Difference between revisions of "Pheochromocytoma"
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+ | =Guidelines= | ||
+ | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
+ | ==ESMO-EURACAN== | ||
+ | *'''2020:''' Fassnacht et al. [https://doi.org/10.1016/j.annonc.2020.08.2099 Adrenocortical carcinomas and malignant phaeochromocytomas: ESMO–EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/32861807 PubMed] | ||
− | =Guidelines | + | ==NANETS== |
+ | *'''2021:''' Fishbein et al. [https://doi.org/10.1097/mpa.0000000000001792 The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Management of Metastatic and/or Unresectable Pheochromocytoma and Paraganglioma] [https://pubmed.ncbi.nlm.nih.gov/33939658 PubMed] | ||
− | == | + | ==NCCN== |
− | *[https://www.nccn.org/ | + | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1448 NCCN Guidelines - Neuroendocrine and Adrenal Tumors]''. |
=All lines of therapy= | =All lines of therapy= | ||
− | |||
==Cyclophosphamide, Dacarbazine, Vincristine {{#subobject:6ff914|Regimen=1}}== | ==Cyclophosphamide, Dacarbazine, Vincristine {{#subobject:6ff914|Regimen=1}}== | ||
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CVD: '''<u>C</u>'''yclophosphamide, '''<u>V</u>'''incristine, '''<u>D</u>'''acarbazine | CVD: '''<u>C</u>'''yclophosphamide, '''<u>V</u>'''incristine, '''<u>D</u>'''acarbazine | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:5998d1|Variant=1}}=== | ===Regimen {{#subobject:5998d1|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | !Study | + | !style="width: 33%"|Study |
− | ![[Levels_of_Evidence#Evidence|Evidence]] | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.7326/0003-4819-109-4-267 Averbuch et al. 1988] |
− | |style="background-color:#ffffbe"|Pilot, | + | |1983-08 to 1985-12 |
+ | |style="background-color:#ffffbe"|Pilot, fewer than 20 pts | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Dacarbazine (DTIC)]] 600 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Dacarbazine (DTIC)]] 600 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> IV once on day 1 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | # Averbuch SD, Steakley CS, Young RC, Gelmann EP, Goldstein DS, Stull R, Keiser HR. Malignant pheochromocytoma: effective treatment with a combination of cyclophosphamide, vincristine, and dacarbazine. Ann Intern Med. 1988 Aug 15;109(4):267-73. [ | + | # Averbuch SD, Steakley CS, Young RC, Gelmann EP, Goldstein DS, Stull R, Keiser HR. Malignant pheochromocytoma: effective treatment with a combination of cyclophosphamide, vincristine, and dacarbazine. Ann Intern Med. 1988 Aug 15;109(4):267-73. [https://doi.org/10.7326/0003-4819-109-4-267 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/3395037/ PubMed] |
− | + | ==Iobenguane I 131 monotherapy {{#subobject:57992a|Regimen=1}}== | |
− | == | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | {| class="wikitable" style=" | + | ===Regimen variant #1 {{#subobject:f4jgjj|Variant=1}}=== |
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6495236/ Pryma et al. 2018 (MIP-IB12B)] | ||
+ | |2009-06 to 2016-02 | ||
+ | | style="background-color:#91cf61" |Phase 2 (RT) | ||
|- | |- | ||
− | |||
|} | |} | ||
− | + | ''Note: This was the study cited by the FDA in their approval.'' | |
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
− | === | + | ====Radiotherapy==== |
− | {| class="wikitable" style="width: | + | *[[Iobenguane I 131 (Azedra)]] by the following weight-based criteria: |
− | !Study | + | **More than 62.5 kg: 18.5 GBq IV over 30 minutes once on day 1 |
− | ![[Levels_of_Evidence#Evidence|Evidence]] | + | **62.5 kg or less: 0.296 GBq/kg IV over 30 minutes once on day 1 |
+ | '''90-day cycle for up to 2 cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2 {{#subobject:f474b2|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1002/cncr.11518 Rose et al. 2003b] |
