Association of Haemoglobin Level with Morbidity and Mortality of Patients with Locally Advanced Oesophageal Carcinoma Undergoing Radiotherapy — A Secondary Analysis of Three Consecutive Clinical Phase III Trials

2006 ◽  
Vol 18 (8) ◽  
pp. 621-627 ◽  
Author(s):  
K.-L. Zhao ◽  
G. Liu ◽  
G.-L. Jiang ◽  
Y. Wang ◽  
L.-J. Zhong ◽  
...  
Keyword(s):  
Haemoglobin Level ◽  
Locally Advanced ◽  
Secondary Analysis ◽  
Oesophageal Carcinoma ◽  
Morbidity And Mortality ◽  
Phase Iii ◽  
Clinical Phase ◽  
Phase Iii Trials

Phase II Trial of 4′-Epi-Doxorubicin in Locally Advanced or Metastatic Gastric Cancer

1988 ◽  
Vol 74 (3) ◽  
pp. 313-315 ◽  
Author(s):  
Eduardo Cazap ◽  
Roberto Estevez ◽  
Mario Bruno ◽  
Daniel Levy ◽  
Carlos Algamiz ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Gastric Adenocarcinoma ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Phase Iii ◽  
Future Studies ◽  
Phase Iii Trials

Patients with locally advanced or metastatic gastric adenocarcinoma received an i.v. bolus of 4′-epi-doxorubicin, 75/mg/m2/cycle, every 21 days. Partial responses were observed in 5 of 23 evaluable patients (21.7%). Treatment was generally well tolerated and toxicity was mild. The response rate to epirubicin appears to be very similar to that reported for doxorubicin. Larger doses of epirubicin could be safely used in future studies, and further evaluation of epirubicin in phase III trials is indicated.

Phase Ib study of sintilimab in combination with chemotherapy for 1L advanced or metastatic non-small cell lung cancer (NSCLC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20546-e20546 ◽  
Author(s):  
Nong Xu ◽  
Kejing Ying ◽  
Ziping Wang ◽  
Yunpeng Liu ◽  
Haiping Jiang ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Primary Objective ◽  
Phase Iii ◽  
Egfr Mutations ◽  
Efficacy And Safety ◽  
Two Phase ◽  
Phase Ib ◽  
Biomarker Analysis ◽  
Phase Iii Trials ◽  
Treatment Naïve

e20546 Background: Anti-programmed death-1 antibodies (PD-1 Abs) have shown benefits in advanced NSCLC. The efficacy and safety of sintilimab, a PD-1 Ab, in combination with chemotherapy for 1L NSCLC is evaluated in this phase Ib study (NCT02937116). Methods: The study enrolled treatment-naïve unresectable locally advanced or metastatic non-squamous (nsq-) and squamous (sq-) NSCLC patients with neither EGFR mutations nor ALK rearrangements in cohort D and E respectively. Patients received sintilimab 200mg IV q3w in combination with pemetrexed 500mg/m2 and cisplatin 75mg/m2 IV q3w (4 cycles) in cohort D, or gemcitabine 1250mg/m2 D1,8 and cisplatin 75mg/m2 D1 IV q3W (6 cycles) in cohort E until disease progression, unacceptable toxicity or death. The primary objective was to evaluate the efficacy and safety of the combination. Results: As data cutoff (15 Jan 2019), 21 and 20 patients were enrolled in cohort D and E respectively. ORR in nsq- and sq-NSCLC were 68.4% (95%CI, 43.4 to 87.4) and 64.7% (95%CI, 38.3 to 85.8) respectively based on data of 19 and 17 patients with at least one radiological assessment. Median PFS was 11.4 months (95%CI, 3.1 to NA) and 6.5 months (95%CI, 5.3 to 8.0) respectively (Table). Totally 38 (92.7%) patients experienced at least one treatment emergent adverse event (TEAE). Treatment-related AEs (TRAEs) occurred in 28 (68.3%) patients. TRAE ≥grade 3 occurred in 4 (9.8%) patients. Immune related AEs occurred in 10 patients (24.4%), the most common of which were skin rash (N = 5), pneumonitis (N = 3) and hypothyroidism (N = 2). There was no AEs leading to death. The biomarker analysis was ongoing. Conclusions: The combination of sintilimab and chemotherapy showed efficacy with an acceptable safety profile in 1L nsq- and sq-NSCLC. Two phase III trials are ongoing to evaluate the combination in 1L nsq- (NCT03607539) and sq-NSCLC (NCT03629925) respectively. Clinical trial information: NCT02937116. [Table: see text]

Application of ASCO Value Framework to Treatment Advances in Hepatocellular Carcinoma

2021 ◽  
pp. OP.20.00558 ◽  
Author(s):  
Emerson Y. Chen ◽  
Madeline Cook ◽  
Christopher Deig ◽  
Asad Arastu ◽  
Vinay Prasad ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Secondary Analysis ◽  
Health Benefit ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Primary Analysis ◽  
Free Survival ◽  
Drug Registration ◽  
Phase Iii Trials

