Glioblastoma multiforme (adult patients) was first detected. The table below shows the side effects noted in the treatment of patients with newly diagnosed multiform glioblastoma during the combined and adjuvant phases of treatment. The frequency distribution of side effects was made in accordance with the following gradation: very often> 10%, often> 1% and <10%, infrequently> 0.1% and <1%.
| Table 4. | | | The nature of the reaction | | System organism | Frequency reactions | Combined phase of treatment (with radiotherapy) n = 288 | adjuvant phase of treatment p-224 | | Infections and | often | candidiasis of the mucosa | mucosal candidiasis | | infestations | infrequently | mucous membrane of the oral cavity, herpes simplex pharyngitis, wound infection, other infection | oral cavity, other infection Herpes simplex, herpes zoster, influenza-like syndrome | | Blood and | often | leukopenia, lymphopenia, | anemia, febrile | | lymphatic | | neutropenia, | neutropenia, leukopenia, | | system | | thrombocytopenia | thrombocytopenia | | | infrequently | anemia, febrile neutropenia | lymphopenia, petechia | | Cordially- | often | edema, incl. swelling of the legs, | swelling of the legs, hemorrhage, | | vascular | | hemorrhage | deep vein thrombosis | | system | infrequently | heart beat, increased blood pressure, hemorrhagic stroke | edema, incl. peripheral edema, pulmonary embolism | | Respiratory system | often | cough, dyspnea | cough, dyspnea | | | infrequently | pneumonia, upper respiratory tract infection, nasal congestion | pneumonia, upper respiratory tract infection, sinusitis, bronchitis | | Endocrine | infrequently | Syndrome Itenko- | Isenko-Cushing syndrome | | system | | Cushing's | | | Skin and | Often | alopecia, rash | alopecia, rash | | subcutaneous tissue, mammary glands | often | dermatitis, dry skin, erythema, skin itching, face swelling | dryness, itching of the skin | | | infrequently | reactions photosensitization, pigmentation disorder, skin detachment | erythema, impaired pigmentation, excessive sweating, pain in the mammary gland, swelling of the face | |
| Nervous system | Often | headache | headache, convulsions |
| | often | anxiety, | anxiety, depression, |
| | | emotional | emotional lability, |
| | | lability, insomnia, | insomnia, dizziness, |
| | | dizziness, | disturbance of balance, |
| | | balance disorder, | concentration disorder |
| | | concentration disorder | attention, confusion |
| | | attention, confusion and | consciousness, speech disorder, |
| | | decreased oppression | hemiparesis, memory impairment, |
| | | consciousness, cramps, | neurological disorders |
| | | memory impairment, | (unspecified), neuropathy, |
| | | neuropathy, paresthesia, | paresthesia, drowsiness, |
| | | drowsiness, speech disorder, tremor | tremor |
| | infrequently | apathy, behavioral | hallucinations, amnesia, |
| | | disorders, depression, | violation of gait, |
| | | hallucinations, violation | hemiplegia, hyperesthesia, |
| | | perception, | violation of |
| | | extrapyramidal | sensitivity / sensory |
| | | disorders of gait, hemiparesis, hyperesthesia, hypoesthesia, neurological disorders (unspecified), epileptic status, parosmia, thirst | violations |
| Oporno- | often | arthralgia, muscular | arthralgia, muscular- |
| motor | | weakness | skeletal pain, myalgia, |
| staff | infrequently | pain in the back, musculoskeletal pain, myalgia, | muscle weakness, back pain; myopathy |
| | | myopathy | |
| Body of sight | often | blurred vision | blurred vision, diplopia, visual field limitation |
| | infrequently | pain in the eye, hemianopsia, | pain in the eye, dry eyes, |
| | | visual impairment, visual acuity, visual field limitation | visual acuity reduction |
| Genitourinary | often | frequent urination, | urinary incontinence |
| system | infrequently | incontinence | dysuria, amenorrhea, menorrhagia, vaginal bleeding, vaginitis |
| The organ of hearing and | often | hearing impairment | hearing impairment, ringing in the ears |
| equilibria | infrequently | pain in the ear, hyperacia, | deafness, pain in the ear, |
| | | ringing in the ears, otitis media | dizziness |
| Digestive system | very often infrequently | anorexia, constipation, nausea, vomiting increased activity of alanine transaminase (ALT), abdominal pain, diarrhea, dyspepsia, dysphagia, stomatitis, impaired taste, increased alkaline phosphatase activity, discoloration of the tongue, increased activity of gamma-glutamyltranspeptase (Gamma-GT), aspartic transaminase (ACT), liver enzymes | anorexia, constipation, nausea, vomiting increased activity of alanine transaminase (ALT), diarrhea, dyspepsia, dysphagia, stomatitis, dry mouth, abnormality of bloating, stool incontinence, hemorrhoids,gastroenteritis, dental diseases |
| Organism as a whole | Often | fatigue | fatigue |
| | often | fever, pain syndrome, | fever, painful |
| | | radiation damage, | syndrome, radiation |
| | | allergic reaction, | defeat, allergic |
| | | weight loss | reaction, weight loss |
| | | | bodies |
| | infrequently | "hot flashes" of heat to the body, | asthenia, worsening |
| | | asthenia, worsening | condition, chills, |
| | | condition, chills, | weight gain |
| | | weight gain | |
Laboratory indicators. Myelosuppression (neutropenia and thrombocytopenia) is a dose-limiting side effect. Among patients in both groups (combined and adjuvant therapy), neutrophil changes, including neutropenia, were noted in 8% of cases, and platelet counts, including thrombocytopenia, in 14% of cases. Hyperglycemia was noted in less than 10% of cases with combined therapy and less than 1% with adjuvant therapy; hypokalemia was noted in less than 1% of cases with combined therapy. Progressive or recurrent malignant glioma (adults and children over 3 years old).
The following undesirable effects, noted with the use of the drug Temcital®,are distributed according to the frequency of occurrence in accordance with the following gradation: very often (> 10% of cases), often (> 1% <10%), infrequently (> 0.1% <1%), rarely (> 0.01% <0.1%) and very rarely (<0.01%).
On the part of the hematopoiesis system: very often - thrombocytopenia, neutropenia, lymphopenia; infrequently - pancytopenia, leukopenia, anemia. In the treatment of patients with glioma, thrombocytopenia and grade 3 or 4 neutropenia were noted in 19% and 17%. Hospitalization of the patient and / or withdrawal of Temcital® was required in 8% and 4% of cases. 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.
On the part of the digestive system: very often - nausea, vomiting, constipation, anorexia; often - diarrhea, abdominal pain, indigestion, taste perversion. 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: very often - headache; often - drowsiness, dizziness, paresthesia, asthenia.
From the skin and skin appendages: often - rash, itching, alopecia, petechiae; very rarely - crapivnitsa, exanthema, erythroderma, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.
From the immune system: very rarely - allergic reactions, including anaphylaxis.
Other: very 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 (MDS) and secondary malignant processes, including leukemia, and also noted the development of prolonged pancytopenia with a risk of developing aplastic anemia.