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© 2002 American Society for Clinical Oncology Voice Rehabilitation After Total Laryngectomy and Postoperative Radiation TherapyByFrom the Departments of Radiation Oncology and Otolaryngology, University of Florida College of Medicine, Gainesville, FL. Address reprint requests to William M. Mendenhall, MD, Department of Radiation Oncology, University of Florida Health Science Center, PO Box 100385, Gainesville, FL 32610-0385; email: mendewil{at}shands.ufl.edu
PURPOSE: The purpose of this study was to evaluate voice rehabilitation after laryngectomy and postoperative irradiation for patients with squamous cell carcinoma of the larynx and hypopharynx. PATIENTS AND METHODS: Between December 1983 and December 1998, 173 patients underwent a total laryngectomy and postoperative irradiation and had follow-up from 3 to 188 months (median, 38 months). Three patients were lost to follow-up at 63, 39, and 4 months after treatment. All other living patients had follow-up for 2 years or longer. Twelve (7%) patients had incomplete data pertaining to voice rehabilitation. RESULTS: Data pertaining to voice rehabilitation were available at 2 to 3 years and longer and 5 years and longer after treatment for 118 and 69 patients, respectively. The methods of voice rehabilitation at 2 to 3 years and longer and 5 years and longer were as follows: tracheoesophageal, 27% and 19%; artificial larynx, 50% and 57%; esophageal, 1% and 3%; nonvocal, 17% and 14%; and no data, 5% and 7%, respectively. CONCLUSION: The most common form of voice rehabilitation after total laryngectomy and postoperative radiation therapy is the artificial larynx. Although the tracheoesophageal puncture is a technique frequently promoted by clinicians as a superior method, a relatively small subset of patients are successfully rehabilitated long-term. However, of those who undergo a tracheoesophageal puncture, approximately half will use this method of voice rehabilitation long term.
TOTAL LARYNGECTOMY results in a significant functional loss.1 The likelihood and method of successful voice restoration may vary with the primary site, extent of disease, method of closure, use of adjuvant radiation therapy (RT), and selection bias.2-5 Patients who are motivated and in better physical condition may be more likely to be successfully rehabilitated by various means. Tracheoesophageal puncture (TEP) is regarded by most to be the method of choice for voice restoration.1,4,6,7 There has been a significant shift toward organ preservation strategies with either altered fractionation alone for patients with relatively favorable lesions,8-13 induction chemotherapy followed by RT alone for responders,14,15 or concomitant chemoradiation schedules.16-20 Although the results of organ preservation trials are encouraging, a subset of patients with high-volume, advanced cancers may be cured but have an incompetent larynx and require a permanent tracheostomy or gastrostomy.10 Although the proportion of patients requiring a total laryngectomy may be decreasing, a subset of patients with advanced disease will be best treated with this operation, and it remains the major alternative treatment option for organ preservation candidates. Therefore, it is important for patients to have a realistic expectation for the method by which they will communicate. The aim of this study was to evaluate the type and success rate of voice rehabilitation techniques in patients treated with a total laryngectomy and postoperative irradiation and to determine parameters that may be related to the likelihood of successful long-term vocal rehabilitation.
Between December 1983 and December 1998, 173 patients with advanced squamous cell carcinomas of the larynx and hypopharynx were treated with a total laryngectomy followed by postoperative RT at the University of Florida. All patients were treated with curative intent. Patients were staged according to the recommendations of the 1998 American Joint Committee on Cancer staging system.21 The characteristics of the patient population are listed in Table 1. There were 158 men and 15 women. Age ranged from 35 to 80 years (median, 60 years). The treatment of choice for pharyngeal wall cancers treated at our institution has been RT with surgery reserved for salvage of local or regional recurrences. Therefore, almost all patients with hypopharyngeal cancers included in this series had pyriform sinus tumors. All patients had either stage III or IV disease. Patients with stage IVB cancers usually were not operated on as the initial step in treatment, because N3 neck disease is often not completely resectable. Patients with advanced laryngeal or hypopharyngeal primary tumors and N3 neck disease are usually treated with preoperative irradiation followed by surgery. Patients had follow-up from 3 to 188 months (median, 38 months). Three patients were lost to follow-up at 4, 39, and 63 months and were censored at that time for data analysis. According to the Social Security Death Index, the patients studied are likely to be alive and, because of the time interval between treatment and data analysis (7, 10, and 11 years), disease-free. Voice rehabilitation was broadly stratified into the following categories: tracheoesophageal, artificial larynx, esophageal, nonvocal, and no data.1,22,23 Information pertaining to voice rehabilitation was collected by the senior author (W.M.M.). Complete information pertaining to voice rehabilitation was unavailable for 12 (7%) patients.
