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Is there a maximum duration for lurbinectedin treatment?



Lurbinectedin is a drug used for the treatment of metastatic small cell lung cancer (SCLC) in adult patients. According to the sources provided, there is no maximum duration for lurbinectedin treatment specified in the FDA-approved label [2]. The recommended dose of lurbinectedin is 3.2 mg/m2 every three weeks until disease progression or unacceptable toxicity occurs [2].

In a Phase II clinical trial, the median number of treatment cycles was four, with a range of 1-19 cycles [3]. Another study showed that patients who received lurbinectedin as a second-line therapy had a median progression-free survival of 3.5 months [3].

The FDA-approved label [2] suggests that clinicians should monitor patients for adverse reactions and adjust the dose or delay the treatment if necessary. The most common adverse reactions observed in clinical trials were myelosuppression, fatigue, nausea, decreased appetite, musculoskeletal pain, vomiting, diarrhea, and constipation [2].

In conclusion, there is no maximum duration specified for lurbinectedin treatment in the FDA-approved label. The recommended dose is 3.2 mg/m2 every three weeks until disease progression or unacceptable toxicity occurs. Clinicians should monitor patients for adverse reactions and adjust the dose or delay the treatment if necessary.

Sources:
[1] Drug Patent Watch. Lurbinectedin. Retrieved from https://www.drugpatentwatch.com/p/tradename/LURBINECTEDIN
[2] FDA. ZEPZELCA (lurbinectedin) injection, for intravenous use. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213702s000lbl.pdf
[3] Trigo, J., Subbiah, V., Besse, B., et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020; 21(5): 645-654. doi: 10.1016/S1470-2045(20)30068-1. PMID: 32251610.



Follow-up:   What are the benefits of long-term lurbinectedin treatment? How does the duration of lurbinectedin treatment affect outcomes? Are there any risks associated with extended lurbinectedin treatment?





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