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ABSTRACT: OBJECTIVES: This study is to identify symptom clusters for head and neck (HNC) patients treated with concurrent chemoradiotherapy. PATIENTS AND METHODS: A secondary data analysis of 684 HNC patients treated on the Radiation Therapy Oncology Group (RTOG) 0129 trial comparing different RT fractionation schedules with concurrent chemotherapy was used to examine clusters. Treatment-related symptoms were measured by clinicians at three time-points during and after chemoradiotherapy using the National Cancer Institute Common Toxicity Criteria v2.0. Exploratory factor analysis was applied to identify symptom clusters, which was further verified by confirmatory factor analysis. Coefficients of congruence and alpha coefficients were employed to examine generalizability of cluster structures over different time-points and in different subgroups. RESULTS: Two clusters were identified. The HNC specific cluster is composed of radiodermatitis, dysphagia, radiomucositis, dry mouth, pain, taste disturbance, and fatigue. The gastrointestinal (GI) cluster involves nausea, vomiting, and dehydration. With the exception of patients 65years old or older, diagnosed with larynx cancer, or with stage III cancer, the two clusters were generalizable to different subgroups defined by age, gender, race, education, marital status, history of tobacco use, treatments, primary sites, disease stages, and tube feedings, as well as to the three symptom assessment time-points. CONCLUSIONS: The data provides preliminary support for two stable clusters in patients with HNC. These findings may serve to inform the symptom management in clinical practice. Moreover, the findings necessitate future research to examine the generalizability of identified clusters in the late symptom phase or other treatment modalities, and to understand the underlying biological mechanism.
Oral Oncology 11/2012; · 2.86 Impact Factor
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New England Journal of Medicine 04/2008; 358(10):1076; author reply 1077-8. · 53.30 Impact Factor
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ABSTRACT: This study was performed retrospectively to determine if Medicare claims data could be used to evaluate the cost effectiveness, from a payer perspective, of different radiation treatment schedules evaluated in a national clinical trial.
Medicare costs from all providers and all places of service were obtained from the Centers for Medicare & Medicaid Services for patients treated in the period 1992-1996 on Radiation Therapy Oncology Group 90-03, and combined with data on outcomes from the trial.
Of the 1,113 patients entered, Medicare cost data and clinical outcomes were available for 187 patients. Significant differences in tolerance of treatment and outcome were noted between patients with Medicare data included in the study and patients without Medicare data, and non-Medicare patients excluded from it. Ninety-five percent confidence ellipses on the incremental cost-effectiveness scatterplots crossed both axes, indicating non-significant differences in cost effectiveness between radiation treatment schedules.
Claims data permit estimation of cost effectiveness, but Medicare data provide inadequate representation of results applicable to patients from the general population.
Journal of Medical Economics 02/2008; 11(4):611-23.
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ABSTRACT: The objective of the current study was to examine whether emotional well-being predicted survival in a large sample of patients with head and neck cancer who were participating in multicenter clinical trials.
Participants were enrolled in 2 Radiation Oncology Group (RTOG) clinical trials (RTOG 9003 and RTOG 9111) and completed a baseline measure of quality of life (the Functional Assessment of Cancer Therapy-General [FACT-G]), which included an Emotional Well-Being subscale. The outcome measure was overall survival. Main statistical analyses included overall survival rates, which were estimated by using the Kaplan-Meier method with univariate comparisons analyzed using the log-rank test. A multivariate Cox proportional hazards model was used to determine whether emotional well-being had prognostic impact on survival after accounting for tumor-related and sociodemographic variables. Additional exploratory analyses examined possible subgroup effects.
No statistically significant univariate or multivariate effects were observed for emotional well-being, and there were no effects limited to subgroups. These results stand in sharp contrast to the prognostic value of a variety of demographic and clinical variables.
The current results add to the weight of the evidence that emotional functioning is not an independent predictor of survival in cancer patients. The study had the advantage of a large number of deaths to be explained in a sample with the uniformity of treatment and quality of care that is required in clinical trials.
