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Oral Mucositis Oral Mucositis Michael Schmitt, MD PhD Head Clinical Stem Cell Transplantation and Immunotherapy Department of Internal Medicine III University of Rostock Germany Oral Toxicity Timeline Injury Starts on Day 1 of Cancer Therapy Baseline Acute Toxicity Chronic Toxicity Treatment Duration Acute Toxicity Late (Long-Term) Toxicity TIME Stages of OM: the initial steps • Phase 1 (Initiation)1 • Phase 2 (up regulation and – CT and RT lead to DNA damage and messenger generation)1 activation of destructive processes, – Multiple destructive processes occur including generation of ROS and simultaneously1 1 cytokines – ROS cause tissue and DNA damage, activation of transcription factors and enzyme activation may also occur 1. Sonis S et al. Cancer 2004;100:(9 Suppl):1995–2025 ROS, reactive oxygen species Stages of OM: the problem worsens • Phase 3 (signalling and amplification)1 • Phase 4 (ulceration and inflammation)1 – Initial CT and RT damage plus – Combined effects of stages 1–3 lead to messenger generation forms ‘positive ulceration1 feedback’ loops intensifying each – Bacterial infection may occur leading to 1 others’ impact further tissue damage1 • Sepsis can also occur – Patient may experience: • Pain • Difficulty swallowing • Dry mouth • Vocal changes • Life-threatening sepsis 1. Sonis S et al. Cancer 2004;100:(9 Suppl):1995–2025 Rates of Oral Mucositis Radiation Therapy to Chemotherapy1 Head and Neck2 % Mucositis 40% % No mucositis 97% 2 Adapted from Köstler WJ, et al.1 Adapted from Sonis ST. Bone Marrow Transplant1 70% Adapted from Köstler WJ, et al.1 1. Köstler WJ, et al. CA Cancer J Clin. 2001;51:290-315. 2. Sonis ST. J Support Oncol. 2004;2(suppl 3):3-8. Common Toxicities of Radiotherapy for Head and Neck Cancer1-4 Toxicity Proportion of Patients Xerostomia 57% to 95% Dysgeusia 90% Anorexia/weight loss/malnutrition 55% to 85% Chewing/eating difficulties 60% to 70% Mucositis/stomatitis 40% to 97% Dysphagia 65% to 100% Radiation necrosis/osteoradionecrosis 5% to 15% Pain 75% to 85% 1. Brizel DM et al. J Clin Oncol. 2000;18:3339-3345. 2. Epstein JB et al. Head Neck. 2001;23:389-398. 3. Gal TJ et al. Arch Otolaryngol Head Neck Surg. 2003;129:72-76. 4. Sonis ST. J Support Oncol. 2004;2(suppl 3):3-8. Stem Cell Transplantation and Oral Mucositis: Factors Associated With Increased Incidence and Toxicity Autologous Allogeneic Amount of chemotherapy administered Pre transplant body mass index >25 kg/m2 Previous exposure to anthracyclines, vinca alkyloids, cyclophosphamide, fludarabine, platinum Use of TBI as conditioning regimen analogues, methotrexate Female gender 6-Mercaptopurine Type of disease (eg, NHL) Etoposide inclusion Melphalan inclusion Busulfan inclusion TBI = total body irradiation; NHL = non-Hodgkin lymphoma Stiff P. Bone Marrow Transplant. 2001;27;(suppl 2):S3-S11. Mucotoxic Regimens in Hematologic Malignancies Regimen Components Cyclophosphamide, doxorubicin, vincristine, CHOP prednisone Intermediate-dose methotrexate, doxorubicin, MACOP-B cyclophosphamide, vincristine, prednisone, bleomycin Doxorubicin, bleomycin, vinblastine, ABVD dacarbazine Fludarabine, cytarabine,G-CSF with or FLAG and Ida-FLAG without idarubicin AIDA ATRA, idarubicin “Hi7 +3” Daunorubicin, cytosine arabinoside D-AC High-dose cytosine arabinoside Multiple drug combinations and permutations ESHAP, DHAP, ICE, ASHAP CAV, hyper CVAD noted above Niscola P. Haematologica. 2007;92:222-231. Palliative Agents for Oral Mucositis • Topical agents – Mixture of agents (e.g. Magic or Miracle Mouthwash), including lidocaine, benzocaine, kaolin, pectin, and chlorhexidine1 – Gelclair®2 • Systemic agents – Patient-controlled analgesia with morphine for stem cell transplant recipients – Transdermal fentanyl 1. Rubenstein EB, et al. Cancer. 2004;100:2026-2046. 