What might the current Westminster Government mean for ... - BOPA

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Maintenance therapy, palliative care and more My two main ‘take home’ messages from the conference were the increasing focus on maintenance therapy and on the widespread sampling and storage of tumour tissue. More specifically, in GOG0128, the phase III trial investigating the primary treatment of advanced ovarian cancer, an improvement in progression free survival was seen in those receiving maintenance bevacizumab but the data was not ‘mature enough’ to be able to evaluate the effects on OS. 1 This highlighted to me the need to closely review any data before prematurely extrapolating early results into changes in clinical practice. Other issues that sprung to mind included the long-term safety consequences of maintenance therapy with bevacizumab and whether such treatment will be cost effective in the light of the limited gains reported. Early intervention with palliative care, integrated with standard first line chemotherapy treatment, was shown to improve OS and quality of life and to reduce the aggressiveness of treatment at the end of life. In this phase II trial of patients with stage IV non-small cell lung carcinoma, OS, although not a pre-defined end point, was increased to 11.6 months from 8.9 months (p=0.02). 2 Indeed the reviewer stated that, when looking at this result figuratively or on the Kaplan Meier curves: “we would have been all over it if this effect had been seen with a new agent!” With the well documented failure of some targeted therapies, there has been no new positive data for metatastic pancreatic cancer in the past five years. It was therefore encouraging that FOLFIRINOX (5FU/leucovorin, irinotecan and oxaliplatin) (given every 2 weeks for 6 months) showed promise compared with gemcitabine as a first line treatment in a randomised phase III trial. 3 PFS was 6.4 months compared with 3.3 months; OS was 11 months compared with 7 months and the response rate was 31% compared with 9%. The presenter suggested that this might be the new global standard of treatment of metastatic pancreatic adenocarcinoma in patients with performance status 0 or 1, with only a modest toxicity cost, although patient numbers will be small. References 1. Burger R et al Abstract LBA1. 2. Temel J et al Abstarct 7509. 3. Conroy T et al Abstract 4010. Contributed by Ewan Morrison, lead pharmacist, South East of Scotland Cancer Network We would like to thank Roche Products Ltd for providing us with an educational grant to attend the ASCO meeting. The American Society of Clinical Oncology 2010 meeting took place in Chicago, US from 4 to 8 June. 13th Annual BOPA Symposium Manchester Central 15–17 October 2010 REGISTRATION IS NOW OPEN BOPA M a n c h e s t e r 2 0 1 0 Key topics:- • Cancer care – a priority for the Government • Updates on the management of rarer cancers • How can pharmacy and nursing help to deliver national policy? Where are we a year on? • Oncology horizon scanning – 2011/2012 • The pharmacy profession – 2010 and the future • Developing a national model for delivering oral chemotherapy in the community Don’t miss out, book your place now! Please go to www.bopasymposium.org to register online and for further information. Enquiries to: Succinct Healthcare Communications Burton House, Repton Place, White Lion Road, Amersham, Bucks, HP7 9LP, UK Tel: +44(0) 1494 549 100 Fax: +44(0) 1494 549 111 Email: bopa2010@succinctcomms.com succinct healthcare communications u n d e r s t a n d i n g Half page BOPA advert June.indd 1 03/06/2010 09:37 BOPA Bulletin Issue 1 Summer 2010
PRESCRIBING INFORMATION HERCEPTIN® (trastuzumab) 150 mg powder for concentrate for solution for infusion Indications: Treatment of HER2 positive early breast cancer (EBC) following surgery, chemotherapy (CT) (neo/adjuvant) and radiotherapy (RT) (if applicable). Treatment of HER2 positive metastatic breast cancer (MBC): (i) as monotherapy following at least 2 CT regimens for MBC. Prior CT to include at least an anthracycline and a taxane, unless unsuitable. Hormone receptor positive patients must have failed hormonal therapy, unless unsuitable. (ii) in combination with paclitaxel for patients who have not received CT for MBC and where anthracyclines are not suitable. (iii) in combination with docetaxel for patients who have not received CT for MBC (iv) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Dosage and Administration: Please refer to Herceptin SmPC for full guidance on administration. HER2 testing mandatory prior to Herceptin. Tumours should have HER2 overexpression at 3+ level by immunohistochemistry (IHC) or HER2 gene amplification by fluorescence or chromogenic in situ hybridisation (FISH or CISH). Physicians experienced with cytotoxic chemotherapy should initiate treatment with Herceptin. Dose (EBC): loading dose 8 mg/kg body weight; subsequent doses 6 mg/kg repeated at 3-weekly intervals. Dose (MBC): (i) loading dose 4 mg/kg body weight; subsequent doses weekly 2 mg/kg; alternatively (ii): loading dose 8 mg/kg body weight; subsequent doses 6 mg/kg repeated at 3-weekly intervals. Initial loading dose should be administered as 90 minute IV infusion; if loading dose well tolerated subsequent doses can be administered as 30 minute IV infusion. Do not administer as an IV push or bolus. Observe for infusion-related symptoms for at least six hours following start of first infusion and for at least two hours for subsequent infusions. Interruption of infusion may help control symptoms; resume when symptoms abate. Resuscitation equipment must be available. Patients with EBC should be treated for 1 year or until disease recurrence. In MBC, administer until disease progression. Contraindications: Hypersensitivity to trastuzumab, murine proteins or any excipients. Severe dyspnoea at rest due to complications of advanced malignancy or requiring oxygen therapy. Precautions: HER2 testing must be performed in a specialised laboratory to ensure adequate validation of test. Herceptin is associated with cardiotoxicity. Congestive heart failure (CHF) observed in patients receiving monotherapy or in combination with paclitaxel or docetaxel, particularly following anthracycline-containing regimen; may be moderate to severe, has been fatal. Candidate patients to undergo baseline cardiac assessment including history and physical examination, ECG, echocardiogram, or MUGA scan or magnetic resonance imaging and risk-benefit assessment. Monitor cardiac function during treatment e.g. every three months and as required in MBC. In addition, repeat cardiac assessment at 6, 12 and 24 months following cessation of treatment in EBC. Risk of cardiotoxicity increases when Herceptin is combined with anthracyclines; avoid use except in well controlled clinical trials with cardiac monitoring. Patients previously treated with anthracyclines are also at risk of cardiotoxicity. Avoid anthracycline based therapy for up to 24 weeks after stopping Herceptin. Consider discontinuing treatment in patients whose left ventricular function decreases but remain asymptomatic or in patients who develop clinically significant heart failure unless benefits outweigh risks. Caution in patients with symptomatic CHF, history of hypertension or coronary artery disease and in EBC, in those patients with an LVEF of 55 % or less. Please refer to the Herceptin Summary of Product Characteristics (SmPC) for further information. Symptomatic CHF should be treated with standard medications. Most who developed CHF in clinical trials improved with appropriate treatment and continued Herceptin therapy without additional clinical cardiac events. Safety of resumption in patients experiencing cardiotoxicity not studied. Serious infusion related reactions (IRR) reported infrequently (see side effects and adverse reactions), majority within 2.5 hours of start of first infusion. Should IRR occur, infusion should be discontinued and patient monitored until resolution. Serious IRRs have been successfully treated with oxygen, beta-agonists and corticosteroids, fatal outcome rare. Severe pulmonary events reported rarely; occasionally fatal; may occur as part of IRR or with delayed onset; patients with dyspnoea at rest may be at increased risk of fatal IRR and/or pulmonary events; these patients should not be treated with Herceptin. Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes. Drug Interactions: Drug interaction studies not performed in humans. Pregnancy and Lactation: Avoid during pregnancy unless potential benefit outweighs risk. Oligohydramnios reported postmarketing in pregnant women. Do not breast-feed during Herceptin and for six months after last dose. Side-effects and Adverse Reactions: For full listings please refer to the Herceptin SmPC. Serious reactions: infusion/hypersensitivity reactions (can be fatal), anaphylaxis and anaphylactic shock, angioedema, ataxia, sepsis, chills and fever, asthenia, rigor, headache, paresis, pain (chest, bone), fatigue, infusion-related symptoms, coma, meningitis, thinking abnormal, progression of neoplasia, oedema (incl. cerebral, laryngeal, acute pulmonary, peripheral, angioedema, papilloedema), cardiomyopathy, CHF, decreased ejection fraction, hypotension, pericardial effusion, bradycardia, cerebrovascular disorder, cardiac