A Viewpoint on Wearable Technology-Enabled Measurement of Wellbeing and Health-Related Quality of Life in Parkinson's Disease.

In this viewpoint, we discuss how several aspects of Parkinson's disease (PD) - known to be correlated with wellbeing and health-related quality of life-could be measured using wearable devices ('wearables'). Moreover, three people with PD (PwP) having exhaustive experience with using such devices write about their personal understanding of wellbeing and health-related quality of life, building a bridge between the true needs defined by PwP and the available methods of data collection. Rapidly evolving new technologies develop wearables that probe function and behaviour in domestic environments of people with chronic conditions such as PD and have the potential to serve their needs. Gathered data can serve to inform patient-driven management changes, enabling greater control by PwP and enhancing likelihood of improvements in wellbeing and health-related quality of life. Data can also be used to quantify wellbeing and health-related quality of life. Additionally these techniques can uncover novel more sensitive and more ecologically valid disease-related endpoints. Active involvement of PwP in data collection and interpretation stands to provide personally and clinically meaningful endpoints and milestones to inform advances in research and relevance of translational efforts in PD.

Phase II study of tolerance and efficacy of hyperfractionated radiotherapy and 5-fluorouracil, cisplatin, and paclitaxel (Taxol) in stage III and IV inoperable and/or unresectable head-and-neck squamous cell carcinoma: A-2 protocol.

PURPOSE: To determine the toxicity and efficacy of concurrent 5-fluorouracil (5-FU), cisplatin, and paclitaxel (Taxol) and hyperfractionated radiotherapy in locally advanced squamous cell carcinoma of the head and neck. METHODS AND MATERIALS: Twenty-seven patients were entered into this Phase II trial. Eligible patients had Stage III or IV head-and-neck squamous cell carcinoma arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, or larynx. The plan of treatment consisted of hyperfractionated radiotherapy (74.4 Gy at twice daily fractions of 1.2 Gy). Chemotherapy was given on Weeks 1, 5, and 8 as follows: 5-FU at 750 mg/m2 as a constant infusion for 24 h for 3 days; cisplatin at 50 mg/m2 in 250-500 mL D5 0.5 NS or NS infusion during 2-4 h, and paclitaxel at 70 mg/m2 infused in 500 mL NS during 3 h. RESULTS: The overall survival rate of the entire group was 81.5%, 66.7%, and 63% at 1, 2, and 3 years, respectively. The median follow-up was 40.2 months (range 30-62). Of the 27 patients, 19 (70%) had a complete response and an overall survival rate of 100% at 1 year and 94% at 2 and 3 years. The disease-free survival rate of the latter group was 95% at 1 year and 84% at 2 and 3 years. Of the 27 patients, 18 (67%) maintained the complete response until the last follow-up visit or death. Percutaneous endoscopic gastrostomy dependency occurred for a median of 7.1 months. Grade 3 and 4 mucositis occurred in 20 and 3 patients, respectively. Six patients were hospitalized for leukopenic fever. Late toxicities included L'Hermitte syndrome (n = 3), osteoradionecrosis (n =1), hypothyroidism (n = 4), paresthesias (n = 1), aspiration pneumonia (n = 3), and esophageal strictures (8 patients underwent dilation). CONCLUSION: Combining hyperfractionated radiotherapy concurrently with 5-FU, cisplatin, and paclitaxel results in acceptable efficacy and toxicity. However, although a locoregional control benefit is suggested by the preliminary results of this trial, it needs to be confirmed in a prospective randomized trial.

Accelerated partial breast irradiation is safe and effective using intensity-modulated radiation therapy in selected early-stage breast cancer.

