Difference between revisions of "Head and neck cancer - null regimens"
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− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | <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}} | {{TOC limit|limit=3}} | ||
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=Locally advanced disease, induction= | =Locally advanced disease, induction= | ||
==No induction== | ==No induction== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===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%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[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 | |1986-1990 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | |[[Head_and_neck_cancer#Cisplatin_. | + | |[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29|PF]] |
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS | |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)] | |[https://doi.org/10.1093/annonc/mdt461 Hitt et al. 2013 (TTCC XRP6976F/2503)] | ||
|2002-2007 | |2002-2007 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 2/3 (C) |
− | |1. [[Head_and_neck_cancer#Cisplatin_. | + | |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:// | + | |[https://doi.org/10.1200/JCO.2012.43.8820 Zhong et al. 2012 (2007BAI18B03)] |
|2008-2010 | |2008-2010 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 3 (C) |
|[[Head_and_neck_cancer#DCF|TPF]] | |[[Head_and_neck_cancer#DCF|TPF]] | ||
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS | |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)] | |[https://doi.org/10.1093/annonc/mdx299 Ghi et al. 2017 (GSTTC H&N07)] | ||
|2008-2012 | |2008-2012 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 2/3 (C) |
|[[Head_and_neck_cancer#DCF|TPF]] | |[[Head_and_neck_cancer#DCF|TPF]] | ||
| style="background-color:#fc8d59" |Seems to have inferior OS | | style="background-color:#fc8d59" |Seems to have inferior OS | ||
Line 43: | Line 50: | ||
|} | |} | ||
''No treatment given prior to definitive therapy.'' | ''No treatment given prior to definitive therapy.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Subsequent treatment==== | ====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| | + | *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# | + | *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=== | ===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:// | + | # 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:// | + | # 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:// | + | ## '''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:// | + | # '''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] | + | ## '''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] | + | # '''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= | =Adjuvant therapy= | ||
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
− | |||
===Regimen=== | ===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%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !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)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6567846/ Burtness et al. 2019 (LUX-Head & Neck 2)] | ||
|2011-2016 | |2011-2016 | ||
− | |style="background-color:#1a9851"|Phase | + | |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 | | style="background-color:#ffffbf" |Did not meet primary endpoint of DFS | ||
|- | |- | ||
|} | |} | ||
''No active antineoplastic treatment.'' | ''No active antineoplastic treatment.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====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=== | ===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. | + | # '''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= | =Recurrent or metastatic disease, subsequent lines of therapy= | ||
==Best supportive care== | ==Best supportive care== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===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%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(11)70034-1 Machiels et al. 2011 (Hx-EGFr-202)] |
|2006-2009 | |2006-2009 | ||
− | |style="background-color:#1a9851"|Phase | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | |Zalutumumab | + | |[[#Zalutumumab_monotherapy_777|Zalutumumab]] |
| style="background-color:#fee08b" |Might have inferior OS | | style="background-color:#fee08b" |Might have inferior OS | ||
|- | |- | ||
|} | |} | ||
''No active antineoplastic treatment.'' | ''No active antineoplastic treatment.'' | ||
− | + | </div> | |
===References=== | ===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:// | + | # '''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]] | [[Category:Head and neck cancer regimens]] |
Latest revision as of 00:07, 30 June 2024
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
- 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
- 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