Difference between revisions of "Thymoma"

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'''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].'''
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Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].
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[[#top|Back to Top]]
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</div>
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{{#lst:Editorial board transclusions|thoracic}}
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{| class="wikitable" style="float:right; margin-right: 5px;"
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|-
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
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|}
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
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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.'''
 +
==[https://www.esmo.org/ ESMO]==
 +
*'''2015:''' Girard et al. [https://www.esmo.org/Guidelines/Lung-and-Chest-Tumours/Thymic-Epithelial-Tumours Thymic epithelial tumours: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/26314779 PubMed]
  
−
=First-line therapy=
+
==NCCN==
−
==ADOC==
+
*[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1469 NCCN Guidelines - Thymomas and Thymic Carcinomas]
−
ADOC: '''<u>A</u>'''driamycin, cis-'''<u>D</u>'''iamminedichloroplatinum, '''<u>O</u>'''ncovin, '''<u>C</u>'''yclophosphamide
 
−
===Regimen===
 
−
''Note: The body of Fornasiero, et al. 1991 specifies that cycles are given every 3 weeks.  However, the abstract says that cycles are given "at monthly intervals," and the NCCN, Thymomas and Thymic Carcinomas version 2.2012, lists the regimen as being given every 4 weeks.''
 
−
*[[Doxorubicin (Adriamycin)]] 40 mg/m2 IV on day 1
 
−
*[[Cisplatin (Platinol)]] 50 mg/m2 IV on day 1
 
−
*[[Vincristine (Oncovin)]] 0.6 mg/m2 IV on day 3
 
−
*[[Cyclophosphamide (Cytoxan)]] 700 mg/m2 IV on day 4
 
−
 
 
−
'''21 to 28-day cycles'''--see note above regarding duration of cycles
 
  
 +
=Neoadjuvant therapy for borderline resectable disease=
 +
==PAC-P {{#subobject:96fd1b|Regimen=1}}==
 +
PAC: '''<u>P</u>'''latinol (Cisplatin), '''<u>A</u>'''driamycin (Doxorubicin), '''<u>C</u>'''yclophosphamide<br>
 +
CAP: '''<u>C</u>'''yclophosphamide, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>P</u>'''latinol (Cisplatin)
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:dcf948|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://doi.org/10.1016/j.lungcan.2003.12.010 Kim et al. 2004]
 +
|1990-02 to 2000-04
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
''Note: while this regimen is conventionally referred to as PAC or CAP, it also includes a high-dose prednisone component with likely antineoplastic properties, and has been renamed PAC-P here.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 30 mg/m<sup>2</sup> IV once per day on days 1 to 3
 +
*[[Doxorubicin (Adriamycin)]] 20 mg/m<sup>2</sup>/day IV continuous infusion over 72 hours, started on day 1 (total dose per cycle: 60 mg/m<sup>2</sup>)
 +
*[[Cyclophosphamide (Cytoxan)]] 500 mg/m<sup>2</sup> IV slow push once on day 1
 +
====Glucocorticoid therapy====
 +
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5
 +
====Supportive therapy====
 +
*[[Metoclopramide (Reglan)]] 1 mg/kg IV once per day on days 1 to 3, prior to chemotherapy
 +
*[[Diphenhydramine (Benadryl)]] 25 mg IV once per day on days 1 to 3, prior to chemotherapy
 +
'''21- to 28-day cycle for 3 cycles'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*[[Surgery#Thymectomy|Surgical resection]] is performed if CT scan 3 to 4 weeks after the third cycle of chemotherapy shows disease amenable to resection, and is followed by adjuvant [[#Radiation_therapy|RT]], then [[#PAC-P_2|PAC]] consolidation
 +
</div></div>
 +
===References===
 +
# Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. [https://doi.org/10.1016/j.lungcan.2003.12.010 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/15140551/ PubMed]
 +
=Adjuvant therapy=
 +
==PAC-P {{#subobject:76239f|Regimen=1}}==
 +
PAC: '''<u>P</u>'''latinol (Cisplatin), '''<u>A</u>'''driamycin (Doxorubicin), '''<u>C</u>'''yclophosphamide<br>
 +
CAP: '''<u>C</u>'''yclophosphamide, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>P</u>'''latinol (Cisplatin)
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:adbf18|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://doi.org/10.1016/j.lungcan.2003.12.010 Kim et al. 2004]
 +
|1990-02 to 2000-04
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
''Note: while this regimen is conventionally referred to as PAC or CAP, it also includes a high-dose prednisone component with likely antineoplastic properties, and has been renamed PAC-P, here. Also note that these doses are 80% of the induction doses, except for the prednisone.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*Definitive [[#Radiation_therapy|RT]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 24 mg/m<sup>2</sup> IV once per day on days 1 to 3
 +
*[[Doxorubicin (Adriamycin)]] 16 mg/m<sup>2</sup>/day IV continuous infusion over 72 hours, started on day 1 (total dose per cycle: 48 mg/m<sup>2</sup>)
 +
*[[Cyclophosphamide (Cytoxan)]] 400 mg/m<sup>2</sup> IV slow push once on day 1
 +
====Glucocorticoid therapy====
 +
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5
 +
'''21- to 28-day cycle for 3 cycles'''
 +
</div></div>
 +
===References===
 +
# Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. [https://doi.org/10.1016/j.lungcan.2003.12.010 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/15140551/ PubMed]
 +
==Radiation therapy {{#subobject:afc56b|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:07cb87|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://doi.org/10.1016/j.lungcan.2003.12.010 Kim et al. 2004]
 +
|1990-02 to 2000-04
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*[[#PAC-P|PAC-P]] induction, then [[Surgery#Thymectomy|surgery]] (in some cases)
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Radiotherapy====
 +
*[[External beam radiotherapy]] by the following response-based criteria:
 +
*If tumor is completely resected and has at least 80% necrosis: 5000 cGy is administered 3 to 6 weeks after surgery
 +
*If tumor is incompletely resected or has less than 80% necrosis: 6000 cGy is administered
 +
'''One course'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*Adjuvant [[#PAC-P_2|PAC-P]] x 3
 +
</div></div>
 +
===References===
 +
# Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. [https://doi.org/10.1016/j.lungcan.2003.12.010 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/15140551/ PubMed]
 +
=Advanced or metastatic disease, first-line therapy=
 +
==ADOC {{#subobject:a329b4|Regimen=1}}==
 +
ADOC: '''<u>A</u>'''driamycin (Doxorubicin), cis-'''<u>D</u>'''iamminedichloroplatinum (Cisplatin), '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:ee5c1b|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://doi.org/10.1002/1097-0142%2819910701)68:1%3C30::AID-CNCR2820680106%3E3.0.CO;2-4 Fornasiero et al. 1991]
 +
|1977-1990
 +
|style="background-color:#ffffbe"|Retrospective
 +
|-
 +
|}
 +
''Note: The body of Fornasiero et al. 1991 specifies that cycles are given every 3 weeks. However, the abstract says that cycles are given "at monthly intervals," and some guidelines list the regimen as being given every 4 weeks.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Doxorubicin (Adriamycin)]] 40 mg/m<sup>2</sup> IV once on day 1
 +
*[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV once on day 1
 +
*[[Vincristine (Oncovin)]] 0.6 mg/m<sup>2</sup> IV once on day 3
 +
*[[Cyclophosphamide (Cytoxan)]] 700 mg/m<sup>2</sup> IV once on day 4
 +
'''21- to 28-day cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Fornasiero A, Daniele O, Ghiotto C, Piazza M, Fiore-Donati L, Calabró F, Rea F, Fiorentino MV. Chemotherapy for invasive thymoma. A 13-year experience. Cancer. 1991 Jul 1;68(1):30-3. [http://onlinelibrary.wiley.com/doi/10.1002/1097-0142%2819910701%2968:1%3C30::AID-CNCR2820680106%3E3.0.CO;2-4/abstract link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/2049749 PubMed]
+
# '''Retrospective:''' Fornasiero A, Daniele O, Ghiotto C, Piazza M, Fiore-Donati L, Calabró F, Rea F, Fiorentino MV. Chemotherapy for invasive thymoma: A 13-year experience. Cancer. 1991 Jul 1;68(1):30-3. [https://doi.org/10.1002/1097-0142%2819910701)68:1%3C30::AID-CNCR2820680106%3E3.0.CO;2-4 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/2049749/ PubMed]
−
 
