Response assessment after induction chemotherapy for head and neck squamous cell carcinoma: From physical examination to modern imaging techniques and beyond

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Abstract

Significant correlations between the response to induction chemotherapy and success of subsequent radiotherapy have been reported and suggest that the response to induction chemotherapy is able to predict a response to radiotherapy. Therefore, induction chemotherapy may be used to tailor the treatment plan to the individual patient with head and neck cancer: following the planned subsequent (chemo)radiation schedule, planning a radiation dose boost, or reassessing the modality of treatment (eg, upfront surgery). Findings from reported trials suggest room for improvement in clinical response assessment after induction chemotherapy, but an optimal method has yet to be identified. Historically, indices of treatment efficacy in solid tumors have been based solely on systematic assessment of tumor size. However, functional imaging (eg, fluorodeoxyglucose‐positron emission tomography (FDG‐PET) potentially provides an earlier indication of response to treatment than conventional imaging techniques. More advanced imaging techniques are still in an exploratory phase and are not ready for use in clinical practice.

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Most cited references 64

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From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors.

Richard L. Wahl, Heather Jacene, Yvette Kasamon … (2009)

The purpose of this article is to review the status and limitations of anatomic tumor response metrics including the World Health Organization (WHO) criteria, the Response Evaluation Criteria in Solid Tumors (RECIST), and RECIST 1.1. This article also reviews qualitative and quantitative approaches to metabolic tumor response assessment with (18)F-FDG PET and proposes a draft framework for PET Response Criteria in Solid Tumors (PERCIST), version 1.0. PubMed searches, including searches for the terms RECIST, positron, WHO, FDG, cancer (including specific types), treatment response, region of interest, and derivative references, were performed. Abstracts and articles judged most relevant to the goals of this report were reviewed with emphasis on limitations and strengths of the anatomic and PET approaches to treatment response assessment. On the basis of these data and the authors' experience, draft criteria were formulated for PET tumor response to treatment. Approximately 3,000 potentially relevant references were screened. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria is widely applied but still has limitations in response assessments. For example, despite effective treatment, changes in tumor size can be minimal in tumors such as lymphomas, sarcoma, hepatomas, mesothelioma, and gastrointestinal stromal tumor. CT tumor density, contrast enhancement, or MRI characteristics appear more informative than size but are not yet routinely applied. RECIST criteria may show progression of tumor more slowly than WHO criteria. RECIST 1.1 criteria (assessing a maximum of 5 tumor foci, vs. 10 in RECIST) result in a higher complete response rate than the original RECIST criteria, at least in lymph nodes. Variability appears greater in assessing progression than in assessing response. Qualitative and quantitative approaches to (18)F-FDG PET response assessment have been applied and require a consistent PET methodology to allow quantitative assessments. Statistically significant changes in tumor standardized uptake value (SUV) occur in careful test-retest studies of high-SUV tumors, with a change of 20% in SUV of a region 1 cm or larger in diameter; however, medically relevant beneficial changes are often associated with a 30% or greater decline. The more extensive the therapy, the greater the decline in SUV with most effective treatments. Important components of the proposed PERCIST criteria include assessing normal reference tissue values in a 3-cm-diameter region of interest in the liver, using a consistent PET protocol, using a fixed small region of interest about 1 cm(3) in volume (1.2-cm diameter) in the most active region of metabolically active tumors to minimize statistical variability, assessing tumor size, treating SUV lean measurements in the 1 (up to 5 optional) most metabolically active tumor focus as a continuous variable, requiring a 30% decline in SUV for "response," and deferring to RECIST 1.1 in cases that do not have (18)F-FDG avidity or are technically unsuitable. Criteria to define progression of tumor-absent new lesions are uncertain but are proposed. Anatomic imaging alone using standard WHO, RECIST, and RECIST 1.1 criteria have limitations, particularly in assessing the activity of newer cancer therapies that stabilize disease, whereas (18)F-FDG PET appears particularly valuable in such cases. The proposed PERCIST 1.0 criteria should serve as a starting point for use in clinical trials and in structured quantitative clinical reporting. Undoubtedly, subsequent revisions and enhancements will be required as validation studies are undertaken in varying diseases and treatments.

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Reporting results of cancer treatment.

A B Miller, B Hoogstraten, M Staquet … (1981)

On the initiative of the World Health Organization, two meetings on the Standardization of Reporting Results of Cancer Treatment have been held with representatives and members of several organizations. Recommendations have been developed for standardized approaches to the recording of baseline data relating to the patient, the tumor, laboratory and radiologic data, the reporting of treatment, grading of acute and subacute toxicity, reporting of response, recurrence and disease-free interval, and reporting results of therapy. These recommendations, already endorsed by a number of organizations, are proposed for international acceptance and use to make it possible for investigators to compare validly their results with those of others.

