Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation

Vijay Maruti Patil; Vanita Noronha; Nandini Menon; Ajay Singh; Sarbani Ghosh-Laskar; Ashwini Budrukkar; Atanu Bhattacharjee; Monali Swain; Vijayalakshmi Mathrudev; Kavita Nawale; Arun Balaji; Zoya Peelay; Mitali Alone; Shruti Pathak; Abhishek Mahajan; Suman Kumar; Nilendu Purandare; Archi Agarwal; Ameya Puranik; Shantanu Pendse; Monica Reddy Yallala; Harsh Sahu; Venkatesh Kapu; Sayak Dey; Jatin Choudhary; Madala Ravi Krishna; Alok Shetty; Naveen Karuvandan; Rahul Ravind; Rahul Rai; Kunal Jobanputra; Pankaj Chaturvedi; Prathamesh S. Pai; Devendra Chaukar; Sudhir Nair; Shivakumar Thiagarajan; Kumar Prabhash

doi:10.1200/JCO.22.00980

Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation

Vijay Maruti Patil, Vanita Noronha, Nandini Menon, Ajay Singh, Sarbani Ghosh-Laskar, Ashwini Budrukkar, Atanu Bhattacharjee, Monali Swain, Vijayalakshmi Mathrudev, Kavita Nawale, Arun Balaji, Zoya Peelay, Mitali Alone, Shruti Pathak, Abhishek Mahajan, Suman Kumar, Nilendu Purandare, Archi Agarwal, Ameya Puranik, Shantanu PendseMonica Reddy Yallala, Harsh Sahu, Venkatesh Kapu, Sayak Dey, Jatin Choudhary, Madala Ravi Krishna, Alok Shetty, Naveen Karuvandan, Rahul Ravind, Rahul Rai, Kunal Jobanputra, Pankaj Chaturvedi, Prathamesh S. Pai, Devendra Chaukar, Sudhir Nair, Shivakumar Thiagarajan, Kumar Prabhash (Lead / Corresponding author)

Population Health and Genomics

Research output: Contribution to journal › Article › peer-review

25 Citations (Scopus)

Abstract

PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation.

METHODS This was a randomized phase II/III study. Adult patients (age a-18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS).

RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value =.002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value =.035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value =.035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P <.001), odynophagia (33.5% v 52.5%; P <.001), and dysphagia (33% v 49.7%; P =.002) with the addition of docetaxel.

CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

Original language	English
Pages (from-to)	2350-2361
Number of pages	12
Journal	Journal of Clinical Oncology
Volume	41
Issue number	13
Early online date	27 Jan 2023
DOIs	https://doi.org/10.1200/JCO.22.00980
Publication status	Published - 1 May 2023

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1200/JCO.22.00980

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Patil, V. M., Noronha, V., Menon, N., Singh, A., Ghosh-Laskar, S., Budrukkar, A., Bhattacharjee, A., Swain, M., Mathrudev, V., Nawale, K., Balaji, A., Peelay, Z., Alone, M., Pathak, S., Mahajan, A., Kumar, S., Purandare, N., Agarwal, A., Puranik, A., ... Prabhash, K. (2023). Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation. Journal of Clinical Oncology, 41(13), 2350-2361. https://doi.org/10.1200/JCO.22.00980

@article{e189268dcbfd40698c047656b8522a5a,

title = "Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation",

abstract = "PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation.METHODS This was a randomized phase II/III study. Adult patients (age a-18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS).RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value =.002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value =.035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value =.035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P <.001), odynophagia (33.5% v 52.5%; P <.001), and dysphagia (33% v 49.7%; P =.002) with the addition of docetaxel.CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.",

author = "Patil, {Vijay Maruti} and Vanita Noronha and Nandini Menon and Ajay Singh and Sarbani Ghosh-Laskar and Ashwini Budrukkar and Atanu Bhattacharjee and Monali Swain and Vijayalakshmi Mathrudev and Kavita Nawale and Arun Balaji and Zoya Peelay and Mitali Alone and Shruti Pathak and Abhishek Mahajan and Suman Kumar and Nilendu Purandare and Archi Agarwal and Ameya Puranik and Shantanu Pendse and {Reddy Yallala}, Monica and Harsh Sahu and Venkatesh Kapu and Sayak Dey and Jatin Choudhary and Krishna, {Madala Ravi} and Alok Shetty and Naveen Karuvandan and Rahul Ravind and Rahul Rai and Kunal Jobanputra and Pankaj Chaturvedi and Pai, {Prathamesh S.} and Devendra Chaukar and Sudhir Nair and Shivakumar Thiagarajan and Kumar Prabhash",