 
−
==Carboplatin (Paraplatin) & Paclitaxel (Taxol)==
 
−
===Regimen===
 
−
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 30 minutes on day 1, given second
 
−
*[[Paclitaxel (Taxol)]] 225 mg/m2 IV over 3 hours on day 1, given first
 
−
 
 
−
'''21-day cycles x up to 6 cycles'''
 
−
 
 
−
Supportive medications:
 
−
*Cimetidine (Tagamet) 300 mg IV 1 hour prior to paclitaxel
 
−
*Diphenhydramine (Benadryl) 25 mg IV 1 hour prior to paclitaxel
 
−
*[[Dexamethasone (Decadron)]] 20 mg IV 1 hour prior to paclitaxel
 
  
 +
==Carboplatin & Paclitaxel (CP) {{#subobject:410ff6|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:34b20a|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/PMC3107762/ Lemma et al. 2011]
 +
|2001-02 to 2008-01
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 30 minutes once on day 1, '''given second'''
 +
*[[Paclitaxel (Taxol)]] 225 mg/m<sup>2</sup> IV over 3 hours once on day 1, '''given first'''
 +
====Supportive therapy====
 +
*[[Cimetidine (Tagamet)]] 300 mg IV once on day 1; 60 minutes prior to paclitaxel
 +
*[[Diphenhydramine (Benadryl)]] 25 mg IV once on day 1; 60 minutes prior to paclitaxel
 +
*[[Dexamethasone (Decadron)]] 20 mg IV once on day 1; 60 minutes prior to paclitaxel
 +
'''21-day cycle for up to 6 cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Lemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. Epub 2011 Apr 18. [http://jco.ascopubs.org/content/29/15/2060.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21502559 PubMed]
+
# Lemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. Epub 2011 Apr 18. [https://doi.org/10.1200/jco.2010.32.9607 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107762/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21502559/ PubMed]
−
 
+
==CISCA {{#subobject:ce7f87|Regimen=1}}==
−
==PAC (CAP)==
+
CISCA: '''<u>CIS</u>'''platin, '''<u>C</u>'''yclophosphamide, '''<u>A</u>'''driamycin (Doxorubicin)
−
PAC: '''<u>P</u>'''latinol, '''<u>A</u>'''driamycin, '''<u>C</u>'''yclophosphamide<br>
+
<br>PAC: '''<u>P</u>'''latinol (Cisplatin), '''<u>A</u>'''driamycin (Doxorubicin), '''<u>C</u>'''yclophosphamide
−
CAP: '''<u>C</u>'''yclophosphamide, '''<u>A</u>'''driamycin, '''<u>P</u>'''latinol
+
<br>CAP: '''<u>C</u>'''yclophosphamide, '''<u>A</u>'''driamycin (Doxorubicin), '''<u>P</u>'''latinol (Cisplatin)
−
===Regimen===
+
<div class="toccolours" style="background-color:#eeeeee">
−
*[[Cisplatin (Platinol)]] 50 mg/m2 IV over at least 1 hour on day 1
+
===Regimen {{#subobject:f15804|Variant=1}}===
−
*[[Doxorubicin (Adriamycin)]] 50 mg/m2 IV by slow injection on day 1
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"
−
*[[Cyclophosphamide (Cytoxan)]] 500 mg/m2 IV by slow injection or infusion on day 1
+
!style="width: 33%"|Study
−
 
+
!style="width: 33%"|Dates of enrollment
−
'''21-day cycles x up to 8 cycles'''
+
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
 
