A Q-TWiST Analysis Comparing Nivolumab and Therapy of Investigator’s Choice in Patients with Recurrent/Metastatic Platinum-Refractory Squamous Cell Carcinoma of the Head and Neck

Abstract

ObjectivesIn the CheckMate 141 trial (NCT02105636), nivolumab demonstrated survival, health-related quality of life, and healthcare resource utilization benefits vs single-agent therapy of investigator’s choice (IC) (methotrexate, docetaxel or cetuximab) in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). We assessed between-treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST).MethodsSurvival data from CheckMate 141 (nivolumab, n = 240; IC, n = 121) was partitioned into toxicity (TOX), time without symptoms or toxicity (TWiST), and relapse (REL). TOX was defined as time spent with all-cause grade 3–4 adverse events after randomization, before disease progression. TWiST was defined as time not in TOX or REL. REL was defined as time between disease progression and death. Utility values derived from three-level EuroQol five-dimensional questionnaire data from CheckMate 141 were used to calculate Q-TWiST as the utility-weighted sum of the mean duration in each health state.ResultsThe between-group difference in Q-TWiST score was 1.23 months (95% confidence interval 1.17–1.29) favoring nivolumab (p < 0.001). The nivolumab group experienced significantly longer mean time in TWiST (3.82 vs 2.78 months) and REL (4.02 vs 3.30 months) compared with the IC group (p < 0.001). Mean time in TOX was lower for nivolumab vs IC (0.30 vs 0.37 months, p < 0.001).ConclusionsIn CheckMate 141, nivolumab resulted in statistically significant and clinically meaningful gains (relative difference > 10%) in quality-adjusted survival vs standard of care in patients with R/M SCCHN.

Quality of life and Q-TWiST were not adversely affected in Ewing sarcoma patients treated with combined anlotinib, irinotecan, and vincristine

“…We noticed a large portion of area under curve of TOX rather than TWiST in our study, which was also in accordance with other trials for advanced solid tumors [48–50] . However, the most significant part of these curves is how could we improve the Q-TWiST with improvement of drug or methods over time.…”

“…We noticed a large portion of area under curve of TOX rather than TWiST in our study, which was also in accordance with other trials for advanced solid tumors. [48][49][50] However, the most significant part of these curves is how could we improve the Q-TWiST with improvement of drug or methods over time. However, because of insufficient QoL data on advanced Ewing's sarcoma and other trials, no comparison could be made to identify the advantages and disadvantages of this treatment.…”

Galvos Ir Kaklo Plokščiųjų Ląstelių Karcinomos Gydymas Pd-1 Inhibitorių Imunoterapija

“…Retesnės pacientų nepageidaujamos reakcijos, jis toleruojamas geriau [16]. Nivolumabą vartojusių pacientų gyvenimo kokybė taip pat geresnė, jie rečiau skundžiasi nuovargiu, dispnėja ir apetito nebuvimu, skausmu bei jutimo (skonio bei kvapo) problemomis, nei gydomi standartiniais medikamentais [17]. Geresnė šio PD-1 inhibitoriaus tolerancija, lyginant su alternatyviu gydymu kitais medikamentais, stebima tiek jaunesnių, tiek vyresnių pacientų grupėje.…”

La qualité de vie dans les essais thérapeutiques d’inhibiteurs de checkpoints immunitaires

“…On peut notamment retenir une différence significative entre les 2 bras en terme de fatigue, de dyspnée et de perte d'appétit sur l'échelle QLQ-C30 et en terme de douleurs et de neuropathie sur l'échelle EORTC QLQ-H&N35 en faveur du bras nivolumab. L'analyse Q-TWIST confirme ces données puisqu'elle retrouve une amélioration statistiquement significative du score de Q-TWIST en faveur du bras nivolumab (22).…”