nach oben

International Journal of Clinical Oncology

Erschienen in:

16.10.2023 | Original Article

Multicenter prospective phase II trial of concurrent chemoradiotherapy with weekly low-dose carboplatin for cisplatin-ineligible patients with advanced head and neck squamous cell carcinoma

verfasst von: Yushi Ueki, Shusuke Ohshima, Yusuke Yokoyama, Takeshi Takahashi, Ryusuke Shodo, Keisuke Yamazaki, Kohei Ohtaki, Kohei Saijo, Ryoko Tanaka, Takafumi Togashi, Yuichiro Sato, Satoshi Takano, Jo Omata, Nao Takahashi, Ryuichi Okabe, Arata Horii

Erschienen in: International Journal of Clinical Oncology | Ausgabe 1/2024

Einloggen, um Zugang zu erhalten

Abstract

Background

The optimal chemotherapy regimen in concurrent chemoradiotherapy (CCRT) for cisplatin-ineligible head and neck squamous cell carcinoma (HNSCC) has not been established. We aimed to evaluate the feasibility, efficacy, and safety of CCRT with weekly low-dose carboplatin for the treatment of advanced HNSCC in patients who are cisplatin-ineligible.

Methods

This prospective phase II study enrolled adult patients (age ≥ 20 years) with HNSCC receiving whole-neck irradiation including bilateral levels II–IV and who were aged (≥ 75-year-old patients with 40 mL/min estimated glomerular filtration rate [eGFR] or better) or had renal dysfunction (< 75-year-old patients with 30–60 mL/min eGFR). Carboplatin was administered weekly (area under the plasma concentration–time curve = 2.0) for up to seven cycles during concurrent radiotherapy (70 Gy/35 Fr). The primary endpoint was the completion rate of CCRT. Secondary endpoints included overall response rate and incidence of adverse events.

Results

Among the 30 patients enrolled, 28 were men. The median age was 73.5 years. Seventeen patients were < 75 years whereas 13 were ≥ 75 years old. The completion rate of CCRT was 90%. The overall response rate was 90%. Grade 3 adverse events that occurred in 10% or more patients were oral/pharyngeal mucositis (47%), leukocytopenia (20%), and neutropenia (10%). Grade 4 adverse events occurred in one patient (elevation of alanine aminotransferase level). No treatment-related deaths occurred.

Conclusion

CCRT with weekly low-dose carboplatin is a promising treatment option, with favorable feasibility, efficacy, and acceptable toxicity, for patients who are cisplatin-ineligible with advanced HNSCC.

Clinical Trial Registration Number

jRCTs031190028.

Sung H, Ferlay J, Siegel RL et al (2021) Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71:209–249. https://doi.org/10.3322/caac.21660CrossRefPubMed

Chow LQM (2020) Head and neck cancer. N Engl J Med 382:60–72. https://doi.org/10.1056/NEJMra1715715CrossRefPubMed

Adelstein DJ, Li Y, Adams GL et al (2003) 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 21:92–98. https://doi.org/10.1200/JCO.2003.01.008CrossRefPubMed

Forastiere AA, Goepfert H, Maor M et al (2003) Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med 349:2091–2098. https://doi.org/10.1056/NEJMoa031317CrossRefPubMed

van Hagen P, Hulshof MC, van Lanschot JJ et al (2012) Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med 366:2074–2084. https://doi.org/10.1056/NEJMoa1112088CrossRefPubMed

Bradley JD, Paulus R, Komaki R et al (2015) Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol 16:187–199. https://doi.org/10.1016/S1470-2045(14)71207-0CrossRefPubMedPubMedCentral

Ajani JA, Barthel JS, Bentrem DJ, et al (2011) Esophageal and esophagogastric junction cancers. Offic J Natl Compr Canc Netw 9:830–887 https://doi.org/10.6004/jnccn.2011.0072 (Version 5; 2022). Accessed December, 2022. https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf

National Comprehensive Cancer Network. Non-small cell lung cancer. Accessed December, 2022. https://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf (Version 6; 2022)

Chitapanarux I, Lorvidhaya V, Kamnerdsupaphon P et al (2007) Chemoradiation comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer 43:1399–1406. https://doi.org/10.1016/j.ejca.2007.03.022CrossRefPubMed

10.

Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228–247. https://doi.org/10.1016/j.ejca.2008.10.026CrossRefPubMed

11.

