tbuckley/cabot-search huggingface dataset:
Efficacy of compound pholcodine syrup and compound codeine phosphate oral solution on lung cancer cough.
Authors: Huiqing Yu, Mengting Chen, Junhui Zhang, Hong Yang
Journal: Journal of Clinical Oncology (2024)

e20548 Background: To assess the therapeutic effect of compound pholcodine syrup and compound codeine phosphate oral solution on lung cancer cough. Methods: A total of 60 patients with diagnosed middle-advanced stage lung cancer accompanied with lung cancer cough from Jan, 2022 to May, 2022 were enrolled . According to the method of random number table, the patients were divided into two groups: observation group and control group. Observation group received compound pholcodine syrup treatment, while control group received compound codeine phosphate oral solution treatment. The dosage of the two drugs was 15 ml each time, 3 times a day, and the treatment course was 5 days. The antitussive effectiveness, cough severity and quality of life , were observed and compared between the two groups before and after the 3 days and 5 days treatment, respectively. Results: All 60 patients completed the treatment. Both two groups were effective in controlling lung cancer cough. After the 3 days treatment, the antitussive effective rates of the observation group and the control group were 83.3% (25/30) and 73.3% (22/30), respectively, with no statistical significance ( P= 0.347). After the 5 days treatment, the antitussive effective rates of observation group and control group were 90.0% (27/30) and 86.6% (26/30), respectively, with no statistical significance ( P= 0.687). There was no significant difference in the composition of patient cough severity between observation group[moderate and severe cough, 56.7% (17/30) ] and control group [moderate and severe cough, 67.7% (20/30) ]. After 3 days treatment, cough symptoms were relieved in both groups. Patients with mild cough accounted for 73.3% (22/30) in the observation group and 56.7% (17/30) in the control group, the difference was not statistically significant ( P= 0.331). What's more, after 5 dyas treatment, there was also no significant difference( P= 0.067)between observation group[mild cough, 86.7%(26/30)] and control group [mild cough, 66.7%(20/30)] . In the meantime, there were no significant differences in the physiological score, psychological score, social score and total score of the Leicester Cough Questionnaire in Mandarin-Chinese scale before the treatment, after 3 days and 5 days treatment between the two groups (all P &gt; 0.05). Patients in the observation group had a lower incidence of xerostomia (0.0% vs 20.0 %, P= 0.024) and constipation (0.0% vs 20.0 %, P= 0.024) than control group. Conclusions: Compound pholcodine syrup and compound codeine phosphate oral solution are effective in treating lung cancer cough with similar antitussive effectiveness. Compound pholcodine syrup has a lower incidence of xerostomia and constipation than control group, which indicates that the security may be better. Clinical trial information: ChiCTR2300076684.
Advanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587).
Authors: Michael Thomas Serzan, Opeyemi Jegede, Robert S. Alter, Mehmet Asim Bilen, David A. Braun, David Johnson Einstein, Naomi B. Haas, Daniel Herchenhorn, Jennifer King, Karie Runcie, Jeffrey A. Sosman, Cora N. Sternberg, Yuanquan (Aaron) Yang, Sabina Signoretti, Toni K. CHOUEIRI, Michael B. Atkins
Journal: Journal of Clinical Oncology (2024)

TPS4614 Background: First-line treatment for patients with metastatic clear cell renal cell carcinoma (mccRCC) often includes an anti-PD1 inhibitor in combination with either an anti-CTLA inhibitor (IO/IO) or a VEGF receptor tyrosine kinase inhibitor (TKI) (IO/TKI). Although some patients treated with nivolumab/ipilimumab (Nivo/Ipi) (IO/IO) experience durable responses leading to treatment free intervals, over two-thirds experience disease progression. Resistance to Nivo (anti-PD1) monotherapy has been associated with increased presence of a subpopulation of Tregs in the tumor microenvironment. Botensilimab (Bot) is an IO agent that leverages novel FcyR-associated mechanisms of action to enhance T cell priming, deplete intratumoral Tregs and enhance myeloid activation. Combination botensilimab/balstilimab (Bot/Bal) (anti-CTLA/anti-PD1) has shown impressive anti-tumor activity in diseases where Nivo/Ipi has shown little to no efficacy. Methods: ARCITECT is a phase II, multicenter investigator initiated trial evaluating the efficacy and safety of Bot/Bal relative to Nivo/Ipi. Patients with mccRCC (favorable, intermediate, or poor risk), no prior systemic therapy (including adjuvant or neoadjuvant), and at least one measurable lesion as defined by RECIST 1.1 are eligible for enrollment. 120 patients will be randomized in a 2:1 fashion to Arm A (Bot/Bal induction followed by Bal maintenance) or Arm B (Nivo/Ipi induction followed by Nivo maintenance) each for a maximum of 2 years. Stratification factors include IMDC risk groups and sarcomatoid histology. The primary endpoint is overall response rate (ORR) per RECIST 1.1. We hypothesize that Bot/Bal will lead to a superior ORR (55%) relative to Nivo/Ipi (40%). This trial has &gt; 90% power to detect the alternative hypothesis while maintaining a one-sided significance level of not more than 0.10 using the exact binomial. The study will be monitored for early stopping in favor of the null hypothesis based on a Simon’s two stage design. In the first stage, 69 patients will be enrolled (Arm A:46 and Arm B:23). If at the end of the first stage, Arm A has either at least 18/42 (42.8%) of eligible patients responding or an ORR at least numerically equivalent to that for eligible patients in Arm B, then the trial will progress to the second stage. The primary endpoint will be met if there are 38/80 responders (ORR &gt; 47.5%) in Arm A. Key secondary endpoints include landmark progression-free survival, treatment-free survival and rates of immune-related adverse events. Correlative studies will explore immune and molecular predictors of response and resistance to IO/IO in tumor and blood. Clinical trial information: NCT05928806 .
