喉癌保喉治疗策略指南【美国2006】

American Society of Clinical Oncology Clinical Practice Guideline for the Use of Larynx-Preservation Strategies in the Treatment of Laryngeal Cancer David G. Pfister, Scott A. Laurie, Gregory S. Weinstein, William M. Mendenhall, David J. Adelstein, K. Kian Ang, Gary L. Clayman, Susan G. Fisher, Arlene A. Forastiere, Louis B. Harrison, Jean-Louis Lefebvre, Nancy Leupold, Marcy A. List, Bernard O. O’Malley, Snehal Patel, Marshall R. Posner, Michael A. Schwartz, and Gregory T. Wolf A B S T R A C T Purpose To develop a clinical practice guideline for treatment of laryngeal cancer with the intent of preserving the larynx (either the organ itself or its function). This guideline is intended for use by oncologists in the care of patients outside of clinical trials. Methods A multidisciplinary Expert Panel determined the clinical management questions to be addressed and reviewed the literature available through November 2005, with emphasis given to randomized controlled trials of site-specific disease. Survival, rate of larynx preservation, and toxicities were the principal outcomes assessed. The guideline underwent internal review and approval by the Panel, as well as external review by additional experts, members of the American Society of Clinical Oncology (ASCO) Health Services Committee, and the ASCO Board of Directors. Results Evidence supports the use of larynx-preservation approaches for appropriately selected patients without a compromise in survival; however, no larynx-preservation approach offers a survival advantage compared with total laryngectomy and adjuvant therapy with rehabilitation as indicated. Recommendations All patients with T1 or T2 laryngeal cancer, with rare exception, should be treated initially with intent to preserve the larynx. For most patients with T3 or T4 disease without tumor invasion through cartilage into soft tissues, a larynx-preservation approach is an appropriate, standard treatment option, and concurrent chemoradiotherapy therapy is the most widely applicable approach. To ensure an optimum outcome, special expertise and a multidisciplinary team are necessary, and the team should fully discuss with the patient the advantages and disadvantages of larynx-preservation options compared with treatments that include total laryngectomy. J Clin Oncol 24. © 2006 by American Society of Clinical Oncology INTRODUCTION In 2005, an estimated 9,880 new cases of laryngeal cancer will be diagnosed in the United States, ac- counting for 3,770 deaths.1 Squamous cell carci- noma is the predominant histologic type, and approximately 40% of patients will have stage III or IVdiseasewhenfirst evaluated.2Most casesof laryn- geal cancer are associated with a history of tobacco and/or alcohol use, so the treatment of patients is complicated bymedical comorbidity and the devel- opment of second primary cancers.3-5 Given the fundamental role the larynx plays in human speech and communication, determining the optimal management of laryngeal cancers must involve consideration of both survival and the functional consequences of a given treatment approach. The potentialmorbidity of curative treatment is a special consideration when total laryngectomy, either for primary therapy or as salvage treatment, is the rec- ommendation. Total laryngectomy is widely recog- nized as one of the surgical procedures most feared by patients. Social isolation, job loss, and depression are common sequelae.6,7 Pioneering work on pa- tient preferences showed that approximately 25%of healthy individuals interviewedwerewilling to trade a 20% absolute difference in survival for the oppor- tunity to save their voice.8Different voice rehabilita- tions exist,9 but many patients are dissatisfied with the results and report associated restrictions in their The unabridged version of this arti- cle can be found at www.asco.org/ guidelines/larynx/unabridged. From the American Society of Clinical Oncology, Alexandria, VA. Submitted May 15, 2006; accepted May 19, 2006; published online ahead of print at www.jco.org on July 10, 2006. Adopted on February 28, 2006, by the American Society of Clinical Oncology Authors’ disclosures of potential conflicts of interest and author contribu- tions are found at the end of this article. Address reprint requests to American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200, Alexandria, Virginia 22314; e-mail: guidelines@asco.org. © 2006 by American Society of Clinical Oncology 0732-183X/06/2422-1/$20.00 DOI: 10.1200/JCO.2006.07.4559 JOURNAL OF CLINICAL ONCOLOGY A S C O S P E C I A L A R T I C L E VOLUME 24 � NUMBER 22 � AUGUST 1 2006 1 http://www.jco.org/cgi/doi/10.1200/JCO.2006.07.4559The latest version is at Published Ahead of Print on July 10, 2006 as 10.1200/JCO.2006.07.4559 Copyright 2006 by American Society of Clinical Oncology Copyright © 2006 by the American Society of Clinical Oncology. All rights reserved. Downloaded from