+
|-
−
Supportive medications:
+
|[https://doi.org/10.7326/0003-4819-113-7-520 Loehrer et al. 1990]
−
*1 liter normal saline over 2 hours at least 2 hours before and after cisplatin therapy
+
|Not reported in abstract
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV over at least 1 hour once on day 1
 +
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV slow push once on day 1
 +
*[[Cyclophosphamide (Cytoxan)]] 500 mg/m<sup>2</sup> IV slow push once on day 1
 +
====Supportive therapy====
 +
*1 liter [[Normal saline|NS]] over 2 hours at least 2 hours before and after cisplatin therapy
 
*Corticosteroids use for antiemesis was specifically discouraged unless the indication was for myasthenia gravis
 
*Corticosteroids use for antiemesis was specifically discouraged unless the indication was for myasthenia gravis
−
 
+
'''21-day cycle for up to 8 cycles'''
 +
</div></div>
 +
===References===
 +
# Loehrer PJ Sr, Perez CA, Roth LM, Greco A, Livingston RB, Einhorn LH. Chemotherapy for advanced thymoma: preliminary results of an intergroup study. Ann Intern Med. 1990 Oct 1;113(7):520-4. [https://doi.org/10.7326/0003-4819-113-7-520 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/2203292/ PubMed]
 +
## '''Update:''' Loehrer PJ Sr, Kim K, Aisner SC, Livingston R, Einhorn LH, Johnson D, Blum R; Eastern Cooperative Oncology Group; Southwest Oncology Group; Southeastern Cancer Study Group. Cisplatin plus doxorubicin plus cyclophosphamide in metastatic or recurrent thymoma: final results of an intergroup trial. J Clin Oncol. 1994 Jun;12(6):1164-8. [https://doi.org/10.1200/jco.1994.12.6.1164 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8201378/ PubMed]
 +
==Cisplatin & Etoposide (EP) {{#subobject:2355da|Regimen=1}}==
 +
PE: '''<u>P</u>'''latinol (Cisplatin), '''<u>E</u>'''toposide
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:906dfc|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://doi.org/10.1200/jco.1996.14.3.814 Giaccone et al. 1996]
 +
|1985-09 to 1991-08
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV over 60 minutes once on day 1
 +
*[[Etoposide (Vepesid)]] 120 mg/m<sup>2</sup> IV over at least 30 minutes once per day on days 1 to 3
 +
====Supportive therapy====
 +
*"A program of forced hydration"
 +
'''21-day cycle for up to 8 cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Loehrer PJ Sr, Kim K, Aisner SC, Livingston R, Einhorn LH, Johnson D, Blum R. Cisplatin plus doxorubicin plus cyclophosphamide in metastatic or recurrent thymoma: final results of an intergroup trial. The Eastern Cooperative Oncology Group, Southwest Oncology Group, and Southeastern Cancer Study Group. J Clin Oncol. 1994 Jun;12(6):1164-8. [http://jco.ascopubs.org/content/12/6/1164.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/8201378 PubMed]
+
# Giaccone G, Ardizzoni A, Kirkpatrick A, Clerico M, Sahmoud T, van Zandwijk N; [[Study_Groups#EORTC|EORTC]] Lung Cancer Cooperative Group. Cisplatin and etoposide combination chemotherapy for locally advanced or metastatic thymoma: a phase II study of the European Organisation for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 1996 Mar;14(3):814-20. [https://doi.org/10.1200/jco.1996.14.3.814 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8622029/ PubMed]
−
 
+
==VIP {{#subobject:e1d675|Regimen=1}}==
−
==PAC, Prednisone (Sterapred), surgery, RT, chemo==
+
VIP: '''<u>V</u>'''epesid (Etoposide), '''<u>I</u>'''fosfamide, '''<u>P</u>'''latinol (Cisplatin)
−
PAC: '''<u>P</u>'''latinol, '''<u>A</u>'''driamycin, '''<u>C</u>'''yclophosphamide
+
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen===
+
===Regimen {{#subobject:2235f2|Variant=1}}===
−
''Note: The NCCN, Thymomas and Thymic Carcinomas version 2.2012, lists only the induction phase of this regimen under its first-line options. No primary reference could be found for treatment with only the induction phase of therapy.''<br>
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"
−
Induction phase:
+
!style="width: 33%"|Study
−
*[[Cisplatin (Platinol)]] 30 mg/m2 IV on days 1-3
+
!style="width: 33%"|Dates of enrollment
−
*[[Doxorubicin (Adriamycin)]] 20 mg/m2/day (60 mg/m2 total dose) IV continuous infusion on days 1-3
+
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
*[[Cyclophosphamide (Cytoxan)]] 500 mg/m2 IV by slow injection or infusion on day 1
+
|-
−
*[[Prednisone (Sterapred)]] 100 mg PO on days 1-5
+
|[https://doi.org/10.1002/1097-0142%2820010601%2991:11%3C2010::AID-CNCR1226%3E3.0.CO;2-2 Loehrer et al. 2001]
−
 
+
|1995-07 to 1997-02
−
'''21 to 28-day cycles x 3 cycles'''
+
|style="background-color:#91cf61"|Phase 2
−
 
+
|-
−
Supportive medications:
+
|}
−
*Metoclopramide (Reglan) 1 mg/kg IV prior to chemotherapy
+
<div class="toccolours" style="background-color:#b3e2cd">
−
*Diphenhydramine (Benadryl) 25 mg IV prior to chemotherapy
+
====Chemotherapy====
−
 
+
*[[Etoposide (Vepesid)]] 75 mg/m<sup>2</sup> IV once per day on days 1 to 4
−
*Surgical resection is performed if CT scan 3-4 weeks after the third cycle of chemotherapy shows disease amenable resection
+
*[[Ifosfamide (Ifex)]] 1200 mg/m<sup>2</sup> IV once per day on days 1 to 4
−
*If tumor is completely resected and has at least 80% necrosis, 50 Gy radiation therapy is  administered 3-6 weeks after surgery
+
*[[Cisplatin (Platinol)]] 20 mg/m<sup>2</sup> IV once per day on days 1 to 4
−
**If tumor is incompletely resected or has <80% necrosis, 60 Gy radiation therapy is administered
+
====Supportive therapy====
−
 
