Prophylactic Cranial Irradiation in Patients With High-Risk Metastatic Non-Small Cell Lung Cancer: Quality of Life and Neurocognitive Analysis of a Randomized Phase II Study

Maldonado, F.; González-Ling, Ana; Oñate‐Ocaña, Luis F.; Cabrera-Miranda, Luis; Zatarain-Barrón, Zyanya Lucía; Turcott, J.; Flores‐Estrada, Diana; Lozano-Ruiz, Francisco; Cacho-Díaz, Bernardo; Arrieta, Óscar

doi:10.1016/j.ijrobp.2021.04.017

Cited by 6 publications

(1 citation statement)

References 41 publications

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“…In terms of QoL, there was no significant difference in the baseline QoL ( 38 ) scores between the three groups; after treatment, the QoL in the SCA and CON group were significantly improved; while the physical/emotional status of DOX group were better than before treatment, but the social/functional status were decreased. These results indicate that compared with single-agent DOX group, single-agent SCA or combination therapy can effectively improve the QoL of patients.…”

Section: Discussionmentioning

confidence: 79%

Efficacy and Safety of Docetaxel and Sodium Cantharidinate Combination vs. Either Agent Alone as Second-Line Treatment for Advanced/Metastatic NSCLC With Wild-Type or Unknown EGFR Status: An Open-Label, Randomized Controlled, Prospective, Multi-Center Phase III Trial (Cando-L1)

Deng

Zhang

et al. 2021

Front. Oncol.

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Second-line treatment options for advanced/metastatic non-small cell lung cancer (NSCLC) patients are limited. We aimed to evaluate the efficacy and safety of docetaxel/sodium cantharidinate combination vs. either agent alone as second-line treatment for advanced/metastatic NSCLC patients with wild-type or unknown EGFR status. A randomized, open-label, phase III study was performed at 12 institutions. Patients with failure of first-line platinum regimens were randomized to receive either single-agent sodium cantharivsdinate (SCA) or single-agent docetaxel (DOX) or docetaxel/sodium cantharidinate combination (CON). The primary endpoints were centrally confirmed progression-free survival (PFS) and overall survival (OS). The secondary endpoints were objective response rate (ORR), disease control rate (DCR), quality of life (QoL) and toxicity. A total of 148 patients were enrolled in our study between October 2016 and March 2020. After a median follow-up time of 8.02 months, no significant difference was observed among the three groups in ORR (SCA vs. DOX vs. CON: 6.00% vs. 8.33% vs. 10.00%, respectively; p=0.814) and DCR (74.00% vs. 52.00% vs. 62.50%, respectively; p=0.080). In additional, the mOS was significantly higher in the CON group, compared with the single-agent groups (7.27 vs. 5.03 vs. 9.83 months, respectively; p=0.035), while no significant differences were observed in terms of PFS (2.7 vs. 2.9 vs. 3.1 months, respectively; p=0.740). There was no significant difference in the baseline QoL scores between the three groups (p>0.05); after treatment, life quality in SCA and CON group was significantly better than that in the DOX group (p<0.05). Furthermore, the incidence of adverse events (AEs) in the SCA group was significantly lower (46.00 vs. 79.17 vs. 25.00%, respectively; p=0.038) and the incidence of grade ≥3 AEs was also significantly lower in the SCA group compared with the DOX and CON groups (10.00 vs. 82.00 vs. 30.00%, respectively; p=0.042). Single-agent SCA and single-agent DOX has similar therapeutic efficacy in the second-line treatment of advanced/metastatic NSCLC with wild-type or unknown EGFR status, but single-agent SCA has fewer AEs and better QoL. Also, SCA plus DOX can significantly improve OS and exerted a significant synergistic effect, with good safety and tolerance profile.

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Section: Discussionmentioning

confidence: 79%

Efficacy and Safety of Docetaxel and Sodium Cantharidinate Combination vs. Either Agent Alone as Second-Line Treatment for Advanced/Metastatic NSCLC With Wild-Type or Unknown EGFR Status: An Open-Label, Randomized Controlled, Prospective, Multi-Center Phase III Trial (Cando-L1)

Deng

Zhang

et al. 2021

Front. Oncol.

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Identification of a high-risk group for brain metastases in non-small cell lung cancer patients

et al. 2021

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Purpose: Identi cation of a truly high-risk group of brain metastases (BM) in patients with non-small cell lung cancer (NSCLC) could lead to early interventions and probably better prognosis. The objective of the study was to identify this group by generating a multivariable model with recognized and accessible risk factors.Methods: A retrospective cohort from patients seen at a single center during 2010-2020, was divided into a training (TD) and validation (VD) datasets, associations with BM were measured in the TD with logit, variables signi cantly associated were used to generate a multivariate model. Model´s performance was measured by 10-Fold cross validation of the TD and in the VD with the AUC/C-statistic, Akaike information index, and Press´s Q precision test.Results: From 570 patients with NSCLC with complete records a TD and VD were formed, no signi cant differences were found amid both datasets. Variables associated with BM in the multivariate logit analyses were age [P 0.021, OR 0.97 (95%CI 0.94-0.99)]; male gender [P 0.010, OR 2.44 (95%CI 1.24-4.82)]; mutational status [P 0.03, OR 2.1 (95%CI 1.07-4.12); and carcinoembryonic antigen levels [P 0.002, OR 1.002 (95%CI 1.001 -1.003). BM were diagnosed in 23% of the whole cohort. Strati cation into low, medium, or high-risk groups after simpli cation of the model, displayed a frequency of BM in the VD of 8%, 16% and 40% respectively (P 0.027). Conclusion:A multivariate model comprising age, gender, CEA, and mutation status allowed the identi cation of a truly high-risk group of BM in NSCLC patients.

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Nitroglycerin Plus Whole Intracranial Radiation Therapy for Brain Metastases in Patients With Non-Small Cell Lung Cancer: A Randomized, Open-Label, Phase 2 Clinical Trial

Arrieta¹,

Hernández‐Pedro²,

Maldonado

et al. 2023

International Journal of Radiation Oncology*Biology*Physics

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Prophylactic Cranial Irradiation in Patients With High-Risk Metastatic Non-Small Cell Lung Cancer: Quality of Life and Neurocognitive Analysis of a Randomized Phase II Study

Cited by 6 publications

References 41 publications

Efficacy and Safety of Docetaxel and Sodium Cantharidinate Combination vs. Either Agent Alone as Second-Line Treatment for Advanced/Metastatic NSCLC With Wild-Type or Unknown EGFR Status: An Open-Label, Randomized Controlled, Prospective, Multi-Center Phase III Trial (Cando-L1)

Efficacy and Safety of Docetaxel and Sodium Cantharidinate Combination vs. Either Agent Alone as Second-Line Treatment for Advanced/Metastatic NSCLC With Wild-Type or Unknown EGFR Status: An Open-Label, Randomized Controlled, Prospective, Multi-Center Phase III Trial (Cando-L1)

Identification of a high-risk group for brain metastases in non-small cell lung cancer patients

Nitroglycerin Plus Whole Intracranial Radiation Therapy for Brain Metastases in Patients With Non-Small Cell Lung Cancer: A Randomized, Open-Label, Phase 2 Clinical Trial

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