodes (SLNs) generally undergo completion axillary lymph node dissection (cALND), either concurrently with SLN biopsy or at a second procedure. The impact of the timing of cALND on pathologic results and complications in these patients has not been examined.

Patients And Methods: We examined outcomes from SLN-positive patients in American College of Surgeons Oncology Group (ACOSOG) trials Z0010 and Z0011.

Full-thickness grafts procured from skin overlying the sentinel lymph node basin; reconstruction of primary cutaneous malignancy excision defects.

Background: Radical excision of a cutaneous malignancy may require skin-graft closure. The skin overlying the sentinel lymph node (SLN) basin may be procured as a full-thickness skin graft (FTSG), eliminating a problematic and painful third wound, the donor site. However, the potential for implantation of malignant cells transferred from the nodal basin to the primary site, resulting in increased perigraft recurrence rates with the FTSG technique, has not been evaluated.

Factors associated with improved survival among young adult melanoma patients despite a greater incidence of sentinel lymph node metastasis.

Introduction: We sought to evaluate the factors that affect sentinel lymph node (SLN) metastasis and survival among young melanoma patients (< or =30 y).

Methods: The Sunbelt Melanoma Trial is a multi-institutional prospective randomized trial of patients aged 18 to 70 y. Statistical analyses were performed to determine if patients < or =30 y of age had a significantly different outcome in terms of SLN metastasis, disease-free survival (DFS), and overall survival (OS) compared to older patients.

Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011.

Purpose: The American College of Surgeons Oncology Group trial Z0011 was a prospective, randomized, multicenter trial comparing overall survival between patients with positive sentinel lymph nodes (SLNs) who did and did not undergo axillary lymph node dissection (ALND). The current study compares complications associated with SLN dissection (SLND) plus ALND, versus SLND alone.

Patients And Methods: From May 1999 to December 2004, 891 patients were randomly assigned to SLND + ALND (n = 445) or SLND alone (n = 446).

Regional node dissection for melanoma: techniques and indication.

Because virtually all microscopic nodal disease left untreated in melanoma patients will progress to clinically apparent macroscopic nodal disease, there is worse prognosis with macroscopic nodal disease, and ineffective systemic treatment currently exists, one must be cautious in favoring an observation approach to the regional basin in patients with a positive sentinel lymph node (SLN) in the hopes of avoiding the potential morbidity of a therapeutic node dissection. In the few patients with untreated microscopic nodal disease, the prognosis will be significantly worsened. Until further data are available, melanoma patients with a positive SLN by H&E analysis should proceed to a complete lymph node dissection.

Sentinel-node biopsy or nodal observation in melanoma.

Background: We evaluated the contribution of sentinel-node biopsy to outcomes in patients with newly diagnosed melanoma.

Methods: Patients with a primary cutaneous melanoma were randomly assigned to wide excision and postoperative observation of regional lymph nodes with lymphadenectomy if nodal relapse occurred, or to wide excision and sentinel-node biopsy with immediate lymphadenectomy if nodal micrometastases were detected on biopsy.

Results: Among 1269 patients with an intermediate-thickness primary melanoma, the mean (+/-SE) estimated 5-year disease-free survival rate for the population was 78.