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Supplemental material, sj-pdf-1-tct-10.1177_15330338231152350 for A Randomized Phase III Study of Anlotinib Versus Bevacizumab in Combination With CAPEOX as First-Line Therapy for RAS/BRAF Wild-Type Metastatic Colorectal Cancer: A Clinical Trial Protocol by Jinjie He, Yue Liu, Chengcheng Liu, Hanguang Hu, Lifeng Sun, Dong Xu, Jun Li, Junye Wang, Xiaobing Chen, Rongbo Lin, Yi Jiang, Yanqiao Zhang, Weisheng Zhang, Ying Cheng, Xiaohong Wu, Mingzhi Fang, Enxiao Li, Ye Xu, Ye Chen, Jiayi Li, Yanyan Cui, Zhanyu Pan, Songnan Zhang, Ying Yuan and Kefeng Ding in Technology in Cancer Research & Treatment

Background: The pretreatment of dexamethasone on the efficacy and immune-related adverse events of immunotherapy involving programmed cell death 1/programmed cell death 1 ligand 1 (PD1/PDL1) inhibitors is an effective option for the first-line treatment of advanced non-small-cell lung cancer (NSCLC). With the immunosuppressive effect, corticosteroids may be used to reduce the efficacy of PDL1 blockade, as well as prevent overactive immune responses, thereby reducing the occurrence of immune-related adverse events (irAEs). This study quantitatively summarized the current evidence, and compared the efficacy and toxicity of therapies involving chemotherapy plus PDL1 inhibitors plus dexamethasone pretreatment (I+C+D) with chemotherapy plus PDL1 inhibitors (I+C) and therapies involving PDL1 inhibitors or chemotherapy alone (I or C). Methods: The protocol of this study was registered with PROSPERO (CRD42021227281). By using a network meta-analysis approach, the different treatments were compared and ranked based on their effectiveness and rates of irAEs at the different grades. Risk rates were determined through direct meta-analysis and indirect treatment comparison. Results: 12 randomized clinical trials were included with a total of 7155 NSCLC patients. Network meta-analysis generated 15 comparisons. The combination treatment of I+C+D showed a longer progression-free survival and overall survival, while I+C was less toxic, and the toxicity of I+C+D or that of I+C had been significantly decreased, compared to that of monotherapy with either drug. According to the ranking analysis, I+C+D is consistently proved to be the most effective therapeutic strategy, while I+C is linked to the lowest rate of irAEs, with the rate of grade value of ≥3 irAEs. Conclusion: The combination treatment of I+C+D is the most effective approach for the first-line treatment of NSCLC patients treated with I+C, I, or C.

Background The traditional Chinese medicine (TCM) formula 01 for nasopharyngeal carcinoma (NPC01) is used in the management of head and neck cancers (HNCs), but whether NPC01 has an impact on the HR-QOL of patients with HNCs is unknown. Methods This was a retrospective study of patients with HNCs who were treated between January 2019 and January 2020 at the Head & Neck Cancer Center of Tianjin Medical University Cancer Institute & Hospital. The patients were grouped according to whether they received NPC01 or not (controls). All patients routinely completed the EORTC QLQ-C30 and QLQ-H&N35 modules before and after 3 months of systemic treatment. Health economics were collected. Results The patients who received NPC01 were older than the controls (48.6 ± 11.4 vs. 43.4 ± 8.8 years, P = 0.004). All other characteristics were comparable between the two groups (all P > 0.05). In EORTC QLQ-C30, physical functioning (P = 0.03), fatigue (P = 0.04), pain (P = 0.02), appetite loss (P = 0.02), and constipation (P = 0.01) scores were improved more in the NPC01 group than in controls. In EORTC H&N35, the scores for pain (P = 0.02), swallowing (P = 0.01), and dry mouth (P = 0.02) were better in the NPC01 group than in controls. The NPC01 cost was 38.94 RMB/patient compared with 12.81 RMB/patient for regular follow-up, but considering insurance coverage, the financial burden was not higher. Conclusions The results suggest that NPC01 improves HNCs-related symptoms and HR-QOL.

