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Topotecan is the long-standing second-line chemotherapy for relapsed small-cell lung cancer, and now the comparator that new drugs must beat.
Topotecan is a topoisomerase-I poison that stabilises the enzyme-DNA cleavage complex so replication forks break the DNA. Approved 1996 (IV) and 2007 (oral) for relapsed SCLC after platinum, it is given on days 1 to 5 of a 21-day cycle and also has roles in ovarian and cervical cancer. Activity is modest, with ORR around 20% and median OS around 6 to 8 months, and myelosuppression is heavy: grade 4 neutropenia in 70% of patients, so weekly blood counts and dose reductions are routine. It was the control arm in DeLLphi-304, where tarlatamab beat it with OS 13.6 versus 8.3 months, and is the comparator again in IDeate-Lung02; in ATLANTIS, lurbinectedin plus doxorubicin did not outperform it. Topotecan defines the floor for relapsed small-cell lung cancer, and new agents are judged by how far they rise above it.
Topoisomerase-I poison; stabilises the cleavage complex causing replication-associated DNA breaks.
1.Enters cell as active lactone
Oral anticancer drug with an injectable equivalent used for the same indication, so Medicare covers the oral form under Part B (the oral anticancer drug benefit) as well as under Part D; the pharmacy bills whichever applies. IV topotecan is Part B.
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA184 · SMC advice: topotecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Region | Year | Indication |
|---|---|---|
| US | 1996 | Relapsed SCLC (IV) |
| US | 2007 | Relapsed SCLC (oral) |
| England (NICE) | 2009 | Relapsed small-cell lung cancer, oral topotecan, only where re-treatment with the first-line regimen is inappropriate and cyclophosphamide, doxorubicin and vincristine is contraindicated · TA184, published 25 November 2009. It remains the only NICE recommendation for a cytotoxic drug in relapsed small-cell lung cancer. |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia (grade 4) | - | 70% |
| Thrombocytopenia (grade 4) | - | 27% |
| Anaemia | 90% | - |
| Diarrhoea (oral) | 30% | - |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Topotecan" OR ABSTRACT:"Topotecan" OR TITLE:"Hycamtin" OR ABSTRACT:"Hycamtin") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Topotecan, not a curated reading list.
Shares Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC, IDeate-Lung02, Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer, Lurbinectedin basket trial, small-cell lung cancer cohort.
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Shares IDeate-Lung02, Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer, DeLLphi-304, Small-cell lung cancer.
Shares Lurbinectedin basket trial, small-cell lung cancer cohort, DeLLphi-304, Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can, Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer, Platinum-resistant ovarian cancer, Topoisomerase-I inhibitors (and ADC payloads).
Shares Lurbinectedin basket trial, small-cell lung cancer cohort, ATLANTIS, Ewing sarcoma, Extensive-stage small-cell lung cancer.
Shares DeLLphi-304, Lung cancer drugs in England: what NICE has recommended, Small cell lung cancer (KEGG map), Extrapulmonary neuroendocrine carcinoma.
Shares Extrapulmonary neuroendocrine carcinoma, Limited-stage small-cell lung cancer, Extensive-stage small-cell lung cancer, Topoisomerase-I inhibitors (and ADC payloads).