Five-year quality of life results of the randomized clinical phase III (RADPLAT) trial, comparing concomitant intra-arterial versus intravenous chemoradiotherapy in locally advanced head and neck cancer.

BACKGROUND: The purpose of this investigation was to present 5-years of quality-of-life (QOL) results of a multicenter randomized phase III trial, assessing intra-arterial (IA) versus standard intravenous (IV) chemoradiation for inoperable stage IV head and neck cancer. METHODS: Evaluation of 71 patients through European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module (EORTC QLQ-C30) and Head and Neck Module (QLQ-H&N35), and trial-specific questionnaires. Treatment consisted of standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions. RESULTS: No significant differences in treatment-related QOL problems between 1 and 5 years posttreatment were observed, except for "dry mouth" (gradually improving; p = .004). Survivors have lower fatigue levels (p = .04), better voice (p = 0.3), and swallowing (p = .03) than patients who could not complete all subsequent follow-up questionnaires. CONCLUSIONS: Most treatment-related QOL issues deteriorate during treatment, improve in the first year, and then remain stable, except xerostomia, improving up to the 5-year assessment point. Survivors show more positive scores for fatigue, voice, and swallowing. QOL issues at 1 year, thus, for most already represent those after 5-year follow-up.

The effect of a Heat and Moisture Exchanger (Provox HME) on pulmonary protection after total laryngectomy: a randomized controlled study.

The goal of this randomized controlled study was to investigate the effect of Heat and Moisture Exchanger use on pulmonary symptoms and quality of life aspects in laryngectomized patients. Eighty laryngectomized patients were included and randomized into an HME and Control group. The effect of the HME was evaluated by means of Tally Sheets and Structured Questionnaires. The results showed a significant decrease in the frequency of coughing, forced expectoration, and stoma cleaning in the HME group. There were trends for the prosthetic speakers to report more fluent speech with the HME and for the HME group to report fewer sleeping problems. In conclusion, this study, performed in Poland, confirms the results of previous studies performed in other countries, showing that pulmonary symptoms decrease significantly with HME use and that related aspects such as speech and sleeping tend to improve, regardless of country or climate.

Pretreatment organ function in patients with advanced head and neck cancer: clinical outcome measures and patients' views.

BACKGROUND: Aim of this study is to thoroughly assess pretreatment organ function in advanced head and neck cancer through various clinical outcome measures and patients' views. METHODS: A comprehensive, multidimensional assessment was used, that included quality of life, swallowing, mouth opening, and weight changes. Fifty-five patients with stage III-IV disease were entered in this study prior to organ preserving (chemoradiation) treatment. RESULTS: All patients showed pretreatment abnormalities or problems, identified by one or more of the outcome measures. Most frequent problems concerned swallowing, pain, and weight loss. Interestingly, clinical outcome measures and patients' perception did no always concur. E.g. videofluoroscopy identified aspiration and laryngeal penetration in 18% of the patients, whereas only 7 patients (13%) perceived this as problematic; only 2 out of 7 patients with objective trismus actually perceived trismus. CONCLUSION: The assessment identified several problems already pre-treatment, in this patient population. A thorough assessment of both clinical measures and patients' views appears to be necessary to gain insight in all (perceived) pre-existing functional and quality of life problems.

First-year quality of life assessment of an intra-arterial (RADPLAT) versus intravenous chemoradiation phase III trial.

BACKGROUND: We report the results of a multicenter randomized phase III study, assessing quality of life (QOL) in intra-arterial (IA) versus standard intravenous (IV) chemoradiation in advanced head and neck cancer. METHODS: Two hundred seven patients with inoperable stage IV disease-152 men and 55 women; mean age, 55 years-were included in this study. The patients were treated with standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions. The QOL assessments carried out were EORTC-C30, H&N35, and trial-specific questionnaires. RESULTS: Overall QOL deteriorated in all patients during treatment, is gradually improving over 1 year. IA patients showed significantly less nausea and vomiting at week 7 (p <.001). IV patients were significantly more fatigued (p <.006). At 1 year, no significant difference in tube feeding was found. Voice quality slightly exceeded the pretreatment values at 1 year. Forty-two of 62 employed patients returned to work. CONCLUSION: During treatment, significantly fewer problems with nausea and vomiting occurred in IA than in IV patients. Both groups showed improved voicing and oral intake during follow-up, often exceeding pretreatment values at 1 year.

A thin tracheal silicone washer to solve periprosthetic leakage in laryngectomies: direct results and long-term clinical effects.

OBJECTIVES: Assessment of the immediate results and long-term clinical effects of a thin silicone washer placed behind the tracheal flange of voice prostheses to treat periprosthetic leakage. PATIENTS AND METHODS: Three year retrospective analysis of 32 laryngectomized patients with 107 periprosthetic leakage events (PLEs). Custom-made silicone washers (outer diameter 18 mm, inner diameter 7.5 mm, thickness 0.5 mm) were placed behind the tracheal flange either in combination with prosthesis replacement or later. RESULTS: There was immediate resolution of periprosthetic leakage in 88 PLEs (median, 38 d; mean, 53 d; range, 8-330 d) and in 6 PLEs with the washer still in situ at the date of analysis (median, 75; mean, 97 d; range, 38-240 d). There was no resolution for periprosthetic leakage in 13 PLEs. Thus, in total, 94 of 107 PLEs (88%) were successfully resolved. In 29 of 32 (91%) patients, the washer resolved the problem at least in one PLE successfully. Twelve of 32 patients, including all 3 with washer failures, also required other interventions to ultimately solve the problem. The vast majority of patients (80%) did not consider placement of the washer to be inconvenient. CONCLUSIONS: In consideration of the high success rate and limited inconvenience for patients, this simple thin silicon washer application provides a good first option for the treatment of periprosthetic leakage.