Sintilimab and anlotinib combination therapy in PD-L1-positive recurrent/metastatic cervical carcinoma: A 3-year follow-up of ALTER-C201 study.
Authors: Qin Xu, Jing Liu, Lele Chang, Fei Zhu, Mingxuan Zhu, Huiqi Zhang
Journal: Journal of Clinical Oncology (2024)

e17526 Background: Sintilimab plus Anlotinib has been shown to be effective in advanced cervical cancer in the ALTER-C201 Study. Here, we report an updated, post-hoc analysis of overall survival from ALTER-C201 Study, after 3 years of follow-up. Methods: ALTER-C201 study was a multicenter, single-arm, prospective phase II trial. Patients with PD-L1–positive (Combined Positive Score ≥ 1) R/M CA who progressed after at least one prior systemic chemotherapeutic regimen or could not tolerate chemotherapy were eligible for the phase II trial. The patients received 200 mg sintilimab once on day 1 and 10 mg anlotinib once daily on days 1-14 every 3 weeks. The second endpoint was OS. The post-hoc analysis included Duration of Response (DoR), second progression-free survival (PFS2), as well as the efficacy of other treatments received by patients after disease progression. Results: Between December 2019 and December 2020, 42 patients were enrolled. We followed up for 38.0 (range, 0.6 - 44.0) months. The median overall survival was 17.59 months (95% CI, 12.831-36.163). Through multivariable analysis, it was found that PIK3CA (HR 3.430; 95%CI 1.040 - 11.310; P = 0.043) and KMT2C (HR 0.236; 95%CI 0.056 - 0.998; P = 0.049) are independent prognostic factors associated with overall survival (OS). In post-hoc analysis, the median DoR was 19 months (95%CI, 8.66 - not reach). Thirteen patients who experienced disease progression were subsequently treated with other anti-tumor therapies. Among them, nine received chemotherapy, three received radiotherapy, four received combination therapy with immune checkpoint inhibitors. The median PFS2 was 23.56 months (95%CI, 14.045 - not reach). The overall response rate (ORR) was 53.84%, with 2 patients (15.38%) achieving complete response (CR) and 5 patients (38.46%) achieving partial response (PR), Among the 4 patients who received immune checkpoint inhibitors, 3 of them achieved a partial response (PR). Conclusions: Sintilimab plus Anlotinib showed durable antitumor activity in patients with heavily pre-treated, PD-L1-positive advanced cervical cancer. PIK3CA and KMT2C may serve as potential prognostic biomarkers, but further studies are needed to validate their effectiveness. Patients who experience progression after treatment with the sintilimab plus anlotinib may still benefit from treatment with chemotherapy or combination therapy of other immune checkpoint inhibitors. Clinical trial information: ChiCTR1900023015.
The safety and short-term efficacy of selective internal radiation therapy combined with systemic treatment for unresectable malignant hepatic tumors in Chinese patients.
