Performance Status Scale For Head And Neck Cancer Patients Research Articles

Supportive care among head and neck cancer patients: An initial validation of the Dutch version of the Performance Status Scale for Head and Neck Cancer (D-PSS-HN).

Acute and late toxicities in patients treated with (chemo)radiotherapy for head and neck cancer (HNC) is common and can negatively impact quality of life and performance. Performance status instruments measure the functional ability to perform daily life activities and are important tools in the oncologic population. Since Dutch performance status scales for the HNC population are lacking, we conducted this study to translate the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) into Dutch (D-PSS-HN) and to validate this version. The D-PSS-HN was translated into Dutch according to the internationally described cross-cultural adaptation process. It was administered to HNC patients and together with the Functional Oral Intake Scale completed by a speech and language pathologist at five different time points during the first 5 weeks of (chemo)radiotherapy. Patients were asked each time to complete the Functional Assessment of Cancer Therapy and the Swallowing Quality of Life Questionnaire. Pearson correlation coefficients were used to calculate convergent and discriminant validity and the evolution of D-PSS-HN scores was assessed by means of linear mixed models. A total of 35 patients were recruited and > 98% of the clinician-rated scales were completed. Convergent and discriminant validity were demonstrated, with all correlations rs between 0.467 and 0.819, and between 0.132 and 0.256, respectively. The subscales of the D-PSS-HN are sensitive to detect changes through time. The D-PSS-HN is a valid and reliable instrument to assess performance status in patients with HNC treated with (chemo)radiotherapy. It is a useful tool to measure HNC patients' current diet level and functional abilities to perform daily life activities. What is already known on the subject Acute and late toxicities in patients treated with (chemo)radiotherapy for HNC are common and can negatively impact quality of life and performance. Performance status instruments measure the functional ability to perform daily life activities and are important tools in the oncologic population. However, Dutch performance status scales for the HNC population are lacking. Therefore, we translated the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) into Dutch (D-PSS-HN) and validated this version. What this paper adds to existing knowledge We translated the PSS-HN and demonstrated its convergent and discriminant validity. The subscales of the D-PSS-HN are sensitive to detect changes through time. What are the potential or actual clinical implications of this work? The D-PSS-HN is a useful tool to measure HNC patients' functional abilities to perform daily life activities. The tool can easily be used in clinical settings: since data collection duration is very short, this facilitates clinical (and research-related) implementation of the scale. Patients' individual needs could be identified by using the D-PSS-HN, resulting in more appropriate approaches and (early) referrals if needed. Interdisciplinary communication could be facilitated.

PERFORMANCE STATUS AND QUALITY OF LIFE AFTER RECONSTRUCTIONS OF BUCCAL MUCOSAL AND RETROMOLAR TRIGONE DEFECTS BY SKIN AND FASCIAL FLAPS IN ONCOLOGYCAL PATIENTS

The aim: of the study is to compare surgical and functional results as well as quality of life after use of skin flaps - platysma myocutaneus flap, supraclavicular artery flap and fascial flaps - temporoparietal fascial flap, buccal fat pad for plastic closure of the buccal and retromolar trigone mucous surgical defects in cancer patients. Material and methods: A retrospective comparative analysis of the results of surgical treatment of buccal and retromolar trigone mucosal cancer in 56 patients operated from 2009 to 2014 was made. The patients were divided into two groups: the first included 26 patients, with reconstruction of fascial flaps, the second group included 30 patients, with reconstruction of postoperative defects with skin flaps. Surgical results: the average duration of surgery, the average duration of inpatient treatment and the presence of complications were compared in the both groups. Functional results in both groups were compared in 6 and 12 months after surgery with the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN), and quality of life was assessed by the University of Washington Quality of Life questionnaire, version 4. Results: Average duration of surgery, average time of inpatient treatment, and postoperative complications did not differ significantly in both groups (P> 0.05). Data of performance status and quality of life in patients with reconstruction of mucosal defects and retromolar trigone with skin flaps were significantly better (P> 0.05) in 6 and 12 months after surgery, compared with the group of patients who underwent defect reconstruction with fascial flaps. Conclusions: The method of choice in reconstruction of medium and large defects of the buccal and the retromolar trigone mucous is usage of skin flaps: the platysma myocutaneus flap and the flap of the supraclavicular artery.

