Hycamtin
Active
Substance: topotecan
Common Name: topotecan
ATC Code: L01XX17
Marketing Authorisation Holder: Novartis Europharm Limited
Active Substance: topotecan
Status: Authorised
Authorisation Date: 1996-11-12
Therapeutic Area: Small Cell Lung Carcinoma Uterine Cervical
Neoplasms Ovarian Neoplasms
Pharmacotherapeutic Group: Antineoplastic agents
Therapeutic
Indication
Hycamtin
capsules are indicated as monotherapy for the treatment of adult patients with
relapsed small cell lung cancer (SCLC) for whom re-treatment with the
first-line regimen is not considered appropriate.
Topotecan is
indicated for the treatment of patients with metastatic carcinoma of the ovary
after failure of first-line or subsequent therapy.
Hycamtin
capsules are indicated as monotherapy for the treatment of adult patients with
relapsed small cell lung cancer (SCLC) for whom re-treatment with the
first-line regimen is not considered appropriate.
What is
Hycamtin?
Hycamtin is a
cancer medicine that contains the active substance topotecan. It is available
as a powder to be made up into a solution for infusion (drip) into a vein and
as capsules (0.25 and 1 mg).
What is Hycamtin
used for?
Hycamtin is used
on its own to treat patients with:
metastatic
cancer of the ovary (when the cancer has spread to other parts of the
body). It is used after at least one other treatment has failed;small
cell lung cancer, when the cancer has relapsed (come back). It is used
when giving the original treatment again is not recommended.
It is also used
together with cisplatin (another cancer medicine) to treat women with cancer of
the cervix, when the cancer has come back after radiotherapy, or when the
disease is at an advanced stage (has spread beyond the cervix).
The medicine can
only be obtained with a prescription.
How is Hycamtin
used?
Treatment with
Hycamtin should only be given under the supervision of a doctor experienced in the
use of chemotherapy. Infusions should be carried out in a specialised cancer
ward.
The dose of
Hycamtin to be used depends on the type of cancer that it is being used to
treat and the patient’s weight and height. When Hycamtin is used on its own for
ovarian cancer, it is given by intravenous infusion over 30 minutes. For lung
cancer, Hycamtin can be given as an infusion or, for adults, as capsules. For
both ovarian and lung cancer, Hycamtin is given every day for five days with a
three-week interval between the start of each course. Treatment may continue
until the disease gets worse.
When used with
cisplatin in cervical cancer, Hycamtin is given as an infusion on days 1, 2 and
3 (with cisplatin given on day 1). This is repeated every 21 days for six courses
or until the disease gets worse.
Doses of
Hycamtin may need to be adjusted or treatment delayed, depending on side
effects. For full details, see the summary of product characteristics, also
part of the EPAR.
How does
Hycamtin work?
The active
substance in Hycamtin, topotecan, is a cancer medicine that belongs to the
group ‘topoisomerase inhibitors’. It blocks an enzyme called
topoisomerase I, which is involved in the division of DNA. When the enzyme
is blocked, the DNA strands break. This prevents the cancer cells from dividing
and they eventually die. Hycamtin also affects non‑cancer cells, which causes
side effects.
How has Hycamtin
been studied?
Hycamtin as an
infusion has been studied in more than 480 women with ovarian cancer who had
failed one treatment with platinum-containing cancer medicines. Three studies
were ‘open’, meaning that the medicine was not compared to any other treatment
and the patients knew that they were receiving Hycamtin. The fourth study
involved 226 women, and compared Hycamtin with paclitaxel (another cancer
medicine). The main measure of effectiveness was the number of patients whose
tumours responded to treatment.
Hycamtin has
also been studied in three main studies in 656 patients with relapsed small cell
lung cancer. One study compared Hycamtin capsules with symptom control alone
and another 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 as capsules. The effectiveness was
measured by looking at survival or response rates.
Hycamtin as an
infusion has been studied in 293 women with advanced cervical cancer, where the
effectiveness of a combination of Hycamtin and cisplatin was compared with that
of cisplatin alone. The effectiveness was measured by looking at overall
survival.
What benefit has
Hycamtin shown during the studies?
ut 16%. In the
main study, 21% of the patients who received Hycamtin (23 out of 112) responded
to treatment, compared with 14% of the paclitaxel patients (16 out of 114).
In lung cancer,
looking at the results obtained in all three studies, the response rate was 20%
(480 patients received Hycamtin). Compared with symptom control alone, Hycamtin
prolonged survival by 12 weeks. It was as effective as the standard combination
chemotherapy. Hycamtin given as capsules was as effective as Hycamtin given as
an infusion.
In cervical
cancer, patients receiving the combination of Hycamtin and cisplatin survived
an average of 9.4 months, compared with 6.5 months for the patients who
received cisplatin only.
What is the risk
associated with Hycamtin?
The most common
side effects with Hycamtin (seen in more than 1 patient in 10) are neutropenia
(low white blood cell counts), febrile neutropenia (neutropenia with fever),
thrombocytopenia (low platelet counts), anaemia (low red blood cell counts),
leucopenia (low white blood cell counts), nausea (feeling sick), vomiting and
diarrhoea (all of which may be severe), constipation, abdominal (tummy) pain,
mucositis (mouth sores), alopecia (hair loss), loss of appetite (which may be
severe), infections, pyrexia (fever), asthenia (weakness) and fatigue
(tiredness).
Hycamtin must
not be used in patients who are breast-feeding, or in patients who have severe
bone marrow depression (low white blood cell and platelet counts) before
treatment. For the full list of all side effects and restrictions with
Hycamtin, see the package leaflet.
Why has Hycamtin
been approved?
The CHMP decided
that Hycamtin’s benefits are greater than its risks and recommended that it be
given marketing authorisation.
What measures
are being taken to ensure the safe and effective use of Hycamtin?
A risk
management plan has been developed to ensure that Hycamtin is used as safely as
possible. Based on this plan, safety information has been included in
the summary of product characteristics and the package leaflet for
Hycamtin, including the appropriate precautions to be followed by healthcare
professionals and patients.
Other
information about Hycamtin
The European
Commission granted a marketing authorisation valid throughout the European
Union for Hycamtin on 12 November 1996.
For more
information about treatment with Hycamtin read the package leaflet (also part
of the EPAR) or contact your doctor or pharmacist.
Source: European
Medicines Agency
