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More than 2 consecutive infusions are withheld or grade 3 skin toxicity occurs for a fourth time despite appropriate dose reduction. If the toxicity resolves to grade 2 or less by the following treatment period, treatment may be resumed. The investigator should also consider concomitant treatment with topical and oral antibiotics. Grade 1 acneiform eruption: consider treatment with topical antibiotics e.g. topical metronidazole or erythromycin ; . Systemic antibiotics e.g. a second generation tetracycline such as doxycycline 100mg po daily ; should be considered for grade 2 acneiform eruption, and are mandatory for grade 3 reactions. The threshold for referral to the dermatology clinic should be planned locally but all patients with grade 3 reactions and probably all with grade 2 reactions should be referred for advice and management. If pruritus occurs an oral antihistamine is advised. Dry skin often occurs and may contribute to pruritus ; general advice on replacing soap with oil for washing, avoidance of hot water for baths or showers and use of emollient creams are beneficial; topical corticosteroids are not recommended. Fissures may occur in dry skin and topical dressings e.g. hydrocolloid dressings and as advised by your dermatologist ; are helpful. Nail toxicities occur in 8% of patients with cetuximab, characterised by a paronychial inflammation with associated swelling of the lateral skin folds of toes and fingers, especially great toes and thumbs, which may be painful. It may persist for up to three months after cessation of cetuximab therapy. Dermatological advice should be sought. Use of daily salt baths and local antiseptic astringent ointments have been found to be helpful. Anti-inflammatory drugs may help to ease the pain. Haematological Check FBC on or up working days before ; day 1 of each cycle. Delay 1 week if neutrophils 1.5 x 109 l or platelets 75 x 109 l. Only treat when neutrophils and platelets are above these limits. The lower limit for the day one platelet count for this regimen is due to the possible occurrence of mild thrombocytopenia after a number of cycles of OxMdG. If 1 delay, or 1 delay of 2 weeks occurs, reduce the capecitabine and oxaliplatin doses by 20% and continue at the lower dose for subsequent cycles unless further toxicity occurs. No adjustment in cetuximab dose is required. If a further delay s ; for myelotoxicity occurs despite a 20% reduction, a further dose reduction may be made, at the discretion of the treating investigator. Neurotoxicity Oxaliplatin commonly causes peripheral sensory symptoms, easily distinguishable from 5FU neurotoxicity, which is uncommon, and cerebellar. Many patients experience transient paraesthesia of hands and feet, and some experience dysaesthesia in the throat. These symptoms are precipitated by cold and last from a few hours to a few days after each oxaliplatin administration. They do not require treatment or dose reduction. DATE OF ISSUE REVIEWED BY C D REVIEW DATE VERSION PAGE 6 of 11.

Users of LNG-IUS, the endometrial blood vessels showed differences in the expression of VEGFR-1 and VEGFR-3 between those with and those without abnormal bleeding patterns. Immunoreactivity of VEGF ligands and receptors in stromal cells The stroma exhibited significant differences in immunoreactivity for VEGF-A, but not for the other studied ligands and receptors, between the LNG-IUS users with and without abnormal bleeding patterns. The pattern of immunoreactivity varied among the studied VEGF ligands and receptors. VEGF-A was present in some prominently stained cells, probably lymphoid cells, which regularly seemed to express all studied VEGF ligands and receptors. VEGF-A showed significantly more immunoreactivity in LNG-IUS users without abnormal bleeding than in those with such bleeding. The staining for VEGF-B was generally seen in the cytoplasm, closely associated with the stromal cell nuclei, while the staining for VEGF-C was usually confined to single cells or clusters of cells. The observed differences in immunostaining 1414.