SKIN-MUSCULAR FLAP OF MAJOR PECTORALIS MUSCLE IN PHARYNGOSTOMAS PLASTIC CLOSURE

Laryngeal and hypopharyngeal cancer accounts for 1.5–3.8% of all malignant neoplasms, accounting for more than half of all ENT-cancer patients in the structure of oncological morbidity in Ukraine. Among them more than 60% are found in III–IV stages. Locally diffused larynx and hypopharynx cancer are indications for laryngectomy and resection of the hypopharynx, depending on the extent of the lesion that, in the presence of regional metastases, can be combined with one-or two-way radical or functional neck dissection. Failure to suture the hypopharynx after laryngectomy further leads to the formation of pharyngeal fistulas, suppurations of postoperative wounds, necrosis of the skin and the formation of pharyngostomas. In the plastic closure of the pharyngostomes, regional skin, and facial, and skin-muscle flaps are used, among which the most common is the large chest muscle. The advantages of the flap are the ease of fence, the large volume of plastic material, stability of a “vascular leg”, reliability and short operating time. Our experience with the use of free and regional flap suggests that the musculo-skeletal system of the large chest muscle can be used not only as a “rescue swaddle”, but also, as a first choice in certain clinical situations. 72 patients with laryngeal and hypopharyngeal cancer were included to the study. The age of patients ranged from 41 to 74 years. All patients (100%) had histologically confirmed flat-cell carcinoma of varying degrees of differentiation. Depending on the spread of the cancer process, stage III (T3N0-1M0) was diagnosed in 47 (65.2%), stage IV (T3N2-3M0, T4N0-3M0) in 25 (34.8%) patients. Laryngeal cancer is found in 52 (72.2%), hypopharyngeal — in 20 (27.8%) patients. Plastic closure of pharyngostomas was carried out after 2–3 months after larynectomy, after reduction of inflammation in postoperative wound and clear formation of pharyngostoma edges. The surgical intervention was carried out by two brigades — one brigade carried out the excision of the skin muscle flap, while the other one carried out the removal of the throat wall in the soft tissues of the neck, and then the sheathing of the skin part of the flap was carried out to the edges of the pharyngostomas, and the stitching of the edges of the skin at the point of excision of the flap on the chest wall. The evaluation of the function was performed on the scale of functioning for head and neck cancer patients, PSS-HN (Performance Status Scale for Head and Neck Cancer Patients). The total necrosis of the flap was observed in 2 patients (2.7%) among 72, that were operated as one of the first, at the stage of development of the surgical technique. Partial flap necrosis was observed in 6 (8.3%) patients. Thus, the plastic closure of pharyngostomas with the help of the skin-mimetic flap of the big chest muscle was successful in the vast majority of patients (70 out of 72). The investigation of the functional status of patients on the PSS-HN scale showed a significant improvement and expansion of the diet from 30 to 90-100 points due to the transfer of patients from probe to usual food intake. The public eating habits improved from 25 to 100 points. The operation of the plastic closure of pharyngostomas did not increase the clarity of the language of patients, but created the anatomical conditions for the development of pseudo-voice and vocal prosthesis. So, the using of the skin-muscular flap of major pectoralis muscle in pharyngostomas plastic closure allows achieving satisfactory surgical and functional results.

Assessment of the quality of life and performance status in patients with oral submucous fibrosis in central India.

Background and aimsMeasuring quality of life in patients with oral submucous fibrosis is of utmost importance in assessing treatment outcomes. This study examined the impact of oral submucous fibrosis and its treatment on the quality of life and performance status of persons with oral submucous fibrosis.MethodsQuality of life was measured in patients with oral submucous fibrosis using the European Organization for Research and Treatment of Cancer Quality of Life head and neck 35 Questionnaire (EORTC QLQ-C35); performance status was measured by Performance Status Scale for Head and Neck Cancer Patients (PSS-HN), at four points in time: baseline, one month, two months and three months after start of treatment.ResultsAt the end of third month Group A and Group B showed 78% and 85% increase in mouth opening respectively. While the burning sensation of oral mucosa was decreased by 72% and 88% in group A and group B respectively (Z>1.96, P<0.05), there were significant differences in patients’ quality of life and functioning at three points in time (P < 0.05).ConclusionThe European Organization for Research and Treatment of Cancer Quality of Life head and neck 35 Questionnaire and Performance Status Scale for Head and Neck Cancer Patients can be used successfully in potentially malignant disorders like oral submucous fibrosis. The results in this study will surely be a good guide forother studies on oral submucous fibrosis.

Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.

The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) is the universal framework for toxicity reporting in oncology trials. The objective of this study was to develop a CTCAE-compatible modified barium swallow (MBS) grade for the purpose of grading pharyngeal dysphagia as a toxicity endpoint in cooperative-group organ-preservation trials for head and neck cancer (HNC). It was hypothesized that a 5-point, CTCAE-compatible MBS grade (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) based on the interaction of pharyngeal residue and laryngeal penetration/aspiration ratings would be feasible and psychometrically sound. A modified Delphi exercise was conducted for content validation, expert consensus, and operationalization of DIGEST criteria. Two blinded raters scored 100 MBSs conducted before or after surgical or nonsurgical organ preservation. Intrarater and interrater reliability was tested with weighted κ values. Criterion validity against oropharyngeal swallow efficiency (OPSE), the Modified Barium Swallow Impairment Profile (MBSImP™©), the MD Anderson Dysphagia Inventory (MDADI), and the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) was assessed with a 1-way analysis of variance and post hoc pairwise comparisons between DIGEST grades. Intrarater reliability was excellent (weighted κ = 0.82-0.84) with substantial to almost perfect agreement between raters (weighted κ = 0.67-0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP™©: r = 0.77; P < .0001), swallow efficiency (OPSE: r = -0.56; P < .0001), perceived dysphagia (MDADI: r = -0.41; P < .0001), and oral intake (PSS-HN diet: r = -0.49; P < .0001). With the development of DIGEST, the MBS rating has been adapted to the CTCAE nomenclature of ordinal toxicity grading used in oncology trials. DIGEST offers a psychometrically sound measure for HNC clinical trials and investigations of toxicity profiles, dose responses, and predictive modeling. Cancer 2017;62-70. © 2016 American Cancer Society.

Understandability of Speech Predicts Quality of Life Among Maxillectomy Patients Restored With Obturator Prosthesis

Maxillary malignant tumor resection by maxillectomy might lead to defects that can be repaired by prosthetic obturation. The aim of this study was to associate quality of life (QoL) and the Obturator Functioning Scale (OFS) with functional performance and salivary flow rate in Brazilian patients rehabilitated with an obturator prosthesis. This retrospective cross-sectional study included patients who underwent surgical resection with or without radiotherapy or without chemotherapy and the rehabilitation with an obturator prosthesis at the Fundação Oncocentro de São Paulo (São Paulo, Brazil). The predictor variables were Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) domains and clinical evaluation of salivary flow rate. The outcome variables were overall scores obtained by the University of Washington QoL Scale (UWQOL) and the OFS. Sociodemographics (gender and age) and clinical characteristics (postoperative radiotherapy, tumor stage, classification of maxillary defect, tooth in maxilla, and type of obturator) also were evaluated. Univariate and multivariate analyses were performed to determinate whether PSS-HN domains and salivary flow were predictors of overall QoL and overall OFS. The sample was composed of 73 patients with a mean age of 62years and 51% were men. According to the PSS-HN domains, some patients (5%) always ate alone, 87% reported that speech is usually or always understandable, and 56% had no dietary restrictions. Sixty-one patients (65%) reported some degree of hyposalivation. The mean overall QoL score was 76.5 (standard deviation, 5.3). Patients with compromised PSS-HN domains had significantly worse overall UWQOL scores (P= .001, P < .001, and P= .006, respectively). In multiple regression analyses, understandability of speech was the only predictor of overall QoL scores. The results of this study showed that understandability of speech was the only predictor of overall QoL scores.