Authors: Hui Zhang, Mingxin Kong, BinBin Tan, MingHua Shao, Ying Fu, Ping Liu, Chao Fan, HaiLei Chen
Journal: Journal of Clinical Oncology (2024)

e16247 Background: There are many systemic treatment options for patients with unresectable malignant hepatic tumors. In China, selective internal radiation therapy (SIRT) with yttrium-90 (Y90) resin microspheres was approved until 2022. The aim of this retrospective study was to investigate the safety and short-term efficacy of SIRT with Y90 resin microspheres followed by systemic treatment in Chinese patients. Methods: The study analyzed patients who received SIRT with Y90 combined with systemic treatment at our center between June 2022 and October 2023. The study's primary endpoint was to determine the objective response rate (ORR), while safety was the secondary endpoint. Response was measured based on modified Response Evaluation Criteria in Solid Tumors criteria (mRECIST) up to 90 days after the initial therapy. Safety was evaluated using the Common Terminology Criteria for Adverse Events Version 5.0. Results: 21 patients wereincluded, of whom 22 times of SIRT were performed. 18 patients had HCC, and 3 had mCRC.The baseline characteristics of the patients are shown in Table. The median age was 54 years (IQR, 48-59 years) and 90.5% of patients were male. According to Eastern Cooperative Oncology Group performance status, grade 0 and grade 1 were 81% and 19%, respectively, whereas Child-Pugh A represented 90.5% of cases. The proportion of patients with hepatitis B virus infection was 95.2%. Thirteen (61.9%) patients received different treatments before SIRT. The median number of tumors was 2.5 (IQR, 1-4.3), whereas the median diameter of the largest lesion was 100.4 mm (IQR, 68.3-127.7 mm). PVTT was classified as follows: Vp1 (n = 3), Vp2 (n = 2), Vp3 (n = 2) and Vp4 (n = 1). Median AFP was 33.2 ng/mL (IQR, 5.9-401 ng/mL). The median total radiation activity administered was 1.4 GBq (IQR, 0.9-2.7 GBq) and the median target tissue dose was 205 Gy (IQR, 155-242 Gy). Nine (43%) patients were downstaged to surgery. Four (19%) patients had a complete response, fifteen (71.4%) had a partial response and two (9.5%) had a progressive disease. ORR and disease control rate were 90.5% and 90.5%, respectively. None of the patients experienced grade 3 and higher adverse events. The most common treatment-related adverse events were fever and abdominal pain, which required no special treatment. Conclusions: SIRT with Y90 resin microspheres combined with systemic treatment is safe and effective in patients with unresectable malignant hepatic tumors, which resulted in encouraging ORR (90.5%) and a downstaging rate (43%). Clinical trial information: ChiCTR2300077524. [Table: see text]
Neoadjuvant chemo-immunotherapy following concurrent immuno-chemoradiotherapy and immune-maintenance therapy as primary treatment for locally advanced cervical cancer: A prospective, single-arm, phase 2 trial.
Authors: Fo-Ping Chen, Kai Chen, Xiaodan Huang, Lin Huang, Hai-Ying Wu, Yi Ouyang, Weijun Ye
Journal: Journal of Clinical Oncology (2024)

5533 Background: Immunotherapy in combination with chemoradiotherapy has shown good efficacy in locally advanced cervical cancer (LACC). We report on the efficacy of neoadjuvant camrelizumab plus chemotherapy (TP) following concurrent immuno-chemoradiotherapy and maintenance immunotherapy for LACC. Methods: Eligible participants were adults with histologically confirmed squamous cell carcinoma, adenosquamous cell carcinoma, or adenocarcinoma of the cervix (FIGO 2018 stage IIB-IVA disease), ECOG PS score 0-2, and adequate bone marrow and organ function. All pts received 2 cycles neoadjuvant camrelizumab (200 mg d1 q3w) plus TP (albumin-bound Paclitaxel 260mg/m 2 d1 q3w; cisplatin 75 mg/m 2 d1-3 q3w) treatment, following 5-week external beam radiotherapy (EBRT) protocol (45-50 Gy/25 fractions with concurrent triweekly camrelizumab and cisplatin) to the whole pelvis plus brachytherapy every 3 weeks for 2 cycles, and then maintenance therapy of camrelizumab (200mg q3w, up to one year). The primary endpoint was progression-free survival (PFS) at 2 years. PFS was evaluated when at least 13 events were observed using a stratified log-rank test with an overall one-sided significance level of 0.05. Results: 67 pts provided informed consent and 12 were excluded for not meeting eligibility. 55 pts received the investigational agent and were evaluable for safety and efficacy analyses. The median age was 54 years [IQR 50 to 60]; 51 [92.7%] were squamous cell carcinoma, and 4 [7.3%] were adenocarcinoma; 9 [16.4%] were stage IIB, 2 [3.6%] were IIIA, 5 [9.1%] were IIIB, 30 [54.5%] were IIIC1r, 6 [10.9%] were IIIC2r, and 3 [5.5%] were IVA. As of data cutoff (Jan. 15, 2024), median follow-up was 9.5 (IQR 7.1 to 10.3) months. Of the 55 pts, 1 (1.8%) pt underwent hysterectomy after EBRT because of pelvic empyema, and was excluded from response evaluation. At three months after brachytherapy, the overall remission rate was 100% (53 [98.1%] complete remission and 1 [1.9%] partial remission). We identified 3 (5.5%) pts with treatment failure (2 [3.6] distant metastasis, and 1 [(1.8%] para-aortic lymph node relapse) during follow-up; 1-year PFS was 90.6% (85.4%-95.8%). The most common clinically significant grade 3-4 adverse events (AEs) were decreased neutrophils (18.2%), thrombocytopenia (9.1%) and anemia (27.3%). Serious AEs occurred in 7 (12.7%), most commonly due to infectious complications. There were no treatment-related deaths. Conclusions: The interim data support Camrelizumab plus TP neoadjuvant chemo-immunotherapy following immuno-chemoradiotherapy and Camrelizumab maintenance therapy as an active go-forward regimen in LACC. No new safety signals were observed, and most AEs were mild to moderate. Clinical trial information: ChiCTR2200061097.