jco.ascopubs.org on August 10, 2010 . For personal use only. No other uses without permission. daily lives. Although the impact of the procedure on voice often receives thegreatest attention, thepresenceof the stomamayadversely affect quality of life as much, if not more.10 Accordingly, there has been keen interest in the development and refinement of organ- preservation therapies, such as radiation therapy alone, the combina- tion of chemotherapy and radiation therapy (chemoradiotherapy therapy), and function-preserving partial laryngectomy procedures. With all three of these approaches, total laryngectomy is reserved for tumor recurrence. The American Society of Clinical Oncology (ASCO) fully appre- ciates the controversy about how to best achieve the dual goals of cure and preservation of function for patients with laryngeal cancer. As a service to patients, to its members, and to practicing physicians gen- erally, ASCO convened an Expert Panel under the auspices of the Health Services Committee to develop recommendations regarding the appropriate application of larynx-preservation therapies. Accordingly, ASCO considers adherence to this guideline to be voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient’s individual circumstances. In addition, the guideline describes administration of therapies in clinical practice; it cannot be assumed to apply to inter- ventions performed in the context of clinical trials, given that clinical studies are designed to test innovative and novel therapies in a disease and setting for which better therapy is needed. Because guideline development involves a review and synthesis of the latest literature, a practice guideline also serves to identify important questions for fur- ther research and those settings in which investigational therapy should be considered. QUESTIONS The following questions about squamous cell laryngeal cancer were addressed by the Panel: (1)What are the larynx-preservation treatment options for lim- ited stage (T1, T2) primary site disease that do not compromise sur- vival?What are the considerations in selecting among them? (2) What are the larynx-preservation treatment options for ad- vanced stage (T3, T4) primary site disease that do not compromise survival?What are the considerations in selecting among them? (3) What is the appropriate treatment of the regional cervical nodes for patients with laryngeal cancer who are treated with an organ-preservation approach? (4) Are there methods for prospectively selecting patients with laryngeal cancer to increase the likelihood of success of larynx preservation? METHODS The members of the Expert Panel were selected for their expertise in clinical medicine; medical, radiation, and surgical oncology; diagnos- tic imaging; clinical research; outcomes/health services research; and related disciplines (biostatistics, quality of life) with a focus on exper- tise in head and neck and laryngeal cancer (Appendix A). To enhance the focus of the published guideline on the implications for clinical practice, the methodology of the guideline development is available online, at both www.jco.org and www.asco.org. GUIDELINE FOR LARYNX-PRESERVATION TREATMENT We have summarized the recommended treatment strategies by T stage, alongwith the basis for the recommendations and the quality of the supporting evidence (Table 1). A complete review of the literature and discussion of study results are available online. What are the larynx-preservation treatment options for limited stage (T1, T2) primary site disease that do not compromise survival? What are the considerations in selecting treatment options in this setting? Evidence base. There are no randomized studies in which radi- ation therapywas comparedwith conservation surgerywith respect to local control or survival for patients with limited-stage laryngeal can- cer. Similarly, therearenorandomizedcontrolleddataoncomparison of functional outcomes, specifically the quality of voice and swallow- ingability, after surgeryor radiation therapy forpatientswith this stage of disease. The recommendations to address these questions are based on evidence from prospective and retrospective cohort studies.11-75 The recommendations for T2 N� disease are based on data from randomized controlled trials of chemoradiotherapy therapy (with either induction or concurrent chemotherapy compared with radia- tion therapy alone or surgery followed by adjuvant radiation thera- py).77,78 The outcomes assessed included overall survival, disease-free survival, rates of laryngeal preservation, local-regional control, toxic- ity of therapy, and cost. Limited-stagedisease represents a spectrum.Treatment selection can be challenging, as the evidence base for most decisions is derived from nonrandomized studies and various factors need to be consid- ered when choosing therapy. Selected examples for glottic cancer are illustrative. If voice outcome is