Assessment of Surgical Treatment Impact on the Quality of Life in 57 Cases of Patients with a Giant Tumor in the Head and Neck Region

Quality of life (QOL) is an important factor to take into consideration in the treatment for giant head and neck tumor. The purpose of this study is to evaluate surgical treatment impact on the quality of life in 57 cases of patients with a giant tumor in the head and neck region. The patients were divided into two groups: a benign group (21 cases; 36.84 %) and a malignant group (36 cases; 63.16 %). QOL was assessed using the Performance status scale for head and neck cancer patients (PSS-HN) and the University of Washington Quality of Life (UW-QOL) questionnaires before and 1 month, 6 months, and 12 months after surgical treatment respectively. Fifty-seven of the 71 questionnaires (80.28 %) were completed for both PSS-HN and UW-QOL at one or two times during the treatment and follow-up periods. The appearance was improved in giant benign head and neck tumor group, but deteriorated significantly in malignant group. The QOL in patients deteriorated by surgical treatment but it could be improved over time. PSS-HN, in conjunction with UW-QOL, can provides a valuable tool for the assessment of quality of life in giant tumor of head and neck before, during and after treatment with surgery.

Late Radiation-Associated Dysphagia (RAD) and Lower Cranial Neuropathy After Oropharyngeal Radiation Therapy: A Case–Control Dosimetric Comparison

Purpose/Objective(s): Many patients will require parenteral nutrition due to dysphagia during definitive radiation therapy for locally advanced head and neck cancer. However, the optimal timing of feeding tube (FT) insertion (prophylactic versus reactive) remains controversial. This study describes prospectively collected functional outcomes comparing prophylactic versus reactive FTs. Materials/Methods: Patients undergoing definitive radiation therapy for stage III and IV head and neck cancer between 2004 and 2009 prospectively underwent functional outcome assessment at baseline and 3, 6, 12, 24, and 36 months post-treatment. The use of FT and timing of insertion was at the discretion of the attending oncologist. Instruments included the Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS), the Performance Status Scale for Head and Neck Cancer Patients (PSSHN), and the Edmonton Symptom Assessment Scale. Multivariable analysis was conducted to determine the significance of FT status while controlling for potential confounding variables including age, gender, tumor stage, chemotherapy use, and primary site of disease. Results: A total of 178 patients were assessed with a median follow-up of 36.4 months. FTs were inserted prophylactically in 92 (51.7%), reactively in 23 (12.9%), and no tube in 63 (35.4%) patients. Compared to patients who received a prophylactic FT, those who had a reactive FT did not have a statistically significant difference in worse swallowing functional outcomes for PSS-HN subscales of eating in public (adjusted odds ratio [AOR] 1.65, p Z 0.42), understandability of speech (AOR 0.73, p Z 0.58), and normalcy of diet (AOR 1.39, pZ 0.66). Similarly, there were no differences in the RBHOMS levels for modified diet (AOR 1.00, pZ 0.99) and FT dependence (AOR 1.78, p Z 0.37). Patients who completed treatment without a FT had statistically significantly improved functional outcomes in PSS-HN and RBHOMS scores compared to both FT groups. Conclusions: Patients who received a reactive FT did not have a statistically significant difference in long-term functional outcomes compared to those with a prophylactically inserted FT. These findings warrant confirmation in a larger cohort of patients and should be considered when comparing the risks and benefits of different strategies for FT placement. Author Disclosure: H.C. Quon: None. C. Myers: None. A. Martens: None. J. Butler: None. R. Stimpson: None. D. Duerksen: None. H. CampbellEnns: None.

Functional Impact of the Arytenoidectomy in SCPL

Objective: The arytenoid is one of the components of sphincteric function of the larynx, and arytenoid resection during supracricoid partial laryngectomy (SCPL) may negatively affect the functional results. The purpose of this study was to evaluate the functional results in patients who underwent unilateral arytenoidectomy during SCPL. Method: Retrospectively reviewed medical records of 116 patients who received SCPL. Regarding the extended procedure of unilateral arytenoidectomy, the patients were divided into 2 groups: Nonextended group and extended group. We evaluated and compared the functional results between the 2 groups. Results: There was a significantly higher rate of aspiration pneumonia ( P = .003*), delay of oral feeding ( P = .038*), and longer hospitalization time ( P = .008*) in the extended group. There was no significant difference in the score of “normalcy of diet,” “eating in public,” and “understandibility of speech” of PSS-HNS (Performance status scale for head and neck cancer patients) at last follow-up between the 2 groups ( P = .675, P = .645, P = 1.000). Conclusion: Resection of the arytenoid may interrupt physiologic airway protection in the early postoperative period, so special cautions may be needed to prevent aspiration pneumonia. However, extended SCPL including arytenoidectomy allows avoidance of functional handicap and social maladjustment.

