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
Randomized Controlled Trial
. 2021 Mar;36(Suppl 1):S217-S224.
doi: 10.3904/kjim.2019.161. Epub 2020 Apr 3.

Induction chemotherapy followed by concurrent chemoradiotherapy versus CCRT for locally advanced hypopharynx and base of tongue cancer

Sung Hee Lim  1   2 , Jong-Mu Sun  2 , Joohyun Hong  2 , Dongryul Oh  3 , Yong Chan Ahn  3 , Man Ki Chung  4 , Han-Sin Jeong  4 , Young-Ik Son  4 , Myung-Ju Ahn  2 , Chung-Hwan Baek  4 , Keunchil Park  2
Affiliations
Randomized Controlled Trial

Induction chemotherapy followed by concurrent chemoradiotherapy versus CCRT for locally advanced hypopharynx and base of tongue cancer

Sung Hee Lim et al. Korean J Intern Med. 2021 Mar.

Abstract

Background/aims: Clinical trials have not consistently supported the use of induction chemotherapy (IC) for locally advanced head and neck squamous cell cancer. Hypopharynx and base of tongue (BOT) cancer has shown relatively poor survival. We investigated the role of IC in improving outcome over current chemoradiotherapy (CRT) in patients with hypopharynx and BOT cancer.

Methods: Treatment-naïve patients with stage III/IV (M0) hypopharynx or BOT cancer were randomly assigned to receive CRT alone (CRT arm: cisplatin 100 mg/m2 on D1 3-weekly, two times plus radiotherapy 68.4 Gy/30 fractions on weekdays) versus two 21-day cycles of IC with TPF (docetaxel & cisplatin 75 mg/m2 on D1, and fluorouracil 75 mg/m2 on D1-4) followed by the same CRT regimen (IC arm). The primary endpoint was progression-free survival (PFS).

Results: This study closed early after enrollment of 36 patients (19 in the CRT arm, 17 in the IC arm). After a median follow-up of 47.2 months, there was no significant difference in PFS: the median PFS was 26.8 months for the CRT arm and was not reached for the IC arm (p = 0.13). However, the survival curves were widely separated with a plateau after 3 years, suggesting a potential survival benefit from IC: 3-year PFS rates were 45% and 68%, and 3-year overall survival rates were 56% and 86%, in the CRT and IC arms, respectively.

Conclusion: This study failed to demonstrate that induction TPF chemotherapy improves survival in patients with BOT and hypopharynx cancer. However, it suggested a favorable outcome with IC to this population.

Keywords: Base of tongue cancer; Concurrent chemoradiotherapy; Hypopharyngeal neoplasms; Induction chemotherapy; Locally advanced.

PubMed Disclaimer

Conflict of interest statement

Keunchil Park has received honoraria from Abbvie, Astellas, Astra Zeneca, Boehringer Ingelheim, Clovis, Eli Lilly, GSK, Hanmi, Kyowa Hakko Kirin, MSD, ONO, and Roche. Keunchil Park’s institution received research funding from Astra Zeneca.

Figures

Figure 1.
Figure 1.
Flow chart of study schema. CRT, chemoradiotherapy; IC, induction chemotherapy; ITT, intention-to-treat.
Figure 2.
Figure 2.
Kaplan-Meier survival curves by treatment arm and corresponding p values. (A) Progression-free survival, (B) overall survival. IC, induction chemotherapy; CRT, chemoradiotherapy.
Figure 3.
Figure 3.
Subset analysis of progression-free survival for patients with (A) hypopharyngeal cancer, (B) base of tongue cancer. IC, induction chemotherapy; CRT, chemoradiotherapy.
See this image and copyright information in PMC

References

    1. Cohen EE, Karrison TG, Kocherginsky M, et al. Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer. J Clin Oncol. 2014;32:2735–2743. - PMC - PubMed
    1. Haddad R, O’Neill A, Rabinowits G, et al. Induction chemotherapy followed by concurrent chemoradiotherapy (sequential chemoradiotherapy) versus concurrent chemoradiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomised phase 3 trial. Lancet Oncol. 2013;14:257–264. - PubMed
    1. Denis F, Garaud P, Bardet E, et al. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004;22:69–76. - PubMed
    1. Pignon JP, le Maitre A, Maillard E, Bourhis J; MACHNC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009;92:4–14. - PubMed
    1. Hitt R, Lopez-Pousa A, Martinez-Trufero J, et al. Phase III study comparing cisplatin plus fluorouracil to paclitaxel, cisplatin, and fluorouracil induction chemotherapy followed by chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2005;23:8636–8645. - PubMed

Publication types

MeSH terms