2. Gelclair Bioadherent Oral Gel [package insert], Lugano, Switzerland: Helsinn Healthcare SA; 2006. Caphosol for Oral Mucositis in Patients Receiving Bone Marrow Transplant • Prospective, randomized, controlled, double-blind study of Caphosol in conjunction with standard oral care for the treatment of oral mucositis in bone marrow transplant recipients • High-risk population: stem cell transplant recipients (N=95) • Stratified by type of transplant: autologous or allogeneic • Patients instructed to rinse a minimum of 4x daily from the start of cancer therapy – Allowed to increase to a maximum of 10x per day as needed Papas AS et al. Bone Marrow Transplantation. 2003;31:705-712. Days of Mucositis (mean) 8 7.2 7 6 5 p<0.001 4 3.7 3 Number of Days 2 1 0 Control Caphosol Adapted from Papas AS et al.1 1. Papas AS et al. Bone Marrow Transplant. 2003;31:705-712. Percent of Patients With Oral Mucositis ≤Grade 1* 100% 90% 80% 70% 60% 50% 40% 40% % of Patients 30% 19% 20% 10% 0% Control Caphosol Adapted from Papas AS et al.1 *Mucositis scored using National Institute of Dental and Craniofacial Research (NIDCR) scale. 1. Papas AS et al. Bone Marrow Transplant. 2003;31:705-712. Days of Pain (mean)* 8 7.7 7 6 5 p<0.0001 4 2.9 3 Number of Days 2 1 0 Control Caphosol Adapted from Papas AS et al.1 * Pain was assessed by patients using a 0-100 visual analog scale where 100 equals the most pain imaginable. 1. Papas AS et al. Bone Marrow Transplant. 2003;31:705-712. Days of Morphine (mean) 5 4.0 4 3 p<0.001 2 Number of Days 1.3 1 0 Control Caphosol Adapted from Papas AS et al.1 1. Papas AS et al. Bone Marrow Transplant. 2003;31:705-712. Total Morphine Use (mean) 140 122.8 120 100 80 p<0.0001 60 Total mg of Morphine 40 34.5 20 0 Control Caphosol Adapted from Papas AS et al.1 1. Papas AS et al. Bone Marrow Transplant. 2003;31:705-712. Caphosol® : Formulation . An advanced electrolyte solution . Supersaturated aqueous solution of calcium and phosphate . Designed to replace ionic and pH balance in oral cavity Caphosol Instructions for use Hypothesised Mechanism of Action . Caphosol® : helps maintain integrity of the oral cavity . Caphosol® : relatively high concentrations of calcium and phosphate ions . Calcium® and phosphate ions diffuse into intracellular spaces in the epithelium and permeate the mucosal lesion • Calcium ions: play a role in inflammatory process, blood clotting cascade, and tissue repair • Phosphate ions: may be a supplemental source of phosphates for damaged mucosal surfaces Papas AS, Clark RE, et al. Bone Marrow Transplantation. 2003;31:705-712. Summary and Conclusions • Oral toxicity—both acute and chronic—is a frequent consequence of current cancer treatment regimens that results in significant morbidity • As a result of increasing intensity of regimens, increasing survival, and altered patient expectations, maintenance of oral health during cancer treatment is of mounting significance • Oral mucositis begins when radiation or chemotherapy begins1 1. Sonis ST. J Support Oncol. 2004;2(suppl 3):3-8. Summary • Caphosol is a supersaturated solution of calcium and phosphate that is indicated for use: – As an adjunct to standard oral care in preventing and treating oral mucositis caused by radiation or high-dose chemotherapy – For treatment of xerostomia (regardless of cause)1 • Among treatment options, Caphosol used from day 1 of cancer therapy has shown improvement of oral mucositis – In bone marrow transplant recipients, Caphosol has been proven to reduce the frequency, duration, and severity of oral mucositis when initiated at the start of cancer therapy2 – Caphosol demonstrated low levels of oral mucositis, dysphagia, and pain in chemotherapy, radiation, and chemotherapy/radiation patients with a high level of patient and physician satisfaction3 1. Caphosol [package insert]. Princeton, NJ: EUSA Pharrma (USA); 2008. 2. Papas AS et al. Bone Marrow Transplant. 2003;31:705-712. 3. COMFORT Registry, data on file. Hui, Xun, Xinchao, Jiju, Yvonne, Michael, Anita, Ely, Leila .
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