Prospective subjective evaluation of swallowing function and dietary pattern in head and neck cancers treated with concomitant chemo-radiation

Prospective subjective evaluation of swallowing function and dietary pattern in locally advanced head and neck cancer patients treated with concomitant chemo-radiotherapy (CRT). Prospective evaluation of swallowing function with performance status scale for head and neck cancer patients (PSSHN) at pre-CRT, CRT completion and at subsequent follow-ups in adult with loco-regionally advanced head and neck squamous cell carcinoma (HNSCC) patients. In 47 patients (40 male, seven females; mean age 53; 72% smoker 53%, oropharyngeal cancer), the mean total PSSHN score at pre-CRT was 258.5 and decreased to 225.2 and 219.2 at two and six months respectively. Understandability of speech, normalcy in diet and eating in public at pre-CRT and six months were 91.5 and 84.4; 80.4 and 63.1; 87.3 and 76.6 respectively. In univariate analysis, pre-CRT PSSHN scores were significantly lesser in patients with severe pre-CRT dysphagia (P = 0.001), hypopharyngeal cancer (P = 0.244) and advanced T-stage (T3/4) disease (P = 0.144). At CRT completion, there was significant reduction of PSSHN scores in patients with severe pre-CRT dysphagia (P = 0.008), post-CRT weight loss (>10%) and disease progression (P = 0.039). At two months and six months, 17 (57%) and 11 (73.5%) patients respectively showed change in dietary habit. Mean increase in meal time was 13% and 21% at two and six-month follow-up. HNSCC patients show deterioration in swallowing function after CRT with normalcy of diet in maximum and eating in public least affected. Pre-CRT severity of dysphagia, weight loss> 10% and disease progression have significant correlation with higher swallowing function deterioration after CRT.

Assessment of functioning in patients with head and neck cancer according to the International Classification of Functioning, Disability, and Health (ICF): A multicenter study

To assess the level of functioning in patients with head and neck cancer (HNC) using the the International Classification of Functioning, Disability, and Health (ICF). Multicenter study at nine different study centers in four European countries. Data collection included structured interviews according to the extended ICF checklist with 145 HNC patients and completion of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaires (EORTC-QLQ). The generic ICF checklist was extended by additional HNC-specific categories identified in six HNC-specific questionnaires: EORTC, University of Washington Quality of Life (UW-QOL), Functional Assessment of Cancer Therapy scale (FACT), Performance Status Scale for Head and Neck cancer patients (PSS-HN), Head and Neck Quality of Life instrument (HN-QOL), and Voice Handicap Index (VHI). The ICF qualifier system was applied on a scale from 0 (not impaired) to 4 (completely impaired), as well as "ns, na" (not specified, not applicable) and "c" (impaired due to comorbidity). ICF categories impaired due to HNC (1-4) in > or = 10% of patients were reported. One hundred fifteen (80%) of 144 categories of the extended ICF checklist were identified to be at least mildly impaired or restricted in > or = 10% of patients. The four areas that were relevant to most of the patients were "immediate family" (91%), "friends" (86%), "health services and policies" (85%) and "health professionals" (85%), all belonging to the ICF component of environmental factors. The most often identified categories were "ingestion" (75%) for body functions and "speaking" (76%) for activities and participation. The summary score of all answers correlated well with the overall level of health and quality of life as assessed in the EORTC questionnaires (0.59, 0.61, respectively). The ICF identifies problems in functioning in patients with HNC comprehensively. The results emphasize the importance of contextual environmental factors. In particular, environmental factors referring to interpersonal support should be more strongly included in rehabilitation plans for HNC.

