A randomized phase 3 trial comparing nimotuzumab plus cisplatin chemoradiotherapy versus cisplatin chemoradiotherapy alone in locally advanced head and neck cancer.

Autor: Patil VM; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Noronha V; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Joshi A; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Agarwal J; Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India., Ghosh-Laskar S; Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India., Budrukkar A; Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India., Murthy V; Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India., Gupta T; Department of Radiation Oncology, Tata Memorial Hospital, HBNI, Mumbai, India., Mahimkar M; Mahimkar Laboratory, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India., Juvekar S; Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India., Arya S; Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India., Mahajan A; Department of Radiology, Tata Memorial Hospital, HBNI, Mumbai, India., Agarwal A; Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India., Purandare N; Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India., Rangarajan V; Department of Nuclear Medicine, Tata Memorial Hospital, HBNI, Mumbai, India., Balaji A; Department of Speech and Therapy, Tata Memorial Hospital, HBNI, Mumbai, India., Chaudhari SV; Biocon Ltd, Bengaluru, India., Banavali S; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Kannan S; Department of Biostatistics, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India., Bhattacharjee A; Department of Epidemiology, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India., D'Cruz AK; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Chaturvedi P; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Pai PS; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Chaukar D; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Pantvaidya G; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Nair D; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Nair S; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Deshmukh A; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Thiagarajan S; Department of Head and Neck Surgery, Tata Memorial Hospital, HBNI, Mumbai, India., Mathrudev V; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Manjrekar A; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Dhumal S; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Maske K; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Bhelekar AS; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Nawale K; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Chandrasekharan A; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Pande N; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Goel A; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Talreja V; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Simha V; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Srinivas S; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Swami R; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Vallathol DH; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Dsouza H; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Shrirangwar S; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Turkar S; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Abraham G; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Thanky AH; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India., Patel U; Mahimkar Laboratory, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India., Pandey MK; Mahimkar Laboratory, Advanced Center for Treatment, Research, and Education in Cancer, Navi Mumbai, India., Prabhash K; Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2019 Sep 15; Vol. 125 (18), pp. 3184-3197. Date of Electronic Publication: 2019 May 31.
DOI: 10.1002/cncr.32179
Abstrakt: Background: Because the addition of nimotuzumab to chemoradiation in patients with locally advanced head and neck cancer improved outcomes in a phase 2 study, the authors conducted a phase 3 study to confirm these findings.
Methods: This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with locally advanced head and neck cancer who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m 2 ) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT).The primary endpoint was progression-free survival (PFS); key secondary endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). An intent-to-treat analysis also was performed.
Results: In total, 536 patients were allocated equally to both treatment arms. The median follow-up was 39.13 months. The addition of nimotuzumab improved PFS (hazard ratio [HR], 0.69; 95% CI, 0.53-0.89; P = .004), LRC (HR, 0.67; 95% CI, 0.50-0.89; P = .006), and DFS (HR, 0.71; 95% CI, 0.55-0.92; P = .008) and had a trend toward improved OS (HR, 0.84; 95% CI, 0.65-1.08; P = .163). Grade 3 through 5 adverse events were similar between the 2 arms, except for a higher incidence of mucositis in the NCRT arm (66.7% vs 55.8%; P = .01).
Conclusions: The addition of nimotuzumab to concurrent weekly CRT improves PFS, LRC, and DFS. This combination provides a novel alternative therapeutic option to a 3-weekly schedule of 100 mg/m 2 cisplatin in patients with locally advanced head and neck cancer who are treated with radical-intent CRT.
(© 2019 American Cancer Society.)
Databáze: MEDLINE
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