Is symptom improvement in patients with small cell lung cancer (SCLC) associated with clinical response? An analysis using the Patient Symptom Assessment Lung Cancer (PSALC) scale in a randomized trial comparing oral topotecan (OT) with best supportive care (BSC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7725-7725 ◽  
Author(s):  
M. E. O'Brien ◽  
M. Duh ◽  
L. Chen ◽  
L. Antras ◽  
M. Neary ◽  
...  

7725 Background: SCLC is a highly symptomatic disease with poor survival in prior treated patients. To evaluate the role of chemotherapy, a recent multicenter trial randomized 141 patients with prior treatment to receive either OT + BSC or BSC only. This was the first trial to use a BSC control group in SCLC while evaluating survival, response and symptoms. Survival data were reported (O'Brien et al JCO 2006; median survival of 25.9 weeks on OT + BSC vs 13.9 weeks on BSC, p = 0.01). 51% on OT had “disease control” (partial response [PR] + stable disease [SD]); no patient on BSC was reported to have a major response, although response was not an endpoint for this group. Trials have shown that those with progressive disease have the most symptom worsening, as occurred in this trial. The objective of this analysis is to determine if patients with PR report greater symptom relief than those with SD, in that SD can reflect a more indolent course in some patients while PR is due to treatment effect only. Methods: We used the investigators evaluation of response (PR or SD) and analyzed these groups by the patients’ scoring of their symptoms using the PSALC instrument which evaluates 9 SCLC symptoms, in the 71 patients on the OT + BSC arm. Results: Patients with lower ECOG PS at baseline reported more severe symptoms (higher PSALC score). Mean changes in PSALC score from baseline are shown in the Table and demonstrate an association between tumor response and decrease in symptoms. Conclusions: Patients who achieved a major response on OT treatment reported significantly better symptom control than those whose best response was SD. This indicates that in addition to a survival benefit, treatment with this chemotherapy can aid in symptom control. While the small number of patients limits the strength of the conclusions, this trial represents the largest BSC controlled study in SCLC. No significant financial relationships to disclose. [Table: see text]

2021 ◽  
Vol 20 ◽  
pp. 153473542199525
Author(s):  
Shih Ming Tsao ◽  
Tz Chin Wu ◽  
JiZhen Chen ◽  
Feichi Chang ◽  
Thomos Tsao

Objectives: The neutrophil-to-lymphocyte ratio (NLR) is a prognostic marker in patients with cancer receiving immunotherapy. Recent studies have shown that a high NLR was associated with a poor response and decreased survival. However, there is no intervention to reverse abnormally high NLR and improve clinical outcomes. Astragalus polysaccharide injection (PG2) is an immunomodulatory therapy for cancer-related fatigue. This study aimed to examine whether PG2 might normalize the NLR and affect the overall survival of patients with lung cancer treated with immunotherapy. Materials and Methods: We retrospectively examined the medical records of patients with lung cancer treated with immune checkpoint inhibitors (ICIs) between October 1, 2015 and November 30, 2019. All patients received ICI combination chemotherapies, and some similarly received PG2 (Control vs PG2). The NLR was assessed before treatment and 6 weeks after ICI initiation, and the survival data was collected at least 4 years after treatment initiation for the first enrolled patient. Results: Fifty-three patients were included. Six weeks after ICI initiation, 91.3% of the patients in the PG2 group exhibited a predefined “Decrease or no change” in the NLR, which was 28% higher than that in the Control group (63.3%) ( P = .028). The NLR significantly decreased by 31.60% from baseline in the PG2 group ( P = .012), whereas it increased by 5.80% in the Control group ( P = .572). Six weeks after ICI treatment initiation, both groups had a median NLR of 3.73, and the overall survival was also similar (PG2 vs Control, 26.1 months vs 25.4 months, respectively); however, the PG2 group had a higher median baseline NLR than the Control group (PG2 vs Control, 4.51 vs 2.81, respectively). Conclusion: This study demonstrated that PG2 could normalize the NLR in patients with lung cancer receiving ICI combination treatments.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16685-e16685
Author(s):  
Li Xu ◽  
Yuhao Tang ◽  
Hua Li ◽  
Jie Zhou ◽  
Zhongguo Zhou ◽  
...  

