Trial Outcomes & Findings for Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer (NCT NCT04030455)

Cisplatin, Docetaxel, and Pembrolizumab in Treating Patients With Stage II-III Laryngeal Cancer

To determine the clinical benefit rate (CBR) of patients with stage II or III larynx squamous cell carcinoma (SCC) after 2 cycles of pembrolizumab, cisplatin and docetaxel (PCD), and the pathologic complete response (pCR) rate after 4 cycles of PCD. The CBR rate of patients with stage II or III larynx SCC after 2 cycles of PCD is 100%, excluding one patient (measurable data not available). The pCR rate after 4 cycles of PCD is 75.0%. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), diseappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions

Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy

To determine the laryngeal preservation rate (LPR) at 2 years in the overall population and in the subgroup who achieves a pCR. KM method was used. The larynx preservation rate is calculated by dividing the number of patients who did not need a laryngectomy (either total or partial) after initial treatment by the total number of patients who were candidates for such a treatment.

Relapse free survival is defined as the time from study registration to recurrence after local therapy or death from any cause. Recurrence was counted only if it occurred after definitive local therapy (surgery and/or radiotherapy). Patients achieving durable complete responses to PCD without local therapy, and patients receiving local therapy without subsequent recurrence, were censored at last follow-up.

Overall survival is defined from study registration to death due to any cause or to the date of censoring measure at the last contact. KM method was used.

To determine swallow function using Dynamic Imaging Grade of Swallowing Toxicity (DIGEST). DIGEST is a validated psychometric tool used during modified barium swallow studies (MBSSs) to grade swallowing safety, efficiency, and overall pharyngeal swallow function. Scores ranging from 0 to 4, where 0 indicates no impairment, 1=mild, 2=moderate, 3=severe, 4=life threatening. The DIGEST grade was collected at three time points: baseline, 6 months post-treatment and long-term follow-up. One subject without any DIGEST data was excluded from analysis. A linear mixed-effects model was used to evaluate the effects of treatment group (chemo-IO alone vs. radiation/surgery) and time on DIGEST grade across three time points.