Hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer: Quality of life in a prospective phase I/II trial

doi:10.1016/j.radonc.2007.12.028

Radiotherapy and Oncology

Volume 87, Issue 2, May 2008, Pages 181-187

https://doi.org/10.1016/j.radonc.2007.12.028 Get rights and content

Abstract

Background and purpose

Quality of life (QOL) was measured prospectively in a dose escalation study of twice daily hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer (HNC).

Materials and methods

Patients with squamous cell HNC (TNM stage III/IV larynx or pharynx, or hypopharynx any stage) received 40 fractions of twice daily RT at 3 dose levels: (L1) 60 Gy, 1.5 Gy/fraction; (L2) 62 Gy, 1.55 Gy/fraction; and (L3) 64 Gy, 1.6 Gy/fraction. QOL was measured on the FACT-H&N at baseline, 6 and 12 months.

Results

Mean QOL scores were: baseline 104, 6 months 108, 12 months 112. At all time points, QOL scores were lower in patients with more advanced T-category. A mixed-model analysis of determinants of QOL showed no dose effect among L1 (n = 22), L2 (n = 26) or L3 (n = 123). QOL improved significantly with time from diagnosis, however post-treatment QOL was lower and improved more slowly in patients who had feeding tubes.

Conclusions

Post-RT QOL improved from baseline by a statistically and clinically significant amount. Hyperfractionated, accelerated RT provides favorable QOL outcomes, and is a viable alternative to chemoradiation for patients with locally advanced HNC.

Section snippets

Materials and methods

Patients with squamous cell HNC, arising in the hypopharynx (any stage), or larynx/oropharynx (stage III/IV) without distant metastases, aged ⩽75 and deemed fit for radical radiotherapy and suitable for neck dissection (if indicated for positive lymph nodes) were recruited from new patient outpatient clinics from 1998 to 2003 [9]. All patients gave informed consent. Patients were treated as previously described [submitted for publication: Waldron et al.] with twice daily radiotherapy delivered

Results

A total of 171 patients were accrued over a 4-year period from November 1998 to January 2003. Median age was 58 (range: 35–75). There were 133 men and 38 women. Stage IVa disease was present in 69%. Baseline patient and tumour characteristics are presented elsewhere [submitted for concurrent publication: Waldron et al.]. There were no statistically significant differences between the 3 dose level groups in age, gender, tumour site or stage. Cause-specific survival at 5 years’ follow up was 73%

Discussion

We found that aggressive radiotherapy with an accelerated, hyperfractionated schedule could be delivered to patients with locally advanced head and neck cancer without any detrimental effect on QOL at 6 months post-treatment. In fact, our study shows a statistically and clinically significant improvement in overall QOL and on Emotional and Functional domains following treatment.

The potential for consequential injury seen with more intensive regimens may have been avoided in this protocol due to

Conclusion

We found that hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer produced an improvement in baseline QOL in survivors at 6 and 12 months post-treatment. Considered in combination with the excellent 5-year survival reported by Waldron et al. [submitted for publication: Waldron et al.], these data establish this treatment approach as a viable alternative to concurrent chemoradiotherapy. We have adopted this strategy routinely for patients unfit for, or who

Acknowledgements

Funding for this study was provided internally by the Princess Margaret Hospital without involvement of any external study sponsor. Table 1 is provided with the permission of Dr. David Cella.

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Among patients with head and neck cancer undergoing resection with immediate pedicled or free flap reconstruction, advanced tumor stage and history of prior radiation therapy are associated with increased likelihood of G-tube placement. More randomized controlled trials are needed to develop a decision-making algorithm.
Psychometric validation of the Chinese version of the M. D. Anderson Symptom Inventory—Head and Neck Module in patients with nasopharyngeal carcinoma
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The MDASI-HN-C shows desirable psychometric properties for evaluating symptom burden in NPC patients, which can be used in both clinical and research contexts.
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The consent rate for the study was 95.2%, and the attrition rate was 5.0%. Although no significant differences between the groups were detected from T1 to T3, favorable effects on relieving the cluster itself (B [95% confidence interval (CI)] = −0.844 [-2.261, 0.572], p = 0.243, Cohen's d [95% CI] = −0.37 [-1.00, 0.28]) and improvements in physical well-being (B [95% CI] = 0.833 [-3.965, 5.632], p = 0.734, Cohen's d [95% CI] = −0.15 [-0.78, 0.49]) and in head and neck cancer–specific QOL (B [95% CI] = 0.061 [-4.061, 4.182], p = 0.977, Cohen's d [95% CI] = −0.05 [-0.68, 0.59]) were observed in the intervention group compared with the control.
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Citation Excerpt :
Evaluate the impact of HN-STAR, compared to usual care, on change in patient-centered outcomes from baseline to one-year follow-up. Our primary endpoint is HNC-specific quality of life, as measured by the Trial Outcome Index from the Functional Assessment of Cancer Therapy – Head and Neck (FACT H&N); other outcomes include symptom burden, patient activation (knowledge, confidence, and skills to manage one's own health), and perceived quality of cancer care [15,45–55]. Evaluate the impact of HN-STAR, compared to usual care, on receipt of ACS/ASCO guideline-concordant care in the year after enrollment, including a visit to a primary care provider in the year following the designated clinic visit.
Survivors of head and neck cancer (HNC) can have multiple health concerns. To facilitate their care, we developed and pilot-tested a clinical informatics intervention, HN-STAR. HN-STAR elicits concerns online from HNC survivors prior to a routine oncology clinic visit. HN-STAR then presents tailored evidence-based clinical recommendations as a clinical decision support tool to be used during the visit where the oncology clinician and survivor select symptom management strategies and other actions. This generates a survivorship care plan (SCP). Online elicitation of health concerns occurs 3, 6, and 9 months after the clinic visit, generating an updated SCP each time. HN-STAR encompasses important methods of improving survivorship care (e.g., needs assessment, tailored interventions, dissemination of guidelines) and will be evaluated in a pragmatic trial to maximize external validity. This hybrid type 1 implementation-effectiveness trial tests HN-STAR effectiveness while studying barriers and facilitators to implementation in community oncology practices within the National Cancer Institute Community Oncology Research Program. Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic visit. The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care. Implementation outcomes will be assessed of survivors, providers, and clinic stakeholders. The hybrid design will provide insight into a dose-response relationship between the extent of implementation fidelity and effectiveness outcomes, as well as how to incorporate HN-STAR into standard practice outside the research setting.
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Phase II trialHyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer: Quality of life in a prospective phase I/II trial

Abstract

Background and purpose

Materials and methods

Results

Conclusions

Section snippets

Materials and methods

Results

Discussion

Conclusion

Acknowledgements

Int J Radiat Oncol Biol Phys

Radiother Oncol

Radiother Oncol

Radiother Oncol

Radiother Oncol

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13

J Clin Oncol

High survival and organ function rates after primary chemoradiotherapy for intermediate-stage squamous cell carcinoma of the head and neck treated in a multicenter phase II trial

J Clin Oncol

Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis

Clin Otolaryngol

Phase II trial
Hyperfractionated, accelerated radiotherapy for locally advanced head and neck cancer: Quality of life in a prospective phase I/II trial