The use of docetaxel as a radiosensitizer in patients with head and neck cancer unsuitable for cisplatin based chemoradiation: Landmark 3-year survival analysis of a randomized phase III trial (DHANUSH).
Abstract
6086 Background: Patients with cisplatin-ineligible locally advanced head and neck squamous cell carcinoma (LA-HNSCC) have limited guideline-recommended treatment options. DHANUSH (CTRI/2017/05/008700), an open-label, phase II/III randomized controlled trial, was among the first studies to demonstrate superior disease-free survival (DFS) and overall survival (OS) in this patient population. Here, we present the 3-year landmark survival analysis update of our study cohort. Methods: This was a single-centre, open-label, randomized controlled phase II/III study conducted at our institute between July 2017 and May 2021. Cisplatin-ineligible patients with LA-HNSCC who were planned for definitive or adjuvant chemoradiation in the multidisciplinary joint clinic were enrolled. Patients were randomly assigned in a 1:1 ratio to receive either radiation therapy alone or concurrent weekly docetaxel (15 mg/m²) for up to seven cycles. The primary endpoint of the study was 2-year disease-free survival (DFS). Here, we present the 3-year landmark survival update, including disease-free (DFS) and overall survival (OS), as of January 25, 2025. Results: The study recruited 356 patients, with 179 receiving concurrent docetaxel and 177 receiving radiation therapy alone. The median follow-up for the entire cohort was 67.9 months (95% CI, 65.7–70.3). At the time of the median follow-up, 123 deaths occurred in the concurrent docetaxel arm compared to 136 deaths in the radiation therapy alone arm. The median DFS in the concurrent docetaxel arm was 11.9 months (95% CI, 8.3–21.7) compared to 5.9 months (95% CI, 4.9–8.2) in the radiation therapy alone arm (p = 0.003). Similarly, the median OS was 23.1 months (95% CI, 17.4–30.6) in the concurrent docetaxel arm versus 15.3 months (95% CI, 13.9–22.3) in the radiation therapy alone arm (p = 0.048). The 3-year DFS was 36.3% (95% CI, 29.9–44.1) in the concurrent docetaxel arm versus 23.2% (95% CI, 17.7–30.3) in the radiation therapy alone arm. Similarly, the 3-year OS was 40.2% (95% CI, 33.7–48.1) in the concurrent docetaxel arm compared to 28.8% (95% CI, 22.9–36.3) in the radiation therapy alone arm. Conclusions: The addition of concurrent docetaxel to radiation therapy significantly improved survival outcomes (DFS and OS) in cisplatin-ineligible LA-HNSCC patients at the 3-year survival landmark. Clinical trial information: CTRI/2017/05/008700 .
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (15)
Sneha Dhar
Tata Memorial Hospital, Mumbai, India
Vanita Noronha
Kumar Prabhash, MD, DM, MBBS, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India, Department of Medical Oncology, Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, India; Vanita Noronha, MD, DM, MBBS, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India; Akash Pawar, MSc, Department of Statistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute (HBNI), Mumbai, India, Ankush Shetake, MSc, Department of Statistics, Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, India; and Rajendra Badwe, MS, Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India
Minit Jalan Shah
Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
Nandini Sharrel Menon
Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
Vijay Maruti Patil
Hinduja Hospital, Mumbai, India
Sarbani Ghosh Laskar
Tata Memorial Centre, Mumbai, India
Ashwini Narsingrao Budrukkar
Tata Memorial Centre, Mumbai, India
Monali Swain
Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
Shwetabh Sinha
ACTREC, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Anuj Kumar S.
ACTREC, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Nivedita Chakrabarty
ACTREC, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India
Amit Janu
Tata Memorial Centre, Mumbai, Maharashtra, India
Kamesh Maske
Tata Memorial Hospital, Mumbai, India
Ankush Shetake
Kumar Prabhash, MD, DM, MBBS, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India, Department of Medical Oncology, Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, India; Vanita Noronha, MD, DM, MBBS, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India; Akash Pawar, MSc, Department of Statistics, Advanced Centre for Treatment, Research and Education in Cancer, Homi Bhabha National Institute (HBNI), Mumbai, India, Ankush Shetake, MSc, Department of Statistics, Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur, India; and Rajendra Badwe, MS, Department of Surgical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India
Kumar Prabhash
Department of Medical Oncology, Division of Adult Solid Tumor Oncology, Tata Memorial Hospital, Mumbai, India