− | |style="background-color:#ffffbe"|Pilot, | + | |1991-2000 |
+ | |style="background-color:#ffffbe"|Pilot, fewer than 20 pts | ||
|- | |- | ||
|} | |} | ||
− | ''Patients underwent stem cell harvest prior to treatment in case autologous stem cell infusion was needed.'' | + | ''Note: Patients underwent stem cell harvest prior to treatment in case autologous stem cell infusion was needed.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Radiotherapy==== | ====Radiotherapy==== | ||
− | * | + | *[[Iobenguane I 131 (Azedra)]] 12 to 18 mCi/kg (maximum single dose of 850 mCi) IV over 2 hours once on day 1 |
− | + | ====Supportive therapy==== | |
− | ====Supportive | ||
*Intravenous fluids started 12 hours before 131I-MIBG administration. | *Intravenous fluids started 12 hours before 131I-MIBG administration. | ||
*Potassium iodide (KI) 6 mg/kg PO once at least 2 hours prior to 131I-MIBG, then potassium iodide (KI) 0.88 mg/kg PO Q4H x 7 days, then potassium iodide (KI) 1 mg/kg PO (frequency not specified) "for 45 days after the infusion." | *Potassium iodide (KI) 6 mg/kg PO once at least 2 hours prior to 131I-MIBG, then potassium iodide (KI) 0.88 mg/kg PO Q4H x 7 days, then potassium iodide (KI) 1 mg/kg PO (frequency not specified) "for 45 days after the infusion." | ||
− | *Potassium perchlorate 8 mg/kg once at least 2 hours prior to 131I-MIBG, then potassium perchlorate 2 mg/kg PO | + | *Potassium perchlorate 8 mg/kg once at least 2 hours prior to 131I-MIBG, then potassium perchlorate 2 mg/kg PO every 6 hours x 5 days. |
− | |||
'''"Repeat 131I-MIBG treatments were administered on a case-by-case basis in an effort to improve the overall response"''' | '''"Repeat 131I-MIBG treatments were administered on a case-by-case basis in an effort to improve the overall response"''' | ||
− | + | </div></div><br> | |
− | === | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | {| class="wikitable" style="width: | + | ===Regimen variant #3 {{#subobject:53e027|Variant=1}}=== |
− | !Study | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | ![[Levels_of_Evidence#Evidence|Evidence]] | + | !style="width: 33%"|Study |
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1210/jcem-72-2-455 Krempf et al. 1991] |
− | |style="background-color:#ffffbe"|Pilot, | + | |Not reported in abstract |
+ | |style="background-color:#ffffbe"|Pilot, fewer than 20 pts | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Radiotherapy==== | ====Radiotherapy==== | ||
− | *m-[131I]iodobenzylguanidine ([131I]MIBG) | + | *[[Iobenguane I 131 (Azedra)]] 740 megabequerel/mg every 3 months |
− | + | </div></div> | |
+ | ===References=== | ||
+ | # Krempf M, Lumbroso J, Mornex R, Brendel AJ, Wemeau JL, Delisle MJ, Aubert B, Carpentier P, Fleury-Goyon MC, Gibold C, Guyot M, Lahneche B, Marchandise X, Schlumberger M, Charbonnel B, Chatal JF. Use of m-[131I]iodobenzylguanidine in the treatment of malignant pheochromocytoma. J Clin Endocrinol Metab. 1991 Feb;72(2):455-61. [https://doi.org/10.1210/jcem-72-2-455 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/1991814/ PubMed] | ||
+ | # Rose B, Matthay KK, Price D, Huberty J, Klencke B, Norton JA, Fitzgerald PA. High-dose 131I-metaiodobenzylguanidine therapy for 12 patients with malignant pheochromocytoma. Cancer. 2003 Jul 15;98(2):239-48. [https://doi.org/10.1002/cncr.11518 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/12872341/ PubMed] | ||
+ | #'''MIP-IB12B:''' Pryma DA, Chin BB, Noto RB, Dillon JS, Perkins S, Solnes L, Kostakoglu L, Serafini AN, Pampaloni MH, Jensen J, Armor T, Lin T, White T, Stambler N, Apfel S, DiPippo VA, Mahmood S, Wong V, Jimenez C. Efficacy and Safety of High-Specific-Activity 131I-MIBG Therapy in Patients with Advanced Pheochromocytoma or Paraganglioma. J Nucl Med. 2019 May;60(5):623-630. Epub 2018 Oct 5. [https://doi.org/10.2967/jnumed.118.217463 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6495236/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30291194/ PubMed] [https://clinicaltrials.gov/study/NCT00874614 NCT00874614] | ||
