Chidel, Mark A. MD; Khuntia, Deepak MD; Rice, Thomas W. MD; Reddy, Chandana A. MS; Adelstein, David J. MD; Carlson, Thomas P. MD et al Author Information
This phase II study tested the addition of the oral epidermal growth factor receptor gefitinib to multiagent concurrent chemoradiotherapy regimen in head and neck squamous cell cancer (HNSCC).Patients with stage III-IV HNSCC received hyperfractionated radiation (72-74.4 Gy at 120 cGy twice daily), with concurrent 96-hour infusions of cisplatin 20 mg/m(2) /day and fluorouracil 1000 mg/m(2) /day given during weeks 1 and 4. Daily gefitinib 250 mg was started on day 1 of radiation and continued for 2 years. Results were retrospectively compared with our previous study using identical chemoradiotherapy without gefitinib.Sixty patients were enrolled in the study; 80% had stage IV disease and 68% had oropharyngeal primary tumors. The full course of gefitinib was not tolerated by 42%; there were 5 treatment-related deaths (8%). With a median follow-up of 54 months, 2- and 3-year overall survival estimates were 80% and 71%, respectively. Projected distant metastatic control at 2 and 3 years was 88%. When compared with our historical cohort, acute toxicities including renal dysfunction and unplanned rehospitalization were worse in the study patients. Projected outcome estimates did not differ between the 2 cohorts.Addition of gefitinib to concurrent chemoradiotherapy was difficult to complete, did not improve outcomes, and increased toxicity.
To report our experience using the neck examination, computed tomography (CT), and positron emission tomography (PET) to clinically evaluate node-positive patients with head and neck squamous cell cancer for residual neck node disease after definitive chemoradiotherapy.
Design
Retrospective review of all Cleveland Clinic patients with head and neck squamous cell cancer and N2 or N3 neck node involvement at presentation who were treated with definitive concurrent chemoradiotherapy and who underwent clinical restaging after treatment using the neck examination, CT, and PET.
Setting
Tertiary care referral institution.
Patients
Forty-eight patients with 72 positive necks at diagnosis were followed up for a median of 20 months.
Main Outcome Measures
Palpable nodes on examination, nodes larger than 1 cm, nodes with central necrosis on CT, or any hypermetabolic lymph nodes on PET were considered clinical evidence of residual nodal disease. The true rate of pathologic involvement was determined by histologic examination after planned neck dissection or if regional recurrence developed. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for all 3 clinical assessment tools.
Results
Planned neck dissection was performed in 33 necks and was positive for residual neck node disease in 5 necks. A delayed neck dissection was performed in 5 necks and was positive in 3 necks. The positive predictive value was low for all 3 clinical assessment tools. The addition of PET did not significantly improve the negative predictive value or positive predictive value of CT and the clinical examination.
Conclusions
Residual neck node disease after definitive chemoradiotherapy was infrequent and was not well predicted by PET. A positive PET finding in this setting is of little utility. Although a negative PET finding was highly predictive for control of neck disease after chemoradiotherapy, it added little to the clinical neck examination and CT.
The American Society of Clinical Oncology (ASCO) developed its own test—the Medical Oncology In-Training Examination (MedOnc ITE)—as a tool to assess trainees' knowledge of the clinical oncology subspecialty, establish consistency in educational standards across training programs, identify areas of strength and weakness in individual programs, and stimulate intraprogrammatic reading and discussion. The Accreditation Council for Graduate Medical Education Outcome Project provided additional incentive for ASCO to develop an ITE. The examination was developed in 4 years. The concept of the examination and the budget were approved by the ASCO governing board. The National Board of Medical Examiners was selected to work with ASCO. Fellowship programs were contacted to determine if they had the information technology support to hold the examination. A blueprint for the examination was developed. The test format, including the number of questions and the selection of case-based single best answers, was determined. Physician volunteers to write the questions were solicited from among program directors, various ASCO committees, and disease experts. A workshop was held to teach volunteers how to write proper case-based questions. From this pool, a smaller group of physicians was selected to develop the test and review all test questions. The final examination was developed and administered in February 2008, with scores provided to fellows and program directors in April 2008. Feedback received after the examination will be helpful for developing future MedOnc ITEs. The process ASCO went through to develop the MedOnc ITE serves as a model for other subspecialties interested in developing their own ITEs.
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