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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main H&N cancer page for regimens that include active anticancer treatment.

Locally advanced disease, induction

No induction

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Mazeron et al. 1992	1982-1986	Phase 3 (C)	BMFP	Did not meet endpoint of OS
Paccagnella et al. 1994	1986-1990	Phase 3 (C)	PF	Did not meet primary endpoint of OS
Hitt et al. 2013 (TTCC XRP6976F/2503)	2002-2007	Phase 2/3 (C)	1. PF 2. TPF	Did not meet co-primary endpoints of PFS/TTF
Zhong et al. 2012 (2007BAI18B03)	2008-2010	Phase 3 (C)	TPF	Did not meet primary endpoint of OS
Ghi et al. 2017 (GSTTC H&N07)	2008-2012	Phase 2/3 (C)	TPF	Seems to have inferior OS

No treatment given prior to definitive therapy.

Subsequent treatment

2007BAI18B03: Surgery, then adjuvant RT
TTCC XRP6976F/2503: Definitive cisplatin & RT
GSTTC H&N07: Definitive cetuximab & RT or cisplatin, 5-FU, RT

References

Mazeron JJ, Martin M, Brun B, Grimard L, Lelièvre G, Vergnes L, Haddad E, Feuilhade F, Piedbois P, Strunski W, Peynègre R, Pierquin B, Le Bourgeois JP. Induction chemotherapy in head and neck cancer: results of a phase III trial. Head Neck. 1992 Mar-Apr;14(2):85-91. link to original article PubMed
Paccagnella A, Orlando A, Marchiori C, Zorat PL, Cavaniglia G, Sileni VC, Jirillo A, Tomio L, Fila G, Fede A, Endrizzi L, Bari M, Sampognaro E, Balli M, Gava A, Pappagallo GL, Fiorention MV. Phase III trial of initial chemotherapy in stage III or IV head and neck cancers: a study by the Gruppo di Studio sui Tumori della Testa e del Collo. J Natl Cancer Inst. 1994 Feb 16;86(4):265-72. link to original article PubMed
1. Update: Zorat PL, Paccagnella A, Cavaniglia G, Loreggian L, Gava A, Mione CA, Boldrin F, Marchiori C, Lunghi F, Fede A, Bordin A, Da Mosto MC, Sileni VC, Orlando A, Jirillo A, Tomio L, Pappagallo GL, Ghi MG. Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up. J Natl Cancer Inst. 2004 Nov 17;96(22):1714-7. link to original article PubMed
PARADIGM: Haddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. Epub 2013 Feb 13. link to original article does not contain dosing details in abstract PubMed NCT00095875
2007BAI18B03: Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. Epub 2012 Nov 5. link to original article link to PMC article PubMed NCT01542931
1. Update: Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Hong CS, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Yin QM, Wang LZ, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Zhuang Z, Lee JJ, Myers JN, Zhang ZY. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma. Oncotarget. 2015 Jul 30;6(21):18707-14. link to original article link to PMC article PubMed
TTCC XRP6976F/2503: Hitt R, Grau JJ, López-Pousa A, Berrocal A, García-Girón C, Irigoyen A, Sastre J, Martínez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernández JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. Epub 2013 Nov 19. link to original article PubMed NCT00261703
GSTTC H&N07: Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codecà C, Nolè F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC (Gruppo di Studio Tumori della Testa e del Collo) Italian Study Group. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer: a phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. link to original article PubMed NCT01086826

Adjuvant therapy

Placebo

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Burtness et al. 2019 (LUX-Head & Neck 2)	2011-2016	Phase 3 (C)	Afatinib	Did not meet primary endpoint of DFS
Racadot et al. 2022 (GORTEC 2010-02)	2011-12 to 2017-12	Phase 3 (C)	Afatinib	Did not meet primary endpoint of DFS

No active antineoplastic treatment.

