Advertisement

Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6)

Published:December 29, 2016DOI:https://doi.org/10.1016/j.ejca.2016.11.008

      Highlights

      • Three hundred twenty head and neck cancer patients participated in a phase III randomised trial comparing standard radiotherapy /cisplatin with accelerated radiotherapy/panitumumab.
      • Quality of life (QOL) and swallowing outcomes were compared between arms.
      • No clinically important differences by arm were seen 2–36 months post-treatment.
      • Swallowing and head and neck–specific QOL showed persistent declines in both study arms.
      • These results do not suggest adopting the experimental arm to improve QOL.

      Abstract

      Aim

      To compare quality of life (QOL) between standard (SFX) chemoradiotherapy (arm A) and altered fractionation radiotherapy (AFX) with panitumumab (PMab; arm B).

      Methods

      Patients with T any N + M0 or T3-4N0M0 squamous cell head-neck carcinoma were randomised to SFX (70 Gy/35/7 wks) plus cisplatin (100 mg/m2 IV × 3) versus AFX (70 Gy/35/6 wks) plus PMab (9 mg/kg IV × 3). QOL was collected at baseline, end of radiation therapy (RT) and 2, 4, 6, 12, 24 and 36 months post-RT using the Functional Assessment of Cancer Therapy Head and Neck (FACT-H&N), MD Anderson Dysphagia Index (MDADI) and SWAL-QOL. We hypothesised a 6-point more favourable change in FACT-H&N score from baseline to 1 year in arm B over arm A.

      Results

      Among 320 patients, median follow-up was 46 (range: 0.1–64.3) months, median age 56, 84% male, Eastern Cooperative Oncology Group PS 0 (71%), 1 (29%). Primary site was oropharynx in 81% (p16+ 68%, p16− 16%, missing 16%). Baseline scores did not differ by arm (A/B): FACT-H&N 116.5/115, MDADI Global 83/77, SWAL-QOL General 67/68. At 1 year, no difference was seen between arms in FACT-H&N change from baseline: A −1.70, B −4.81, p = 0.194. Subscale change scores by arm were (A/B): last week RT, FACT-Physical (−11.6, −10, p = 0.049), MDADI Physical (−40.4, −33.9, p = 0.045), and SWAL-QOL Eating Duration (−61.2, −51.2, p = 0.02), Eating Desire (−53.3, −43.9, p = 0.031) and Mental Health (−42, −32.6, p = 0.009); 4 months, HN subscale (−7.7, −10, p = 0.014). No clinically important differences by arm were seen post-treatment.

      Conclusions

      PMab with AFX did not durably improve QOL or swallowing as compared with SFX with cisplatin.

      Trial registration

      ClinicalTrials.gov: NCT00820248.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to European Journal of Cancer
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Martino R.
        • Ringash J.
        Evaluation of QOL and organ function in head and neck squamous cell cancer.
        Hematol Oncol Clin North Am. 2008; 22: 1239-1256
        • Blanchard P.
        • Baujat B.
        • Holostenco V.
        • et al.
        Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site.
        Radiother Oncol. 2011; 100: 33-40
        • Mirghani H.
        • Amen F.
        • Blanchard P.
        • et al.
        Treatment de-escalation in HPV positive oropharyngeal cancer: ongoing trials, critical issues and perspectives.
        IJC. 2014; 136: 1494-1503
      1. RTOG 1016: https://clinicaltrials.gov/ct2/show/NCT01302834. [Accessed 5 September 2016].