e16685 Background: Hepatocellular carcinoma (HCC) with microvascular invasion (MVI) is established with poorer outcome and more frequent postoperative recurrence. Sorafenib is the first target drug that successfully prolongs the survival of advanced HCC, but it failed to prolong the survival of HCC after radical resection or ablation in the STORM study. After that, series studies revealed that sorafenib could improve the survival of HCC with MVI after surgery, while most studies with positive results were retrospective ones. Methods: A multicenter, prospective non-randomized, open-label study was performed in pts undergoing radical resection, postoperative pathology confirming HCC with MVI (BCLC A or B stage; T2 or part T3aN0M0). Pts in the treatment group (S group) started sorafenib within 4-6 postoperative weeks at the dose of 400mg per day at most 2 years, and the control group (C group) never received sorafenib. The primary endpoint is recurrence-free survival (RFS) rate at the 2nd postoperative year, and the secondary endpoints include postoperative median time to recurrence (TTR), 1-year postoperative RFS, pts’ overall survival (OS), and safety. This study was approved by Ethical Committee of Sun Yat-sen University Cancer Center, and registered at ClinicalTrials.gov with number NCT02867280. Results: Between 1 June 2015 and 31 August 2019, 154 eligible pts from 3 academic hospitals in China were enrolled (83 in C group and 53 in S group). Baseline demographics were balanced between the two groups. The 2-yr RFS rate was 56.1% in the S group vs. 55.7% in the C group, respectively ( P = 0.955), and the median RFS was 15.5 vs. 16.0 months ( P = 0.827).The recurrence rates at the 1st postoperative year were 38.6% vs. 34.0% ( P = 0.568), and the median TTR was the same as the RFS. There were 31 pts (54.4%) of the S group experienced treatment-related adverse events (AEs). The most common AE was hand-foot syndrome (HFS, 19/57, 10 pts ≥ grade-2). Other AEs included diarrhoea (15/57, 26.4%), alopecia (11/57, 19.3%), hypertension (5/57, 8.8%) and decreased platelet (3/57, 5.3%), and gastric ulcer with bleeding (1/57, 1.8%). Sorafenib was interrupted or discontinued in 7 pts due to AEs. Recruiting of this study was closed according to the results of the planned mid-term analysis, and all pts were followed on schedule to observe the other survival data. Conclusions: Postoperative sorafenib treatment with dose of 400mg once daily was well tolerated, but did not improve the RFS and TTR of Chinese HCC pts with MVI. Clinical trial information: NCT02867280 .


2020 ◽  
Vol 36 (7) ◽  
Author(s):  
Shaohui Zhang ◽  
Yuan-da Zhang ◽  
Qing-wei Dong ◽  
Fang Gu

Objective: To compare curative effect and safety of omeprazole under different treatment courses in treatment of children with peptic ulcer (PU, diameter ≤1.0cm) and helicobacter pylori (HP) infection and its influence on inflammatory cytokines. Methods: The study was a randomized controlled study and conducted at Baoding children’s hospital from June 2015 to June 2018. In this study 100 PU children with positive HP were chosen and classified into two groups at random. The 58 cases in the observation group were given omeprazole + amoxicillin + clarithromycin, and the antibiotics were not used two weeks later. Then, omeprazole was used to treat for two weeks. 42 cases in the control group were given omeprazole + amoxicillin + clarithromycin for two weeks. Curative effect, HP eradication rate, clinical symptoms, incidence of adverse reactions, level of serum inflammatory cytokine interleukin-6 (IL-6) and level of tumor necrosis factor-a (TNF-a) in two groups were compared. Results: Total effective rate, HP eradication rate and clinical symptom relief of observation group were better than those of control group, and the differences showed statistical significance (P<0.05). The differences of two groups in the incidence of adverse reactions had no statistical significance (P<0.05). Serum IL-6 level and TNF-a level of observation group were significantly lower than those of control group and before the treatment, and the differences had statistical significance (P<0.05). Conclusion: The application of omeprazole in treatment of PU patients with positive HP for four weeks can significantly improve PU cure rate and HP eradication rate, relieve clinical symptoms and reduce inflammatory response, so it deserves to be promoted clinically. doi: https://doi.org/10.12669/pjms.36.7.3048 How to cite this:Zhang S, Zhang Y, Dong Q, Gu F. Curative effect of Omeprazole under different treatment courses in treatment of children with PU and HP infection and its influence on inflammatory factors. Pak J Med Sci. 2020;36(7):---------. doi: https://doi.org/10.12669/pjms.36.7.3048 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Yan Zhao ◽  
Mudan Ren ◽  
Xin Wang ◽  
Guifang Lu ◽  
Xinlan Lu ◽  
...  

