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Effect of nausea vs. vomiting on patients' quality of life during chemotherapy.

8514 Background: Antiemetic guidelines are based largely on the presumption that vomiting is of greater concern to cancer patients, and impacts their quality of life (QOL) more strongly, than nausea. We examined the relative influence of chemotherapy-induced nausea and emesis on patients' overall QOL and on the specific domains of social, emotional, physical and functional well-being.


METHODS
667 patients enrolled in a three-arm, randomized, controlled Phase III study that detected no difference in the ability of a serotonin receptor antagonist vs. prochlorperazine (given regularly three times daily or taken only as needed for symptoms) to control the severity of nausea, completed the FACT-G before treatment and on the third day following their first infusion of anti-cancer chemotherapy containing doxorubicin (Day 4 of cycle 1). 93% were female, and 90% had breast cancer.


RESULTS
There was a significant reduction in overall QOL and in physical and functional well-being, but no significant change in emotional or social well-being, over the four day period. In a stepwise linear regression analysis predicting change in overall QOL, average nausea severity entered first and accounted for 24% of the variance in reduced QOL (p < 0.001). Occurrence of vomiting (yes, no) accounted for a non-significant less than 1% of additional variance (p = 0.240). No other factors (gender, age, the degree to which patients expected to experience nausea or vomiting, whether or not nausea or vomiting occurred, and maximum nausea severity over the four days) were significant predictors of the reduction in QOL. Similar results were obtained when the relative influence of nausea and vomiting on physical and functional decline were studied.


CONCLUSIONS
Severity of nausea, not the occurrence of vomiting, was the key factor in patients' perceived decline in quality of life in the days immediately following chemotherapy infusion. Nausea severity should be a primary outcome measure in studies evaluating antiemetic efficacy. Supported in part by NCI Public Health Service grant U10 CA37420 and ACS grant RSG-01-071-PBP No significant financial relationships to disclose.