Prevention of wound complications following salvage laryngectomy using free vascularized tissue

Total laryngectomy following radiation therapy or concurrent chemoradiation therapy is associated with unacceptably high complication rates because of wound healing difficulties. With an ever increasing reliance on organ preservation protocols as primary treatment for advanced laryngeal cancer, the surgeon must develop techniques to minimize postoperative complications in salvage laryngectomy surgery. We have developed an approach using free tissue transfer in an effort to improve tissue vascularity, reinforce the pharyngeal suture line, and minimize complications in this difficult patient population. The purpose of this study was to outline our technique and determine the effectiveness of this new approach. We conducted a retrospective review of a prospective cohort and compared it with a historical group (surgical patients of Radiation Therapy Oncology Group (RTOG)-91-11 trial). Eligibility criteria for this study included patients undergoing salvage total laryngectomy following failed attempts at organ preservation with either high-dose radiotherapy or concurrent chemo/radiation therapy regimen. Patients were excluded if the surgical defect required a skin paddle for pharyngeal closure. The prospective cohort consisted of 14 consecutive patients (10 males, 4 females; mean age, 58 years) who underwent free tissue reinforcement of the pharyngeal suture line following total laryngectomy. The historical comparison group consisted of 27 patients in the concomitant chemoradiotherapy arm of the RTOG-91-11 trial who met the same eligibility criteria (26 males, 1 female; mean age, 57 years) but did not undergo free tissue transfer or other form of suture line reinforcement. Minimum follow-up in both groups was 12 months. The overall pharyngocutaneous fistula rate was similar between groups-4/14 (29%) in the flap group, compared with 8/27 (30%) in the RTOG-91-11 group. There were no major wound complications in the flap group, compared with 4 (4/27, 14.8%) in the RTOG-91-11 group. There were no major fistulas in the flap group, compared with 3/27 (11.1%) in the RTOG-91-11 group. The rate of pharyngeal stricture requiring dilation was 6/14 (42%) in the flap group, compared with 7/27 (25.9%) in the RTOG-91-11 group. In our patients, the rate of tracheoesophageal speech was 14/14 (100%), and complete oral intake was achieved in 13/14 (93%) patients. Voice-Related Quality of Life Measure (V-RQOL) and Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) scores suggest that speech and swallowing functions are reasonable following free flap reinforcement. Free vascularized tissue reinforcement of primary pharyngeal closure in salvage laryngectomy following failed organ preservation is effective in preventing major wound complications but did not reduce the overall fistula rate. Fistulas that developed following this technique were relatively small, did not result in exposed major vessels, and were effectively treated with outpatient wound care rather than readmission to the hospital or return to operating room. Speech and swallowing results following this technique were comparable to those following total laryngectomy alone.

Functional results with advanced hypopharyngeal carcinoma treated with circular near-total pharyngolaryngectomy and jejunal free-flap repair

Patients treated by a circular pharyngolaryngectomy for advanced hypopharyngeal carcinoma have a poor prognosis and disappointing speech restoration. Three carefully selected patients underwent a near-total laryngectomy circular pharyngectomy with jejunal free flap repair and dynamic tracheopharyngeal shunt for treatment of advanced hypopharyngeal carcinoma. They received induction chemotherapy and postoperative radiotherapy. We assessed the functional outcome. There was no major local complication. One year after the end of radiotherapy, all patients were able to eat solid diets. Two patients were able to speak immediately after the end of the treatment. After speech re-education, a high-quality tracheopharyngeal voice was restored in all three patients. Performance Status Scale for Head and Neck Cancer Patients (PSSHN) showed a mean score equal to 81/100 at 1 year. In selected patients, near-total laryngectomy circular pharyngectomy with tracheopharyngeal shunt and jejunal free-flap repair offers good voice rehabilitation without impairing swallowing function.

Voice and swallowing outcomes of an organ-preservation trial for advanced laryngeal cancer

