Therapies

Topotecan hydrochloride

Hycamtin

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SUMMARY

Company: GlaxoSmithKline
Approval Status: FDA Approved October 2007
Specific Treatments: small cell lung cancer
Drug: Topotecan hydrochloride

 

GENERAL INFORMATION

Hycamtin (topotecan hydrochloride) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks.

Hycamtin is specifically indicated for the treatment of relapsed small cell lung cancer in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

Hycamtin is supplied as a 0.25 mg and 1 mg capsule designed for oral administration. The recommended initial dose of the drug is 2.3 mg/m2/day once daily for 5 consecutive days, repeated every 21 days. The calculated oral daily dose should be rounded to the nearest 0.25 mg, and the minimum number of 1 mg and 0.25 mg capsules should be prescribed. The same number of capsules should be prescribed for each of the 5 dosing days.

 

CLINICAL RESULTS

FDA Approval

FDA approval of Hycamtin (topotecan hydrochloride) was based on the results of a clinical trial. This randomized, comparative, open label study enrolled 115 subjects who were prior responders (complete or partial) to firstline chemotherapy, were not considered candidates for standard intravenous chemotherapy, and had relapsed at least 45 days from the end of first-line chemotherapy. The subjects received Hycamtin (2.3 mg/m2/day administered for 5 consecutive days repeated every 21 days) and Best Supportive Care (BSC) or BSC alone. The primary endpoint was overall survival. Median survival in the Hycamtin arm was 25.9 weeks (95% CI, 18.3 to 31.6) versus 13.9 weeks (95% CI, 11.1 to 18.6) in the BSC alone arm (log-rank P = .0104).

 

SIDE EFFECTS

The side effects associated with the use of Hycamtin may include, but are not limited to, the following:

  • Anemia
  • Leukopenia
  • Neutropenia
  • Thrombocytopenia
  • Nausea
  • Vomiting
  • Diarrhea

 

MECHANISM OF ACTION

Hycamtin (topotecan hydrochloride) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks. The cytotoxicity of topotecan is thought to be due to double strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I, and DNA. Mammalian cells cannot efficiently repair these double strand breaks.

Source: centerwatch