Surrogate End Points for Median Overall Survival in Metastatic Colorectal Cancer: Literature-Based Analysis From 39 Randomized Controlled Trials of First-Line Chemotherapy

Tang, Patricia A.; Bentzen, Søren M.; Chen, Eric X.; Siu, Lillian L.

doi:10.1200/jco.2006.08.1935

Cited by 213 publications

(158 citation statements)

References 61 publications

Supporting

Mentioning

142

Contrasting

Unclassified

Order By: Relevance

“…This issue is even more complicated in international clinical trials when the clinical practice of secondline therapy varies as widely as is seen in advanced gastric cancer. The use of surrogate endpoints, including PFS or time to tumor progression, to evaluate the efficacy of firstline treatment has been extensively studied in trials of colorectal and breast cancers, and data from many metaanalyses indicate that PFS is a good endpoint to evaluate the efficacy of first-line chemotherapy [56][57][58]. Standardization of evaluation of tumor progression is needed to validate the usefulness of these surrogate endpoints in trials of systemic therapy for gastric cancer [59].…”

Section: Discussionmentioning

confidence: 99%

Geographic difference in safety and efficacy of systemic chemotherapy for advanced gastric or gastroesophageal carcinoma: a meta-analysis and meta-regression

et al. 2012

View full text Add to dashboard Cite

Background The standard of chemotherapy regimens for advanced or metastatic gastric cancer and the clinical outcome were heterogeneous in Asian versus non-Asian countries. This study aimed to explore predictors of safety and efficacy of chemotherapy for patients with advanced or metastatic gastric cancer. Methods Treatment group-based meta-analysis and metaregression were performed to analyze results of randomized trials published since 2005 for advanced or metastatic gastric cancer patients who received systemic chemotherapy as first-line treatment. Data were extracted and synthesized according to the Cochrane guidelines. Results Twenty-five trials (8 Asian, 17 Western or international) with 56 treatment groups were analyzed.Asian trials reported a lower percentage of gastroesophageal junctional carcinoma, higher percentage of diffusetype histology, and more frequent use of second-line chemotherapy. Meta-analysis revealed significant heterogeneity both in treatment safety (grade 3-4 neutropenia and diarrhea) and efficacy [6-month progression-free survival (PFS) and 1-year overall survival (OS)]. Meta-regression analyses indicate that Asian trials are associated with an 8.2% lower incidence of grade 3-4 neutropenia and 2.1% lower incidence of grade 3-4 diarrhea. A lower percentage of patients with gastroesophageal junction carcinoma and the use of combination regimens predicted better PFS. The use of second-line chemotherapy predicts better 1-year OS, which will increase by 10% for every 10% increase in patients who received second-line chemotherapy. Conclusion Geographic region (Asian vs. non-Asian) is an independent predictor of safety in systemic therapy for gastric cancer.C. Hsu and Y.-C. Shen contributed equally to this work.Electronic supplementary material The online version of this article

show abstract

Section: Discussionmentioning

confidence: 99%

Geographic difference in safety and efficacy of systemic chemotherapy for advanced gastric or gastroesophageal carcinoma: a meta-analysis and meta-regression

et al. 2012

View full text Add to dashboard Cite

show abstract

“…The primary efficacy endpoint was PFS. Because randomized studies with 5-fluorouracil-based chemotherapy have generally demonstrated that longer PFS is accompanied by longer OS, the demonstration of a clinically meaningful longer PFS time in the absence of data suggesting an adverse effect on OS in an adequate and well controlled study would likely have been sufficient to support accelerated approval [13,14].…”

