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1.
J Cutan Pathol ; 48(4): 547-557, 2021 Apr.
Article in English | MEDLINE | ID: mdl-32644218

ABSTRACT

Langerhans cell sarcoma (LCS) is rare and aggressive; patients have an overall survival rate of less than 50%. We present a 62-year-old man with a history of superficial spreading melanoma of the upper back with sentinel lymph node metastasis, Langerhans cell histiocytosis, and LCS. The patient presented with erythematous papules and scaly areas on his face, neck, arms, chest, abdomen, and legs. A skin biopsy revealed a proliferation of large neoplastic cells involving the dermis and with epidermotropism. These cells had atypical bean-shaped nuclei, with ample cytoplasm and abundant mitotic figures including atypical forms. Immunohistochemical studies showed the tumor to be diffusely positive for CD1a, S100 protein, and langerin (CD207) and negative for melanocytic markers. Some tumor cells were positive for cyclin D1. A diagnosis of LCS involving the skin was established. The present study is a very unusual case of LCS showing epidermotropism. The patient's history of metastatic melanoma posed additional challenges for diagnosis, underlying the need of immunophenotyping in these cases. Consensus for optimal standard therapy has not been established in LCS, and thus, early recognition is important since these neoplasms tend to recur and metastasize. LCS in skin is discussed and published cases are comprehensively reviewed.


Subject(s)
Langerhans Cell Sarcoma/diagnosis , Langerhans Cell Sarcoma/metabolism , Melanoma/diagnosis , Skin/pathology , Adolescent , Adult , Aftercare , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Child , Child, Preschool , Diagnosis, Differential , Female , Humans , Immunohistochemistry/methods , Infant , Langerhans Cell Sarcoma/drug therapy , Male , Melanoma/pathology , Middle Aged , Recurrence , S100 Proteins/metabolism , Treatment Outcome , Young Adult
4.
J Cutan Pathol ; 45(10): 786-790, 2018 Oct.
Article in English | MEDLINE | ID: mdl-30021048

ABSTRACT

Small-molecule inhibitors (nibs) have revolutionized cancer therapy with the emergence of clinically efficacious treatment for advanced-stage malignancies. Fibroblast growth factor receptor (FGFR) inhibitors have shown therapeutic efficacy in malignancies with molecular-genetic alterations in the FGFR/fibroblast growth factor pathway. In a phase 1 clinical trial, erdafitinib, a pan FGFR inhibitor, was well tolerated with a manageable toxicity profile. Hyperphosphatemia was a frequent adverse event in patients treated with erdafitinib; however, no serious complications were observed with this therapy. Here, we report the development of calcinosis cutis dermatologic toxicity in a patient with hyperphosphatemia while treated with a novel selective FGFR inhibitor, INCB 54828-101. Awareness of this form of dermatologic toxicity from an FGFR inhibitor will be important for close monitoring of serum levels of phosphate, FGF23, vitamin D, and calcitriol, the management of adverse serum chemistry with chelators, and treatment decisions to either reduce dose or withhold FGFR inhibitor.


Subject(s)
Antineoplastic Agents/adverse effects , Calcinosis/chemically induced , Drug Eruptions/etiology , Kidney Neoplasms/drug therapy , Organic Chemicals/adverse effects , Skin Diseases/chemically induced , Wilms Tumor/drug therapy , Antineoplastic Agents/therapeutic use , Clinical Trials, Phase I as Topic , Drug Eruptions/pathology , Fibroblast Growth Factor-23 , Humans , Male , Organic Chemicals/therapeutic use , Receptors, Fibroblast Growth Factor/antagonists & inhibitors , Young Adult
5.
Rep Pract Oncol Radiother ; 23(1): 47-49, 2018.
Article in English | MEDLINE | ID: mdl-29872368

ABSTRACT

Radiation induced morphea (RIM) is an increasingly common complication of radiation treatment for malignancy as early detection has made more patients eligible for non-surgical treatment options. In many cases, the radiation oncologist is the first person to learn of the initial skin changes, often months before a dermatologist sees them. In this paper we present a breast cancer patient who developed a rare bullous variant of RIM, which delayed her diagnosis and subsequent treatment. It is imperative to diagnose RIM early as it carries significant morbidity and permanent deformity if left untreated. The lesions typically present within 1 year of radiation therapy and extend beyond the radiated field. RIM is often mistaken for radiation dermatitis or cellulitis. Bullae, when present, are often hemorrhagic in appearance, which can serve as another clinical clue. It is important to refer these patients for a full gynecologic exam as there can be concurrent anogenital lichen sclerosus et atrophicus which is both debilitating and carries a long term risk for squamous cell carcinoma. Treatment with systemic agents is often necessary, and can be managed by a dermatologist. The most proven regimen in the literature appears to be methotrexate, with our without concurrent narrow band UVB phototherapy.

