No abstract

Background Wearable activity monitors are widely available and marketed as fitness trackers. We performed a prospective trial testing the feasibility and utility of acquiring activity data as a measure of health status during concurrent chemoradiotherapy. Methods Ambulatory patients who were planned for treatment with concurrent chemoradiotherapy with curative intent for cancers of the head and neck, lung, or gastrointestinal (GI) tract were provided with activity monitors prior to treatment initiation. Patients were asked to wear the devices continuously throughout the radiotherapy course. Step count data were downloaded at weekly during radiotherapy and two and four weeks after radiotherapy completion. The primary objective was to demonstrate feasibility, defined as collection of step counts for 80% of the days during study subjects’ radiotherapy courses. Secondary objectives included establishing step count as a dynamic predictor of unplanned hospitalization risk. Results Thirty-eight enrolled patients were treated with concurrent chemoradiotherapy. Primary diagnoses included head and neck cancer (n=11), lung cancer (n=13), and a variety of GI cancers (n=14). Step data were collected for 1524 out of 1613 days (94%) during patients’ radiotherapy courses. Fourteen patients were hospitalized during radiotherapy or within four weeks of radiotherapy completion. Cox regression modeling demonstrated a significant association between recent step counts (3-day average) and hospitalization risk, with a 38% reduction in the risk of hospitalization for every 1,000 steps taken each day (HR = 0.62, 95% CI: 0.46 to 0.83, p=0.002). Inferior quality of life scores and impaired performance status were not associated with increased hospitalization risk. Conclusion Continuous activity monitoring during concurrent chemoradiotherapy is feasible and well-tolerated. Step counts may serve as powerful, objective, and dynamic indicators of hospitalization risk.

Objective Uterine carcinosarcoma (CS) is a rare uterine tumor with an extremely poor prognosis. In the adjuvant setting, efficacy has been shown with radiotherapy (RT), systemic chemotherapy, or both. This is the first report describing the efficacy and toxicity of adjuvant ifosfamide or ifosfamide plus cisplatin “sandwiched” with RT in patients with surgically staged and completely resected uterine carcinosarcoma. Methods Women with surgically staged CS with no gross residual disease were initially administered ifosfamide (1.2 g/m2/day × 5 days) with cisplatin (20 mg/m2/day × 5 days) every 3 weeks for 3 cycles followed by pelvic external beam RT and brachytherapy followed by 3 additional cycles of ifosfamide (1.0 g/m2/day) with cisplatin (20 mg/m2/day × 5 days) every 3 weeks. Similar to the GOG trial in recurrent CS (Sutton et al, 2000), the addition of cisplatin added toxicity without additional efficacy, so mid-study, the cisplatin was eliminated from the regimen. Toxicities were recorded and disease-free survival (DFS) was calculated with Kaplan-Meier statistical methods. Results In total, 12 patients received ifosfamide and cisplatin and 15 patients received ifosfamide alone, both ‘sandwiched’ with RT. The median follow up was 35.9 months (range 6–88). The 2 year DFS was similar in both the ifosfamide/cisplatin and ifosfamide groups (log-rank p = 0.16), so they were combined for analysis. 19 patients (70%) completed the protocol. As expected, stage 1 patients had a better 2-year DFS (18.75 ± 1.12 months; log-rank p = 0.008 when compared to stages 2, 3, 4). Also, in stages 2, 3 and 4 patients, the DFS was 15.81 ± 1.73 months. Grade 3/4 neutropenia, anemia and thrombocytopenia occurred in 18%, 4% and 4% of cycles, respectively. Conclusions Ifosfamide “sandwiched” with RT appears to be an efficacious regimen for surgically staged CS patients with no residual disease, even in patients with advanced stage. The addition of cisplatin to the regimen added toxicity without improving efficacy. Even with ifosfamide alone, the efficacy of this ‘sandwich’ regimen comes with a moderate but tolerable toxicity profile.