Preceding treatment

LUX-Head & Neck 2: Definitive Carboplatin & RT or Cisplatin & RT
GORTEC 2010-02: Definitive Cisplatin & RT

References

LUX-Head & Neck 2: Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck: a randomized clinical trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. Epub 2019 Jun 13. link to original article link to PMC article PubMed NCT01345669
GORTEC 2010-02: Racadot S, Thennevet I, Ouldbey Y, Kaminsky MC, Bosset M, Martin L, Tao Y, Sire C, de Raucourt D, Alfonsi M, Malaurie E, Tourani JM, Fournel P, Vauleon E, Modesto A, Rolland F, Metzger S, Pommier P, Chabaud S, Dussart S; GORTEC group. Afatinib maintenance therapy following post-operative radiochemotherapy in head and neck squamous cell carcinoma: Results from the phase III randomised double-blind placebo-controlled study BIB2992ORL (GORTEC 2010-02). Eur J Cancer. 2023 Jan;178:114-127. Epub 2022 Nov 9. link to original article PubMed NCT01427478

Recurrent or metastatic disease, subsequent lines of therapy

Best supportive care

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Machiels et al. 2011 (Hx-EGFr-202)	2006-2009	Phase 3 (C)	Zalutumumab	Might have inferior OS

No active antineoplastic treatment.

References

Hx-EGFr-202: Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sørensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. Epub 2011 Mar 4. link to original article PubMed NCT00382031