+
*[[Mesna (Mesnex)]] 240 mg/m<sup>2</sup> IV push two times per day on days 1 to 4, given 4 hours after and 8 hours after ifosfamide (total dose per cycle: 1920 mg/m<sup>2</sup>)
−
Consolidation phase (at 80% of the induction doses of cisplatin, doxorubicin, and cyclophosphamide; 100% dose of prednisone):
+
*1 liter normal saline once per day on days 1 to 4, prior to cisplatin
−
*[[Cisplatin (Platinol)]] 24 mg/m2 IV on days 1-3
+
*[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day on days 5 to 15, until WBC count at least 10 x 10<sup>9</sup>/L above nadir
−
*[[Doxorubicin (Adriamycin)]] 16 mg/m2/day (48 mg/m2 total dose) IV continuous infusion on days 1-3
+
'''21-day cycle for 4 cycles'''
−
*[[Cyclophosphamide (Cytoxan)]] 400 mg/m2 IV by slow injection or infusion on day 1
+
</div></div>
−
*[[Prednisone (Sterapred)]] 100 mg PO on days 1-5
 
−
 
 
−
'''21 to 28-day cycles x 3 cycles'''
 
−
 
 
 
===References===
 
===References===
−
# Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. [http://www.lungcancerjournal.info/article/S0169-5002%2803%2900626-3/abstract link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15140551 PubMed]
+
# Loehrer PJ Sr, Jiroutek M, Aisner S, Aisner J, Green M, Thomas CR Jr, Livingston R, Johnson DH. Combined etoposide, ifosfamide, and cisplatin in the treatment of patients with advanced thymoma and thymic carcinoma: an intergroup trial. Cancer. 2001 Jun 1;91(11):2010-5. [https://doi.org/10.1002/1097-0142%2820010601%2991:11%3C2010::AID-CNCR1226%3E3.0.CO;2-2 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/11391579/ PubMed]
−
 
+
=Advanced or metastatic disease, subsequent lines of therapy=
−
==PE==
+
==Capecitabine & Gemcitabine {{#subobject:cabb5e|Regimen=1}}==
−
PE: '''<u>P</u>'''latinol, '''<u>E</u>'''toposide
+
CAP-GEM: '''<u>CAP</u>'''ecitabine & '''<u>GEM</u>'''citabine
−
===Regimen===
+
<div class="toccolours" style="background-color:#eeeeee">
−
*[[Cisplatin (Platinol)]] 60 mg/m2 IV over 1 hour on day 1
+
===Regimen {{#subobject:335173|Variant=1}}===
−
*[[Etoposide (Vepesid)]] 120 mg/m2 IV over at least 30 minutes on days 1-3
+
{| class="wikitable sortable" style="width: 80%; text-align:center;"
−
 
+
!style="width: 25%"|Study
−
'''21-day cycles x up to 8 cycles'''
+
!style="width: 25%"|Dates of enrollment
−
 
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
Supportive medications:
+
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
−
*"A program of forced hydration"
+
|-
−
 
+
|[https://doi.org/10.1093/annonc/mdp483 Palmieri et al. 2009]
 +
|2005-11 to 2008-08
 +
|style="background-color:#91cf61"|Phase 2
 +
|ORR: 40%
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Capecitabine (Xeloda)]] 650 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 +
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8
 +
'''21-day cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Giaccone G, Ardizzoni A, Kirkpatrick A, Clerico M, Sahmoud T, van Zandwijk N. Cisplatin and etoposide combination chemotherapy for locally advanced or metastatic thymoma. A phase II study of the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 1996 Mar;14(3):814-20. [http://jco.ascopubs.org/content/14/3/814.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/8622029 PubMed]
+
# Palmieri G, Merola G, Federico P, Petillo L, Marino M, Lalle M, Milella M, Ceribelli A, Montella L, Merola C, Del Prete S, Bergaglio M, De Placido S, Di Lorenzo G. Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs). Ann Oncol. 2010 Jun;21(6):1168-72. Epub 2009 Oct 30. [https://doi.org/10.1093/annonc/mdp483 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19880439/ PubMed]
−
 
+
## '''Update:''' Palmieri G, Buonerba C, Ottaviano M, Federico P, Calabrese F, Von Arx C, De Maio AP, Marino M, Lalle M, Montella L, Merola C, Milella M, Bergaglio M, Di Lorenzo G, Damiano V. Capecitabine plus gemcitabine in thymic epithelial tumors: final analysis of a Phase II trial. Future Oncol. 2014 Nov;10(14):2141-7. [https://doi.org/10.2217/fon.14.144 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/25471029/ PubMed]
−
==VIP==
+
==Everolimus monotherapy {{#subobject:e7a59f|Regimen=1}}==
−
VIP: '''<u>V</u>'''epesid, '''<u>I</u>'''fosfamide, '''<u>P</u>'''latinol
+
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen===
+
===Regimen {{#subobject:82c282|Variant=1}}===
−
*[[Etoposide (Vepesid)]] 75 mg/m2 IV on days 1-4
+
{| class="wikitable sortable" style="width: 80%; text-align:center;"
−
*[[Ifosfamide (Ifex)]] 1200 mg/m2 IV on days 1-4
+
!style="width: 25%"|Study
−
*[[Mesna (Mesnex)]] 240 mg/m2 IV push before, 4 hours after, and 8 hours after ifosfamide on days 1-4
+
!style="width: 25%"|Dates of enrollment
−
*[[Cisplatin (Platinol)]] 20 mg/m2 IV on days 1-4
+
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
 
+
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
−
'''21-day cycles x 4 cycles'''
+
|-
−
 
