TY - JOUR
T1 - Effect of Early Palliative Care on Quality of Life of Advanced Head and Neck Cancer Patients
T2 - A Phase III Trial
AU - Patil, Vijay Maruti
AU - Singhai, Pankaj
AU - Noronha, Vanita
AU - Bhattacharjee, Atanu
AU - Deodhar, Jayita
AU - Salins, Naveen
AU - Joshi, Amit
AU - Menon, Nandini Sharrel
AU - Abhyankar, Anuja
AU - Khake, Ashwini
AU - Dhumal, Sachin Babanrao
AU - Tambe, Rupali
AU - Muckaden, Mary Ann
AU - Prabhash, Kumar
N1 - Publisher Copyright:
© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.
PY - 2021/9/4
Y1 - 2021/9/4
N2 - BACKGROUND: Early palliative care (EPC) is an important aspect of cancer management but, to our knowledge, has never been evaluated in patients with head and neck cancer. Hence, we performed this study to determine whether the addition of EPC to standard therapy leads to an improvement in the quality of life (QOL), decrease in symptom burden, and improvement in overall survival. METHODS: Adult patients with squamous cell carcinoma of the head and neck region planned for palliative systemic therapy were allocated 1:1 to either standard systemic therapy without or with comprehensive EPC service referral. Patients were administered the revised Edmonton Symptom Assessment Scale and the Functional Assessment of Cancer Therapy for head and neck cancer (FACT-H&N) questionnaire at baseline and every 1 month thereafter for 3 months. The primary endpoint was a change in the QOL measured at 3 months after random assignment. All statistical tests were 2-sided. RESULTS: Ninety patients were randomly assigned to each arm. There was no statistical difference in the change in the FACT-H&N total score (P = .94), FACT-H&N Trial Outcome Index (P = .95), FACT-general total (P = .84), and Edmonton Symptom Assessment Scale scores at 3 months between the 2 arms. The median overall survival was similar between the 2 arms (hazard ratio for death = 1.01, 95% confidence interval = 0.74 to 1.35). There were 5 in-hospital deaths in both arms (5.6% for both, P = .99). CONCLUSIONS: In this phase III study, the integration of EPC in head and neck cancer patients did not lead to an improvement in the QOL or survival.
AB - BACKGROUND: Early palliative care (EPC) is an important aspect of cancer management but, to our knowledge, has never been evaluated in patients with head and neck cancer. Hence, we performed this study to determine whether the addition of EPC to standard therapy leads to an improvement in the quality of life (QOL), decrease in symptom burden, and improvement in overall survival. METHODS: Adult patients with squamous cell carcinoma of the head and neck region planned for palliative systemic therapy were allocated 1:1 to either standard systemic therapy without or with comprehensive EPC service referral. Patients were administered the revised Edmonton Symptom Assessment Scale and the Functional Assessment of Cancer Therapy for head and neck cancer (FACT-H&N) questionnaire at baseline and every 1 month thereafter for 3 months. The primary endpoint was a change in the QOL measured at 3 months after random assignment. All statistical tests were 2-sided. RESULTS: Ninety patients were randomly assigned to each arm. There was no statistical difference in the change in the FACT-H&N total score (P = .94), FACT-H&N Trial Outcome Index (P = .95), FACT-general total (P = .84), and Edmonton Symptom Assessment Scale scores at 3 months between the 2 arms. The median overall survival was similar between the 2 arms (hazard ratio for death = 1.01, 95% confidence interval = 0.74 to 1.35). There were 5 in-hospital deaths in both arms (5.6% for both, P = .99). CONCLUSIONS: In this phase III study, the integration of EPC in head and neck cancer patients did not lead to an improvement in the QOL or survival.
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U2 - 10.1093/jnci/djab020
DO - 10.1093/jnci/djab020
M3 - Article
C2 - 33606023
AN - SCOPUS:85116957830
SN - 0027-8874
VL - 113
SP - 1228
EP - 1237
JO - Cancer chemotherapy reports. Part 1
JF - Cancer chemotherapy reports. Part 1
IS - 9
ER -