Neoadjuvant tislelizumab combined with lenvatinib plus transcatheter arterial chemoembolization in resectable hepatocellular carcinoma with high-risk of recurrence: A prospective, single-arm, phase II trial.
Authors: Zhiyu Chen, Leida Zhang, Hui Zhang, Yi Gong, Kai Feng, Kuansheng Ma, Huaqiang Bi, Feng Xia, Haisu Dai
Journal: Journal of Clinical Oncology (2024)

e16242 Background: Currently, more than 55% of liver cancer patients have recurrence within 1 years after radical surgery. However,there is no standard treatment of neoadjuvant therapy for resectable HCC patients. This study aimed to explore the efficacy and safety of the triple therapy [Tislelizumab combined with lenvatinib plus transcatheter arterial chemoembolization (TACE)] as neoadjuvant therapy in patients with resectable HCC with high-risk of recurrence. Methods: This prospective, single-arm, phase II trial (ChiCTR2200059574) enrolled patients with primary resectable HCC who had not received prior anti-tumor therapy. The recurrence rate was predicted to be &gt; 50% according to the risk predictor ( http://www.asapcalculate.top/Cal2_ch.html ) of early recurrence before surgery. TACE will be performed once on Day 1. Tislelizumab (an anti-PD-1 antibody, 200 mg) intravenously once every 3 weeks and lenvatinib (body weight ≥ 60 kg, 12 mg;&lt; 60 kg, 8 mg) orally daily was initiated 3 days after TACE treatment. Surgery was performed after two cycles of neoadjuvant treatment. After 4-6 weeks of surgery, patients continued to receive tislelizumab and lenvatinib for 6 months to 1 year. Primary endpoint was adverse events (AE) and major pathological reactions. Secondary endpoints were objective response rate (ORR) by mRECIST, relapse-free survival (RFS) and overall survival (OS). Results: From April 2022 to August 2023, 19 patients (median age, 55 years) were enrolled, all Child-Pugh A and ECOG PS 0, mostly males (89.5%) and HBV infection (94.7%). According to mRECIST, the ORR was 94.7% (18/19, CR 2, PR 16), and the DCR was 94.7% too (18/19, CR 2, PR 16, SD 0). In 19 patients, 14 patients had received surgical treatment (R0 resection rates were 100%), 12 patients (12/14, 85.7%) achieved major pathological reaction (necrosis≥90%), and 2 patients (2/14, 14.3%) achieved complete pathological response. For those patients who did not undergo surgery, 3 of them refused surgery, and 2 patients lost the chance of surgery because of disease progression and high ICG R-15, respectively. At the end of the last follow-up (January 20, 2024), tumor recurrence was detected in 2 patients after surgery. The 12-month RFS rate and OS rate were 80.2%(95% CI: 40.4%-94.8%)and 94.7%(95% CI: 68.1%-99.2%), respectively. Median RFS and OS were not reached. No grade 3 or above AE were observed. Conclusions: Tislelizumab, lenvatinib, and TACE were safe and showed promising efficacy as a neoadjuvant therapy for resectable HCC with high risk of recurrence. Clinical trial information: ChiCTR2200059574.
Hepatic artery infusion of FOLFOX chemotherapy and camrelizumab combined with sorafenib for advanced stage hepatocellular carcinoma (Double-IA-001): A phase II trial.
