What is Hycamtin?
Hycamtin is a medicine that contains the active substance topotecan. It is available as a powder for the preparation of a solution for infusion (drip into a vein) and as a capsule (white: 0.25 mg; pink: 1 mg).
What is Hycamtin used for?
Hycamtin is an anticancer medicine. It is indicated as a unique therapy for the treatment of patients suffering from:
- metastatic ovarian carcinoma (ie that has spread to other parts of the body). It is used after the negative outcome of at least one other treatment;
- small cell lung cancer, when the carcinoma is recurrent (in case of reappearance). It is used when further treatment with the original therapeutic regimen is not recommended.
It is also used in combination with cisplatin (another anticancer medicine) in the treatment of patients with cervical cancer, in case of relapse after radiotherapy or in the case where the disease is at an advanced stage (stage IVB: carcinoma occurs) it is spread beyond the cervix).
The medicine can only be obtained with a prescription.
How is Hycamtin used?
Treatment with Hycamtin should only be administered under the direction of a doctor experienced in the use of chemotherapy. Infusions must be carried out in a specialized cancer ward. Before treatment it is necessary to carry out an examination of the levels of white blood cells, platelets and hemoglobin in the blood, to ensure that these levels are above the minimum levels set. In the case where the level of white blood cells is particularly low, a dose adjustment or the administration of other drugs to the patients can be carried out.
The dose of Hycamtin to be used depends on the type of cancer you want to treat as well as the patient's height and body weight. If the drug is taken alone, for the treatment of ovarian cancer, it is administered by intravenous infusion lasting 30 minutes. In the case of lung cancer, Hycamtin can be given by infusion, or, in adults, in capsule form. In the case of ovarian and pulmonary cancer, Hycamtin is given every day for
five days with an interval of three weeks between the start of each cycle. Treatment may continue until the disease gets worse.
If the drug is used in combination with cisplatin in cervical cancer, Hycamtin is given as an infusion on days 1, 2 and 3 (with cisplatin on day 1). This treatment scheme is repeated every 21 days for six cycles or until the disease gets worse.
For further details, please refer to the summary of product characteristics, also included with the EPAR.
How does Hycamtin work?
The active substance in Hycamtin, topotecan, is an anticancer medicine belonging to the group of "topoisomerasic inhibitors". It blocks an enzyme called topoisomerase I, which is involved in DNA duplication. When the enzyme is blocked, the DNA strands break off; no longer able to proliferate, cancer cells die. Hycamtin also affects non-cancer cells, thus causing undesirable effects.
How has Hycamtin been studied?
Hycamtin as an infusion was studied in more than 480 women with ovarian cancer who reported no improvement following treatment with platinum-containing anticancer drugs. Three studies were "open-label", meaning that the drug was not compared to another treatment and that patients knew they were receiving Hycamtin. In the fourth study, involving 226 women, Hycamtin was compared to paclitaxel (another anticancer medicine). The main measure of effectiveness was the number of patients whose tumors reacted to the therapy.
Hycamtin has also been analyzed in three main studies involving 656 patients with relapsing small cell lung cancer. In the first study, Hycamtin in capsule form was compared only with symptomatic control therapy and another study compared Hycamtin as an infusion with cyclophosphamide, doxorubicin and vincristine (a standard combination of chemotherapy). The third study compared Hycamtin given as an infusion and in capsule form. Efficacy was measured by evaluating survival or response rates.
Hycamtin as an infusion was studied in 293 women with advanced cervical cancer, in which the efficacy of a combination of Hycamtin and cisplatin was compared to cisplatin therapy alone. Efficacy was measured based on overall survival.
What benefit has Hycamtin shown during the studies?
In ovarian cancer, the effectiveness of Hycamtin has been demonstrated, with an overall response rate of 16%. In the main study, 21% of patients who received Hycamtin (23 of 112) responded to treatment, compared with 14% of patients who received paclitaxel (16 of 114).
In lung cancer, considering the results obtained from all three studies, the response rate was 20% (Hycamtin was administered to 480 patients). Compared to symptomatic control therapy alone, Hycamtin prolonged the survival of patients by 12 weeks and was as effective as the standard chemotherapy combinations. Hycamtin given as a capsule was as effective as Hycamtin given as an infusion.
In cervical cancer, the median survival of patients treated with Hycamtin in combination with cisplatin was 9.4 months compared to 6.5 months in patients receiving cisplatin alone.
What is the risk associated with Hycamtin?
The most common side effects seen with Hycamtin (seen in more than 1 patient in 10) are neutropenia (decreased number of white blood cells in defense of the body in infections), febrile neutropenia (neutropenia associated with fever), thrombocytopenia (reduction in blood platelets), anemia (reduction in the number of red blood cells in the blood), leukopenia (decrease in the number of white blood cells in the blood), nausea (feeling sick), vomiting and diarrhea (which can be serious), constipation, abdominal pain, mucositis (inflammation of the mouth), alopecia (hair loss), anorexia (loss of appetite, which can be severe), pyrexia (fever), asthenia (weakness) and fatigue. Neutropenia, as a side effect of Hycantin,
can cause neutropenic colitis (inflammation of the intestine) which causes severe abdominal pain, fever and perhaps diarrhea, and may require hospital treatment. For the full list of all side effects reported with Hycamtin, see the Package Leaflet.
Hycamtin should not be used in people who are hypersensitive (allergic) to topotecan or any of the other substances. Do not administer during lactation and to patients who have severe bone marrow depression (low white blood cell and platelet count) before starting treatment.
Why has Hycamtin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Hycamtin's benefits are greater than its risks in the treatment of metastatic ovarian cancer or recurrent small cell lung cancer, as well as in the treatment of cervical cancer (in combination with cisplatin ) and therefore recommended that the product be granted marketing authorization.
More information on Hycamtin:
On 12 November 1996 the European Commission granted a marketing authorization for Hycamtin, valid throughout the European Union, to SmithKline Beecham. The marketing authorization was renewed on 12 November 2001 and 12 November 2006.
The full EPAR for Hycamtin can be found here.
Last update of this summary: 07-2009.
