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

Author(s): Vijay Maruti Patil, MBBS, MD, DM1;Vanita Noronha, MBBS, MD, DM1;Nandini Menon, MBBS, MD, DNB1;Ajay Singh, MBBS, MD, DM1;Sarbani Ghosh-Laskar, MBBS, MD2;Ashwini Budrukkar, MBBS, MD2;Atanu Bhattacharjee, PhD3;Monali Swain, MBBS, MD2;Vijayalakshmi Mathrudev, BHMS, MBA1;Kavita Nawale, PGDCR1;Arun Balaji, MASLP4;Zoya Peelay, MSc1;Mitali Alone, MSc1;Shruti Pathak, MSc1;Abhishek Mahajan, MBBS, MD5;Suman Kumar, MBBS, DNB5;Nilendu Purandare, MBBS, DNB6;Archi Agarwal, MBBS, DNB6;Ameya Puranik, MBBS, DNB6;Shantanu Pendse, MBBS, MD, DM1;Monica Reddy Yallala, MBBS, MD1;Harsh Sahu, MBBS, MD1;Venkatesh Kapu, MBBS, MD1;Sayak Dey, MBBS, MD1;Jatin Choudhary, MBBS, MD1;Madala Ravi Krishna, MBBS, MD1;Alok Shetty, MBBS, MD1;Naveen Karuvandan, MBBS, MD1;Rahul Ravind, MBBS, MD, DM1;Rahul Rai, MBBS, MD1;Kunal Jobanputra, MBBS, MD1;Pankaj Chaturvedi, MBBS, MS7;Prathamesh S. Pai, MBBS, MS7;Devendra Chaukar, MBBS, MS7;Sudhir Nair, MBBS, MS7;Shivakumar Thiagarajan, MBBS, MS7;and Kumar Prabhash, MBBS, MD, DM1
Source: DOI: 10.1200/JCO.22.00980 Journal of Clinical Oncology
Original Article
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Phase II/III study of weekly docetaxel+RT vs. RT alone in cis-ineligible patients. This study was done in India, where oral cancers are an epidemic and possibly biologically unique, as most are related to the use of oral tobacco + betel nut products. >70% of patients were stage IVA / IVB, and HPV was only positive in 4% of patients. Still, the survival benefit was sizeable, and the treatment was tolerable. This is a good option for cis-ineligible HPV-neg patients with bulky disease.

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 ≥ 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 Affiliations

1Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India; 2Department of Radiation Oncology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India; 3Leicester Real World Evidence Unit, Leicester University, Leicester, United Kingdom; 4Department of Speech and Therapy, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India; 5Department of Radiology, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India; 6Department of Nuclear Medicine, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India; 7Department of Head and Neck Surgery, Tata Memorial Hospital, Homi Bhabha National Institute (HBNI), Mumbai, India

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