ABSTRACT
BACKGROUND: Fall-related injuries are a well-described cause of morbidity and mortality in the community-dwelling elderly population, but have not been well described in patients with cancer. Cancer treatment with chemotherapy can result in many unwanted side effects, including peripheral neuropathy if the drugs are potentially neurotoxic. Peripheral neuropathy and other side effects of chemotherapy may lead to an increased risk of fall-related injuries. METHODS: We conducted a retrospective cohort analysis using the records of 65,311 patients with breast, colon, lung, or prostate cancer treated with chemotherapy in the SEER-Medicare database from 1994 to 2007. The primary outcome was any fall-related injury defined as a traumatic fracture, dislocation, or head injury within 12 months of the first dose of chemotherapy. The sample population was divided into 3 cohorts based on whether they most frequently received a neurotoxic doublet, single agent, or a non-neurotoxic chemotherapy. Cox proportional-hazards analyses were adjusted for baseline characteristics to determine the risk of fall-related injuries among the 3 cohorts. RESULTS: The rate of fall-related injuries for patients receiving a doublet of neurotoxic chemotherapy (9.15 per 1000 person-months) was significantly higher than for those receiving a single neurotoxic agent (7.76 per 1000 person-months) or a non-neurotoxic agent (5.19 per 1000 person-months). Based on the Cox proportional-hazards model risk of fall-related injuries was highest for the cohort receiving a neurotoxic doublet after the model was adjusted for baseline characteristics. CONCLUSIONS: Among elderly patients with cancer, use of neurotoxic chemotherapy is associated with an increased risk of fall-related injuries.
Subject(s)
Accidental Falls/statistics & numerical data , Antineoplastic Agents/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Fractures, Bone/chemically induced , Neoplasms/drug therapy , Aged , Aged, 80 and over , Female , Humans , Male , Neurotoxicity Syndromes/etiology , Peripheral Nervous System Diseases/chemically induced , Retrospective StudiesABSTRACT
OBJECTIVES: This study aims to determine the efficacy and tolerability of capecitabine (CAP) plus bevacizumab (BEV) as treatment for frontline metastatic colorectal cancer (mCRC) in frail and/or elderly patients. MATERIALS AND METHODS: This was an open label, multi-site, single arm, phase II study in frontline mCRC. In this study, patients (pts) who were frail (ECOG 2) or older patients with ECOG 1 performance status (PS) received CAP (1000 mg/m(2) bid, 14 days of every 21 days) plus BEV (7.5mg/kg iv once every 21 days). The primary objective was progression free survival (PFS). Secondary objectives were overall response rate (ORR) and toxicity. RESULTS: In terms of patients: 50 were enrolled; 5 withdrew consent prior to treatment; 45 were treated, and 41 were evaluable. The mean age was 75.9 (range 54-93) and 62% had an ECOG 2 PS. The median PFS was 6.87 months (95% CI, 5.1-11.5 months) and median overall survival was 12.7 months (95% CI, 6.9-12.7 months). The most common grades 3-4 toxicities were: diarrhea (17.8%), fatigue (13.3%), hand-foot syndrome (13.3%), dehydration (8.9%), hypertension (6.7%) and vomiting (6.7%). CONCLUSIONS: The results of this trial support the use of CAP plus BEV as first-line treatment for frail/elderly patients with metastatic CRC. The ORR (40%) is comparable to pooled data in elderly on fluorouracil (5-FU)+BEV. The median PFS (7.2 months) in this study is slightly lower than that seen with 5-FU+BEV but this study had a high percentage of ECOG PS 2 patients. Side effects were manageable with no new safety signals.
