Background
Patients and methods
Electronic literature search strategy
Data collection and analysis
Results
Case presentation
Systematic literature revision
Condition | PI | PY | Study design | Phase | Enrolled patients | Dose (mg/daily) |
---|---|---|---|---|---|---|
DTC | Cabanillas | 2014 | Clinical Trial | I | 15 | 140 |
DTC | Shah | 2015 | Clinical Trial | II | 25 | 60 or 80 (if tolerated) |
DTC | Konda | 2017 | Prospective analysis on clinical trial | II | 25 | 60 or 80 (if tolerated) |
DTC | Brose | 2021 | Clinical Trial | III | 187 | 60 |
DTC | Taylor | 2022 | Clinical Trial | Ib | 102 | 40 or 60 (plus atezolizumab) |
MTC | Elisei | 2013 | Clinical Trial | III | 330 | 140 |
MTC | Bentzien | 2013 | Preclinical | preclinical | biochemical assays/mice model | N/A |
MTC | Rinciog | 2014 | Adjusted indirect comparison | indirect comparison | N/A | N/A |
MTC | Sherman | 2016 | Correlative analysis | indirect comparison | 330 | 140 |
MTC | Schlumberger | 2017 | Clinical Trial | III | 330 | 140 |
MTC | Koehler | 2021 | Real World Comparative Study | N/A | 48 | N/A |
MTC | Capdevila | 2022 | Clinical Trial | IV | 247 | 60 vs 140 |
MTC (+ other cancers) | Kurzrock | 2011 | Clinical Trial | I | 37, (85) | MTD (175) |
MCC | Rabinowits | 2018 | Clinical Trial | II | 8 | 60 (40 or 20 if not tolerated) |
MCC | Tarabadkar | 2018 | Case Series | N/A | 5 | 60 reduced to 40 |
PPGL | Roman | 2017 | Review | N/A | N/A | N/A |
PPGL | Jimenez | 2018 | Expert Opinion | N/A | N/A | N/A |
PPGL | Economides | 2020 | Case Report | N/A | 1 | 60/40 |
GU Tract Tumours | Apolo | 2020 | Clinical Trial | I | 54 | 40 |
ACC | Phan | 2015 | Preclinical | N/A | biochemical assays/mice model | N/A |
ACC | Kroiss | 2020 | Retrospective cohort study | N/A | 16 | 60/100/140/20 |
ACC | Miller | 2020 | Retrospective cohort study | N/A | 15 | N/A |
NEN | Sennino | 2012 | Preclinical | preclinical | biochemical assays/mice model | N/A |
NEN | Reuther | 2016 | Preclinical | preclinical | biochemical assays/mice model | N/A |
NEN | Chan | 2018 | Clinical Trial | II | 35 | 60 |
NEN | Grillo | 2018 | Review | N/A | N/A | N/A |
Thyroid cancers
Use of CBZ in MTC
Frequent AEs (>50%) | All grades (%) | G3 (%) | Common AEs (50-10%) | All grades (%) | G3 (%) | Not common AEs (<10%) | All grades (%) | G3 (%) |
---|---|---|---|---|---|---|---|---|
Cardiovascular | ||||||||
hypertension | 33–53 | 8.4–20 | pulmonary embolism | 3.3 | 0 | |||
Dermatological | ||||||||
palmar-plantar erythrodyesthesia | 40–53 | 13–12 | rash | 19.2–23 | 0.9 | |||
mucositis | 20–53 | 0–3.3 | dry skin | 19.2–20.1 | 0–2.8 | |||
Gastrointestinal | ||||||||
diarrhoea | 52–87 | 7.3–21 | dysgeusia | 26–45 | 0.1–0.5 | |||
decreased appetite | 49–80 | 7–13 | constipation | 26–34 | 0-1 | |||
nausea | 43–80 | 0–6.9 | stomatitis | 19–30 | 1.4–2.6 | |||
vomiting | 24–60 | 2.3–7 | ||||||
Constitutional | ||||||||
fatigue | 41–80 | 7–13 | arthralgia | 14 | 2.3 | |||
weight decrease | 35–73 | 3.4–13 | myalgia | 7–27 | 1 | |||
insomnia | 10.7 | 0 | ||||||
pruritus | 13.6 | 0.5 | ||||||
headache | 13–18.2 | 0.4–0.5 | ||||||