Authors: Gulijiayina Nuerhashi, Lujun Shen, Weijun Fan
Journal: Journal of Clinical Oncology (2024)

e16199 Background: Hepatic arterial infusion chemotherapy (HAIC) using a combination of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) has shown excellent local control for hepatocellular carcinoma (HCC) patients classified under Barcelona Clinic Liver Cancer (BCLC) stage C. In China, both camrelizumab (a PD-1 inhibitor) and sorafenib were approved first-line approach for advanced stage HCC. This study (ChiCTR2100041874) aimed to the efficacy of combined hepatic artery infusion of FOLFOX chemotherapy and camrelizumab, together with sorafenib in BCLC stage C. Methods: Eligible patients were given a maximum of six cycles of hepatic artery infusion of HAIC-FOLFOX and camrelizumab, along with sorafenib, until either disease progression, intolerable toxicities emerged or disease downstaged and converted to received surgical resection. The primary outcome measured was the objective response rate (ORR) based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST). Results: Twenty-five patients were enrolled. Based on mRECIST criteria, by the end of Feb 4, 2024, the confirmed ORR stood at 44.0%, with a disease control rate of 60.0%. The median progression-free survival was 3.33 months. Patient quality of life had a transient deterioration within four cycles of treatment, and generally recovered thereafter. A total of 28.0% of patients had grade ≥3 or above treatment-related adverse events, which could be alleviated after symptomatic treatment. Conclusions: The combination of double intrahepatic infusion of FOLFOX and camrelizumab with sorafenib demonstrated encouraging results and manageable safety concerns for BCLC stage C HCC. Clinical trial information: ChiCTR2100041874.
A prospective cohort study on the improvement of disease-free progression survival in patients with hepatocellular carcinoma by combining <i>Sophora japonica</i> granules with targeted and immune checkpoint inhibitors.
Authors: Hui Li, Hongliang Zhang, Tong Zhang, Wenting He
Journal: Journal of Clinical Oncology (2024)

e16187 Background: To evaluate the clinical efficacy of combining Sophora japonica granules with targeted therapy and immune checkpoint inhibitors (ICIs) in patients with unresectable hepatocellular carcinoma (HCC) who had not undergone systemic treatment. Methods: A prospective cohort study design was adopted (ChiCTR2400079626), collecting HCC patients visited the Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region from July 1, 2019, to July 1, 2023. All patients received targeted therapy and ICIs treatment. "Whether Sophora japonica granules were combined during treatment" was considered as the exposure factor. Patients who met this exposure factor were included in the exposure group (n = 48), and those who did not meet this factor were included in the non-exposure group (n = 44). The disease-free survival (PFS), six-month PFS rate, and subgroup analysis between two groups. Results: The PFS of the exposure group was 8.9 months (m), and that of the non-exposure group was 5m(P = 0.001 HR = 0.50, 95%CI (0.32~0.78)). The six-month PFS rates were 66.7% compared to 34.1%(P = 0.001). Subgroup analysis showed that in subgroups with hepatitis, cirrhosis, vascular invasion, extrahepatic metastasis, tumor maximum diameter ≥5cm, combined TKI, the exposure group had significantly longer PFS than the non-exposure group (respectively: 9m VS 5m, 10m VS 4m, 13m VS 3m, 8.3m VS 4m, 9m VS 4m, 9m VS 5m),(P &lt; 0.05). In the subgroup with a history of alcohol consumption, the exposure group's PFS was extended by 9 m (14m VS 5m; P = 0.010); in the subgroup with baseline AFP ≥400ng/ml, PFS was extended by 6m (9m VS 3m; P = 0.017), and in the subgroup with baseline AFP &lt; 400ng/ml, PFS was also extended by 2.9m (8.9m VS 6m; P = 0.024), with all differences being statistically significant. Multivariate analysis showed that extrahepatic metastasis was an independent prognostic factor, with a disease progression risk 1.77 times higher than that of patients without extrahepatic metastasis [HR = 1.77, 95%CI (1.11~2.81), P = 0.016]. Combining Sophora japonica granules was a protective factor [HR = 0.53, 95%CI (0.33~0.84), P = 0.006], reducing the risk of disease progression in HCC patients treated with targeted therapy and ICIs by 47%. Conclusions: Combining Sophora japonica granules can extend the progression-free survival of HCC patients treated with targeted therapy and ICIs, increase the six-month PFS rate, and significantly reduce the risk of disease progression. The survival benefit was more pronounced in subgroups with vascular invasion and a history of alcohol consumption, with PFS exceeding one year. After combining Sophora japonica granules, the survival benefit improved more in the ICIs + TKI subgroup compared to the ICIs + bevacizumab subgroup. Clinical trial information: ChiCTR2400079626.