This site is intended for US healthcare professionals only.
This site is intended for US healthcare professionals only.
For adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy,
Select the characteristics of one of your patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy from the drop-down lists below. While age and ECOG PS are important treatment considerations, this tool will provide subgroup data based only on chemotherapy-free interval (CTFI) subgroups. This tool and these data sets are not intended as treatment recommendations.
Age, in years
Please select one
Eastern Cooperative
Oncology Group Performance
Status
(ECOG PS)
Please select one
Time to relapse following the last dose of platinum-based chemotherapy (CTFI)
Please select one
IN AN EXPLORATORY ANALYSIS, Disease control rate (CR + PR + SD) IN THE 20 PATIENTS WITH A CTFI ≥180 DAYS WAS2*:
Limitations of disease control rate data
No conclusions about efficacy can be drawn from these descriptive data because they are results from exploratory end points in a phase 2, single-arm study.
DURATION OF RESPONSE (DOR) IN THE 20 PATIENTS WITH A CTFI ≥180 DAYS IN THE PHASE 2, SINGLE-ARM STUDY2*:
CR=complete response; CTFI=chemotherapy-free interval; IRC=independent review committee;
ORR=overall response rate; PR=partial response; SD=stable disease.
Limitations of subgroup exploratory analyses
These subgroup exploratory analyses were not powered to determine statistical significance. Results are descriptive only.
*CTFI ≥180 days=recurrence or progression 180 days or more after the last dose of platinum-based chemotherapy.
Click here to select another patient
IN AN EXPLORATORY ANALYSIS, Disease Control Rate (CR + PR + SD) IN THE 40 PATIENTS WITH A CTFI OF 90 TO <180 DAYS WAS1*:
Limitations of disease control rate data
No conclusions about efficacy can be drawn from these descriptive data because they are results from exploratory end points in a phase 2, single-arm study.
DURATION OF RESPONSE (DOR) IN THE 40 PATIENTS WITH A CTFI OF 90 TO <180 DAYS IN THE PHASE 2, SINGLE-ARM STUDY1*:
CR=complete response; CTFI=chemotherapy-free interval; IRC=independent review committee;
ORR=overall response rate; PR=partial response; SD=stable disease.
Limitations of subgroup exploratory analyses
These subgroup exploratory analyses were not powered to determine statistical significance. Results are descriptive only.
*CTFI 90 to <180 days=recurrence or progression between 90 and <180 days after the last dose of platinum-based chemotherapy.
Click here to select another patient
IN AN EXPLORATORY ANALYSIS, Disease Control Rate (CR + PR + SD) IN THE 24 PATIENTS WITH CTFI 30 TO <90 DAYS WAS1*:
Limitations of disease control rate data
No conclusions about efficacy can be drawn from these descriptive data, because they are results from exploratory end points in a phase 2, single-arm study.
DURATION OF RESPONSE (DOR) IN THE 24 PATIENTS WITH A CTFI OF 30 TO <90 DAYS IN THE PHASE 2, SINGLE-ARM STUDY1*:
CR=complete response; CTFI=chemotherapy-free interval; IRC=independent review committee;
ORR=overall response rate; PR=partial response; SD=stable disease.
Limitations of subgroup exploratory analyses
These subgroup exploratory analyses were not powered to determine statistical significance. Results are descriptive only.
*CTFI 30 to <90 days=recurrence or progression between 30 and <90 days after the last dose of platinum-based chemotherapy.
Click here to select another patient
IN AN EXPLORATORY ANALYSIS, Disease Control Rate (CR + PR + SD) IN THE 21 PATIENTS WITH CTFI <30 DAYS WAS1*:
Limitations of disease control rate data
No conclusions about efficacy can be drawn from these descriptive data because they are results from exploratory end points in a phase 2, single-arm study.
DURATION OF RESPONSE (DOR) IN THE 21 PATIENTS WITH CTFI <30 DAYS 1*:
CR=complete response; CTFI=chemotherapy-free interval; IRC=independent review committee;
ORR=overall response rate; PR=partial response; SD=stable disease.
Limitations of subgroup exploratory analyses
These subgroup exploratory analyses were not powered to determine statistical significance. Results are descriptive only.