Calvert AH, Newell DR, Gumbrell LA et al (1989) Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 7:1748–1756. https://doi.org/10.1200/jco.1989.7.11.1748CrossRefPubMed

12.

Kataria T, Gupta D, Bisht SS et al (2015) Chemoradiation in elderly patients with head and neck cancers: a single institution experience. Am J Otolaryngol 36:117–121. https://doi.org/10.1016/j.amjoto.2014.07.015CrossRefPubMed

13.

Matsuyama H, Yamazaki K, Okabe R et al (2018) Multicenter phase I/II study of chemoradiotherapy with high-dose CDDP for head and neck squamous cell carcinoma in Japan. Auris Nasus Larynx 45:1086–1092. https://doi.org/10.1016/j.anl.2018.02.008CrossRefPubMed

14.

Suntharalingam M, Haas ML, Conley BA et al (2000) The use of carboplatin and paclitaxel with daily radiotherapy in patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys 47:49–56. https://doi.org/10.1016/s0360-3016(00)00408-9CrossRefPubMed

15.

Kanda Y (2013) Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant 48:452–458. https://doi.org/10.1038/bmt.2012.244CrossRefPubMed

16.

Sun L, Candelieri-Surette D, Anglin-Foote T et al (2022) Cetuximab-based vs carboplatin-based chemoradiotherapy for patients with head and neck cancer. JAMA Otolaryngol Head Neck Surg 148:1022–1028. https://doi.org/10.1001/jamaoto.2022.2791CrossRefPubMedPubMedCentral

17.

Bonner JA, Harari PM, Giralt J et al (2006) Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. New Engl J Med 354:567–578. https://doi.org/10.1056/NEJMoa053422CrossRefPubMed

18.

Wendt TG, Grabenbauer GG, Rödel CM et al (2009) Simultaneous radiochemotherapy versus radiotherapy alone in advanced head and neck cancer: a randomized multicenter study. J Clin Oncol 16:1318–1324. https://doi.org/10.1200/JCO.1998.16.4.1318CrossRef

19.

Ahn MJ, D’Cruz A, Vermorken JB et al (2016) Clinical recommendations for defining platinum unsuitable head and neck cancer patient populations on chemoradiotherapy: a literature review. Oral Oncol 53:10–16. https://doi.org/10.1016/j.oraloncology.2015.11.019CrossRefPubMed

20.

Imai C, Saeki H, Yamamoto K et al (2009) Radiotherapy plus cetuximab for locally advanced squamous cell head and neck cancer in patients with cisplatin-ineligible renal dysfunction: a retrospective study. Oncol Lett 23:152. https://doi.org/10.3892/ol.2022.13271CrossRef

21.

Hamauchi S, Yokota T, Onozawa Y et al (2015) Safety and efficacy of concurrent carboplatin plus radiotherapy for locally advanced head and neck cancer patients ineligible for treatment with cisplatin. Jpn J Clin Oncol 45:1116–1121. https://doi.org/10.1093/jjco/hyv142CrossRefPubMed

22.

Kiyota N, Tahara M, Mizusawa J et al (2022) Weekly cisplatin plus radiation for postoperative head and neck cancer (JCOG1008): a multicenter, noninferiority, phase II/III randomized controlled trial. J Clin Oncol 40:1980–1990. https://doi.org/10.1200/JCO.21.01293CrossRefPubMedPubMedCentral

Titel: Multicenter prospective phase II trial of concurrent chemoradiotherapy with weekly low-dose carboplatin for cisplatin-ineligible patients with advanced head and neck squamous cell carcinoma
verfasst von: Yushi Ueki
Shusuke Ohshima
Yusuke Yokoyama
Takeshi Takahashi
Ryusuke Shodo
Keisuke Yamazaki
Kohei Ohtaki
Kohei Saijo
Ryoko Tanaka
Takafumi Togashi
Yuichiro Sato
Satoshi Takano
Jo Omata
Nao Takahashi
Ryuichi Okabe
Arata Horii
Publikationsdatum: 16.10.2023
Verlag: Springer Nature Singapore
Erschienen in: International Journal of Clinical Oncology / Ausgabe 1/2024
Print ISSN: 1341-9625
Elektronische ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-023-02423-w

Klimawandel und Gesundheit: Was Sie in der Hausarztpraxis wissen müssen und tun können

Springer Medizin

Multicenter prospective phase II trial of concurrent chemoradiotherapy with weekly low-dose carboplatin for cisplatin-ineligible patients with advanced head and neck squamous cell carcinoma