Damian, S., Celio, L., De Benedictis, E., Mariani, P., Agustoni, F., Ricchini, F., & De Braud, F. (2013). Is a dexamethasone-sparing strategy capable of preventing acute and delayed emesis caused by combined doxorubicin and paclitaxel for breast cancer? Analysis of a phase II trial. Oncology, 84(6), 371–377.

DOI Link

Study Purpose

To evaluate the effectiveness of palonosetron without delayed dexamethasone in breast cancer patients receiving doxorubicin and paclitaxel (AT) for three cycles

Intervention Characteristics/Basic Study Process

Palonosetron 0.25 mg IV was given as a premedication in combination with prednisone 25 mg PO the night before chemotherapy and hydrocortisone 250 mg IV just prior to paclitaxel. Patients were then asked to record their nausea, vomiting, and use of antiemetics on a home record. The severity of nausea was graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for the first five days of each cycle.

The primary endpoint of the study was to evaluate complete control of chemotherapy-induced nausea and vomiting (CINV) during the first five days of the first cycle. If patients completed the first cycle satisfactorily, they had the option to continue in the study with this premedication regimen for two additional cycles (up to three cycles) of AT.

Sample Characteristics

N = 76
MEDIAN AGE = 50 years (range = 23–74 years)
FEMALES: 100%
KEY DISEASE CHARACTERISTICS: Chemotherapy-naïve, female patients with breast cancer receiving doxorubicin and paclitaxel
OTHER KEY SAMPLE CHARACTERISTICS: 59.2% were age 50 or older and 40.8% were under age of 50; 51.3% of the women drank no alcohol and 48.7% reported drinking one or two glasses of wine per day.

Setting

SITE: Single site
SETTING TYPE: Outpatient
LOCATION: Italy

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Elder care

Study Design

Phase II, nonrandomized, single-arm feasible study

Measurement Instruments/Methods

The Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 was given as a card to patients in order to grade the severity of nausea experienced. Patients also were asked to record emetic episodes and any antiemetic use.

Results

56 of 76 patients, or 74%, achieved overall complete control (CC, defined as no vomiting, no rescue anti-emetics, and no more than mild nausea) during the overall phase, days 1–5 of the first cycle of treatment. Specifically, 78% of patients achieved CC during the acute phase and 74% achieved CC during the delayed phase. All 76 patients were evaluable for efficacy in cycle 1. 13 of the 76 patients who entered cycle 1 did not continue the study due to antiemetic failure.

More than 80% of patients were vomiting-free during the overall phase, and more than 50% were nausea-free. Of the patients that continued on study for cycles 2 and 3, 70% and 66% achieved CC, respectively.

Conclusions

74% of the patients achieved CC in the first cycle, but there was a small reduction in CC as treatment continued to subsequent cycles. Authors even mentioned that delayed dexamethasone can be added in to the regimen if more optimal CINV control is needed. It is challenging to see the relevance of the proposed regimen if delayed dexamethasone would still be needed and steroids are still a part of the premeds, even if delayed dexamethasone is not required.

Limitations

Small sample (< 100)
Risk of bias (no control group)
Risk of bias (no blinding)
Risk of bias (no random assignment)
Risk of bias (no appropriate attentional control condition)
Measurement validity/reliability questionable

Nursing Implications

Data have shown that dexamethasone can be decreased to day 1 only in combination with palonosetron with comparable nausea control. Data also have shown that CINV control with dexamethasone/palonosetron is superior than palonosetron as a single agent. Further investigation is required to determine if dexamethasone can be successfully replaced by other steroids in a premedication regimen.