Background The purpose of this study was to compare the effects of pemetrexed and carboplatin plus bevacizumab (PC + B) versus pemetrexed and carboplatin (PC) in lung adenocarcinoma patients with EGFR non‐T790M mutations after progression on first‐line EGFR‐tyrosine kinase inhibitors (TKIs). Methods Patients with EGFR‐positive lung adenocarcinoma who had received second‐line PC with or without bevacizumab harboring EGFR non‐T790M mutations after progression on first‐line EGFR‐TKIs between April 2015 and 2017 at Tianjin Medical University Cancer Institute and Hospital were enrolled in the study. The primary endpoint was progression‐free survival and secondary endpoints were overall survival, objective response rate, disease control rate, and safety. Results A total of 85 patients were eligible for the study: 55 and 30 cases were enrolled in the PC and PC + B groups, respectively. The median progression‐free survival was prolonged with PC + B compared to PC (median 8.2 vs. 5.1 months; P = 0.037). The objective response rate was improved with PC + B compared to PC (46.7% vs. 25.5%; P = 0.047) and overall survival prolonged with PC + B compared to PC (median 26.3 vs. 19.2 months; P = 0.012). Safety was similar to previous studies of bevacizumab in non‐small cell lung cancer: one patient experienced grade 3 hypertension and proteinuria but did not require the discontinuation of therapy. Conclusion The addition of bevacizumab to PC was superior to PC alone as second‐line therapy in patients with advanced non‐T90M EGFR‐positive lung adenocarcinoma. However, this result needs to be confirmed by prospective clinical trials.

This study aims to examine the effects of wellness education (WE) intervention on the behavioral change, psychological status, performance status on patients with stage IV non-small cell lung cancer (NSCLC) undergoing icotinib hydrochloride treatment and their relationships with family caregivers.We conducted an intervention study involving 126 individuals with confirmed activating epidermal growth factor receptor mutation-positive stage IV NSCLC who received icotinib hydrochloride as first-line therapy between January 2014 and January 2016; their caregivers were also included in the study. For a period of 12 weeks, participants were randomly assigned into WE and control groups. The patients and family members in the WE group were provided with WE information about treatment, diet, social needs, rehabilitation, physical/mental health education, communication strategies, and patient care advice at least 3 times per week during treatment. Qualitative feedback of the participants was recorded during the intervention. Food Composition Database, the Family Environment Scale, patients/caregivers quality-of-life (Functional Assessment of Cancer Therapy-Lung/Caregiver Quality of Life Index-Cancer Scale), and Hospital Anxiety and Depression Scale (HADS) were measured at baseline and for 12 weeks. Data were analyzed to compare the different outcomes.Of the 126 caregivers (64 WE and 62 control), 120 completed the study. We observed significant differences between the WE group and control group with respect to low daily calorie intake (31.0% vs 77.4%, p0.05), smoking cessationaaa and awareness of cancer (85.48% vs 100%, p0.05). The WE group showed high ratings on awareness of cancer risk and benefit, as well as confidence relating to the behaviors of healthful diet and self-motivation to conduct cancer test. Family caregivers had high ratings on 30-minute daily moderate physical activity (p0.05). After 12 weeks, WE intervention had improved scores on Functional Assessment of Cancer Therapy-Lung-EWB and Caregiver Quality of Life Index-Cancer Scale adaptation. In addition, the patients also showed improvements in HADS.WE interventions in patients with stage IV NSCLC undergoing icotinib hydrochloride treatment and their family resulted in strong intentions to engage in health-promoting behaviors related to physical activity, smoking cessationaaa, and nutrition at the treatment period. WE intervention is a viable way to improve quality of life and HADS.Findings from this study suggest that WE interventions in patients' family with stage IV NSCLC undergoing icotinib hydrochloride treatment are significant improvements in both HADS and quality of life. These data also indicate that lung cancer disparities are unlikely to be associated with differential willingness to receive care but that Chinese may perceive financial and insurance ebarriers to treatment.