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-The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the [[Head and neck cancer|main H&N cancer page]] for current regimens.
+<span id="BackToTop"></span>
+<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
+[[#top|Back to Top]]
+</div>
+The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Head and neck cancer|main H&N cancer page]] for regimens that include active anticancer treatment.
 {{TOC limit|limit=3}}
@@ Line 5: / Line 9: @@
 =Locally advanced disease, induction=
 ==No induction==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen===
-{| class="wikitable" style="width: 100%; text-align:center;"
+{| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!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://academic.oup.com/jnci/article-abstract/86/4/265/894237 Paccagnella et al. 1994]
+|[https://doi.org/10.1002/hed.2880140202 Mazeron et al. 1992]
+|1982-1986
+|style="background-color:#1a9851"|Phase 3 (C)
+|[[#BMFP_999|BMFP]]
+|style="background-color:#ffffbf"|Did not meet endpoint of OS
+|-
+|[https://doi.org/10.1093/jnci/86.4.265 Paccagnella et al. 1994]
 |1986-1990
-|style="background-color:#1a9851"|Phase III (C)
+|style="background-color:#1a9851"|Phase 3 (C)
-|[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil|PF]]
+|[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29|PF]]
 |style="background-color:#ffffbf"|Did not meet primary endpoint of OS
 |-
 |[https://doi.org/10.1093/annonc/mdt461 Hitt et al. 2013 (TTCC XRP6976F/2503)]
 |2002-2007
-|style="background-color:#1a9851"|Phase II/III (C)
+|style="background-color:#1a9851"|Phase 2/3 (C)
-|1. [[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil|PF]]<br> 2. [[Head_and_neck_cancer#DCF|TPF]]
+|1. [[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29|PF]]<br>2. [[Head_and_neck_cancer#DCF|TPF]]
-|style="background-color:#ffffbf"|Did not meet primary endpoints of PFS/TTF
+|style="background-color:#ffffbf"|Did not meet co-primary endpoints of PFS/TTF
 |-
 |[https://doi.org/10.1200/JCO.2012.43.8820 Zhong et al. 2012 (2007BAI18B03)]
 |2008-2010
-|style="background-color:#1a9851"|Phase III (C)
+|style="background-color:#1a9851"|Phase 3 (C)
 |[[Head_and_neck_cancer#DCF|TPF]]
 |style="background-color:#ffffbf"|Did not meet primary endpoint of OS
@@ Line 37: / Line 44: @@
 |[https://doi.org/10.1093/annonc/mdx299 Ghi et al. 2017 (GSTTC H&N07)]
 |2008-2012
-|style="background-color:#1a9851"|Phase II/III (C)
+|style="background-color:#1a9851"|Phase 2/3 (C)
 |[[Head_and_neck_cancer#DCF|TPF]]
 | style="background-color:#fc8d59" |Seems to have inferior OS
@@ Line 43: / Line 50: @@
 |}
 ''No treatment given prior to definitive therapy.''
+<div class="toccolours" style="background-color:#cbd5e8">
 ====Subsequent treatment====
-*2007BAI18B03: [[Surgery#Head_and_neck_cancer_surgery|Surgery]], then adjuvant RT
+*2007BAI18B03: [[Surgery#Head_and_neck_cancer_surgery|Surgery]], then adjuvant [[Head_and_neck_cancer#Radiation_therapy_2|RT]]
-*TTCC XRP6976F/2503: [[Head_and_neck_cancer#Cisplatin_.26_RT|Definitive cisplatin & RT]]
+*TTCC XRP6976F/2503: Definitive [[Head_and_neck_cancer#Cisplatin_.26_RT|cisplatin & RT]]
-*GSTTC H&N07: Definitive [[Head_and_neck_cancer#Cetuximab_.26_RT|cetuximab & RT]] or [[Head_and_neck_cancer#Cisplatin.2C_Fluorouracil.2C_RT|cisplatin, 5-FU, RT]]
+*GSTTC H&N07: Definitive [[Head_and_neck_cancer#Cetuximab_.26_RT|cetuximab & RT]] or [[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|cisplatin, 5-FU, RT]]
+</div></div>
 ===References===
-# Paccagnella A, Orlando A, Marchiori C, Zorat PL, Cavaniglia G, Sileni VC, Jirillo A, Tomio L, Fila G, Fede A, Endrizzi L, Bari M, Sampognaro E, Balli M, Gava A, Pappagallo GL, Fiorention MV. Phase III trial of initial chemotherapy in stage III or IV head and neck cancers: a study by the Gruppo di Studio sui Tumori della Testa e del Collo. J Natl Cancer Inst. 1994 Feb 16;86(4):265-72. [https://academic.oup.com/jnci/article-abstract/86/4/265/894237 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8158680 PubMed]
+# Mazeron JJ, Martin M, Brun B, Grimard L, Lelièvre G, Vergnes L, Haddad E, Feuilhade F, Piedbois P, Strunski W, Peynègre R, Pierquin B, Le Bourgeois JP. Induction chemotherapy in head and neck cancer: results of a phase III trial. Head Neck. 1992 Mar-Apr;14(2):85-91. [https://doi.org/10.1002/hed.2880140202 link to original article] [https://pubmed.ncbi.nlm.nih.gov/1376306/ PubMed]
-## '''Update:''' Zorat PL, Paccagnella A, Cavaniglia G, Loreggian L, Gava A, Mione CA, Boldrin F, Marchiori C, Lunghi F, Fede A, Bordin A, Da Mosto MC, Sileni VC, Orlando A, Jirillo A, Tomio L, Pappagallo GL, Ghi MG. Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up. J Natl Cancer Inst. 2004 Nov 17;96(22):1714-7. [https://academic.oup.com/jnci/article/96/22/1714/2521051 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15547184 PubMed]