failure, cardiogenic shock, pericarditis, supraventricular tachyarrhythmia, hepatocellular damage, liver tenderness, diarrhoea, nausea and vomiting, pancreatitis, hepatic failure, jaundice, leukaemia, febrile neutropenia, neutropenia, thrombocytopenia, anaemia, hypoprothrombinemia, cellulitis, erysipelas, hyperkalaemia, myalgia, paraneoplastic cerebellar degeneration, membranous glomerulonephritis, glomerulonephropathy, renal failure, bronchospasm, respiratory distress, respiratory insufficiency, dyspnoea, hypoxia, acute respiratory distress, acute respiratory distress syndrome, Cheyne-Stokes breathing, pulmonary infiltrates, pneumonia, pneumonitis, pulmonary fibrosis, pleural effusion, reduced oxygen saturation, wheezing, rash, dermatitis, urticaria, Stevens-Johnson syndrome, abnormal lacrimation, retinal haemorrhage, deafness. Common reactions: IRR [(fever, chills, headache, rash, pain, asthenia, nausea, vomiting) usually during or following first infusion. Other signs and/or symptoms include hypertension, rigors, cough, dizziness; usually mild to moderate and rare with subsequent infusions. Can be treated with analgesic/ antipyretic or antihistamines], fatigue, malaise, mastitis, CHF, cardiomyopathy, hypotension, palpitation, decreased ejection fraction, vasodilation, diarrhoea, constipation, dyspepsia, dry mouth, haemorrhoids, leucopenia, ecchymosis, infection (incl. urinary tract, respiratory, Herpes zoster), sepsis, weight loss, anorexia, pain (abdominal, neck, back, bone, chest wall, musculoskeletal, extremities), arthralgia, myalgia, muscle spasms, leg cramps, arthritis, paraesthesia, somnolence, hypertonia, peripheral neuropathy, tremor, insomnia, anxiety, depression, asthma, dyspnoea, epistaxis, pruritus, nail disorder, dry skin, alopecia, acne, taste perversion. Other reactions: orthopnoea, increased cough and S 3 gallop observed. In HERA trial, NYHA class III-IV CHF seen in 0.6 % of patients in the oneyear arm. In MBC, haematological toxicity was infrequent following monotherapy. WHO Grade 3/4 haematological toxicity increased with Herceptin plus paclitaxel or docetaxel. In HERA trial, 0.4 % of Herceptin-treated patients experienced a shift of 3 or 4 grades from baseline, compared with 0.6 % in the observation arm. Grade 3/4 hepatic toxicity less frequent with Herceptin and paclitaxel than with paclitaxel alone. No Grade 3/4 renal toxicity observed. Any of the above may develop into serious side effects. Legal Category: POM. Presentation and Basic NHS Cost: Pack of one 150 mg single dose vial (reconstituted solution contains 21 mg/ml trastuzumab): £407.40 excluding VAT. Marketing Authorisation Number: EU/1/00/145/001. Marketing Authorisation Holder: Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom. Herceptin is a registered trade mark. MEDI00092 Date of Preparation: January 2010 HERC00454c. Date of preparation: June 2010 Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Roche Products Limited. Please contact UK Drug Safety Centre on: 01707 367554 References 1. Norris B et al. San Antonio Breast Cancer Symposium 2006; Poster 2031. 2. Joensuu H et al. Clinical Cancer Research 2003; 9: 923-930. 3. Slamon DJ et al. Science 1987; 235: 177-182. 4. Dawood S et al. J Clin Oncol 2010; 28(1): 92-8. 5. Smith I et al. Lancet 2007; 369: 29-36. 6. Marty M et al. J Clin Oncol 2005; 23: 4265-4274. 7. National Institute for Health and Clinical Excellence. Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer. NICE technology appraisal 107, London, England, August 2006. 8. National Institute for Health and Clinical Excellence. Guidance on the use of trastuzumab for the treatment of advanced breast cancer. NICE technology appraisal 34, London, England, March 2002. 9. Herceptin Summary of Product Characteristics, January 2010. 10. Marty M et al. San Antonio Breast Cancer Symposium 2006; Abs 2067. 11. Slamon DJ et al. N Engl J Med 2001; 344: 783-792. 12. Smith IE. Anti-Cancer Drugs 2001; 12(Suppl 4): S3-S10. 13. Kaufman B et al. J Clin Oncol 2009; 27(33): 5529-5537. trastuzumab Precision Power Partner BOPA Bulletin Issue 1 Summer 2010
Page 1 and 2: Registered Charity No. 1065026 BULL
Page 3 and 4: ABBREVIATED PRESCRIBING INFORMATION
Page 5 and 6: Update to the Innovation BOPA Strat
Page 7 and 8: Horizon scanning for new cancer reg
Page 9 and 10: Out of hours arrangements and triag
Page 11 and 12: homologues, known as PTCH-1 and PTC
Page 13 and 14: to new cancer drugs in Wales. The A
Page 15 and 16: A regimen including ® — Powerful
Page 17: Meetings Personal perspectives from

What might the current Westminster Government mean for ... - BOPA

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