Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2020 Dec;9(24):9256-9265.
doi: 10.1002/cam4.3529. Epub 2020 Oct 19.

Phase II trial of individualized/dynamic cisplatin regimens for definitive concurrent chemoradiation therapy in patients with head and neck squamous cell carcinoma

Dongbin Ahn  1 , Gil Joon Lee  1 , Jin Ho Sohn  1 , Jeong Eun Lee  2
Affiliations
Clinical Trial

Phase II trial of individualized/dynamic cisplatin regimens for definitive concurrent chemoradiation therapy in patients with head and neck squamous cell carcinoma

Dongbin Ahn et al. Cancer Med. 2020 Dec.

Abstract

The current standard cisplatin regimen for concurrent chemoradiation therapy (CCRT) involves generalized static administration of cisplatin without considering patient characteristics and patient/tumor responses during treatment. We aimed to evaluate the oncological feasibility of individualized/dynamic cisplatin regimens for definitive CCRT in patients with head and neck squamous cell carcinoma (HNSCC). This prospective, single-center study enrolled patients with biopsy-confirmed HNSCC for whom CCRT was indicated as the primary treatment. Concurrent with radiation therapy (RT), patients received individualized and dynamically modified cisplatin chemotherapy based on patient characteristics, such as age and Eastern Cooperative Oncology Group performance status (PS), and patient/tumor treatment responses. The primary endpoints of the study were grade ≥3 toxicity and progression-free survival (PFS). The study enrolled 150 patients; 146 (97.3%) received ≥2 cycles of cisplatin in addition to scheduled RT. Incidence of any grade 3-4 toxicities was 40.7% (61/150). During the 40.1 ± 25.1-month follow-up period, the 2-year locoregional control, distant control, PFS, disease-specific survival, and overall survival were 81.7%, 89.2%, 73.0%, 89.2%, and 86.1%, respectively. The treatment compliance and grade ≥3 toxicities did not differ between patients aged <70 years and ≥70 years, or those with PS 0 and PS 1-2, respectively. CCRT using individualized, dynamic cisplatin regimens based on patient age, PS, and patient/tumor responses during treatment was oncologically safe and effective for treating patients with HNSCC, including those aged ≥70 years and with PS 1-2.

Keywords: chemoradiotherapy; cisplatin; head and neck squamous cell carcinoma; performance status; protocol; toxicity.

PubMed Disclaimer

Figures

FIGURE 1
FIGURE 1
Kaplan‐Meier curves for oncological outcomes. DSS, disease‐specific survival; LR, locoregional; OS, overall survival; PFS, progression‐free survival
FIGURE 2
FIGURE 2
Kaplan‐Meier curves for comparing oncological outcomes between patients aged <70 and ≥70. DSS, disease‐specific survival; LR, locoregional; OS, overall survival; PFS, progression‐free survival
FIGURE 3
FIGURE 3
Kaplan‐Meier curves for comparing oncological outcomes between patients with PS 0 and PS 1‐2. DSS, disease‐specific survival; LR, locoregional; OS, overall survival; PFS, progression‐free survival; PS, performance status
See this image and copyright information in PMC

References

    1. Cooper JS, Pajak TF, Forastiere AA, et al. Postoperative concurrent radiotherapy and chemotherapy for high‐risk squamous‐cell carcinoma of the head and neck. N Engl J Med. 2004;350:1937‐1944. - PubMed
    1. Bernier J, Domenge C, Ozsahin M, et al. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004;350:1945‐1952. - PubMed
    1. Adelstein DJ, Li YI, Adams GL, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003;21:92‐98. - PubMed
    1. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091‐2098. - PubMed
    1. Grégoire V, Lefebvre J‐L, Licitra L, Felip E. Squamous cell carcinoma of the head and neck: EHNS‐ESMO‐ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow‐up. Ann Oncol. 2010;21(Suppl 5):v184‐186. - PubMed

Publication types

MeSH terms