PURPOSE: To report the feasibility, toxicity, cosmesis, and efficacy of using intensity-modulated radiation therapy (IMRT) with respiratory gating to deliver accelerated partial breast irradiation (APBI) in selected Stage I/II breast cancer after breast-conserving surgery. METHODS AND MATERIALS: Eligible patients with node-negative Stage I/II breast cancer were prospectively enrolled in an institutional review board approved protocol to receive APBI using IMRT after breast-conserving surgery. The target volume was treated at 3.8 Gy/fraction twice daily for 5 days, to a total dose of 38 Gy. RESULTS: Thirty-six patients were enrolled for a median follow-up time of 44.8 months. The median tumor size was 0.98 cm (range, 0.08-3 cm). The median clinical target volume (CTV) treated was 71.4 cc (range, 19-231 cc), with the mean dose to the CTV being 38.96 Gy. Acute toxicities included Grade 1 erythema in 44% of patients and Grade 2 in 6%, Grade 1 hyperpigmentation in 31% of patients and Grade 2 in 3%, and Grade 1 breast/chest wall tenderness in 14% of patients. No Grade 3/4 acute toxicities were observed. Grade 1 and 2 late toxicities as edema, fibrosis, and residual hyperpigmentation occurred in 14% and 11% of patients, respectively; Grade 3 telangiectasis was observed in 3% of patients. The overall cosmetic outcome was considered "excellent" or "good" by 94% of patients and 97% when rated by the physician, respectively. The local control rate was 97%; 1 patient died of a non-cancer-related cause. CONCLUSIONS: APBI can be safely and effectively administered using IMRT. In retrospective analysis, IMRT enabled the achievement of normal tissue dose constraints as outlined by Radiation Therapy Oncology Group 04-13/NSABP B-13 while providing excellent conformality for the CTV. Local control and cosmesis have remained excellent at current follow-up, with acceptable rates of acute/late toxicities. Our data suggest that cosmesis is dependent on target volume size. Further prospective multi-institutional trials should be performed to evaluate IMRT to deliver APBI.

Radiation technique influence on percutaneous endoscopic gastrostomy tube dependence: Comparison between two radiation schemes.

BACKGROUND: Our aim was to determine whether percutaneous endoscopic gastrostomy (PEG) dependence was significantly different between 2 prospective trials with different radiation fractionation schemes. METHODS: Stage III or IV locally advanced head and neck squamous cell carcinomas arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, or larynx were treated using hyperfractionation (A-3 protocol) or accelerated fractionation (A-4 protocol) with chemotherapy. Amifostine was administered 15 to 30 minutes preradiation, at a dose of 500 mg/day in both protocols. It was given as an infusion over 5 to 7 minutes (A-3 protocol) or subcutaneously (A-4 protocol). Data regarding PEG placement and removal were collected prospectively. RESULTS: Thirty-five evaluable A-3 protocol patients, 14 evaluable A-4 protocol patients, and 6 patients treated per A-4 protocol guidelines, but without amifostine as they refused the medication, were included in the analysis. Pretreatment characteristics, such as sex, age, race, T classification, N classification, American Joint Committee on Cancer (AJCC) stage, were compared between the 2 groups of patients. The only significant difference between the 2 groups was AJCC stage. Thirty-five A-3 patients and 20 A-4 patients had overall survivals of 88% versus 80%, 82% versus 75%, and 66% versus 67.5% at 1, 2, and 3 years, respectively (p = .958). With regard to PEG dependence, no significant differences were seen between the 2 groups at 6, 12, or 18 months. CONCLUSION: PEG dependence was not significantly different between the 2 study groups. Type of altered fractionation scheme may not influence PEG dependence in patients treated with similar protocols. Future randomized studies are needed to confirm these findings.

Treatment of early non-small cell lung cancer, stage IA, by image-guided robotic stereotactic radioablation--CyberKnife.