predicted to be good after endoscopic laser resection for aT1glottic cancer (eg, a superficial tumor located in themiddle thirdof the cord, especiallyon its free edge), thenuseof this modality is more efficient and thus preferred. However, lesions that are indistinct, especially those arising in the context of widespread, abnormal-appearingmucosa, are more suitable for radiation therapy than for surgery. Radiation therapy is preferred bymany clinicians for treatment of T2 glottic carcinoma characterized as superficial on ra- diographic imaging, with preserved cord mobility, as local control rates arehighandanticipated functionaloutcomesaregood.But some investigators have noted compromised survival after the failure of radiation therapy inT2glottic carcinoma indicating the importanceof obtaining initial local control.56,59 As such, supracricoid partial laryn- gectomy with cricohyoidoepliglottopexy remains a reasonable alter- native for patientswith aT2 glottic carcinomawho after pretreatment counseling would be willing to sacrifice voice quality in an effort to improve local control. Induction chemotherapy has been investigated as treatment for patients with limited-stage laryngeal cancer. How- ever, insufficient data are currently available to recommend such an approach outside the context of a clinical trial. Recommendations • All patients with T1-T2 laryngeal cancer should be treated, at least initially, with intent to preserve the larynx. • T1-T2 laryngeal cancer can be treated with radiation or larynx-preservation surgery with similar survival outcomes. Se- lection of treatment depends on patient factors, local expertise, Pfister et al 2 JOURNAL OF CLINICAL ONCOLOGY Copyright © 2006 by the American Society of Clinical Oncology. All rights reserved. Downloaded from jco.ascopubs.org on August 10, 2010 . For personal use only. No other uses without permission. and the availability of appropriate support and rehabilitative services. Every effort should be made to avoid combining surgery with radia- tion therapy because functional outcomes may be compromised by combined-modality therapy; single-modality treatment is effective for limited-stage, invasive cancer of the larynx. • Surgical excision of the primary tumor with intent to preserve the larynx should be undertaken with the aim of achieving tumor-free margins; so-called narrow-margin exci- sion followed by postoperative radiation therapy is not an ac- ceptable treatment approach. Table 1. Summary of Recommended Strategies for Treatment of the Primary Site for Larynx Preservation Type of Cancer Organ-Preservation Strategy Basis for Recommendation Quality of EvidenceRecommended Other Options T1 cancer of the glottis: T1—tumor limited to the vocal cord(s) (may involve anterior or posterior commissure) with normal mobility T1a—tumor limited to one vocal cord T1b—tumor involves both vocal cords Endoscopic resection (selected patients) OR radiation therapy Open organ- preservation surgery High local control rates and quality of voice after endoscopic resection compared with radiation therapy; possible cost savings; ability to reserve radiation for possible second primary cancers of the upper aerodigestive tract; however, not suitable for all patients Comparison of outcomes from case series/ prospective single-arm studies T2 cancer of the glottis, favorable�:T2—tumor extends to supraglottis and/or subglottis, or with impaired vocal cord mobility Open organ-preservation surgery OR radiation therapy Endoscopic resection (selected patients) Open organ-preservation surgery is associated with highest local control rates; however, leads to permanent hoarseness; local control rates after radiation therapy are also high, and functional outcomes may be better Comparison of outcomes from case series/ prospective single-arm studies T2 cancer of the glottis, unfavorable� Open organ-preservation surgery OR concurrent chemoradiation therapy (selected patients with node-positive disease) Radiation therapy Endoscopic resection (selected patients) Higher local control rates after surgery compared with radiation therapy alone; quality of voice after therapy of less concern if vocal cord function is irreversibly compromised by tumor invasion; endoscopic surgery requires careful patient selection For patients with T2 N� disease, evidence from randomized trials supports concurrent chemoradiation therapy as an organ- preservation option Comparison of outcomes from case series/ prospective single-arm studies; randomized controlled clinical trials comparing concurrent chemoradiation therapy, and/or induction chemotherapy followed by radiation, and/or radiation therapy alone, and/or surgery followed by radiation T1-T2 cancer of the supraglottis, favorable�:T1—tumor limited to one subsite of supraglottis with normal vocal cord mobility T2—tumor invades mucosa of more than one adjacent subsite of supraglottis or glottis or region outside the