The surgical procedures that were performed are listed in Table 2. Reconstructive procedures performed at the time of laryngectomy include 12 pectoralis major flaps, two deltopectoral flaps, five jejunal interpositions, and two gastric transpositions. Eighty-four patients were operated on at Shands Hospital or private hospitals, and 89 patients were operated on at Veterans Administration hospitals. The interval between surgery and the initiation of postoperative irradiation ranged from 21 to 115 days (median, 37 days). One hundred seventy-two patients were treated with once-daily fractionation, and one patient was treated with twice-daily fractionation. All patients were treated with a planned continuous course. The dose per fraction was usually 1.2 Gy for patients irradiated twice daily and 2 Gy for those treated once daily. The median total dose was 64 Gy (range, 58 to 70.2 Gy). The stoma was included in the low neck field, and, if necessary, the dose to the stoma was boosted with electrons (usually 12 MeV). The median stoma dose was 60 Gy (range, 40.5 to 70 Gy). Patients were irradiated with megavoltage beams, as follows: 60Co, 168 patients; 6 MV x-ray, three patients; 60Co and 6 MV x-ray, one patient; and other, one patient. The overall treatment time for the course of RT ranged from 36 to 64 days (median, 46 days). Treatment techniques have been previously described.24 No patients received chemotherapy as part of their initial treatment.
SAS statistical software (SAS Institute, Cary, NC) was used for the statistical analyses.25 The rates of local-regional control, freedom from distant metastases, absolute survival, and cause-specific survival were calculated according to the product-limit method.26 The Cox proportional hazards model was implemented to test whether the following variables had any effect on the end point of having a TEP as of the time of last follow-up: primary site (larynx v hypopharynx), T stage (T2 or T3 v T4), method of closure (primary v flap), neck dissection (none v unilateral or bilateral), location of operation (Veterans Administration hospital v other), and stoma dose (50 Gy v > 50 Gy). Almost all patients operated on at other hospitals were operated on at Shands Hospital. Two other variables of interest, overall stage and primary operation, were not included in the analysis, because overall stage was highly correlated with T stage and primary operation was almost perfectly correlated with primary site. A logistic regression was implemented to test whether the same six explanatory variables had any impact on the likelihood of having TEP at any time. Backward elimination was implemented in both cases to arrive at a final model. Information pertaining to performance status was not available for most of the patients in the study. Complications were coded as severe if they necessitated a second operation, a second hospitalization, or hyperbaric oxygen therapy or were fatal.27
The time interval between surgery and the development of recurrent disease ranged from 4 to 41 months (median, 13 months). The rates of local and regional control, distant metastases, survival, and cause-specific survival are listed in Table 3.
The results of voice rehabilitation are listed in Table 4. Seventy-seven (45%) patients had TEP at any time; 39 (51%) of 77 patients had TEP as of the time of last follow-up or death. Nine (32%) of 28 patients who had TEP at the time of laryngectomy had TEP at last follow-up or death compared with 29 (62%) of 47 patients who underwent a delayed TEP (P = .0175). The logistic regression analysis of TEP at any time is depicted in Table 5 and at last follow-up is depicted in Table 6. Each regression included 158 of the original 173 patients; seven patients were excluded who had reconstruction other than primary closure or muscle flap, and eight additional patients were excluded because TEP information was missing. The logistic regression found stoma dose (P = .0347 in the reduced model) and surgery location (P = .0485 in the reduced model) to be significant explanatory variables of the binary response of TEP at any time (Table 5). No explanatory variables were found to be significant in the Cox regression analysis with the end point of TEP at last follow-up (Table 6). Presence of TEP at last follow-up calculated according to the product-limit method is depicted in Fig 1. An event was defined as the presence of a TEP at last follow-up or death. Because only one patient was lost to follow-up within 2 years of treatment, all but one of the events observed during the first 2 years were deaths with TEP present. The curve flattens at 4 to 5 years, and the likelihood of TEP at last follow-up is approximately 20% (see Table 2).