Cancer 01/2008; 110(11):2568-75. · 4.77 Impact Factor
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New England Journal of Medicine 12/2007; 357(18):1872-3; author reply 1873. · 53.30 Impact Factor
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ABSTRACT: Recurrent squamous cell carcinoma of the head and neck (SCCHN) or new second primary tumor (SPT) in a previous radiation field, if not curable by surgery or radiation, is almost always fatal. Chemotherapy alone yields a median survival time (MST) of no more than 10 months and 1-year overall survival (OS) of 35% at best. Concurrent reirradiation and chemotherapy is an alternative strategy.
Eligibility for Radiation Therapy Oncology Group (RTOG) protocol 9911 stipulated recurrent SCCHN or SPT in a previous radiation field. Patients received twice-daily radiation (1.5 Gy per fraction bid x 5 days every 2 weeks x4), plus cisplatin 15 mg/m2 intravenously (IV) daily x 5 and paclitaxel 20 mg/m2 IV daily x 5 every 2 weeks x4. Granulocyte colony-stimulated factor was administered days 6 through 13 of each 2-week cycle.
One hundred five patients were enrolled from March 2000 through June 2003; 23% had SPT. Oropharynx (40%) and oral cavity (27%) were the predominant primary sites. Median prior radiation dose was 65.4 Gy. Seventy-four percent of patients completed chemotherapy. Grade 4 or worse acute toxicity occurred in 28%, grade 4 or worse acute hematologic toxicity in 21%. Eight treatment-related deaths (8%) occurred: five in the acute setting, three late (including two carotid hemorrhages). MST was 12.1 months, with estimated 1- and 2-year OS rates of 50.2% and 25.9%.
Despite a high incidence of grade 5 toxicity, 1- and 2-year OS rates for split-course bid radiation therapy and concurrent cisplatin/paclitaxel exceed results generally seen with chemotherapy alone.
Journal of Clinical Oncology 11/2007; 25(30):4800-5. · 18.37 Impact Factor
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Elizabeth A Elliott,
James R Wright,
R Suzanne Swann,
Felix Nguyen-Tân,
Cristiane Takita,
M Kara Bucci,
Adam S Garden,
Harold Kim,
Eugen B Hug,
Janice Ryu,
Michael Greenberg,
Jerrold P Saxton, Kian Ang,
Lawrence Berk
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ABSTRACT: This multicentered phase III trial was designed to compare an emulsion containing trolamine against the usual supportive care within each participating institution for patients with head and neck cancer undergoing radiation therapy.
Patients with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to one of the following treatments: prophylactic trolamine emulsion, interventional trolamine emulsion, or declared institutional preference. The primary outcome was the reduction in grade 2 or higher skin toxicity, as per National Cancer Institute Common Toxicity Criteria version 2.0. Secondary outcomes included patient-reported quality of life (QOL).
From October 2000 to April 2002, 547 patients from 51 institutions were entered onto the trial. The average age was 59 years. Patients were predominately male (79%) and most continued to use tobacco products (52%). The rates of grade 2 or higher radiation dermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms of the study, respectively. No significant differences in QOL were found.
The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis.
Journal of Clinical Oncology 06/2006; 24(13):2092-7. · 18.37 Impact Factor
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Suresh K Mukherji,
Alicia Y Toledano,
Clifford Beldon,
Ilona M Schmalfuss,
Jay S Cooper,
JoRean D Sicks,
Robert Amdur,
Scott Sailer,
Laurie A Loevner,
Phil Kousouboris, Kian Ang
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ABSTRACT: Prior studies have determined that macroscopic ("gross") tumor volume (GTV), as calculated from pretreatment computer tomography (CT), was capable of predicting local control in squamous cell carcinoma arising in different subsites in the head and neck in patients who were treated with nonsurgical organ-preservation therapy. The majority of these studies were single-institution, retrospective investigations. Consequently, there has been concern that GTV measurements may not be reproducible by different readers at different institutions. The objective of the current study was to measure the interobserver reliability for GTV measurements for squamous cell carcinoma of the supraglottic larynx (SGSCCA) performed by different readers at different institutions.