+# Paccagnella A, Orlando A, Marchiori C, Zorat PL, Cavaniglia G, Sileni VC, Jirillo A, Tomio L, Fila G, Fede A, Endrizzi L, Bari M, Sampognaro E, Balli M, Gava A, Pappagallo GL, Fiorention MV. Phase III trial of initial chemotherapy in stage III or IV head and neck cancers: a study by the Gruppo di Studio sui Tumori della Testa e del Collo. J Natl Cancer Inst. 1994 Feb 16;86(4):265-72. [https://doi.org/10.1093/jnci/86.4.265 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8158680/ PubMed]
-# '''PARADIGM:''' Haddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. Epub 2013 Feb 13. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70011-1/fulltext link to original article] '''does not contain protocol in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23414589 PubMed]
+## '''Update:''' Zorat PL, Paccagnella A, Cavaniglia G, Loreggian L, Gava A, Mione CA, Boldrin F, Marchiori C, Lunghi F, Fede A, Bordin A, Da Mosto MC, Sileni VC, Orlando A, Jirillo A, Tomio L, Pappagallo GL, Ghi MG. Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up. J Natl Cancer Inst. 2004 Nov 17;96(22):1714-7. [https://doi.org/10.1093/jnci/djh306 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15547184/ PubMed]
-# '''2007BAI18B03:''' Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. Epub 2012 Nov 5. [https://doi.org/10.1200/JCO.2012.43.8820 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569675/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23129742 PubMed]
+# '''PARADIGM:''' Haddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, Clark J, Sarlis N, Lorch J, Beitler JJ, Limaye S, Riley S, Posner M. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013 Mar;14(3):257-64. Epub 2013 Feb 13. [https://doi.org/10.1016/S1470-2045(13)70011-1 link to original article] '''does not contain dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23414589/ PubMed] [https://clinicaltrials.gov/study/NCT00095875 NCT00095875]
-## '''Update:''' Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Hong CS, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Yin QM, Wang LZ, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Zhuang Z, Lee JJ, Myers JN, Zhang ZY. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma. Oncotarget. 2015 Jul 30;6(21):18707-14. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4621922/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26124084 PubMed]
+# '''2007BAI18B03:''' Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Wang LZ, Fan XD, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Wang BS, Kies MS, Lee JJ, Myers JN, Zhang ZY. Randomized phase III trial of induction chemotherapy with docetaxel, cisplatin, and fluorouracil followed by surgery versus up-front surgery in locally advanced resectable oral squamous cell carcinoma. J Clin Oncol. 2013 Feb 20;31(6):744-51. Epub 2012 Nov 5. [https://doi.org/10.1200/JCO.2012.43.8820 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569675/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23129742/ PubMed] [https://clinicaltrials.gov/study/NCT01542931 NCT01542931]
-# '''TTCC XRP6976F/2503:''' Hitt R, Grau JJ, López-Pousa A, Berrocal A, García-Girón C, Irigoyen A, Sastre J, Martínez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernández JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. Epub 2013 Nov 19. [https://doi.org/10.1093/annonc/mdt461 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/24256848 PubMed] NCT00261703
+## '''Update:''' Zhong LP, Zhang CP, Ren GX, Guo W, William WN Jr, Hong CS, Sun J, Zhu HG, Tu WY, Li J, Cai YL, Yin QM, Wang LZ, Wang ZH, Hu YJ, Ji T, Yang WJ, Ye WM, Li J, He Y, Wang YA, Xu LQ, Zhuang Z, Lee JJ, Myers JN, Zhang ZY. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma. Oncotarget. 2015 Jul 30;6(21):18707-14. [https://doi.org/10.18632/oncotarget.4531 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4621922/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26124084/ PubMed]
-# '''GSTTC H&N07:''' Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codecà C, Nolè F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC (Gruppo di Studio Tumori della Testa e del Collo) Italian Study Group. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer: a phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. [https://doi.org/10.1093/annonc/mdx299 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28911070 PubMed] NCT01086826
+# '''TTCC XRP6976F/2503:''' Hitt R, Grau JJ, López-Pousa A, Berrocal A, García-Girón C, Irigoyen A, Sastre J, Martínez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernández JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. Epub 2013 Nov 19. [https://doi.org/10.1093/annonc/mdt461 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24256848/ PubMed] [https://clinicaltrials.gov/study/NCT00261703 NCT00261703]
+# '''GSTTC H&N07:''' Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codecà C, Nolè F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC (Gruppo di Studio Tumori della Testa e del Collo) Italian Study Group. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer: a phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. [https://doi.org/10.1093/annonc/mdx299 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28911070/ PubMed] [https://clinicaltrials.gov/study/NCT01086826 NCT01086826]