*CTFI <30 days=recurrence or progression <30 days after the last dose of platinum-based chemotherapy.
Click here to select another patient
ZEPZELCA® (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Myelosuppression
ZEPZELCA can cause myelosuppression. In clinical studies of 554 patients with advanced solid tumors receiving
ZEPZELCA, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median
duration of 7 days. Febrile neutropenia occurred in 7% of patients.
Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days. Grade 3 or 4 anemia occurred in 17% of patients.
Administer ZEPZELCA only to patients with baseline neutrophil count of at least 1,500 cells/mm3 and platelet count of at least 100,000/mm3.
Monitor blood counts including neutrophil count and platelet count prior to each administration. For neutrophil count less than 500 cells/mm3 or any value less than lower limit of normal, the use of G-CSF is recommended. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.
Hepatotoxicity
ZEPZELCA can cause hepatotoxicity. In clinical studies of 554 patients with advanced solid tumors receiving
ZEPZELCA, Grade 3 elevations of ALT and AST were observed in 6% and 3% of patients, respectively, and Grade 4
elevations of ALT and AST were observed in 0.4% and 0.5% of patients, respectively. The median time to onset of
Grade ≥3 elevation in transaminases was 8 days (range: 3 to 49), with a median duration of 7 days.
Monitor liver function tests, prior to initiating ZEPZELCA, periodically during treatment, and as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.
Extravasation Resulting in Tissue Necrosis
Extravasation of ZEPZELCA
resulting in skin and soft tissue injury, including necrosis requiring
debridement, can occur. Consider use of a central venous catheter to reduce the risk of extravasation, particularly
in patients with limited venous access. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA
infusion.
If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis. The time to onset of necrosis after extravasation may vary.
Administer supportive care and consult with an appropriate medical specialist as needed for signs and symptoms of extravasation. Administer subsequent infusions at a site that was not affected by extravasation.
Rhabdomyolysis
Rhabdomyolysis has been reported in patients treated with
ZEPZELCA.
Monitor creatine phosphokinase (CPK) prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold or reduce the dose based on severity.
Embryo-Fetal Toxicity
ZEPZELCA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to
a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with
ZEPZELCA and for 6 months after the final dose. Advise male patients with female partners of reproductive potential
to use effective contraception during treatment with ZEPZELCA and for 4 months after the final dose.
Lactation
There are no data on the presence of ZEPZELCA in human milk, however, because of the potential for serious adverse
reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with ZEPZELCA and for
2 weeks after the final dose.
The most common adverse reactions, including laboratory abnormalities, (≥20%) are leukopenia (79%), lymphopenia (79%), fatigue (77%), anemia (74%), neutropenia (71%), increased creatinine (69%), increased alanine aminotransferase (66%), increased glucose (52%), thrombocytopenia (37%), nausea (37%), decreased appetite (33%), musculoskeletal pain (33%), decreased albumin (32%), constipation (31%), dyspnea (31%), decreased sodium (31%), increased aspartate aminotransferase (26%), vomiting (22%), decreased magnesium (22%), cough (20%), and diarrhea (20%).
Strong and Moderate CYP3A Inhibitors
Avoid coadministration with a strong or a moderate CYP3A inhibitor as this increases lurbinectedin systemic exposure which may increase the incidence and severity of adverse reactions to ZEPZELCA. If coadministration of ZEPZELCA with a moderate CYP3A inhibitor cannot be avoided, consider dose reduction of ZEPZELCA, if clinically indicated.
Strong and Moderate CYP3A Inducers
Avoid coadministration with a strong or moderate CYP3A inducer. Coadministration with a strong CYP3A inducer decreases lurbinectedin systemic exposure which may reduce ZEPZELCA efficacy.
Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients.
There was a higher incidence of serious adverse reactions in patients ≥65 years of age than in patients <65 years of age (49% vs 26%, respectively). The serious adverse reactions most frequently reported in patients ≥65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%).
Please see accompanying full Prescribing Information.
References: 1. Data on file. LUR-2020-003. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2. Subbiah V, Paz-Ares L, Besse B, et al. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment. Lung Cancer. 2020;150:90-96.
Myelosuppression
ZEPZELCA can cause myelosuppression. In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients.
Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days. Grade 3 or 4 anemia occurred in 17% of patients.