6.
J Drugs Dermatol ; 16(7): 714-716, 2017 Jul 01.
Article in English | MEDLINE | ID: mdl-28697228

ABSTRACT

Cutaneous reactions to interferon, including a lichenoid drug reaction, are most commonly reported in patients undergoing treatment for hepatitis C virus (HCV) infection. There have been case reports of interferon-induced lichen planus in seronegative HCV patients with lymphoproliferative disorders and melanoma. We report the case of a 71-year-old man undergoing treatment with interferon for metastatic renal cell carcinoma (RCC) who developed an eruption 2 months after starting interferon. Clinical and histological findings from biopsies supported a diagnosis of interferon-induced lichen planus. To our knowledge, this is the first known case of a lichenoid drug eruption from interferon in a seronegative HCV patient with metastatic RCC.

J Drugs Dermatol. 2017;16(7):714-716.

.


Subject(s)
Carcinoma, Renal Cell/drug therapy , Drug Eruptions/diagnosis , Hepacivirus , Interferon-alpha/adverse effects , Kidney Neoplasms/drug therapy , Lichenoid Eruptions/diagnosis , Aged , Humans , Interferon alpha-2 , Lichenoid Eruptions/chemically induced , Male , Recombinant Proteins/adverse effects
7.
J Cutan Pathol ; 44(2): 158-176, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27859479

ABSTRACT

Immunomodulatory drugs that leverages host immune mechanisms to destroy tumor cells have been met with great promise in the treatment of cancer. Immunotherapy, targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and the programmed cell death 1 (PD-1) receptor and its ligand (PD-L1) have shown tremendous improvements in the survival of patients with advanced solid tumors. However, the development of dermatologic toxicity (DT) is a consequence to immunotherapy. Review of published reports of the DT to immunotherapy revealed patients receiving anti-CTCLA-4 antibody or anti-PD-1/PD-L1 antibody often develop a DT of any type and grade. In this article, of the 3825 patients who were treated with anti-PD-1 and of 556 patients receiving anti-PD-L1, DT of any type and grade were reported in 1474 (∼39%) and 95 (∼17%) of patients, respectively. The emergence of specific types of DT to immunotherapy is beginning to be recognized can be categorized into four groups: (a) inflammatory, (b) immunobullous, (c) alteration of keratinocytes and (d) alteration of melanocytes. Lichenoid dermatitis and bullous pemphigoid appear to be DT more associated with anti-PD-1/PD-L1 antibody. The DT profile in patients receiving immunotherapy is diverse, and early recognition of specific types of DT that clinicians may encounter is critical for optimal patient care.


Subject(s)
Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal/adverse effects , Antineoplastic Agents/adverse effects , Drug Eruptions/pathology , Drug Eruptions/etiology , Humans , Ipilimumab , Nivolumab
8.
Hum Pathol ; 50: 79-89, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26997441

ABSTRACT

Newly appearing or changing melanocytic lesions (MLs) are a recently reported toxicity of BRAF inhibitor (BRAFi) therapy. Morphologically, MLs associated with BRAFi therapy (BRAFi-MLs) may demonstrate alarming features of melanoma with an epithelioid cell phenotype with notable cytologic atypia. We sought to characterize the clinicopathological and molecular features of BRAFi-MLs. A retrospective review over a 4-year period revealed 20 patients in which 44 MLs (including 11 control nevi) were characterized by histopathology, review of clinical medical records, and immunohistochemical (IHC) studies (with anti-BRAF V600E, anti-BAP1, anti-cyclin D1, and anti-p16); the percentage of IHC+ cells was scored. Of the 20 patients, 3 (15%) whose BRAFi-MLs were biopsied had a second primary cutaneous melanoma. Of the 44 BRAFi-MLs tested, 37 (100%) of 37 MLs available for BRAF V600E testing lacked expression in contrast to 1 (9%) of 11 control nevi (lesions not associated with targeted therapy). A significantly higher level of cyclin D1 expression (>50% IHC+ cells) was more commonly seen in BRAFi-MLs (44%) than in control nevi (9%). No difference in p16 expression in melanocytes was seen between the 2 groups. BRAF mutation status distinctly differs between BRAFi-MLs from melanomas and nevi biopsied in patients who do not receive BRAFi therapy. Morphologically, BRAFi-MLs demonstrate a greater degree of atypia than do control nevi. Furthermore, BRAFi-MLs with coexisting cutaneous keratinocyte toxicity developed during fewer days of targeted therapy. Paradoxical activation of the MAPK pathway in BRAF(WT) melanocytes may account for ~15% to 21% of patients developing a second new primary melanoma within a year of starting BRAFi therapy; thus, close clinical surveillance is warranted.


