Effect of time-of-day nivolumab and stereotactic body radiotherapy in metastatic head and neck squamous cell carcinoma: A secondary analysis of a prospective randomized trial Journal Article
| Authors: | Janopaul-Naylor, J. R.; Boe, L.; Yu, Y.; Sherman, E. J.; Pfister, D. G.; Lee, N. Y.; McBride, S. |
| Article Title: | Effect of time-of-day nivolumab and stereotactic body radiotherapy in metastatic head and neck squamous cell carcinoma: A secondary analysis of a prospective randomized trial |
| Abstract: | Background: Prior work documented circadian rhythm impacts on efficacy and toxicity of cancer therapies. Methods: Secondary analysis of prospective, phase II trial of metastatic HNSCC randomized to nivolumab+/−SBRT. Used cutoffs of 1100 and 1630. Timing classified by first infusion or majority of SBRT (e.g., PM SBRT defined by two or three fractions after 1630). Results: Of 62 patients, there was no significant difference in median PFS between AM nivolumab (n = 7, 175 days), PM nivolumab (n = 21, 58 days), or Mid-Day nivolumab (n = 34, 67 days; p = 0.8). There was no significant difference in median PFS with AM SBRT (n = 4, 78 days), PM SBRT (n = 13, 111 days), or Mid-Day SBRT (n = 15, 63 days; p = 0.8). There was no significant difference in Grade 3–4 toxicity or ORR. Sensitivity analyses with other timepoints were negative. Conclusions: Further work may elucidate circadian impacts on select patients, tumors, and therapies; however, we found no significant effect in this study. © 2024 Wiley Periodicals LLC. |
| Keywords: | adult; cancer survival; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; major clinical study; overall survival; clinical trial; mortality; multimodality cancer therapy; unspecified side effect; cancer radiotherapy; combined modality therapy; prospective study; prospective studies; cancer immunotherapy; metastasis; progression free survival; phase 2 clinical trial; randomized controlled trial; drug administration schedule; pathology; time factors; immunotherapy; head and neck cancer; head and neck neoplasms; radiation dose fractionation; radiosurgery; stereotactic body radiotherapy; drug administration; stereotactic body radiation therapy; therapy; head and neck tumor; secondary analysis; head and neck squamous cell carcinoma; randomized controlled trial (topic); phase 2 clinical trial (topic); circadian rhythm; time factor; procedures; overall response rate; response evaluation criteria in solid tumors; Common Terminology Criteria for Adverse Events; nivolumab; time to treatment; very elderly; intention to treat analysis; humans; human; male; female; article; median survival time; patient history of chemotherapy; nasopharynx squamous cell carcinoma; oropharynx squamous cell carcinoma; monoclonal antibody therapy; squamous cell carcinoma of head and neck; immunological antineoplastic agent; antineoplastic agents, immunological; chrono-oncology |
| Journal Title: | Head & Neck |
| Volume: | 46 |
| Issue: | 9 |
| ISSN: | 1043-3074 |
| Publisher: | John Wiley & Sons, Inc. |
| Date Published: | 2024-09-01 |
| Start Page: | 2292 |
| End Page: | 2300 |
| Language: | English |
| DOI: | 10.1002/hed.27825 |
| PUBMED: | 38794815 |
| PROVIDER: | scopus |
| PMCID: | PMC11305937 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PubMed record and PDF. Corresponding MSK author is James R. Janopaul-Naylor -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work