+
|[https://doi.org/10.1200/JCO.2017.74.4078 Zucali et al. 2017 (ONC-2010-001)]
−
Supportive medications:
+
|2011-02-17 to 2013-10-21
−
*1 liter normal saline prior to cisplatin
+
|style="background-color:#91cf61"|Phase 2
−
*[[Filgrastim (Neupogen)]] 5 mcg/kg SC on days 5-15, until WBC at least 10,000 postnadir
+
|DCR: 88%
−
 
+
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Everolimus (Afinitor)]] 10 mg PO once per day
 +
'''Continued indefinitely'''
 +
</div></div>
 
===References===
 
===References===
−
# Loehrer PJ Sr, Jiroutek M, Aisner S, Aisner J, Green M, Thomas CR Jr, Livingston R, Johnson DH. Combined etoposide, ifosfamide, and cisplatin in the treatment of patients with advanced thymoma and thymic carcinoma: an intergroup trial. Cancer. 2001 Jun 1;91(11):2010-5. [http://onlinelibrary.wiley.com/doi/10.1002/1097-0142%2820010601%2991:11%3C2010::AID-CNCR1226%3E3.0.CO;2-2/full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/11391579 PubMed]
+
<!--
−
 
+
# '''Abstract:''' Paolo A. Zucali, Tommaso Martino De Pas, Giovannella Palmieri, Adolfo G. Favaretto, Antonio Chella, Marcello Tiseo, Michele Caruso, Matteo Perrino... Fabio De Vincenzo, Matteo Simonelli, Francesca Toffalorio, Piera Federico, Giulia Pasello, Marco Ali, Laura Giordano, Monica Bertossi, Armando Santoro. Phase II study of everolimus in patients with thymoma and thymic carcinoma previously treated with cisplatin-based chemotherapy. Journal of Clinical Oncology 32, no. 15_suppl (May 2014) 7527-7527. [https://doi.org/10.1200/jco.2014.32.15_suppl.7527 link to abstract] -->
−
=Second-line therapy=
+
# '''ONC-2010-001:''' Zucali PA, De Pas T, Palmieri G, Favaretto A, Chella A, Tiseo M, Caruso M, Simonelli M, Perrino M, De Vincenzo F, Toffalorio F, Damiano V, Pasello G, Garbella E, Ali M, Conforti F, Ottaviano M, Cioffi A, De Placido S, Giordano L, Bertossi M, Destro A, Di Tommaso L, Santoro A. Phase II study of everolimus in patients with thymoma and thymic carcinoma previously treated with cisplatin-based chemotherapy. J Clin Oncol. 2018 Feb 1;36(4):342-349. Epub 2017 Dec 14.[https://doi.org/10.1200/JCO.2017.74.4078 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/29240542/ PubMed]
−
==Ifosfamide (Ifex)==
+
==Ifosfamide monotherapy {{#subobject:69edc9|Regimen=1}}==
−
===Regimen #1, Highley, et al. 1999===
+
<div class="toccolours" style="background-color:#eeeeee">
−
*[[Ifosfamide (Ifex)]] 1500 mg/m2 IV over 30 minutes on days 1-5
+
===Regimen variant #1, intermittent dosing {{#subobject:d0877e|Variant=1}}===
−
*[[Mesna (Mesnex)]] 400 mg IV bolus before ifosfamide, then Mesna (Mesnex) 1000 mg/m2 in 1 liter NS IV over 7.5 hours after ifosfamide on days 1-5
+
{| 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://doi.org/10.1200/jco.1999.17.9.2737 Highley et al. 1999]
 +
|1984-07 to 1996-07
 +
|style="background-color:#ffffbe"|Pilot, fewer than 20 pts
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Ifosfamide (Ifex)]] 1500 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5
 +
====Supportive therapy====
 +
*[[Mesna (Mesnex)]] 400 mg IV bolus once per day on days 1 to 5, '''given before ifosfamide''', then 1000 mg/m<sup>2</sup> IV over 7.5 hours (total dose per cycle: 7000 mg/m<sup>2</sup>)
 
'''21-day cycles'''
 
'''21-day cycles'''
−
 
+
</div></div><br>
−
===Regimen #2, Highley, et al. 1999===
+
<div class="toccolours" style="background-color:#eeeeee">
−
*[[Mesna (Mesnex)]] 2000 mg IV bolus on day 1, given first
+
===Regimen variant #2, continuous dosing {{#subobject:1d5654|Variant=1}}===
−
*A 3 liter solution of D5NS containing the following is then given IV continuous 24-hour infusion on days 1-5
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"
−
**[[Ifosfamide (Ifex)]] 1500 mg/m2/day IV continuous 24-hour infusion on days 1-5
+
!style="width: 33%"|Study
−
**[[Mesna (Mesnex)]] 1500 mg/m2/day IV continuous 24-hour infusion on days 1-5
+
!style="width: 33%"|Dates of enrollment
−
*[[Mesna (Mesnex)]] 1500 mg/m2/day in 3 liters of D5NS IV continuous 24-hour infusion on days 6-8
+
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
 
+
|-
 +
|[https://doi.org/10.1200/jco.1999.17.9.2737 Highley et al. 1999]
 +
|1984-07 to 1996-07
 +
|style="background-color:#ffffbe"|Pilot, fewer than 20 pts
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Ifosfamide (Ifex)]] 1500 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1, '''given second''' (total dose per cycle: 6000 mg/m<sup>2</sup>)
 +
====Supportive therapy====
 +
*[[Mesna (Mesnex)]] 2000 mg IV bolus once on day 1, '''given first''', then 1500 mg/m<sup>2</sup>/day IV continuous infusion over 7 days (total dose per cycle: 12,500 mg/m<sup>2</sup>)
 
'''21-day cycles'''
 