Subject(s)
Antineoplastic Agents/adverse effects , Cyclin D1/metabolism , Melanocytes/drug effects , Melanoma/chemically induced , Mutation , Neoplasms, Second Primary/chemically induced , Protein Kinase Inhibitors/adverse effects , Proto-Oncogene Proteins B-raf/antagonists & inhibitors , Skin Neoplasms/chemically induced , Adult , Aged , Biopsy , Female , Humans , Immunohistochemistry , Male , Melanocytes/enzymology , Melanocytes/pathology , Melanoma/enzymology , Melanoma/genetics , Melanoma/pathology , Middle Aged , Neoplasms, Second Primary/enzymology , Neoplasms, Second Primary/genetics , Neoplasms, Second Primary/pathology , Proto-Oncogene Proteins B-raf/genetics , Proto-Oncogene Proteins B-raf/metabolism , Retrospective Studies , Skin Neoplasms/enzymology , Skin Neoplasms/genetics , Skin Neoplasms/pathology , Time Factors , Treatment Outcome , Up-Regulation , Young Adult
9.
J Am Acad Dermatol ; 71(4): 745-53, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24993601

ABSTRACT

BACKGROUND: Chronic graft-versus-host disease (GVHD) may present with various cutaneous manifestations. Isolated case reports describe eruptive angiomas in this setting. OBJECTIVE: We sought to provide a clinical and pathologic description of vascular proliferations in patients with GVHD. METHODS: Cases of documented GVHD associated with vascular proliferations were collected from the National Institutes of Health, Ohio State University, and MD Anderson Cancer Center. RESULTS: Eleven patients with a diagnosis of GVHD who developed vascular proliferations were identified. All patients manifested sclerotic type chronic GVHD of the skin. Vascular lesions were first documented a median of 44 months after transplantation and occurred primarily on the lower extremities or trunk. Histopathology revealed anastomosing networks of thin-walled vascular proliferations in a vague lobular growth pattern, with overlying epidermal acanthosis, peripheral collarette, ulceration, and disorganized fibroblast-rich and fibrotic stroma. Improvement was noted in 1 patient treated with propranolol and sirolimus and 1 patient with electrocautery. LIMITATIONS: Given the retrospective nature of the study, the overall incidence of vascular lesions in patients with GVHD is unknown. Histopathology was present for review on only 3 of 11 patients. CONCLUSION: The phenomenon of vascular lesions appears to be relatively specific for sclerotic type chronic GVHD when compared with other fibrosing diseases. We propose the term "graft-versus-host disease-associated angiomatosis" to describe this entity.


Subject(s)
Angiomatosis/epidemiology , Angiomatosis/pathology , Graft vs Host Disease/epidemiology , Graft vs Host Disease/pathology , Skin Ulcer/epidemiology , Skin Ulcer/pathology , Adult , Age Distribution , Aged , Angiomatosis/physiopathology , Biopsy, Needle , Bone Marrow Transplantation/adverse effects , Bone Marrow Transplantation/methods , Chronic Disease , Cohort Studies , Comorbidity , Databases, Factual , Female , Graft vs Host Disease/physiopathology , Hematologic Neoplasms/pathology , Hematologic Neoplasms/surgery , Hematopoietic Stem Cell Transplantation/adverse effects , Hematopoietic Stem Cell Transplantation/methods , Humans , Immunohistochemistry , Incidence , Male , Middle Aged , Prognosis , Retrospective Studies , Risk Assessment , Severity of Illness Index , Sex Distribution , Skin Ulcer/physiopathology
11.
Cutis ; 93(1): 50-4, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24505586

ABSTRACT

Granulomatous dermatitis (GD) is known to occur following varicella-zoster virus (VZV) infection. Lesions may appear at varying times after the acute eruption in both immunosuppressed and immunocompetent hosts. The etiology of GD is unclear, and findings of VZV in the lesions often are inconsistent. We describe 2 immunocompromised patients who presented with GD following VZV infection; their lesions were examined for the presence of VZV. We also review the literature on postzoster GD.


