First Quarter 2008 - Issues in Hematology - ION Solutions

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XELODAEfficacy that makes a differenceEligible for only Medicare Part B coverage in oncologyIndicationsXELODA is indicated as a single agent for adjuvant treatment in patientswith Dukes’ C colon cancer who have undergone complete resection ofthe primary tumor when treatment with fluoropyrimidine therapy alone ispreferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV)for disease-free survival (DFS). Although neither XELODA nor combinationchemotherapy prolongs overall survival (OS), combination chemotherapy has beendemonstrated to improve disease-free survival compared to 5-FU/LV. Physiciansshould consider these results when prescribing single-agent XELODA in theadjuvant treatment of Dukes’ C colon cancer.XELODA is indicated as first-line treatment of patients with metastaticcolorectal carcinoma when treatment with fluoropyrimidine therapy aloneis preferred. Combination chemotherapy has shown a survival benefit comparedto 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated withXELODA monotherapy. Use of XELODA instead of 5-FU/LV in combinations has notbeen adequately studied to assure safety or preservation of the survival advantage.XELODA monotherapy is indicated for the treatment of patients with metastaticbreast cancer resistant to both paclitaxel and an anthracycline-containingchemotherapy regimen or resistant to paclitaxel and for whom furtheranthracycline therapy is not indicated, eg, patients who have received cumulativedoses of 400 mg/m 2 of doxorubicin or doxorubicin equivalents. Resistance is definedas progressive disease while on treatment, with or without an initial response, or relapsewithin 6 months of completing treatment with an anthracycline-containing adjuvant regimen.XELODA in combination with docetaxel is indicated for the treatment ofpatients with metastatic breast cancer after failure of prior anthracyclinecontainingchemotherapy.Important Safety InformationWARNINGFor patients receiving XELODA and warfarin concomitantly, frequent monitoring of INR orprothrombin time (PT) is recommended. A clinically important drug interaction betweenXELODA and warfarin has been demonstrated. Altered coagulation parameters and/orbleeding and death have been reported. Clinically significant increases in PT and INR havebeen observed within days to months after starting XELODA, and infrequently within onemonth of stopping XELODA. These events occurred in patients with and without livermetastases. Age greater than 60 and a diagnosis of cancer independently predisposepatients to an increased risk of coagulopathy.Adverse EventsIn XELODA monotherapy for colon cancer in the adjuvant setting, the most common adverseevents for all grades (≥10%) in patients receiving XELODA (%) were hand-foot syndrome (60),diarrhea (47), nausea (34), stomatitis (22), fatigue (16), lethargy (16), vomiting (15), abdominalpain (14), and asthenia (10). Grade 3/4 adverse events (≥5%) in patients receiving XELODAwere hand-foot syndrome (17) and diarrhea (12). In XELODA monotherapy for metastaticcolorectal cancer, the most common adverse events (≥10%) in patients receiving XELODA (%)were anemia (80), diarrhea (55), hand-foot syndrome (54), hyperbilirubinemia (48), nausea (43),fatigue/weakness (42), abdominal pain (35), dermatitis (27), vomiting (27), appetite decrease (26),stomatitis (25), pyrexia (18), edema (15), constipation (14), dyspnea (14), neutropenia (13), pain (12),back pain (10), headache (10), gastrointestinal motility disorder (10), oral discomfort (10),peripheral sensory neuropathy (10), and eye irritation (13). Grade 3/4 adverse events (≥5%) inpatients receiving XELODA were hyperbilirubinemia (23), hand-foot syndrome (17), diarrhea (15),