alopecia | 16.4 | 0 | ||||||
hair colour changes | 33–34 | 0.5 | ||||||
Renal | ||||||||
proteinuria | 47 | 7 | ||||||
Lab alteration | ||||||||
incresed AST | 10–100 | 7–3.2 | hypophosphatemia | 20 | 13 | increased ALP | 3 | 0 |
increased ALT | 24–73 | 7-5 | hyponatremia | 13–33 | 7–27 | |||
increased LDH | 73 | 7 | ||||||
hypocalcemia | 23–60 | 13-0 | ||||||
hypokalemia | 47 | 13-3.8 | ||||||
Haematologic | ||||||||
anaemia | 20–31 | 7 | ||||||
leukopenia | 27 | 7 | ||||||
Respiratory tract | ||||||||
pneumonia | 4.2–13 | 13 | ||||||
dyspnoea | 13.6–21 | 2.3–3.5 | ||||||
dysphonia | 21–27 | 0–10.1 | ||||||
Thyroid | ||||||||
thyroid disfunction | 14 | 0 |
Use of CBZ in RAIR-DTC
Condition | Identifier | Status | Study Start Date | Study Completion Date | Ph | EP | Primary Objectives | Drugs |
---|---|---|---|---|---|---|---|---|
RAIR- DTC | NCT05660954 | not yet recruiting | April, 2023 | June, 2025 | II | 41 | Gene expression | cabozantinib |
DTC | NCT03914300 | active, not recruiting | July 15, 2019 | January 15, 2024 | II | 27 | ORR | cabozantinib, nivolumab and ipilimumab |
RAIR- DTC | NCT02041260 | active, not recruiting | January 2014 | May 2022 | II | 43 | AEs | cabozantinib |
Advanced DTC (+others) | NCT04514484 | recruiting | November 4, 2020 | November 2, 2025 | I | 18 | DLTs | cabozantinib and nivolumab |
DTC (+others) | NCT03170960 | active, not recruiting | September 5, 2017 | August 2024 | Ib | 1732 | MTD | cabozantinib and atezolizumab |
PPGL | NCT02302833 | recruiting | February 17, 2015 | December 31, 2023 | II | 22 | ORR | cabozantinib |
ACC | NCT03612232 | recruiting | June 4, 2019 | April 30, 2025 | II | 37 | PFS | cabozantinib |
ACC | NCT03370718 | active, not recruiting | February 26, 2018 | February 28, 2026 | II | 18 | PFS | cabozantinib |
NEN | NCT03375320 | recruiting | July 18, 2018 | October 1, 2025 | III | 395 | PFS | cabozantinib |
NEC | NCT04079712 | active, not recruiting | January 14, 2020 | October 1, 2023 | II | 30 | ORR | cabozantinib, nivolumab, and ipilimumab |
NEN | NCT04412629 | recruiting | November 24, 2020 | July 31, 2025 | II | 32 | ORR | cabozantinib |
NEN | NCT04893785 | recruiting | June 15, 2021 | December 2024 | II | 35 | ORR | cabozantinib, temozolomide |
NEN | NCT04427787 | recruiting | June 20, 2020 | November 2023 | II | 69 | ORR | cabozantinib, lanreotide |
NEN | NCT05249114 | recruiting | December 28, 2022 | December 1, 2031 | Ib | 90 | MTD | cabozantinib, PRRT |
Carcinoid Tumours | NCT04197310 | active, not recruiting | December 26, 2019 | December 26, 2023 | II | 35 | ORR | cabozantinib, nivolumab |
NEN, PPGL, ATC, Adenocarcinoma | NCT04400474 | active, not recruiting | October 7, 2020 | March 2024 | II | 93 | ORR | cabozantinib, atezolizumab |
NEN | NCT05048901 | recruiting | September 17, 2021 | December 31, 2025 | I/II | 49 | MTD, PFS | cabozantinib |
NEN G3 | NCT04524208 | recruiting | March 1, 2021 | June 30, 2023 | II | 40 | DCR | cabozantinib |
NEN G3 | NCT05289856 | recruiting | March 28, 2022 | December 1, 2025 | II | 30 | DCR | cabozantinib, avelumab |