Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer: A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study.

OBJECTIVE: Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients >70years with advanced NSCLC. MATERIALS AND METHODS: Patients with treatment naïve metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL). RESULTS: The study closed at second interim analysis as 6/19 patients had ≥grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response+stable disease) was 47% (n=9); 37% (n=7) progressed. No complete responses were seen. Median PFS was 3.5months (95% CI: 1.4, 5.5) and OS 7.8months (95% CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17. CONCLUSIONS: Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.

Readmission rates due to venous thromboembolism in cancer patients after abdominopelvic surgery, a retrospective chart review.

PURPOSE: Venous thromboembolism (VTE) is a known cause of morbidity in the oncology patient population. As hospital readmission rates are more frequently scrutinized, we sought to determine the most common causes of 30-day readmissions in the cancer patient following abdominopelvic surgery. Furthermore, due to the high risk of VTE, there have been guidelines established for prophylaxis. As guidelines are based on asymptomatic VTE, we studied the compliance rates of these guidelines in our institution and the rate of symptomatic VTE in the 30-day postoperative period. METHODS: We conducted a retrospective chart review at Pennsylvania Hospital of abdominopelvic surgeries between January 1, 2010 and December 31, 2012 in patients with abdominopelvic malignancies, totaling 263 patients. RESULTS: The median age of our patient population was 67 years and 51.3 % were female. The most common malignancy locations were colorectal (44 %) and pancreas (11 %). One patient did not receive perioperative anticoagulation; most received heparin subcutaneously three times daily, mean duration 5.5 days. Fourteen patients (5 %) received outpatient anticoagulation after discharge; only two had a primary intent of VTE prophylaxis. Thirty-five patients (13 %) were readmitted within 30 days of discharge, the most common reasons being abdominal symptoms and postoperative/surgical complications. There was one patient readmitted for a new, symptomatic VTE. CONCLUSIONS: Our study showed only one new, symptomatic VTE in the study population, despite 95 % of patients not receiving outpatient anticoagulation, which suggests that continued larger and multicenter trials may be needed to study anticoagulation benefits and risks in this patient population.