Thirty-seven (21%) patients sustained a significant complication secondary to treatment, including the following: pharyngocutaneous fistula requiring surgery (six patients) or hyperbaric oxygen (three patients), wound breakdown requiring rehospitalization or surgery (three patients), permanent gastrostomy (three patients), pharyngocutaneous fistula necessitating rehospitalization (two patients), chyle fistula requiring surgery (two patients), bleeding requiring surgery (two patients), peristomal necrosis requiring surgery (two patients), stomal revision (eight patients), postoperative myocardial infarction (one patient), postoperative arterial thrombosis necessitating an above-the-knee amputation (one patient), infection necessitating hospitalization for intravenous antibiotics (two patients), necrosis of the clavicular head necessitating surgery (one patient), and peristomal necrosis with a fatal arterial rupture after a negative biopsy (one patient). Only one complication was fatal, and this occurred 15 months after treatment.
The likelihood of successful long-term use of TEP depends on a variety of factors, including patient selection and length of follow-up. The probability of TEP use likely decreases with more liberal selection criteria and as the length of follow-up increases. Hillman et al22 reported a series of 166 patients included in the Veterans Affairs Laryngeal Cancer Study Group trial who underwent voice evaluation at various time intervals ranging from 1 to 24 months after treatment.14,22 One hundred four patients were alive 2 years after treatment; eight (7%) had undergone a partial laryngectomy. The following methods of voice rehabilitation were observed in the remaining 96 patients 2 years after a total laryngectomy and postoperative irradiation: tracheoesophageal, 27 (28%) patients; artificial larynx, 47 (49%) patients; esophageal, five (5%) patients; nonvocal, seven (7%) patients; and no data, 10 (11%) patients. Patients in this study were selected to the extent that they were motivated to participate in a phase III prospective randomized trial, and they had to be able to tolerate induction chemotherapy if they were randomized to the organ preservation arm of the study. The proportion of patients using TEP to communicate 2 years after treatment is almost identical to that observed in the present study (Table 4). St Guily et al28 reported on 81 patients who underwent a total laryngectomy at the Tenon Hospital (Paris) and were preoperatively evaluated for voice restoration. The ability to obtain an intelligible voice with short follow-up according to the restoration procedure was achieved in the following patients: esophageal speech, six (32%) of 19; tracheoesophageal puncture, 22 (79%) of 28; and myomucosal shunt, 10 (77%) of 13. Twenty-one (26%) patients underwent no effective voice restoration. Artificial larynx was not used as a primary technique for voice restoration in this series. Twenty-nine (41%) of 71 patients had follow-up for longer than 1 year and were able to obtain an intelligible voice for occasional or daily use. Of 28 patients who underwent tracheoesophageal puncture and had follow-up for 1 to 2 years, 75% obtained an intelligible voice. Long-term follow-up revealed that 30 (37%) patients were not successfully rehabilitated vocally. Geraghty et al29 reported on 202 patients who underwent total laryngectomy at the University of Illinois between 1984 and 1994; tracheoesophageal puncture using the Blom-Singer prosthesis was performed in 40 (20%) patients. The initial and long-term follow-up (median follow-up, 39 months) success rates after TEP were 70% and 66%, respectively. Thus, of 202 patients who underwent a total laryngectomy, 19 (9%) had long-term successful voice restoration with TEP. LaBruna et al30 reported on a series of 77 patients who had undergone a total laryngectomy, RT, and tracheoesophageal puncture at the Manhattan Eye, Ear, and Throat Hospital, New York, and had follow-up for at least 6 months. All patients were initially communicating successfully with TEP, and 75 (95%) patients continued to use this method of communication thereafter. Seventy-seven (45%) of 173 patients in the present series underwent TEP compared with 