Safety and Tolerability
Adverse reactions occurring in ≥10% (all grades) of patients in the LARTRUVO + doxorubicin arm and at a higher incidence than in the doxorubicin alone arm (between arm difference of ≥5% for all grades or ≥2% for Grades 3 and 4).
*Abdominal pain includes: abdominal pain, lower abdominal pain, and upper abdominal pain.
†Fatigue includes: asthenia and fatigue.
‡Musculoskeletal pain includes: arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity.
The most common (≥20%) adverse reactions of LARTRUVO + doxorubicin were nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache.
- Adverse reactions resulting in permanent discontinuation of LARTRUVO occurred in 8% (5/64) of patients
- The most common adverse reaction leading to LARTRUVO discontinuation was infusion-related reaction (3%)
- Dose reductions of LARTRUVO for adverse reactions occurred in 25% (16/64) of patients; the most common adverse reaction leading to dose reduction was Grade 3 or 4 neutropenia (20%)
- Dose delays of LARTRUVO for adverse reactions occurred in 52% (33/64) of patients; the most common adverse reactions resulting in dose delays were neutropenia (33%), thrombocytopenia (8%), and anemia (5%)
Laboratory abnormalities worsening from baseline in >10% (all grades) of patients in the LARTRUVO + doxorubicin arm and occurring at a higher incidence than in the doxorubicin arm (between arm difference of ≥5% for all grades or ≥2% for Grades 3 and 4).
*The incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement: LARTRUVO + doxorubicin arm (range 60 to 63 patients) and doxorubicin arm (range 39 to 62 patients).
†aPTT=activated partial thromboplastin time.
Febrile neutropenia: 13% of LARTRUVO + doxorubicin-treated patients vs 12% of doxorubicin-treated patients.1
Cardiac adverse events2
All patients received dexrazoxane prior to doxorubicin in Cycles 5 to 8.
Median cumulative doxorubicin dose
- LARTRUVO + doxorubicin: 488 mg/m2 (7 cycles; 4.9 months)
- Doxorubicin: 300 mg/m2 (4 cycles; 2.8 months)
*Includes ejection fraction decreased, cardiac failure congestive, hepatojugular reflux, jugular vein distension, and left ventricular dysfunction.
†Excludes peripheral edema.