Subject(s)
Dermatitis/etiology , Granuloma/etiology , Herpes Zoster/complications , Herpesvirus 3, Human/isolation & purification , Aged , Dermatitis/pathology , Dermatitis/virology , Female , Granuloma/pathology , Granuloma/virology , Humans , Immunocompromised Host , Male , Middle Aged , Time Factors
12.
JAMA Dermatol ; 149(3): 322-6, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23552670

ABSTRACT

IMPORTANCE: Approximately 10% to 25% of patients treated with BRAF inhibitors develop cutaneous squamous cell carcinoma (SCC), but the mechanism responsible has not yet been determined. We report what we believe to be the first case in which Merkel cell polyomavirus (MCPyV) and human papillomavirus subtype 17 (HPV-17) were associated with cutaneous SCC that developed during treatment with the BRAF inhibitor dabrafenib. OBSERVATIONS: A 62-year-old woman with V600E BRAF -mutant metastatic melanoma enrolled in a phase 1 trial of dabrafenib, a selective inhibitor of V600-mutant BRAF kinase. During the first 6 weeks of treatment, the patient developed multiple skin lesions, including a 6-mm crusted papule on the left eyebrow, which was resected and, on pathology examination, revealed SCC. The DNA extracted from paraffin-embedded tissue was amplified by polymerase chain reaction for detection of MCPyV and epidermodysplasia verruciformis HPV (EV-HPV) types. Analysis of the cloned and sequenced polymerase chain reaction products revealed the presence of MCPyV and HPV-17 DNA. Other EV-HPV subtypes were not detected. CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first report demonstrating the coexistence of MCPyV and HPV-17 in cutaneous SCC. Because both viruses have oncogenic potential, their role in the development of BRAF inhibitor-related SCC merits further investigation.


Subject(s)
Carcinoma, Merkel Cell/virology , Carcinoma, Squamous Cell/virology , Imidazoles/therapeutic use , Oximes/therapeutic use , Skin Neoplasms/virology , Tumor Virus Infections/virology , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Carcinoma, Merkel Cell/pathology , Carcinoma, Squamous Cell/pathology , DNA, Viral/isolation & purification , Female , Humans , Imidazoles/adverse effects , Melanoma/drug therapy , Melanoma/pathology , Merkel cell polyomavirus/isolation & purification , Middle Aged , Oximes/adverse effects , Papillomavirus Infections/complications , Papillomavirus Infections/pathology , Papillomavirus Infections/virology , Polymerase Chain Reaction , Polyomavirus Infections/complications , Polyomavirus Infections/pathology , Polyomavirus Infections/virology , Proto-Oncogene Proteins B-raf/antagonists & inhibitors , Skin Neoplasms/drug therapy , Skin Neoplasms/pathology , Tumor Virus Infections/pathology
13.
Dermatol Online J ; 18(6): 4, 2012 Jun 15.
Article in English | MEDLINE | ID: mdl-22747928

ABSTRACT

Chronic cutaneous graft-versus-host disease (GVHD) classically presents with lichenoid papules or sclerotic plaques. This case highlights an unusual clinical manifestation of chronic GVHD and demonstrates that the skin morphology of chronic GVHD and cutaneous lymphoma may be similar. We report for the first time a case of annular scleroderma-like graft-versus-host disease in a patient following allogeneic stem cell transplant for CD30+ anaplastic large cell lymphoma. Treatment of these skin lesions with ultraviolet A1 (UVA1) phototherapy resulted in significant improvement.