40 (20%) of 202 patients reported by Geraghty et al29 and 28 (35%) of 81 patients reported by St Guily et al.28 Patients who underwent laryngectomy at a Veterans Administration hospital were less likely to undergo TEP compared with those operated on at Shands Hospital or a private hospital. The reason for this is unclear but may be related to more stringent selection criteria in an effort to conserve resources at the Veterans Administration hospitals. Patients who received a higher irradiation dose to the stoma (> 50 Gy) were less likely to undergo a TEP compared with those who received a lower dose. There are several possible explanations for this observation, including concern that a higher irradiation dose might increase the risk of a complication after the procedure. Additionally, patients who require a higher dose are likely to have more advanced disease and may be less compliant and thus less likely to undergo the procedure. Patients who underwent TEP at the time of the primary surgical procedure were less likely to use TEP long-term compared with those who underwent TEP as a secondary procedure. The reason for this observation may be that patients who underwent TEP as a secondary procedure had completed treatment and had been observed for a longer period of time so that patients more likely to use this method of voice rehabilitation long-term were selected to undergo the procedure. Neither stoma dose nor surgery location were related to the presence of TEP at the last follow-up. Although it would be interesting to compare the present series to a larger series of patients who have undergone TEP after surgery alone, most patients presently undergoing total laryngectomy have either failed prior RT or have advanced disease and thus require adjuvant irradiation in addition to laryngectomy. A relatively small subset of unselected patients are successfully rehabilitated long-term with a tracheoesophageal puncture. However, of those who undergo TEP, approximately half will use this method of voice rehabilitation long-term. A relatively small subset of patients remains nonvocal. The likelihood and method of successful long-term voice rehabilitation depend on a variety of parameters, including selection bias.
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Jeremic B, Shibamoto Y, Milicic B, et al: Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: A prospective randomized trial. J Clin Oncol 18: 1458-1464, 2000 21. American Joint Committee on Cancer: AJCC Cancer Staging Handbook. Philadelphia, PA, Lippincott-Raven, 1998, pp 45-49 22. Hillman RE, Walsh MJ, Wolf GT, et al: Functional outcomes following treatment for advanced laryngeal cancer. Part I: Voice preservation in advanced laryngeal cancer. Part II: Laryngectomy rehabilitation. The state of the art in VA system. Ann Otol Rhinol Laryngol 107: 2-27, 1998 23. Goldstein LP, Merwin GE: Speech rehabilitation after total laryngectomy, in Million RR, Cassisi NJ (eds): Management of Head and Neck Cancer: A Multidisciplinary Approach, ed 2. Philadelphia, PA, JB Lippincott, 1994, pp 499-503 24. Amdur RJ, Parsons JT, Mendenhall WM, et al: Postoperative irradiation for squamous cell carcinoma of the head and neck: An analysis of treatment results and complications. Int J Radiat Oncol Biol Phys 16: 25-36, 1989[Medline] 25. SAS Institute: SAS OnlineDoc®, Version 8. Cary, NC, SAS Institute, 1999 26. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457-481, 1958[CrossRef] 27. Taylor JMG, Withers HR, Mendenhall WM: Dose-time considerations of head and neck squamous cell carcinomas treated with irradiation. Radiother Oncol 17: 95-102, 1990[CrossRef][Medline] 28. St Guily JL, Angelard B, el-Bez M, et al: Postlaryngectomy voice restoration: A prospective study in 83 patients. Arch Otolaryngol Head Neck Surg 118: 252-255, 1992 29. Geraghty JA, Wenig BL, Smith BE, et al: Long-term follow-up of tracheoesophageal puncture results. Ann Otol Rhinol Laryngol 105: 501-503, 1996[Medline] 30. LaBruna A, Klatsky I, Huo J, et al: Tracheoesophageal puncture in irradiated patients. Ann Otol Rhinol Laryngol 104: 279-281, 1995[Medline] Submitted July 11, 2001; accepted February 27, 2002.
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