+ | =Subsequent lines of therapy= | ||
+ | ==Sunitinib monotherapy {{#subobject:ec3261|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:38e8e3|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | ! style="width: 20%" |Study | ||
+ | ! style="width: 20%" |Dates of enrollment | ||
+ | ! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | ! style="width: 20%" |Comparator | ||
+ | ! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0140-6736(23)02554-0 Baudin et al. 2024 (FIRSTMAPPP)] | ||
+ | |2011-12-01 to 2019-01-31 | ||
+ | | style="background-color:#1a9851" |Randomized Phase 2 (E-esc) | ||
+ | |[[#Placebo|Placebo]] | ||
+ | | style="background-color:#1a9850" |Superior PFS12 (primary endpoint)<br>PFS12: 36% vs 19% | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Targeted therapy==== | ||
+ | *[[Sunitinib (Sutent)]] 37.5 mg PO once per day on days 1 to 28 | ||
+ | '''28-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | #'''FIRSTMAPPP:''' Baudin E, Goichot B, Berruti A, Hadoux J, Moalla S, Laboureau S, Nölting S, de la Fouchardière C, Kienitz T, Deutschbein T, Zovato S, Amar L, Haissaguerre M, Timmers H, Niccoli P, Faggiano A, Angokai M, Lamartina L, Luca F, Cosentini D, Hahner S, Beuschlein F, Attard M, Texier M, Fassnacht M; ENDOCAN-COMETE; ENSAT Networks. Sunitinib for metastatic progressive phaeochromocytomas and paragangliomas: results from FIRSTMAPPP, an academic, multicentre, international, randomised, placebo-controlled, double-blind, phase 2 trial. Lancet. 2024 Mar 16;403(10431):1061-1070. Epub 2024 Feb 22. [https://doi.org/10.1016/s0140-6736(23)02554-0 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/38402886/ PubMed] [https://clinicaltrials.gov/study/NCT01371201 NCT01371201] |
− | |||
[[Category:Pheochromocytoma regimens]] | [[Category:Pheochromocytoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Endocrine cancers]] | [[Category:Endocrine cancers]] |
Latest revision as of 23:34, 15 July 2024
Section editor | |
---|---|
Unfilled If you are interested in this role, please contact us at [email protected]. |
3 regimens on this page
5 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
ESMO-EURACAN
- 2020: Fassnacht et al. Adrenocortical carcinomas and malignant phaeochromocytomas: ESMO–EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
NANETS
- 2021: Fishbein et al. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Management of Metastatic and/or Unresectable Pheochromocytoma and Paraganglioma PubMed
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Neuroendocrine and Adrenal Tumors.
All lines of therapy
Cyclophosphamide, Dacarbazine, Vincristine
CVD: Cyclophosphamide, Vincristine, Dacarbazine
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Averbuch et al. 1988 | 1983-08 to 1985-12 | Pilot, fewer than 20 pts |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Dacarbazine (DTIC) 600 mg/m2 IV once per day on days 1 & 2
- Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
21-day cycles
References
- Averbuch SD, Steakley CS, Young RC, Gelmann EP, Goldstein DS, Stull R, Keiser HR. Malignant pheochromocytoma: effective treatment with a combination of cyclophosphamide, vincristine, and dacarbazine. Ann Intern Med. 1988 Aug 15;109(4):267-73. link to original article dosing details in abstract have been reviewed by our editors PubMed
Iobenguane I 131 monotherapy
Regimen variant #1
Study | Dates of enrollment | Evidence |
---|---|---|
Pryma et al. 2018 (MIP-IB12B) | 2009-06 to 2016-02 | Phase 2 (RT) |
Note: This was the study cited by the FDA in their approval.