      2. TROG: https://clinicaltrials.gov/ct2/show/NCT01855451. [Accessed 5 September 2016].

      3. ECOG 3311: https://clinicaltrials.gov/ct2/show/NCT1898494. [Accessed 5 September 2016].

      4. NRG HN002: https://clinicaltrials.gov/ct2/show/NCT02254278. [Accessed 5 September 2016].

        • Dische S.
        • Saunders M.
        • Barrett A.
        • Harvey A.
        • Gibson D.
        • Parmar M.
        A randomized multicentre trial of CHART versus conventional radiotherapy in head and neck cancer.
        Radiother Oncol. 1997; 44: 123-136
        • Rogers S.N.
        • Ahad S.A.
        • Murphy A.P.
        A structured review and theme analysis of papers published on ‘quality of life’ in head and neck cancer: 2000–2005.
        Oral Oncol. 2007; 43: 843-868
        • Bonner J.A.
        • Harari P.M.
        • Giralt J.
        • et al.
        Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.
        N Engl J Med. 2006 Feb 9; 354: 567-578
        • Curran D.
        • Giralt J.
        • Harari P.M.
        • et al.
        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; 25: 2191-2197
        • Ringash J.
        • Lockwood G.
        • O'Sullivan B.
        • et al.
        Hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer: quality of life in a prospective phase I/II trial.
        Radiother Oncol. 2008; 87: 181-187
        • Siu L.L.
        • Waldron J.N.
        • Chen B.E.
        • et al.
        Effect of standard radiotherapy with cisplatin vs accelerated radiotherapy with panitumumab in locoregionally advanced squamous cell head and neck carcinoma: A Randomized Clinical Trial.
        JAMA Onc. 2016; https://doi.org/10.1001/jamaoncol.2016.4510
        • Ringash J.
        • Bezjak A.
        • O'Sullivan B.
        • Redelmeier D.
        Interpreting small differences in quality of life: the fact-H&N in laryngeal cancer patients.
        QoL Res. 2004; 13: 721-729
        • McHorney C.A.
        • Robbins J.
        • Lomax K.
        • et al.
        The SWAL–QOL and SWAL–CARE outcomes tool for oropharyngeal dysphagia in adults: III. Documentation of reliability and validity.
        Dysphagia. 2002; 7: 97-114
        • Chen A.Y.
        • Frankowski R.
        • Bishop-Leone J.
        • et al.
        The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory.
        Arch Otolaryngol Head Neck Surg. 2001; 127: 870-876
        • Crary M.A.
        • Mann G.D.
        • Groher M.E.
        Initial psychometric assessment of a functional oral intake scale for dysphagia in stroke patients.
        Arch Phys Med Rehabil. 2005; 86: 1516-1520
        • Ringash J.
        • O'Sullivan B.
        • Bezjak J.
        • Redelmeier D.A.
        Interpreting the clinical significance of changes in patient reported outcomes.
        Cancer. 2007; 110: 196-202
        • Osoba D.
        • Zee B.
        Completion rates in health-related quality-of-life assessment: approach of the National Cancer Institute of Canada Clinical Trials Group.
        Stat Med. 1998; 17: 603-612
        • Calvert M.
        • Blazeby J.
        • Altman D.B.
        • et al.
        Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.
        JAMA. 2013; 309: 814-822
        • Fairclough D.
        Design and analysis of quality of life studies in clinical trials.
        CRC Press, Boca Ratan, USA2010: p. 126
        • Sadura A.
        • Pater J.
        • Osoba D.
        • Levine M.
        • Palmer M.
        • Bannett K.
        Quality-of-life assessment: patient compliance with questionnaire completion.
        J Nat Cancer Inst. 1994; 84: 1023-1028
        • Zee B.
        • Osoba D.
        Health related quality of life outcomes.
        in: Crowley J. Handbook of statistics in clinical oncology. Marcel Dekker, New York, NY2001: 249-267
        • Ringash J.
        • Fisher R.
        • Peters L.
        • et al.
        Effect of P16 status on the quality of life experience during chemoradiation for locally advanced oropharyngeal cancer: a sub-study of randomized trial TROG 02.02 (HeadSTART).
        Int J Radiat Oncol Biol Phys. 2016; https://doi.org/10.1016/j.ijrobp.2016.03.017