In the Literature – October 2015

October 2015, Vol 6, No 9 - In the Literature


In This Article




Bevacizumab for Advanced Lung Cancer Does Not Increase Risk for Hospitalization or Unexpected Toxicity

Although chemotherapy consisting of the combination of carboplatin (Paraplatin), paclitaxel (Taxol), and bevacizumab (Avastin; CPB) has been used since 2006 for the treatment of patients with non–small-cell lung cancer (NSCLC), few studies have assessed toxicity and hospitalizations associated with the use of bevacizumab in a community setting. However, studies show that 60% of net medical costs for patients with lung cancer are related to hospitalization, and 72% of community-based patients with advanced NSCLC require at least 1 hospitalization after chemotherapy, making research in regard to hospitalization after chemotherapy prevalent. To understand the effects of bevacizumab, a new retrospective analysis focused on toxicity and hospitalization within 180 days of receiving CPB compared with those receiving carboplatin plus paclitaxel (Carroll NM, et al. J Oncol Pract. 2015;11:356-362).

The primary data source was the Cancer Research Network’s Virtual Data Warehouse, which contains patient data taken from electronic health records as well as administrative and claims databases. The study included 1109 patients from the Virtual Data Warehouse’s Virtual Tumor Registry who had stage IIIB to stage IV nonsquamous NSCLC and were diagnosed between January 2005 and December 2010. All the participants received first-line carboplatin plus paclitaxel (82%) or CPB (18%).

The patients were monitored from the initiation of chemotherapy until death, health plan termination, or 180 days, whichever came first. Follow-up continued until December 31, 2011.

Approximately 57% of patients receiving CPB and approximately 53% of patients receiving carboplatin plus paclitaxel had evidence of any toxicity event. The patients receiving CPB were more likely to have hemorrhage, proteinuria, and gastrointestinal perforation.

Furthermore, 34% of patients receiving carboplatin plus paclitaxel and 19% of patients receiving CPB had at least 1 hospitalization. Specifically, 310 patients receiving carboplatin plus paclitaxel had 438 hospitalizations for a total of 2360 days, with 6% of those hospital stays resulting in death. Only 38 patients receiving CPB had hospital stays (total, 62 hospitalizations) for a total of 282 days, with 3% resulting in death.

Although not aligned with the toxicity findings, this study found that patients receiving CPB as first-line chemotherapy had a significantly lower risk for hospitalization and length of hospital stay in the first 180 days after treatment. This information should provide reassurance to oncologists that the use of bevacizumab for advanced NSCLC is not associated with any increased risks for hospitalization or unexpected toxicity.

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Early Palliative Care for Patients with Advanced Cancer Greatly Increases Cost-Savings

The American Society of Clinical Oncology recommends palliative care as standard practice, but there is little information on whether earlier treatment provides economic benefit. Previous studies have shown that palliative care is associated with clinical benefits and a reduction in the cost of care; new research has addressed the timing of palliative care and its impact on cost (May P, et al. J Clin Oncol. 2015;33:2745-2752).

The study observed 969 adults with a diagnosis of advanced cancer from 2007 to 2011. The participants joined the study within 48 hours of admission to 1 of 5 participating US hospitals. A total of 256 participants saw a palliative care consultation team within 20 days of admission, and 713 patients received usual care only.

Using a prospective, observational design, the researchers collected multisite clinical and cost data, and examined the effects of palliative care on patients, processes of care, and hospital service utilization. The palliative care consultation teams across all sites were trained and monitored, and meetings were only initiated at the request of a physician.

Subsamples were created based on the timing of each patient’s first meeting with a palliative care consultation team, with 75% of patients receiving a consultation within 2 days of admission. The clinical data came from medical records, patient interviews, and daily symptom inventory. The cost data were taken from hospital databases and were adjusted for regional variations in healthcare costs.

The analysis showed that earlier palliative treatment is associated with an increased cost-saving effect. When an intervention by the palliative care consultation team took place within 6 days of hospital admission, the estimated cost reduction was 14% of the total direct hospital costs compared with patients who were not referred to a palliative care consultation team. A meeting with a palliative care consultation team within 2 days yielded a cost reduction of 24% compared with no consultation.

The clinical data collected also demonstrated the positive effects of working with a palliative care consultation team. Laboratory costs were significantly reduced in accordance with earlier palliative care. Noteworthy results were also observed in regard to length of stay, pharmacy costs, and intensive care unit costs, but only when the first palliative care consultation team meeting was conducted within 2 days of admission to a hospital.

The results show that palliative care during the first 20 days of hospital admission greatly impacts the direct hospital costs, which increases in correlation to how soon the palliative care consultation team encounter is initiated. Specifically, the effect on intensive care unit costs is prominent and suggests that hospitals prioritize palliative care for critically ill patients, especially when palliative resources are limited.

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Daratumumab, an Anti-CD38 Monoclonal Antibody, Effective Treatment Option for Patients with Relapsed and/or Refractory Multiple Myeloma

Although the currently available therapies improve outcomes for patients with multiple myeloma, their prognosis is poor if the disease relapses or is refractory to proteasome inhibitors and immunomodulatory drugs.

Daratumumab is a monoclonal antibody that induces the killing of CD38-­expressing tumor cells, a substantial target in the treatment of myeloma. As a result of daratumumab’s successful performance in preclinical studies, a new phase 1/2 study investigated the use of daratumumab in patients with relapsed and/or refractory multiple myeloma (Lokhorst HM, et al. N Engl J Med. 2015;373:1207-1219).

The study included adult patients with myeloma whose disease relapsed after or was refractory to 2 or more different previous therapies, with 64% of patients having disease refractory to lenalidomide (Revlimid) and bortezomib (Velcade). All patients were enrolled in the study between March 2008 and January 2015.

The study was an open-label, multicenter trial that was conducted in 2 parts. In the dose-escalation phase, 32 patients received daratumumab at doses of 0.005 mg/kg to 24 mg/kg of body weight. In the dose-expansion phase, 72 patients received either 8 mg/kg of daratumumab (30 patients) or 16 mg/kg (42 patients), with the doses being administered on different schedules. The patients received therapy until disease progression or until unmanageable toxic events occurred. The end points included safety, pharmacokinetics, objective response, time to disease progression, and progression-free survival.

The results show that daratumumab has an acceptable safety profile, with infusion-related reactions of grade 1 or 2, including bronchospasm, headache, dyspnea, and fever. No patient dis­continued treatment as a result of an infusion-­related reaction.

Moreover, daratumumab induced favorable clinical responses in both parts of the study. In the dose-escalation phase, 33% of patients had a partial response to doses ranging from 4 mg/kg to 24 mg/kg. In the dose-expansion phase, the response rate for patients receiving 8 mg/kg of daratumumab was 10% compared with 36% for patients receiving a dose of 16 mg/kg, with 65% of patients who had a response remaining progression-free at 12 months.

In addition, of the patients who received 16 mg/kg of daratumumab, 46% saw a 50% reduction in the level of M protein or free light chains.

Daratumumab has shown to be an effective single-agent treatment option for patients with difficult-to-treat multiple myeloma. The drug’s target of CD38 and its mechanism of action make this treatment superior to currently available therapies.

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