Poor adherence to treatment instructions may play an important role in the failure of Helicobacter pylori eradication. The aim of this study was to evaluate the effects of telephone-based reeducation on 14-day quadruple H. pylori eradication therapy. In total, 162 patients were randomly assigned (1 : 1) to either the intervention group (patients received telephone-based reeducation on the 4th, 7th, and 10th days of the course) or the control group (patients received instructions only at the time of getting the prescriptions). All patients received a 14-day quadruple H. pylori eradication therapy. The primary outcome was the H. pylori eradication rate. The secondary outcomes included the symptom relief rates and the incidence rates of adverse events. Seventy-five patients in the reeducation group and 74 patients in the control group completed the follow-up. The H. pylori eradication rate in the reeducation group was statistically higher than that in the control group (intention-to-treat: 72.8% vs. 50.6%, P=0.006; per-protocol: 78.7% vs. 55.4%, P=0.003). However, the symptom relief rates and the adverse event rates in these two groups were not significantly different. Overall, the results from this study suggest that telephone-based reeducation can be potentially applied to improve the H. pylori eradication rate in clinical practice, without significantly increasing the adverse effects.


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Mi Li ◽  
Lijuan Zhao ◽  
Li Ma ◽  
Wen Zhang ◽  
Hua Huang ◽  
...  

Background. Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial. Methods. We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed. Results. Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( P < 0.05 ). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( P < 0.05 ). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups. Conclusion. Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19548-19548
Author(s):  
T. J. Miner ◽  
J. Gaydos-Gabriel ◽  
W. Kim ◽  
W. Mayo-Smith ◽  
D. Dupuy

19548 Background: To effectively and appropriately manage the debilitating symptoms of advanced cancer, physicians must balance the potential promise of palliative interventions against requirements to avoid toxic or futile therapy. Ablative technologies are increasingly used for the local destruction of tumors. This study examines the outcomes of ablative procedures performed with palliative intent. Methods: Minimally invasive ablative procedures (microwave and radiofrequency) to explicitly palliate symptoms of advanced cancer were identified from all procedures performed. Patients were observed for >90 days or until death. Results: There were 175 palliative ablative procedures performed in 129 patients from 1999 to 2004. Ablations were performed most commonly for pain (90%) caused by metastatic (90%), locally advanced (5%), and locally recurrent (5%) disease. Primary malignancies treated were lung (31%), colorectal (14%), renal (11%), breast (9%), sarcoma (9%) and other (26%). Symptom improvement or resolution within 30 days was achieved in 69% (89/129). Median duration of symptom control was 315 days. Recurrence of the primary symptom occurred in 46% (59/129) while treatment of additional symptoms was needed in 22% (29/129). Palliative ablative procedures were associated with postoperative morbidity (25%) and mortality (7%). A postoperative complication reduced the probability of symptom improvement to 25% (p<0.001). Effective symptom relief was associated with improved overall survival (median 408 days vs. 161 days, p<0.001). Conclusions: In carefully selected patients, relief of symptoms following palliative ablative procedures can be expected, but new or recurrent symptoms limit durability. As observed in other palliative procedures, potential benefits are minimized by postoperative complications. Optimal management for these patients with advanced cancer, who are often not suitable candidates for operation, requires the highest level of multidisciplinary care. No significant financial relationships to disclose.


BMJ ◽  
2020 ◽  
pp. m4284 ◽  
Author(s):  
Hartmuth Nowak ◽  
Nina Zech ◽  
Sven Asmussen ◽  
Tim Rahmel ◽  
Michael Tryba ◽  
...  

Abstract Objective To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use. Design Blinded randomised controlled study. Setting Five tertiary care hospitals in Germany. Participants 385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group. Intervention The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape. Main outcome measures The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain). Results Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen’s d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported. Conclusions Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery. Trial registration German Clinical Trial Register DRKS00013800.


2020 ◽  
Vol 38 (6) ◽  
pp. 1862-1871
Author(s):  
Yuxiao Wang ◽  
Xuemei Li ◽  
Liang Zhang ◽  
Mengxia Li ◽  
Nan Dai ◽  
...  

