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 the combined and adjuvant phases of treatment during clinical trials (the causal relationship between drug administration and side effects has not been established). Frequency distribution of side effects was performed in accordance with the following gradation: very often (> 10%), often (> 1% <10%), infrequently (> 0.1% <1%).
| Table №4 | System organism | Frequency reactions | Character | p reaction | | combined phase of treatment (with radiotherapy) | adjuvant phase of treatment | | Mechanisms resilience infections | often | candidiasis of the oral cavity, herpes simplex, pharyngitis, wound infection, other infection | candidiasis of the oral cavity, another infection | | infrequently | | herpes simplex, herpes zoster, influenza-like syndrome | | Blood and lymphatic system | often | leukopenia, lymphopenia, neutropenia, thrombocytopenia | anemia, febrile neutropenia, leukopenia, thrombocytopenia | | infrequently | anemia, febrile neutropenia | lymphopenia, petechia | | Cordially vascular system | often | edema, incl. swelling of the legs, hemorrhage | edema of the legs, hemorrhage, deep vein thrombosis | | infrequently | heart beat, increased blood pressure, cerebral hemorrhage | 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 system | infrequently | cushingoid | cushingoid | | Skin and subcutaneous tissue, mammary glands | Often | alopecia, rash | alopecia, rash | | often | dermatitis, dry skin, erythema, skin itching, face swelling | dryness, itching of the skin | | infrequently | reactions photosensitivity, pigmentation disorder, exfoliation | erythema, impaired pigmentation, excessive sweating, pain in the chest, swelling of the face | | Nervous system | Often | headache | headache, convulsions | |
| 1 | often | anxiety, emotional lability, insomnia, dizziness, balance disorder, impaired concentration, confusion and decreased consciousness, convulsions, memory impairment, neuropathy, paresthesia, drowsiness, speech disorder, tremor | anxiety, depression, emotional lability, insomnia, dizziness, disturbed balance, impaired concentration, confusion, speech disorder, hemiparesis, memory impairment, neurological disorders (unspecified), neuropathy, paresthesia, drowsiness, tremor, peripheral neuropathy |
| infrequently | apathy, behavioral disorders, depression, hallucinations, impaired perception, extrapyramidal disorders, gait disorders, hemiparesis, hyperesthesia, hypesis, neurological disorders (unspecified), epileptic status, parosmia, thirst, agitation, dysphagia, ataxia, peripheral neuropathy | hallucinations, amnesia, gait disorders, hemiplegia, hyperesthesia, impaired sensory organs, impaired coordination, ataxia |
| Oporno motor staff | often | arthralgia, muscle weakness | arthralgia, musculoskeletal pain, myalgia, muscle weakness |
| infrequently | pain in the back, musculoskeletal pain, myalgia, myopathy | back pain, myopathy |
| Body of sight | 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 |
| Genitourinary system | often | frequent urination, urinary incontinence | urinary incontinence |
| infrequently | impotence | dysuria, amenorrhea, menorrhagia, vaginal bleeding, vaginitis |
| Organs of hearing and vestibular | often | hearing impairment | hearing impairment, ringing in the ears |
| system | infrequently | pain in the ear, hyperacia, ringing in the ears, otitis media | deafness, earache, vertigo |
| Digestive system | 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 activity of alanine aminotransferase, weight loss, diarrhea, dyspepsia, dysphagia, stomatitis, dry mouth, impaired taste |
| infrequently | hypokalemia, increased activity of alkaline phosphatase, weight gain, discoloration of the tongue, increased activity of gamma-glutamyltransferase, aspartate aminotransferase, liver enzymes | hyperglycemia, weight gain, bloating, fecal incontinence, hemorrhoids, gastroenteritis, dental diseases |
| Organism as a whole | Often | increased fatigue | increased fatigue |
| often | fever, pain syndrome, radiation damage, allergic reaction | fever, pain syndrome, radiation damage, allergic reaction |
| infrequently | "hot flushes" to the body, asthenia, worsening of the condition, chills | asthenia, worsening of the condition, chills |
| Other | highly rarely | interstitial pneumonitis, pulmonary fibrosis, development hepatotoxicity with increased activity of hepatic enzymes, cholestasis, hepatitis with a violation of liver function, including fatal cases, hyperbilirubinemia | |
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. Progressive or recurrent malignant glioma (adults and children over 3 years old) or malignant melanoma (adults)
The following undesirable phenomena noted with the administration of temozolomide 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 and metastasizing melanoma, thrombocytopenia and neutropenia of grade 3 or 4 were noted. In some cases, hospitalization of the patient or / and removal of temozolomide were required. Oppression of bone marrow function 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 - hives, 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, as well as the development of prolonged pancytopenia with a risk of developing aplastic anemia.