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Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort

Laura Q.M. Chow, Robert I Haddad, Shilpa Gupta … (2016)

Purpose Treatment with pembrolizumab, an anti–programmed death-1 antibody, at 10 mg/kg administered once every 2 weeks, displayed durable antitumor activity in programmed death-ligand 1 (PD-L1) –positive recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) in the KEYNOTE-012 trial. Results from the expansion cohort, in which patients with HNSCC, irrespective of biomarker status, received a fixed dose of pembrolizumab at a less frequent dosing schedule, are reported. Patients and Methods Patients with R/M HNSCC, irrespective of PD-L1 or human papillomavirus status, received pembrolizumab 200 mg intravenously once every 3 weeks. Imaging was performed every 8 weeks. Primary end points were overall response rate (ORR) per central imaging vendor (Response Evaluation Criteria in Solid Tumors v1.1) and safety. Secondary end points included progression-free survival, overall survival, and association of response and PD-L1 expression. Patients who received one or more doses of pembrolizumab were included in analyses. Results Of 132 patients enrolled, median age was 60 years (range, 25 to 84 years), 83% were male, and 57% received two or more lines of therapy for R/M disease. ORR was 18% (95% CI, 12 to 26) by central imaging vendor and 20% (95% CI, 13 to 28) by investigator review. Median duration of response was not reached (range, ≥ 2 to ≥ 11 months). Six-month progression-free survival and overall survival rates were 23% and 59%, respectively. By using tumor and immune cells, a statistically significant increase in ORR was observed for PD-L1–positive versus –negative patients (22% v 4%; P = .021). Treatment-related adverse events of any grade and grade ≥ 3 events occurred in 62% and 9% of patients, respectively. Conclusion Fixed-dose pembrolizumab 200 mg administered once every 3 weeks was well tolerated and yielded a clinically meaningful ORR with evidence of durable responses, which supports further development of this regimen in patients with advanced HNSCC.

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Author and article information

Contributors

Remco de Bree:

ORCID: http://orcid.org/0000-0001-7128-5814

r.debree@umcutrecht.nl

Journal

Journal ID (nlm-ta): Head Neck

Journal ID (iso-abbrev): Head Neck

Journal ID (doi): 10.1002/(ISSN)1097-0347

Journal ID (publisher-id): HED

Title: Head & Neck

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 1043-3074

ISSN (Electronic): 1097-0347

Publication date (Electronic): 17 August 2017

Publication date (Print): November 2017

Volume: 39

Issue: 11 ( doiID: 10.1002/hed.v39.11 )

Pages: 2329-2349

Affiliations

[ ¹ ] Department of Head and Neck Surgical Oncology UMC Utrecht Cancer Center, University Medical Center Utrecht Utrecht The Netherlands

[ ² ] Department of Otolaryngology‐Head and Neck Surgery University of Michigan Health System Ann Arbor Michigan

[ ³ ] Department of Radiology and Nuclear Medicine University Medical Center Utrecht Utrecht The Netherlands

[ ⁴ ] Ear, Nose, and Throat Department, NHS Lothian Edinburgh UK

[ ⁵ ] Department of Otolaryngology ‐ Head and Neck Surgery Institut Gustave Roussy Villejuif Cedex France

[ ⁶ ] Laboratoire de Phonétique et de Phonologie Sorbonne Nouvelle Paris France

[ ⁷ ] Department of Oncology The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine Baltimore Maryland

[ ⁸ ] Department of Medicine Division of Oncology, Albert Einstein College of Medicine, Montefiore Medical Center Bronx New York

[ ⁹ ] University of Udine School of Medicine Udine Italy

[ ¹⁰ ] Instituto Universitario de Oncología del Principado de Asturias University of Oviedo Oviedo Spain

[ ¹¹ ] Department of Otolaryngology Hospital Universitario Central de Asturias Oviedo Spain

[ ¹² ] Department of Hematology and Medical Oncology The Winship Cancer Institute of Emory University Atlanta Georgia

[ ¹³ ] Fundación de Investigación e Innovación Biosanitaria del Principado de Asturias Oviedo Spain

[ ¹⁴ ] Department of Medical Oncology Antwerp University Hospital Edegem Belgium

[ ¹⁵ ] Coordinator of the International Head and Neck Scientific Group

Author notes

[*] [* ] Correspondence Remco de Bree, Department of Head and Neck Surgical Oncology, UMC Utrecht Cancer Center, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. Email: r.debree@ 123456umcutrecht.nl

Author information

Remco de Bree http://orcid.org/0000-0001-7128-5814

Iain J. Nixon http://orcid.org/0000-0002-8919-8783

Nabil F. Saba http://orcid.org/0000-0003-4972-1477

Article

Publisher ID: HED24883

DOI: 10.1002/hed.24883

PMC ID: 5656833

PubMed ID: 28815841

SO-VID: 6b84b9b2-dd54-4039-b7d2-3ec19c899dfd

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This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

History

Date received : 20 January 2017

Date revision received : 27 April 2017

Date accepted : 31 May 2017

Page count

Figures: 0, Tables: 4, Pages: 21, Words: 12132

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source-schema-version-number 2.0

component-id hed24883

cover-date November 2017

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.2.1 mode:remove_FC converted:26.10.2017

ScienceOpen disciplines: Otolaryngology

Keywords: fluorodeoxyglucose‐positron emission tomography (fdg‐pet),head and neck squamous cell carcinoma,induction chemotherapy,response assessment

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ScienceOpen disciplines: Otolaryngology

Keywords: fluorodeoxyglucose‐positron emission tomography (fdg‐pet), head and neck squamous cell carcinoma, induction chemotherapy, response assessment

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Response assessment after induction chemotherapy for head and neck squamous cell carcinoma: From physical examination to modern imaging techniques and beyond

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Most cited references 64

From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors.

Reporting results of cancer treatment.

Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort

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Cited by 16

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