BACKGROUND: Determination of the comparative efficacy of one therapy over another for hepatocellular carcinoma (HCC) can be challenging. Application of a recognized value framework to published studies could objectively compare the potential benefit across available therapies. MATERIALS AND METHODS: An umbrella review of phase III trials for HCC therapies was performed. ASCO Value Framework Net Health Benefit Score version 2 (ASCO-NHB v2) scores, the primary analysis, and European Society of Medical Oncology Magnitude of Clinical Benefit Scale version 1.1 scores, the secondary analysis, were computed using selected drug registration trials. Both scores were compared between drugs that were Food and Drug Administration (FDA)-approved by 2020 and those that were not. RESULTS: Of the 22 studies identified, nine were FDA-approved and 13 were not. Across 22 trials, the median overall survival (OS) was 9.2 months (range, 1.9-16.4 months), with a median gain of 0.35 month (range, 2.3-3.3 months). HCC therapies that were FDA-approved showed longer OS (median 10.7 v 7.9 months, P < .01) and higher ASCO NHB scores (+18.4 v −5.7 scores, P < .01). The median gain in OS was 2.2 months in the approved treatments compared with −0.3 months in the unapproved group, with no difference in progression-free survival between the two groups. CONCLUSION: The nine FDA-approved therapies for HCC have higher mean NHB score than those that were not FDA-approved. The application of ASCO-NHB v2 and other proposed value frameworks could examine data of future therapies for HCC through a patient-oriented approach.

Controversies in the Treatment of Local and Locally Advanced Gastric and Esophageal Cancers

2015 ◽  
Vol 33 (16) ◽  
pp. 1754-1759 ◽  
Author(s):  
Deirdre J. Cohen ◽  
Lawrence Leichman
Keyword(s):  
Gastric Cancer ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Phase Iii ◽  
Postoperative Treatment ◽  
Treatment Regimens ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Adenocarcinomas ◽  
Operative Specimen ◽  
Phase Iii Trials

Despite overall progress in the therapy of local and locally advanced esophageal, gastroesophageal junction, and gastric adenocarcinomas, death as a result of these tumors remains a common outcome. Most randomized phase III trials on which level-one evidence has been built have included the heterogeneous histologies and locations associated with these tumors. However, the different etiologies, molecular biology, and recurrence patterns associated with gastroesophageal malignancies suggest the need to split rather than lump. Biologic and response differences exist between squamous and adenocarcinomas, as well as diffuse and intestinal histologies. This may be a cause behind conflicting outcomes in similar trials. The accepted standard of chemoradiotherapy for locally advanced esophageal and gastroesophageal junction cancers is based on a few positive trials, with the best chemotherapy and total dose of radiation remaining controversial. In the West, the staging evaluations of locally advanced gastric cancer are not uniform. Yet, these evaluations will inform the results of preoperative and perioperative treatments. Although postoperative chemoradiotherapy for gastric cancer has been an accepted treatment option for the last decade, more recent studies have called into question the need for radiotherapy. In perioperative strategies, it has yet to be determined whether histologic or molecular changes in the operative specimen should inform postoperative treatment. An appropriate place for targeted therapy needs to be found in preoperative and postoperative treatment regimens. Finally, because so much is lost when trials are forced to close for lack of accrual, it is imperative to build multidisciplinary consensus before they are launched.

The treatment of glioblastomas: A systematic update on clinical Phase III trials

2013 ◽  
Vol 87 (3) ◽  
pp. 265-282 ◽  
Author(s):  
An-an Yin ◽  
Jin-xiang Cheng ◽  
Xiang Zhang ◽  
Bo-lin Liu
Keyword(s):  
Phase Iii ◽  
Clinical Phase ◽  
Phase Iii Trials

Hormonal adjuvant treatment plus radiotherapy versus exclusive radiotherapy in locally advanced prostate cancer: Pooled analsys of 6 randomized trials

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4642-4642
Author(s):  
P. Carlini ◽  
E. Bria ◽  
M. Ciccarese ◽  
M. Milella ◽  
G. Arcangeli ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Recurrence Rate ◽  
Locally Advanced ◽  
Hormonal Treatment ◽  
Pooled Analysis ◽  
Phase Iii ◽  
Significant Heterogeneity ◽  
Adjuvant Hormonal Treatment ◽  
Phase Iii Trials

4642 Background: The magnitude of the benefit of adding adjuvant hormonal treatment to radiotherapy for locally advanced prostate cancer is still unclear. We performed a pooled-analysis of phase III trials, to quantify the eventual benefit in recurrence decrease. Methods: All prospective phase III trials were considered eligible. A pooled analysis was accomplished, and event-based relative risk ratios (RR) with 95% confidence interval (CI) were derived through both a fixed- (FEM) and a random-effect model (REM) approach. Significant differences in primary outcome (recurrence rate), and secondary outcomes (overall survival), were explored. Magnitude outcome measures were: absolute benefits and number of patients needed to treat (NNT) for 1 patient to benefit. Heterogeneity test was applied as well. Results: Six trials designed to look if hormonal treatment plus radiotherapy decreases recurrence rate (3,571 patients) were gathered. In the primary outcome, the combined approach significantly improves the recurrence rate when applying the FEM (RR 0.72, 95% CI 0.68, 0.77, p < 0.0001), with an absolute benefit of 10.7%. The NNT was 9 patients. Although significant heterogeneity was found (p = 0.00001), the benefit remains significant at the REM as well (RR 0.67, 95% CI 0.54, 0.82, p < 0.0001). Although significant at FEM (RR 0.93, 95% CI 0.86, 1.00, p = 0.039) but heterogeneous (p = 0.0007), the overall survival demonstrated a not-significant trend in favour of the combined strategy at REM (RR 0.90, 95% CI 0.75, 1.10, p = 0.263). Conclusions: Considered all the available phase III trials, the combination of adjuvant hormonal treatment with radiotherapy over standard exclusive radiotherapy significantly decreases the recurrence rate in patients affected by localized prostate cancer. The significant heterogeneity in the analysis underscores the existing difference in patient’ characteristics. No significant benefit in overall survival was found. No significant financial relationships to disclose.

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