Summary Background Overexpression of apurinic/apyrimidinic endonuclease 1 (APE1) is an important cause of poor chemotherapeutic efficacy in advanced non-small cell lung cancer (NSCLC) patients. Gossypol, a new inhibitor of APE1, in combination with docetaxel and cisplatin is believed to improve the efficacy of chemotherapy for advanced NSCLC with high APE1 expression. Methods Sixty-two patients were randomly assigned to two groups. Thirty-one patients in the experimental group received 75 mg/m2 docetaxel and 75 mg/m2 cisplatin on day 1 with gossypol administered at 20 mg once daily on days 1 to 14 every 21 days. The control group received placebo with the same docetaxel and cisplatin regimen. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), response rate, and toxicity. Results There were no significant differences in PFS and OS between the experimental group and the control group. The median PFS (mPFS) in the experimental and control groups was 7.43 and 4.9 months, respectively (HR = 0.54; p = 0.06), and the median OS (mOS) was 18.37 and 14.7 months, respectively (HR = 0.68; p = 0.27). No significant differences in response rate and serious adverse events were found between the groups. Conclusion The experimental group had a better mPFS and mOS than did the control group, though no significant difference was observed. Because the regimen of gossypol combined with docetaxel and cisplatin was well tolerated, future studies with larger sample sizes should be performed.


2006 ◽  
Vol 24 (24) ◽  
pp. 3831-3837 ◽  
Author(s):  
Andrea Bezjak ◽  
Dongsheng Tu ◽  
Lesley Seymour ◽  
Gary Clark ◽  
Aleksandra Trajkovic ◽  
...  

Purpose This report describes the quality of life (QOL) findings of a randomized placebo controlled study of erlotinib, an epidermal growth factor receptor inhibitor, in patients with non–small-cell lung cancer (NSCLC). Patients and Methods This double-blind phase III trial randomly assigned 731 patients with NSCLC who had progressed after prior chemotherapy to erlotinib 150 mg daily or placebo, with survival as the primary study outcome. QOL was assessed by European Organisation for Research and Treatment of Cancer QLQ-C30 and the lung cancer module QLQ-LC13. The primary end points for QOL analysis were time to deterioration of three common lung cancer symptoms: cough, dyspnea, and pain. Results Survival was significantly longer (hazard ratio, 0.70; P < .0001) in the erlotinib arm. Compliance with QOL was 87% at baseline and more than 70% during treatment. Patients receiving erlotinib had significantly longer median time to deterioration for all three symptoms (4.9 v 3.7 months for cough [P = .04]; 4.7 v 2.9 months for dyspnea [P = .04], and 2.8 v 1.9 months for pain [P = .03]). QOL response analyses showed that 44%, 34%, and 42% of patients receiving erlotinib had improvement in these three symptoms, respectively. This was accompanied by a significant improvement in the physical function (31% erlotinib v 19% placebo, P = .01), and global QOL (35% v 26%, P < .0001). Patients with complete or partial response were more likely to have improvement in the QOL response than patients with stable or progressive disease (P < .01). Conclusion Erlotinib not only improves survival in previously treated patients with NSCLC, but also improves tumor-related symptoms and important aspects of QOL.


Author(s):  
Xiaolin Yuan ◽  
Wanrong Yi ◽  
Baoyi Liu ◽  
Simiao Tian ◽  
Fang Cao ◽  
...  

AbstractBackgroundAs increasing cases of COVID-19 around world, urgent need for effective COVID-19-specific therapeutic drugs is necessary; therefore, we conducted a pilot randomized-controlled study to evaluate the efficacy of 99mTc-MDP for COVID-19 therapeutic treatment.MethodsA total of 21 mild patients with COVID-19 were enrolled in this pilot RCT from February 2020 through March 2020, and then were assigned, in a 1:1 ratio, into control (11 patients) and 99mTc-MDP group (10 patients). Patients in the control group received routine treatment and patients assigned to the 99mTc-MDP group received a combination of routine treatment and an administration of 99mTc-MDP injection of 5ml/day. Both of the patients in the control and 99mTc-MDP groups were treated for 7 days with the primary end point of CT-based radiological pulmonary changes during 7-day follow-up.FindingsFrom baseline to the day 7, 8 (80%) of 10 mild patients in the 99mTc-MDP group had a significant radiological improvement in lung and a decline in inflammatory infiltration, whereas only 1 (9.1%) of 11 patients in the control group had a radiological improvement in lung. None of the patients in the 99mTc-MDP group had disease progression from mild to severe, as well as an inflammatory cytokine storm, and 2 mild patients (18.2%) in the control group developed severe. During days 7 through 14, the number of patients with radiological improvement in the 99mTc-MDP group remained consistent, and only 1 additional case (22%) in the control group were reported.ConclusionIn this randomized pilot study, 99mTc-MDP had an effective inhibitory effect on the inflammatory disease progression for the therapy of COVID-19, and it can accelerate the absorption of pulmonary inflammation in a short period of time during the process of treatment.


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