If two or more references have the same first author and date, you must use `a', `b', etc. after the date to distinguish them e.g. Smith et al. 1990a ; . NB For two-author references, you need only do this if both authors are the same. Lower case particles are listed under the letter of the name proper but upper case particles under the letter of the particle e.g. da Silva under `S' but Von Trapp under `V' ; . VA N straight Vancouver, references are numbered sequentially as they occur in the text. Citations in the text take the form of superscript or parenthetical numbers, which refer the reader to the references in the list. References in the list are ordered according to these numbers. In alphabetical Vancouver, the references are ordered alphabetically in the list and then numbered, and it is these numbers that appear in the text so they will be out of sequence in the text; e.g. reference 51 might come before reference 6 and carbenicillin.

XELODA capecitabine ; hand-and-foot syndrome, subsequent doses of XELODA should be decreased see DOSAGE AND ADMINISTRATION ; . Cardiotoxicity: The cardiotoxicity observed with XELODA includes myocardial infarction ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, electrocardiographic changes, and cardiomyopathy. These adverse events may be more common in patients with a prior history of coronary artery disease. Dihydropyrimidine Dehydrogenase Deficiency: Rarely, unexpected, severe toxicity eg, stomatitis, diarrhea, neutropenia and neurotoxicity ; associated with 5-fluorouracil has been attributed to a deficiency of dihydropyrimidine dehydrogenase DPD ; activity. A link between decreased levels of DPD and increased, potentially fatal toxic effects of 5-fluorouracil therefore cannot be excluded. Hepatic Insufficiency: Patients with mild to moderate hepatic dysfunction due to liver metastases should be carefully monitored when XELODA is administered. The effect of severe hepatic dysfunction on the disposition of XELODA is not known see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ; . Hyperbilirubinemia: In the overall clinical trial safety database of XELODA monotherapy N 875 ; , grade 3 1.5-3 x ULN ; hyperbilirubinemia occurred in 15.2% n 133 ; and grade 4 3 x ULN ; hyperbilirubinemia occurred in 3.9% n 34 ; of 875 patients with either metastatic breast or colorectal cancer who received at least one dose of XELODA 1250 mg m2 twice daily as monotherapy for 2 weeks followed by a 1-week rest period. Of 566 patients who had hepatic metastases at baseline and 309 patients without hepatic metastases at baseline, grade 3 or 4 hyperbilirubinemia occurred in 22.8% and 12.3%, respectively. Of the 167 patients with grade 3 or 4 hyperbilirubinemia, 18.6% n 31 ; also had postbaseline elevations grades 1 to 4, without elevations at baseline ; in alkaline phosphatase and 27.5% n 46 ; had postbaseline elevations in transaminases at any time not necessarily concurrent ; . The majority of these patients, 64.5% n 20 ; and 71.7% n 33 ; , had liver metastases at baseline. In addition, 57.5% n 96 ; and 35.3% n 59 ; of the 167 patients had elevations grades 1 to 4 ; both prebaseline and postbaseline in alkaline phosphatase or transaminases, respectively. Only 7.8% n 13 ; and 3.0% n 5 ; had grade 3 or 4 elevations in alkaline phosphatase or transaminases. In the 596 patients treated with XELODA as first-line therapy for metastatic colorectal cancer, the incidence of grade 3 or 4 hyperbilirubinemia was similar to the overall clinical trial safety database of XELODA monotherapy. The median time to onset for grade 3 or 4 hyperbilirubinemia in the colorectal cancer population was 64 days and median total bilirubin increased from 8 mm L baseline to 13 mm during treatment with XELODA. Of the 136 colorectal cancer patients with grade 3 or 4 hyperbilirubinemia, 49 patients had grade 3 or 4 hyperbilirubinemia as their last measured value, of which 46 had liver metastases at baseline. In 251 patients with metastatic breast cancer who received a combination of XELODA and docetaxel, grade 3 1.5 to 3 x ULN ; hyperbilirubinemia occurred in 7% n 17 ; and grade 4 3 x ULN ; hyperbilirubinemia occurred in 2% n 5 and carmustine.

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