Radiotherapy
- Iobenguane I 131 (Azedra) by the following weight-based criteria:
- More than 62.5 kg: 18.5 GBq IV over 30 minutes once on day 1
- 62.5 kg or less: 0.296 GBq/kg IV over 30 minutes once on day 1
90-day cycle for up to 2 cycles
Regimen variant #2
Study | Dates of enrollment | Evidence |
---|---|---|
Rose et al. 2003b | 1991-2000 | Pilot, fewer than 20 pts |
Note: Patients underwent stem cell harvest prior to treatment in case autologous stem cell infusion was needed.
Radiotherapy
- Iobenguane I 131 (Azedra) 12 to 18 mCi/kg (maximum single dose of 850 mCi) IV over 2 hours once on day 1
Supportive therapy
- Intravenous fluids started 12 hours before 131I-MIBG administration.
- Potassium iodide (KI) 6 mg/kg PO once at least 2 hours prior to 131I-MIBG, then potassium iodide (KI) 0.88 mg/kg PO Q4H x 7 days, then potassium iodide (KI) 1 mg/kg PO (frequency not specified) "for 45 days after the infusion."
- Potassium perchlorate 8 mg/kg once at least 2 hours prior to 131I-MIBG, then potassium perchlorate 2 mg/kg PO every 6 hours x 5 days.
"Repeat 131I-MIBG treatments were administered on a case-by-case basis in an effort to improve the overall response"
Regimen variant #3
Study | Dates of enrollment | Evidence |
---|---|---|
Krempf et al. 1991 | Not reported in abstract | Pilot, fewer than 20 pts |
Radiotherapy
- Iobenguane I 131 (Azedra) 740 megabequerel/mg every 3 months
References
- Krempf M, Lumbroso J, Mornex R, Brendel AJ, Wemeau JL, Delisle MJ, Aubert B, Carpentier P, Fleury-Goyon MC, Gibold C, Guyot M, Lahneche B, Marchandise X, Schlumberger M, Charbonnel B, Chatal JF. Use of m-[131I]iodobenzylguanidine in the treatment of malignant pheochromocytoma. J Clin Endocrinol Metab. 1991 Feb;72(2):455-61. link to original article dosing details in abstract have been reviewed by our editors PubMed
- Rose B, Matthay KK, Price D, Huberty J, Klencke B, Norton JA, Fitzgerald PA. High-dose 131I-metaiodobenzylguanidine therapy for 12 patients with malignant pheochromocytoma. Cancer. 2003 Jul 15;98(2):239-48. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- MIP-IB12B: Pryma DA, Chin BB, Noto RB, Dillon JS, Perkins S, Solnes L, Kostakoglu L, Serafini AN, Pampaloni MH, Jensen J, Armor T, Lin T, White T, Stambler N, Apfel S, DiPippo VA, Mahmood S, Wong V, Jimenez C. Efficacy and Safety of High-Specific-Activity 131I-MIBG Therapy in Patients with Advanced Pheochromocytoma or Paraganglioma. J Nucl Med. 2019 May;60(5):623-630. Epub 2018 Oct 5. link to original article link to PMC article PubMed NCT00874614
Subsequent lines of therapy
Sunitinib monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Baudin et al. 2024 (FIRSTMAPPP) | 2011-12-01 to 2019-01-31 | Randomized Phase 2 (E-esc) | Placebo | Superior PFS12 (primary endpoint) PFS12: 36% vs 19% |
References
- FIRSTMAPPP: Baudin E, Goichot B, Berruti A, Hadoux J, Moalla S, Laboureau S, Nölting S, de la Fouchardière C, Kienitz T, Deutschbein T, Zovato S, Amar L, Haissaguerre M, Timmers H, Niccoli P, Faggiano A, Angokai M, Lamartina L, Luca F, Cosentini D, Hahner S, Beuschlein F, Attard M, Texier M, Fassnacht M; ENDOCAN-COMETE; ENSAT Networks. Sunitinib for metastatic progressive phaeochromocytomas and paragangliomas: results from FIRSTMAPPP, an academic, multicentre, international, randomised, placebo-controlled, double-blind, phase 2 trial. Lancet. 2024 Mar 16;403(10431):1061-1070. Epub 2024 Feb 22. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT01371201