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Purpose <p>In the RATIONALE-307 trial, favorable overall survival (OS) outcomes with tislelizumab plus chemotherapy versus chemotherapy alone have been reported, along with improvements in patient-reported outcomes (PROs), including global health status/quality of life (GHS/QoL) and lung cancer–specific symptoms such as cough and dyspnea. Here, we aimed to evaluate the association between patient-reported symptoms and OS among patients with first-line advanced sq-NSCLC.</p> Methods <p>PROs were assessed using the EORTC QLQ-C30 and QLQ-LC13 instruments. A novel three-component joint model (JM) was developed, linking linear mixed and Cox models to evaluate associations between PRO change from baseline scores, recurrent-symptomatic deterioration (RS-D) events, and OS. The association between PROs and OS was summarized via association-effect hazard ratios (HRs) from the JMs.</p> Results <p>Overall, 328 patients were included: 111 in the tislelizumab plus paclitaxel–carboplatin arm (Tisle + PC), 110 in the tislelizumab plus nab-paclitaxel–carboplatin arm (Tisle + nPC), and 107 in the paclitaxel–carboplatin (PC) alone arm. Compared to PC alone, Tisle + PC and Tisle + nPC arms significantly improved GHS/QoL (mean difference: 6.29 and 10.23, respectively; both <i>p</i> &lt; 0.05). Dyspnea significantly improved in both Tisle arms; chest pain improved in the Tisle + nPC arm only. In the Tisle + PC arm, chest pain and cough were significantly associated with a 36.3% reduced risk of death (both HRs = 0.64; <i>p</i> = 0.02).</p> Conclusion <p>In this analysis, compared to PC alone, Tisle + PC improved GHS/QoL and dyspnea in both arms, while chest pain improvement was observed only with Tisle + nPC.</p>

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Prognostic associations between patient-reported outcomes and overall survival among patients with advanced squamous non-small cell lung cancer: results from the RATIONALE-307 trial

  • 期刊论文

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  • 发表日期：

    2026年6月19日

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  • Jie Wang,
  • Xinmin Yu,
  • Shiangjiin Leaw,
  • Frederick B. Barnes,
  • Timothy Victor,
  • Gisoo Barnes

摘要

Purpose

In the RATIONALE-307 trial, favorable overall survival (OS) outcomes with tislelizumab plus chemotherapy versus chemotherapy alone have been reported, along with improvements in patient-reported outcomes (PROs), including global health status/quality of life (GHS/QoL) and lung cancer–specific symptoms such as cough and dyspnea. Here, we aimed to evaluate the association between patient-reported symptoms and OS among patients with first-line advanced sq-NSCLC.

Methods

PROs were assessed using the EORTC QLQ-C30 and QLQ-LC13 instruments. A novel three-component joint model (JM) was developed, linking linear mixed and Cox models to evaluate associations between PRO change from baseline scores, recurrent-symptomatic deterioration (RS-D) events, and OS. The association between PROs and OS was summarized via association-effect hazard ratios (HRs) from the JMs.

Results

Overall, 328 patients were included: 111 in the tislelizumab plus paclitaxel–carboplatin arm (Tisle + PC), 110 in the tislelizumab plus nab-paclitaxel–carboplatin arm (Tisle + nPC), and 107 in the paclitaxel–carboplatin (PC) alone arm. Compared to PC alone, Tisle + PC and Tisle + nPC arms significantly improved GHS/QoL (mean difference: 6.29 and 10.23, respectively; both p < 0.05). Dyspnea significantly improved in both Tisle arms; chest pain improved in the Tisle + nPC arm only. In the Tisle + PC arm, chest pain and cough were significantly associated with a 36.3% reduced risk of death (both HRs = 0.64; p = 0.02).

Conclusion

In this analysis, compared to PC alone, Tisle + PC improved GHS/QoL and dyspnea in both arms, while chest pain improvement was observed only with Tisle + nPC.