Eight experienced readers (4 neuroradiologists and 4 radiation oncologists) from different institutions independently measured the pretreatment GTV of 20 patients with SGSCCA. The CT scans were obtained from patients entered into the definitive radiation therapy arm of Radiation Therapy Oncology Group protocol 91-11, who had supraglottic carcinoma and underwent pretreatment CT scans of the neck. Statistical analysis focused on interobserver reliability as measured by the intraclass correlation coefficient.
The intraclass correlation coefficient was 0.81 (95% lower confidence bound, 0.71). This value was interpreted as "excellent."
GTV measurements were reliable and reproducible when performed by neuroradiologists and radiation oncologists who were experienced in the interpretation of CT scans of the extracranial head and neck in patients with SGSCCA. The result implied that the correlation between GTV and local control should be reproducible across institutions.
Cancer 07/2005; 103(12):2616-22. · 4.77 Impact Factor
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Suresh K. Mukherji M.D,
Alicia Y. Toledano Sc.D,
Clifford Beldon M.D,
Ilona M. Schmalfuss M.D,
Jay S. Cooper M.D,
JoRean D. Sicks M.S,
Robert Amdur M.D,
Scott Sailer M.D,
Laurie A. Loevner M.D,
Phil Kousouboris M.D, [......],
Alicia Y. Toledano,
Clifford Beldon,
Ilona M. Schmalfuss,
Jay S. Cooper,
JoRean D. Sicks,
Robert Amdur,
Scott Sailer,
Laurie A. Loevner,
Phil Kousouboris, Kian Ang
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ABSTRACT: BACKGROUND
Prior studies have determined that macroscopic (“gross”) tumor volume (GTV), as calculated from pretreatment computer tomography (CT), was capable of predicting local control in squamous cell carcinoma arising in different subsites in the head and neck in patients who were treated with nonsurgical organ-preservation therapy. The majority of these studies were single-institution, retrospective investigations. Consequently, there has been concern that GTV measurements may not be reproducible by different readers at different institutions. The objective of the current study was to measure the interobserver reliability for GTV measurements for squamous cell carcinoma of the supraglottic larynx (SGSCCA) performed by different readers at different institutions.METHODS
Eight experienced readers (4 neuroradiologists and 4 radiation oncologists) from different institutions independently measured the pretreatment GTV of 20 patients with SGSCCA. The CT scans were obtained from patients entered into the definitive radiation therapy arm of Radiation Therapy Oncology Group protocol 91-11, who had supraglottic carcinoma and underwent pretreatment CT scans of the neck. Statistical analysis focused on interobserver reliability as measured by the intraclass correlation coefficient.RESULTSThe intraclass correlation coefficient was 0.81 (95% lower confidence bound, 0.71). This value was interpreted as “excellent.”CONCLUSIONSGTV measurements were reliable and reproducible when performed by neuroradiologists and radiation oncologists who were experienced in the interpretation of CT scans of the extracranial head and neck in patients with SGSCCA. The result implied that the correlation between GTV and local control should be reproducible across institutions. Cancer 2005. © 2005 American Cancer Society.
Cancer 06/2005; 103(12):2616 - 2622. · 4.77 Impact Factor
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Arlene A Forastiere, Kian Ang,
David Brizel,
Bruce Earl Brockstein,
Frank Dunphy,
David W Eisele,
Helmuth Goepfert,
Wesley L Hicks,
Merrill S Kies,
William M Lydiatt, [......],
John A Ridge,
Sandeep Samant,
David E Schuller,
Jatin P Shah,
Sharon Spencer,
Andrew Trotti,
Richard H Wheeler,
Gregory T Wolf,
Frank Worden,
Bevan Yueh
Journal of the National Comprehensive Cancer Network: JNCCN 06/2005; 3(3):316-91. · 4.41 Impact Factor
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Gregory T Wolf,
Arlene A Forastiere, Kian Ang,
Bruce Brockstein,
Barbara Conley,
Helmuth Goepfert,
Dennis Kraus,
Jean-Louis Lefebvre,
Thomas F Pajak,
David Pfister,
Susan G Urba
