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
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Article info
Publication history
Published online: December 29, 2016
Accepted:
November 15,
2016
Received in revised form:
November 14,
2016
Received:
September 19,
2016
Identification
Copyright
© 2016 Elsevier Ltd. All rights reserved.
