The newly discovered multiform glioblastoma (adult patients)
The table below shows the side effects noted in the treatment of patients with newly diagnosed multiform glioblastoma during combined and adjuvant phases of treatment during clinical trials (cause-effect relationship
between taking the drug and side effects has not been established). Frequency distribution of side effects was made in accordance with the following gradation: very often (> 10%), often (> 1%, <10%), infrequently (> 0.1%, <1%).
| Frequency reactions | The nature of the reaction |
| combined phase of treatment (with radiotherapy) | adjuvant phase of treatment |
| Mechanisms of resistance to infections |
| often | candidiasis of the oral cavity, herpes simplex, pharyngitis, wound infection, other infection | candidiasis of the oral cavity, another infection |
| infrequently With Stors | | herpes simplex, herpes zoster, influenza-like symptoms |
| you are a system of hematopoiesis and lymphatic system |
| often | leukopenia, lymphopenia, neutropenia, thrombocytopenia | anemia, febrile neutropenia, leukopenia, thrombocytopenia |
| infrequently | anemia, febrile neutropenia | lymphopenia, petechia |
| From the side of the cardiovascular system |
| often | edemas, t.ch. swelling of the legs, hemorrhage | edema of the legs, hemorrhage, deep vein thrombosis |
| infrequently | heart palpitations, increased blood pressure, cerebral hemorrhage | edemas, t.ch. peripheral edema, pulmonary embolism |
| From the respiratory system |
| often | cough, dyspnea | cough, dyspnea |
| infrequently | pneumonia, upper respiratory tract infection, nasal congestion | pneumonia, upper respiratory tract infection, sinusitis, bronchitis |
| From the endocrine system |
| infrequently | cushingoid ................................................. cushingoid |
| From the nervous system |
| highly often | headache | headache, convulsions |
| often | anxiety, emotional lability, insomnia, dizziness, balance disorder, concentration disorder, ataxia, confusion and decreased consciousness, aphasia, dysphasia, convulsions, memory impairment, peripheral neuropathy, paresthesia, agitation, drowsiness, speech disorder, tremor | anxiety, depression, emotional lability, insomnia, dizziness, balance disorder, concentration disorder, ataxia, confusion, aphasia, dysphasia, speech disorder, hemiparesis, memory impairment, neurological disorders (unspecified), peripheral neuropathy, paresthesia, drowsiness, tremor |
| infrequently | apathy, behavioral disorders, depression, hallucinations, impaired perception, extrapyramidal disorders, gait disorders, hemiparesis, hyperesthesia, hypoesthesia, neurological disorders (unspecified), epileptic status, parosmia, thirst | hallucinations, amnesia, gait disorders, hemiplegia, hyperesthesia, sensory disturbances |
| From the side of the rut and subcutaneous tissue, the mammary glands |
| highly often | alopecia, rash | alopecia, rash |
| often | dermatitis, dry skin, erythema, itchy skin, face swelling | dry skin, itchy skin |
| infrequently | photosensitivity, pigmentation disorder, exfoliation | erythema, pigmentation disorder, increased sweating, pain in the mammary gland, face swelling |
| Co of the musculoskeletal system |
| often | arthralgia, muscle weakness | arthralgia, muscle weakness, myalgia, musculoskeletal pain |
| infrequently | back pain, musculoskeletal pain, myalgia, myopathy | back pain, myopathy |
| From the side of the organ of vision |
| often | blurred vision | blurred vision, diplopia, visual field limitation |
| infrequently | pain in the eye, hemianopsia, visual impairment, decreased visual acuity, limitation of visual fields | pain in the eye, dry eyes, decreased visual acuity |
| From the organs of hearing and vestibular system |
| often | hearing impairment | hearing impairment, ringing in the ears |
| pain in the ear, hyperacia, otitis media, infrequently: tinnitus | deafness, earache, dizziness |
| From the digestive system |
| highly often | anorexia, constipation, nausea, vomiting | anorexia, constipation, nausea, vomiting |
| often | increased activity of alanine aminotransferase, hyperglycemia, weight loss, abdominal pain, diarrhea, dyspepsia, dysphagia, stomatitis, impaired taste | increased alanine aminotransferase activity, weight loss, diarrhea, dyspepsia, dysphagia, stomatitis, dry mouth, impaired taste |
| infrequently | hypokalemia, increased alkaline phosphatase activity, weight gain, discoloration of the tongue, increased activity of gamma-glutamyltranspeptidase, aspartate aminotransferase, liver enzymes | hyperglycemia, weight gain, bloating, fecal incontinence, hemorrhoids, gastroenteritis, dental diseases |
| From the genitourinary system |
| often | frequent urination, urinary incontinence | urinary incontinence |
| infrequently | impotence | dysuria, amenorrhea, menorrhagia, vaginal bleeding, vaginitis |
| From the body as a whole |
| highly often | increased fatigue | increased fatigue |
| often | fever, pain syndrome, radiation damage, allergic reaction | fever, pain syndrome, radiation damage, allergic reaction |
| infrequently | "hot flashes", asthenia, worsening of the condition, chills | asthenia, worsening of the condition, chills |
| Laboratory indicators: myelosuppression (neutropenia and thrombocytopenia), is a dose-limiting side effect. Among patients of both groups (with combined and adjuvant therapy) changes in levels 3 and 4 on the part of neutrophils, including neutropenia, were noted in 8% of cases, and on the part of platelets, including thrombocytopenia, in 14% of cases. |
Progressive or recurrent malignant glioma (adults and children over 3 years old) or malignant melanoma (adults)
The following undesirable phenomena noted with the use of Temozolomide-Rus are distributed according to the frequency of occurrence in accordance with the following gradation: very often (> 10%), often (> 1%, <10%), infrequently (> 0.1% <1%), rarely (> 0.01%, <0.1%) and very rarely (<0.01%).
From the hemopoietic system: often - thrombocytopenia, neutropenia, lymphopenia; infrequently - pancytopenia, leukopenia, anemia. In the treatment of patients with glioma and metastatic melanoma, thrombocytopenia and grade 3 or 4 neutropenia were noted in 19% and 17%, respectively, in glioma and 20 % and 22%, respectively - with melanoma. Hospitalization of the patient and / or withdrawal of the drug Temozolomide-Rus in this case was required in 8% and 4% of cases, respectively, with glioma and in 3% and 1.3 % - with melanoma. Oppression of the bone marrow developed usually during the first few cycles of treatment, with a maximum between 21 and 28 days; recovery occurred, usually within 1-2 weeks. No evidence of cumulative myelosuppression was noted.
From the side of the digestive system: very often - nausea, vomiting, anorexia, constipation; often - diarrhea, abdominal pain, indigestion, perversion of taste. The most frequent were nausea and vomiting. In most cases, these events were 1-2 (from mild to moderate) severity and were treated independently or were easily controlled with standard antiemetic therapy. The frequency of severe nausea and vomiting is 4%.
From the nervous system: often - headache; often - drowsiness, dizziness, paresthesia, asthenia.
Dermatological reactions: often - rash, itching, alopecia, petechiae; very rarely - hives, exanthema, erythroderma, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.
From the immune system: very rarely - allergic reactions, including anaphylaxis. Other: often - increased fatigue; often - weight loss, shortness of breath, fever, chills, general malaise; rarely opportunistic infections, including pneumonia caused by Pneumocystis carinii; very rarely observed the development of myelodysplastic syndrome and secondary malignant processes, including leukemia, and also noted the development of prolonged pancytopenia with a risk of developing aplastic anemia and irreversible infertility.