Section: Discussionmentioning

confidence: 99%

FDA Review of a Panitumumab (Vectibix™) Clinical Trial for First-Line Treatment of Metastatic Colorectal Cancer

et al. 2009

View full text Add to dashboard Cite

On September 27, 2006, the U.S. Food and Drug Administration granted accelerated approval to panitumumab (Vectibix™; Amgen, Inc., Thousand Oaks, CA) for the treatment of patients with epidermal growth factor receptor-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Accelerated approval was based on demonstration of a beneficial effect on progression-free survival (PFS).The present submission summarizes a second clinical trial, to be included in the panitumumab package insert in June 2008, of chemotherapy and bevacizumab with and without panitumumab in the first-line treatment of patients with metastatic colorectal cancer. The study was closed when inferior PFS and greater toxicity were demonstrated at the time of the planned interim efficacy analysis.Patients receiving panitumumab in combination with bevacizumab and chemotherapy experienced a higher incidence of death (9% versus 4%) and a higher risk for grade 3 and 4 toxicities than patients receiving bevacizumab and chemotherapy alone. The incidences of any Common Terminology Criteria for Adverse Events grade 3 and 4 adverse events (AEs) were 87% and 72% in the panitumumab and control groups, respectively. Grade 3 and 4 AEs occurring more commonly in panitumumab-treated patients included rash/acneiform dermatitis, diarrhea, dehydration, primarily resulting from diarrhea, hypokalemia, stomatitis/mucositis, and pulmonary embolism.The addition of panitumumab to bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer was harmful when compared with bevacizumab and chemotherapy alone. The use of panitumumab in this setting cannot be recommended. The Oncologist 2009;14:284 -290

show abstract

“…In turn, this is likely to impact the choice of primary endpoints for first-line studies in a situation analogous to that seen already in colorectal cancer [69]. It is therefore probable that the use of time to disease progression endpoints as surrogate markers for the survival benefit conferred by new firstline gastric cancer regimens will become more common.…”

Section: Is Second-line Cytotoxic Treatment In Gastric Cancer Likely mentioning

confidence: 99%

Is There an Optimal Chemotherapy Regimen for the Treatment of Advanced Gastric Cancer That Will Provide a Platform for the Introduction of New Biological Agents?

Pozzo

Barone

2008

The Oncologist

View full text Add to dashboard Cite

Globally, gastric cancer is the second most common cause of cancer-related death. The majority of gastric cancer patients will have at presentation or will ultimately develop overt metastatic disease. Meta-analysis has demonstrated not only that systemic chemotherapy can improve survival in patients with advanced disease but also that the best survival results in earlier randomized studies have been achieved with three-drug regimens containing a fluoropyrimidine, an anthracycline, and cisplatin. Although there has been little progress historically in improving median overall survival times beyond the 9-month plateau achievable with the standard epirubicin–cisplatin–infusional 5-fluoropyrimidine (ECF) combination, the availability of newer cytotoxic anticancer agents has provided some measure of optimism that current outcomes can be improved. A number of new triplet and doublet combinations incorporating docetaxel, oxaliplatin, irinotecan, capecitabine, and S-1 have been explored in randomized trials. Although some combinations, such as epirubicin–oxaliplatin–capecitabine, have been shown to be as effective as (or perhaps more effective than) ECF, and although promising early data have been derived for S-1 in combination with cisplatin, a lack of studies in which direct comparisons have been made currently hinders the identification of the optimal regimen in this setting. One factor that might contribute to the lack of clear progress is the absence of consensus on the utility of second-line cytotoxic treatments. It can therefore be concluded that, although there is no first-line regimen that is clearly the most appropriate platform for the investigation of biological agents, there are a number of combinations that have been shown to be effective and therefore good candidates.

show abstract

Surrogate End Points for Median Overall Survival in Metastatic Colorectal Cancer: Literature-Based Analysis From 39 Randomized Controlled Trials of First-Line Chemotherapy

Cited by 213 publications

References 61 publications

Geographic difference in safety and efficacy of systemic chemotherapy for advanced gastric or gastroesophageal carcinoma: a meta-analysis and meta-regression

Geographic difference in safety and efficacy of systemic chemotherapy for advanced gastric or gastroesophageal carcinoma: a meta-analysis and meta-regression

FDA Review of a Panitumumab (Vectibix™) Clinical Trial for First-Line Treatment of Metastatic Colorectal Cancer

Is There an Optimal Chemotherapy Regimen for the Treatment of Advanced Gastric Cancer That Will Provide a Platform for the Introduction of New Biological Agents?

Contact Info

Product

Resources

About