OBJECTIVE: To evaluate the efficacy of using image-guided robotic stereotactic radioablation as an alternative treatment modality for patients with surgically resectable, but medically inoperable, T1 N0 M0, stage IA non-small cell lung cancer. METHODS: Between January 2004 and May 2006, 19 patients, 11 women and 8 men ranging in age from 52 to 88 years, with stage IA non-small cell lung cancer were treated. Tumor volume ranged from 1.7 to 13 mL. Total doses ranged from 24 to 60 Gy delivered in 3 fractions. Eleven patients received 60 Gy. Real-time target localization was accomplished by radiographic detection of fiducial marker(s) implanted within the tumor combined with respiratory motion tracking. RESULTS: All patients tolerated radioablation well with fatigue as the main side effect. Fourteen patients are alive from 1 to 25 months posttreatment. Four patients died: 2 of comorbid disease and 2 of cancer progression (status post 60 and 55.5 Gy). Three patients developed grade I radiation pneumonitis. Two patients have stable disease. In 3 patients, cancer recurred in the planning treatment volume: in 2 patients after treatment with 60 Gy and in 1 patient after treatment with 55.5 Gy. One patient had local control in the target volume but developed metastasis to the ipsilateral hilum. Nine patients had a complete response and show no evidence of disease. CONCLUSIONS: In our early experience, stereotactic radioablation using the CyberKnife system appears to be a safe, minimally invasive, and effective modality for treating early stage lung cancer in patients with medically inoperable disease. Dose escalation and/or increasing the treatment volumes, with the aid of the high conformality of this technique, may help to achieve further improvements in these promising results.

Quality-of-life assessment after hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and paclitaxel (Taxol) in inoperable and/or unresectable head and neck squamous cell carcinoma.

PURPOSE: To determine quality of life (QOL) after hyperfractionated radiation and chemotherapy. MATERIALS AND METHODS: Functional Assessment of Cancer Therapy (FACT) and the Functional Assessment of Cancer Therapy-Head and Neck (FACT H-N) questionnaires were administered to protocol patients at baseline study entry, during and at the completion of therapy, and during subsequent follow-up. RESULTS: Twenty-four patients completed baseline QOL questionnaires. Six subsequent assessments were given to patients who were available for follow-up. Social/family well-being and relationship with doctor subscores were not significantly different from baseline. Emotional well-being was not different from baseline initially, but actually showed a significant increase 6 months after completion of radiation, seen on assessments 5 and 6 (P < 0.01). Physical and functional well-being subscores, total FACT-G score, head and neck subscores, and total FACT H-N score all showed initial decreases during, at the completion of radiation, or, in some subscores, up to 3 months postradiation. However, all these scores recovered to baseline levels. These scores subsequently showed a significant increase after 6 months to 1 year in all but the physical well-being and head and neck subscores, which remained at baseline. CONCLUSION: QOL scores returned to baseline levels or increased at 6 to 12 months postradiation in long-term survivors who completed QOL questionnaires.

Phase II study of tolerance and efficacy of hyperfractionated radiation therapy and 5-fluorouracil, cisplatin, and paclitaxel (taxol) and amifostine (ethyol) in head and neck squamous cell carcinomas: A-3 protocol.

The objective of this study was to determine the toxicity and efficacy of the current phase II chemoradiation protocol. Stage III or IV locally advanced head and neck squamous cell carcinomas arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, or larynx were treated using hyperfractionated radiation (74.4 Gy at twice-daily fractions of 1.2 Gy) in combination with a 5-fluorouracil, cisplatin, paclitaxel regimen, and an amifostine infusion. Thirty-five of 36 eligible patients were evaluable. The overall survival (OVS) was 88%, 82%, and 66% at 1, 2, and 3 years respectively. Twenty-five patients (71%) had a complete response, which was maintained in 20 (57%) patients until last follow up or death. Disease-free survival (DFS) of the complete responders was 92% at 1 year and 77% at 2 years and 3 years, respectively. Percutaneous endoscopic gastrostomy dependency lasted for a median of 7 months. Grade 3 and 4 mucositis occurred in 23 and 3 patients, respectively. Comparison with a similar study (A-2) that did not include amifostine showed no significant benefit to the addition of amifostine in these patients. A locoregional control benefit should be confirmed in a prospective, randomized trial. Alternative amifostine delivery methods should be investigated.