Subject(s)
Graft vs Host Disease/complications , Hematopoietic Stem Cell Transplantation , Hodgkin Disease/therapy , Lymphoma, Large B-Cell, Diffuse/therapy , Lymphoma, T-Cell, Cutaneous/therapy , Scleroderma, Localized/etiology , Skin Diseases/therapy , Skin Neoplasms/therapy , Graft vs Host Disease/pathology , Humans , Male , Middle Aged , PUVA Therapy , Phototherapy , Scleroderma, Localized/pathology
15.
J Am Acad Dermatol ; 66(4): 515.e1-18; quiz 533-4, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22421123

ABSTRACT

Approximately 25,000 allogeneic hematopoietic cell transplants are performed worldwide each year for a variety of malignant and non-malignant conditions. Graft-versus-host disease represents one of the most frequent complications and is a major source of long-term morbidity and mortality. Whereas acute graft-versus-host disease is induced by recognition of host tissues as foreign by immunocompetent donor cells, the pathogenesis of chronic graft-versus-host disease is not as well understood, and continues to be a major treatment challenge. Part I of this two-part series reviews the epidemiologic factors, classification, pathogenesis, and clinical manifestations of acute and chronic graft-versus-host disease. Part II discusses the topical, physical, and systemic treatment options available to patients with graft-versus-host disease.


Subject(s)
Graft vs Host Disease/diagnosis , Graft vs Host Disease/etiology , Acute Disease , B-Lymphocytes/physiology , Chronic Disease , Graft vs Host Disease/classification , Graft vs Host Disease/complications , Graft vs Host Disease/physiopathology , Humans
16.
J Am Acad Dermatol ; 66(4): 535.e1-16; quiz 551-2, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22421124

ABSTRACT

Dermatologists are ideally suited to manage the various cutaneous sequelae of graft-versus-host disease (GVHD) outlined in part I of this review. However, the complexity of the patient with GVHD, including comorbidities, potential drug interactions related to polypharmacy, and the lack of evidence-based treatment guidelines, are significant challenges to optimizing patient care. In this section, we will provide an outline for the role of the dermatologist in a multispecialty approach to caring for patients with GVHD.


Subject(s)
Graft vs Host Disease/therapy , Acute Disease , Administration, Topical , Algorithms , Chronic Disease , Combined Modality Therapy , Graft vs Host Disease/complications , Graft vs Host Disease/drug therapy , Humans , Skin Diseases/etiology , Skin Diseases/therapy , Ultraviolet Therapy
17.
Int J Gynecol Cancer ; 22(1): 123-31, 2012 Jan.
Article in English | MEDLINE | ID: mdl-22193645

ABSTRACT

PURPOSE: The objective of the study was to determine the impact of brachytherapy implant quality on outcome among cervical cancer patients treated on Radiation Therapy Oncology Group prospective trials 0116 and 0128. METHODS: All enrolled patients received concurrent chemoradiation followed by brachytherapy. Individual brachytherapy parameters, including the symmetry of ovoids in relation to the tandem, displacement of ovoids in relation to the cervical os, tandem bisecting the ovoids, tandem in the midpelvis, and appropriateness of packing, were scored for each implant. Multivariate Cox proportional hazards models were constructed for each parameter for local recurrence (LR), regional recurrence, distant recurrence, disease-free survival (DFS), and overall survival. RESULTS: Records for 103 patients were analyzed. The median follow-up time was 24.5 months. Patients with unacceptable symmetry of ovoids to the tandem had a significantly higher risk of LR than patients in the acceptable group (hazard ratio [HR], 2.67; 95% confidence interval [CI], 1.11-6.45; P = 0.03). Patients with displacement of ovoids in relation to the cervical os had a significantly increased risk of LR (HR, 2.50; 95% CI, 1.05-5.93; P = 0.04) and a lower DFS rate (HR, 2.28; 95% CI, 1.18-4.41; P = 0.01). Inappropriate placement of packing resulted in a lower DFS rate (HR, 2.06; 95% CI, 1.08-3.92; P = 0.03). CONCLUSIONS: Assessment of the quality of a brachytherapy implant is imperative, as proper placement has an impact on patient DFS. If feasible, inappropriate placements should be corrected before treatment initiation. Brachytherapy applicators for cervical cancer should preferably be placed and assessed by experienced practitioners.