'''21-day cycles'''
−
 
+
</div></div>
 +
===References===
 +
# Highley MS, Underhill CR, Parnis FX, Karapetis C, Rankin E, Dussek J, Bryant B, Rowland C, Hodson N, Hughes J, Harper PG. Treatment of invasive thymoma with single-agent ifosfamide. J Clin Oncol. 1999 Sep;17(9):2737-44. [https://doi.org/10.1200/jco.1999.17.9.2737 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/10561348/ PubMed] content property of [https://hemonc.org HemOnc.org]
 +
==Octreotide monotherapy {{#subobject:109390|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, brief course {{#subobject:d7858d|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://doi.org/10.1200/jco.2004.02.047 Loehrer et al. 2004]
 +
|1998-04 to 2000-11
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Endocrine therapy====
 +
*[[Octreotide (Sandostatin)]] 0.5 mg SC three times per day
 +
'''1-month cycle for 2 cycles'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*Loehrer et al. 2004, stable disease: [[#Octreotide_.26_Prednisone|octreotide & prednisone]]
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #2, extended course {{#subobject:2fffe4|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://doi.org/10.1200/jco.2004.02.047 Loehrer et al. 2004]
 +
|1998-04 to 2000-11
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Endocrine therapy====
 +
*[[Octreotide (Sandostatin)]] 0.5 mg SC three times per day
 +
'''1-month cycle for up to 12 cycles'''
 +
</div></div>
 +
===References===
 +
# Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. [https://doi.org/10.1200/jco.2004.02.047 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/14722038/ PubMed]
 +
==Octreotide & Prednisone {{#subobject:5a36da|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:860b16|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://doi.org/10.1200/jco.2004.02.047 Loehrer et al. 2004]
 +
|1998-04 to 2000-11
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*[[#Octreotide_monotherapy|Octreotide]] x 2 mo
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Endocrine therapy====
 +
*[[Octreotide (Sandostatin)]] 0.5 mg SC three times per day
 +
*[[Prednisone (Sterapred)]] 0.6 mg/kg PO once per day
 +
'''1-month cycle for up to 10 cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Highley MS, Underhill CR, Parnis FX, Karapetis C, Rankin E, Dussek J, Bryant B, Rowland C, Hodson N, Hughes J, Harper PG. Treatment of invasive thymoma with single-agent ifosfamide. J Clin Oncol. 1999 Sep;17(9):2737-44. [http://jco.ascopubs.org/content/17/9/2737.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/10561348 PubMed] content property of HemOnc.org
+
# Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. [https://doi.org/10.1200/jco.2004.02.047 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/14722038/ PubMed]
−
 
+
==Sunitinib monotherapy {{#subobject:b3730c|Regimen=1}}==
−
==Octreotide (Sandostatin)==
+
<div class="toccolours" style="background-color:#eeeeee">
−
===Regimen===
+
===Regimen {{#subobject:1d254c|Variant=1}}===
−
*[[Octreotide (Sandostatin)]] 0.5 mg SC TID
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"
−
 
+
!style="width: 33%"|Study
−
'''1-month cycles x up to 12 cycles'''
+
!style="width: 33%"|Dates of enrollment
−
 
+
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4401497/ Thomas et al. 2015 (NCI 12-C-0118)]
 +
|2012-05-15 to 2013-10-02
 +
|style="background-color:#91cf61"|Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Sunitinib (Sutent)]] 50 mg PO once per day on days 1 to 28
 +
'''42-day cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group Phase II Trial. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. [http://jco.ascopubs.org/content/22/2/293.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/14722038 PubMed]
+
# '''NCI 12-C-0118:''' Thomas A, Rajan A, Berman A, Tomita Y, Brzezniak C, Lee MJ, Lee S, Ling A, Spittler AJ, Carter CA, Guha U, Wang Y, Szabo E, Meltzer P, Steinberg SM, Trepel JB, Loehrer PJ, Giaccone G. Sunitinib in patients with chemotherapy-refractory thymoma and thymic carcinoma: an open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):177-86. Epub 2015 Jan 13. Erratum in: Lancet Oncol. 2015 Mar;16(3):e105. [https://doi.org/10.1016/s1470-2045(14)71181-7 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4401497/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25592632/ PubMed] [https://clinicaltrials.gov/study/NCT01621568 NCT01621568]
  
−
==Octreotide (Sandostatin) & Prednisone (Sterapred)==
+
[[Category:Thymoma regimens]]
−
===Regimen===
+
[[Category:Disease-specific pages]]
−
*[[Octreotide (Sandostatin)]] 0.5 mg SC TID
+
[[Category:Thoracic cancers]]
−
 
 
−
'''1-month cycles x 2 cycles'''
 
−
 
 
−
If stable disease after 2 cycles, patients would then receive:
 
−
*[[Octreotide (Sandostatin)]] 0.5 mg SC TID
 
−
*[[Prednisone (Sterapred)]] 0.6 mg/kg PO daily
 
−
 
 
−
'''1-month cycles x up to 10 additional cycles'''
 
−
 
 
−
===References===
 
−
# Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group Phase II Trial. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. [http://jco.ascopubs.org/content/22/2/293.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/14722038 PubMed]
 

Latest revision as of 23:41, 15 July 2024

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Section editor
Amit Kulkarni.jpg
 Amit Kulkarni, MBBS
University of Minnesota
Minneapolis, MN, USA
LinkedIn
14 regimens on this page
16 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

NCCN

Neoadjuvant therapy for borderline resectable disease

PAC-P

PAC: Platinol (Cisplatin), Adriamycin (Doxorubicin), Cyclophosphamide
CAP: Cyclophosphamide, Adriamycin (Doxorubicin), Platinol (Cisplatin)

Regimen

Study Dates of enrollment Evidence
Kim et al. 2004 1990-02 to 2000-04 Phase 2

Note: while this regimen is conventionally referred to as PAC or CAP, it also includes a high-dose prednisone component with likely antineoplastic properties, and has been renamed PAC-P here.

