Head and neck cancer - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main head and neck cancer page for current regimens.

5 regimens on this page
5 variants on this page


Locally advanced disease, definitive therapy

Bleomycin, Methotrexate, Vinblastine/RT

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Merlano et al. 1988 1983-1986 Phase 3 (E-switch-ic) Bleomycin, MTX, Vinblastine, then RT Seems to have superior PFS

Chemotherapy

Radiotherapy

References

  1. Merlano M, Rosso R, Sertoli MR, Bonelli L, Margarino G, Grimaldi A, Benasso M, Gardin G, Corvó R, Scarpati D, Barbieri A, Pallestrini E, Castiglia G, Santelli A, Scasso F, Bottero G, Ciurlo E, Fracchia P, Moratti M, Santi L. Sequential versus alternating chemotherapy and radiotherapy in stage III-IV squamous cell carcinoma of the head and neck: a phase III study. J Clin Oncol. 1988 Apr;6(4):627-32. link to original article PubMed

Cetuximab & RT

Cetuximab & RT: Cetuximab & Radiation Therapy

Regimen variant #1, conventional RT (68 Gy)

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Gebre-Medhin et al. 2020 (ARTSCAN III) 2013-2018 Phase 3 (E-switch-ooc) Cisplatin & RT Did not meet primary endpoint of OS
OS36: 78% vs 88%
(HR 1.63, 95% CI 0.93-2.86)

Targeted therapy

  • Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins; then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy

Supportive therapy

Radiotherapy

  • Concurrent radiation therapy to primary tumor and lymph node metastases: 2 Gy fractions x 34 fractions, once per day, 5 days per week (total dose: 68 Gy)
  • Concurrent radiation therapy to elective neck volumes: 1.6 Gy fractions x 34 fractions, once per day, 5 days per week (total dose: 54.4 Gy)

7-week course


Regimen variant #2, conventional RT (70 Gy)

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bonner et al. 2006 (IMCL-9815) 1999-2002 Phase 3 (E-RT-esc) Radiation therapy Seems to have superior OS (secondary endpoint)
Median OS: 49 vs 29.3 mo
(HR 0.74, 95% CI 0.57-0.97)
Lefebvre et al. 2013 (TREMPLIN) 2006-2008 Randomized Phase 2 (E-switch-ooc) Cisplatin & RT Did not meet primary endpoint of LP at 3 months
Ghi et al. 2017 (GSTTC H&N07) 2008-2012 Non-randomized part of phase 2/3 RCT
Tao et al. 2018 (GORTEC 2007-01) 2008-01 to 2014-03 Phase 3 (C) Carboplatin, 5-FU, Cetuximab, RT Inferior PFS
Hitt et al. 2013 (TTCC-2007-01) 2008-07-15 to 2013-07-05 Phase 3 (E-switch-ooc) Cisplatin & RT Inconclusive whether non-inferior OS (primary endpoint)
Median OS: 42.9 vs 63.6 mo
(HR 1.11, 90% CI 0.89-1.38)

Preceding treatment

Targeted therapy

  • Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins, then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
    • IMCL-9815: A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose

Supportive therapy

Radiotherapy

  • Concurrent radiation therapy, 2 Gy fractions x 35 fractions, once per day, 5 days per week (total dose: 70 Gy)

7-week course


Regimen variant #3, twice-daily RT

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bonner et al. 2006 (IMCL-9815) 1999-2002 Phase 3 (E-RT-esc) Radiation therapy Seems to have superior OS (secondary endpoint)
Median OS: 49 vs 29.3 mo
(HR 0.74, 95% CI 0.57-0.97)

Superior LRC (primary endpoint)

Targeted therapy

  • Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins, then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
    • A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose

Supportive therapy

Radiotherapy

  • Concurrent radiation therapy, 1.2 Gy fractions x 60 to 64 fractions, twice per day, 5 days per week (total dose: 72 to 76.8 Gy)

6- to 6.5-week course


Regimen variant #4, concomitant boost

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bonner et al. 2006 (IMCL-9815) 1999-2002 Phase 3 (E-RT-esc) Radiation therapy Seems to have superior OS (secondary endpoint)
Median OS: 49 vs 29.3 mo
(HR 0.74, 95% CI 0.57-0.97)

Targeted therapy

  • Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins, then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
    • A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose

Supportive therapy

Radiotherapy

  • Concurrent radiation therapy, 1.8 Gy fractions x 18 fractions (total dose: 32.4 Gy), once per day, 5 days per week for 3.6 weeks; and twice per day fractions:
    • Morning dose: 1.8 Gy fractions x 12 fractions (total dose: 21.6 Gy), given 5 days per week over 2.4 weeks
    • Afternoon dose: 1.5 Gy fractions x 12 fractions (total dose: 18 Gy), given 5 days per week over 2.4 weeks
    • Total dose for concomitant boost regimen: 72 Gy