Subject(s)
Adenocarcinoma/radiotherapy , Brachytherapy/standards , Carcinoma, Squamous Cell/radiotherapy , Quality Assurance, Health Care , Uterine Cervical Neoplasms/radiotherapy , Adenocarcinoma/drug therapy , Adenocarcinoma/mortality , Adenocarcinoma/pathology , Adult , Aged , Brachytherapy/instrumentation , Carcinoma, Squamous Cell/drug therapy , Carcinoma, Squamous Cell/mortality , Carcinoma, Squamous Cell/pathology , Chemoradiotherapy , Disease-Free Survival , Female , Follow-Up Studies , Humans , Logistic Models , Middle Aged , Neoplasm Recurrence, Local/epidemiology , Proportional Hazards Models , Prospective Studies , Treatment Outcome , Uterine Cervical Neoplasms/drug therapy , Uterine Cervical Neoplasms/mortality , Uterine Cervical Neoplasms/pathology
18.
J Cutan Pathol ; 39(2): 294-7, 2012 Feb.
Article in English | MEDLINE | ID: mdl-22077555

ABSTRACT

Granulomatous cutaneous reactions are well described in association with T-cell non-Hodgkin lymphoma and Hodgkin lymphoma, but are rarely seen in association with B-cell non-Hodgkin lymphoma or leukemia. We report a case of a 65-year-old woman with B-cell chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who presented with multiple, tender, firm pink papules on the face, upper trunk and upper extremities 6 years after diagnosis of CLL. Biopsy revealed both palisading granulomatous dermatitis consistent with actinic granuloma and a dense perivascular lymphocytic infiltrate consistent with the patient's known history of leukemia. This is an unusual manifestation of cutaneous B-cell CLL that is rarely seen.


Subject(s)
Facial Neoplasms/pathology , Granuloma/pathology , Leukemia, Lymphocytic, Chronic, B-Cell/pathology , Skin Neoplasms/pathology , Aged , Dermatitis/pathology , Female , Humans
19.
Int J Gynecol Cancer ; 21(7): 1266-75, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21892091

ABSTRACT

OBJECTIVES: Radiation Therapy Oncology Group (RTOG) 0116 was designed to test the ability of amifostine (Ethyol; MedImmune LLC, Gaithersburg, MD), a cytoprotective agent, to reduce the acute toxicity of combined therapy with extended-field irradiation, brachytherapy, and cisplatin chemotherapy in patients with cervical cancer with para-aortic or high common iliac disease. This report presents the results of part 2. MATERIALS AND METHODS: Radiation Therapy Oncology Group 0116 was a 2-part trial. Part 1 delivered extended-field irradiation, brachytherapy, and cisplatin; part 2 added amifostine and required 16 evaluable patients to assess an improved toxicity profile. Eligibility included evidence for high common iliac or para-aortic metastasis. Patients were treated for a total dose of 45 Gy in 25 fractions with intracavitary irradiation. Intensity-modulated radiation therapy was not allowed. The final point A dose was 85 Gy low-dose rate equivalent. High-dose rate techniques were allowed. The positive para-aortic and iliac nodes were to be boosted to 54 to 59.4 Gy. Amifostine at 500 mg was to be delivered with every fraction of radiotherapy. RESULTS: The study opened on August 1, 2001, and closed March 3, 2007, after accruing 45 patients, 18 for the second part with amifostine. This analysis reports the primary end point for the patients entered on part 2 of the study. Three patients were excluded, one was ineligible, and 2 withdrew. The median follow-up was 22.9 months (range, 6.5-45.4 months). The median dose of amifostine delivered was 5000 mg (range, 500-13,500 mg). Thirteen patients (87%) experienced an acute grade 3/4 toxicity (excluding grade 3 leukopenia). This compared to an 81% rate in part 1 of the trial. The estimated median survival was 34.8 months with a 20% late grade 3/4 toxicity rate. CONCLUSIONS: Amifostine, as delivered in this study, did not reduce acute toxicity in this patient population.


Subject(s)
Amifostine/therapeutic use , Carcinoma/radiotherapy , Radiation Injuries/prevention & control , Radiation-Protective Agents/therapeutic use , Uterine Cervical Neoplasms/radiotherapy , Adult , Aged , Antineoplastic Agents/therapeutic use , Brachytherapy/adverse effects , Carcinoma/drug therapy , Cisplatin/therapeutic use , Female , Humans , Lymphatic Metastasis , Middle Aged , Radiation Injuries/etiology , Uterine Cervical Neoplasms/drug therapy
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