Chemotherapy

Glucocorticoid therapy

Supportive therapy

21- to 28-day cycle for 3 cycles

Subsequent treatment

  • Surgical resection is performed if CT scan 3 to 4 weeks after the third cycle of chemotherapy shows disease amenable to resection, and is followed by adjuvant RT, then PAC consolidation

References

  1. Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Adjuvant therapy

PAC-P

PAC: Platinol (Cisplatin), Adriamycin (Doxorubicin), Cyclophosphamide
CAP: Cyclophosphamide, Adriamycin (Doxorubicin), Platinol (Cisplatin)

Regimen

Study Dates of enrollment Evidence
Kim et al. 2004 1990-02 to 2000-04 Phase 2

Note: while this regimen is conventionally referred to as PAC or CAP, it also includes a high-dose prednisone component with likely antineoplastic properties, and has been renamed PAC-P, here. Also note that these doses are 80% of the induction doses, except for the prednisone.

Preceding treatment

  • Definitive RT

Chemotherapy

Glucocorticoid therapy

21- to 28-day cycle for 3 cycles

References

  1. Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Radiation therapy

Regimen

Study Dates of enrollment Evidence
Kim et al. 2004 1990-02 to 2000-04 Phase 2

Preceding treatment

Radiotherapy

  • External beam radiotherapy by the following response-based criteria:
  • If tumor is completely resected and has at least 80% necrosis: 5000 cGy is administered 3 to 6 weeks after surgery
  • If tumor is incompletely resected or has less than 80% necrosis: 6000 cGy is administered

One course

Subsequent treatment

References

  1. Kim ES, Putnam JB, Komaki R, Walsh GL, Ro JY, Shin HJ, Truong M, Moon H, Swisher SG, Fossella FV, Khuri FR, Hong WK, Shin DM. Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report. Lung Cancer. 2004 Jun;44(3):369-79. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Advanced or metastatic disease, first-line therapy

ADOC

ADOC: Adriamycin (Doxorubicin), cis-Diamminedichloroplatinum (Cisplatin), Oncovin (Vincristine), Cyclophosphamide

Regimen

Study Dates of enrollment Evidence
Fornasiero et al. 1991 1977-1990 Retrospective

Note: The body of Fornasiero et al. 1991 specifies that cycles are given every 3 weeks. However, the abstract says that cycles are given "at monthly intervals," and some guidelines list the regimen as being given every 4 weeks.

Chemotherapy

21- to 28-day cycles

References

  1. Retrospective: Fornasiero A, Daniele O, Ghiotto C, Piazza M, Fiore-Donati L, Calabró F, Rea F, Fiorentino MV. Chemotherapy for invasive thymoma: A 13-year experience. Cancer. 1991 Jul 1;68(1):30-3. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Carboplatin & Paclitaxel (CP)

Regimen

Study Dates of enrollment Evidence
Lemma et al. 2011 2001-02 to 2008-01 Phase 2

Chemotherapy

Supportive therapy

21-day cycle for up to 6 cycles

References

  1. Lemma GL, Lee JW, Aisner SC, Langer CJ, Tester WJ, Johnson DH, Loehrer PJ Sr. Phase II study of carboplatin and paclitaxel in advanced thymoma and thymic carcinoma. J Clin Oncol. 2011 May 20;29(15):2060-5. Epub 2011 Apr 18. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed

CISCA

CISCA: CISplatin, Cyclophosphamide, Adriamycin (Doxorubicin)
PAC: Platinol (Cisplatin), Adriamycin (Doxorubicin), Cyclophosphamide
CAP: Cyclophosphamide, Adriamycin (Doxorubicin), Platinol (Cisplatin)

Regimen

Study Dates of enrollment Evidence
Loehrer et al. 1990 Not reported in abstract Phase 2

Chemotherapy

Supportive therapy

  • 1 liter NS over 2 hours at least 2 hours before and after cisplatin therapy
  • Corticosteroids use for antiemesis was specifically discouraged unless the indication was for myasthenia gravis

21-day cycle for up to 8 cycles

References

  1. Loehrer PJ Sr, Perez CA, Roth LM, Greco A, Livingston RB, Einhorn LH. Chemotherapy for advanced thymoma: preliminary results of an intergroup study. Ann Intern Med. 1990 Oct 1;113(7):520-4. link to original article dosing details in manuscript have been reviewed by our editors PubMed
    1. Update: Loehrer PJ Sr, Kim K, Aisner SC, Livingston R, Einhorn LH, Johnson D, Blum R; Eastern Cooperative Oncology Group; Southwest Oncology Group; Southeastern Cancer Study Group. Cisplatin plus doxorubicin plus cyclophosphamide in metastatic or recurrent thymoma: final results of an intergroup trial. J Clin Oncol. 1994 Jun;12(6):1164-8. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Cisplatin & Etoposide (EP)

PE: Platinol (Cisplatin), Etoposide

Regimen

Study Dates of enrollment Evidence
Giaccone et al. 1996 1985-09 to 1991-08 Phase 2

Chemotherapy

Supportive therapy

  • "A program of forced hydration"

21-day cycle for up to 8 cycles

References

  1. Giaccone G, Ardizzoni A, Kirkpatrick A, Clerico M, Sahmoud T, van Zandwijk N; EORTC Lung Cancer Cooperative Group. Cisplatin and etoposide combination chemotherapy for locally advanced or metastatic thymoma: a phase II study of the European Organisation for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 1996 Mar;14(3):814-20. link to original article dosing details in manuscript have been reviewed by our editors PubMed

VIP

VIP: Vepesid (Etoposide), Ifosfamide, Platinol (Cisplatin)

Regimen

Study Dates of enrollment Evidence
Loehrer et al. 2001 1995-07 to 1997-02 Phase 2

Chemotherapy

Supportive therapy

  • Mesna (Mesnex) 240 mg/m2 IV push two times per day on days 1 to 4, given 4 hours after and 8 hours after ifosfamide (total dose per cycle: 1920 mg/m2)
  • 1 liter normal saline once per day on days 1 to 4, prior to cisplatin
  • Filgrastim (Neupogen) 5 mcg/kg SC once per day on days 5 to 15, until WBC count at least 10 x 109/L above nadir