supraglottis (eg, mucosa of base of tongue, vallecula, medial wall of pyriform sinus) without fixation of the larynx Open organ-preservation surgery OR radiation therapy Endoscopic resection (selected patients) Open organ-preservation surgery associated with highest local control rates; however, requires temporary tracheostomy and may lead to increased risk of aspiration after therapy; local control rates after radiation therapy are also high, and functional outcomes may be better Comparison of outcomes from case series/ prospective single-arm studies T2 cancer of the supraglottis, unfavorable� Open organ-preservation surgery OR concurrent chemoradiation therapy (selected patients with node-positive disease) Radiation therapy Endoscopic resection (selected patients) Open organ-preservation surgery is more likely to yield higher local control rates than radiation therapy; for patients with T2 N� disease, evidence from randomized trials supports concurrent chemoradiation therapy as an organ- preservation option Comparison of outcomes from case series/ prospective single-arm studies; randomized controlled clinical trials comparing concurrent chemoradiation therapy, and/or induction chemo- therapy followed by radiation, and/or radiation therapy alone, and/or surgery followed by radiation T3-T4 cancers of the glottis or supraglottis: T3 glottis—tumor limited to the larynx with vocal cord fixation, and/or invades paraglottic space, and/or minor thyroid cartilage erosion (eg, inner cortex) T3 supraglottis—tumor limited to larynx with vocal cord fixation and/or invades any of the following: postcricoid area, pre-epiglottic tissues, paraglottic space, and/or minor thyroid cartilage erosion (eg, inner cortex) T4a glottis or supraglottis—tumor invades through the thyroid cartilage and/or invades tissues beyond the larynx (eg, trachea, soft tissues of neck including deep extrinsic muscle of the tongue, strap muscles, thyroid, or esophagus) T4b glottis or supraglottis—tumor invades prevertebral space, encases carotid artery, or invades mediastinal structures Concurrent chemoradiation therapy OR open organ- preservation surgery (in highly selected patients) Radiation therapy Highest rate of larynx preservation is associated with concurrent chemoradiation therapy compared with other radiation- based approaches, at the cost of higher acute toxicities but without more long-term difficulties in speech and swallowing; when salvage total laryngectomy incorporated, no difference in overall survival; organ preservation surgery is an option in highly selected patietns (eg, there are patients with T3 supraglottic cancers that have minimal or moderate pre-epiglottic invasion and are candidates for organ preserving surgery) Randomized controlled clinical trials comparing concurrent chemoradia- tion therapy, and/or induction chemotherapy followed by radiation, and/or radiation therapy alone; and/or surgery followed by radiation; comparison of outcomes from case series/prospective single- arm studies �A favorable T2 glottic lesion is defined as a superficial tumor, on radiographic imaging, with normal cord mobility. An unfavorable T2 glottic lesion is defined as a deeply invasive tumor on radiographic imaging, with or without subglottic extension, with impaired cord mobility (indicating deeper invasion). A favorable supraglottic lesion is defined as a T1 or T2 tumor with superficial invasion on radiographic imaging and preserved cord mobility, and/or tumor of the aryepiglottic fold with minimal involvement of the medial wall of the pyriform sinus. More locally advanced and invasive T2 suproglottic lesions are considered unfavorable. Larynx Guideline www.jco.org 3 Copyright © 2006 by the American Society of Clinical Oncology. All rights reserved. Downloaded from jco.ascopubs.org on August 10, 2010 . For personal use only. No other uses without permission. • Local tumor recurrence after radiation therapy may be amenable to salvage by organ-preservation surgery, but total lar- yngectomy will be necessary for a substantial proportion of pa- tients, especially those with index T2 tumors. • Concurrent chemoradiotherapy therapy may be used for larynx preservation for selected patients with stage III, T2 N� cancers when total laryngectomy is the only surgical option, when the functional outcome after larynx-preservation surgery is ex- pected to be unsatisfactory, or when surgical expertise in such procedures is not available. • Limited-stage laryngeal cancer constitutes a wide spec- trum of disease. The clinician must exercise judgment when recommending treatment in this category. For a given patient, factors that may influence the selection of treatment modality include extent and volume of tumor; involvement of the ante- rior commissure; lymph node metastasis; the patient’s age, occupation, preference, and compliance; availability of exper- tise in radiation therapy or surgery; and history of