Organ-preservation treatment approaches for advanced laryngeal cancer patients that use combination chemoradiotherapy result in cure rates similar to primary laryngectomy with postoperative radiotherapy. In the national VA Larynx Cancer Trial, successful organ preservation was associated with an overall improvement in quality of life but not in subjective speech compared with long-term laryngectomy survivors. As part of a Phase II clinical trial, a prospective study of speech and swallowing results was conducted to determine if larynx preservation is associated with improved voice and swallowing compared with results in patients who require salvage laryngectomy. A total of 97 patients with advanced laryngeal cancer (46 Stage III, 51 Stage IV) were given a single course of induction chemotherapy (cisplatin 100 mg/m2 on Day 1 and 5-FU 1,000 mg/m2/day x 5 days), followed by assessment of response. Patients with less than 50% response underwent early salvage laryngectomy, and patients with 50% or better response underwent concurrent chemoradiation (72 Gy and cisplatin 100 mg/m2 on Days 1, 22, and 43), followed by two cycles of adjuvant chemotherapy (DDP/5-FU). Direct laryngoscopy and biopsy were performed 8 weeks after radiation therapy to determine final tumor response. Late salvage surgery was performed on patients with persistent or recurrent disease. Completed survey data on voice and swallowing utilizing the Voice-Related Quality of Life Measure (V-RQOL) and the List Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) were obtained from 56 patients who were alive and free of disease at the time of survey, with a minimum follow-up of 8 months. Comparisons were made between patients with an intact larynx (n = 37) vs. laryngectomy (n = 19), as well as early (n = 12) vs. late salvage laryngectomy (n = 7). Multivariate analysis was performed to determine factors predictive of voice and swallowing outcomes. Overall 3-year determinant survival was 87%, with median follow-up of 40 months. Patients with an intact larynx demonstrated significantly higher (p = 0.02) mean V-RQOL scores (80.3) than did laryngectomy patients (65.4). This finding was consistent in the social-emotional (p = 0.007) and physical functioning domains (p = 0.03). No differences in V-RQOL scores were found in comparisons between early and late salvage laryngectomy. Multiple linear regression revealed that predictors of higher total V-RQOL scores include lower T stage (p = 0.03), organ preservation (p = 0.0007), and longer duration since treatment (p = 0.01). Understandability of speech was better in patients with an intact larynx (p = 0.001). Overall swallowing function was comparable between groups. Multiple logistic regression revealed that longer duration since treatment (p = 0.03, odds ratio = 1.1) and lower maximal mucositis grade (p = 0.03, odds ratio = 0.3) were predictive of higher likelihood of eating in public. Nutritional mode consisting of oral intake alone without nutritional supplements was achieved in 88.9% of patients with an intact larynx compared with 64.3% of laryngectomees (p = 0.09). Voice-related quality of life is better in patients after chemoradiation therapy compared with salvage laryngectomy. Earlier salvage, although known to be associated with fewer surgical complications, did not result in improved voice; however, the number of patients analyzed is small. Overall swallowing function is good in all patients; however, patients with an intact larynx are more likely to obtain nutrition with oral intake alone without supplements. Such measures of function and quality of life are important endpoints to help judge overall effectiveness as newer, more aggressive treatment protocols with added toxicities are developed and evaluated.

The performance status scale for head and neck cancer patients and the functional assessment of cancer therapy‐head and neck scale: A study of utility and validity

BACKGROUND The goal of this investigation was to examine the relationship between, and application of, two disease specific quality of life (QL) measures currently being employed for head and neck cancer patients: the Functional Assessment of Cancer Therapy-Head and Neck Scale (FACT-H & N) and the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN). METHODS The FACT-H & N and PSS-HN were administered to 151 head and neck cancer patients with a range of disease sites, treatment status (on vs. off treatment), and treatment modalities (surgery, radiation, and chemotherapy). RESULTS FACT-H & N subscale and total scores and PSS-HN subscale scores proved sensitive to patients groups (showed significant and clinically meaningful differences) on the basis of treatment status (on vs. off treatment) and global performance status (Karnofsky scores). The pattern of correlations between FACT-H & N and PSS-HN subscales supported the scales' construct (convergent vs. divergent) validity. The strongest and most significant associations were observed between PSS-HN Normalcy of Diet and Eating in Public, and the head and neck subscale (HNS) of FACT-H & N, both of which were designed to measure the unique problems of head and neck cancer patients. More modest associations were observed between subscales measuring physical and functional areas of performance, social functioning, and emotional well-being. CONCLUSIONS The FACT-HNS was found to be reliable and valid when applied to head and neck cancer patients. It clearly adds information to that collected by the parent (core) instrument. The PSS-HN also provides unique information, independent of that provided by the Karnofsky or the FACT-H & N. This study supported the multidimensional nature of QL for head and neck cancer patients, and thus the importance of assessing disease specific concerns in addition to general health status when assessing functional and QL outcome. Cancer 1996;77:2294-301.