6-week course

References

  1. IMCL-9815: Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. link to original article contains dosing details in manuscript PubMed NCT00004227
    1. HRQoL analysis: Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. link to original article contains partial protocol PubMed
    2. Update: Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. Epub 2009 Nov 10. link to original article contains partial protocol PubMed
    3. Subgroup analysis: Rosenthal DI, Harari PM, Giralt J, Bell D, Raben D, Liu J, Schulten J, Ang KK, Bonner JA. Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab. J Clin Oncol. 2016 Apr 20;34(12):1300-8. Epub 2015 Dec 28. link to original article link to PMC article PubMed
  2. TREMPLIN: Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. Epub 2013 Jan 22. link to original article contains dosing details in manuscript PubMed NCT00169247
  3. 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. 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 contains dosing details in manuscript PubMed NCT01086826
  4. GORTEC 2007-01: Tao Y, Auperin A, Sire C, Martin L, Khoury C, Maingon P, Bardet E, Kaminsky MC, Lapeyre M, Chatellier T, Alfonsi M, Pointreau Y, Jadaud E, Géry B, Zawadi A, Tourani JM, Laguerre B, Coutte A, Racadot S, Hasbini A, Malaurie E, Borel C, Meert N, Cornely A, Ollivier N, Casiraghi O, Sun XS, Bourhis J. Improved outcome by adding concurrent chemotherapy to cetuximab and radiotherapy for locally advanced head and neck carcinomas: results of the GORTEC 2007-01 phase III randomized trial. J Clin Oncol. 2018 Nov 1;36(31):3084-90. Epub 2018 Jun 7. link to original article contains dosing details in manuscript PubMed NCT00609284
  5. ARTSCAN III: Gebre-Medhin M, Brun E, Engström P, Haugen Cange H, Hammarstedt-Nordenvall L, Reizenstein J, Nyman J, Abel E, Friesland S, Sjödin H, Carlsson H, Söderkvist K, Thomasson M, Zackrisson B, Nilsson P. ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer. J Clin Oncol. 2021 Jan 1;39(1):38-47. Epub 2020 Oct 14. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01969877
  6. TTCC-2007-01: Hitt R, Mesía R, Lozano A, Iglesias Docampo L, Grau JJ, Taberna M, Rubió-Casadevall J, Martínez-Trufero J, Morillo EDB, García Girón C, Vázquez Estévez S, Cirauqui B, Cruz-Hernández JJ. Randomized phase 3 noninferiority trial of radiotherapy and cisplatin vs radiotherapy and cetuximab after docetaxel-cisplatin-fluorouracil induction chemotherapy in patients with locally advanced unresectable head and neck cancer. Oral Oncol. 2022 Nov;134:106087. Epub 2022 Sep 18. link to original article PubMed NCT00716391
  7. GORTEC 2017-01: NCT02999087

Recurrent or metastatic disease, first-line therapy

CABO

CABO: Cisplatin, Amithopterin (Methotrexate), Bleomycin, Oncovin (Vincristine)

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Clavel et al. 1994 1984-1987 Phase 3 (E-esc) 1. CF Seems to have superior ORR
2. Cisplatin Superior ORR

Chemotherapy

References

  1. Clavel M, Vermorken JB, Cognetti F, Cappelaere P, de Mulder PH, Schornagel JH, Tueni EA, Verweij J, Wildiers J, Clerico M, Dalesio O, Kirkpatrick A, Snow GB; EORTC Head and Neck Cancer Cooperative Group. Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck: a phase III study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1994 Jul;5(6):521-6. link to original article contains dosing details in abstract PubMed

Cisplatin & Cetuximab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Burtness et al. 2005 (ECOG E5397) 1999-2001 Phase 3 (E-esc) Cisplatin Did not meet primary endpoint of PFS

Note: Per physician discretion, patients with complete response (CR) could have treatment discontinued 2 cycles past the point at which CR was attained. Patients with partial response (PR) continued on treatment until there was evidence of CR or progression disease. Patients with stable disease (SD) could discontinue treatment after 6 cycles. Patients with progressive disease discontinued therapy.

Chemotherapy

Targeted therapy

  • Cetuximab (Erbitux) as follows:
    • Cycle 1: 400 mg/m2 IV over 2 hours once on day 1, then 250 mg/m2 IV over 60 minutes once per day on days 8, 15, 22
    • Cycle 2 onwards: 250 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, 22

28-day cycles (see note)

References

  1. ECOG E5397: Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; ECOG. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. link to original article contains dosing details in manuscript PubMed NCT00003809
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