note = "Publisher Copyright: {\textcopyright} American Society of Clinical Oncology.",

year = "2023",

month = may,

day = "1",

doi = "10.1200/JCO.22.00980",

language = "English",

volume = "41",

pages = "2350--2361",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "13",

}

Patil, VM, Noronha, V, Menon, N, Singh, A, Ghosh-Laskar, S, Budrukkar, A, Bhattacharjee, A, Swain, M, Mathrudev, V, Nawale, K, Balaji, A, Peelay, Z, Alone, M, Pathak, S, Mahajan, A, Kumar, S, Purandare, N, Agarwal, A, Puranik, A, Pendse, S, Reddy Yallala, M, Sahu, H, Kapu, V, Dey, S, Choudhary, J, Krishna, MR, Shetty, A, Karuvandan, N, Ravind, R, Rai, R, Jobanputra, K, Chaturvedi, P, Pai, PS, Chaukar, D, Nair, S, Thiagarajan, S & Prabhash, K 2023, 'Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation', Journal of Clinical Oncology, vol. 41, no. 13, pp. 2350-2361. https://doi.org/10.1200/JCO.22.00980

Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation. / Patil, Vijay Maruti; Noronha, Vanita; Menon, Nandini et al.
In: Journal of Clinical Oncology, Vol. 41, No. 13, 01.05.2023, p. 2350-2361.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation

AU - Patil, Vijay Maruti

AU - Noronha, Vanita

AU - Menon, Nandini

AU - Singh, Ajay

AU - Ghosh-Laskar, Sarbani

AU - Budrukkar, Ashwini

AU - Bhattacharjee, Atanu

AU - Swain, Monali

AU - Mathrudev, Vijayalakshmi

AU - Nawale, Kavita

AU - Balaji, Arun

AU - Peelay, Zoya

AU - Alone, Mitali

AU - Pathak, Shruti

AU - Mahajan, Abhishek

AU - Kumar, Suman

AU - Purandare, Nilendu

AU - Agarwal, Archi

AU - Puranik, Ameya

AU - Pendse, Shantanu

AU - Reddy Yallala, Monica

AU - Sahu, Harsh

AU - Kapu, Venkatesh

AU - Dey, Sayak

AU - Choudhary, Jatin

AU - Krishna, Madala Ravi

AU - Shetty, Alok

AU - Karuvandan, Naveen

AU - Ravind, Rahul

AU - Rai, Rahul

AU - Jobanputra, Kunal

AU - Chaturvedi, Pankaj

AU - Pai, Prathamesh S.

AU - Chaukar, Devendra

AU - Nair, Sudhir

AU - Thiagarajan, Shivakumar

AU - Prabhash, Kumar

PY - 2023/5/1

Y1 - 2023/5/1

N2 - PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation.METHODS This was a randomized phase II/III study. Adult patients (age a-18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS).RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value =.002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value =.035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value =.035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P <.001), odynophagia (33.5% v 52.5%; P <.001), and dysphagia (33% v 49.7%; P =.002) with the addition of docetaxel.CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

AB - PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation.METHODS This was a randomized phase II/III study. Adult patients (age a-18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS).RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value =.002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value =.035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value =.035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P <.001), odynophagia (33.5% v 52.5%; P <.001), and dysphagia (33% v 49.7%; P =.002) with the addition of docetaxel.CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.

UR - http://www.scopus.com/inward/record.url?scp=85152158567&partnerID=8YFLogxK

U2 - 10.1200/JCO.22.00980

DO - 10.1200/JCO.22.00980

M3 - Article

C2 - 36706347

AN - SCOPUS:85152158567

SN - 0732-183X

VL - 41

SP - 2350

EP - 2361

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 13

ER -

Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation

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