 =Adjuvant therapy=
 ==Placebo==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen===
-{| class="wikitable" style="width: 100%; text-align:center;"
+{| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
@@ Line 75: / Line 80: @@
 |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6567846/ Burtness et al. 2019 (LUX-Head & Neck 2)]
 |2011-2016
-|style="background-color:#1a9851"|Phase III (C)
+|style="background-color:#1a9851"|Phase 3 (C)
-|Afatinib
+|[[#Afatinib_monotherapy_999|Afatinib]]
+| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS
+|-
+|[https://doi.org/10.1016/j.ejca.2022.10.023 Racadot et al. 2022 (GORTEC 2010-02)]
+|2011-12 to 2017-12
+|style="background-color:#1a9851"|Phase 3 (C)
+|[[#Afatinib_monotherapy_999|Afatinib]]
 | style="background-color:#ffffbf" |Did not meet primary endpoint of DFS
 |-
 |}
 ''No active antineoplastic treatment.''
+<div class="toccolours" style="background-color:#cbd5e8">
 ====Preceding treatment====
-*[[Head_and_neck_cancer#Carboplatin_.26_RT|Carboplatin & RT]] or [[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]]
+*LUX-Head & Neck 2: Definitive [[Head_and_neck_cancer#Carboplatin_.26_RT|Carboplatin & RT]] or [[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]]
+*GORTEC 2010-02: Definitive [[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]]
+</div></div>
 ===References===
-# '''LUX-Head & Neck 2:''' Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck: a randomized clinical trial. JAMA Oncol. 2019 Jun 13. [Epub ahead of print] [https://jamanetwork.com/journals/jamaoncology/fullarticle/2735890 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6567846/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31194247 PubMed] NCT01345669
+# '''LUX-Head & Neck 2:''' Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck: a randomized clinical trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. Epub 2019 Jun 13. [https://doi.org/10.1001/jamaoncol.2019.1146 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6567846/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31194247/ PubMed] [https://clinicaltrials.gov/study/NCT01345669 NCT01345669]
+# '''GORTEC 2010-02:''' Racadot S, Thennevet I, Ouldbey Y, Kaminsky MC, Bosset M, Martin L, Tao Y, Sire C, de Raucourt D, Alfonsi M, Malaurie E, Tourani JM, Fournel P, Vauleon E, Modesto A, Rolland F, Metzger S, Pommier P, Chabaud S, Dussart S; GORTEC group. Afatinib maintenance therapy following post-operative radiochemotherapy in head and neck squamous cell carcinoma: Results from the phase III randomised double-blind placebo-controlled study BIB2992ORL (GORTEC 2010-02). Eur J Cancer. 2023 Jan;178:114-127. Epub 2022 Nov 9. [https://doi.org/10.1016/j.ejca.2022.10.023 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36434888/ PubMed] [https://clinicaltrials.gov/study/NCT01427478 NCT01427478]
 =Recurrent or metastatic disease, subsequent lines of therapy=
 ==Best supportive care==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen===
-{| class="wikitable" style="width: 100%; text-align:center;"
+{| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!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://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70034-1/fulltext Machiels et al. 2011 (Hx-EGFr-202)]
+|[https://doi.org/10.1016/S1470-2045(11)70034-1 Machiels et al. 2011 (Hx-EGFr-202)]
 |2006-2009
-|style="background-color:#1a9851"|Phase III (C)
+|style="background-color:#1a9851"|Phase 3 (C)
-|Zalutumumab
+|[[#Zalutumumab_monotherapy_777|Zalutumumab]]
 | style="background-color:#fee08b" |Might have inferior OS
 |-
 |}
 ''No active antineoplastic treatment.''
+</div>
 ===References===
-# '''Hx-EGFr-202:''' Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sørensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. Epub 2011 Mar 4. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70034-1/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/21377930 PubMed] NCT00382031
+# '''Hx-EGFr-202:''' Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sørensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. Epub 2011 Mar 4. [https://doi.org/10.1016/S1470-2045(11)70034-1 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21377930/ PubMed] [https://clinicaltrials.gov/study/NCT00382031 NCT00382031]
 [[Category:Head and neck cancer regimens]]

Difference between revisions of "Head and neck cancer - null regimens"

Latest revision as of 00:07, 30 June 2024

Contents

Locally advanced disease, induction

No induction

Regimen

Subsequent treatment

References

Adjuvant therapy

Placebo

Regimen

Preceding treatment

References

Recurrent or metastatic disease, subsequent lines of therapy

Best supportive care

Regimen

References

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