Evaluation of pedometry as a patient-centered outcome in patients undergoing hematopoietic cell transplant (HCT): a comparison of pedometry and patient reports of symptoms, health, and quality of life.

AIMS: We evaluated pedometry as a novel patient-centered outcome because it enables passive continuous assessment of activity and may provide information about the consequences of symptomatic toxicity complementary to self-report. METHODS: Adult patients undergoing hematopoietic cell transplant (HCT) wore pedometers and completed PRO assessments during transplant hospitalization (4 weeks) and 4 weeks post-discharge. Patient reports of symptomatic treatment toxicities (single items from PRO-CTCAE, http://healthcaredelivery.cancer.gov/pro-ctcae ) and symptoms, physical health, mental health, and quality of life (PROMIS(®) Global-10, http://nih.promis.org ), assessed weekly with 7-day recall on Likert scales, were compared individually with pedometry data, summarized as average daily steps per week, using linear mixed models. RESULTS: Thirty-two patients [mean age 55 (SD = 14), 63 % male, 84 % white, 56 % autologous, 43 % allogeneic] completed a mean 4.6 (SD = 1.5, range 1-8) evaluable assessments. Regression model coefficients (ß) indicated within-person decrements in average daily steps were associated with increases in pain (ß = -852; 852 fewer steps per unit increase in pain score, p < 0.001), fatigue (ß = -886, p < 0.001), vomiting (ß = -518, p < 0.01), shaking/chills (ß = -587, p < 0.01), diarrhea (ß = -719, p < 0.001), shortness of breath (ß = -1018, p < 0.05), reduction in carrying out social activities (ß = 705, p < 0.01) or physical activities (ß = 618, p < 0.01), and global physical health (ß = 101, p < 0.001), but not global mental health or quality of life. CONCLUSIONS: In this small sample of HCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Pedometry may be a valuable outcome measure and validation anchor in clinical research.

Comparative effectiveness of mitoxantrone plus prednisone versus prednisone alone in metastatic castrate-resistant prostate cancer after docetaxel failure.

BACKGROUND: Mitoxantrone was approved for use in metastatic castrate-resistant prostate cancer (mCRPC) based on pain palliation without observed survival benefit in a small phase III trial in 1996. To re-evaluate for possible survival benefits in a larger contemporary sample and to demonstrate analytic uses of the newly available Project Data Sphere online resource, we used data from control arms of completed clinical trials to compare survival and toxicity among patients with postdocetaxel mCRPC treated with mitoxantrone and prednisone. PATIENTS AND METHODS: Control arm data from two phase III randomized control trials, SUN 1120 and TROPIC, were used to examine the efficacy of mitoxantrone plus prednisone (n = 305) versus prednisone alone (n = 257) among patients with postdocetaxel mCRPC. Propensity score matching was used to balance patient characteristics between the separate trials, conditioned on age and key prognostic variables of survival. The primary outcome was overall survival. Secondary endpoints evaluated safety. RESULTS: Median survival was similar among patients receiving mitoxantrone plus prednisone versus prednisone alone (385 days vs. 336 days; deceleration factor = 0.04; 95% confidence interval: -0.12 to 0.22). Prevalence of several any-grade toxicity, including fatigue, back pain, and peripheral neuropathy, was increased among patients who received mitoxantrone. CONCLUSION: There was no significant survival benefit for mitoxantrone plus prednisone over prednisone alone among men with mCRPC after docetaxel therapy. This finding is consistent with prior studies showing no survival advantage with mitoxantrone in the predocetaxel setting. Furthermore, our data suggest that mitoxantrone may be associated with increased toxicity compared with prednisone alone.

Challenges for cancer care delivery to adolescents and young adults: present and future.

Adolescents and young adults occupy a unique place within the cancer community due to the challenges they face related to disease biology, access to care, and psychosocial and socioeconomic circumstances. Efforts to define specific needs and targets for intervention in these areas are under way and evolving. This review will discuss the current and future challenges in delivering quality care to this population.

Clinical nodal staging of T1-2 tonsillar squamous cell carcinoma stratified by p16 status and implications for ipsilateral neck irradiation.

BACKGROUND AND PURPOSE: Previous studies have reported <5% incidence of contralateral nodal metastasis in patients with T1-2 tonsillar squamous cell carcinoma. We analyzed the nodal staging of T1-2 tonsillar squamous cell carcinoma stratified for p16 status, a marker of human papillomavirus positivity. MATERIALS AND METHODS: Clinical and radiographic nodal staging and p16 status of 41 T1-2 tonsillar squamous cell carcinoma patients who were treated between January 2002 and June 2009 were retrospectively analyzed. Patients with a history of prior head and neck cancer, synchronous cancers, base of tongue or soft palate invasion, or distant metastases at diagnosis were excluded. RESULTS: Of the 41 patients, 28 (68.2%) had p16+ tumors and 13 (31.7%) had p16- tumors. Seven patients (17.0%) presented with contralateral cervical nodal disease, all of whom had p16+ tumors. Furthermore, 25.0% of patients with p16+ tumors presented with contralateral cervical nodal disease compared with 0% of patients with p16- tumors. CONCLUSIONS: Patients with p16+ T1-2 tonsillar squamous cell carcinoma present with a higher incidence of contralateral nodal spread than those patients with p16- disease. This may have clinical implications when determining which patients are good candidates for ipsilateral cervical nodal irradiation.

Intensity-modulated radiotherapy outcomes for oropharyngeal squamous cell carcinoma patients stratified by p16 status.

BACKGROUND: Patients with oropharyngeal squamous cell carcinoma (OPSCC) treated with intensity-modulated radiotherapy (IMRT) were stratified by p16 status, neck dissection, and chemotherapy to correlate these factors with outcomes. METHODS: A total of 112 patients with OPSCC treated with IMRT from 2002 to 2008 were retrospectively analyzed. All patients received RT to 66-70 Gray. Forty-five of the tumors were p16 positive (p16+), 27 were p16 negative (p16-), and 41 had unknown p16 status. Sixty-two patients had postradiation neck dissections. Nine patients with p16- tumors and 28 patients with p16+ tumors received chemotherapy. The distribution of T, N, and stage grouping among the p16+ and p16- patients was not significantly different, and 87.5% patients had stage III/IV disease. RESULTS: The median follow-up was 26.3 months. For patients with p16+ tumors, p16- tumors, and the overall cohort, the actuarial 3-year locoregional progression-free survival rate was 97.8%,73.5%, and 90.5% respectively (P = .006) and the disease-free survival rate was 88.2%, 61.4%, and 81.7%, respectively (P = .004). Patients with p16+ tumors had an 89.5% and 87.5% pathologic complete response (CR) on neck dissection with and without chemotherapy, respectively. In contrast, patients with p16- tumors had a 66.7% and 25.0% pathologic CR on neck dissection with and without chemotherapy, respectively. CONCLUSIONS: In this series, p16 status was found to be a significant predictive biomarker and patients with p16+ tumors had much better outcomes than patients with p16- tumors. Further investigation is warranted to determine whether less intense therapy is appropriate for selected patients with p16+ OPSCC, whereas more aggressive strategies are needed to improve outcomes in patients with p16- disease.