21-day cycle for 4 cycles

References

  1. Loehrer PJ Sr, Jiroutek M, Aisner S, Aisner J, Green M, Thomas CR Jr, Livingston R, Johnson DH. Combined etoposide, ifosfamide, and cisplatin in the treatment of patients with advanced thymoma and thymic carcinoma: an intergroup trial. Cancer. 2001 Jun 1;91(11):2010-5. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Advanced or metastatic disease, subsequent lines of therapy

Capecitabine & Gemcitabine

CAP-GEM: CAPecitabine & GEMcitabine

Regimen

Study Dates of enrollment Evidence Efficacy
Palmieri et al. 2009 2005-11 to 2008-08 Phase 2 ORR: 40%

Chemotherapy

21-day cycles

References

  1. Palmieri G, Merola G, Federico P, Petillo L, Marino M, Lalle M, Milella M, Ceribelli A, Montella L, Merola C, Del Prete S, Bergaglio M, De Placido S, Di Lorenzo G. Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs). Ann Oncol. 2010 Jun;21(6):1168-72. Epub 2009 Oct 30. link to original article PubMed
    1. Update: Palmieri G, Buonerba C, Ottaviano M, Federico P, Calabrese F, Von Arx C, De Maio AP, Marino M, Lalle M, Montella L, Merola C, Milella M, Bergaglio M, Di Lorenzo G, Damiano V. Capecitabine plus gemcitabine in thymic epithelial tumors: final analysis of a Phase II trial. Future Oncol. 2014 Nov;10(14):2141-7. link to original article dosing details in abstract have been reviewed by our editors PubMed

Everolimus monotherapy

Regimen

Study Dates of enrollment Evidence Efficacy
Zucali et al. 2017 (ONC-2010-001) 2011-02-17 to 2013-10-21 Phase 2 DCR: 88%

Targeted therapy

Continued indefinitely

References

  1. ONC-2010-001: Zucali PA, De Pas T, Palmieri G, Favaretto A, Chella A, Tiseo M, Caruso M, Simonelli M, Perrino M, De Vincenzo F, Toffalorio F, Damiano V, Pasello G, Garbella E, Ali M, Conforti F, Ottaviano M, Cioffi A, De Placido S, Giordano L, Bertossi M, Destro A, Di Tommaso L, Santoro A. Phase II study of everolimus in patients with thymoma and thymic carcinoma previously treated with cisplatin-based chemotherapy. J Clin Oncol. 2018 Feb 1;36(4):342-349. Epub 2017 Dec 14.link to original article dosing details in manuscript have been reviewed by our editors PubMed

Ifosfamide monotherapy

Regimen variant #1, intermittent dosing

Study Dates of enrollment Evidence
Highley et al. 1999 1984-07 to 1996-07 Pilot, fewer than 20 pts

Chemotherapy

Supportive therapy

  • Mesna (Mesnex) 400 mg IV bolus once per day on days 1 to 5, given before ifosfamide, then 1000 mg/m2 IV over 7.5 hours (total dose per cycle: 7000 mg/m2)

21-day cycles


Regimen variant #2, continuous dosing

Study Dates of enrollment Evidence
Highley et al. 1999 1984-07 to 1996-07 Pilot, fewer than 20 pts

Chemotherapy

  • Ifosfamide (Ifex) 1500 mg/m2/day IV continuous infusion over 120 hours, started on day 1, given second (total dose per cycle: 6000 mg/m2)

Supportive therapy

  • Mesna (Mesnex) 2000 mg IV bolus once on day 1, given first, then 1500 mg/m2/day IV continuous infusion over 7 days (total dose per cycle: 12,500 mg/m2)

21-day cycles

References

  1. Highley MS, Underhill CR, Parnis FX, Karapetis C, Rankin E, Dussek J, Bryant B, Rowland C, Hodson N, Hughes J, Harper PG. Treatment of invasive thymoma with single-agent ifosfamide. J Clin Oncol. 1999 Sep;17(9):2737-44. link to original article dosing details in manuscript have been reviewed by our editors PubMed content property of HemOnc.org

Octreotide monotherapy

Regimen variant #1, brief course

Study Dates of enrollment Evidence
Loehrer et al. 2004 1998-04 to 2000-11 Phase 2

Endocrine therapy

1-month cycle for 2 cycles

Subsequent treatment


Regimen variant #2, extended course

Study Dates of enrollment Evidence
Loehrer et al. 2004 1998-04 to 2000-11 Phase 2

Endocrine therapy

1-month cycle for up to 12 cycles

References

  1. Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Octreotide & Prednisone

Regimen

Study Dates of enrollment Evidence
Loehrer et al. 2004 1998-04 to 2000-11 Phase 2

Preceding treatment

Endocrine therapy

1-month cycle for up to 10 cycles

References

  1. Loehrer PJ Sr, Wang W, Johnson DH, Aisner SC, Ettinger DS; Eastern Cooperative Oncology Group. Octreotide alone or with prednisone in patients with advanced thymoma and thymic carcinoma: an Eastern Cooperative Oncology Group Phase II Trial. J Clin Oncol. 2004 Jan 15;22(2):293-9. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Sunitinib monotherapy

Regimen

Study Dates of enrollment Evidence
Thomas et al. 2015 (NCI 12-C-0118) 2012-05-15 to 2013-10-02 Phase 2

Targeted therapy

42-day cycles

References

  1. NCI 12-C-0118: Thomas A, Rajan A, Berman A, Tomita Y, Brzezniak C, Lee MJ, Lee S, Ling A, Spittler AJ, Carter CA, Guha U, Wang Y, Szabo E, Meltzer P, Steinberg SM, Trepel JB, Loehrer PJ, Giaccone G. Sunitinib in patients with chemotherapy-refractory thymoma and thymic carcinoma: an open-label phase 2 trial. Lancet Oncol. 2015 Feb;16(2):177-86. Epub 2015 Jan 13. Erratum in: Lancet Oncol. 2015 Mar;16(3):e105. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01621568
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