Effect of Oral Chemotherapy Management Program on Capecitabine Toxicity

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In a health system retrospective study reported in JCO Oncology Practice, Nhean et al found that implementation of an oral chemotherapy management program was associated with reduced rates of any-grade and severe capecitabine toxicity, less frequent toxicity-related emergency department visits and hospitalization, and improved drug adherence.

Study Details

The Oral Chemotherapy Management Program (OCMP) is a system-wide multidisciplinary program designed and implemented at the Henry Ford Cancer Institute at Henry Ford Health System. Elements of the program include patient education on drug use and potential adverse effects, assistance in obtaining drugs, patient access to OCMP team members, monitoring through clinic visits and telephone contact, and triaging and management of adverse events.

The current analysis compared adverse events, toxicity-related emergency department visits and hospitalization, and capecitabine adherence rates among all patients aged ≥ 18 years who received at least one dose of capecitabine between January 1, 2012, and July 31, 2014 (pre-OCMP group, n = 175), or between August 1, 2014, and September 30, 2016 (OCMP group, n = 175). The co-primary outcomes were the incidence of any grade and grade 3 to 4 adverse events commonly associated with capecitabine, consisting of hand-foot syndrome, nausea, vomiting, diarrhea, and stomatitis.

Key Findings

Compared with the pre-OCMP group, patients in the OCMP group had lower rates of any-grade toxicity (58.9% vs 70.3%, P = .03), including significantly lower rates of nausea (28.6% vs 36.6%, P = .003), vomiting (11.4% vs 20.0%, P = .03), and diarrhea (28.6% vs 40.6%, P = .018), and numerically lower rates of hand-foot syndrome (28.6% vs 36.6%, P = .11) and stomatitis (8.0% vs 12.0%, P = .21).

For grade 3 to 4 adverse events, rates were significantly lower in the OCMP group for hand-foot syndrome (2.9% vs 10.9%, P = .003), nausea (3.4% vs 21.1%, P < .001), vomiting (2.9% vs 9.7%, P = .008), and diarrhea (4.6% vs 14.3%, P =.002); there was also a numerically lower rate of stomatitis (1.7% vs 4.6%, P = .13).

The OCMP group had significantly reduced rates of toxicity-related emergency department visits (8.9% vs 18.9%, P = .005) and hospitalizations (6.3% vs 17.1%, P = .002).

The capecitabine adherence rate (measured by medication possession ratio) was significantly higher in the OCMP group (97% vs 94%, P = .03).

The investigators concluded: “This study found that OCMP reduced the incidence and severity of capecitabine-related toxicities because of close monitoring and management of patients on oral chemotherapy. OCMP also decreased emergency department visits and hospitalizations because of toxicity and improved medication adherence.”

Diana Kostoff, PharmD, of the Henry Ford Cancer Institute, is the corresponding author for the JCO Oncology Practice article.

Disclosure: For full disclosures of the study authors, visit

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