Proven efficacy in adjuvant stage III (Dukes’ C) colon cancer andmetastatic colorectal cancer 1-2Proven efficacy in metastatic breast cancer, regardless of HER2 status 3-5Dose modification does not appear to compromise efficacyacross indications 5-8Established safety profileFor more information about XELODA, contact your Roche representative or visit www.xeloda.com.abdominal pain (10), vomiting (5), and ileus (5). In XELODA monotherapy for metastatic breastcancer, the most common adverse events (≥10%) in patients receiving XELODA (%) werelymphopenia (94), anemia (72), diarrhea (57), hand-foot syndrome (57), nausea (53), fatigue (41),dermatitis (37), vomiting (37), neutropenia (26), stomatitis (24), thrombocytopenia (24),anorexia (23), hyperbilirubinemia (22), paresthesia (21), abdominal pain (20), constipation (15),eye irritation (15), and pyrexia (12). Grade 3/4 adverse events (≥5%) in patients receivingXELODA were lymphopenia (59), diarrhea (15), hand-foot syndrome (11), hyperbilirubinemia (11),fatigue (8), stomatitis (7), and dehydration (5). In XELODA combination therapy (XELODA plusdocetaxel) for breast cancer, the most common adverse events (≥10%) in patients receivingXELODA plus docetaxel (%) were lymphocytopenia (99), leukopenia (91), neutropenia/granulocytopenia (86), anemia (80), diarrhea (67), stomatitis (67), hand-foot syndrome (63),nausea (45), alopecia (41), thrombocytopenia (41), vomiting (35), edema (33), abdominal pain (30),pyrexia (28), asthenia (26), fatigue (22), constipation (20), hyperbilirubinemia (20), neutropenicfever (16), taste disturbance (16), weakness (16), arthralgia (15), headache (15), myalgia (15),dyspnea (14), dyspepsia (14), nail disorder (14), anorexia (13), cough (13), pain in limb (13),back pain (12), dizziness (12), lacrimation increase (12), paresthesia (12), sore throat (12),appetite decrease (10), and dehydration (10). Grade 3/4 adverse events (≥5%) in patients receivingXELODA plus docetaxel (%) were lymphocytopenia (89), leukopenia (61), neutropenia/granulocytopenia (69), hand-foot syndrome (24), stomatitis (18), neutropenic fever (16), diarrhea (15),anemia (10), hyperbilirubinemia (9), nausea (7), alopecia (6), vomiting (5), and asthenia (5).Contraindications and WarningsXELODA is contraindicated in patients who have a known hypersensitivity to capecitabine or toany of its components or to 5-fluorouracil. XELODA is contraindicated in patients with knowndihydropyrimidine dehydrogenase (DPD) deficiency. XELODA is contraindicated in patients withsevere renal impairment. Patients with mild or moderate renal impairment at baseline should becarefully monitored for adverse events. Patients with moderate renal impairment at baseline requirea reduced starting dose.XELODA can induce diarrhea, sometimes severe. Patients with severe diarrheashould be carefully monitored and given fluid and electrolyte replacement ifthey become dehydrated.If an adverse event of grade 2, 3, or 4 occurs (eg, diarrhea), administration of XELODAshould be immediately interrupted until the adverse event resolves or decreases inintensity to grade 1. Subsequent doses of XELODA may need to be decreased. Pleaseconsult XELODA Prescribing Information for recommended dose modifications.Women of childbearing potential should be advised to avoid becoming pregnant whilereceiving treatment with XELODA. Men should use birth control while taking XELODA.Women should not nurse when receiving XELODA therapy.References: 1. Data on file (Ref. 111-041), Hoffmann-La Roche Inc., Nutley, NJ07110. 2. Van Cutsem E, Hoff PM, Harper P, et al. Oral capecitabine vs intravenous5-fluorouracil and leucovorin: integrated efficacy data and novel analyses fromtwo large, randomised, phase III trials. Br J Cancer. 2004;90:1190-1197. 3. Tykerb[package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007. 4. Ixempra[package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2007.5. O’Shaughnessy JA. Superior survival with the combination of docetaxel andcapecitabine compared to docetaxel alone in anthracycline-pretreated metastatic breastcancer patients. Am J Oncol Rev. 2002;1(5):280-285. 6. Cassidy J, Twelves C,Van Cutsem E, et al. First-line oral capecitabine therapy in metastatic colorectal cancer:a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. AnnOncol. 2002;13:566-575. 7. Data on file (Ref. 111-036), Hoffmann-La Roche Inc.,Nutley, NJ 07110. 8. O’Shaughnessy J, Miles D, Vukelja S, et al. Superior survival withcapecitabine plus docetaxel combination therapy in anthracycline-pretreated patientswith advanced breast cancer: phase III trial results. J Clin Oncol. 2002;20(12):2812-2823.Please see summary of XELODA Prescribing Information,including boxed WARNING, on adjacent pages.Copyright © 2008 Roche Laboratories Inc. All rights reserved.
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First Quarter 2008 - Issues in Hematology - ION Solutions

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