High-dose superselective intra-arterial cisplatin and concomitant radiation (RADPLAT) for advanced head and neck cancer.

BACKGROUND: The purpose of this study was to study the effect of intensive targeted chemoradiation in a group of patients with head and neck cancer with stage IV inoperable disease. METHODS: We examined 79 patients with inoperable stage IV head and neck cancer receiving intra-arterial infusion of high-dose cisplatin (150 mg/m(2)) on days 2, 9, 16, and 23 concomitant with delivery of external beam radiotherapy (total dose, 70 Gy; 2 Gy, 35 fractions; 1 fraction/day for 7 weeks). Sodium thiosulfate was administered intravenously to provide effective cisplatin neutralization. RESULTS: Four patients were not assessable. Complete local tumor response was achieved in 72 patients (91%) and a partial response in three patients. The complete response rate of neck node metastases was 90%. The 1- and 2-year locoregional control rates were 82% and 69%, respectively. The median overall survival time was 2.2 years, with a 3-year overall survival probability of 43%. Acute toxicities were as follows: grade III/IV hematologic toxicity (22%/16%), grade III/IV nephrotoxicity (0%), grade III mucositis (43%), grade III skin reactions (24%), grade III toxicity of the upper gastrointestinal tract (57%), grade III nausea (20%), and grade III subjective hearing loss (10%). Grade V toxicity (treatment-related deaths) was 3.8%. Six (18%) of 33 patients with complete remission needed tube feeding 2 years after treatment without intercurrent salvage surgery. CONCLUSIONS: Supradose superselective intra-arterial cisplatin and concomitant radiation is an effective organ-preserving therapy in an unfavorable group of patients. Our series confirms encouraging results reported previously. This regimen is justified in unresectable patients despite the substantial toxicity.

Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized individuals.

OBJECTIVE: A multicenter study based in the United States assessed the heat-moisture exchanger effect on respiratory symptoms and "voice quality" of laryngectomees. PATIENTS AND MEASURES: The study group consisted of 81 consecutive laryngectomees (62 men and 19 women; mean age, 66 years; age range, 45 to 89 years), with a median follow-up of 3.5 years (range, 0.5 to 24 years). A structured questionnaire was used to assess 3-month results, and tally sheets recorded the frequency of cough-expectoration during first and last trial weeks. RESULTS: Compliance was 73% (n = 59); decrease in coughing, 68%; sputum production, 73%; forced expectoration, 60%; and need for stoma cleaning, 52% of these 59 patients. Regarding daily cough-expectoration frequency, a statistically significant decrease (P < 0.0001) was found between the first and last trial weeks. Regarding influence on voice quality, 46% of regular users reported improvement in intelligibility, 30% in loudness, 37% in fluency, and 40% in telephone intelligibility. Fourteen patients (19%) reported skin irritation, with discontinuation of 7 patients. CONCLUSION: The observed decrease in pulmonary symptoms and improvement in voice quality confirm earlier reports from the Netherlands, United Kingdom, and Spain indicating improvement in postlaryngectomy quality of life.

Quality-of-life assessment after supradose selective intra-arterial cisplatin and concomitant radiation (RADPLAT) for inoperable stage IV head and neck squamous cell carcinoma.

OBJECTIVE: To evaluate quality-of-life (QOL) aspects of an organ preservation intra-arterial chemotherapy and concomitant radiation protocol, RADPLAT. DESIGN: Nonrandomized phase 2B feasibility trial. PATIENTS: Fifty consecutive patients with inoperable stage IV head and neck cancer. INTERVENTION: Supradose selective intra-arterial cisplatin and concomitant standard radiation (RADPLAT). MEASURES: Assessment with structured questionnaires before treatment and at 3, 6, and 12 months. RESULTS: Twenty-six patients were available for QOL assessment at 1 year (the "1-year QOL" group), as 16 patients died, 5 needed salvage surgery, and 3 were not available for interview (the "failure" group). Twelve-month results were mainly based on the first group. The functional well-being and head and neck scales showed a statistically significant improvement over time (P<.001). After 12 months, 21 patients (81%) returned to an oral diet, while 5 patients still needed tube feeding. For 23 patients (88%), the quality and strength of the voice was more or less normal. Of the 18 patients who were employed before their treatment, 10 were able to return to their job within 12 months. Xerostomia was reported by 17 patients (65%). Further detailed analysis showed statistically significant differences in pretreatment scores between the 1-year QOL group and the failure group, ie, physical well-being, functional well-being, and the head and neck scales (P<.05). Differences in these groups with respect to sex, age, tumor site, or stage could not be found. CONCLUSION: Given that only patients with locally (anatomic or functional) inoperable stage IV disease were treated, the results are promising, underlining the feasibility of the RADPLAT protocol.